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Science Policy Around the Web – June 10, 2017

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By: Allison Dennis, BS

Source: pixabay

Animal Testing

Lack of Clarity Puts Chemical Safety and Animal Welfare at Odds

In the lineup of American stereotypes, the health-nut who cares about the chemicals in his shampoo is often the same person who cares if that shampoo was tested on animals or not. However, a bill signed June 22, 2016, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, may be placing those two views at odds. The bill requires the U.S. Environmental Protection Agency (EPA) to implement a risk-based process to evaluate the safety of chemical substances currently being used in the marketplace and approve the use of new chemicals before their introduction. The bill was passed with bipartisan support and offered EPA the new-found power to fully regulate the use of well-known carcinogens like asbestos.

Yet the pathway forward for the EPA is daunting. More than 62,000 substances find their way into and onto our bodies through the products we use and our environment. While many of these substances have become associated with disease over time, how can the EPA certify the risks associated with different exposures to varying amounts of each substance on such an extensive list? The Act itself suggested that once the EPA has evaluated the existing information on the 62,000 substances currently in use, it spend the next twelve months triaging chemicals according to their potential risk. Next, the highest priority chemicals will be evaluated on a three-year deadline to develop knowledge of their toxicity and guidelines for their regulation. Ultimately, by clearly cataloging the risk of common chemicals the Frank R. Lautenberg Chemical Safety for the 21st Century Act promises to greatly reduce the amount of animal testing needed in the long-term.

In the meantime, however, the companies that use to-be-regulated substances in their products may be inclined to undertake independent toxicity testing, collecting enough data to guarantee that their favorite substances meet the low-risk criteria and avoid a drawn-out evaluation. Defining toxicity requires careful experimentation, which can sometimes be carried out in human cells outside of the body, but often require evaluation in animals. Animal rights groups like the Human Society find concern with the lack of transparency in the pre-prioritization process. They fear the eagerness of companies to provide data without any clear guidelines about how that data will be evaluated or what substances will require extensive evaluation could result in extensive and unnecessary animal testing. Further they suggested that the EPA require any new pre-approval data obtained by companies to be collected using non-animal methods. (Maggie Koerth-Baker, FiveThirtyEight)

CRISPR

Small Study may Reveal Big Concerns over CRISPR-Based Therapy

A one-page letter published in Nature Methods last week reports unexpectedly high levels of unintended changes to the genomes of mice that underwent a CRISPR-based therapy. Since it’s renaissance as a therapeutic tool in 2012, CRISPR has occupied the imaginations of scientists, doctors, patients, investors, and ethicists. CRISPR technology provides a relatively straight-forward and reproducible means to gene editing on the cellular level, but its applications to create heritable mutations in the human germ line is on hold until more is understood about the long-term effects such treatments would have.

The original study sought to explore potential long-term effects of germline manipulation by CRISPR in a mouse model. Guide RNA along with the Cas9 enzyme were injected into mouse zygotes, which introduced a correction in a mutation in the rd1 gene of otherwise blind mice. Initiating this change before the first cell division enabled this corrected mutation to be inherited by all cells arising in the developing mouse, consequently restoring the ability for the eyes to develop normally. In a follow-up experiment described in their one page letter, the researchers looked for mutations in the genomic DNA of two CRISPR-treated adult mice compared with a control mouse, revealing over 2,000 unintended mutations following CRISPR treatments. None of these mutations appeared to affect the mice, suggesting that deep genomic sequencing may be required to reveal unanticipated changes in an outwardly healthy mouse. Further, the nature of these unintended mutations offered few clues explaining how they might have occurred.

This result stands in contrast with other reports quantifying the extent of these unintended changes, which found CRISPR to be highly specific. While the CRISPR-Cas9 system has been observed to sometimes alter off-target regions of the genome, this activity can usually be curbed through the careful design and evaluation of the guide RNA. The limitations of this small study have been discussed extensively since its publication. However, the findings have sparked the need for further investigation into the long-term-whole-animal effects of germline-editing by CRISPR. As human germline-editing creeps closer to reality, the FDA will be tasked with developing an entirely new means of evaluating the safety of such technologies (Megan Molteni, Wired)

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Written by sciencepolicyforall

June 10, 2017 at 11:33 am

Science Policy Around the Web – May 31, 2016

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By: Emily Petrus, Ph.D.

Biomedical Research Salaries

Higher Salary for Postdocs Coming Soon

What do a Metrobus driver and a recent biomedical PhD graduate in have in common? Their salary! Although both positions are important to keeping society moving forward, figuratively or literally speaking, one can imagine the disparity between the educational time commitment between these two positions.

New rules set forth by the US Department of Labor dictate that employees with annual salaries falling below $47,476 must be paid overtime for hours they work beyond 40 hours per week.  Research scientists who have recently (typically within 5 years) received a PhD in biomedical sciences will undergo additional training before the next step in their career, similar to residency among medical school graduates.  These highly skilled postdoctoral researchers are called postdocs, and they fall below this threshold, with an average starting salary of $45,000.

This gives research organizations such as academic universities and the National Institutes of Health two options: track the hours their postdocs log at the bench and pay them overtime, or raise the base salary above the threshold.  Because scientific research rarely falls neatly into a 9-5 time table, NIH director Francis Collins is leading the NIH to increase postdoc pay to avoid logging hours for overtime pay.  Most academic research labs follow NIH guidelines for postdoc salary, so the NIH’s commitment to increase their pay should spill over into most other areas of biomedical research.  In a recent article penned by Collins and Thomas Perez, the U.S. Secretary of Labor, they called on the nation to “embrace the fact that increasing the salary threshold for postdocs represents an opportunity to encourage more of our brightest young minds to consider choosing careers in science.”

Although these salary increases will increase the pressure on labs already struggling with tight funding, it may serve as an incentive for future generations to choose biomedical research careers over driving a Metrobus. (Beryl Lieff Benderly, Science Articles)

Chemical Safety

United States poised to approve major chemical safety overhaul

Did you know that companies can use new chemicals in their products without demonstrating their safety for consumers or the environment? How about that the Environmental Protection Agency (EPA) cannot ask them to remove it until they demonstrate toxicity, which requires a costly amount of research and legislative action? If this sounds backwards to you, take heart: the House of Representatives has approved a long overdue overhaul of the Toxic Substances Control Act (TSCA).  This measure is expected to be approved by the Senate and President Obama with the next few months.

The TSCA was originally passed in 1976, and contains wording difficult for environmentalists, consumers, and even industry to follow. The original act required the EPA to consider regulatory costs during safety review, effectively reducing the importance of science-based research into chemical safety for consumers and the environment while favoring regulatory cost saving measures. It also made toxicity testing difficult by the EPA by requiring the minimal (“least burdensome”) amount of testing instead of full-fledged studies. The new TSCA will enable the EPA to order companies to prove chemicals are safe for consumers and/or the environment before introducing them to the marketplace, to hopefully avoid another issue such as the widespread use of asbestos in construction until the 1970’s.

Other components of the revised TSCA include an emphasis on reducing numbers of animals used in toxicity studies by replacing them with other testing methods when possible. The act also aims to identify and increase studies on “cancer clusters,” areas of the country which have higher incidences of cancer which may be due to environmental effects.

The revision of the TSCA is arguably the biggest environmental legislative success since the Clean Air Act amendment of the 1990’s. By containing clearer language, it makes the act “a careful compromise that’s good for consumers, good for jobs, and good for the environment” – said John Shimkus (R-IL). (Puneet Kollipara, ScienceInsider)

Mental Health

Children in Poverty at Risk for Increased Incidence of Mental Health Issues

Is it the chicken or the egg?  When it comes to mental health and poverty, it can be difficult to determine causation versus correlation: are mentally unstable people unable to provide for themselves, or is the stress of poverty causing mental health issues?  A recent study in children has determined a third genetic component to the puzzle, related to how the structure of DNA differs between poor and healthy children.

Although it has long been known that children from families below the poverty line have increased incidences of mental and physical ailments such as depression and diabetes, many have pointed to environmental factors such as relatives smoking or poor nutrition as the main culprits. New evidence suggests exposure to stress in utero and during childhood changes the very DNA of these children. Serotonin is a neurotransmitter important for maintaining “happy” brain chemistry and is often targeted for treating depression. New researchers found that the DNA for a serotonin transporter protein is altered in poor children, which may decrease the amount of serotonin allowed to get into brain cells. This was also correlated with higher levels of stress, indicating that growing up in poverty can change fundamental biological components and create lifetime mental health issues for these children.

Growing up in poverty is stressful for children; however there are ways to attenuate their suffering.  High quality, affordable, preschool and childcare is one way the government can step up to the plate.  “Headstart” is a program which enables children of families below the federal poverty line to enjoy a stimulating, warm environment and may reduce the burden of their families to choose between working and providing for their families or staying home to avoid daycare expenses. There are a multitude of issues creating stressful environments for poor families, but providing high quality child care and healthy meals for kids for part of the day is a small investment towards a big, epigenetic payoff in generations to come. (Sara Reardon, Nature News)

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Written by sciencepolicyforall

May 31, 2016 at 12:00 pm

Science Policy Around the Web – June 30, 2015

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By: Eric Cheng, Ph.D.

Photo credit link: Affordable Care Act via photopin (license)

Health policy

Affordable Care Act survives Supreme Court challenge

On June 25, 2015, the Supreme Court upheld a key provision of the Affordable Care Act that allows the federal government to provide subsidies to people in all 50 states, and not just the 16 states that administer their own online insurance exchanges. This ruling means that people in states without their own exchanges can still get federal subsidies for the purchase of health insurance allowing an estimated 6.4 million people to keep their health care coverage, according to the Kaiser Family Foundation. Without access to subsidies, millions of Americans would have been at risk of failing to meet the mandate that requires every American to buy health coverage. This ruling affirmed that the legislation that created the Affordable Care Act intended to improve the health care system and to provide support to all who needed help to buy health insurance.

Two of the court’s conservatives, Chief Justice John G. Roberts Jr. and Justice Anthony Kennedy, joined the court’s four liberal Justices in rejecting the lawsuit in a 6-3 vote to side with the Obama administration. “Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them,” Roberts wrote for the majority. While Justice Antonin Scalia, who wrote in dissent, called the majority’s reasoning “quite absurd” and “interpretive jiggery-pokery.”

President Obama made a statement on the recent ruling, saying the Affordable Care Act “is here to stay.” (Robert Barnes, Washington Post)

Federal research funding

Senate panel approves $2 billion raise for NIH in 2016

A Senate appropriations subcommittee voted to approve $32 billion in funding for the National Institutes of Health (NIH) for the 2016 fiscal year, representing an increase of $2 billion from 2015. This increase in funding could be the largest increase since 2003. Senator Roy Bunt (R-Mo.), chairman of the Senate Labor, Health and Human Services, and Education and Related Agencies Appropriations Subcommittee commented that “this year’s Labor-HHS appropriations bill prioritizes programs that will provide a significant benefit to all Americans and, most importantly, provides the National Institutes of Health with a $2 billion increase to make critical life-saving medical treatments and high-quality cures available to all Americans.”

The Senate panel approval will match the $200 million request by President Obama for the development of the Precision Medicine Initiative along with a $100 million increase for new funding to combat antibiotic resistance from the previous fiscal year. Other highlights include a $350 million increase for the National Institute on Aging, the lead Institute researching Alzheimer’s disease, and an additional $70 million for the BRAIN Initiative to map the human brain. These increases to every Institute and Center are intended help NIH to continue their development of new therapies, diagnostics, and preventative measures to enhance health, lengthen life, and reduce illness and disability. (Jocelyn Kaiser, ScienceInsider)

Environment and public health

House Advances Chemical Safety Reform Bill, Teeing Up Senate Vote

The U.S. House of Representatives passed legislation to overhaul the nearly 40 year old Toxic Substances Control Act (TSCA). This bipartisan bill aims to improve chemical safety. Some updates include the determination of risk by the Environmental Protection Agency (EPA) based on scientific evidence of its health impact instead of the cost of regulation. For new chemicals, the bill would shift the burden to industry to show that the substances they manufacture are not unreasonably risky. Other provisions in the bill would increase transparency by preventing industry efforts to keep safety data secret by declaring them confidential business information. This would allow EPA to more easily share chemical information with states, doctors, and first responders. These new reforms will help address an outdated law to protect human health and the environment from significant risks while also protecting commercial and competitive interests of the United States chemical industry and the national economy. (Kate Sheppard, Huffington Post; Puneet Kollipara, ScienceInsider)

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Written by sciencepolicyforall

June 30, 2015 at 9:00 am