Apr 20, 2017

NIOSH online network helps healthcare facilities address bloodborne pathogens and other hazards


Occupational Health Safety Network (OHSN)
NIOSH's Occupational Health Safety Network (OHSN) can help reduce worker injuries

The National Institute for Occupational Safety and Health has established a web-based injury and exposure monitoring system available at no cost to healthcare facilities. This secure system enables participating facilities to analyze worker injury and exposure data that they already collect. Trends for traumatic injury and hazardous exposures are visualized using a chart function. The system allows facilities to track five common work-related injuries and exposures in healthcare: sharps injuries; blood and body fluid exposure; slips, trips, and falls; patient handling injuries; and workplace violence. Visit the OHSN webpage for more information and to begin the enrollment process.

Workers' Memorial Day — April 28 — honors lives lost on the job


Workers' Memorial Day

Every year, more than 4,000 workers die on the job and nearly four million workers are injured or made sick at work. Workers' Memorial Day is held on April 28 to honor those workers and renew the commitment to protect the safety and health of all workers. Regional OSHA offices, worker organizations, and individuals affected by these tragedies will hold events to honor workers across the country. For a full list of events, and to find one near you, visit the Workers' Memorial Day webpage.

Apr 19, 2017

EPA is Seeking Feedback on Reducing Regulatory Burden

EPA is Soliciting Recommendations on Regulations that could be Repealed, Replaced or Modified to make them Less Burdensome

On February 24, 2017, President Donald Trump issued Executive Order 13777 on Enforcing the Regulatory Reform Agenda. The order establishes the policy of the United States to alleviate unnecessary regulatory burdens placed on the American people. Among other things, it requires each agency to create a Regulatory Reform Task Force to evaluate existing regulations and to identify regulations that could be repealed, replaced or modified to make them less burdensome.

As part of implementing the order, EPA is soliciting public comments and engaging in additional outreach to identify such regulations. We will be accepting comments through May 15, 2017 at docket EPA-HQ-OA-2017-0190. Go to https://www.epa.gov/laws-regulations/regulatory-reform to learn more about this effort.

In addition, EPA's Office of Land and Emergency Management (OLEM), will host a public meeting to obtain additional stakeholder feedback on Tuesday, May 9, 2017, from 9:00am to 5:00pm EDT in Arlington, Virginia.  The intent of the meeting is to provide an opportunity for interested parties to present recommendations specific to OLEM's regulations. Please see https://www.epa.gov/rcra/office-land-and-emergency-management-seeking-feedback-reducing-regulatory-burden on how you can submit comments and participate in or listen to the OLEM public meeting.  

For more information on OLEM programs, please see https://www.epa.gov/aboutepa/about-office-land-and-emergency-management.

Apr 14, 2017

How much recycled material actually goes to industry?

Most waste professionals know that the amount of material collected in recycling programs differs from the amount that is eventually used in making new products - because of contamination and processing losses. Unfortunately, there are very few comprehensive accounts of how much is actually lost.
 
A recent study<http://onlinelibrary.wiley.com/doi/10.1111/jiec.12506/full> in Yale's Journal of Industrial Ecology quantifies this gap with rigor. The authors, from the Swiss Federal Institute of Technology, examine Switzerland, a country with both a high waste generation rate and an extensive recycling system, quantifying these differences and finding not only gaps between collection and recycling rates, but also differences with official, published rates. The study also quantifies how much occurs as closed vs. open loop recycling, another calculation rarely done for municipal recycling programs.
 
This analysis also has interesting implications for circular economy and zero waste strategies, raising questions about the goals of recycling: (1) - is the central goal to divert waste from disposal or to displace primary (virgin) materials in production? And (2) is the primary goal of the circular economy improving resource utilization (from secondary sources, etc.) or the minimization of environmental impact?

CDC- Worker Recovery and Return to Work ​Resources

Via CDC: Work-related disability is associated with many negative health and social outcomes including reduced quality of life, job loss, reduced lifetime income, injuries among family caregivers, and premature death. For example, a recent NIOSH-funded study found that workers who suffer serious injuries requiring days away from work are more likely to die sooner than workers with injuries requiring only medical treatment.

Other studies have shown that the chances of returning to work drop dramatically the longer the worker remains away from work. While more serious diagnoses are associated with longer periods off work, minor diagnoses can also lead to disability if the recovery and return-to-work processes are not properly managed.

We are interested in learning from you about resources related to worker recovery and helping them return-to-work. To start the discussion, we have listed some resources below and we welcome your suggestions, as well as input on the following questions.

  • What evidence-based resources exist?
  • How can best practices be shared?
  • What specific research is needed?

 

Worker Recovery
​​
Resources:

Division of Federal Employees' Compensation (DFEC) POWER Initiative: The Protecting Our Workers and Ensuring Reemployment (POWER) Initiative collected and analyzed data on the causes and consequences of frequent or severe injury and illness among Federal employees, and identified effective safety and health management programs. This includes resources on achieving successful return-to-work of injured employees:

Washington State Department of Labor and Industries Centers of Occupational Health and Education (COHEs): These Washington State centers work with medical providers, employers, and injured workers in a community-based program. COHEs improve injured worker outcomes and reduce disability by training providers and coordinating cases.

Office of Disability Employment Policy (ODEP) Stay-at-Work / Return-to-Work: The Office of Disability Employment Policy (ODEP) is a non-regulatory federal agency that promotes policies and coordinates with employers and all levels of government to increase workplace success for people with disabilities. Since 2013, ODEP has utilized a Community of Practice and policy work groups led by subject matter experts to guide their SAW/RTW work. Through this collaboration, ODEP continues to explore effective practices to inform policy recommendations targeting federal and state agencies, as well as the private sector. For example, one policy working group is focused on adapting the Washington State WC COHE program.

International Association of Industrial Accident Boards and Commissions (IAIABC): IAIABC is a not-for-profit trade association representing government agencies charged with the administration of workers' compensation systems throughout the United States, Canada, and other nations and territories.

The American College of Occupational and Environmental Medicine (ACOEM): ACOEM represents more than 4,500 physicians and other health care professionals specializing in the field of occupational and environmental medicine.

  • ACOEM Coding Initiative Guidance Statement: ACOEM supports changing the rules for documentation of care in workers' compensation cases in order to provide reimbursement and other incentives for delivering care that adheres to best practices.

The Institute for Work & Health (IWH): The IWH is an independent, not-for-profit organization whose mission is to conduct and share research that protects and improves the health of working people.

  • Return-to-Work: The IWH conducts research on return-to-work as practiced by workplaces, workers' compensation boards, insurance companies and rehabilitation providers. Return-to-work includes disability management and prevention, vocational rehabilitation, and work rei
    ​​
    ntegration.
  • Clinical Treatment: The IWH conducts research on evidence-based practice for health care in treating back pain, neck pain, chronic pain, upper extremity disorders, and other soft-tissue injuries. This includes studies on health-care delivery and policy.
  • Compensation-Benefits (Canadian Provinces): The IWH has examined trends in workers' compensation claims and benefits, their adequacy and equity, and their effects on workers.
  • Measuring Health-Function: The IWH conducts research to measure worker health, function, and disability; predict the course and pattern of recovering from disability; and determine the prevalence of certain health conditions among workers.

​By: ​
​​
Steve Wurzelbacher, PhD, is the Director of the NIOSH Center for Workers' Compensation Studies (CWCS)

Apr 13, 2017

America’s Toxic Workplace Rules

NYtimes: By RACHEL CERNANSKY
Last month, President Trump's nomination of R. Alexander Acosta to be secretary of labor was approved by a Senate committee, even though the nominee's testimony had left unclear whether he would be more interested in protecting employers' prerogatives than in guarding workers' interests.

We may soon find out, and here's one test — an issue of worker health that President Barack Obama's Labor Department tried to resolve, without much success: Why does the department's Occupational Safety and Health Administration allow workers to be exposed to dangerous chemicals at limits far higher than those set for everyone by the Environmental Protection Agency?

Mr. Acosta should know that issue. He served on the National Labor Relations Board during George W. Bush's presidency. And OSHA was making slow progress toward equalizing some standards when Mr. Obama's presidency ended.

The issue of toxic hazards at work went national nearly 20 years ago, when former employees brought more than 200 lawsuits against IBM, accusing it of having concealed knowledge that it was exposing them to carcinogenic chemicals. Ultimately, IBM settled the suits, with the details sealed.

Continue reading the main story
Perhaps the most striking feature of those suits was that IBM seems to have not violated any OSHA regulations. The real problem was that OSHA's standards, across the board, allowed — and still allow — workers to be exposed to much higher concentrations of chemicals than are permitted in the general environment. For example, its standard for lead allows up to 50 micrograms per cubic meter of air, averaged over eight hours; the E.P.A. ambient air quality standard is 0.15 micrograms.

Standards for other chemicals are similarly unbalanced — so much so that David Michaels, an epidemiologist who headed OSHA under President Obama, told me in 2015 that because of the current law, the agency's chemical exposure standards were much too weak.

Today's limits "are driven more by economic and technological feasibility than they are by the risk assessments," he said. "Congress would have to change that."

OSHA has estimated that chemical exposure kills 50,000 American workers a year and sickens more than 190,000, but Dr. Michaels and other experts say these figures are gross underestimates.

One explanation for the disparity between OSHA and E.P.A. standards, offered by Amanda Hawes, a California lawyer, is that E.P.A. rules "are supposed to protect the most vulnerable in the population — typically children, fetuses, the elderly and folks with pre-existing health problems." Environmental standards, she added, "more often look at chronic effects."

Dr. Robert Harrison, an occupational medicine specialist at the University of California, San Francisco, explained that cancer and other chronic diseases are usually not recognized as occupational illnesses. Doctors often don't know when patients have been continually exposed to carcinogens like lead or formaldehyde.

The IBM case also illustrates how difficult it is in court to pinpoint chemical exposure as the cause of illness. To show that IBM knew it was risking workers' health, the plaintiffs obtained a company study of employee deaths. An epidemiologist said the data showed abnormally high rates of some cancers. IBM said the data's purpose was intended to determine survivor benefits. The judge refused to admit it. Two years later, an IBM-supported study found an elevated rate of mortality from brain cancer among former employees.

The American Chemistry Council, a trade association, says safety is a core concern of the industry. "In addition to strictly adhering to OSHA's worker health and safety standards," it said in an email, its members accept recommendations from other organizations. Nevertheless, Ms. Hawes says she has argued enough cases involving birth defects to understand that voluntary standards don't work.

Dr. Michaels adds that some OSHA standards are so weak they send a false message of safety. In an interview this winter, he said OSHA did eke out some progress last year after a public dialogue among industry, unions and advocates. The agency moved to revoke the most outdated workplace exposure limits in favor of general-duty standards. It also set new limits for beryllium and silica.

But those measures "don't deal with the bigger issue," Dr. Michaels said. "There are many, many chemicals that either have no permissible exposure limits, or that have out-of-date permissible exposure limits."

OSHA does encourage companies to comply with limits set by other organizations. And Congress took a first step in June by requiring the E.P.A. to regulate more chemicals and add vulnerable populations, including workers, to health risk assessments. Dr. Michaels said this is the first time "that workers will be treated like other populations."

Still, he added, "It's only going to be done on a chemical-by-chemical basis, and only for certain uses."

Apr 6, 2017

Occupational exposure to magnetic fields increases risk of ALS

Amyotrophic lateral sclerosis is a rare neurodegenerative disease of unknown origin that is currently untreatable. New research suggests that workplace exposure to magnetic fields may be responsible for the disease.

Written by Ana Sandoiu

Previous research has pointed to a variety of occupational exposures that may drive the illness. Some of these include extremely low-frequency magnetic fields (ELF-MFs), electrical shocks, metals, and toxic substances such as solvents and pesticides.

The correlations found in these studies, however, have been questioned due to methodological flaws in the analysis.

A new study aims to succeed where previous research has failed, examining the existing evidence and analyzing the effects of the above-mentioned occupational exposures on ALS mortality.

The research was carried out by scientists from Utrecht University, Maastricht University, and the University Medical Center Utrecht - all in the Netherlands - and the results were published in the journal Occupational & Environmental Medicine.

Studying the link between ALS mortality and occupational exposures

The researchers used the data available from the Netherlands Cohort Study - a large-scale, cohort study that examined diet and cancer risk in more than 58,000 men and 62,500 women.

Using job exposure matrices - a validated tool commonly used to assess occupational health hazards - the scientists estimated the occupational exposure to metals, electrical shocks, ELF-MFs, and to pesticides and solvents.

Men exposed to ELF-MFs more than twice as likely to develop ALS

Men who were occupationally exposed to high levels of ELF-MFs were 2.19 times more likely to develop ALS than those who had never been exposed to them. Additionally, those in the top tertile (or the top 30 percent) of cumulative exposure were almost twice as likely to develop ALS.

The study did not find a proportional link between ALS risk and the amount of exposure.

The authors conclude that their study "strengthens the evidence" and provides "further support for an association between occupational exposure to ELF-MF and an increased risk of ALS mortality."

Free Webcast on Toxic Release Inventory (TRI)- The deadline is July 1st! @jjkeller

The Toxic Release Inventory (TRI) deadline of July 1, 2017, is quickly approaching.  If you manufacture, process, or otherwise use EPCRA Section 313 chemicals, then this Federal requirement at 40 CFR 372 may be applicable to your facility. 

Join us for an upcoming webinar to learn the details of this annual reporting requirement, whether you are a new or seasoned filer, you won't want to miss the information that will be covered.

This free webcast - hosted by J. J. Keller & Associates, Inc. and U.S. Compliance Corporation - will help you gain a better understanding of:

• What is EPCRA 313 chemical and where do I find them?
• Reporting applicability and threshold determinations
• Common TRI reportable chemicals (including commonly missed ones)
• Overview of the TRI Form R and Form A
• Reporting exemptions
• Using the EPA Central Data Exchange (CDX)

This complimentary one-hour webcast will also include a question and answer session. 

Free Webcast!
Tuesday, April 11th, 2017 
10:00 AM Central Time
(11:00 ET, 9:00 MT, 8:00 PT)


EPA Hosts Webinar on Innovative State Water Agency Practices: Working Toward Resilience

State agencies are developing innovative practices to build resilience into the water resource programs they administer. This webinar will highlight three innovative state initiatives that address novel stressors and improve the resilience of program operations. These examples are drawn from the Innovative State Water Agency Practices database, which includes additional practices and is a collaborative effort between the Association of Clean Water Administrators, Association of State Drinking Water Administrators, Association of State Wetland Managers, and the EPA's Office of Water.

The webinar will be held from 1–3 p.m. Eastern on April 27, 2017.


For more information on the U.S. Environmental Protection Agency's (EPA) Innovative State Water Agency Practices, please visit the online database. 

New study of neonicotinoids in Iowa drinking water (evidence farm pesticides in drinking water)

There is newly published evidence from a team from U.S. Geological Survey and University of Iowa that they found neonicotinoids (thought to harm insect pollinators such as bees) in treated drinking water samples from Iowa. It marks the first time that anyone has identified this class of pesticide in residential tap water, the scientists write in Environmental Science & Technology Letters.

Apr 4, 2017

Employers reminded to post injury and illness summaries through April


OSHA's Form 300A

OSHA reminds employers of their obligation to post a copy of OSHA's Form 300A, which summarizes job-related injuries and illnesses logged during 2016. The summary must be displayed from February through April in a common area where notices to employees are usually posted. Businesses with 10 or fewer employees and those in certain low-hazard industries are exempt from OSHA recordkeeping and posting requirements.

FREE Safety seminars available online

Recordings of two recent training seminars are available to watch online. One is a symposium on ladder safety hosted by the OSHA Education Center at the University of Texas, Arlington. The other is a webinar on "Communicating with Workers about Hazardous Materials" hosted by the American Staffing Association as part of its alliance with OSHA.

OSHA releases three new publications on Process Safety Management

OSHA has released three guidance documents to help employers comply with the agency's Process Safety Management standard. PSM is critically important to facilities that store highly hazardous chemicals. Implementing the required safety programs helps prevent fires, explosions, large chemical spills, toxic gas releases, runaway chemical reactions, and other major incidents. The new documents focus on PSM compliance for Small BusinessesStorage Facilities and Explosives and Pyrotechnics Manufacturing.

National campaign aims to prevent roadway worker deaths and injuries


roadwork stand-down
Objects and vehicles striking workers are the leading cause of roadside-related construction deaths.

As road construction projects ramp up this spring, the Federal Highway Administration is partnering with OSHA, the American Traffic Safety Services Association, and other groups to encourage safe driving in work zones. The campaign, called National Work Zone Awareness Week, is an annual event set for April 3-7 this year. Tragically, 700 people, including 130 workers, were killed in crashes at roadway worksites in 2015. Many states and localities across the country will hold events to bring attention to these hazards and encourage safe driving around work zones.

A national kick-off event is planned for April 4, at 10:30 a.m., at the Maryland state Randolph Road/Georgia Avenue Interchange Project. In addition, the Georgia Struck-By Alliance, which includes OSHA, will hold stand-downs at highway construction locations throughout Georgia this week to train workers on the dangers of distracted drivers and flying debris. For more information on the Georgia events, see the news release.

Cancer added to 1-bromopropane health concerns

A new Health Hazard Alert from the Hazard Evaluation System and Information Service adds cancer to the growing list of negative health effects that may be caused by 1-bromopropane.

1-Bromopropane, also called 1-BP, is a solvent used in degreasing, spray adhesives, aerosol solvents, and dry cleaning. We have known for some time that 1-BP harms the reproductive and nervous systems. There is now evidence that 1-BP may also damage the genes and cause cancer.

The alert details health damage 1-BP can cause, citing recent scientific findings on its cancer risks. It provides a list of products that contain 1-BP and offers comprehensive recommendations for reducing exposure.

The Hazard Evaluation System and Information Service, or HESIS, investigates new and unrecognized workplace hazards, provides early warning, and works to prevent illness and disease on the job.

For more information, see Health Hazard Alert: 1-Bromopropane.

Apr 3, 2017

EPA RMP Rule Delayed Again

​(PAINT.ORG) ​On March 13, EPA Administrator Scott Pruitt signed a final rule that provides a three-month (90-day) administrative stay of the effective date of the Risk Management Program (RMP) final rule amendments. The RMP effective date is now delayed until June 19, 2017.

The final RMP rule amendments have encountered extreme resistance since EPA first issued them in mid-January. EPA stated that the amendments made to the final rule were aimed at modernizing RMP by (1) making changes to the accident prevention program requirements, (2) enhancing the emergency response and preparedness requirements, and (3) modifying the information availability requirements. However, numerous industry members and trade associations have continued to push back against implementation of these amendments.

After the White House's regulatory freeze pushed back RMP's effective date to March 21, ACA and 20 other trade associations signed onto a coalition petition to Congressional leaders urging them to utilize the Congressional Review Act (CRA) to block implementation of this rule. ACA and the other trade associations maintained that the final RMP rule not only imposes significant new costs without identifying or quantifying the safety benefits that will be achieved through these new requirements; but that it may compromise the security of facilities, emergency responders, and communities. Moreover, ACA and the other trade associations underscored that the current RMP regulations are not in need of revision because they include requirements that have produced and will continue to drive continuous safety improvements and already provide robust protection for our employees and the public.

Because of this coalition effort, Representative Markwayne Mullin (R-OK-2) introduced H.J.Res.59 on February 1 that would allow RMP to be overturned in Congress if the CRA joint resolution of disapproval passes in both the House and Senate. Sen. James Inhofe (R-OK) is the Senate sponsor of this CRA joint resolution. Industry members and trade associations are continuing their lobbying effort in D.C. to try and push this joint resolution through Congress.

In the meantime, newly confirmed EPA Administrator Pruitt further delayed the effective date of the final RMP rule amendments last week. The further delay to June 19 will provide the Administrator and his staff more time to reconsider these amendments. It will also allot additional time for industry members and trade associations to make their case against implementation. In fact, EPA announced that it will prepare a notice of proposed rulemaking soon that will provide industry members and the public an opportunity to comment further on the issues raised in the petition for reconsideration and other potential matters.

Lastly, a lawsuit filed in the U.S. Circuit Court of Appeals for the District of Columbia Circuit on March 13 against implementation of the RMP rule amendments challenges the legality of the final RMP rule amendments. The suit brought by the American Chemistry Council against EPA claims that the agency exceeded its statutory authority in issuing that final rule; failed to follow procedures required by the Administrative Procedures Act and Clean Air Act for agency rulemaking; did not adequately consider costs or assess benefits; and did not adequately respond to all significant comments.

These responses to the final RMP rule amendments now leave options for industry to block RMP through EPA action, a win at the D.C. Circuit Court, or by legislative repeal under the CRA.

Congress Passes Resolution to Overturn OSHA Final Rule on Recordkeeping Citations

​(PAINT.ORG) ​On March 22, the U.S. Senate voted 50-48 to pass H.J. Res. 83 under the Congressional Review Act (CRA), to repeal the U.S. Occupational Safety and Health Administration's (OSHA) "Clarification of Employer's Continuing Obligation to Make and Maintain Accurate Records of Each Recordable Injury and Illness," also known as the "Volks Rule." A related House resolution passed on March 1 by a vote of 231-191. President Trump is expected to sign the resolution into law, effectively overturning the rule and barring OSHA from issuing a similar one.

Last December, OSHA released its final rule clarifying an employer's continuing obligation to make and maintain accurate injury and illness records.

The amendments in the final rule didn't add any new compliance obligations or require employers to make records of any injuries or illnesses for which records are not already required. However, the final rule did extend the statute of limitations for which the agency can issue citations for recording, keeping violations to five years and six months, as opposed to just six months that most employers interpreted previously. OSHA maintained that it can cite employers for recordkeeping violations for up to six months after the five-year retention period expires, not just six months after the initial failure to record (first day of occurrence, or injury), without running afoul of the OSH Act's statute of limitations.

The rule was the result of the AKM LLC v. Secretary of Labor (Volks) decision in 2012, a case decided against OSHA. In that case, the U.S. Court of Appeals for the District of Columbia Circuit ruled that OSHA citations for recordkeeping violations must be issued within six months of the first day of an alleged failure to record the injury or illness; a citation issued after the six-month period is barred. OSHA had subsequently issued its final rule to go against the D.C. Circuit ruling.

Reminder: New OSHA Penaties - FREE Webcast @jjkeller

New OSHA Penalties:  Impacts to expect, ways to minimize risk

Tuesday, April 4, 2017 at 10:00 AM Central Time
(11:00 ET, 9:00 MT, 8:00 PT) – Register Now!

In August 2016, as a result of Congressional action, OSHA increased their maximum penalties by approximately 80 percent. What does this mean for you as an employer? Is OSHA frequently using the full amounts at their disposal? Has the increase changed the way local area offices are giving penalty reductions? This webcast will answer these questions and more.

Join us to learn more about OSHA enforcement trends and statistics, so you can be prepared should you face an inspection! 

Link
  

$54 Billion Boost in U.S. Defense Budget Comes as Pluristem's "100% recovery rate" Radiation Antidote Nears FDA Approval

ACCESSWIRE  (YAhoo) The largest increase in defense spending in history was proposed by the Trump administration last month. The budget increases military and defense spending by $54 billion. "This budget will be a public safety and national security budget…" Trump stated. If we take the President at his word, that public safety and national security will be a priority, then a major boost in spending to stockpile radiation antidotes may be in the future.

As Pluristem Therapeutics (PSTI), a cell therapy company, moves its acute radiation syndrome (ARS) antidote towards U.S. FDA approval, the proposed increase in defense spending is very favorable timing for Pluristem and potentially, for the U.S. population.

The U.S. already has a $600 billion annual defense budget, the largest in the world by far. Increasing this by $54 billion and making public safety a priority must mean spending on protecting Americans at home against a potential nuclear or dirty bomb attack, or a nuclear meltdown akin to Fukushima, resulting from earthquakes or other natural phenomena.

Deadly ARS is caused by exposure to high doses of radiation to the entire body in a very short period of time. This results in a depletion of immature parenchymal stem cells in specific tissues. Bone marrow can be damaged or destroyed, leading to the inability to produce blood cells and fight infection. PLX-R18 is potentially the perfect antidote because it is a stem cell therapy product that boosts production of platelets, red blood cells and white blood cells.

A 100% recovery rate was shown in animals exposed to radiation when they were treated with PLX-R18. This compares with the placebo group in which only 30% recovered. Bone marrow blood cell production returned to normal within just 48 hours of injecting PLX-R18.

Data is expected in the first half of 2017 from the U.S. National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) dose finding study of PLX-R18 in large animals.

The NIAID is expected to complete the study any day now, if it hasn't already. The aim of the study is to determine the proper dosage for PLX-R18 in humans. Due to ethical reasons, PLX-R18 studies for ARS cannot be conducted in humans. FDA approval for PLX-R18 as an ARS antidote therefore falls under the Animal Rule, which can lead to FDA approval without testing in humans. Exposure to radiation is the concern. The FDA has already cleared PLX-R18 for a Phase I clinical trial in humans for the treatment of hematopoietic recovery following bone marrow transplants, an indication to treat the side effects of radiation and chemotherapy. That study is expected to commence enrolling patients soon.

The NIAID has indicated that once optimum dosage has been established, it plans to move into the pivotal and final trial, under the Animal Rule, for full FDA approval of PLX-R18 as an ARS antidote for use in humans. It appears the costs these ARS studies are covered by the NIH, leaving Pluristem more room in its budget to move several other indications forward on its own dime. By 2018, Pluristem may have an FDA approved ARS antidote. Amgen's (NASDAQ:AMGN) blockbuster cancer drug Neupogen® became the first FDA drug approved for the indication of radiation induced myelosuppression, following a nuclear incident, the hematopoietic syndrome of ARS. The FDA granted Amgen this approval under the Animal Rule.

A $157.5 million contract was granted to Amgen for Neupogen by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority's (BARDA) Project BioShield.

BARDA made two more purchases in 2016 to add to its stockpile. $37.7 million worth of Neulasta was purchased from Amgen and $37.6 million worth of Leukine was bought from Sanofi. These are both leukocyte growth factor products but not specifically FDA approved for ARS.

Assuming BARDA gets a major boost in its budget, based on a $54 billion increase in defense spending, PLX-R18 may be next on BARDA's shopping list. As an off-the-shelf cell therapy product, with a long shelf life and no tissue matching required, PLX-R18 is ideally suited for defense stockpiles. One hopes that there is a miniscule chance that the American homeland will ever face a nuclear bomb incident or a Fukushima like event. However, by definition, defense spending should mean defending U.S. citizens. The U.S. government should invest in protecting its people from radiation threats. Pluristem should reap the benefits of its work in developing cell therapies that can save lives.

Ramifications of the Three Mile Island Incident

In the end, Unit 2 at Three Mile Island was shut down because it was too badly damaged to continue operations. Cleanup for the reactor started almost immediately after the accident in August of 1979. It wasn't completed until nearly 15 years later in December of 1993 at the cost of nearly $1 billion.

Fears over incidents like Three Mile Island have kept nuclear power stagnating worldwide.
Contaminated radioactive material is removed from Three Mile Island during cleanup of the accident. [Image by Paul Vathis/AP Images]

Immediately following the accident, the governor of Pennsylvania, Dick Thornburgh, advised that pregnant women and pre-school age children within 20 miles of the reactor should evacuate. This caused nearly 140,000 people to be displaced for almost a month. However, within that time, 98 percent of the evacuees returned to their homes.

There were concerns about the venting of radiological materials into the atmosphere during the accident, and this was the focus of numerous lawsuits against both Metropolitan Edison, the owners, and the various governments of Pennsylvania, the local borough, and the United States. All were dismissed, primarily because studies showed that the release of material amounted to minimal additional exposure to residents.

According to a study released at the time, the average dose to a resident was roughtly 8 millirems, which is about the amount of radiation exposure received from a chest x-ray. Numerous studies by the Pennsylvania Department of Health on residents in the area saw no uptick in the number of cancer diagnoses or a rise in infant mortality.

As far as the nuclear power industry in the United States is concerned, the Three Mile Island incident was a turning point. Because of heightened fears, several other plants under construction were shut down and a temporary ban on new reactors was put into place. While Three Mile Island didn't kill the nuclear power industry, it did put a stop to its historic growth. After the accident, of 129 approved power plants, only 53 were finished. Additionally, no new nuclear power plants were authorized until 2012.

Read full: http://www.inquisitr.com/4097831/the-three-mile-island-incident-anniversary-38-years-later/

H.R. 1430, Honest and Open New EPA Science Treatment (HONEST) Act of 2017

​H.R. 1430 would amend the Environmental Research, Development, and Demonstration Authorization Act of 1978 to prohibit the Environmental Protection Agency (EPA) from proposing, finalizing, or disseminating a "covered action" unless all scientific and technical information relied on to support that action is publicly available online in a manner that is sufficient for independent analysis and substantial reproduction of research results. Covered actions would include assessments of risks, exposure, or hazards; documents specifying criteria, guidance, standards, or limitations; and regulations and regulatory impact statements.
Although H.R. 1430 would not require the EPA to disseminate any scientific or technical information that it relies on to support covered actions, the act would not prohibit the agency from doing so. Whether the EPA would choose to disseminate such information would determine the cost of implementing H.R. 1430.
Based on information from the EPA and other federal agencies, as well as organizations and researchers in the scientific community that publish in peer-reviewed journals, CBO estimates that the agency could spend between a few million dollars per year to more than one hundred million dollars per year over the 2018-2022 period to ensure that data and other information underlying studies are publicly available in a format sufficient to allow others to substantially reproduce the results of studies. That range reflects the uncertainty about the number of studies the EPA would choose to rely on to support covered actions, the extent to which the agency would invest in data infrastructure to make researchers' data and models available to others, and in the number of covered actions the agency would issue in future years. The range also reflects the uncertainty in the extent to which the research community would tailor their data management activities to comply with the requirements of the act and how quickly those changes might occur.
EPA officials have explained to CBO that the agency would implement H.R. 1430 with minimal funding and generally would not disseminate information for the scientific studies that it uses to support covered actions. That approach to implementing the legislation would significantly reduce the number of studies that the agency relies on when issuing or proposing covered actions for the first few years following enactment of the legislation. In total, CBO estimates the EPA would spend about $5 million over the 2018-2022 period; such spending would be subject to the availability of appropriated funds.​


Huge nuclear cost overruns push Toshiba's Westinghouse into bankruptcy

CNBC- Westinghouse Electric, a unit of Japanese conglomerate Toshiba, filed for bankruptcy on Wednesday, hit by billions of dollars of cost overruns at four nuclear reactors under construction in the U.S. Southeast.

The bankruptcy casts doubt on the future of the first new U.S. nuclear power plants in three decades, which were scheduled to begin producing power as soon as this week, but are now years behind schedule.

The four reactors are part of two projects known as V.C. Summer in South Carolina, which is majority owned by SCANA, and Vogtle in Georgia, which is owned by a group of utilities led by Southern Co.

Costs for the projects have soared due to increased safety demands by U.S. regulators, and also due to significantly higher-than-anticipated costs for labor, equipment and components.

Pittsburgh-based Westinghouse said it hopes to use bankruptcy to isolate and reorganize around its "very profitable" nuclear fuel and power plant servicing businesses from its money-losing construction operation.

Westinghouse said in a court filing it has secured $800 million in financing from Apollo Investment, an affiliate of Apollo Global Management , to fund its core businesses during its reorganization.

For Toshiba, the filing will help keep the crisis-hit parent company afloat as it lines up buyers for its memory chip business, which could fetch $18 billion. Toshiba said Westinghouse-related liabilities totalled $9.8 billion as of December.

Toshiba said it would guarantee up to $200 million of the financing for Westinghouse. Toshiba shares closed up 2.2 percent but have lost half their value since the nuclear problems surfaced late last year.

The Apollo loan needs court approval and is expected to carry Westinghouse for a year, people familiar with the matter said. The funds would support the company's global operations, including its healthier services and maintenance businesses, and pay for construction workers on site in Georgia and South Carolina, the people said.

However, the money cannot be used to repay the liabilities stemming from cost overruns and delays at the projects, the people said.

SCANA told investors on a conference call on Wednesday that 5,000 workers would continue working on its South Carolina site for 30 days while the company weighed options.

"Our preferred option is to finish the plants. The least preferred option is abandonment," said SCANA CEO Kevin Marsh. Southern Co said in a statement it would hold Westinghouse and Toshiba accountable for its contract.

State regulators have approved costs of around $14 billion for each project but Morgan Stanley has estimated the final bill of around $22 billion for the South Carolina project and around $19 billion for the Georgia plant.....

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Mar 22, 2017

Free Webinar: Better Care in Workers' Compensation: ACOEM's Documentation & Coding Initiative

    Better Care in Workers' Compensation: ACOEM's Documentation & Coding Initiative
Thursday, March 23, 2017 10:00:00 AM CST - 11:00:00 AM CST
Join us for a free NIOSH Center for Workers' Compensation Studies (CWCS) webinar on Thursday, March 23, 12-1pm Eastern, in which CWCS will discuss proposed changes to improve workers' compensation patient encounters and care. Event Schedule (all times Eastern): 12:00-12:45pm: CWCS Presentation; 12:45-1:00pm: General Audience Q/A.    Presentation Summary: In the US, every year there are more than one million workplace injuries or illnesses severe enough that days are lost from work. Injured workers require medical care and careful attention to factors that will help them recover their ability to work, but American medical practice focuses on disease diagnosis and treatment, with little attention paid to functional ability. In the workers' compensation arena, health care providers must address issues such as causation, functional impact and return-to-work planning, issues that are not represented in the most widely used payment systems, based on codes and coding rules designed for primary care and other group practice settings.    The American College of Occupational and Environmental Medicine (ACOEM) supports modifying the rules for documentation of care in workers' compensation in order to provide reimbursement and other incentives to deliver care that adheres to best practices, including focus on assessing and improving patient function.   The recommended changes include alternative ground rules for documentation and coding evaluation and management encounters, physician case management services and consultation services as they relate to workers' compensation care. These alternative rules may be adopted by states or payers seeking to realign incentives toward improved functional and clinical outcomes and decreased costs.    Speakers include:   Marianne Cloeren, MD, MPH, FACOEM    DISCLOSURE:  In compliance with continuing education requirements, all presenters must disclose any financial or other associations with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters as well as any use of unlabeled product(s) or product(s) under investigational use.    CDC, our planners, content experts, and their spouses/partners wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Planners have reviewed content to ensure there is no bias. Presentations will not include any discussion of the unlabeled use of a product or a product under investigational use.   CDC did not accept commercial support for this continuing education activity.

Mar 20, 2017

H.R. 1029, Pesticide Registration Enhancement Act of 2017

CBO: H.R. 1029 would modify the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the law that regulates the distribution, sale, and use of pesticides, with the aim of strengthening the Environmental Protection Agency's (EPA's) ability to evaluate and regulate pesticides. Under FIFRA, the EPA is required to evaluate the safety of new pesticides entering the market by conducting risk assessments and must periodically re-evaluate the health and environmental effects of pesticides. The EPA charges fees to pesticide manufacturers and distributors to cover the agency's costs of performing those registration and reregistration activities.

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Mar 16, 2017

Trump Takes Hatchet To EPA And Foreign Aid, to use Billions on building border wall with Mexico

President Donald Trump will ask the U.S. Congress for dramatic cuts to many federal programs as he seeks to bulk up defense spending, start building a wall on the border with Mexico and spend more money deporting illegal immigrants.

In a federal budget proposal with many losers, the Environmental Protection Agency and State Department stand out as targets for the biggest spending reductions. Funding would disappear altogether for 19 independent bodies that count on federal money for public broadcasting, the arts and regional issues from Alaska to Appalachia.

Trump's budget outline is a bare-bones plan covering just "discretionary" spending for the 2018 fiscal year starting on Oct. 1. It is the first volley in what is expected to be an intense battle over spending in coming months in Congress, which holds the federal purse strings and seldom approves presidents' budget plans. 

Congress, controlled by Trump's fellow Republicans, may reject some or many of his proposed cuts. Some of the proposed changes, which Democrats will broadly oppose, have been targeted for decades by conservative Republicans.

Moderate Republicans have already expressed unease with potential cuts to popular domestic programs such as home-heating subsidies, clean-water projects and job training.

Trump is willing to discuss priorities, said White House budget director Mick Mulvaney, a former South Carolina congressman who made a name for himself as a spending hawk before Trump plucked him for his Cabinet.

"The president wants to spend more money on defense, more money securing the border, more money enforcing the laws, and more money on school choice, without adding to the deficit," Mulvaney told a small group of reporters during a preview on Wednesday.

"If they have a different way to accomplish that, we are more than interested in talking to them," Mulvaney said.

Trump wants to spend $54 billion more on defense, put a down payment on his border wall, and breathe life into a few other campaign promises. His initial budget outline does not incorporate his promise to pour $1 trillion into roads, bridges, airports and other infrastructure projects. The White House has said the infrastructure plan is still to come.

The defense increases are matched by cuts to other programs so as to not increase the $488 billion federal deficit. Mulvaney acknowledged the proposal would likely result in significant cuts to the federal workforce.

"You can't drain the swamp and leave all the people in it," Mulvaney said.


Twitter
@jeffspross
Oh hey look Trump wants to fiscally gut American society. 
No big deal.

 

'AMERICA FIRST'

White House officials looked at Trump's campaign speeches and "America First" pledges as they crunched the numbers, Mulvaney said.

"We turned those policies into numbers," he said, explaining how the document mirrored pledges to spend more on the U.S. nuclear weapons arsenal, veterans' health care, the FBI, and Justice Department efforts to fight drug dealers and violent crime.

The Department of Homeland Security would get a 6.8 percent increase, with more money for extra staff needed to catch, detain and deport illegal immigrants.

Trump wants Congress to shell out $1.5 billion for the border wall with Mexico in the current fiscal year - enough for pilot projects to determine the best way to build it - and a further $2.6 billion in fiscal 2018, Mulvaney said.

The estimate of the full cost of the wall will be included in the full budget, expected in mid-May, which will project spending and revenues over 10 years.

Trump has vowed Mexico will pay for the border wall, which the Mexican government has flatly said it will not do. The White House has said recently that funding would be kick-started in the United States.

The voluminous budget document will include economic forecasts and Trump's views on "mandatory entitlements" - big-ticket programs like Social Security and Medicare, which Trump vowed to protect on the campaign trail.

Database of hazardous reactions launched allows scientists to submit and search for safety information not publicly cataloged elsewhere



[+]Enlarge
Screen shot of a reaction entry in the Chemical Safety Library.
A screen shot of a reaction entry in the Chemical Safety Library.
Credit: Pistoia AllianceA nonprofit group today released a database tool chemists can use to share information about hazardous chemical reactions. Called the Chemical Safety Library, the tool was developed by a group that included representatives from pharmaceutical companies and academic institutions.

A nonprofit group today released a database tool chemists can use to share information about hazardous chemical reactions. Called the Chemical Safety Library, the tool was developed by a group that included representatives from pharmaceutical companies and academic institutions.

"We feel this will be a valuable and unique set of data that is currently not available and should advance safety for all researchers," says Carmen Nitsche, executive director for business development in North America at the Pistoia Alliance, which brings together companies, vendors, publishers, and academic groups to address research and development challenges in the life sciences industry.

The project started when chemists at Bristol-Myers Squibb were looking for a better way to catalog and share information about lab accidents and other adverse events. Eventually the project landed at Pistoia.

"I didn't know if we were going to get any interest" in putting together the library, says Mark Manfredi, a business capability manager at Bristol-Myers Squibb. "But right from the first meeting, we had several organizations that were interested in participating."

To use the Chemical Safety Library, chemists must first register for an account. They can then start entering reaction information, including specific reagents as well as reaction class, hazard category, scale, warning message, and additional information such as a literature reference. Pistoia worked with Millipore Sigma and Biovia to preload more than 75,000 reagents to help ensure accuracy. Library administrators review submitted reaction entries to ensure they are appropriate.

Chemists may search the library for particular reactions or reagents or even download the full data set. An organization could incorporate downloaded data into an electronic laboratory notebook system to issue an alert when a particular combination of reagents associated with a known hazard is entered. Bristol-Myers Squibb is already using the data in an electronic laboratory notebook system and an ordering system, Manfredi says.

Pistoia sees the current library tool as an experiment to gather information about the willingness of the community to populate and use the database, Nitsche says. Pistoia will analyze database use to determine the resources and technology needed to sustain the library long-term.

The library will be a "wonderful resource" for researchers to use as an additional source of information when doing hazard and risk assessments of experiments, comments Bettyann Howson, chair of the American Chemical Society's Committee on Chemical Safety. ACS also publishes C&EN. C&EN plans to encourage scientists who submit safety letters to also enter the information into the Chemical Safety Library.


Article By Jyllian Kemsley

Full credits to: Chemical & Engineering News American Chemical Society

http://cen.acs.org/articles/95/i12/Database-hazardous-reactions-launched.html