The U.S. DoL OSHA Final Rule Protecting Workers From Beryllium Exposure
Mark Gradert CIH, CSP
Friday, November 17, 2017
You should be aware that on January 9, 2017, OSHA issued the final Beryllium Standard which was effective on May 20, 2017. The initial compliance date for affected workplaces is currently March 12, 2018. A copy of the USDOL OSHA Beryllium Standard is available here.
The final Beryllium Standard includes Permissible Exposure Limits (PEL) of 0.2 micrograms per cubic meter (0.2 µg/m3) as an 8-hour Time Weighted Average (TWA) and 2.0 µg/m3 as a Short-Term Exposure Limit (STEL) determined over a 15-minute sampling period. The standard also includes ancillary requirements prompted at or above an Action Level (AL) of 0.1 µg/m3 or other specified situations.
Included with the issuance of the standard for general industry (29 CFR 1910.1024), OSHA issued Beryllium Standards for the shipyard and construction industries (29 CFR 1915.1024 and 29 CFR 1926.1124, respectively). However, OSHA almost immediately proposed to revoke the ancillary provisions applicable to the construction and shipyard sectors, but to retain the new lower PEL of 0.2 μg/m3 and the STEL of 2.0 μg/m3 for those sectors. OSHA publically stated that it will not enforce the ancillary provisions construction and shipyard standards without further notice.
Are you compliant to OSHA's new Crystalline Silica Ruling?
Mark Gradert CIH, CSP
Friday, September 15, 2017
In 2016, OSHA established a new rule for Crystalline Silica Exposure. The new rule lowers the Permissible Exposure Limit (PEL) to 50 ug/m3 averaged over an 8-hour Shift, with an Action Limit of 25 ug/m3 averaged over an 8-hour Shift
Occupational exposure to Crystalline Silica occurs when working with such items as rock/stone, ceramics, brick, and concrete. Exposure occurs when the dust particles become airborne; typically by means of abrasive blasting, cutting, sawing, drilling, or crushing such materials.
Some of the affected industries include: construction, manufacturing, foundries, fracking, asphalt roofing, dental laboratories, pottery, shipyards, and railroads. Given such specific conditions to the various fields, OSHA's ruling was been separated into two standards. Thus giving employers the opportunity to adjust accordingly.
We are here to help!
For more information regarding the OSHA Ruling, please visit: https://www.osha.gov/silica/index.html.
The Compounding Pharmacy of America wrote an excellent article in their blog about Chapter 797 that we felt compelled to share. Chapter 797 is designed to decrease the risk of patients receiving infected medication. This documentation effects our pharmaceutical clients. To read the full article click the link in the heading above.
What Pharmacists Need to Know Ahead of USP <800>
Katie Eder, Senior Editor
Published Online: Thursday, December 11, 2014
Although the proposed USP General Chapter <800> is not anticipated to take effect for at least the next 2 years, an expert panel at the American Society of Health-System Pharmacists 2014 Midyear Clinical Meeting described how pharmacists can start preparing for the new standards in handling hazardous drugs.
Patricia C. Kienle, MPA, BSPharm, FASHP, director of accreditation and medication safety for Cardinal Health Pharmacy Solutions and a member of the USP Compounding Expert Committee, noted that the scope of USP <800> is wider than that of USP <795> and <797>, but it will be supplementing those standards, rather than replacing them.
According to Kienle, the key elements of USP <800> are:
- Facility design: Hazardous drugs must be stored in negative or normal/neutral pressure, and compounding must be completed in certified biological safety cabinets or compounding aseptic containment isolators in a separate room with negative pressure.
- Garb: Details for personal protective equipment are based on the function being performed
- Cleaning: Deactivation and disinfection with an oxidizer, cleaning with a germicidal detergent, and disinfection with sterile alcohol.
- Administering: Closed-system drug-transfer devices should be used when compounding and shall be used when administering.
While USP <800> is open to public comments through May 31, 2015, Kienle said pharmacists should use that time to become familiar with the proposed publication and its revised list of hazardous drugs.
That updated list is derived from the 2014 National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, which added 28 drugs and removed 12 drugs from previous editions, according to Thomas H. Connor, PhD, a research biologist in the Division of Applied Research & Technology at NIOSH.
Dr. Connor explained that the safe handling of hazardous drugs is not a new issue, as the first list with 39 harmful antineoplastic agents was published in 1986. Since that time, NIOSH has expanded the list to include hazardous non-antineoplastic drugs and medications with reproductive effects.
While USP <800> currently cites the NIOSH 2014 hazardous drugs list, Dr. Connor noted that the federal agency is now working on a 2016 update, and a total of 330 drugs have met the criteria for initial review.
Unlike NIOSH, the Joint Commission has not yet moved in the direction of USP <800>, said Jeannell M. Mansur, PhD, FASHP, FSMSO, CJCP, practice leader of medication safety for Joint Commission Resources.
"There is recognition in the Joint Commission that it needs more focus on hazardous drug handling," Dr. Mansur explained. "Where will the Joint Commission be going with regards to USP <800>? I am not sure."
Nevertheless, Dr. Mansur said the accreditation program administer has set standards for handling hazardous waste that surveyors can cite noncompliant hospitals for. For instance, the inability to describe spill procedures during the accreditation survey process may result in a finding in the Human Resources chapter, and Leadership standards may be scored for hazardous medication findings.
OSHAs announces new silica rule!
To improve worker protection, OSHA has issued its long awaited silica rule. The rule consists of two new crystalline silica standards: one for general industry and maritime, and the other for construction. The final rule will go into effect on June 23rd, 2016. Industries have 1 to 5 years to comply with the most requirements.
Key provisions of the new rule include:
- Reduction of the permissible exposure limit (PEL) for respirable crystalline silica to 50 micrograms per cubic meter of air, averaged over an 8-hour shift.
- Requirements for employers to: use engineering controls (such as water or ventilation) to limit worker exposure to the PEL; provide respirators when engineering controls cannot adequately limit exposure; limit worker access to high exposure areas; develop a written exposure control plan, offer medical exams to highly exposed workers, and train workers on silica risks and how to limit exposures.
- Requirement to provides medical exams to monitor highly exposed workers and gives them information about their lung health.
OSHA says that it has included flexibility for employers, especially small businesses, to comply with the rule in order to protect workers from silica exposure.
According to OSHA, about 2.3 million workers are exposed to respirable crystalline silica in their workplaces, including 2 million construction workers who drill, cut, crush, or grind silica-containing materials such as concrete and stone, and 300,000 workers in general industry operations such as brick manufacturing, foundries, and hydraulic fracturing, also known as fracking.
Approximately 676,000 workplaces will be affected, including in construction and in general industry and maritime. OSHA pegged the rule’s cost at about $1,524 per workplace and less for smaller companies. However, a coalition of construction associations issued a report in March 2015 (Costs to the Construction Industry and Jobs Impacts from OSHA’s Proposed Occupational Exposure Standards for Crystalline Silica) that estimates compliance with the Occupational Safety and Health Administration’s (OSHA) new rule will cost the construction industry more than $4.9 billion per year.
The construction industry has until June 23, 2017 to comply with the new rule, while general industry, maritime, and hydraulic fracturing operations must comply by June 23, 2018.
Click to read more about OSHA's Final Rule to Protect Workers from Exposure to Respirable Crystalline Silica.
Environmental Protection Agency on Pharmaceutical Hazardous Waste
In 2008, the Environmental Protection Agency (EPA) proposed to place pharmaceutical hazardous waste under the regulatory umbrella of RCRA universal wastes. But after receiving negative feedback from environmental groups because of the absence of notification requirements, as well as for the lack of tracking requirements for shipments of pharmaceutical wastes, the EPA dropped the proposal and is now working on new disposal standards for hazardous waste pharmaceuticals generated by healthcare facilities.
The EPA’s 2015 proposal for the regulation of hazardous waste pharmaceuticals, expected to be released any day now, focuses on a “healthcare facility-specific” form of management.
Currently, the best way for any healthcare facility to manage their pharmaceutical waste is to make use of take-back programs, reverse distribution, or some other method of sending unused, damaged, or mishandled hazardous medications back to the manufacturer. The new changes to the current system of pharmaceutical waste management could possibly mean less strict adherence to RCRA for generators and an easing of disposal responsibilities for healthcare workers.
The Role of Certified Industrial Hygienist®
The American Board of Industrial Hygiene® (ABIH®) created of a short video about the role of the Certified Industrial Hygienist® (CIH®). The video lasts 105 seconds and serves as an introduction to what CIHs can do to protect people in the workplace and beyond.
Also, ABIH® recently conducted a survey in conjunction with the Alliance of Hazardous Materials Professionals® (AHMP®), the American Industrial Hygiene Association® (AIHA®), the American Society of Safety Engineers® (ASSE®), the Board of Certified Safety Professionals® (BCSP®), and the Institute of Hazardous Materials Management® (IHMM®) to learn more about the current economic climate. The survey results have been tabulated. Click this link to access the on-line salary calculator that will allow you compare a CIH's salary with other health and safety practitioners. You can also access the link to the salary calculator through the website at www.abih.org/salary.
Visit the ABIH® website for the most up-to-date information about ABIH® activities.
OSHA Proposes Lower PEL for Beryllium
During a media teleconference held this afternoon, OSHA announced a new proposed rule that would lower the agency’s permissible exposure limit (PEL) for beryllium in general industry from 2 μg/m3 to 0.2 μg/m3. Assistant Secretary of Labor for OSHA David Michaels, PhD, MPH, said that the rule would prevent an estimated 100 deaths and 50 additional illnesses per year.
Michaels highlighted the significance of the “historic collaboration effort between industry and labor” that helped advance the beryllium standard in the rulemaking process. He credited Materion, the largest U.S. producer of beryllium, and the United Steelworkers, a union that represents many of the workers who handle beryllium in their jobs, for jointly suggesting a stronger standard.
“It’s noteworthy that [Materion and the United Steelworkers union] agreed that greater protections are needed,” he said. “Together, they created a framework for moving forward with a rule, and they brought it to OSHA in 2012. At that time, we were already hard at work on the beryllium standard, but the joint proposal from Materion and the Steelworkers gave our efforts new momentum and propelled us forward.”
Exposure to beryllium mist, dust, and fumes can cause chronic beryllium disease (CBD), which scars lung tissue and impairs the lungs’ ability to get oxygen to the bloodstream.
This proposed rule is “a long overdue step toward protecting workers from harmful exposure to beryllium,” Michaels said.
The proposed rule will be published in the Federal Register tomorrow, Aug. 7. The pre-publication PDF version of the proposal is available to read now. OSHA will accept public comments on the proposal through Nov. 9, 2015.