Get Ready for New REACH Requirements for Nanomaterials

October 28, 2019
New REACH information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH. Nanoforms of substances are those that fulfil the European Commission’s recommendation for a definition of a nanomaterial. The revised REACH annexes addressing nanoforms introduce clarifications and new provisions for:
  • Characterization of nanoforms or sets of nanoforms covered by the registration (Annex VI);
  • The chemical safety assessment (Annex I);
  • Registration information requirements (Annexes III and VII-XI); and
  • Downstream user obligations (Annex XII).
 
The purpose is to make sure companies provide enough information to demonstrate the safe use of their nanoforms for human health and the environment. The amendments apply to all the new and existing registrations covering nanoforms. This means that registrants are expected to update their existing dossiers with nanoform-specific information by 1 January 2020.
 
ECHA’s new nano-specific guidance helps companies to comply with the changes in Annex VI. In addition, the guidance on read-across between nanoforms or sets of nanoforms is being updated to reflect the changes. Both documents are expected to be ready by the end of 2019. The draft documents are published on the ongoing guidance consultation page.
 
The 2017 ECHA guidance for human health and the environment is also being updated. The OECD is revising some of their existing test guidelines used under REACH, to ensure that data generated on nanoforms is reliable and meets regulatory standards. An overview of the revised REACH Annexes and the available test methods are available on the EU observatory for nanomaterials (EUON).
 
On 30 October 2019, IUCLID will be updated with new data fields for reporting the characteristics of nanoforms and sets of nanoforms. From that day onwards, registrants who intend to submit registrations covering substances in nanoform must provide complete characterization information on their nanoforms or sets of nanoforms. The completeness check will include a verification that the sets of nanoforms are accompanied by a justification for creating the set. As before, the IUCLID tool will include the means to link these nanoforms or sets of nanoforms with the relevant data on their properties and hazards in the other parts of the dossier.
 
The updated IUCLID manual will advise registrants on how to fill the data fields. They are also encouraged to use the Validation assistant tool to check that all the required elements for their nanoforms are included before submitting their dossier to ECHA.
 
ECHA will update its manual on dissemination and confidentiality under the REACH Regulation, which, together with the Dissemination preview tool in IUCLID, will assist registrants in preparing their dossiers.
 
Companies submitting information on nanoforms must use the new version of IUCLID as it is not possible to prepare a successful submission with previous versions.
 
ECHA is hosting a webinar on 12 November 2019 to introduce the guidance on identifying and reporting nanoforms and sets of nanoforms. During the webinar, companies have the possibility to get advice directly from ECHA’s experts.
 
ECHA’s help desk is ready to assist companies to prepare for the new requirements.
 
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Company to Pay Over $2 Million for Welding Death
 
A court sentenced C&J Well Services, Inc. (C&J), successor to Nabors Completion and Production Services (NCPS) on August 28, 2019, after previously pleading guilty to violating the OSHA Act (29 U.S.C. § 666(e)).
 
Justin Payne worked for NCPS at its Williston, North Dakota facility. On October 3, 2014, Payne welded on an uncleaned tanker trailer that had previously carried “production water” or “saltwater,” a liquid waste generated by oil wells that contains flammable chemicals. The tank exploded killing Payne.
 
C&J and NCPS maintained written policies prohibiting welding in unclean tanks. NCPS policies mandated special training for welders and internal auditing procedures to ensure that workers followed the welding rules. However, NCPS did not provide welding- specific training to Payne or other welders at the Williston facility, did not effectively supervise the work of the Williston welders, did not require the welders to obtain hot work permits prior to welding, and did not follow internal auditing procedures. As a result, Payne and other welders repeatedly welded on uncleaned tanks that contained flammable hydrocarbon residue.
 
The court ordered C&J to pay a $500,000 fine and $1.6 million in restitution to the victim’s estate. The company will complete a three-year term of probation, during which OSHA personnel may inspect its facilities and equipment across the country unannounced for any reason.
 
This case was investigated by OSHA, EPA’s Criminal Investigation Division; the Bureau of Alcohol, Tobacco, Firearms and Explosives; and the Department of Transportation Office of Inspector General.
 
ECHA to Propose New OELs for Lead
 
At the request of the Commission, the European Chemicals Agency (ECHA) has evaluated two groups of substances, lead and its compounds and diisocyanates for occupational exposure limits (OELs), and has prepared scientific reports which are subject to a 60-day public consultation.
 
ECHA has proposed a biological limit value (BLV) of 150 µg Pb/L in blood for inorganic and for organic lead compounds and a OEL of 30 μg/m3 as an 8-hour time-weighted average.
 
ECHA did not propose an OEL for diisocyanates, but the agency did propose skin sensitization, respiratory sensitization, and skin notations for this class of chemicals.
 
You can keep up to date with the latest ECHA OEL activities at this web page.
 
Alabama Newspaper Publisher Cited for Exposing Employees to Amputations After Injury
 
OSHA has cited BH Media Group Inc. for exposing employees to amputation hazards after an employee suffered an injury at the Opelika, Alabama, facility. The company faces $145,858 in penalties.
 
An employee suffered a finger amputation after their hand was caught in a stacking machine that unintentionally started while being serviced. OSHA cited the company for failing to effectively guard machinery, and develop and implement written procedures to prevent unintentional start-up during service or maintenance. The agency conducted the inspection in conjunction with the National Emphasis Program on Amputations.
 
“Employers’ failure to instruct workers on how to control hazardous energy when they are servicing machines can lead to this type of preventable injury,” said OSHA Mobile Area Director Jose A. Gonzalez. “Using proper lockout/tagout energy control procedures can protect workers from potential amputations.”
 
OSHA’s Machine Guarding eTool provides information on how to recognize and control common amputation hazards associated with operating certain types of machines.
 
Managers Sentenced to Probation and Ordered to Pay Fines for Conspiracy to Obstruct Justice in U.S. Department of Labor Fatality Investigation 
 
The U.S. District Court for the Northern District of Ohio has sentenced Brian L. Carder and Paul Love – former managers at Extrudex Aluminum’s plant in North Jackson, Ohio – after each pleaded guilty to conspiracy to obstruct justice charges. The court’s action follows an investigation by the U.S. Department of Labor’s Office of Inspector General (OIG) that found the managers attempted to hide information and intimidate employees from speaking to the OSHA investigators about an employee fatality in October 2012.
 
On October 15, 2019, Carder was sentenced to three years of probation with weekend only confinement for the first five months and ordered to pay a fine of $20,100. On October 22, 2019, Love was sentenced to three years of probation – including three months of home confinement – and ordered to pay a fine of $1,100.
 
OSHA’s investigation found that, on October 30, 2012, the 21-year-old employee suffered fatally injuries when a rack containing hot aluminum parts tipped over and pinned him in an oven. A co-worker also suffered severe injuries. In a settlement agreement with OSHA, Extrudex Aluminum accepted one willful and seven serious citations, and agreed to pay a $112,000 penalty.
 
The indictment states Carder and Love devised a plan to coerce subordinates – by suggesting their jobs might be in jeopardy – to draft statements to recant previous emails about safety issues at the plant to conceal that management had not acted on those concerns. During an OSHA interview, Love also gave false information about safety issues.
 
“Employers cannot mislead or coerce workers to mislead federal investigators. Further, employers are required to operate workplaces free of hazardous conditions posing risk to worker safety and health,” said Principal Deputy Assistant Secretary of Labor for Occupational Safety and Health Loren Sweatt. “We commend the cooperation of our federal partners in the prosecution of this case.”
 
On August 1, 2019, the District Court sentenced Extrudex Aluminum to three years’ probation, and ordered the company to pay a $250,400 fine after pleading guilty to concealing knowledge of a felony in connection with efforts to hide information from OSHA inspectors. The company must also have an outside safety auditor monitor their workplace for compliance for the next two years. During the sentencing hearing, Extrudex Aluminum provided the court with information on how the company has now fully automated the extrusion heating process to prevent employee exposure to the hazard that led to the fatality.
 
The U.S. Attorney for the Northern District of Ohio prosecuted the cases, with assistance from the Department’s OIG and OSHA.
 
South Jersey Manufacturer Cited for Repeat Violations of Workplace Safety and Health Laws
 
OSHA has cited Aruvil International Inc. for multiple workplace violations – including four willful safety citations - at the company’s Pennsauken, New Jersey, facility. The commercial and residential fencing company faces $370,298 in penalties.
 
OSHA initiated an inspection in April 2019, as a follow-up to a prior inspection. OSHA cited Aruvil International Inc. for willfully violating federal standards related to lockout/tag out procedures to prevent machine startup, machine guards and proper warehouse lighting. OSHA also cited the company for an obstructed loading dock and blocked electrical disconnects for forklift truck chargers.
 
“OSHA has inspected Aruvil International Inc. three times since 2015, and repeated violators cannot be tolerated,” said Principal Deputy Assistant Secretary of Labor for Occupational Safety and Health Loren Sweatt. “Employers who do not comply with the law will continue to see full and fair enforcement.”
 
“Employers must make worker safety its top priority,” said OSHA Area Director Paula Dixon-Roderick, in Marlton, New Jersey. “This company continues to expose employees to multiple safety and health deficiencies that put them at risk for serious or fatal injuries.”
 
OSHA offers resources on what can be done to control hazardous energy, and recognizing and controlling common amputation hazards when using machinery.
 
The company has 15 business days from receipt of the citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
 
South Florida Contractor Cited for Cave-in and Engulfment Hazards After Fatality
 
OSHA has cited Westwind Contracting Inc. for exposing employees to excavation and confined spaces hazards after a fatality at a Pembroke Pines, Florida, work site. The contractor faces $185,239 in penalties.
 
The employee drowned after water and mud filled a catch basin in which the employee was working. OSHA cited the Pembroke Park, Florida-based engineering company for failing to protect employees working in an excavation; train employees on how to recognize hazards related to catch basins and permit-required confined spaces; and develop and implement a permit-required confined space program. OSHA also cited the contractor for exposing workers who attempted to rescue their co-worker, to engulfment hazards.
 
“Employers have a legal responsibility to protect and train their employees on well-known confined space and excavation hazards to avoid tragedies such as this,” said OSHA Fort Lauderdale Area Director Condell Eastmond.
 
OSHA recently updated the National Emphasis Program on preventing injuries related to trenching and excavation collapses. OSHA’s trenching and excavation webpage provides additional information on trenching hazards and solutions. The webpage includes a trenching operations QuickCard that provides information on protecting employees before they enter a trench, and the “Protect Workers in Trenches” poster reminding employers to slope, shore, or shield trenches to prevent collapses.
 
Alabama Auto Parts Manufacturer Cited for Amputation Hazards After Employee Injury
 
OSHA has cited Strahle + Hess USA Inc. for exposing employees to amputation hazards at the company’s Auburn, Alabama, facility. The auto parts manufacturer faces $140,554 in penalties.
 
An employee suffered a partial finger amputation while attempting to remove material from a lamination machine. OSHA cited the manufacturer for allowing employees to operate machinery without proper guarding, and for failing to develop and train employees on lockout/tagout procedures to control hazardous energy, lockout energy sources, and notify OSHA within 24 hours of the employee’s hospitalization, as required by law.
 
OSHA conducted the inspection in conjunction with the Agency’s National Emphasis Program on Amputations and Regional Emphasis Program for Safety Hazards in Auto Parts Industry.
 
“This company exposed workers to hazards that put them at risk for serious injuries,” said OSHA Mobile Area Director Jose A. Gonzalez. “Companies must continually evaluate and correct workplace safety deficiencies to ensure workers return home safe and healthy at the end of each day.”
 
OSHA’s Safeguarding Equipment and Protecting Employees from Amputations booklet explains how employers and workers can recognize and control amputation hazards, and what safety methods to use to prevent specific machine hazards.
 
Ohio Roofing Contractor Cited for Repeatedly Exposing Employees to Fall Hazards
 
OSHA has cited Mike Krueger – doing business as Altogether Roofing in Martin, Ohio – for exposing employees to fall hazards. The contractor faces penalties totaling $247,544 for willful, repeated and serious violations of OSHA standards at construction sites in Toledo and Perrysburg, Ohio.
 
OSHA inspectors cited Krueger for failing to install and require the use of a guardrail, safety net, or personal fall arrest system, train employees on fall hazards, and develop an accident prevention program. Inspectors also cited the company for a repeated violation for unsafe ladder use, and a serious violation for failing to require eye protection for employees operating pneumatic nail guns. OSHA has cited Krueger for fall protection violations five times since 2008.
 
“Falls continue to be the number one cited standard by OSHA,” said OSHA Toledo Area Director Kim Nelson. “Employers are expected to provide safe workplaces for their workers.”
 
OSHA offers compliance assistance resources on preventing falls from ladders, scaffolds, and roofs on the OSHA Fall Protection webpage at https://www.osha.gov/SLTC/fallprotection/.
 
The company has 15 business days from receipt of the citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
 
$1,591,176 in Penalties to AB Specialty Silicones After 4 Fatalities
 
OSHA has cited AB Specialty Silicones LLC for 12 willful federal safety violations after four employees suffered fatal injuries in an explosion and fire at the company's Waukegan, Illinois, plant on May 3, 2019. The company faces $1,591,176 in penalties. OSHA has placed the silicon chemical products manufacturer in the Severe Violator Enforcement Program.
 
OSHA investigators determined AB Specialty Silicones failed to ensure that electrical equipment and installations in the production area of the plant complied with OSHA electrical standards, and were approved for hazardous locations. The company also used forklifts powered by liquid propane to transport volatile flammable liquids, and operated these forklifts in areas where employees handled and processed volatile flammable liquids and gases, creating the potential for ignition.
 
"Employers must employ hazard recognition to protect workers from harm, especially in high hazard industries," said Principal Deputy Assistant Secretary of Labor for Occupational Safety and Health Loren Sweatt. "By ignoring safety and health requirements, this employer created an unsafe work environment with deadly consequences."
 
"An employer's adherence to safety and health standards, including the proper use of electrical equipment and forklifts when handling flammable liquids, is critical to preventing fire, explosions and other incidents that can seriously or fatally injure workers," said OSHA Acting Regional Administrator Nancy Hauter, in Chicago, Illinois.
 
OSHA provides resources on electrical safety and using forklifts when working with hazardous materials. The company has 15 business days from receipt of the citations and penalties to comply, request an informal conference with OSHA's area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
 
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