David Savastano, Editor01.19.18
Keeping up with the latest government regulations is one of the most important and most challenging jobs facing ink manufacturers. These mandates are becoming more complex all the time, and a wrong ruling can have a costly impact.
In speaking with industry executives, there are a number of key hot spots to keep an eye on heading into 2018. Here are three of particular note:
• OSHA eReporting
The OSHA eReporting measure is expected to go into effect shortly. George Fuchs, director regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), noted that there are a couple of reasons behind OSHA’s illness/injury electronic data reporting rule, beginning with efficiency and transparency.
“Management of the data is simplified for OSHA because it is in electronic format, which will result in more efficient government resource allocation,” said Fuchs. “It is important to note here company specific illness/injury data will, for the first time, be publically available. This was intentional on OSHA’s part because they believe it will increase public pressure on companies to improve their occupational safety programs.
“Companies should be prepared for the potential impact of public access to their health and safety statistics,” Fuchs added. “Prior to the implementation of this requirement, there were significant data security concerns which OSHA indicates have been addressed.”
Duane Ness, corporate director of EHS and regulatory compliance for INX International Ink Co., added that publicizing safety records could improve safety overall.
“The new safety recording system is intended to make workplace injury information public,” Ness continued. “OSHA believes that by making workplace injury information publicly available, it will ‘nudge’ employers to focus on safety. The new requirements won’t require much additional work on the part of employers as the data being submitted is already available.”
“OSHA promulgated the rule to improve the tracking of workplace injuries and illnesses on Jan. 1, 2017 and developed it with the purpose of compiling already collected facility data and elevating it to the public domain, thus creating greater accountability through transparency and competitiveness,” said Chris Stenger, PE, corporate EHS&S manager, Sun Chemical. “OSHA also sees that the data collected will allow greater research in ways to prevent safety incidents by identifying hazard trends in the workplace.”
Stenger reported that the compliance schedule is the following:
All establishments (or facilities) with 250 employees or more in recordkeeping regulated industries are required to submit their 2016 Form 300A forms electronically by Dec. 15, 2017. Going forward they must submit all of their 2018 forms (300A, 300, 301) by July 1, 2018, then subsequent years (2019+) all forms by March 2.
Establishments with 20 to 249 employees of certain high-risk industries (i.e. NAICS 31-33 manufacturing, etc.…) are required to submit their 2016 Form 300A electronically by Dec. 15, 2017. These organizations are only required to submit their 2017 Form 300A by July 1, 2018 and subsequent years (2019+) their 300A Form by March 2.
Sites that are below 20 employees are not subject to this rule, however they may elect to voluntarily submit their data.
“Our industry should not take this lightly,” Stenger added. “We could see greater scrutiny because of this rule. As data becomes more publicly available, the impact to employers could affect customer and investor ratings, job seekers, and broader public perception. Each company could find themselves benchmarked against specific competitors, where before they were only compared to the industry as a whole.”
For more information, see https://www.osha.gov/recordkeeping/finalrule/
• ANSI Standard for Three-Roll Mills
On the equipment side, the goal of the ANSI standard for three-roll mills is to improve safety. Ness says that goal was accomplished.
“The challenge to those in the ink industry with numerous three-roll mills was significant – planning, engineering, downtime and expense,” said Ness. “The resulting improvements to safety are without question and the effect will show in coming years.”
Fuchs noted that the 2017 revisions to Z177.1 – Three Roll Mills and Z177.2 Vertical Post Mixers – were completed in the fall of this year.
“There were significant changes to both standards – some more challenging to implement than others,” Fuchs said. “For example, depending of the type and age of the mill, dynamic braking requirement for printing ink three roll mills can be an expensive and time-consuming upgrade.
The ink industry has made great strides in reducing equipment-related occupational injuries and adherence to the requirements of these standards will move us further in that direction. Hazards cannot be completely ‘engineered out’ of manufacturing equipment however – employee safety training plays a very significant role here. To assist in this regard, NAPIM has two safety training DVDs available to its members to supplement their safety training programs.”
Stenger noted that the American National Standards Institute (ANSI) recently approved and published a new three-roll-mill (3RM) and vertical post mixer (VPM) standards on Sept. 15, 2017. The standard will become effective one-year from the date of approval (Sept. 15, 2018).
The standard compliance schedule requires the following:
Existing 3RMs and VPMs shall be brought into compliance with this standard by Jan. 1, 2020, except if the 3RM and VPM changes ownership and location. When this happens, it shall comply with the provisions of the standard before it is placed into service.
For small-scale 3RMs only (12 inches or less), non-production mills are excluded from certain provisions in the standard.
Rebuilt 3RMs and VPMs shall be brought into compliance with this standard before the equipment is placed in-service.
“Companies should purchase these recent standards and determine what gaps they have and plan capital improvements accordingly,” added Stenger.
For more information, see https://webstore.ansi.org/default.aspx
• TSCA Amendment
The amendment of the Toxic Substances Control Act of 1976 (TSCA) was a long time in coming. In June 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended TSCA, was signed into law. This is leading to changes in how the US Environmental Protection Agency is regulating chemicals.
“As ink manufacturers are not base chemical manufacturers, much but not all of impact of the Lautenberg Chemical Safety Act (LCSA) is felt through our supply chain,” said Fuchs.
“Significantly, the LCSA ‘inventory reset’ rule has the potential for supply chain disruption for downstream users. Ink manufacturers should verify that their raw material suppliers have taken the appropriate steps to ensure that their products remain on the LSCA inventory.”
“It depends on whether or not your company is a chemical manufacturer or a chemical processor,” added Ness. “If you are a TSCA defined processor, the new rule will have little impact or require much attention. If, however, your company manufactures chemicals or directly imports them, there is much more to do.”
Alexandra Wallace, global regulatory affairs specialist, Sun Chemical, discussed the impact of the TSCA rule.
“The TSCA Inventory Notification (Active-Inactive) Rule, published Aug. 11, 2017 has placed a burden on chemical suppliers to review chemicals manufactured or imported in the US over the past 10 years, for the period ending June 21, 2016. Once that review has been completed, a comparison must be made to the Environmental Protection Agency’s (EPA) interim list of active substances and exempt substances to determine what needs to be reported,” Wallace said.
“This reporting will be used to identify which chemical substances on the TSCA Inventory are active in U.S. commerce and will help determine the prioritization of chemicals for risk evaluation,” she said. “The reporting period for manufacturers and importers ends on Feb. 7, 2018 and the voluntary period for processors ends on Oct. 5, 2018.
Wallace noted that another effect of the amendment is the view the agency is taking with confidential business information.
“They initially challenged 25% of the 2016 chemical data reporting submissions and any future submissions require substantiation on anything that is indicated as CBI,” said Wallace. “CBI can now only be claimed for a 10-year maximum, and EPA reviews to what extent the information has been disclosed to others, what measures have been taken to guard against the disclosure and whether the business asserts there would be an effect on competitive position before they will accept it as confidential. They have also developed templates to assist industry in what they need to provide to support a substantiation claim.
“The EPA’s implemented changes as a result of the 2016 amendment to TSCA have resulted in transparency and better communication during the review process for new chemicals. The new administrator, Scott Pruitt, announced that he is committed to eliminate the backlog in the review of PMN submissions. He claimed over 600 chemicals were stuck in the review process,”
Wallace noted. “Thus, the EPA has committed to new operating principles in reviewing new chemicals wherein they will work directly with submitters to make amendments and have agreed to look at facts for intended proposed uses and leaving those ‘foreseeable uses’ to be addressed through significant new use rules (SNUR). They also want to reduce and replace animal testing as appropriate by mandating the use of alternative test methods.
“Under the new law, EPA has the power to require safety reviews of all chemicals in the marketplace,” said Wallace. “The agency selected 10 chemicals to evaluate and determine whether they present an unreasonable risk to humans and the environment. We expect to see a document within six months which will include any hazards, exposure, conditions of use, and any potentially exposed sub-population risks as determined by the EPA. As one chemical risk assessment is completed, the law requires that EPA begin another. So, by the end of 2019 they have to have at least 20 evaluations in process at the same time.”
Wallace reported that the EPA is continuing its quest to provide transparency and communication by holding two meetings in December 2017, which engaged the public to provide an update concerning their progress in the New Chemicals Review Program, discuss its decision-making framework and seek input concerning its approach to identify potential candidate chemicals for risk evaluation.
“Although it creates a lot of work for regulatory professionals, let’s hope the new TSCA will help the EPA provide more knowledgeable reviews that are quicker to market to allow safe chemicals into the marketplace,” Wallace concluded.
For more information on regulatory issues, please contactGeorge Fuchs at NAPIM at gfuchs@napim.org.
For more information on this story, including food packaging, please see the online version
at www.inkworldmagazine.com.
In speaking with industry executives, there are a number of key hot spots to keep an eye on heading into 2018. Here are three of particular note:
• OSHA eReporting
The OSHA eReporting measure is expected to go into effect shortly. George Fuchs, director regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), noted that there are a couple of reasons behind OSHA’s illness/injury electronic data reporting rule, beginning with efficiency and transparency.
“Management of the data is simplified for OSHA because it is in electronic format, which will result in more efficient government resource allocation,” said Fuchs. “It is important to note here company specific illness/injury data will, for the first time, be publically available. This was intentional on OSHA’s part because they believe it will increase public pressure on companies to improve their occupational safety programs.
“Companies should be prepared for the potential impact of public access to their health and safety statistics,” Fuchs added. “Prior to the implementation of this requirement, there were significant data security concerns which OSHA indicates have been addressed.”
Duane Ness, corporate director of EHS and regulatory compliance for INX International Ink Co., added that publicizing safety records could improve safety overall.
“The new safety recording system is intended to make workplace injury information public,” Ness continued. “OSHA believes that by making workplace injury information publicly available, it will ‘nudge’ employers to focus on safety. The new requirements won’t require much additional work on the part of employers as the data being submitted is already available.”
“OSHA promulgated the rule to improve the tracking of workplace injuries and illnesses on Jan. 1, 2017 and developed it with the purpose of compiling already collected facility data and elevating it to the public domain, thus creating greater accountability through transparency and competitiveness,” said Chris Stenger, PE, corporate EHS&S manager, Sun Chemical. “OSHA also sees that the data collected will allow greater research in ways to prevent safety incidents by identifying hazard trends in the workplace.”
Stenger reported that the compliance schedule is the following:
All establishments (or facilities) with 250 employees or more in recordkeeping regulated industries are required to submit their 2016 Form 300A forms electronically by Dec. 15, 2017. Going forward they must submit all of their 2018 forms (300A, 300, 301) by July 1, 2018, then subsequent years (2019+) all forms by March 2.
Establishments with 20 to 249 employees of certain high-risk industries (i.e. NAICS 31-33 manufacturing, etc.…) are required to submit their 2016 Form 300A electronically by Dec. 15, 2017. These organizations are only required to submit their 2017 Form 300A by July 1, 2018 and subsequent years (2019+) their 300A Form by March 2.
Sites that are below 20 employees are not subject to this rule, however they may elect to voluntarily submit their data.
“Our industry should not take this lightly,” Stenger added. “We could see greater scrutiny because of this rule. As data becomes more publicly available, the impact to employers could affect customer and investor ratings, job seekers, and broader public perception. Each company could find themselves benchmarked against specific competitors, where before they were only compared to the industry as a whole.”
For more information, see https://www.osha.gov/recordkeeping/finalrule/
• ANSI Standard for Three-Roll Mills
On the equipment side, the goal of the ANSI standard for three-roll mills is to improve safety. Ness says that goal was accomplished.
“The challenge to those in the ink industry with numerous three-roll mills was significant – planning, engineering, downtime and expense,” said Ness. “The resulting improvements to safety are without question and the effect will show in coming years.”
Fuchs noted that the 2017 revisions to Z177.1 – Three Roll Mills and Z177.2 Vertical Post Mixers – were completed in the fall of this year.
“There were significant changes to both standards – some more challenging to implement than others,” Fuchs said. “For example, depending of the type and age of the mill, dynamic braking requirement for printing ink three roll mills can be an expensive and time-consuming upgrade.
The ink industry has made great strides in reducing equipment-related occupational injuries and adherence to the requirements of these standards will move us further in that direction. Hazards cannot be completely ‘engineered out’ of manufacturing equipment however – employee safety training plays a very significant role here. To assist in this regard, NAPIM has two safety training DVDs available to its members to supplement their safety training programs.”
Stenger noted that the American National Standards Institute (ANSI) recently approved and published a new three-roll-mill (3RM) and vertical post mixer (VPM) standards on Sept. 15, 2017. The standard will become effective one-year from the date of approval (Sept. 15, 2018).
The standard compliance schedule requires the following:
Existing 3RMs and VPMs shall be brought into compliance with this standard by Jan. 1, 2020, except if the 3RM and VPM changes ownership and location. When this happens, it shall comply with the provisions of the standard before it is placed into service.
For small-scale 3RMs only (12 inches or less), non-production mills are excluded from certain provisions in the standard.
Rebuilt 3RMs and VPMs shall be brought into compliance with this standard before the equipment is placed in-service.
“Companies should purchase these recent standards and determine what gaps they have and plan capital improvements accordingly,” added Stenger.
For more information, see https://webstore.ansi.org/default.aspx
• TSCA Amendment
The amendment of the Toxic Substances Control Act of 1976 (TSCA) was a long time in coming. In June 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended TSCA, was signed into law. This is leading to changes in how the US Environmental Protection Agency is regulating chemicals.
“As ink manufacturers are not base chemical manufacturers, much but not all of impact of the Lautenberg Chemical Safety Act (LCSA) is felt through our supply chain,” said Fuchs.
“Significantly, the LCSA ‘inventory reset’ rule has the potential for supply chain disruption for downstream users. Ink manufacturers should verify that their raw material suppliers have taken the appropriate steps to ensure that their products remain on the LSCA inventory.”
“It depends on whether or not your company is a chemical manufacturer or a chemical processor,” added Ness. “If you are a TSCA defined processor, the new rule will have little impact or require much attention. If, however, your company manufactures chemicals or directly imports them, there is much more to do.”
Alexandra Wallace, global regulatory affairs specialist, Sun Chemical, discussed the impact of the TSCA rule.
“The TSCA Inventory Notification (Active-Inactive) Rule, published Aug. 11, 2017 has placed a burden on chemical suppliers to review chemicals manufactured or imported in the US over the past 10 years, for the period ending June 21, 2016. Once that review has been completed, a comparison must be made to the Environmental Protection Agency’s (EPA) interim list of active substances and exempt substances to determine what needs to be reported,” Wallace said.
“This reporting will be used to identify which chemical substances on the TSCA Inventory are active in U.S. commerce and will help determine the prioritization of chemicals for risk evaluation,” she said. “The reporting period for manufacturers and importers ends on Feb. 7, 2018 and the voluntary period for processors ends on Oct. 5, 2018.
Wallace noted that another effect of the amendment is the view the agency is taking with confidential business information.
“They initially challenged 25% of the 2016 chemical data reporting submissions and any future submissions require substantiation on anything that is indicated as CBI,” said Wallace. “CBI can now only be claimed for a 10-year maximum, and EPA reviews to what extent the information has been disclosed to others, what measures have been taken to guard against the disclosure and whether the business asserts there would be an effect on competitive position before they will accept it as confidential. They have also developed templates to assist industry in what they need to provide to support a substantiation claim.
“The EPA’s implemented changes as a result of the 2016 amendment to TSCA have resulted in transparency and better communication during the review process for new chemicals. The new administrator, Scott Pruitt, announced that he is committed to eliminate the backlog in the review of PMN submissions. He claimed over 600 chemicals were stuck in the review process,”
Wallace noted. “Thus, the EPA has committed to new operating principles in reviewing new chemicals wherein they will work directly with submitters to make amendments and have agreed to look at facts for intended proposed uses and leaving those ‘foreseeable uses’ to be addressed through significant new use rules (SNUR). They also want to reduce and replace animal testing as appropriate by mandating the use of alternative test methods.
“Under the new law, EPA has the power to require safety reviews of all chemicals in the marketplace,” said Wallace. “The agency selected 10 chemicals to evaluate and determine whether they present an unreasonable risk to humans and the environment. We expect to see a document within six months which will include any hazards, exposure, conditions of use, and any potentially exposed sub-population risks as determined by the EPA. As one chemical risk assessment is completed, the law requires that EPA begin another. So, by the end of 2019 they have to have at least 20 evaluations in process at the same time.”
Wallace reported that the EPA is continuing its quest to provide transparency and communication by holding two meetings in December 2017, which engaged the public to provide an update concerning their progress in the New Chemicals Review Program, discuss its decision-making framework and seek input concerning its approach to identify potential candidate chemicals for risk evaluation.
“Although it creates a lot of work for regulatory professionals, let’s hope the new TSCA will help the EPA provide more knowledgeable reviews that are quicker to market to allow safe chemicals into the marketplace,” Wallace concluded.
For more information on regulatory issues, please contactGeorge Fuchs at NAPIM at gfuchs@napim.org.
For more information on this story, including food packaging, please see the online version
at www.inkworldmagazine.com.