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Michigan's PFAS Challenge and MMA's Call to Get the Science Right

This article appeared in the May 2020 issue of MiMfg Magazine. Read the full issue and find past issues online.

Water is crucial to Michigan’s identity. So much of the state’s rich history is based on the water that surrounds it. For transportation of raw materials and finished products, as a natural resource itself and vacation destination for tourists from around the globe, the safety and sustainability of our water should be an integral part of any Michigan policy or regulation.

With emerging environmental and public health science relating to per- and polyfluoroalkyl substances (PFAS) in drinking water continuing to evolve, the Michigan Department of Environment, Great Lakes, and Energy (EGLE) PFAS Science Advisory Workgroup (SAW) was tasked by the Governor to create effective and enforceable rules in an uncertain environment.

As a result, EGLE now is proposing a Michigan-specific drinking water standard for PFAS stricter than the federal advisory.

MMA commends every effort being made to prioritize human health and safety, and agrees that safe drinking water and trust in drinking water supplies are paramount. However, substantial questions remain about the process for implementing new proposed drinking water standards. The longer these questions remain unanswered and the closer the proposed rule set gets to completion, the harder it will be for Michigan to undo potential damage to our long-term economic success, the competitiveness of our manufacturing sector and, indeed, to the health and safety of our people.

“As proposed, the PFAS standard for public drinking water supplies currently lacks the kind of science and process integrity necessary for defensibility, compliance and affordability, and it could threaten Michigan’s economic competitiveness by being out of step with federal and other state PFAS standards for community drinking water supplies,” said Mike Johnston, MMA vice president of government affairs. “MMA is encouraging a resolution of these scientific shortcomings before finalizing new standards.”

Time is running out for changes to be made. As recently as 3/16/20, EGLE submitted the proposed rule set to the Legislature’s Joint Committee on Administrative Rules (JCAR). From there, JCAR has 15 session days to review the rule set, which tentatively establishes 5/12/20 as the final day JCAR has the rule set before the rules are promulgated.

The proposed rule set would:

  • Establish a sampling requirement at every entry point to the distribution system.
  • Modify existing reporting requirements to require PFAS sampling be included.
  • Develop Maximum Containment Levels for six PFAS compounds, the lowest being 6 PPT for PFNA. PFOA and PFOS are 8 and 16, respectively, almost 10-fold lower than the Federal EPA advisory levels.
  • Require public notification if in noncompliance.
  • Require new, costly treatment technology if exceedances are found.

“MMA continues to stand at the forefront of an effort to enact the standards that neither endanger the health of our people nor the competitiveness of its innovators and entrepreneurs,” said Johnston. “For the better part of two years, the MMA PFAS Work Group has worked tirelessly to provide a response to these rules, offer input and devise commonsense strategies for moving forward on a proper PFAS standard.”

In late 2019, the Association commissioned an independent, technical peer review of the proposed rules and offered public and formal written comment in January 2020.

MMA continues to highlight the concerns raised as a result of this review; concerns which were not addressed by EGLE or SAW or asked to be resolved by Michigan’s Environmental Rules Review Committee (ERRC). Issues including the scientific and technical credibility of proposed rules, the ability of municipalities and their customers to afford adherence with them and Michigan’s overall economic competitiveness when regulations such as these are not aligned with federal and surrounding state standards are all critical questions that deserve answers before rule implementation makes a fix nearly impossible.

MMA’s Independent Peer-Review Study

On 1/30/20, Dr. Michael L. Dourson, Dr. Edward J. Calabrese and Mr. Richard J. Welsh provided a report commissioned by MMA titled Independent Technical Review of the Health-Based Drinking Water Value Recommendations for PFAS in Michigan to offer technical comments on the SAW recommendations to EGLE that were used to establish the health-based drinking water values (HBVs) for PFAS. Since this was the first time that Michigan had established a Maximum Contaminant Level (MCL) without one first being established by the EPA, MMA’s objective was to see that Michigan implemented a sustainable and defensible regulation.

While the work of SAW is considerable and significant, an obvious weakness is the absence of a robust peer review as part of the SAW rule development process. A robust, properly credentialed peer review protocol is required practice for the EPA when it establishes an MCL, and Michigan should follow this example in some credible manner.

“The public’s confidence is achieved by ensuring the integrity and soundness of the process and information used as the solid foundation for setting safety standards,” said Dave Greco, MMA director of regulatory affairs. “Anything less would subject regulators, drinking water systems and others to potential skepticism and lack of confidence in drinking water safety.”

As SAW did not include a proper peer review phase in its process, MMA believed it essential to engage an expert review so as to properly and credibly inform our members of the soundness of the proposed rule set and also to provide SAW with a foundational peer review for ensuring the soundness of the final rules package.

“We understand that Michigan has one chance to get it right, and there is a lot at stake — the confidence of our residents, the effectiveness of the regulations and the health of the state’s economy,” Greco explained. “Michigan cannot and should not find itself in such a position, especially in light of PFAS rule-related litigation and implementation delays being experienced in other states that have failed to properly underpin standards and account for costs.”

Critical Shortcomings in State Report

In the report, it was identified that the SAW recommendations used to establish the standard lacked the kind of robust scientific and technical integrity to fully complete the state’s goal.

“It is in the best interest of Michigan, its manufacturing sector and the individuals and communities that rely on clean drinking water that the state follow the lead of the EPA when setting standards,” said Greco. “This ensures that those standards are scientifically credible and defensible, avoid overreach and prevent Michigan from losing economic competitiveness by finding itself out of step nationally or with other states.”

MMA’s independent peer review identified five critical shortcomings in EGLE’s proposed rules:

  1. Key studies were not referenced or discussed by the Science Advisory Workgroup (SAW) in its risk assessment calculations.
  2. Significant data gaps and scientific uncertainty are evident in SAW’s calculations.
  3. Curious conclusions and assumptions are evident in calculations for the HBVs.
  4. SAW deviated from accepted standard practice when developing its MCLs.
  5. An inadequate assessment of the compliance costs of the proposed rule that, ultimately, the public will bear, and this could weaken acceptance and support for the proposed criteria.

“With this being the first instance in Michigan of pursuing an MCL ahead of EPA input, any proposed rules at the state level must be ‘regulation ready’ and that means providing necessary clarity, consistency and certainty,” said Johnston. “It also means that the state must rely on settled and established science as the foundation for developing regulatory standards and properly consider the significant costs such a rule could have on local communities, citizens and employers.”

MMA’s Key Recommendations

Based on the findings of the independent peer review, MMA advocates for four clear recommendations which, if implemented, would allow Michigan to be viewed as a credible leader in PFAS-related safe drinking water standards.

Ensure public confidence in the process
SAW should address and resolve any key scientific uncertainties and shortcomings that have been identified during the public comment period and subsequent to the development of proposed rules. MMA trusts that the peer review information provided in the report will assist EGLE in addressing some of the information gaps and questions that remain.

“As the EPA has historically developed MCLs, it remains best equipped in both resources and expertise to address these complex public health questions,” said Greco. “The EPA remains engaged in addressing the PFAS issue and, in order to best ensure public confidence and the protection of human health, the state should consult and incorporate research conducted by the EPA and others to enable Michigan to access critical new findings as PFAS science evolves.”

Rely on settled science to develop MCLs
Michigan should rely upon universally settled science when developing MCLs and ensure that Michigan is using a scientific community-consensus database. EGLE refrained in this rule set and should continue to refrain from developing MCLs on a class basis due to the unique and varying effects of different PFAS constituents. As the body of scientific knowledge on exposure continues to grow, Michigan should reassess its previous determinations, consider adding or removing other individual PFAS constituents or modify the compliance requirements.

“There is a significant lack of settled science on PFAS. Among both scientists and governments, there is still considerable debate about what constitutes safe dose exposure,” Johnston explained. “Our commissioned report identified a 500-fold difference in projected safe dose levels between Australia’s 160 parts-per-trillion (ppt) and the safe dose level of 1,500 ppt in the UK.”

Recognizing and understanding that the SAW had a more than 40,000-fold difference in safe doses based on the different PFAS constituents, EGLE should not use SAW’s proposed levels as an automatic trigger for a point of violation as is proposed in the draft rule set. Rather, MMA has continued to present an alternative plan that is a slight revision to the proposed rules and uses SAW’s report to set monitoring, attainment and maintenance requirements through regular screening as empowered under the Safe Drinking Water Act. This would ensure continued sampling while also utilizing state and federal data and standards over time, meaning water systems could continue to ensure safe drinking water through sampling and putting a plan in place to ensure that the system has safe drinking water rather than triggering a shutdown of the system if an exceedance is recorded.

Lead with regulation-ready rules
It is imperative that the rules being promulgated are legally defensible and provide clarity, consistency and certainty. The rule set must also establish the proper mechanisms to ensure that EGLE, individuals, communities and industry can understand, adapt to and comply with the rules.

“Regulation-ready rules must include a screening and review process, as well as a site-specific plan approach for any testing site that registers a level that results in further action,” Greco said.

Fully account for the cost
EGLE must properly account for the costs to be incurred by employers, municipal water systems and their citizens by identifying the cost for retrofitting of existing municipal water supply systems of differing scale, costs as they relate to Industrial Pretreatment Programs and for disposal cost elimination of PFAS material remaining after treatment. The Regulatory Impact Statement (RIS) also did not appropriately account for the ongoing operating costs, including a full assessment of the compliance monitoring costs, for municipal systems or the impact and cost the rules would have on Michigan’s Part 201 clean-up program. Lastly, SAW should fully identify and consider costs when establishing HBVs, which does not appear to have been included in the overall assessment.

“While EGLE did include some minimal estimate of the costs when preparing its RIS, SAW failed to provide a similar analysis. As a result, SAW failed to analyze the quantifiable and non-quantifiable benefits that are likely to occur as a result of compliance with the proposed standards,” said Johnston. “The lack of a complete accounting for the cost of any proposed drinking water rules is of major concern for the public and the regulated community to understand the benefits of this proposal relative to the costs all will be asked to bear. The State should not move forward without fully knowing and accounting for the financial impact on communities and their citizens of the cost of implementing safe drinking water standards.”

Next Steps

The next step in the rules process involves the legislature’s Joint Administrative Rules Committee. MMA is encouraging the committee to review the additional question raised by the ERRC and contained in the letter sent to JCAR by ERRC Chairman Rob Nederhood.

“We find it very interesting that the ERRC voted to move the process along, but also sent a very detailed list of questions about the underpinnings of the scientific conclusions of the workgroup,” said Johnston. “There are several outstanding scientific questions deserving attention to ensure we are relying on settled science.”

For more information on PFAS, the process to a workable drinking water standard and more, members are encouraged to join the MMA PFAS Work Group or contact MMA’s Dave Greco, at 517-487-8543 or greco@mimfg.org, to get involved.

Contact Brett Gerrish

Brett GerrishCommunications Coordinator
Call 517-487-8533
E-mail gerrish@mimfg.org

Sources:

This article appeared in the May 2020 issue of MiMfg Magazine. Read the full issue and find past issues online.

Water is crucial to Michigan’s identity. So much of the state’s rich history is based on the water that surrounds it. For transportation of raw materials and finished products, as a natural resource itself and vacation destination for tourists from around the globe, the safety and sustainability of our water should be an integral part of any Michigan policy or regulation.

With emerging environmental and public health science relating to per- and polyfluoroalkyl substances (PFAS) in drinking water continuing to evolve, the Michigan Department of Environment, Great Lakes, and Energy (EGLE) PFAS Science Advisory Workgroup (SAW) was tasked by the Governor to create effective and enforceable rules in an uncertain environment.

As a result, EGLE now is proposing a Michigan-specific drinking water standard for PFAS stricter than the federal advisory.

MMA commends every effort being made to prioritize human health and safety, and agrees that safe drinking water and trust in drinking water supplies are paramount. However, substantial questions remain about the process for implementing new proposed drinking water standards. The longer these questions remain unanswered and the closer the proposed rule set gets to completion, the harder it will be for Michigan to undo potential damage to our long-term economic success, the competitiveness of our manufacturing sector and, indeed, to the health and safety of our people.

“As proposed, the PFAS standard for public drinking water supplies currently lacks the kind of science and process integrity necessary for defensibility, compliance and affordability, and it could threaten Michigan’s economic competitiveness by being out of step with federal and other state PFAS standards for community drinking water supplies,” said Mike Johnston, MMA vice president of government affairs. “MMA is encouraging a resolution of these scientific shortcomings before finalizing new standards.”

Time is running out for changes to be made. As recently as 3/16/20, EGLE submitted the proposed rule set to the Legislature’s Joint Committee on Administrative Rules (JCAR). From there, JCAR has 15 session days to review the rule set, which tentatively establishes 5/12/20 as the final day JCAR has the rule set before the rules are promulgated.

The proposed rule set would:

  • Establish a sampling requirement at every entry point to the distribution system.
  • Modify existing reporting requirements to require PFAS sampling be included.
  • Develop Maximum Containment Levels for six PFAS compounds, the lowest being 6 PPT for PFNA. PFOA and PFOS are 8 and 16, respectively, almost 10-fold lower than the Federal EPA advisory levels.
  • Require public notification if in noncompliance.
  • Require new, costly treatment technology if exceedances are found.

“MMA continues to stand at the forefront of an effort to enact the standards that neither endanger the health of our people nor the competitiveness of its innovators and entrepreneurs,” said Johnston. “For the better part of two years, the MMA PFAS Work Group has worked tirelessly to provide a response to these rules, offer input and devise commonsense strategies for moving forward on a proper PFAS standard.”

In late 2019, the Association commissioned an independent, technical peer review of the proposed rules and offered public and formal written comment in January 2020.

MMA continues to highlight the concerns raised as a result of this review; concerns which were not addressed by EGLE or SAW or asked to be resolved by Michigan’s Environmental Rules Review Committee (ERRC). Issues including the scientific and technical credibility of proposed rules, the ability of municipalities and their customers to afford adherence with them and Michigan’s overall economic competitiveness when regulations such as these are not aligned with federal and surrounding state standards are all critical questions that deserve answers before rule implementation makes a fix nearly impossible.

MMA’s Independent Peer-Review Study

On 1/30/20, Dr. Michael L. Dourson, Dr. Edward J. Calabrese and Mr. Richard J. Welsh provided a report commissioned by MMA titled Independent Technical Review of the Health-Based Drinking Water Value Recommendations for PFAS in Michigan to offer technical comments on the SAW recommendations to EGLE that were used to establish the health-based drinking water values (HBVs) for PFAS. Since this was the first time that Michigan had established a Maximum Contaminant Level (MCL) without one first being established by the EPA, MMA’s objective was to see that Michigan implemented a sustainable and defensible regulation.

While the work of SAW is considerable and significant, an obvious weakness is the absence of a robust peer review as part of the SAW rule development process. A robust, properly credentialed peer review protocol is required practice for the EPA when it establishes an MCL, and Michigan should follow this example in some credible manner.

“The public’s confidence is achieved by ensuring the integrity and soundness of the process and information used as the solid foundation for setting safety standards,” said Dave Greco, MMA director of regulatory affairs. “Anything less would subject regulators, drinking water systems and others to potential skepticism and lack of confidence in drinking water safety.”

As SAW did not include a proper peer review phase in its process, MMA believed it essential to engage an expert review so as to properly and credibly inform our members of the soundness of the proposed rule set and also to provide SAW with a foundational peer review for ensuring the soundness of the final rules package.

“We understand that Michigan has one chance to get it right, and there is a lot at stake — the confidence of our residents, the effectiveness of the regulations and the health of the state’s economy,” Greco explained. “Michigan cannot and should not find itself in such a position, especially in light of PFAS rule-related litigation and implementation delays being experienced in other states that have failed to properly underpin standards and account for costs.”

Critical Shortcomings in State Report

In the report, it was identified that the SAW recommendations used to establish the standard lacked the kind of robust scientific and technical integrity to fully complete the state’s goal.

“It is in the best interest of Michigan, its manufacturing sector and the individuals and communities that rely on clean drinking water that the state follow the lead of the EPA when setting standards,” said Greco. “This ensures that those standards are scientifically credible and defensible, avoid overreach and prevent Michigan from losing economic competitiveness by finding itself out of step nationally or with other states.”

MMA’s independent peer review identified five critical shortcomings in EGLE’s proposed rules:

  1. Key studies were not referenced or discussed by the Science Advisory Workgroup (SAW) in its risk assessment calculations.
  2. Significant data gaps and scientific uncertainty are evident in SAW’s calculations.
  3. Curious conclusions and assumptions are evident in calculations for the HBVs.
  4. SAW deviated from accepted standard practice when developing its MCLs.
  5. An inadequate assessment of the compliance costs of the proposed rule that, ultimately, the public will bear, and this could weaken acceptance and support for the proposed criteria.

“With this being the first instance in Michigan of pursuing an MCL ahead of EPA input, any proposed rules at the state level must be ‘regulation ready’ and that means providing necessary clarity, consistency and certainty,” said Johnston. “It also means that the state must rely on settled and established science as the foundation for developing regulatory standards and properly consider the significant costs such a rule could have on local communities, citizens and employers.”

MMA’s Key Recommendations

Based on the findings of the independent peer review, MMA advocates for four clear recommendations which, if implemented, would allow Michigan to be viewed as a credible leader in PFAS-related safe drinking water standards.

Ensure public confidence in the process
SAW should address and resolve any key scientific uncertainties and shortcomings that have been identified during the public comment period and subsequent to the development of proposed rules. MMA trusts that the peer review information provided in the report will assist EGLE in addressing some of the information gaps and questions that remain.

“As the EPA has historically developed MCLs, it remains best equipped in both resources and expertise to address these complex public health questions,” said Greco. “The EPA remains engaged in addressing the PFAS issue and, in order to best ensure public confidence and the protection of human health, the state should consult and incorporate research conducted by the EPA and others to enable Michigan to access critical new findings as PFAS science evolves.”

Rely on settled science to develop MCLs
Michigan should rely upon universally settled science when developing MCLs and ensure that Michigan is using a scientific community-consensus database. EGLE refrained in this rule set and should continue to refrain from developing MCLs on a class basis due to the unique and varying effects of different PFAS constituents. As the body of scientific knowledge on exposure continues to grow, Michigan should reassess its previous determinations, consider adding or removing other individual PFAS constituents or modify the compliance requirements.

“There is a significant lack of settled science on PFAS. Among both scientists and governments, there is still considerable debate about what constitutes safe dose exposure,” Johnston explained. “Our commissioned report identified a 500-fold difference in projected safe dose levels between Australia’s 160 parts-per-trillion (ppt) and the safe dose level of 1,500 ppt in the UK.”

Recognizing and understanding that the SAW had a more than 40,000-fold difference in safe doses based on the different PFAS constituents, EGLE should not use SAW’s proposed levels as an automatic trigger for a point of violation as is proposed in the draft rule set. Rather, MMA has continued to present an alternative plan that is a slight revision to the proposed rules and uses SAW’s report to set monitoring, attainment and maintenance requirements through regular screening as empowered under the Safe Drinking Water Act. This would ensure continued sampling while also utilizing state and federal data and standards over time, meaning water systems could continue to ensure safe drinking water through sampling and putting a plan in place to ensure that the system has safe drinking water rather than triggering a shutdown of the system if an exceedance is recorded.

Lead with regulation-ready rules
It is imperative that the rules being promulgated are legally defensible and provide clarity, consistency and certainty. The rule set must also establish the proper mechanisms to ensure that EGLE, individuals, communities and industry can understand, adapt to and comply with the rules.

“Regulation-ready rules must include a screening and review process, as well as a site-specific plan approach for any testing site that registers a level that results in further action,” Greco said.

Fully account for the cost
EGLE must properly account for the costs to be incurred by employers, municipal water systems and their citizens by identifying the cost for retrofitting of existing municipal water supply systems of differing scale, costs as they relate to Industrial Pretreatment Programs and for disposal cost elimination of PFAS material remaining after treatment. The Regulatory Impact Statement (RIS) also did not appropriately account for the ongoing operating costs, including a full assessment of the compliance monitoring costs, for municipal systems or the impact and cost the rules would have on Michigan’s Part 201 clean-up program. Lastly, SAW should fully identify and consider costs when establishing HBVs, which does not appear to have been included in the overall assessment.

“While EGLE did include some minimal estimate of the costs when preparing its RIS, SAW failed to provide a similar analysis. As a result, SAW failed to analyze the quantifiable and non-quantifiable benefits that are likely to occur as a result of compliance with the proposed standards,” said Johnston. “The lack of a complete accounting for the cost of any proposed drinking water rules is of major concern for the public and the regulated community to understand the benefits of this proposal relative to the costs all will be asked to bear. The State should not move forward without fully knowing and accounting for the financial impact on communities and their citizens of the cost of implementing safe drinking water standards.”

Next Steps

The next step in the rules process involves the legislature’s Joint Administrative Rules Committee. MMA is encouraging the committee to review the additional question raised by the ERRC and contained in the letter sent to JCAR by ERRC Chairman Rob Nederhood.

“We find it very interesting that the ERRC voted to move the process along, but also sent a very detailed list of questions about the underpinnings of the scientific conclusions of the workgroup,” said Johnston. “There are several outstanding scientific questions deserving attention to ensure we are relying on settled science.”

For more information on PFAS, the process to a workable drinking water standard and more, members are encouraged to join the MMA PFAS Work Group or contact MMA’s Dave Greco, at 517-487-8543 or greco@mimfg.org, to get involved.

Contact Brett Gerrish

Brett GerrishCommunications Coordinator
Call 517-487-8533
E-mail gerrish@mimfg.org

Sources:
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