Home > Uncategorized > Running The Regulatory Gauntlet – A Dispatch from the Weeds

Running The Regulatory Gauntlet – A Dispatch from the Weeds

How Your Health Is Compromised by Industry Lobbying and DEP’s Big Stall

Why Recent Actions on PFOA and Chromium Are No Change

[Update below]

Regulatory policy is an exceedingly wonkish topic – and the development of protective standards is perhaps the most esoteric aspect of regulation – but it is literally a matter of life and death.

Understanding how the regulatory game is played allows one to influence outcomes, like whether you and your loved ones are exposed to and sickened by toxic chemicals.

That’s why Tony Russo of the NJ Chemistry Council started monitoring last week’s Drinking Water Quality Institute (DWQI) meeting, and why Dupont consultants made a presentation to the DWQI on August 7, 2009. 

Russo’s industry members own the costly cleanup liability for the hundreds of toxic chemicals that pollute our air, soil, water, wildlife and the human body itself.

The last thing the Chemical Lobby wants to see are strict DEP environmental and public health standards – or for DEP to adopt the European Union’s Precautionary Policy for chemicals, known as REACH.  Russo and Company want any drinking water standards reviewed by the new industry dominated Science Advisory Board.

But I’m getting way ahead of myself here, so let me take a step back and explain.

In light of last week’s Drinking Water Quality Institute (DWQI) meeting, I’d like to touch upon recent regulatory steps on two cancer causing toxic chemicals that illustrate how public health is compromised by the broken process I will call The Regulatory Gauntlet.

Following last Friday’s DWQI meeting, I criticized the DWQI for failing to support a new precautionary treatment based approach to setting drinking water standards for over 500 chemicals known to be present in drinking water. Based on DEP’s own studies, which have been underway for over 13 years, we recently petitioned DEP to adopt regulations. DEP announced a plan to do that back in 2004, but shelved that plan.

I also blasted the DWQI for failing to hold DEP accountable for not implementing several prior DWQI recommended standards (known as MCL’s for “Maximum Contaminant Levels”) for numerous toxic chemicals, including:

I was disgusted that the DWQI failed to take any action or follow-up or engage on any of this.

However, on Friday (9/10/10), the Health Effects SubCommitee of the DWQI made recommendations on two longstanding controversial chemicals, PFOA and hexavalent chromium.

Some people now are exagerating the significance of these recommendations, which, in reality, do not change the scientific or regulatory status quo and instead will lead to years of additional delay before enforceable standards are in place.

In fact, these two recommendations are superb illustrations of precisely how and why the regulatory system is badly broken.

To show why this is the case, first I will explain exactly what the Health Effects SubCommitee recommended and discuss its significance; second, I will provide  quick overview of the  chronology thus far; and third, outline the 15+ steps of the regulatory process going forward.

I will show how this regulatory process provides multiple opportunities for industry lobbying to intervene to derail, weaken, or delay DEP action, as well as multiple excuses for DEP not to take action.

I)  Hexavalent Chromium and PFOA

What the DWQI Health Effects SubCommittee actually did and what it means

The Subcommittee did two things on Friday 9/10/10.

First, for hexavalent chromium, they recommended a Health Based Maximum Contaminant Level (HBMCL)  of 0.07 ug/L (or 0.07 parts per billion).

The 0.07 HBMCL is based upon a risk assessment by Dr. Allan Stern of DEP (i.e the 0.5 mg/kg/day oral slope factor). Stern completed this work in April of 2009. We disclosed that work even before DEP publicly released it.

So, scientifically, there was no change in the status quo by the DWQI SubCommittee recommendations.

In May 2009, Jersey City based ICO and the NRDC petitioned DEP to develop soil cleanup standards based on Stern’s risk assessment.

Stern’s work translates into a soil standard of 1 part per million, which is from 20 – 240 times lower than the DEP current voluntary chromium policy of 20 ppm and the 240 ppm residential regulatory soil cleanup standard

(Note: Groundwater standards incorporate the drinking water MCLs. But translating groundwater standards to soil cleanup standards is complex. According to DEP April 2010 policy, impact to ground water soil standards are site specific and must meet a 70 ug/L  groundwater quality standard for total chromium, assuming that all is hexavalent. So the recommended 0.07 ug/L HBMCL could be 1,000 times lower than current policy. New regulations would be required to clarify and enforce this change).

DEP denied the ICO/NRDC petition in June 2009, in part on the basis that DEP was then conducting a review of the technological feasibility of imposing a health based chromium standard based on Stern’s risk assesment. DEP stated:

Consistent with the Safe Drinking Water Act requirement at N.J.S.A. 58:12A-13b to “adopt rules and regulations which develop, within the limits of medical, scientific, and technological feasibility,” the Department must develop and require the use of appropriate testing techniques to ensure that all parties can accurately measure health-based standards. The Department’s scientific and technical experts are undertaking this process at this time for hexavalent chromium. (DEP denial at page 2)

DEP then issued a June 12, 2009 press release that explained that petition denial and projected a new hexavalent chromium soil standard would be “in place by early 2011″.

Second, for hexavalent chromium, the SubCommittee referred the recommended HBMCL to the Testing SubCommittee and the Treatment SubComittee for review.

However, just like the science, this recommendation does not change the status quo because DEP said that they already were conducting exactly this same review back in June 2009 when DEP denied the ICO/NRDC petition – see the above quote.

The DWQI Testing and Treatment SubCommittees review the HBMCL to determine: a) Testing: whether current technology is available to reliably detect and quantify levels of chromium at or below the recommended HBMCL standard, and b) Treatment: whether technology is available to treat drinking water to meet the recommended HBMCL.

On PFOA, the Health Effects SubCommitee recommended a HBMCL range of 0.01 to 0.04 ppb. This range includes a lower value than the current Voluntary Guidance value of 0.04 ppb. The Health Effects SubCommittee also referred that range to the Testing and Treatment SubCommittees for review.

[Clarification – technically, the Health Effects SubCommittee did not make a recommendation. Here is exactly what the did, from the memo distributed at the meeting:

The health effects subcommittee is in the process of developing a health based MCL for PFOA.  While the health effects subcommittee has not completed its review, potential health based MCLs under consideration are in the range of 0.04 ug/L to 0.01 ug/L, or as low as reasonably achievable. 

At this time, the health effects subcommittee is  recommending that the testing and treatment subcommittees begin their review to identify analytical or treatment issues that might affect health based MCLs within this general range.  As you are aware, such analytical or treatment limitations could impact the DWQI’s recommendation for a PFOA MCL. “

Both Testing and Treatment processes inject months or years of delay, and provide multiple oportunities for industry to intervene and challenge DEP science.

This review process also could include new research on analytical methods and laboratory certification requirements, because of a lack of EPA or DEP approved methods. For example, we understand that EPA approved method can detect chromium below 65 ppt, but would need to be modified for NJ chromium standards, which require a PQL (don’t ask, but a PQL is the level that can reliably be quantified for enforcement purposes. The detection level is typically 5-10 X lower than the PQL).

Let’s now move on to overview the complete step by step process.

II)  The Regulatory Gauntlet – the process going forward

The following is the sequence of events that describe how the MCL adoption and implementation process works.

1) The Health Effects SubCommiteee reviews the science, documents occurance of a chemical in drinking water, conducts a health risk assessment and then recommends a HBMCL. This is a process that typically takes years.

After that, other DWQI SubCommittees conduct a technological feasibility review of the recommended health based level to determine if it is technologically feasible to achieve.

This process often becomes the back door for industry compliance cost and political considerations to pollute the science and engineering considerations to undermine the stringency of the recommended health based standard.

2) The Testing and  Treatment SubCommittees then make recommendations to the full DWQI as to whether the HBMCL is technologically feasible and what the final MCL should be.

Those recommendations could include the need for new methods development and amendments to the laboratory certification regulations. These sidesteps themselves could take years.

3) The full DWQI then reviews all the SubCommittee recommendations and makes a decision about whether to recommend an MCL to the DEP Commissioner and what the level should be.

Last Friday, the DWQI refused to set a date for this decision on PFOA or chromium, but they meet quarterly so it could take many months.

4) After receiving the DWQI recommendations, the DEP Commissioner then decides whether to issue MCL regulations. There is no deadline for this step – it typically takes years. For example, the arsenic MCL took several years and the DWQI made recommendation for MCLs for radon, perchlorate and 30 other MCLs that were ignored and never adopted by DEP.

5)  Under Governor Christie’s Executive Order #2, BEFORE DEP can take regulatory action, the DWQI recommended MCL must then undergo two more types of review that can take months or years and also provide opportunities for industry to challenge DEP.

EO # 2 requires:  a) a cost benefit analysis; and b) a federal standards justification if the MCL is more stringent (i.e. lower) than current federal standards. This step could take many months – there are no timeframes.

6) After these two new reviews, the DEP Commissioner then decides whether to propose a regulatory standard and at what level the standard should be set. Add several more months.

The Commissioner has 3 options:

  • a) he/she can decide to do nothing (as Commissioner Martin has done by ignoring DWQI recommedations on perchlorate, radon, and 30 other chemicals);
  • b) he can accept the DWQI recommendations and propose new regulations; or
  • c) he can modify the DWQI recommendations based on his own review (including the new cost benefit test) and propose a regulation that relaxes (i.e. weakens) the DWQI recommendation.

7) If the Commissioner decides to propose rules, he establishes and tasks an internal DEP rule development committee of DEP staff that actually writes the regulation. This takes 3-6 months or so.

8. The staff draft rule undergoes DEP internal management review and approval, including review by political appointees that have no science or engineering training or education. Add several months more.

9) The staff draft is approved by the DEP Commissioner, conveyed to the Office of Administrative Law, and proposed in the NJ Register for public comment. Add 6 months to 1 year.

10) The DEP rule proposal is submitted upon NJ Register publication to the legislature who can kill the proposal via a finding that it is inconsistent with legisaltive intent. In practice, Legislators also often intevene behind the scenes with the Governor’s Office and/or the DEP Commissioner to kill, delay, or weaken rules before they are even proposed.

11) Based on public comments on the proposal (and industry criticisms), the DEP Commissioner then decides to abandon or adopt the proposed regulation.

But before acting,, the DEP Commisisoner must first brief and  receive approval by the Governor’s Office for any significant regulation (e.g. significant in terms of political opposition, industry opposition, or compliance costs). Industry uses this Governor’s Office political approval requirement to kill, delay, or weaken DEP adoption of rules. They do this by lobbying the Governor’s Counsel, head of Policy,  and/or Chief of Staff.

12) Additionally, under Governor Christie’s Executive Order #2, the Lt Governor can intervene at any stage of this rule development process, prior to rule adoption.

13) In the event that the DEP Commisisoner adopts the regulation, the MCL becomes an enforceable standard.

14) However, we’re not nearly done yet in terms of enforcing the standard and changing current conditions on the ground.

Industry can appeal the standard in two venues: a) before an administrative law judge in OAL for a trial type hearing, a process that can take several years; or b) in courts, before a judge, another process that can tie a rule up for years.

15) should the rule escape or survive industry legal challenge, it then become an enforceable standard. But its still not over yet.

The standard is not actually fully implemented until facility permits are modified and toxic site cleanup plans modified and approved. This typically takes 2-5 additional years to occur (and often, the fine print of the rule provides many loopholes, grandfathering, and exemptions for existing permits.)

And to cap things off, each individual facility permit and toxic cleanup plan is subject to similar legal and scientific challenges, possibly adding years more delay after the standard is actually legally adopted (and DEP would need to adopt the “impact to groundwater” standard they recently abandoned before most cleanups would be impacted by the new MCLs).

So there it is in all its glory – The Regulatory Gauntlet.

This is what industry pays high priced lobbyists and consultants to manipulate.

That is why the Precautionary Policy and a Treatment Based Approach are far preferrable to the current practice of individual chemical by chemical risk assessment based drinking water standards.

Feel safer now?

III) DEP History Does Not Inspire Confidence

Successful completion of all of the above steps relies upon a critical assumption: that DEP is aggressively seeking to protect public health and  supports strong  regulation of industry.

But a cursory overview of the history does not inspire confidence or validate that assumption. In fact, just the opposite. 

Thus, the cumbersome and complex Regulatory Gauntlet becomes the political cover and excuse for inaction and delay. Thumbnail history:

1) Hexavalent Chromium

Hexavalent chromium is a known human carcinogen. (See DEP Chromium website for documents).

DEP has failed to adopt cleanup standards for chromium for many years. There are about 185 toxic chromium sites in Hudson and Essex County, a big problem in Jersey City.

Lawsuits and pressure from local activists  finally forced DEP to establish a chromium Task Force way back in 2004.

We released a DEP whistelblower report on that Task Force work back in 2005.

Almost 7 years later, DEP still has not adopted soil, groundwater, or drinking water standards for this potent carcinogen which poisons communities surrounding 185 toxic waste sites in Hudson and Essex Counties.

Worse, as noted above, in June of 2009, DEP denied a petition filed by Jersey City based Interfaith Community Organization (ICO) and the Natural Resource Defense Council (NRDC) that would have forced DEP to adopt soil cleanup standards based on DEP’s own science, which was finalized in April 2009.


The history of  PFOA is better than chromium, but the botom line is that DEP science is far ahead of DEP regulation.

There have been years of delay and behind the scenes attacks by Dupont. Here’s a thumbnail sketch:

DEP issued a PFOA risk assessment and Voluntary Guidance on February 13, 2007. The Guidance value was set at  0.04 ppb.

You can find all this information of  the DEP’s PFOA web page.

The US EPA then issued a provisional drinking water advisory on January 8, 2009. The non-enforceable EPA advisory is 10 times higher than DEP’s,  0.4 ppb

Since then, Dupont has been pressuring DEP behind the scenes (see this).

On September 10, 2010, the DWQI Health Effects SubCommittee recommended a PFOA HBMCL range of  0.01 – 0.04 ppb.

End of story?

No way, just the beginning of the fight to get the DEP science implemented and standards adopted.

[Update – 9/16/10 – Ed Rodgers of NJN TV covered the story last night – to watch, hit this link and then click on “Water Contaminants“]

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  1. September 17th, 2010 at 13:05 | #1

    CLEAR AS MUD! Dr. Max Costa: Exposure of humans to ANY amount of Chromium VI, whether by inhalation, ingestion, or on the skin, SHOULD ALWAYS BE AVOIDED!!!! #ZEROTolerance

  2. September 17th, 2010 at 13:08 | #2

    @Leslie Scales
    Who was it who said – I didn’t have enough time to write a clear concise post!

  3. September 17th, 2010 at 13:10 | #3

    @Leslie Scales

    BTW: I strongly agree with it, so I await your proposal on how to enact and implement a zero tolerance policy!!

  4. Zoe Kelman
    September 17th, 2010 at 16:48 | #4

    I wonder how fast the Governor and Commissioner would adopt standards and prosecute these companies if they had family members living near either a DuPont PFOA site or a Honeywell chromium site. Its sad that it has to become so personal but they have to be reminded that their job is to protect public health and the environment not their private interest. They should be sued along with DuPont by the community group to wake them up.

  5. September 18th, 2010 at 01:25 | #5

    We found 49 ppb chromium in our son’s vomit, and 13 & 17 ppb in the creek water from which he took two sips. (Baechtel Creek, outside Willits, Calif.) Calif. courts ruled our son’s death was from chromium. Also given that authorities destroyed any samples from his body, and that a minimum lethal dose is, to my knowledge, unknown, this amount must be assumed to be lethal. Also, all standards in use were calculated based on studies of adult males, not women, children, etc. Rep. Markey addressed this in a recent BP hearing. Documents in our case state, “additional data (e.g. exposure on children) would be useful.” To Whom? Not to any of the people being experimented upon! How to Implement zero tolerance is another issue. How to ‘clean it up’? You just have to stop using any soil or water that is contaminated.

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