WolfeNotes.com

[Update: 4/25/23 – I got played by Highlands Council Ex. Director Spinelli (and simply stonewalled by Highlands Coalition Director Julia Somers). Not really. I knew the game that they played from the get go. It was merely confirmed today. Here’s the tale in a nutshell.

Yesterday afternoon, ED Spinelli finally sent me the “Policy Standards” document adopted by the Council last week. Apparently, that document was not available to the public BEFORE the Council deliberated on and adopted it. How do they get away with that?

Well, after reading NJ Spotlight reporter Jon Hurdle’s praiseworthy puff piece today,  I now understand.

The game is called shut out the critics and marginalize and keep the local activists – who face warehouse developments that the “Policy Standards” do nothing to stop – in the dark and under control. Control the message and manage the news. It’s an old and disgustingly maipulative and dishonest game they play. I sent Ben this “congratulatory” note:

Ben – touche! Excellent message control and news management!

After reading NJ Spoltight story today, I now understand why Julia at HiCo failed to alert all the local activists (including myself) and you provided the policy just yesterday, after Hurdle had written his story. So much for public participation and democracy.

Another low in NJ government (and I was occupied by the DEP budget hearing yesterday so didn’t even get a chance to review your “policy standards” yet).

Wolfe ~~~ end update]

Completely out of the blue, less than 24 hours before tomorrow’s Highlands Council meeting, via an email group of north jersey local activists, I just learned that the Council will consider “policy standards” for warehouses.

Item #8 on the meeting agenda vaguely provides:

a. Policy Standards for Warehousing in the New Jersey Highlands Region

The Highlands Council is an independent regional land use planning and regulatory agency that implements the Highlands Act through planning and regulatory powers.

So, despite having been involved in drafting that Act, I’m not sure just what “policy standards” are. Oh well.

If this is a serious planning initiative by the Council, given the Statewide prominence of the warehouse controversy, I’m surprised that there has not been some major heads up by the Highlands Coalition – you know, something like a press release, press event, action alert, and policy paper that such an important policy and Council agenda item deserves.

What the hell is the Highlands Coalition doing?

So, consider this a heads up I feel obligated to provide.

I sent this question to Executive Director Ben Spinelli and reporter Jon Hurdle at NJ Spotlight who has been covering the warehouse issue (the same question posed to Julia Somers and Elliott Ruga at the Highlands Coalition, who should be active and high profile organizing around this):

Ben – Question on agenda for tomorrow.

Where did this come from and where can I find the background documents? What kind of “standards” are under consideration?

Agenda item #8

a. Policy Standards for Warehousing in the New Jersey Highlands Region

https://www.nj.gov/njhighlands/about/calend/2023/apr20/agenda_apr20.pdf

Wolfe

[Update: 4/20/23 – Executive Director Ben Spinelli graciously provided this timely and helpful reply (a lot more info than the folks at the Highlands Coalition provided). We’ll get back after we digest the material, but be advised that the meeting is at 4 pm today at Council HQ in Chester (in person, no zoom):

We have prepared a Highlands supplement to the OPA warehouse guidelines. They are intended to provide guidance to both Highlands municipalities and state agencies when considering warehouse proposals in the region. They highlight the protection of Highlands resources and the various other planning elements that must be accounted for when there is an application anywhere in the Highlands. Our position is that warehousing in the Highlands needs to be addressed differently (or more thoroughly) than in other areas of the state and the priority of protecting the region’s resources needs to be paramount. We took this step because these resources are not adequately addressed in the state guidelines beyond a simple statement advising that the RMP should be considered.  The aim is to increase the influence of the Highlands RMP in the Planning Area-which we are actively engaged in pursuing in several different policy areas- with warehousing obviously being one of the issues that we needed to catch up to (and try to get ahead of ) when I walked in the door here at the Highlands. What stood out to me, and I’m sure you’re well aware of this too, is that the Planning Area along Route 78 is particularly vulnerable to inappropriately sited warehouse development, and this is our attempt to use whatever tools we can to remedy or reduce that vulnerability.  There will be a detailed presentation at today’s meeting.  If the council approves, (and I have no reason to believe that they won’t) the document will be available following the meeting today. I’ll have staff (Carole) send you a copy of the document when the meeting is over this afternoon-assuming its released.

DEP Deserves Tough Questions

Enforcement fines and permit fee revenue declined by $45 million (30%) from FY’22 

From Billions In Carbon Pollution Subsidies To Mismanagement Of State Lands

DEP’s Budget is up before the Assembly Budget Committee on Monday April 24 at 1 pm.

So, to hopefully spur some critical effort by NJ environmental groups and perhaps even generate media coverage (and encourage something other than the routine softball oversight questions), I just sent the below letter to the budget Committee chairs, urging oversight.

I’ve previously written to oppose diversion of $700 million of federal COVID pandemic relief funds ($1 billion so far), especially when NJ’s public health system is broken and underfunded.

And why are corporations getting a $400 million tax cut, which slashed over $36 million from open space and DEP environmental programs?

I focused primarily on natural resources, and intentionally left out the standard diversion of Clean Energy Fund revenues – absurd at a time of a record $10 billion surplus – and extension of the $300 Million PSE&G nuclear subsides for Doug O’Malley and Tom Johnson to rant about the so called high price of renewables.

Legislators also might want to ask why NJ has not demanded, during RGGI update renegotiations, that the paltry RGGI carbon allowance price ($12.50/ton) be increased to reflect the Social Cost of Carbon. 

The current RGGI allowance price results in billions of dollars of subsidies to fossil fuels. If NJ can not negotiate that increase with the other RGGI States, then DEP could unilaterally impose a carbon emission permit fee based on the SCC. Failure to do so provides BILLIONS of dollars of subsidies to NJ carbon polluters.

And has DEP accelerated the expenditure of RGGI revenues?

• After Gov. Murphy Repeatedly Touted The Importance Of NJ Rejoining RGGI, DEP Has Spent Less Than 1% Of Over $250 Million Collected

In a presentation to Senator Smith’s Forestry Task Force, DEP stated that they were developing a carbon credit and trading scheme for NJ’s forests. That is a huge policy issue that involves millions of dollars and would take legislation. Commissioner LaTourette must be asked about that.

[Update – DEP budget also raided the Spill Fund for $11 million for administrative (staff) costs.]

Here’s my letter:

Dear Chairwoman Marin and Chairman Sarlo:

I am a retired DEP planner and former Policy Director at Sierra Club, NJ Chapter.

For your information, I submit the following material of relevance on 5 specific issues regarding the DEP budget and urge budget committee oversight.

Please ask DEP Commissioner LaTourette:

1) DEP Ignores Economic Value Of Natural Resources

Why has DEP abandoned and failed to implement their own studies? Taxpayers are being ripped off:

• THE ECONOMIC VALUE OF NEW JERSEY STATE PARKS AND FORESTS

“we can confidently state that New Jersey derives very substantial economic benefits from its State parks, forests, and recreation areas, and on economic grounds alone these sites deserve to be preserved and protected. The extent of that preservation and protection depends on many things, some of which are not under human control. However, as a primary actor in the on-going effort to protect and enhance these valuable natural assets, NJDEP has a major responsibility and impact, and the resources it deploys clearly earn a substantial return on society’s investment. The State parks, forests, and recreation areas are not assets that New Jersey can afford to lose; they are in most cases irreplaceable, and their protection merits the constant attention and stewardship of the public officials and residents of New Jersey. (page 55)

DEP also issued this report:

• Valuing New Jersey’s Natural Capital: An Assessment of the Economic Value of the State’s Natural Resources

Section III of that Report shows, inclusion of certain ecosystem services provided by New Jersey’s forests could add between $630 and $840 million of benefits annually (present value $21-28 billion). (page 5)

DEP’s scientists and economists found that NJ’s forests provide huge “ecosystems services” and that the value of preserved forests far exceeds logging or “actively managed” forests:

“Valuation of Specific Ecosystem Services Preservation of parks and forests can yield substantial economic benefits in the form of ecosystem services. In fact, ecoservices such as watershed protection and carbon storage can be more valuable than forest products such as wood pulp and timber.”

“A 1997 study in the highly-regarded peer-reviewed journal Nature estimated the value of forest hydrological services at $92/hectare/year in 1994 dollars, including $87 for waste treatment, $3 for water supply, and $2 for flow regulation Costanza et al. (1997). Converting this to U.S. measurement units and 2004 dollars, we obtain a value of $47/acre/year. The 1997 estimate was based on the damage costs incurred when deforestation leads to reduction in water quality or fisheries production, the market value of water lost to reduced quality created by deforestation, and the replacement cost for natural decomposition of wastes.” (see p.30-31)

2) DEP Leases of State Land Fail To Reflect Market Based Value

OLS has also conducted at least 3 audits of the DEP’s leases and concessions program and made negative findings. Over a decade ago, the Legislature directed DEP to Report on the fair market value of State land leases and concession, yet DEP has failed to renegotiate leases to reflect current market value. As result, the State is losing millions of dollars, see:

• Christie Parks Funding Policy: Oil & Gas Pipelines and Electric Transmission Lines Get Cheap Leases, While River Tubers, Kayakers, and Boaters Pay New Fees

3) Natural Resource Damage Program Needs Transparency & Regulatory Standards

NJ Courts have rejected DEP NRD lawsuits because DEP failed to adopt science based enforceable standards and economic valuation methods. DEP was required under a judicial consent order to adopt NRD regulations, but has failed to do so. Some suggest that this legal weakness lead to Gov. Christie’s notorious 3 cents on the dollar Exxon settlement. (NJ Law Journal):

… some lawyers and environmental advocates said the state’s failure to adopt a methodology for calculating damages for harm to natural resources through the formal rule-making process—as it committed to do more than a decade ago when it settled another suit—may have weakened its negotiating position and led to a lower settlement in not just the Exxon case but in other natural resource damage suits it has brought. …

A March 23, 2003, letter from deputy attorney general Richard Engel to Picco said the DEP “has long planned to promulgate regulations to improve the current Natural Resource Damage program” and “is currently developing its regulatory proposals, and plans to file one or more rule proposals prior to Aug. 1, 2005.” [end NJLJ]

The DEP is relying on private legal Counsel to litigate “Natural Resource Damage” (NRD) lawsuits, yet they have denied my OPRA requests for information regarding how much those law firms are being paid, see:

• Legislators Asked To Force Disclosure Of Private Law Firm’s “Bounty” For $9.5 Million ExxonMobil NRD Settlement

The voters approved a referendum to constitutionally dedicate NRD revenues, yet the budget does not include any NRD recovery revenues, despite DEP filing 20 NRD lawsuits (and just one settlement).

DEP entered into a NRD settlement agreement with BASF at the Ciba Geigy Toms River Superfund site, yet that settlement failed to include economic compensation. Why?

4) Budget Shifts Burden From Polluters To Taxpayers

It appears that the DEP is shifting the revenue burden from polluters to taxpayers via the General Fund (and federal funds).

Specifically, enforcement fines and permit fee revenue declined by $45 million (30%) from FY’22 – FY24.  (from $151,178,000 to $105,890,000)

What explains that?

Has DEP abandoned enforcement and longstanding polluter pays policy?

5) DEP Forest Management Program Is Broken

Finally, the DEP’s management and logging of State lands has been a longstanding controversy. The recent case of DEP’s clearcutting of wetlands in the Glassboro Wildlife Management Area is just the most recent example. Senator Smith created a Forestry Task Force, who delivered their framework recommendations in January. Senator Smith has announced pending reform legislation.

According, I recommend that the Committee include budget language to impose a moratorium on DEP Forest management projects until Senator Smith’s Legislative Task Force recommendations are adopted in new legislation. Senator Smith stated that he will introduce a bill in June.

The people and taxpayers want to know why they are being ripped off and their natural resources mismanaged.

I am available to provide further supporting information or clarification upon request.

Respectfully,

Bill Wolfe

Mingus Mountain, Prescott National Forest

Montanan George Ochenski explains what’s goin’ on:

• Springtime in the Rockies: Conservation and Renewal

[Update: 4/19/23 – Walked in Woodchute Wilderness today – unusual “wilderness”:

Woodchute Trail #102 was established along what was once a bulldozer track on the south side of Woodchute Mountain. The bulldozer was used to create several cattle watering tanks. The ponderosa pines along the trail are all second growth. The original forest was cut down when the copper mines at Jerome were in operation and loggers came to this mountain to harvest shoring timbers for the mines. They transported the logs by way of a chute extending down the north side of the mountain to loading platforms for the narrow gauge railroad that served Jerome. It is from this chute that the mountain and trail take their name. The narrow gauge railroad is now Forest Road 318, which marks the end of the Woodchute Trail #102.

There are splendid views in all directions from the top of Woodchute Mountain. From the south trailhead, it is a fairly easy 2.3 mile climb, with an elevation gain of only 600 feet. The elevation difference between the summit and the north trailhead, however, is over 2,000 feet. There are some steep switchbacks on this side.

This trail is within the Woodchute Wilderness. Motor vehicles and the use of any mechanized equipment, including bicycles, are prohibited. Wilderness is an important resource and national heritage—please, leave no trace.

DEP Will Rely Exclusively On Pollution Controls

DEP Not Required To Consider And Can Ignore Legally Meaningless Local Comments

Overburdened Communities And EJ Activists Were Duped

[Updates Below]

The Murphy DEP issued another self congratulatory press release today announcing the adoption of the proposed environmental justice regulations.

I am reading the 398 page DEP adoption document and response to public comments right now, so will limit my writing now to get out a crucial issue that proves – in DEP’s own words – that the EJ regulations are toothless (and actually LESS stringent than the statute).

Let’s hope the “journalists” out there read the documents – not just the DEP press release – and talk to experts, not just Murphy DEP cheerleaders.

Below is text from the documents that exposes DEP’s claims that the law prevents them from denying permits

(In fact, contrary to DEP’s claims, the statute actually authorizes DEP to deny permits for new facilities. The law does not provide authority to DEP to deny renewal of existing permits for existing facilities. DEP admits this too: (@ p. 120)

This limitation of DEP power to deny permits to existing facilities is actually WEAKER than current environmental laws, which provide clear authority to deny or revoke permits for facilities that are creating unacceptable risks or impacts. Great job EJ activists!)

[Note: The “technical feasibility” standard in these rules to determine the stringency of pollution controls is WEAKER than current NJ Air Pollution Control Act’s “advances in the art of pollution control” standard (also referred to as “State-of-the-art” or SOTA.

DEP explicitly grandfathered existing pollution sources from more stringent requirements (p. 316)

In this response, DEP announces a major policy concession: that DEP will never deny permits, – for existing facilities, expansions, AND new facilities – but instead rely exclusively on pollution controls (and mitigation).

In response to critical comments by the business community, DEP admits this on page 52-53:

“the adopted rules do not prevent construction of new facilities or continued operation or expansion of existing facilities in overburdened communities. Rather, the procedures set forth in the rulemaking seek to fully and accurately assess facilities’ impacts to baseline environmental and public health stressors in overburdened communities and implement appropriate and feasible conditions necessary to avoid disproportionate impacts. As set forth in the notice of proposal, 54 N.J.R. 985-986, the Department does not anticipate that the adopted rules will prevent construction of new subject facilities provided the proper environmental controls are instituted to avoid disproportionate impacts upon overburdened communities. Moreover, only certain types of facilities are subject to the adopted rules at all, and existing facilities of those types are only required to comply with the rules when they seek to renew a major source permit pursuant to the Air Pollution Control Act ( APC Act) or seek to expand operations. In both instances,the APC Act specifically prevents the Department from denying applications or preventing continued operation, authorizing only the implementation of protective permit conditions.”

Where does the NJ APC Act say this? DEP does not provide a citation or legal text.

This is absurd. It would mean that a toxic polluter that created unsafe or unhealthy conditions could not be shut down and permits denied. Even DEP’s flawed “acceptable risk” Technical Manual for Risk Assessment very clearly says DEP can deny an air permit if emissions exceed unacceptable risks.

DEP reiterates this totally lame interpretation later in a conclusion on page 55:

Accordingly, the Department does not anticipate that the rules will result in a loss of economic opportunities for covered facilities as speculated by commenters. New covered facilities will not be prevented from being sited in overburdened communities where their operations can avoid a disproportionate impact or if a compelling public interest is shown, and existing facilities are ensured the right to continue or expand operations subject to appropriately protective conditions.

This is a major concession to the regulated business community.

Everyone was duped – this is even a worse interpretation of DEP authority than the law actually provides and makes DEP even worse than the many criticisms I have made.

The law does not authorize DEP to deny a permit renewal for an existing facility – but it clearly provides authority to deny permits for new facilities.

More to follow as I read the documents.

[Update #1 – DEP made another concession and created another large loophole for “public works” projects, which allegedly would reduce stressors. Industry commenters identified these projects, including under pending legislation, as various energy projects and major new pollution sources under the guise of “public-private partnerships”, which would also include garbage incinerators and “micro-grid” fossil power plants: (@ page 62)

Consistent with the Legislative intent to reduce the environmental and public health stressors within overburdened communities due to historic inequities in facility siting, notwithstanding the economic benefits associated with such facilities, the compelling public interest standard allows the Department to consider whether a proposed facility, such as a public works project, would directly reduce adverse environmental or public health stressors in the host overburdened community, thereby serving an essential environmental, health, or safety need of the host overburdened community and provides an appropriate pathway to allow projects that address host community needs, such as appropriately scaled food waste facilities, public water infrastructure, renewable energy facilities, and projects designed to reduce the effects of combined sewer overflows.

And reiterated and expanded this interpretation on page 66:

to provide a level of guidance, the Department expressly provided in the notice of proposal Summary, and in the adopted rules at N.J.A.C. 7:1C-5.3(c), that facilities, such as a public works project, that would directly reduce adverse environmental or public health stressors in the host overburdened community are the types of facilities that are likely to serve an essential environmental, health, or safety need of the host overburdened community. The Department also provided a non-exclusive list of illustrative examples of potential qualifying projects, such as appropriately scaled food waste facilities, public water infrastructure, renewable energy facilities, and projects designed to reduce the effects of combined sewer overflows.

[Update #2 – The introduced version of the EJ legislation included a provision that would allow local governments to veto permits and approvals independent of DEP – i..e vote NO to stop a project. That local veto provision was stripped out of the bill Gov. Murphy signed into law.

The law also included a huge loophole for projects that would provide a “compelling public interest”.

In an attempt to address these severe weakness in the law and enhance the power of local residents, a commenter suggested that DEP change the word “may” to “shall” to force DEP to consider local comments: (p. 96)

Public Input – “May” vs. “Shall”

142. COMMENT: The regulation should be modified from “may consider public input” regarding the public interest exception to “shall consider public input.”

Revealingly, DEP denied that request and is not required to consider local comment, and they did so with incredible bureaucratic gaslighting: (p. 98

Given the criticality of ensuring that this provision remains narrowly tailored to maintain the integrity of the adopted rules, the need to assess the relativity and credibility of public interest related to a specific application, and the infeasibility in establishing an appropriate numerical standard to gauge public interest, the Department believes the more permissive “may” rather than a mandatory “shall” is appropriate to provide the Department with the necessary flexibility to assess public interest and consider it as a determinative factor in its assessment of compelling public interest only where appropriate. This provides the appropriate balance in providing communities self-determination while maintaining the Department’s statutory decision-making authority. To maintain this balance, the Department is committed to considering all public input and will heavily weigh significant opposition or support for any given project from individuals in the host overburdened community in its decisions under the adopted rules.

What this does is make public comments legally meaningless and unenforceable. It provides unbounded discretion to DEP to ignore or not really respond to public comments.

The DEP is given the sole power to “assess compelling public interest” and your comments don’t legally mean jack shit.

That’s all you need to know – DEP will allow the public interest loophole to be exploited and will ignore local opposition and outrage.

Duped again! Strike 3, you’re out.

[Update #4 – this is another quiet loophole – garbage transfer stations that use rail: (@ p. 125)

Comment: DEP’s regulations require the registration and licensing of intermodal container facilities, so these facilities must obtain the “permit, registration, or license issued by the department” that triggers the EJ Law process. Thus, DEP’s final EJ Rule should make clear that these intermodal container facilities are also covered by the EJ Law

RESPONSE  

The Department agrees that it was the intention of the EJ Law to include transfer stations, however the Department’s solid waste rules explicitly do not include intermodal containers facilities as solid waste facilities per the definition of “solid waste facility” at N.J.A.C. 7:26-1.4.… the Department does not consider intermodal container facilities to be transfer stations or other solid waste facilities. [Note: therefore they are not regulated by the EJ law definition of “permit”]

[Update #5 – another loophole – land application of sludge is exempt not by statute because DEP narrowly defined the NJPDES permits to include individual permits, not NJPDES General Permits. That also means hundreds of NJPDES General Permits are exempt too (see page 126-127)

[Update #6 – another set of loopholes – and there are a lot of surface impoundments and land treatment units, including hazardous waste sites. Landfill closure and disruption permits are pretty nasty operations (p. 129):

Additionally, to the extent a surface impoundment, waste pile, or other land treatment unit would not otherwise be considered a landfill under the existing rules, it would be exempt.

The Department notes that landfills are subject to the rules to the extent they require a permit as defined at N.J.A.C. 7:1C-1.5, which notably excludes those permits, including certain landfill disruption permits, “necessary to perform a remediation,” ensuring that necessary remedial activities may continue.

Access To Drugs Elevated Above Regulatory Policy On Safety And Agency Accountability

FDA Made Mistakes And Pro-Choice Advocates Relied On Retrograde Arguments

There Are Reasons Big Pharma Is Blasting The Decision

[Update below]

I strongly support a woman’s right to choose, and have not followed the long controversy over FDA approvals, but I did recently read the Texas decision striking down FDA approval of the abortion inducing drug mifepristone.

There are surprising regulatory things in that Texas decision (that explain why Big Pharma has gone ballistic) and I find it incredible that the progressives are openly advocating Executive Branch defiance of a federal court.

I found several contradictions and deep ironies in that decision.

Over my 40 year career, I’ve always pushed the envelope on regulation of public health, environment, and safety risks. I’ve consistently urged regulatory agencies to conduct the most conservative credible interpretations of the science and data, and demanded rigorous regulatory review, under the “precautionary principle”. Key principles I’ve supported include transparency and broad administrative law procedures to assure public access to hold government and corporations accountable (administratively and in courts).

So, basically, I was shocked that progressive pro-choice advocates seemed to be advancing retrograde arguments about regulatory policy and public health and safety protections, while a right wing pro-corporate judge was relying on progressive preventative health and regulatory oversight and risk management principles.

As someone who has filed and strongly advocates for regulatory petitions, I was surprised to learn that the case originated in a regulatory petition to FDA by an anti-abortion group.

(Note: does anyone remember that environmental groups successfully petitioned EPA, a move that forced EPA regulation of greenhouse gas emissions?)

The Texas FDA decision begins with the judge blasting FDA for an extremely long delayed response to that petition: (emphasis in original)

Why did it take two decades for judicial review in federal court? …

Simply put, FDA stonewalled judicial review – Before Plaintiffs filed this case, FDA ignored their petitions for over 16 years, even though the law requires an agency response within 180 days..

That is just totally unacceptable and indefensible. No way would environmental groups tolerate a 16 year delay. No way.

I really don’t know enough about the science issues to write intelligently about them, but in just now reading a politically oriented piece on that decision by a favorite lefty historian writer Paul Street, I felt adequate to engage a few ill informed points he made on the substance of the Texas decision. Read Street’s superb piece:

• “We’ll Show’em at the Ballot Box”  – The Mifepristone Mess and the Dismal Judas Goat Dems

Here’s my note to Paul, which explores some of the contradictions and ironies:

Paul – a couple of points in response (and of course I strongly agree with your political argument about electoral versus street activism):

1. Reading the Texas decision, it seems clear that the pro-choice movement long ago made a strategic choice to quietly pursue drug induced abortion – which could take place in the privacy of the home, not the visible abortion clinic – for many of the same cowardly liberal conflict avoidance postures that led them to not demand street protest.

2. I’ve spent my career in environmental regulation, so am quite familiar with the science and administrative procedures and legal challenges at issue in the Texas decision. And how industry and right wing judges manipulate them all. So, what’s happening here is that Big Pharma is attempting to craft an exception to traditional administrative law. What they are saying is that we’re different and should not be subject to the same judicial and public scrutiny and legal challenge. On their behalf, the FDA brief asserted all sorts of retrograde, pro-corporate legal barriers to citizen access to the Courts, e.g. standing, statute of limitations, burdens of proof, judicial deference, et al. These are all frequent industry arguments to attack EPA regulations.

3. You have made the same retrograde legal arguments to attack a very bad decision – you make those arguments in this excerpt, which I will rebut point by point:

“Kacsmaryk’s ruling is based on thoroughly false, fake-scientific allegations about mifepristone’s safety and defied the six-year statute of limitations on challenges to FDA decisions. It ignored the anti-abortion plaintiffs’ lack of standing and flouted the Supreme Court’s decision in Dobbs returning abortion law “to the states.””

a. In term of “fake science” – did you read the decision? Did you note that FDA eliminated adverse health effects reporting requirements for all but death? That makes it impossible to have reliable data. If FDA or EPA did that on other risks, the public health and environmental communities would go ballistic. Some of the data that is available (and I read a GAO Report that verified the data in the opinion, so it is not “fake”) is shocking in terms of health risks. Yes, the mortality risk from the drugs is an order of magnitude LOWER than normal pregnancy, but that is not a valid benchmark, as there are serious non-fatal effects and the background rate of mortality in pregnancy is WAY too high.

There is also a very interesting science based regulatory argument that the safety conditions under the FDA safety clinical trials were not mandated by FDA use and labelling requirements. If that argument holds, big Pharma is SCREWED. This has HUGE implications for FDA regulatory review of vaccines and drugs.

Regardless of the risks, it seems obvious to me that pro-choice advocates convinced FDA to elevate access above safety (based on a 1992 law enacted in response to the AIDS crisis to expedite FDA review and approval). That is a very bad policy and would never obtain support for other drugs or environmental risks. Public health and regulatory science are supposed to follow the precautionary principle and “first do no harm”.

b. Statute of limitations – aside from being a retrograde legal argument and barrier to citizen access to the courts and accountability for regulatory agencies, there is a legitimate legal argument that FDA reopened the regulatory proceeding. This is not a slam dunk either way.

c. standing – same retrograde legal argument at SoL.

d. “return to States” – that is pure legal bullshit and even your prior writing on Dobbs says so. Don’t you remember when you wrote that the real agenda was to enact a national ban on abortion? (i.e. via CONGRESS). Dobbs did NOT return the abortion decision to the states, it eliminated a constitutional right and said that LEGISLATURES (Congress and State) could regulate and restrict abortion.

Finally, FDA took many years to respond to a regulatory petition that they are legally required to respond to in 180 days. This is the kind of administrative foot dragging bullshit I fight all the time. Agencies use delay to hope tough decisions will just disappear. No way environmental advocates who petition EPA would stand for that crap. Again, very retrograde arguments are being used to support the pro-choice case.

I thought you were a little smarter than that and would never swallow corporate and right wing legal arguments.

That right wing pro-corporate nut job Texas judge relied on some liberal legal and public health arguments – and that’s the irony here.

[End Note: Paul Street actually wrote this absurdly false statement, a claim I’ve heard repeatedly made:

If the ruling is backed by the US Supreme Court, a single far-right arch-reactionary among the nation’s 673  district federal judges will have been absurdly granted the power to trump the regulatory power and science-based judgement of the FDA. There is no precedent for such a dark possibility. …[…]

[Update: 4/17/23 – Just read an amicus brief from “FDA legal experts” (filed by beltway elite law firms who often represent Big Pharma) and they are not shy about putting their cards on the table. Here’s what it’s all about:

Plaintiff’s proposed remedy would profoundly undermine the well-established statutory and regulatory framework for the approval of new drugs and the due process accorded to drug marketing application holders by statute. It would also create harmful reverberations that would affect patients, healthcare providers, and the biopharmaceutical industry, all of whom rely on the expertise of FDA to make scientific determinations regarding the safety and effectiveness of our nation’s medical products. … […]

… overriding FDA’s safety and efficacy determination and forcing FDA to withdraw a longstanding drug approval would profoundly undermine the statutory and regulatory framework underpinning the approval of new drugs, thereby threatening patient access to therapeutics and chilling industry research and development. … […]

FDA has the scientific and medical expertise to make the complex determinations necessary to ascertain safety and effectiveness, including determinations regarding clinical trial design, dosing, and labeling. Here, Plaintiffs ask the Court to override FDA’s safety and effectiveness determinations and force it to withdraw an approved application for a drug that has been on the market for more than 20 years. Such an order would “seismically disrupt the agency’s governing authority as to whether drugs are safe and effective.” Danco’s Opp’n 1. It would also be unprecedented: We are not aware of any case in which a court has removed a drug from the market over FDA’s objection.

The effects could extend far beyond mifepristone. No drug is without risk, and a ruling for Plaintiffs could lead to challenges to FDA’s benefit-risk determinations for drugs it has approved to treat other diseases and conditions. Patients who rely on life-saving medications could see their drugs removed from the market with little notice.

Additionally, Plaintiffs’ remedy, if granted, would create widespread uncertainty in the pharmaceutical industry and chill research and development. FDA is the sole U.S. agency with which industry engages on issues related to drug review, approval, and labeling changes. Manufacturers are familiar with the FDCA and FDA’s regulations and procedures, and they invest in clinical research and costly clinical trials against the backdrop of that framework. If courts can unilaterally overturn safety and effectiveness determinations, manufacturers would simultaneously have to navigate a patchwork of judicial decisions regarding what is required for drug approval. This would fundamentally confound the expectations of industry, leave manufacturers vulnerable to challenges to their currently marketed drugs, and discourage investment in research and development of new drugs.

Profits are on the line! BOOM!

An additional sharp legal irony is that this case presents huge conflicts for the Supreme Court.

Everyone knows the Court strongly opposes abortion.

Because of how the Texas decision was written, the case also provides an opportunity for the Court to enforce it’s views on limiting judicial deference to administrate agencies (reversing the “Chevron” doctrine, a key element of the right wing ideological attack on “the administrative state” ) (Amicus)

But the court is pro-corporate. If the Supreme Court follows the attack on FDA discretion, it would hurt Big Pharma.

Big Pharma does not want federal courts reversing or taking hard looks at FDA decisions, because Big Pharma has captured FDA and their regulatory decisions PROMOTE Big Pharma profits.

I will predict that the Court will find a way to uphold the Texas decision partially, allowing the restrictions to stand in anti-abortion Red States, but they will do so in a way that does NOT allow stricter judicial scrutiny of FDA decisions.