In the early 2000s, Dr. Robert Moroney, introduced the IonCleanse® total body detoxification foot bath system. With its patented technology and unique delivery programming, the IonCleanse by AMD was marketed by Dr. Moroney’s newly formed company, A Major Difference (AMD). Dr. Moroney realized early in his detoxification career that an important part of detoxification is being able to recognize and avoid toxins whenever and wherever possible. AMD, originally guided by Dr. Moroney and currently by his son, Neill Moroney, who is the President of the company, looked to the Toxic Substance Control Act (TSCA) and its enforcer, the Environment Protection Agency (EPA). The original findings were not encouraging.
HISTORY
The TSCA is considered by many to be a failed law.
AMD undertook a review of the history of TSCA and how it came to be. Environmental Defense Fund (EDF) in 2017 offered a detailed and well-referenced account of the beginnings of the TSCA through the most recent attempt at reform, the Lautenberg Chemical Safety Act for the 21st Century, signed into law in June 2016. EDF concluded with undisguised hope and optimism, which may have been premature in 2017:
Passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act in the 114th Congress has at last provided EPA with new authority and tools it sorely needs to better ensure the safety of chemicals in use and entering the market. These authorities and tools include a health based safety standard, a mandate to address risks to vulnerable subpopulations, required safety reviews of both new and existing chemicals, stronger testing authority, and expanded access to chemical information. With strong and effective implementation of the new law’s authorities, the new TSCA may at last bring our nation’s chemical safety system into the 21st century.1
An abbreviated version of TSCA’s and EPA’s history was prepared by the Science History Institute and may be found at its website.2
In short, the US government took a step in the direction of overseeing the chemical industry which, until that time had been largely unregulated. The Environmental Protection Agency (EPA) was designated to be the overseer, and its strength was to be in the form of the Toxic Substance Control Act (TSCA). Prior to TSCA, the EPA concentrated solely on waste entering the environment — waste that came from production processes. TSCA was to allow the EPA to monitor new chemicals and chemicals to be used in a way significantly different from its original use (New Chemicals). The hope and belief was that the EPA would evaluate and regulate New Chemicals according to the risk they posed to the health of people and the environment. In practice, there was no provision for the EPA to enforce regulations and “business groups . . . wanted the preponderance of regulatory power shifted [from the federal EPA] to the states where they found it easier to outmaneuver or bully state officials into not enforcing regulations.”3
ENFORCEMENT
Is the EPA a bear without teeth?
While EPA claims to have “explicit authority to enforce the law and assess fines at federal facilities violating environmental statutes including the Clean Air Act. Resource Conservation and Recovery Act (RCRA) – Sep 23, 2019,”4 there is concern that under the current administration the EPA has backed off enforcement. According to The Conversation US*, an independent, nonprofit publisher of commentary and analysis, authored by academics and edited by journalists for the general public, the EPA “follows the lead of regulated industry, rather than acting as an independent, scientifically and statutorily driven regulator.” Additionally, The Conversation US indicates their “. . . analysis of the EPA’s preliminary data – the raw data that forms the basis of the final numbers that will be published in the agency’s annual report – shows the agency’s enforcement of federal environmental laws has decreased dramatically under the [current] administration.” The Conversation, a news source credited by mediabiasfactcheck.com as having minimal bias, says that there have been steep drops in civil and criminal enforcement, and across environmental programs under major environmental laws like the Clean Air Act and Clean Water Act, and in nearly all regions of the U.S.,5 and fewer cases being brought means fewer fines being levied with the end result being less effective enforcement.
THE ASBESTOS CHALLENGE
The EPA Loses Authority – How it Happened
It seems that from the start, in 1976, the chemicals industry had been waiting for just the right time to challenge the EPA’s authority under TSCA and in the 80s finally found its chance. The asbestos issue was the perfect candidate for one very big reason: there was no substitute material for asbestos and its fire-protection properties. In 1989, the EPA issued the Asbestos and Phase-Out Rule. In that action the EPA imposed a “partial ban on the manufacture, import, processing, and distribution of some asbestos-containing products.” Additionally, the ban covered “new uses of asbestos and prevented “new asbestos products from entering the marketplace after August 26, 1989.”6
Unfortunately or fortunately, depending on the view from consumer or manufacturer, much of the 1989 asbestos ban was “vacated and remanded by the U.S. Fifth Circuit Court of Appeals in 1991 . . . and did not remain in effect.” 7 According to the EPA, the 1991 reversal resulted in a greatly diluted asbestos regulation that only banned “new uses of asbestos in products that would be initiated for the first time after 1989.” The Court rendered its decision claiming “the EPA failed to demonstrate that a ban was the least burdensome alternative to regulating asbestos.” In other words, the EPA made a strategic error by imposing a complete ban and not seriously addressing intermediate levels of regulation. Ultimately, in this precedent-setting ruling by the Court, the TSA lost the fight.8
Finally, in 2019, the EPA issued the April 2019 Final Rule, in which it identified 3 main parts to the asbestos ban progression from 1989 through 2019, including the ban’s entire regulatory history. These 3 steps included (1) the 1989 partial ban on the manufacture, import, processing, and distribution of some asbestos-containing products, as well as prevention of new asbestos products from entering the marketplace after August 25, 1989; (2) the 2019 Final Rule, which ensures that asbestos products that are no longer on the market cannot return without being evaluated by the EPA; and (3) ongoing risk evaluation under TSCA of asbestos products was still allowed by the EPA. The EPA emphasized that the April 2019 Final Rule did not provide a way for currently banned asbestos products to re-enter the marketplace.7 Still the issue remains: there is no substitute material for asbestos and its fire-protection properties. Two decades have passed since that ruling and during that time asbestos has been banned in 55 countries, which represent most of the world’s developed nations.
In the U.S., asbestos proved to be a much larger health hazard than the Fifth Circuit Appellate Court imagined. Since 1991 there have been hundreds of thousands of liability claims against asbestos companies, sending a large portion of them to bankruptcy court for protection. This calamity certainly dwarfs the projected $250 million the Fifth Circuit calculated would be the chemicals industry’s loss if asbestos had been banned. Also during these twenty years, the general public has understandably become skeptical about the safety of chemicals and very aware of the unseen chemicals that permeate their everyday lives.
MODERN DAY – CSIA – REFORM
Problems with the original Toxic Substances Control Act (TSCA)/EPA
In addition to EPA’s weak role as enforcer under TSCA, the EPA at inception was not intended to be a safety testing organization. According to the TSCA legislature, the EPA was a lost opportunity to have the authority to demand safety testing data from manufacturers and importers of New Chemicals. For instance, Section 4 of TSCA empowers the EPA to require chemical manufacturers and processors to test chemical substances and mixtures and provide the data to the EPA. Section 8(b) of TSCA allows for the creation of TSCA Inventory. As new chemicals are commercially manufactured or imported, they are placed on EPA’s Inventory list.
However, despite the brave language, there were flaws from the beginning. First was the presumption that chemicals already manufactured or imported and being used commercially were safe; and most of those chemicals enjoyed the position of being “grandfathered” in. At the time, there were approximately 62,000 chemicals that were grandfathered in, which represented 99 percent by volume of the chemicals being used. For those chemicals, it would be EPA’s responsibility to test for safety as deemed necessary, a task the EPA was ill equipped to do and consequently the EPA tested only about 200.
Secondly, the TSCA was never intended to have domain over all chemicals. Fungicides, insecticides and rodenticides were at the time and still are covered under separate legislation, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA is known to be so weak that the Pesticide Action Network North America considers it broken. 8 The current chain of responsibility — from setting tolerances for pesticide residues to enforcement — starts with the EPA. The EPA is responsible to determine and set tolerances for pesticides, and it is the FDA’s responsibility to enforce. TSCA does have a role in pesticide regulation.
The third substantial flaw is the EPA’s tolerance for secrecy that is built into Section 14 of the TSCA, Disclosure of Data. This long section, in complicated language, demonstrates EPA’s extraordinary tolerance for secrecy in the guise of trade secrets. In practice, access to the complete confidential inventory is prohibited. The EPA will only release information of a confidential chemical on a chemical-by-chemical basis, and the requesting party must prove intent to manufacture or import in a formal submission of bona fide intent. The Agency will release information only if the bona fide intent to manufacture or import is evaluated to be genuine. An average citizen cannot get the information needed to make an individual determination of safety.
While the TSCA provides authority for the EPA to require additional safety testing from manufacturers and importers of New Chemicals, the agency must first prove that the subject chemical presents an unreasonable risk to human health or the environment during any phase of manufacturing, distribution, use, or disposal. With only inadequate safety data provided by the manufacturer, making such a determination becomes virtually impossible. Therefore, in practice the TSCA is largely dependent on the voluntary willingness of manufacturers and importers to participate and trust in their good faith to put public and environmental health and safety above financial considerations.
Modern times
“The best laid schemes o’ mice an’ men gang aft a-gley.” – Robert Burns
(Best laid plans of mice and men often go awry.)
The asbestos challenge is a good example of how even the best intentions of the EPA can be thwarted by an aggressive lobbying campaign. As the EPA’s authority under TSCA steadily eroded, ultimately failing to ensure chemical safety in the U.S.(around 2005), serious attempts began to reform TSCA. The result was the first Chemical Safety Improvement Act (CSIA). The CSIA was introduced in the Senate in 2013 during the 2013-2015 session, but was not enacted. Legislation not enacted by the end of a Congressional session is cleared from the books and not carried forward to the next session period; therefore, the Chemical Safety Improvement Act died in the 113th Congress 2013-2015.
It was reintroduced to the 114th Congress, 2015-2017, as the Lautenberg Chemical Safety Improvement Act and signed into law in 2016. Both Chemical Safety Improvement Acts, 2013 and 2016, were intended to strengthen EPA’s position to protect the general population and the environment from harmful effects of toxic substances that are chemicals. Amid much political fanfare that CSIA 2013 was a bipartisan effort, the chemicals industry was striking back. The chemicals industry was spending a large amount of money lobbying to weaken regulations imposed on the chemical industry.
CHEMICAL INDUSTRY LOBBYING
Dollars to donuts
According to MapLight, a nonpartisan group that tracks campaign contributions, the top 10 chemical industry donors increased their political donations just prior to the introduction of CSIA 2013 and in 2014 increased their lobbying amount to $76 million. In addition, these same chemical companies gave more than $1 million to sitting senators during the previous election cycle. Sponsors and co-sponsors of CSIA 2013 received nearly 70% more money ($15,176 on average) than senators who did not co-sponsor CSIA 2013.9
The chemical industry did not slow down their donations and lobbying spending as CSIA 2016 was approaching introduction. According to the Environmental Working Group (EWG), in 2015, alone, The American Chemistry Council, along with chemical giants Dow, DuPont, BASF, 3M, Honeywell and Koch Industries, together spent more than $55 million lobbying lawmakers. While these giants were spending $55 million lobbying, another group of chemical giants, Ashland, Celanese, Dow, DuPont, Eastman, Ecolab and Monsanto, spent $25 million on crafting their own version of a TSCA overhaul bill. During all this activity, the House of Representatives came up with their own industry-backed version of reform that contained a small print provision that would relieve Monsanto of liability for the environmental damage caused by PCBs until banned in 1979.
The bottom line is that the four-year (2012-2015) contributions by the chemical cowboys, as reported in March 2016 by the EWG, citing data from the Center for Responsive Politics and figures from lobbying disclosure forms, totaled over $245 million.10
There is much to consider when evaluating the CSIA 2016. AMD’s review of CSIA 2013 identified several areas of particular concern.
- The presumption of chemical safety.
- An exaggerated concern that safety testing would place an undue burden upon the chemicals industry.
- The ability of states to enact more protective regulations.
- The creation of a prohibitive environment for individuals seeking legal recourse for damages.
A LITTLE GOOD NEWS
As a result of CSIA 2016, EPA was required to update the TSCA Inventory. The goal of the update was to identify which of the 86,228 chemicals are actually in use today. In February 2019, the EPA released a revised TSCA Inventory list, which showed that less than half, 40,655, are currently in commerce. However, of the 40,655 chemicals currently in use, 7,757 are granted special treatment under the Confidential Business Information rule. Under the CBI rule, chemicals are protected (hidden).11
MODERN DAY ACTIONS
Presumption of Chemical Safety
The Lautenberg CSIA 2016 required the EPA to publish a list of ten chemicals to start safety evaluation within 180 days of the enactment of the Lautenberg CSIA 2016. The EPA published the list:
- Asbestos
- 1-Bromopropane
- Carbon Tetrachloride
- 1, 4 Dioxane
- Cyclic Aliphatic Bromide Cluster (HBCD)
- Methylene Chloride
- N-Methylpyrrolidone
- Perchloroethylene
- Pigment Violet 29
- Trichloroethylene
By the Lautenberg CSIA 2016, risk evaluation of any chemical brought up on safety review must be completed within 3 years.12
How Complicated can it get? Example: Asbestos
EPA’s publication of its draft assessment for asbestos was published in March 2020. EPA’s summary of the draft assessment for asbestos indicated that under the present partial ban of 1989, asbestos poses no unreasonable risk to the environment.13
According to Bergeson & Campbell, a law firm based in Washington, D.C. that represents clients before the EPA, FDA, OSHA, Congress and other global regulatory bodies, there are several forms of asbestos, none of which has been produced within the U.S. since 2002. As of the date of the draft risk assessment, only asbestos in the form of chrysotile, used exclusively by the chlor-alkali industry, is known to be imported, processed or distributed for use in the U.S.13
Based on 2019 data, the total amount of raw asbestos imported into the U.S. was 750 metric tons. Certain asbestos-containing products, like sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets are also imported into the U.S. Further, the EPA “preliminarily found unreasonable risk to workers, occupational non-users, consumers, and bystanders could be adversely affected by asbestos under certain conditions of use.”14
The Next Step
The publication of a notice of availability in the Federal Register will begin a 60-day comment period in preparation for a peer review meeting of the Science Advisory Committee on Chemicals on the draft risk evaluation.
How Successful Has the Process Been? – Appearances Can Be Deceiving
It appears that as of April 2020, the EPA is on track with the asbestos issue? Well, no and yes. In 2017, the EPA published its Final Rule regarding asbestos use, importation, etc. Within the Final Rule was a portion, written in by the then-administrator of the EPA under the current president’s administration, to exclude legacy uses of toxic substances, like asbestos-containing insulation and lead pipes, from health risk evaluations. While these items containing toxic substances may no longer be manufactured or imported, there is still the issue of disposal. For instance, disposal of asbestos-containing insulation
A long list of environmental organizations shared in a lawsuit against the EPA claiming the agency, under Scott Pruitt, acted unlawfully when it refused to consider legacy uses of toxic substances. Ultimately, the ruling in 2019 of the U.S. Court of Appeals for the 9th Circuit, agreed and reinstated the requirement for the EPA to consider legacy uses of toxic substances, which included asbestos and lead. The ruling by Judge Michelle Friedland, in favor of the environmental organizations, wrote in the opinion of the Court that “TSCA’s definition of ‘conditions of use’ clearly includes uses and future disposals of chemicals even if those chemicals were only historically manufactured for those uses. . . EPA’s exclusion of legacy uses and associated disposals from the definition of ‘conditions of use’ is therefore unlawful.”15
Transparency – Now You See It, Now You Don’t
The current EPA administration, under Andrew Wheeler, a former lobbyist for the coal industry, is heralding a new draft of the EPA proposal as a vehicle to strengthen transparency in regulatory science which would “require that scientists disclose all of their raw data, including confidential medical records, before the agency could consider an academic’s study’s conclusions.”
“We are committed to the highest quality science,” Andrew Wheeler, the E.P.A. administrator, told a congressional committee in September. “Good science is science that can be replicated and independently validated, science that can hold up to scrutiny. That is why we’re moving forward to ensure that the science supporting agency decisions is transparent and available for evaluation by the public and stakeholders.”
A new draft of the Environmental Protection Agency proposal, titled Strengthening Transparency in Regulatory Science, would require that scientists disclose all of their raw data, including confidential medical records, before the agency could consider an academic study’s conclusions. E.P.A. officials called the plan a step toward transparency and said the disclosure of raw data would allow conclusions to be verified independently16
The NY Times does not agree. The measure that the EPA claims would grant greater transparency, according to The Times, would actually “make it more difficult to enact new clean air and water rules” because of the very fact that many studies detailing the links between pollution and disease rely on personal health information gathered under confidentiality agreements.
The measure would make it more difficult to enact new clean air and water rules because many studies detailing the links between pollution and disease rely on personal health information gathered under confidentiality agreements. And, unlike a version of the proposal that surfaced in early 2018, this one could apply retroactively to public health regulations already in place.17
Can Individual States Make Up Their Own List of Chemicals to Ban?
This was a debated subject under CSIA 2013. California had Under the Lautenberg CSIA 2016,
A Final Note on Pre-emption: This Is How Complicated It Can Be
Does the EPA, a Federal agency, have the authority to pre-empt individual states? This will finally answer the question, how complicated can it be. Under the CSIA 2013, the answer was forthcoming and could be covered in three sentences:
States can’t require testing “reasonably likely to produce the same data” as EPA requires, or require notification of uses of a chemical for which EPA requires the same notification
States can’t establish or continue to enforce a requirement that restricts a chemical once EPA has completed a safety determination on the chemical
States can’t impose a new restriction on a chemical once EPA has: (a) designated it low-priority, or (b) for high-priority chemicals, upon publication of EPA’s schedule for conducting a safety assessment and determination
Lautenberg 2016 greatly complicated the issue of pre-emption with exceptions. The text of the officially entitled, ‘Frank R. Lautenberg Chemical Safety for the 21st Century Act’ covers 66 pages. Entire papers could be and have been written about the boundaries of the rules and exceptions. The Environmental Defense Fund (EDF) makes an effort to summarize the 66 pages of ation of CSIA 2016:
There are matters of scope; pausel; pause pre-emption; grandfathering* (specifically those actions taken by a state prior to April 22 of 2016 and past and future actions taken under individual states laws in effect on August 31, 2003); there is the possibility of a waiver of pause pre-emption; there are windows of time; there are penalties for missed deadlines.
Finally, all the previous matters have been identified and satisfied, and the EPA makes a final ruling. A state may still obtain a waiver to restrict a chemical, but only under very stringent conditions.
*According EDF an indirect way of preserving California’s Proposition 65 warning/label law and Massachusetts’ Toxics Use Reduction Act.19
And there is always a chance the EPA may reverse itself, as explained in the EDF blog:
Once EPA issues its final risk evaluation: If EPA finds the chemical does not present an unreasonable risk, final preemption would apply; or if EPA finds the chemical does present an unreasonable risk, states could again impose new restrictions while EPA develops its requisite regulation.20
Built into CSIA 2016 and CSIA 2013 is one chance for the EPA Administrator to still all opposition to a particular chemical use. Exemption under CSIA 2016.
CRITERIA FOR EXEMPTION.—The Administrator may, as part of a rule promulgated under subsection (a), or in a separate rule, grant an exemption from a requirement of a subsection (a) rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that—
‘‘(A) the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure;
‘‘(B) compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or
‘‘(C) the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety.
The full text of the Frank R. Lautenberg Chemical Safety for the 21st Century Act may be found at:
https://www.epa.gov/sites/production/files/2016-06/documents/bills-114hr2576eah.pdf
The EPA provides highlights of Lautenberg CSIA 2016 at:
Of most interest to AMD is the showdown brewing between the EPA under its new administrator, Andrew Wheeler, and California’s Proposition 65. In 2017, California listed glyphosate as a Proposition 65 carcinogen, which should have grandfathered it in as an action taken “prior to April 22 of 2016 and past and future actions taken under individual states laws in effect on August 31, 2003.” However, Mr. Wheeler brought the EPA into the fray in 2019. Chemical Watch Global Risk & Regulation News quotes Mr. Wheeler:
It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk,” said EPA Administrator Andrew Wheeler. “We will not allow California’s flawed programme to dictate federal policy.”21
And in August 2019, an EPA news release states:
For any pesticide product that currently contains Proposition 65 warning language exclusively on the basis that it contains glyphosate, EPA requests the submission of draft amended labeling that removes such language within ninety (90) days of the date of this letter.
This Dear Registrant Letter is seen as more of a denouncement of the Proposition 65 glyphosate listing than as a practical matter. It is also the latest in an unresolved conflict about pesticides between California and the EPA that began with the passage of Prop 65 in 1986.22
How and Why Does All This Affect AMD?
AMD’s position has always been that it is important to know the sources of toxic substances and, if possible, avoid them. Probably no one disputes that the EPA, TSCA and its updated Lautenberg CSIA are great concepts. Unfortunately, when millions of dollars are spent in pursuit of billions of dollars profit, if not properly supervised and accountability imposed, the outcome becomes a little less reliable. In the end, each of us is responsible for our own health.
AMD specializes in one product: the IonCleanse by AMD, a full body ionic detox foot bath system. Over the years, AMD has undertaken research within the strict regulatory guidelines of an Independent Review Board (IRB). Visit our blog article. to see how important impartial oversight is to the credibility and, more importantly, to the honesty and reliability of research results. The IRB ensures there is no conflict of interest in AMD research and holds AMD true to the old concept, too often lost, of accountability.
