Tag Archives: EPA

Tedium

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Another day of grinding tedium at work. I’m rattling around in the ever-diminishing operating space of EPA regulatory compliance, bouncing off the statutory walls. Between myself, an industrial organic chemist, and a regulatory toxicologist we attempt to convince EPA that no, we will not be splashing new chemical substances (NCS) over workers and the environment. We are legally bound to be truthful and disclose any and all tox data there might be on an NCS. We have the full support of a very safety-oriented management. Our business practice and mission statement mandates that we be in compliance. We are strictly business-to-business and not a single thing goes directly to consumers or is meant to be strewn about in the environment. Everything we make is meant to have a temporary existence. Every single bit of chemical waste goes off-site to incineration.

EPA levies fines that are based on a per day, per violation basis. This can rack up the cost of an incident to a company dramatically. Civil action fines can be up to $37,500 per day per violation to a maximum of $295,000 for a Clean Air Act violation. And, even if they cannot pin a specific violation on you, there is still the General Duty clause (same as with OSHA). Companies commonly lawyer-up when dealing with EPA (and OSHA) on a violation matter because not only are there the CFRs, but case law as well to understand. Only a fool does not bring in a specialist lawyer.

All this being said, the folks who review our applications for commercial production are deeply skeptical about everything and require evidence of claims. They are statutorily obligated to approve commercial production only if there is no “unreasonable risk” to workers, the public or the environment. EPA’s use of unreasonable risk substantially relies on numerical data. In the case of missing data, they use computer models to estimate exposure if there are analogs. The human health group uses the exposure data to guide them through the maze of health effects possible.

One thing I have learned from my toxicologist colleague is that health effects that I thought were easily described as “irritant” or “corrosive” are actually full of subclassifications. It’s not enough to say on the Safety Data Sheet not to breathe it or get it on you. There are categories of hazard that matter and must be ascertained by testing.

Example of Hazard Categories, EPA. Source– https://www.epa.gov/sites/default/files/2015-03/documents/chap-07-jul-2014.pdf

The upshot is that EPA takes exposure to new chemical substances very seriously and does their best to protect everyone and the environment from unreasonable risk. The “trick” to getting them to approve the commercial manufacture of an NCS is to have proper engineering controls in place, industrial hygiene data, appropriate PPE and compliant waste management. OSHA defines proper engineering as being Recognized And Generally Accepted Good Engineering Practices–RAGAGEP. This should be followed anyway, irrespective of regulatory compliance.

EPA has been accumulating public comment on its impending ruling on the phaseout of methylene chloride (dichloromethane, DCM, CH2Cl2). This might lump together fine chemical and pharmaceutical manufacturing with paint stripping and degreasing.

Risk and Regulations: An Epistle to the Bohemians, Redux.

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Attached is an updated reprint of an essay I posted 10/28/07. Since then I have shifted into EPA regulatory compliance within the chemical industry. My views have changed a little, it turns out.

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“We live in an age of miracle and wonder” is the refrain from Paul Simon’s album Graceland. All around us and through us are engineered materials devised for their specific physical and chemical properties. Time-released magic bullet drugs that inhibit specific enzymes. Flavors & fragrances, colorants, rheology modifiers, UV absorbers, emollients, preservatives, food irradiation and manufactured food additives are engineered and marketed to satisfy our lizard brain’s willingness to shell out cash-for-fun and stimulate our limbic system’s emotive triggers. 

It is hard to avoid contact with manufactured goods that aren’t affected by chemistry. A century and a half of tinkering with substances at the molecular scale has given us the ability to optimize the composition and performance of products that make our lives easier and safer.  Microprocessors and Lycra, Hastelloy and Lipitor- the chemical industry has evolved to produce the raw materials and finished goods needed for the performance we have come to expect.

Industry has a Spotty Record of Safety

Along with the considerable list of positive contributions, history provides a detailed record of the problems associated with the exuberant but uncritical acceptance of the flood of manufactured goods.  From radium poisoning of watch dial painters to chromium VI to asbestos, there is a long list of accidents, ignorance, negligence and environmental insult. The trail blazing of our chemical industry leaves behind it a chronicle of tragedy as well as benefits.

The result of the checkered past of industry is a growing (some would say “metastasizing”) and intertwined web of state, federal, and international regulatory oversight and requirements. And with it- arguably as a result of it- has come greater institutional risk aversion. 

Risk Aversion

In a general way, risk aversion is a type of survival trait and is likely hardwired into our ape brains. It is hard to blame people for being wary or fearful of risks, especially those they do not understand. Over time risk aversion is useful survival trait. But on the other hand, risk aversion is also a type of inertia. Or, it can be a fulcrum from which policy and imaginary justifications are leveraged.  The fear of risk may be firmly grounded on experience or it might be imagined or a mixture of the two. The hard part of risk management is identifying real hazards and the probability and magnitude of a bad outcome for managing safety day-to-day. Basically, the hard part is the whole part.

Risk = Probability x Severity of a negative outcome.

Corporate officers have a fiduciary responsibility to the stockholders. They’re purpose is to maximize profits without undue risk to the organization. Most respond to the regulatory environment by perhaps heaving a sigh and relenting to the requirements. Regulatory compliance can have costs associated with it like animal testing of chemical products and intermediates, or engineering upgrades and these costs need to be built into annual budgetary calculations.

How Granular Does Safety Have to Be?

Can safety practices be excessive? I would say that if some specific activity is based on imaginary risks, risks identified by the untrained or massively overestimated risks, the cold eyes of an industry consultant may be needed. Who knows, you may have actually underestimated a risk.

Safety has a large psychological component to it. How do you compel people to behave consistently in a way that keeps everyone safe? Not just immediately, but in the twentieth or five hundredth time they perform a task with associated hazards? Complacency is a normal human weakness where a misstep can lead to casualties.

The amount and type of safety measures in chemical processing required greatly depends on the chemical substance. Some company’s batch records give very detailed instructions to maintain constant safety. Others are less so on the assumption that the operations staff know what they are doing. Too much detail can lead to operator impatience and freelancing.

It is possible for organizations to be dominated by confident voices that are quite risk averse but not very knowledgeable about the technology. Leaders will state that “safety-first is our policy”.  A paper storm of SOPs will issue, dragging out the most elementary actions into numerous steps and check boxes. There is great merit to SOPs, but enlightened and proactive interpersonal management of hazardous operations is just as important. Management by walking around works.

Organizations can find themselves spiraling into micromanagement of even the smallest details for fear that the regulatory and liability hammer could fall at any moment. Indeed, if one studies many regulations in detail, it is easy to fall into habit of overreacting. Risk aversion isn’t just a personality issue, it is statutory under numerous regulatory umbrellas.

Being a baby boomer, the chemical safety practices I have been exposed to and have practiced is rather out of date. My education occurred during a time when running chemical reactions on an unventilated bench top was normal. We used Tirrill burners to flame dry our glassware on the sophomore organic lab benchtop and set the hot glass on a Transite square, an asbestos product from Johns Manville. I still would have no problem using Transite. In fact, I have done many things since summer of 1980 that would be frowned upon today. My grad school and post doc time went way into the weeds on using hazardous materials with minimal oversight.

You learn how to safely handle chemicals by safely handling chemicals. In the course of using a chemical, you might conclude that the known hazard of the substance appears to be exaggerated, so over time and repetition you let your safety practices loosen up a bit. Then one day, you cross some unseen line and an energetic event happens. While what you did leading to this outcome might be categorized as carelessness, as they drag you out of the lab by your one remaining arm, your ears ringing, a metallic taste in your mouth, and partially covered by your torn and smoldering lab coat, you recognize that you actually learned something from that experience. You now have a better appreciation for the safe operating range for that chemical. You’ve gotten one quantum unit of expertise. This is one way to gain expertise, albeit a painful one. Perhaps it will be useful once you start your next career. I have had many close calls and each one taught me something. Perversely, not having close calls with chemicals- some would call it luck -actually deprives one of practical and useful experience.

Today I am a senior chemist involved in chemical safety in industry. Until recently, I was involved in finding the thermal safety boundaries of chemical reactions through calorimetry. But with the past experience that I have, I know a bit more about the boundary conditions of handling chemicals than the younger chemists may get to acquire. In order to know how to work with hazardous chemicals you must have worked previously with hazardous chemicals and perhaps seen for yourself what can happen with sloppy technique.

This is nothing reckless like poking alligators with a stick in Florida or free climbing El Capitan. I mean things like seeing what actually happens when you pour concentrated H2SO4 into water fast enough right up to the boiling point taking care not to have a splash. Maybe you can see the heat of dilution boiling the water at the H2SO4/water interface.

The Regulatory Environment

Statutory risk aversion is the domain of the state. The name “Nanny State” is a sarcastic descriptor referring to a perceived excess of regulated requirements and conditions in our lives as well as the set of penalties.  Though perhaps well intended, the Nanny State seeks to zero out risk. Even if a situation arises for which there is no explicit regulation, OSHA has the General Duty Clause where employers are required to provide:

“employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees…”

This provision exists to address any gaps in OSHA regulations that may not account for unforeseen circumstances. The plethora of regulations is partly due to the vast array of situations in which industrial employees might be injured or killed. Additionally, lawyers have identified and exploited loopholes in the regulations, which are subsequently closed by regulatory agencies. Ambiguities are often resolved through statutory amendments or the application of established case law.

EPA TSCA has the job of generating and enforcing regulations regarding the manufacture and use of a range of industrial chemicals in a limited sector of manufacturing. The central doctrine is from:

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is issuing a rule that establishes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. [Emphasis mine]

TSCA does not include Food, Drugs, Petroleum, Pesticides and a few other areas.

The key words above are unreasonable risk. With every New Chemical Substance filing sent to the TSCA folks at EPA, an assessment must be made by various subgroups for unreasonable risk by the human health group, the engineering group and the environmental group. Thresholds for “unreasonable” have been quantified in order to exclude subjectivity. EPA has many computer models of exposure thresholds, migration in the soil and toxicity to many creatures including humans.

The regulatory environment can make the production of a new chemical substance more expensive or even unfeasible. Nobody advocates the idea that we should be free to pollute and risk the lives of workers and communities.  But even for the most skillful and well-intended, there are many regulatory landmines to dodge: air, water, and waste permits; local zoning; OSHA; EPA (TSCA); fire codes; insurance inspections; MSDS’s in multiple languages; ITAR; and DEA. All have reporting requirements, statutes, and paper trails to maintain.

Pragmatics

There are two kinds of disaster that can bring down a chemical plant. One is obviously a fire or explosion in the plant made even worse by casualties. The other is an administrative or legal disaster. This could be a tax problem or worse like having been determined to be out of EPA regulatory compliance for a chemical release into the environment or worker exposure over time. EPA fines are levied per day per violation.

In my view, the USA began ossifying many years ago in regulatory paralysis in much the same way the EU or Japan has.  The combination of business risk aversion along with the popular sport of outsourcing our means of production only serves to accelerate the de-industrialization of the USA and the EU. At present there is some effort by the semiconductor manufacturers and others to repatriate manufacturing back to the US out of fear of foreign governments using strategic trade regulation as a competitive cudgel.

What can one reasonably do? Consider even if regulations could be softened, this could take a long time. Until such time as there is a change in regulation, it is best to knuckle under willingly. First on the list is to just be compliant with regulations. Even an excellent argument against an “unjust” regulation enforced by an agency will get you nowhere because regulators are legally required to enforce the regulations and fine violators. If you are facing a regulatory judgement, it is well worth having a lawyer who specializes in that area of the law.

Accepting a harsh judgement on your record can possibly hurt you in the future by having a history of serious earlier infractions. A lawyer can search the case law and possibly find a lesser judgement or better interpretation of the regulations. Avoid at all costs the possibility of being found a repeat violator in some future court action. There could be extenuating circumstances that should be taken into account, but this is the lawyer’s domain and is no place for amateurs.

Fiat Lux

In the chemical industry we have regulatory specialists and EH&S departments who keep on top of the regulations and are responsible for maintaining timely compliance. They help keep the doors open and should be appreciated. That said, executives lurking in the C-Suite should be at least conversant in labor and environmental regulation to the point where they know to get advice before issuing directions relating to this.

Note: Obviously I’m not a damned lawyer and my words should not be construed as actual legal advice. I am simply recollecting learnings from my experiences.

Chaos at the EPA

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It’s difficult to describe how badly the New Chemicals division in the Office of Pollution Prevention and Toxics (OPPT) at EPA is performing these days, but let me try. The commercialization of new chemicals (not on the TSCA Inventory) not otherwise regulated requires that new chemical substances (NCS) be reviewed and granted following a Pre-Manufacture Notice (PMN) or a Low Volume Exemption (LVE) submission under the Toxic Substances Control Act (TSCA), should they meet internal criteria regarding safety. Exposures and doses to workers or the environment may be measured by the applicant or modeled using EPA in-house software. R&D only chemicals are exempt from such evaluation no matter the scale.

The application process requires the disclosure of the NCS composition and structure, the manufacturing and/or use operation in considerable detail, physicochemical properties and, if available, a wide range of worker and environmental hazards. Imported chemicals not on the TSCA inventory also require TSCA approval just as though they were being manufactured in the USA. Food, drugs and pesticides are not controlled under TSCA. Under penalty of law, all submissions must have the best and most accurate available information, particularly with regard to hazard information. No fibbing allowed.

The issues I’m about to recount started sometime in early 2021. Some speculate that a particular interpretation of the law promulgated by TSCA was adopted. I can’t provide references, however.

By statute, an LVE filing for instance, must be examined and be given a grant, conditional grant, or denial within 30 days. It is currently taking much longer than that: 60 to 100 days or longer. I have some that are still pending after 7 months. PMN filings take longer to process, about 9-12 months. or worse.

Aren’t these delays just a petty annoyance? Well, no. Part of a new product development timeline is getting regulatory approval. If this approval is subject to large delays with uncertain outcomes, then the launch date can become very fuzzy. The consequence for the end user is that scheduling their production activity becomes impossibly vague. Denials of LVE and PMN filings are not uncommon. Don’t expect a lot of sympathy from customers about EPA problems.

The last thing you want is some plebe right out of school with no professional experience in commerce to be handing out the regulatory death penalty to your expensive new technology. Handling hazardous materials safely and without environmental harm is done all day every day all over the world. There is a saying in the chemical industry: If you think safety is expensive try having an accident. There is considerable financial incentive to running a chemical plant safely and within regulations.

There seems to be a troubling issue involving the assumptions that EPA makes in regard to handling the NCS. The feedback I receive suggests that the engineers and toxicologists are ruling based on the worst case exposures that they imagine are going to happen. They imagine that workers and the environment will be exposed to the NCS as if workers aren’t wearing personal protection equipment (PPE) or there was no barrier to the environment. You can plainly state that these exposures won’t happen and state why, but they want evidence evidence that they cannot define that something will not happen. In other words, they want proof of a negative.

Another problem with EPA seems to be the sophomoric view that chemical hazards can always be abated by using safer chemicals. There may be a speck of truth to this generalization. In the formulations industry, for example. Replacing hazardous ingredients in mascara or shampoo with those that are less hazardous may be quite uncomplicated. Reducing chemical hazards is part of ethical business operations and is expected with ISO 9001 registration. The catch for chemical manufacturing is that the chemical features that make chemicals reactive and hazardous are usually the same features that make them essential to synthesis. Except for solvents and filter aid, unreactive chemicals are not very useful in synthesis. Synthetic chemistry is about manipulating the reactive features of one molecule with another to yield a useful product.

The delay issue is not unknown to EPA. In fact they are painfully aware of it all the way up to the EPA administrator. The good folks at EPA are doing their best with absurdly limited resources. We’re told that the TSCA division is 50 % understaffed, and many of the staff they do have are inexperienced. They have a computer system that is obsolete by many generations. You can see this by filing on their website. They have taken to denying submissions that are flawed in a minor way rather than continuing to work with the applicant to fix the problem. This excess fastidiousness ratchets down their backlog, at least in the short term.

The problems at EPA stem from the inability of congress to buckle down and provide proper funding. Only congress can act to boost staffing or computers. Lobbyists are working on it but, unfortunately, this is not an appealing issue for a congress person to take up and run with. Maybe we can get that cancerous A-hole Tucker Carlson to howl about it on the tube. Then we might see some movement.

Scott Pruitt- A man without scientific credentials. Yet, he speaks.

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EPA administrator Scott Pruitt has made clear by his comments that he knows little about science generally, let alone those areas that EPA is charged to oversee. If the Wikipedia site is to be believed, Pruitt’s education and career track in no way qualifies him to direct or make assertions on behalf of the EPA.

I would say that Pruitt does not have the credentials to speak authoritatively on the matter of climate science. This contention should be printed everywhere 24/7.

Plainly, he is the boss man of a wrecking crew for dismantling environmental protection.

 

 

Does the oil & gas market have a brain?

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In the course of my professional society memberships I receive an email newsletter called API SmartBrief from the American Petroleum Institute. An article caught my attention today. The API newsletter blurb read-

“Senators say methane rule will have unexpected impact“

“The Obama administration doesn’t understand the full economic effect of new federal rules meant to cut methane emissions from oil and natural gas production, according to a letter signed by Sen. David Vitter, R-La., and colleagues. “Given that so many of our communities are being impacted by current market conditions, [italics added for emphasis] any new regulations impacting oil and natural gas should be based on reliable, transparent data that is devoid of any political considerations,” read the letter sent to Environmental Protection Agency Administrator Gina McCarthy.” 5/23/16

This API summary is sourced from HoumaToday.com.

The alarm expressed by Vitter, API, and unnamed others struck me as amusing. The methane rule will have unexpected impact. Golly Mr. Wizard, tell us more. Naturally, API is beating the drum for petroleum interests. It is their charter, after all. Vitter bemoans the cost impact on workers and communities in his state and, to be sure, that is his job. Thus, the interpenetrating political-industrial partnership seems aligned in their opposition to possible rule making by EPA. Alles ist in Ordnung.

The funny part is that the current market condition cited by Vitter and, I would suppose, API, is the result of years of delirious drilling and hydrofracturing of oil and gas deposits. Perhaps someone of credible standing mentioned that a bubble was forming and that maybe, just maybe, we’ll end up with a glut. If such a voice did arise, it was not widely cited, at least to my knowledge.

So, this self-inflicted malady of excess supply and low prices has crept up on this colossal industry with it’s legions of swingin’ d**ks leasing and drilling methane glory holes. Boom and bust is not new to big oil. Not unexpectedly, OPEC failed to cooperate and reduce their oil production, the greedy bastards. King coal is staggering like a large sauropod after an asteroid impact. And even more dismaying to big petro is that solar, wind, and who knows what else is creeping upwards in power production and taking market share.

With all of this recklessness with oversupply, could it really be that big oil is bad at basic price collusion? Shiver me timbers!

My point is that using a self-inflicted market down-turn to justify reckless disregard in furthering large scale contamination of the atmosphere is a malfeasance of the first magnitude. If the free market gave birth to such an awful turn of events as an oil and gas oversupply, how can we expect the invisible hand of the market to steer us away from certain ecological ruin through destruction of the biosphere from accelerating consumption and advancing overpopulation?

The market is like the male sex organ. It has no brain and seeks only one thing- More.