Common Fallacies about Agency Inspections

There are some common fallacies out there concerning how to mange agency inspections. Here area a few of them:

1. Ask the inspector for a copy of compliant against your facility. If the inspector shows up as a result of complaints filed against your facility, you can ask about the nature of the compliant. But the inspector will not likely give you the names of the people who filed complaints against you – especially if they are your employees.

2. Restrict inspector’s scope of inspection. An inspector will not allow you to restrict his movement at your facility. If he is doing a general environmental or safety inspection, he has a wide scope as long as the inspection pertains to environmental or safety issues. It is not like a search warrant where the government is restricted to the scope of the search warrant.

3. Stop the inspector from tape recording conversations. Good luck with that. If you try that with an OSHA inspector, it could be considered as “refusal of entry”, according to OSHA’s Field Operations Manual. OSHA inspector has the right to tape conversations, take photos and videotape the inspection.

The Real Problems with Corporate Audits

The following is a reprint of Norman Wei’s article that was published in an EHS online journal a few years ago.

The Problems with Many Corporate Audits

 by Norman Wei

Many companies have policies in place that specify the frequency of their internal environmental audits. Once a year or every other year, a company does an internal audit or hire external auditors to do it.

When a company has a major chemical accident, investigative bodies such as the US Chemical Safety Board comes in and look into the causes of the accident. More often than not, these investigation bodies discover that internal audits had identified the root cause of these accidents.

And yet the facility still blew up and killed hundreds of workers. Why is that? Why didn’t senior management pay heed to the warning signs highlighted in the audit reports?  

There are basically several underlying reasons.

There first reason is that many corporate auditors look for “consistent” audits. They want to see consistency year after year. Yet, good audits are never consistent. At a recent conference of auditors, many environmental managers said they wanted the same old external auditors to do their audits every year in order to get “consistent” results. They didn’t want to spend time explaining their manufacturing process to a new external auditor. They wanted someone who is very familiar with their operation. 

These managers obviously have never heard of the term “familiarity breeds contempt”. They are also perhaps a bit lazy. They get tired of explaining their manufacturing process to a new auditor every year. Some may say they are in effect just going through the motion of getting their annual audit done because their corporate policy requires it. They are not interested in having a new auditor with a fresh set of eyes to find ways to improve their process or fix any problems that had been overlooked before. They could have just photocoped the previous year’s report and save themselves some money.

The second reason why audit reports are often ignored is how audits are perceived by plant management. 

One of the many reasons auditors (mostly inexperienced ones) like checklists is that they provide a scoring mechanism in addition to helping them remember what they ought to know in the first place. They run through a list of 100 items on the list and when 80 are checked off, the facility gets a 80% score. And that’s better than the 75% score they got the year before. So there is improvement! And a good reason for them to go out to the local pub and celebrate. They may even get a nice bonus at the end of the year because they have “improved”! It is for this reason that many facilities view an audit as an examination that they need to pass. 

How often have we heard our clients say this “Whew..we passed another audit” as if it was a freshman 101 examination? They see the audit report as a report card. The problem with such reasoning is that it takes the focus away from FIXING the problems. Where is the incentive to fix problems if you “score” 90%? And what specifically are in those missing 10%? What if some of the missing 10% include some very serious environmental issues?
And that’s the main reason why so many audit reports sit on manager’s book shelf collecting dust. It is the erroneous misconception that audit is not about fixing problems. They forget all about it after they have passed “the test”. As mentioned earlier, there are numerous major environmental disasters that occurred because management ignored previous audit findings and allowed (knowingly or unknowingly) the manageable problems to fester into a major environmental catastrophe. 

One of the largest sugar mills in the US was decimated as a result of combustion of fine sugar dust. An internal audit had identified the underlying problems. One of them was a malfunctioning dust collection system. No one took any action to correct it and the plant blew up soon after killing a number of employees and injuring hundreds..

Sometimes we get into the bad habit of testing just for the purpose of testing. The focus should always be on fixing the problem.

The completion of an audit is not the end. It is just the beginning.

The final reason is with the use of strict audit protocol. Such protocol places unnecessary restrictions on the auditors – especially the inexperienced ones. Strict protocol tells the auditors to look for very specific things. It places blinders on the auditors unnecessarily. That’s where the excuse “it is not on my checklist or protocol” comes up most often. There should be broad outline and objective for the audit so that when an auditor walks past a badly corroded water tank next to a power substation on his way to complete the checklist elsewhere, he will have the good sense and “freedom” to include that in his report even though corroded water tank is not on his checklist or protocol. Because when the tank collapses and takes out the substation and the plant is out of commission for a week, there will be hell to pay and senior management will not buy the “it is not on my checklist” excuse.

About the Author. Norman Wei is an environmental consultant and founder of Environmental Management and Training, LLC. in Cape Coral  Florida. He has trained over 3000 environmental professionals through his seminars on environmental compliance. He has just complete his book “A PRACTICAL Approach to Environmental Compliance – a blueprint for Environmental Managers” available on his website www.proactenv.com/book.html. His email address is norman@proactenv.com. 

You don’t know what you don’t know

Former Defense Secretary Donald Rumsfeld once said this:

“There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don’t know. But there are also unknown unknowns. There are things we don’t know we don’t know.”

So there are things that we know for sure and there are things that we know we don’t know. And then we also have things that we don’t know that we don’t know.

The third category is what we want to uncover in an environmental audit.

When we ask the question “Why do you do it this way?” during an audit, we often get the answer: “We have always done it this way. We have been doing it this way for years”,

There are two possible interpretations of this answer. The first one is that they have been doing it correctly for years and there is no problem. Or the other interpretation is that they have been doing it incorrectly for year WITHOUT knowing it. In other words, they don’t know what they don’t know.

For example, a waste generator in California may know that his spent solvent is a hazardous waste. He may not know exact how to manage that hazardous waste. That is not a big issue since he knows that he lacks that knowledge and he will seek assistance. But does he know that if a drum of virgin solvent is mislabeled or shows signs of deterioration, that drum of virgin solvent becomes a waste after a short period of time in accordance with 22 CCR 66261.2(f)? [see footnote]. Since the solvent is ignitable, that drum of virgin solvent will be classified as hazardous waste.

The owner of the drum of mislabelled virgin solvent is very likely someone who does not know what he does not know and he will stay that way until either an auditor or inspector points it out to him.

So it is the job of an environmental auditor to identify areas of knowledge where the facility does not know what it does not know.

That is a very good reason to have periodic environmental audits.

 

Come to our 2-day seminar on May 8-9, 2017 in California and learn about things you don’t know you don’t know.

[Footnote] 22 CCR 66261.2(f) A material is a waste if it poses a threat to human health or the environment and meets either, or both, of the following:
(1) it is mislabeled or not adequately labeled, unless the material is correctly labeled or adequately labeled within 10 days after the material is discovered to be mislabeled or inadequately labeled;
(2) it is packaged in deteriorated or damaged containers, unless the material is contained in sound or undamaged containers within 96 hours after the containers are discovered to be deteriorated or damaged.

How will the Trump EPA affect you?

There are a lot of discussions out there about how the EPA will operate under a new administration. Here are my thoughts.

Will EPA be decimated or gutted completely? I doubt it. Regardless of politics, people enjoy clean air and clean water and they want the environmental quality to be maintained. But there will be significant budget cuts.

Will some federal regulations be rolled back? Most likely especially on the carbon emission side.

Will there be less enforcement? Probably at the federal level. History has shown us that EPA enforcement drops a little when a Republican occupy the White House. That being said, keep in mind that individual states run their own environmental enforcement programs. I don’t see states such as California and New York slacking off at all on their enforcement front. Environmental regulations at the state level are already at least as stringent as the federal regulations. So if EPA rolls back on its regulations, the states wil simply enforce theirs.

Contact us for our in-house environmental training program.

 

Details about Norman’s Book on Environmental Compliance

It is a 340-page book written by Norman Wei and it contains 17 chapters and 10 appendices. It offers a PRACTICAL approach to environmental compliance designed for anyone who is responsible for environmental compliance in his or her organization.
The book is not a recitation of environmental regulations. The focus of this book is on the skills required of an environmental manager.

The first chapter of this book lays out how senior management views the role of an environmental manager vis-a-vis that of a safety manager. It is not that senior management views environmental protection any less than safety. It is all in how “effectiveness” and “return on investment” are often perceived by management on a daily basis.

Chapter 2 discusses how you as an environmental manager should work with your colleagues in the office as well as attorneys and plant managers. Your relationship with these folks dictates your effectiveness as an environmental manager.

The third chapter is about your working relationship with the regulatory agencies. How you or your agents (consultants) interact with them is paramount to your success. This is because people generally work with people they like. Permit writers are no exception.

Chapter 4 discusses how you should view regulations and why it is critical that you understand how the agencies enforce environmental laws. Those of you who understand the agencies’ thinking will be able to steer your organizations away from being targeted for enforcement action. The last part of this chapter talks about how to set up an early warning system to minimize your own personal liability.

The discussions of liability are carried over into Chapter 5 where environmental risks and hazards are further quantified. You have to know your risks before you can manage them.

Chapter 6 reviews the danger of letting someone else manage and control your environmental data. This chapter goes on to discuss the over-used term “environmental sustainability” and what it really means. There is also discussions on the fallacy of “environmental indices” and why they should be avoided.

Environmental audits are an essential tool for environmental managers. If done properly, a full environmental audit can identify current state of compliance and predict future performance. Chapter 7 discusses EPA’s Environmental Audit Policy of 1986 and the two different types of audits. There is a lengthy discussion of the difference between a compliance audit and management audit. It covers the art of asking the right questions and getting high quality information during an audit. An example of root cause analysis is also included in the chapter.

Chapter 8 is one of the most important areas many environmental managers face. How you choose your consultant can make or break you. If you hire the wrong consultant to get a permit from an agency, that consultant can cause irreparable harm to your relationship and reputation with the agency. This chapter shows you what to look for in a consultant and what to avoid.

Chapter 9 is all about ownership of environmental plans. If your plant personnel do not have ownership of your environmental plans, the plans will not be implemented no matter how well they are written.

Citizen lawsuits are very common under federal environment laws – especially under the Clean Water Act. Chapter 10 offers a case study on what you should do in case you are faced with a citizen lawsuit.

Chapter 11 is on how to cope with agency inspections. What you do before, during and after an inspection defines the eventual outcome. This chapter contains numerous practical tips on how to prepare for an inspection and what to do during and after the inspection.

Accidents happen all the time and they often happen in the middle of the night. Chapter 12 outlines the steps you should take to prepare for an incident such as a chemical spill. It discusses your obligations under federal spill reporting requirements. It also describes what you need to do in California which has a very different spill reporting requirement. This chapter contains a list of all 50 state agencies and their state-specific spill reporting requirements. It also discusses what you can learn from the BP oil spill of 2010 in the Gulf of Mexico.

Chapter 13 introduces a rather tricky question of an auditor’s duty to report should the auditor come across an event that could pose imminent danger to public health. The duty-to-report principle applies to auditors and environmental managers.

Chapter 14 has little to do with environmental regulations. But it touches on one of the key job skills of an environmental manager – how to communicate effectively with your managers and peers. You may have the best ideas in the world. But if your presentations put your audience in a coma, your ideas are not going to go very far. This chapter presents a much more effective and field tested way of preparing your PowerPoint slides. This is the approach the author used in all his environmental compliance seminars.

Chapter 15 describes the step-by-step approach in setting up your own environmental management systems. Having an EMS in place will help you to stay in compliance and better manage your programs.

Chapter 16 summarizes the key differences in environmental regulations in California. Included is a discussion of the state’s Prop 65 requirements which are unique in the country. Anyone who has a facility in California will need to understand the far reaching arms of Prop 65 and the liability it poses.

The last chapter is a summary of all the things an effective environmental manager should have or follow. Chapter 17 is in effect a blueprint for environmental managers to stay in compliance.

There are 10 appendices in this book. One of them is an in-depth discussion of the Clean Water Act which includes the permitting process, SPCC and storm water management.

Another appendix discusses the approach you should take in obtaining air permits and how to avoid Title V permits under the Clean Air Act. There is also a brief description of what Cap-and-Trade means.

Appendix 8 discusses five bad environmental/safety decisions or actions taken by companies that led to catastrophic results. These are teachable moments. It is always good management practice to learn from other people’s mistakes.

At the end of book is a section on Additional Resources. Here you will find reading material that are used in the preparation of this book.

This book sells for $95. To order this book, go to Norman’s website.

 

 

A PRACTICAL Approach to Compliance

Coming in February 2016. A 330-page book on how to comply with environmental regulations written specifically for the environmental managers.For more details, click here.

Why many internal environmental auditors go wrong

Some environmental managers get into a routine of doing environmental audit every year as part of their company policy. They develop a checklists and require the audit team members to follow the lists and never deviate from them. The checklists define the scope of the audit. Their efforts are more focused on documentation than discovery.

One auditor even went so far as to state in LinkedIn that “you don’t conduct an audit to “fix” something, but rather as part of your quality/risk management policy.” So he was just going the motion to “fulfill” some nebulous risk management policy.

Somehow they have lost sight of the real reason people do environmental audits.

The fundamental reason and basis for doing routine audits is to uncover things that are wrong and fix them BEFORE they become unmanageable and/or too costly to fix. It is just like doing your annual physical examination. You want to see if there are any emerging medical problems that you can take care of before they become deadly. You absolutely do audit for the expressed purpose of identifying problems and fixing them. Otherwise you are just going through the motion. People should do auditing as part of their continuous improvement program. The word “improvement” means correcting things, fixing things and making things better. In fact, one of the continuous improvement steps is corrective actions. An annual medical check up is like your compliance audit. You look for problems and FIX them before they kill you. When your doctor sits down and discusses with you your life style (how much you drink and how often you smoke, etc), he is doing a management audit on you. And if your doctor has to refer to a checklist, get another doctor.
Checklists are only good for compliance audits – and marginally so. They tell you your compliance status at the time you perform your audit. The only thing they provide is a snap shot of compliance status and nothing more. If an auditor is any good at all, he should not have to rely on a list of things to tell him or remind him what to do. If you are doing management audit, you definitely do not want a checklist. But if you need a checklist to tell you what to look for, then you should not be doing management audit.

Be very wary of venders out there who try to sell you audit programs that consists of nothing but a bunch of canned checklists. If you feel you have to use a checklist, you need to take the time to develop or customize your own checklist. No two facilities are the same. 

Many auditors look for “consistent” audits. They want to see consistency year after year. Yet, a good audit is never consistent. At a recent conference of auditors, many environmental managers said they wanted the same old external auditors to do their audits every year in order to get “consistent” results. They didn’t want to spend time explaining their manufacturing process to a fresh face. They wanted someone who is very familiar with their operation.

These managers obviously have never heard of the term “familiarity breeds contempt”. They are in effect just going through the motion of getting their annual audit done because their corporate policy requires it. They are not interested in having a new auditor with a fresh set of eyes to find ways to improve their process or fix any problems that had been overlooked before. They might as well just photocopy the previous year’s report and save themselves some money.

One of the many reasons auditors (mostly inexperienced ones) like checklists is that they provide a scoring mechanism in addition to helping them remember what they ought to know in the first place. They run through a list of 100 items on the list and 80 are checked off. The facility gets a 80% score. And that’s better than the 75% score they got the year before. So there is reason for them to go out and celebrate. It is for this reason that many facilities view an audit as an examination that they need to pass. How often have we heard our clients say this “Whew..we passed another audit” as if it was an freshman examination? They see the audit report as a report card. The problem with such reasoning is that it takes the focus away from FIXING problems. Where is the incentive to fix problems if you “score” 80%? And what specifically are those missing 20%? What if the missing 20% include some serious environmental issues?
And that’s the main reason why so many audit reports sit on manager’s book shelf collecting dust. It is the erroneous misconception that audit is not about fixing problems. They forget all about it after they have passed “the test”. There are numerous major environmental disasters that occurred because management ignored previous audit findings and allowed (knowingly or unknowingly) the manageable problems to fester into a major problem. One of the largest sugar mills in the U.S. was decimated as a result of combustion of fine sugar dust. An internal audit had identified the underlying problems. One of them was a malfunctioning dust collection system. No one took any action to correct it adn the plant blew up.

Sometimes we get into the bad habit of testing just for the purpose of testing. The focus should always be on fixing the problem.

The completion of an audit is not the end. It is just the beginning.

The problem with setting audit protocol is that it places unnecessary restrictions on other auditors. Strict protocol tells the auditors to look for things that you want them to look for. It places blinders on the auditors unnecessarily. That’s where the excuse “it is not on my checklist or protocol” comes up most often. There should be broad outline and objective for the audit so that when an auditor walks past a badly corroded water tank next to a power substation on his way to complete the checklist elsewhere, he will have the good sense and “freedom” to include that in his report even though water tank is not on his checklist or protocol. Because when the tank collapses and takes out the substation and the plant is out of commission for a week, there will be hell to pay and senior management will not buy the “it is not on my checklist” excuse.

Author’s note: this is an except from an upcoming book “Practical Guide for Environmental Managers” by Norman Wei who has taught over 2000 corporate environmental managers on how to comply with enviornmental regulations.

How to Manage Your Environmental Risks

As environmental managers, we are faced with the task of determining what kind of risks there are and how to manage them.There are many ways to determine environmental risks. One of the most common methods is to look at the environmental impact (severity) of a process and how often it occurs (frequency). If your process has significant impact on the environment and the impact occurs on a regular basis, that process poses a relatively high environmental risk as compared to others.

The environmental impact of a chemical can be easily determined by reviewing its Safety Data Sheet which will also tell you its pathway and its impact on receptors. How does it affect the receptor? Is it through ingestion, dermal contact, or inhalation? All of this information should help you determine the severity of that chemical.

You can assign a scale of 1-5 (with 5 being the greatest) to both severity and frequency and multiply them out. The product of the two would give you a quantitative indication of the risk. For example, if we are storing some highly flammable wastes onsite all the time, the severity and frequency would each carry a rating of 5 and the product would be 25. Any other activities or processes that are less hazardous or less frequent would have a risk factor of less than 25.

As we go through our facility and determine the risk factor for each individual manufacturing process or step, we would come up with a long list of risk factors with ratings ranging from 0 to 25. This list then gives us a road map on where to use our limited resources by starting to manage those processes with the highest risk factors.

That is just one of many ways to manage environmental risks.

Note that we are not dealing with zero risks here because they are essentially unattainable. There is no such thing. We are focusing on minimizing the identifiable risks to the greatest extent possible within the constraint of our manpower and financial resources.

Many examples come to mind:

Perform due diligence on the Treatment Storage and Disposal Facility (TSDF) before you ship your hazardous wastes to it. Here you are trying to minimize the chance that the TSDF will turn into a Superfund site which would cost your company large amount of money for clean-up costs.
Reduce the amount of hazardous wastes you generate by practicing waste minimization and source reduction. The less wastes you generate, the less liability you incur for your company.
Reduce the amount of waste you keep onsite at any given time by shipping them out more frequently. The less waste you have onsite, the less you have to spill. This may incur higher shipping costs. Look at your risk and determine how much you are willing to pay to reduce it.

When determining environmental risks, try to avoid using probabilistic percentage figures as indicators. It makes little sense to say that one particular activity has a 50% chance of having an accident.

Here is why.

All those probabilities are calculated based on large pool of samples. The chance of a coin toss yielding a head or tail is 50% in the long run. It does not mean that if we toss a coin four times in a row, the outcome will always be head/tail/head/tail. All it means is that if we toss it hundreds of times, the numbers of head or tail will be about the same. That’s why it is not a good idea to base your risk management strategy on these numbers. Accident can happen to you the next day. You can end up with four heads in a row.

The Perils of Environmental Crimes and How to Avoid them

EPA’s enforcement data over the most recent 9 years shows a relatively small number of environmental crime cases initiated by the federal government.

The fact that less than 300 persons are charged by the federal government for environmental crime in a year points to several interesting facts. Why are there so few cases at the federal level with hundreds of thousands of companies operating in the country? There are two answers to this questions. The first one is that most environmental crime cases are prosecuted at the state or county levels. The second reason is that EPA mainly targets only the most egregious kinds of environmental violations for prosecution.

Internal memos with EPA show that the federal government looks at several factors before pursuing an environmental crime case. The first thing they look for is public endangerment. Any illegal activities that impact or have the potential to endanger the general public will be prime candidates for prosecution. For example, if a waste generator were to abandon its hazardous wastes at or near a school yard or discharge its toxic effluents into a public waterways that impact a public beach, the perpetrator will likely be prosecuted.

Another factor the agencies often consider is the mindset or behavior of the violator before the violations are committed. Although most environmental laws carry strict liability and do not require proof of intent, the agencies will still want to know what the violator was thinking. Did he intentionally commit the unlawful act in order to save money? Or did he knowingly operate a facility without an environmental permit knowing full well such a permit is required? Did he receive ample warnings from an agency inspector but choose to ignore the warnings and correct the violations? 

All of these factors go into the decision by the federal government on whether or not to file environmental crime charges against a violator.

The best way to avoid being targeted or appearing on the federal government’s radar screen is to heed the following advice:

1. Always be responsive to an agency inspector’s warning and directive to correct a violation – no matter how small that violation may seem to be at the time. Many large enforcement cases started as a minor violation that management ignored and allowed it to fester into a negligent or knowing violation. Ignoring a agency’s first warning is never a good strategy under any circumstances.

2. Perform internal environmental review or audit on a regular basis. It is like doing a regularly scheduled medical checkup. The sooner you discover a minor problem, the less costly it will be for you to fix it if you do it in a timely manner. Early detection is the key here. A small tumor can grow into a cancerous one if left untreated.

3. Make sure your staff have sufficient knowledge of regulations to recognize a festering environmental problem. Your staff do not need to be environmental experts. But they do need to know enough to ask the right questions or stop a pending illegal act. Ignorance of environmental regulations is not blitz and is no excuse in the agency’s eyes.

4. Always read your permits and understand what they require you to do in terms of operational conditions and recordkeeping. Seek outside help if you are not sure. Never wait for an inspection so that you can ask the inspector about your permit. By the time the inspector is at your facility, it is too late. The inspector is there not to provide you with free consulting advice. He is there to evaluate how well you are performing under your permit conditions.

5. Do your own due diligence when it comes to hiring vendors to dispose of your hazardous wastes. If they offer you something that sounds too good to be true, it probably is.

6. Never ever lie to a federal investigator or provide false information to the agency. Bad things will happen to you if you do. As with most white collar crimes, the cover-up is much more problematic than the actual crime itself.

Last but not least, always try to develop and maintain a cordial and professional working relationship with your agencies. If you are constantly “at war” with the regulatory agencies, you are diverting much needed energy and resources from your production and you also instill a high level of mistrust within the agencies about you. And that’s not a good position to be in.

EPA’s New Rule on Solvent-Contaminated Shop Rags

Back in 1992, the foreman and plant manager of a print shop in Tampa Florida disposed of their solvent-soaked shop rags in their dumpsters. They had been warned by the county inspector to cease such practice because the rags contained a spent solvent. They ignored the warnings and one day two 9-year kids got inside the dumpster to play and died from toluene fume asphyxiation. The plant manager and foreman were subsequently sentenced to prison for knowing endangerment and illegal disposal of hazardous wastes without a permit.

The proper disposal of shop rags that are soaked in spent solvent has always been a thorny issue for generators. The disposal practice has been mainly regulated by individual states. Many states prohibit the disposal of shop rags in dumpsters. EPA has never promulgated any regulations on such practice until very recently.

On July 30, 2013, EPA published its final rules on the proper disposal of solvent-contaminated shop rags and wipes. These final rules are set to go into effective January 31, 2014.

According to EPA, over 2.2 billion wipes are generated by industries annually and many of them contain spent solvents. The new EPA rule can be summarized as follows:

If you have a wipe that is contaminated with spent solvents or is ignitable, you have several options to manage and dispose of these.

If the wipe is reusable (made of cloth), you can send it to a laundry facility that has  been approved by EPA to wash these wipes.

If the wipe is non-reusable (made of paper), you can dispose of it in a municipal landfill or hazardous waste landfill or an industrial incinerator.

You must meet the following conditions:

1. You may not store the wipes for more than 180 days.
2. There must not be free liquids as determined by the Paint Filter Liquids Test (EPA Methods Test 9095B)
3. The wipes must be kept in a non-leaking closed contained
4. Documentation must be kept that these wipes are being managed as excluded solvent-contaminated wipes.

If you meet all of these conditions, your solvent-contaminated wipes are then excluded from the definition of hazardous wastes. In essence, these wastes will be viewed by EPA as being somewhat similar to universal wastes.

One note of caution, ONLY the wipes are being excluded. The spent solvent that comes out of these wipes are not excluded. Wipes containing trichloroethylene are NOT part of this exclusion.

You can download a copy of EPA’s final rule here.