By Tom Badstubner, Marilyn Dempsey, Michael Dodd, Rick Schweitzer and Steve Guglielmo
In the First Quarter 2021 issue of Welding & Gases Today¸ GAWDA’s consultants discussed how the incoming Biden administration may differ from the outgoing Trump administration. Now that the new Congress and White House have assumed power and cabinet secretaries continue to be confirmed and policy proposals start to take shape, the consultants revisited the topic of how a new ruling party could impact the day-to-day business of GAWDA members.
Thank you to Tom Badstubner, GAWDA’s FDA and Medical Gases Consultant, Marilyn Dempsey, DHS, EPS and OSHA Consultant, Michael Dodd, DOT Consultant, and Rick Schweitzer, Government Affairs and Human Resources Consultant, for lending their time and expertise to discuss these important topics. The following is a lightly edited transcript of that conversation.
Welding & Gases Today: When we spoke last time, it was after the election but before the inauguration. Now that we’re well into the Biden Administration, I’d like to talk about some of the changes and potential changes that we’re seeing in the regulatory agencies. Whether that’s new philosophies or new regulations or potential regulations. What are you seeing?
Marilyn Dempsey: OSHA is considering a COVID-19 standard. Currently, Virginia is the only state with an emergency COVID standard, so I would expect to see a similar standard come through OSHA this year.
Rick Schweitzer: What is a COVID-19 standard? What does that mean?
Marilyn: It means that there will be rules for how to deal with people who are ill, how long employees must be out of work after a COVID exposure and criteria for PPE. In addition to the potential emergency standard from OSHA, the CDC has stated on their update calls that they’re all expecting the current recommendations to be in place for at least the next two years.
Rick: I just read a report from another expert today that said we’re already down 77% in the reported cases and that we’re going to have herd immunity by April.
Marilyn: That’s interesting. There’s a new variant coming out of South Africa and England and it has that S-protein that I was concerned about. They’re saying it’s much more infective and much more dangerous. Similar to the original variant that was out. But we’ll see. I think we’re all waiting to see.
WGT: Marilyn, when you say, “new standards,” are you talking about best practices or would these be mandated things, like the two-mask practice that you mentioned, that you have to abide by?
Marilyn: The standard will be mandated. I don’t know exactly what is going to be in the standard, but I do know that they’re taking a hard look at Virginia.
With the rumors of an OSHA emergency standard and the fact that OSHA seeks to hire more inspectors, they will, in all likelihood, take bigger, more stringent look at COVID inspections and worker illnesses. During the Trump administration, inspections were held back a little bit. Now I believe we will see a significant increase in inspection and enforcement from OSHA.
I’ll let Rick speak to the administration part of this, but OSHA is also taking a good, long look at the Hazard Communication standard, which is the backbone of our training and what members depend on us for guidance. OSHA’S proposing greater harmonization to conform to the latest revisions to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals. These revisions include changes to the classifications for chemicals, including the physical and health hazards, label changes and SDS changes. These changes would require some SDS and labels to change and GAWDA members would then have to change out labels and send the amended SDS to all affected customers and retrain employees on the changes.
Tom Badstubner: Label text revisions are a huge expense, too.
Rick: And for minimal, if any, safety benefit, quite frankly.
Marilyn: They’re saying that it will have significant safety benefits. We’ll see.
WGT: And this is theoretical at this point, but your gut feeling is that is where the winds are blowing?
Marilyn: Yes. Rick can speak to this a little bit more, but for me that’s mainly from the leadership that is being put in place.
Mike Dodd: Just to clarify, these are things that they’re thinking about doing, there haven’t been proposals or anything?
Marilyn: Correct. They are proposing to review the Haz Com standard. In that, they are going to look at the chemical classifications for both health and physical hazards, which may also address label changes and SDS changes. And we will keep members updated as any changes occur, if any do occur.
Rick: That’s right. OSHA published this proposal on February 16. It’s a 400-plus page proposal and it does propose revisions to SDS contents and labeling for certain products. So, it’s certainly something we’ll be monitoring.
WGT: Tom, from an FDA perspective, is there anything you’re keeping your eye on?
Tom: There are two things I’d like to bring up. The first is with regards to new regulations. We’ve been working with the FDA since 2007 about having regulations that are appropriate for medical gases. And we think we’re very close. The FDA, in their last communication, last summer, said that new regulations would be proposed in August 2021. We are eagerly awaiting their proposed regulations.
There are some sections of the present regulations that are clearly inappropriate for medical gases (e.g., theoretical yield, expiration dates and certain label elements). Based on conversations in public meetings, we expect the FDA to modernize these Good Manufacturing Practices.
The other thing is that the General Accounting Office did an accounting of the FDA and their inspections and between March and September, the FDA did 52 domestic inspections and 3 foreign inspections. That compares with 400 domestic inspections in the previous year and 600 foreign inspections. So, they went from 600 foreign inspections down to 3 foreign inspections. That’s a huge decrease in inspection activity, mostly due to COVID. And so, the FDA is now using alternate inspection techniques. For example, in some cases, the agency has started using a questionnaire process called Form 4003. Typically, the questions on the FDA Form 4003 are not appropriate for medical gas companies. In response, we wrote a white paper that explains to members, “If you get this question, here is an answer to consider.” Due to COVID, I think we will see more of those initiatives from the FDA to do inspections remotely. And I also think there will be more and more on-site inspections as the year goes on. Keep in mind, that our industry is recognized by the FDA as being very low risk. And so, we will probably have fewer inspections than a traditional pharmaceutical company would have.
WGT: Where is that white paper available to members?
Tom: If members call me, I can send the appropriate sample responses to them.
WGT: How about from DOT?
Rick: Let’s talk first about the highway and infrastructure legislation that we’re going to have this year. The current highway bill is going to expire September 30. So, Congress has to do something to reauthorize the program by then. We expect that bills are going to be introduced in the House and the Senate probably in April or May. And they will probably be finished with them by August, maybe September. That’s assuming that all goes well. But there are going to be several themes in those bills besides increasing some sort of tax to pay for increased investment in highways and bridges. You’re going to see a great deal of emphasis on promoting electric vehicles, perhaps even to the extent of a federal mandate to prohibit the purchase of fossil-fueled vehicles after a certain date. California and Massachusetts have already prohibited the purchase of fossil-fueled vehicles after 2035. And you can already see in TV ads that the industry is headed this way. Ford Motor Companies are doing ads saying that they’re going to have all electric vehicles in their fleet by 2030 or 2035. The trucking industry is doing the same thing. So, there will be a great deal of emphasis on promoting electric vehicles, including the funding of charging stations nationwide at truck stops, rest stops and other public places.
They’re going to have to try to figure out some mechanism for generating a great deal of additional revenue to fund investments in highways and infrastructure. The fuel tax is one way to do it. Nobody seems interested in increasing gasoline or diesel taxes. They haven’t been increased since 1993. There is a study underway, and I’m on an advisory committee, talking to a number of states, about whether or not or how they would implement a vehicle miles traveled tax. So, we’re trying to figure out how to fund this.
In his confirmation hearing, Secretary of Transportation Pete Buttigieg said that everything, including a fuel tax increase was on the table. And then the White House very quickly walked back those remarks. But if they don’t do that, then they’re going to have to come up with, essentially, hundreds of billions of dollars over five years or so, from some other revenue source. It is possible that, they will continue to deficit spend and call it an investment in infrastructure. It’s also possible that, over the next several years, they will develop a vehicle miles traveled tax that will replace gasoline and diesel fuel taxes and perhaps other taxes and excise fees at both the federal and state levels.
I do expect that DOT is going to look at the changes that were recently made in the driver hours of service regulations, particularly the short haul exemption for 14 hours and 150 air miles for CDL drivers. This exempts those drivers from electronic logging devices and from the 30-minute rest break. My guess is that DOT will at least look at that and see whether or not it has generated any additional fatigue related accidents.
I do think that DOT is also going to implement a rulemaking to increase the minimum levels of liability insurance for motor vehicle carriers. These have not changed since 1985. A study that was done by DOT back in 2013 indicated that, just on a straight inflation basis, those minimum amounts, which, for most HAZMAT haulers within GAWDA is $1 million, would have to go up two to three times to keep pace with inflation, not to mention medical inflation. My guess is that there will be a proposed rulemaking on that probably within the next year, to substantially increase the minimum financial responsibility requirements. I’m not saying it will necessarily be two to three times what we have now, but I do expect it will be a significant increase.
I can also see changes on things like sleep apnea. A proposed rule, perhaps, to establish new standards for drivers who have sleep disorders and to take some of the discretion away from the medical examiners and to have more specific requirements for that. That might not be a bad thing, frankly, to have more black and white regulations that everyone can predict, rather than just putting it in the hands of the medical examiners.
And then, finally, I think this is not particularly a DOT matter, although it does have implications for drivers, but either the legalization or decriminalization of marijuana at a federal level. I do expect this to happen sometime in the Biden administration. It’s going to have a great deal of implications for employers generally. For drivers, perhaps less so, because they will still be subject to drug and alcohol testing, which will include testing for marijuana. My expectation is that marijuana will still be a prohibited substance. The problem is that the test we have now is not an impairment test, it’s simply a test for the presence of marijuana in the system. So, the argument from defense lawyers is that, yes, the driver might have used marijuana sometime in the last month, but was not necessarily impaired when he or she tested positive or on the job. That’s going to be the difficulty here. Recreational or medical use of marijuana off the job may still show up in a test, but it won’t necessarily indicate than an employee was impaired at the time of the test or at the time the employee was at work. So, we’re going to have to figure out how to come to terms with that. We’ve done that, to a certain extent, with alcohol and drivers. But the alcohol test is an impairment test. The marijuana test is not. So, it’s going to be a difficult situation for drivers and non-drivers, as well. And for employers to figure out the sweet spot in prohibiting use of what will be a largely legal product.
Mike: One thing I wanted to talk about is the fact that we have seen a lot of changes in distributor personnel, recently. In the Consultant Webinars that we have been running this year, we’ve noticed a lot of new compliance people. I would say we’ve seen more in the last year than ever before. That’s good. It’s like a new stream of people coming on. A new age.
With that in mind, I just wanted to remind them that the consultants are here to help. That’s our job. We enjoy doing that. So, we just want to make sure that they know that we’re here. Don’t be shy. There are lots of ways to find our contact information on the GAWDA website, in the things we mail out, even in this article. We just want to encourage them to use us. Ask us questions. We have tons of information to send from all these years of experience.
And then, on the members-only section on the GAWDA website, we’ve got all kinds of things archived. That’s one of the reasons that I prefer emails over phone calls. I’ll take either one, but email is so nice because I usually send them back lots of attachments that will help them see some of the things that we talked about and they can digest it better. I just want to make sure that they know that those resources are out there.
Here’s the scary part, if you add up the years of experience on this phone call, that’s a big number. I’ve got 47.
Marilyn: 32.
Rick: 33 for me.
Tom: 47 for me.
Mike: That’s 159 years of experience for the members to call on.
WGT: That’s a good point, I think it’s important to take a step back and discuss why the consultant program is such a great resource. So, on that topic, is there anything anybody wants to add?
Tom: I think this is a time for members to take a look at the basics of training, calibration and maintenance. Just get ourselves prepared with our personnel and our equipment.
Rick: I would also suggest that they look at their employee and human resources policies just to make sure if they have written employee handbooks, which I suggest they should have, that they are up to date and that they have responded to the challenges of the last year. As Marilyn said, with OSHA considering coming out with a COVID standard in the workplace, a lot of that will implicate HR standards and how you deal with employees. Number one, protecting them in the workplace, but number two, not penalizing them either for refusing to work or for trying to protect themselves and their families. There is going to be a great deal of litigation spawned by that, particularly encouraged by this Department of Labor. I think companies need to make sure that they have the best information available to them and that their policies are defensible.
Marilyn: I think we hit on it. We talked about changes that may be coming up, but as Tom pointed out, it’s back to the basics. Do you have the programs and policies that you need in order to have the culture to survive and thrive? All of our members are such strong people that we get questions from. They really care and they want to succeed. We want to give them the tools.
Rick: Hopefully once the virus goes away and things return to normal, business is going to come back with a vengeance. Those companies that are well positioned are going to do very, very well.
