By Tom Badstubner, Marilyn Dempsey, Michael Dodd, Rick Schweitzer and Steve Guglielmo
GAWDA consultants have been busy since the Second Quarter Issue of Welding & Gases Today. They held a multiple day safety and compliance webinar at Chart Industries, a panel discussion during the GAWDA SMC in Dallas, and have continued to host their monthly Safety Manager Safety Meeting calls.
The GAWDA Consultant Program is a GAWDA member benefit that is included as part of your member dues to the association. It is consistently rated as one of the most valuable member benefits that GAWDA provides. Thank you to Tom Badstubner, GAWDA’s FDA and Medical Gases Consultant; Marilyn Dempsey, DHS, EPA, and OSHA Consultant; Mike 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: GAWDA hosted its Spring Compliance Workshop at Chart. Can you tell me about that? What topics did you cover, and was it an overall success?
Marilyn Dempsey: The three of us covered the components necessary for successful FDA, OSHA, and DOT programs.
Mike Dodd: The Compliance Webinar-Seminar was a success. Everyone was happy, successful, and, of course, we enjoyed our visit to Chart, and I think the members did as well.
We also had our panel at the SMC. We were able to answer lots of questions from the audience. We had people come up afterwards to continue talking. They like talking with us. So, both events were great.
WGT: There was a question about laser safety that came up at the SMC that had never been raised before, or at least that I had never seen discussed before. Was there anything else that surprised you or questions that were especially pertinent that you want to make sure the entire membership gets eyes on?
Marilyn: The sale of laser welding machines has been growing, and it is encouraging that the safety aspect of these welders is being addressed. Safety precautions are published in the machine’s user manual; however, when a machine is sold, a demonstration is often provided, during which the salesman should be knowledgeable about how to operate the machine safely. The GAWDA Safety Committee is developing a sample safety practice for laser machines. Tom has more FDA regulatory changes than OSHA due to the new regulations.
Tom Badstubner: We’ve been discussing the new medical gas regulations for the last six months. We have prepared new procedures to comply with the new regulations. Members have until December 18th to implement the new SOPs and update their medical oxygen and medical air labels. Those items were discussed at the SMC and are still current.
WGT: Speaking of the new regulations and labels, in the recent GAWDA Connection, we had the Medical Oxygen and Air Labels revision alert. What exactly changed there, and what do members need to do?
Tom: The FDA specified a different kind of a prescription warning for oxygen. Instead of the old “Rx only” as it is for oxygen and almost all the other prescription drugs, the FDA specified that now we have to use the term “Rx required.” That will require a lot of labels to be changed, just for that purpose alone.
In addition to that, there are some new pictograms that are required on oxygen labels that say, “no smoking/no vaping.” This requirement can be met with a single pictogram or with three pictograms.
Thirdly, there are some new OSHA GHS warnings in the body of the label that have been changed. Now, those aren’t mandatory right now, not even by December, but they will be mandatory soon, and it just makes sense to make one oxygen label change, rather than change it for the FDA and then change it again later for OSHA. It’s time-consuming and very expensive for members to change labels, so it made sense to change the OSHA and FDA label at the same time. That delayed the release of the artwork by a few months, so CGA could make sure that the new OSHA text was appropriate.
For medical air, there used to be some allowance for emergency use, and the FDA has explicitly denied that medical air can be used without a prescription for emergency use. We needed to change our labels for medical air to no longer allow medical air to be used for emergencies without a prescription. You can still use OSHA grade D air for emergencies, but not medical air.
WGT: Another couple of Safety Alerts that had come were a DOT special cylinder permit that had expired and then was subsequently renewed. What exactly happened there? Has anything changed, or do people have to change their procedures in some way?
Mike: What had happened there was that Worthington Canada had let the special permit for the special light-weight steel medical ease permit expire. We had to let everyone know that they couldn’t use it anymore, since it had expired. About two weeks later, Worthington was able to get it renewed, and everyone was back in business again. However, they let everyone know that this is the last time they were going to renew it, and the next time someone would have to pick it up and renew it under their own name. We’re hoping that means our people could still use it without having to be a “party to” status. If they change the wording to make it “party to” status, then all those who want to use it would have to apply for a “party to” status. We’re hoping they’ll just leave it alone and someone will renew it and keep it nice and simple, so it won’t affect anybody when they renew it.
WGT: When will it come up for renewal again?
Mike: It’s every four years. And they said they’re not going to renew it again. So, four years from now, unless they change their mind, somebody else will have to pick it up. And there are enough of these cylinders out there that somebody will pick it up.
WGT: During the two weeks that it was lapsed, did those cylinders have to come out of circulation?
Mike: If you don’t renew the permit, technically, that cylinder is considered dead. Not permitted anymore. There were a lot of people during the two-week period who were using these cylinders that had to stop, cease, and desist. But the moral of the story is, even though it was late, they got it renewed, everybody is back in business, and everybody is happy.
WGT: Another thing that impacts DOT is the FMCSA English language proficiency requirements…
Rick Schweitzer: June 25th, that went into effect. It’s going to be enforced by all of the states as well as the federal government, and it is not going to change the regulation, because the drivers have always been subjected to a requirement that they be able to speak/read the English language proficiently, so as to converse with enforcement officials on the roadside and to read/understand street/road signs. That hasn’t changed. What’s changed is that if you’re found in violation of it, it is now an “out of service violation.” It used to just be a fine. This new approach means that the driver will have to stop driving and will no longer be able to drive a commercial vehicle until they can somehow show proficiency in the English language. That is one of the big questions: “How do you show proficiency to become requalified?”
Now, the FMCSA has issued a few guidance documents to enforcement officials and company management. The company management guidance indicates how a company should, essentially, test their drivers or determine proficiency to meet the requirements. The interview should be conducted in English with the driver, and the driver should be able to respond to questions about shipping papers, routing, destinations, trips, and hours of service, as well as information about the equipment that the driver is operating.
How this will go, we don’t know. The reason FMCSA changed this from an out-of-service requirement to simply a fine, essentially downgrading the violation, was that, a little over 10 years ago, there was litigation and some allegations of racial profiling, and there really weren’t any very good standards on how this requirement was being enforced at the roadside. So, instead of changing the requirement, the FMCSA just issued an enforcement memo that said, “Alright, we’re not going to put people out of service for not being able to read or speak English. We’re simply going to issue them a fine.” And that’s how it’s been for over 10 years now. However, as of the end of June, it went back to an out-of-service violation.
WGT: Obviously, I understand what happens if a driver is pulled over and fails to demonstrate proficiency in the English Language. But, functionally, how is this going to impact GAWDA members?
Mike: If they get pulled out of service on the side of the road, they won’t let them drive that truck any further. The company will have to send another driver out there to drive that truck, drive the driver home, and then finish the route. The trucks could be sitting there for quite a while before somebody shows up.
Rick: This change does not apply to drivers operating in the Commercial Zones along the U.S.-Mexico border. The commercial zones are defined as an area within two to four miles from various ports of entry on the border.
Mike: Typically, it’s never been a Canadian issue; it’s always been along the Mexican border. I don’t think they’re permitted to go very many miles from the entry point. It’s more about driving across, disconnecting, letting our driver hook up, and taking from there. It is a small area they’re allowed to stay in.
Rick: There are only a handful of ports of entry along the Mexican border where this applies. Where the commercial zone is actually defined, it’s somewhere between 2-4 miles.
WGT: You said earlier that it is difficult to gauge proficiency, what is proficiency? So, what is your advice for GAWDA members if they have drivers that they fear may not be able to demonstrate proficiency?
Rick: An English language class as quickly as possible.
Mike: When they test, Rick, they have to be able to read certain things and describe your shipping paper, tell us what road signs mean, or what they convey. It’s all about being able to converse with the inspector about what they’re carrying, where they’re going, and, during an emergency, to be able to converse with emergency responders.
WGT: I understand that, from a safety aspect. Would you speculate that this is a program that will receive a lot of emphasis? Why would someone be pulled over and have to demonstrate this proficiency if they weren’t driving unsafely?
Mike: I don’t think they’ll stop them for just any reason, with regard to what they look like. I don’t think they’ll profile anyone. This will be your typical, normal roadside inspections, or if there is an accident. I don’t think they’ll make it a point to search people out.
WGT: Of course, I didn’t mean to imply that. I guess I’m asking, do you expect roadside inspections to increase in frequency in light of this program, or will it just become a normal part of the existing roadside inspection plan?
Rick: I think it will just be an enforcement emphasis as part of normal roadside inspections. These typically take place at weigh stations.
Mike: Another item, after June 23rd, is that from now on, anytime the driver gets a new medical exam the medical examiner is required to enter it directly into the system rather than the driver having to take the certificate and fax/email it. The medical examiner will have to do that directly. That will most likely take a while to go into effect. In the meantime, you might want to carry a copy of your medical exam along, just in case the doctor hasn’t done it, or the system has some quirks in it. Hopefully, by the time the members read this, the system has ironed out all the quirks.
Rick: As of the middle of June, about half the states have implemented this program. I think a driver getting a qualification exam should check with the medical examiner or the state driver licensing agency to see if they have implemented the new program.
Mike: It will be easy for them to verify, because if the doctor says he will do it, the motor carrier still has to, within a 14-day period, pull an MVR. They consider the MVR with the new medical stuff on it to be the official medical documentation. The motor carrier will be able to prove that it’s there by just pulling the MVR.
WGT: Speaking of areas of emphasis, we spent the last four years talking about the heat emphasis program through OSHA. With the new administration having new priorities, is that something that is still an emphasis program, as we’re entering the hot months?
Rick: I think it is. Marylin mentioned that OSHA is having a series of public hearings on their proposed rule that would impose new requirements for combating heat injury/illness for workers. That was first issued under the Biden Administration as a proposal. The Trump administration might go through with a new rule on this, although a number of changes would come, including eliminating paid rest breaks and such.
Marilyn: The Heat Illness Prevention Standard is still “in the works.” Public hearings were held from June 16 through July 2 and those individuals that signed up to participate can submit further comments until September of this year – so the publication of this Standard has been delayed so that more information can be gathered from companies. This does not mean we will not see the standard, just that it is going to be reviewed and perhaps relaxed a bit. I suggest that companies take a look at the GAWDA Sample Safety Practice, “Heat Related Illness Prevention” to start the process of creating a Heat Illness Prevention plan.
WGT: Is there anything else of note that has come up from the agencies/courts that could potentially have an impact on GAWDA members in the third quarter?
Rick: One thing that has happened is that Congress has passed a resolution and President Trump has now signed it, that rescinds two waivers that were granted by the EPA in the Biden administration to the California Air Resources Board that allowed California to impose requirements for manufacturing/selling zero-emission vehicles. The first is the “Advanced Clean Trucks Rule,” and the second is the “NOX Emissions Rule.”
Based on these resolutions enacted by Congress, neither California nor any other state may impose additional zero-emission vehicle requirements. As of now, the EPA waivers are no longer effective. But, the Governor of California is saying that Congress had no authority to rescind these waivers and has challenged the recissions in court. There is still a question in the courts about whether they will continue to have these mandates on a temporary basis or a permanent basis. As it is right now, manufacturers of commercial trucks are not subjected to these zero-emission mandates anymore. Companies are going to be allowed to buy diesel equipment/gasoline-powered equipment in the future. If they want to use hydrogen or electric vehicles, that is obviously allowed, but it’s no longer required under these rules.
WGT: Functionally, how much will change? I imagine that if companies were operating under the understanding that these zero-emission rules were going into effect, they would have had to change their manufacturing processes pretty far downstream. Are there still a lot of companies that were still producing vehicles that would have been out of compliance?
Rick: There are. There is a big divide between “over-the-road,” typical tractor trailers, and smaller local distribution vehicles. The smaller, lighter-weight distribution vehicles are much more likely to adopt electric vehicle options as they come back to the same facility and can be charged overnight and only travel within 100 miles or so. There’s no concern with range. With an over-the-road truck, it’s very difficult to adopt EV technology under the current technology. While large truck and engine manufacturers were trying to retool to capture this market, market demand was simply not there.
Mike: It would have to involve a huge battery storage system that would take up a lot of extra weight, reducing cargo capacity, finding charging stations, and driving prices up on purchasing vehicles. It will help our people to purchase vehicles at a reasonable price. I think it solves a future issue.
The thing I was going to add, during a Wednesday webinar I’ve seen an uptick in DOT audits. Between truck/driver audits and hazardous materials audits. Both groups have gotten active again with membership. The membership should have nothing to fear, as long as they are prepared. They usually do very well with visits.
WGT: What should members be doing to succeed at these audits?
Mike: I’ve been promoting my record-keeping system. Tom and I both have been helping individual reminders on how to survive audits. We emphasize how to survive a DOT audit multiple times during the year to help members. Those who pay attention, listen, and engage in it usually do very well.
WGT: And this information can be found on the members-only pages?
Mike: Correct, on the members pages, and also, just by asking us. If members just contact us, we have lots of things to give people to help them out.
Tom: One advantage of this, Steve, is that this goes to a slightly different audience than we’re usually speaking to. So, whoever this is reaching, should look at their self-audit program for their own compliance.
From an FDA perspective, members should make sure they did their mid-year review of their drug product label listing. Members can get their registrar to provide the information. Make sure the label is still correct, and the packages and cylinder sizes are still correct on the drug product listing. This must be done twice a year.
