A Word From Big Brother

Key government officials discuss regulatory issues.

Government regulatory agencies have a huge impact on our industry. Members are greatly impacted by their presence, yet rarely get a chance to ask them why they do what they do. Welding & Gases Today recently had a chance to speak with representatives from each major department. We spoke with officials from the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Federal Motor Carrier Safety Administration (FMCSA), the Food and Drug Administration (FDA), Transportation Security Administration (TSA) and the Infrastructure Security Compliance division of the Department of Homeland Security (DHS), all of whom provided insight on what exactly their agency does, and why they do it.

WHO WE TALKED WITH AND WHAT THEY DO

Bob Richard, Deputy Associate Administrator for the Pipeline and Hazardous Materials Safety Administration, a division of the Department of Transportation
Employed by DOT since 1992, Bob has worked with hazardous materials regulations for 20 years. Prior to his current position, he directed the International Standards Branch. Reporting to a political appointee, he is the number two person in the Office of Hazardous Materials Safety. PHMSA’s mission is to protect people and the environment from the risks inherent in the transportation of hazardous materials.

 

Bill Arrington, General Manager for the Office of Highway and Motor Carrier, a division of the Transportation Security Agency
Bill retired from the Maryland State Police where he served as a Trooper since 1974, and joined TSA as an Area Director for the South Central Area. He serves on the Homeland Security Committee and the Infrastructure Protection subcommittee as a member of the International Association of Chiefs of Police. OHMC has responsibility for transportation as it relates to motor carriers, motor coaches, school buses and critical infrastructure, which includes bridges and tunnels within the U.S.

 

Duane DeBruyne, Deputy Director of Public Affairs for the Federal Motor Carrier Safety Administration, a division of the Department of Transportation
The FMCSA’s mandate is to reduce the number of and severity of crashes involving large commercial vehicles in interstate commerce. Their bottom line is safety.

 

Sue Armstrong, Acting Director of the Infrastructure Security Compliance Division, a division of the Department of Homeland Security’s Office of Infrastructure Protection
A true insider, Sue Armstrong has been with the Office of Infrastructure Protection since its inception. With a background in federal law enforcement, she has worked for the State Department Inspector General and was a special agent at the General Services Administration Office of Inspector General. She also ran the internal investigations office at Immigration and Naturalization Services before coming to DHS in 2003. She previously served as Chief of Staff for the Office of Infrastructure Protection (IP). IP’s purpose is to lead the coordinated national effort to protect critical infrastructure and key resources. Armstrong directs the effort required to develop and regulate the recently established Chemical Facility Anti-Terrorism Standards (CFATS).

 

FDA – Answers were provided by an assortment of key officials from the Center for Drug Research & Evaluation’s (CDER) Office of Compliance.

 

MAKING THE RULES
WGT: First, thank you for agreeing to talk with us. Each of your agencies has a huge impact on our members. It’s important to them that they understand how best to remain in compliance and to structure their businesses so that they can meet future standards as they are established by your agencies. So let’s begin with a basic question…Where do your regulations come from? What do they start out as?

Bob Richard: Believe it or not, hazmat regulations have been around since the early 1900s, so it’s not like they’re brand new. The first regulations were developed for mining and explosives operations. They’ve evolved as technology evolved, but they still hold true to the basic premise of safety regarding any dangerous or hazardous materials.

Bill Arrington: TSA looks at how vulnerable the industry might be in a particular area. We have a requirement under the Homeland Security Act to conduct risk assessments for hazmat carriers. We talk to people within the industries impacted by hazardous materials to find out what they’re seeing, and then we pool that information together with our expertise to determine how vulnerable the industry is, as a whole.

WGT: How do you decide what must be regulated?

Duane DeBruyne: Sometimes Congress will direct an agency to look at an issue; other times it comes through petitions; and other times it comes through the agency’s own internal processes.

Sue Armstrong: Like many other departments, DHS has statutory authority from Congress. Our statute mandates that the Secretary implement regulations to identify and secure high-risk chemical facilities. That is why we came up with the CFATS.

Bill Arrington: TSA conducts risk, vulnerability and threat assessments. Based on information gathered, we determine the programs that we need to put in place in order to enhance the security practices to better secure our nation.

Bill Arrington, TSA
“In June, TSA published a series of Security Action Items for hazmat, which is essentially a list of best practices.”
– Bill Arrington, TSA

Duane DeBruyne: Once an issue is deemed necessary for regulation, it goes into rulemaking. During rulemaking, there’s a legal standard process for regulations that all government departments follow.

WGT: What does that process entail?

Bob Richard: It’s a collaborative effort between the department and the industry, which is a process that is unique to the United States. PHMSA interacts with the Compressed Gas Association and various welding trade groups. The regulations are fairly mature and we strive not to make changes unless they are needed to enhance safety or to make commerce more efficient.

FDA: The procedure begins with the publication of a proposal in the Federal Register which establishes or changes a regulation. We invite public comments, which are then carefully evaluated and taken into account when finalizing the regulation.

Bob Richard: PHMSA conducts public, regional meetings to gather information about the issue at hand. We don’t necessarily think that we know all the answers, which is why we try to talk to people who do have the answers. We use all of that information to go ahead and make a proposed rule, which is then put out for comments.

FDA: All final regulations are then published in the Code of Federal Regulations, which can be accessed online at www.regulations.gov.

Bob Richard: And even after that, people can appeal the final rule. We don’t like to see that because if we did a good job, there shouldn’t be any appeals, but sometimes they’re unavoidable.

Sue Armstrong: For the CFATS, the DHS published an advanced proposal in December 2006, and then used industry comments to publish the final rule. In April 2008, we published Appendix A, which identifies 322 chemicals of interest and establishes rules regarding specific amounts of each chemical.

WGT: Is there a timeline for the development of a typical regulation?

Bob Richard: It varies. We may be able to publish a regulation in a year, but that’s an aggressive time frame. It typically takes up to two years.

Bob Richard, PHMSA
“One of the big problems we face is human error.”
– Bob Richard, PHMSA

FDA: Finalizing a regulation can take from several months to years, depending on the complexity of the regulation and its potential impact on the regulated industry.

WGT: Once you’ve published a new regulation, how do you alert the public and the industry?

Sue Armstrong: Now that we have identified the chemicals of interest, we alert the high-risk facilities that possess predetermined amounts of those chemicals. We have sent notices to all of the high-risk facilities.

Bob Richard: PHMSA puts all new regulations on our Web site and alerts the media and major trade groups, such as the Compressed Gas Association.

Duane DeBruyne: We at the FMCSA have a very robust public outreach unit. We recently did a series of posters and announcements featuring NASCAR driver Rusty Wallace encouraging truck drivers to wear safety belts.

Bob Richard: We also have a number of publications written specifically for hazmat, such as the Hazardous Cargo Bulletin and Hazmat Packager and Shipper. We don’t go to the New York Times because this is hazmat, it’s not like it is written for the general public.

Bill Arrington: As a component of the DHS, the TSA publicizes items through the Government Coordinating Councils as well as the Sector Coordinating Councils, which consist of a large number of industry trade associations.

Sue Armstrong: We also utilize the Sector and Government Coordinating Councils, which are a part of DHS’s National Infrastructure Protection Plan.

WGT: What is the purpose of these councils?

Sue Armstrong: They are a means for the government to communicate with industry sectors. There are 18 industry sectors and each has a Sector Coordinating Council, which is a group of private sector representatives, and a Government Coordinating Council, which is comprised of all the federal agencies that have business with that sector.

Bill Arrington: TSA just published a series of 23 Security Action Items for hazmat at the end of June, which we pushed through these councils.

Departmental Structure

WGT: You mentioned Security Action Items, Bill. Are these new regulations?

Bill Arrington: Currently, this is a voluntary compliance program that outlines standards of care and best practices when dealing with the transportation of hazmats. They are not regulations at this point. They are recommended practices.

WGT: Will these items eventually become regulations?

Bill Arrington: There’s no requirement or regulation as of yet, but that’s not to say that at some point in the very near future, TSA won’t move towards rulemaking and these items will become requirements. We have found, however, that many of the premier companies already conduct many of these best practices.

ARE THEY WORKING?

WGT: How do you measure success?

“Stay tapped into the Sector Coordinating Council and be aware of what’s going on in terms of security initiatives and protection measures.”

– Sue Armstrong, DHS

Bill Arrington: We are all operating under a performance-based budget, but as of now we have no way of measuring success. We are currently trying to identify ways to measure our success.

Bob Richard: That’s an interesting question because the government is being challenged more and more to have effective metrics and to measure our performance. Plus, our budget depends on our being able to effectively measure our achievements. We look at fatalities associated with hazardous materials and other data indicators, like shipments of diagnostic specimens, i.e., blood and urine. We measure serious incidents each year and set goals to reduce those incidents by a certain percentage.

WGT: How are you doing?

Bob Richard: We have an extremely safe record. On average, there are 11 to 13 deaths per year associated with hazardous materials, and an average of 450 to 475 serious incidents. I know that we passed our target for this year.

FDA: The ongoing success of an FDA regulation, such as those intended to assure good practices by a drug manufacturer, are normally evaluated by inspecting manufacturers for conformance to the requirement.

ENFORCEMENT and INSPECTIONS

WGT: Tell me about how inspections are handled.

Bob Richard: PMHSA has a team of 45 inspectors who do compliance inspections. We also have outreach people, and we are hoping to take more of an integrity management approach in which we work with the industry to do safety audits, identify problems and then work collectively to solve those problems. We aren’t there yet.

FDA: Drug manufacturers, including those that manufacture active ingredients and medical gases, are subject to routine inspection for compliance with CGMP regulations.

Top 5 Security Action Items

Bill Arrington: Due to the relative lack of maturity of the TSA, we do not currently handle enforcement of regulations regarding highways. That is handled by DOT. The TSA does handle enforcement on the freight rail end, though. We will be hiring additional inspectors later this year and will broaden their responsibility into the highway mode. While we’ve not yet produced the rule that requires companies to comply with the Security Action items, we do intend on exploring that further. But until TSA can manage this, the responsibility remains with DOT.

Sue Armstrong: DHS is also not at the stage of taking any enforcement action yet regarding CFATS. In mid-June we notified over 7,000 facilities that were identified as belonging to one of four high-risk tiers. We will have these facilities conduct security vulnerability assessments and write site security plans. Once those plans are reviewed by the secretary, we will begin conducting inspections at these facilities.

WGT: When do you expect to be at the stage of enforcement?

Sue Armstrong: Not until next year. We’re in the process of hiring about 82 field inspectors right now. However, we don’t intend to take any action towards a facility that hasn’t completely gone through the security vulnerability assessment and site security plan process.

Bill Arrington: We also will be hiring additional inspectors later this year, which will broaden our responsibility to enforcement on the highways. The PHMSA has regulations on the books and FMCSA is the enforcement arm for DOT in those matters.

WGT: What exactly does the DOT do to enforce these regulations?

Duane DeBruyne: FMCSA conducts inspections, called compliance reviews, which are audits of a company’s safety management practices.

Bob Richard: PHMSA conducts similar inspections to ensure regulatory compliance. We typically inspect facilities that handle the transportation of hazmat. That’s our largest mode of enforcement.

Duane DeBruyne: A large part of the FMCSA enforcement process is random roadside inspections, which are typically handled by the state. We give over $300 million a year to the states to support their commercial vehicle inspection programs. These inspections look at the vehicle and the driver’s qualifications.

WGT: Who within the state handles these inspections?

Duane DeBruyne: States typically have their own commercial vehicle inspection unit, which is part of the highway patrol or the state police. FMCSA has a national training center where we provide training to these inspectors. We have federal inspectors as well, but the bulk of it is done by the state.

WGT: How do you decide who receives an inspection?

Duane DeBruyne: We conduct random inspections at weigh stations, truck stops and rest stops.

“For everything we do at FMCSA, the bottom line is safety.”

– Duane DeBruyne, FMCSA

Bob Richard: We have a risk-based, data-driven approach to selecting whom we inspect. PHMSA’s resources are too limited to inspect every company, so we base our inspection selection on a combination of factors—whether the company has had previous incidents, size of the company, and the products that they transport. We try to get around to a lot of the cylinder manufacturers and the cylinder fillers, and the carriers that transport cylinders from one location to another.

Bill Arrington: Like I mentioned, we don’t conduct inspections, but we do conduct voluntary corporate security reviews. We look at the major stakeholders in the industry and make recommendations regarding security improvement. Right now, there are about 23 best practices that the Office of Highway and Motor Carrier applies to a Tier 1 product. There is no rule or regulation that you have to do anything under these recommendations. We believe that a company should institute these best practices or standards of care, but it is strictly voluntary. That’s not to say that at some point in the very near future we won’t move towards rulemaking and they will become an absolute requirement.

Sue Armstrong: DHS sorted the high-risk chemical facilities into four tiers, and Tier 1 facilities will receive more frequent inspections.

WGT: How do you determine what risk tier a company falls into?

Sue Armstrong: We look at the type and amount of chemicals handled by a facility, as well as the facility’s proximity to high-population areas. There are three main types of security issues we look at in terms of chemicals of interest, and those are: 1) Do the chemicals represent a public health and safety concern in terms of a toxic release or explosive flammable issue? 2) Are the chemicals something that could be stolen or diverted and weaponized outside of the facility? and 3) Do the chemicals represent a sabotage or contamination issue? This, again, is a public health and safety issue.

Top 10 PHMSA Violations (2005-2007)

WGT: Do you give any advance notice before conducting an inspection?

Bob Richard: None.

Duane DeBruyne: No, they are typically random inspections.

Sue Armstrong: Facilities received DHS notices alerting them that they must conduct a security vulnerability assessment and will next have to develop a site security plan. After that, they will all be undergoing inspections.

Bill Arrington: We absolutely do. But again, keep in mind that no company has to consent to an OHMC security review. I think, however, that a wise person would want to know how they are doing from a security stance and look for an opportunity to review their practices.

WGT: What makes a good compliance inspector?

Bob Richard: We recently revamped our entire training program for PHMSA inspectors. It’s now a combination of classroom and on-the-job training. I think a good compliance inspector has to be able to focus on solving problems and not visit a company with the sole purpose of uncovering violations.

WGT: What are some of the main things you look for when conducting an inspection?

Bob Richard: Ensuring that the cylinders being used are properly maintained and inspected, and that they’re of the right specifications. DOT is responsible for specification of the cylinders as well as re-testing requirements and regulation of valve and pressure relief devices.

Duane DeBruyne: Some of the big things FMCSA is looking at right now are medical qualifications for drivers and whether or not a company has a random drug and alcohol testing program in place. They need to have this to acquire DOT operating authority for interstate commerce. All commercial drivers now must have a DHS background check before being issued a CDL.

Bob Richard: The idea of any inspection is to go in, identify problems that have potential safety implications, and then work with that company to educate them. Our ultimate goal is to educate. We’d like to see everybody in compliance. If a company takes a proactive stance with corrective actions, a violation is often negotiated down. I am very proud of the fact that 80 percent of the violations that we find are corrected when we visit the next time.

FDA: Inspections cover areas of manufacturing that determine or assure a drug’s quality, including evaluation of a manufacturer’s raw material controls, facility and equipment maintenance and qualification, production process controls and validation, testing, record-keeping and review, proper and timely handling of complaints and problems, and quality control practices.

WGT: What are the most common violations found during inspections?

FDA: The most frequent deviation of Good Manufacturing Practices over the last 18 months was inadequate personnel training.

Bob Richard: We’ve found that at PHMSA too. I think one of the biggest problems that we face is human error. Unfortunately, this is usually a result of training infractions. We have to realize that human error will always be there, and we have to design our systems and have appropriate checks, balances, warnings and measures in place so that even if a person makes a mistake, they can avoid a serious incident where people get hurt. Training records need to be available.

Did You Know…
  • The Department of Homeland Security is the youngest U.S. Cabinet department, yet it boasts the seventh largest budget at $38 billion for FY2008.
  • The Transportation Security Administration was originally created as a component agency of DOT, but was transferred to the authority of DHS in 2003.
  • While its budget is only $1.8 billion, the Food and Drug Administration oversees products that account for approximately $1 trillion a year in U.S. consumer spending.
  • DHS has the third largest number of employees of any government department with over 170,000 men and women. Only the Department of Defense (669,281 civilian personnel) and the Department of Veterans Affairs (roughly 240,000 personnel) have more.

WGT: Do you have a target or goal for reducing serious incidents?

Duane DeBruyne: Yes. There are departmental goals for all modes of transit, which are tied to reducing fatalities and the severity of crashes. They’re all based on fatalities and total vehicle miles traveled.

Bob Richard: And we’d always like to get those numbers down to zero, but that’s not practical. PHMSA’s target for the 2008 fiscal year is no more than 462 serious incidents, which was the number of incidents for 2007. We don’t set a number for fatalities, we just try to keep them as low as possible.

Bill Arrington: Well that’s tough to measure for TSA. As I’ve always said, the bad guy only has to be right once, we have to be right every time. So how many incidents have we been able to stop or deter as a result of our efforts? I can’t tell you that. There’s no way to put down a marker and say we’ve had a 50 percent success rate based on our efforts.

WGT: What advice do you have for GAWDA members regarding inspections?

Bob Richard: Don’t wait until the last minute before the inspector comes. They should have a continuous improvement safety program in place. They also can call PHMSA at any time about compliance issues. We’re here to help. All they have to do is call us at 202-366-4900. Also, our hazardous materials safety assistance teams are more than willing to participate in association regional meetings.

Bill Arrington: At TSA, we simply believe that the more individuals who comply with our recommendations, the better our success rate will be and the safer the industry will be.

Sue Armstrong: Just stay tapped into the Sector Coordinating Council and be aware of what’s going on in terms of security initiatives and protection measures. I also recommend getting involved in the Homeland Security Information Network, a portal where we post information and enable collaboration amongst the various private sectors. It’s a good way for companies to stay up-to-date on DHS regulatory affairs.

LOOKING AHEAD, WHAT’S NEXT FOR THE REGULATORY BODIES?

WGT: What are some of the big issues on the horizon for your agency as related to the gases and welding industry?

Bill Arrington: Certainly it’s hard to predict what the future may hold, but TSA is continuing to watch the intelligence to see what’s happening around the world. Based on threats and worldwide events, we must ask: Can that happen here, and if so, what are we doing about it?

Sue Armstrong: DHS is anticipating a permanent authorization in legislation for the CFATS program. Once we get the program operating, we will develop a specific inspection cycle for each tier. Tier 1 facilities will be inspected every year; Tier 2 facilities will be inspected every other year; and we will make determinations regarding Tiers 3 and 4 when we get to those.

Bill Arrington: Right now, OHMC is looking at the entire hazmat table, the 101 Table, from a security perspective. For example, while hairspray is classified as a hazardous material, there’s not a whole lot a terrorist can do with hairspray. I’m kind of rusty on my chemistry, but I don’t think hairspray can be turned into a weapon of mass destruction!

WGT: What about the dangerous materials?

Bill Arrington: We eliminated the items that aren’t dangerous, reducing the table by about 50 percent. The Security Action Items I discussed earlier address the security issues associated with hauling these remaining materials. And like I said, right now they’re strictly voluntary, but we are exploring mandatory compliance.

FDA: A proposed rule change published in the Federal Register of April 10, 2006, will make use of the color coding system, which is already standard practice in most of the medical gases industry. We expect to finalize these regulations soon.

Duane DeBruyne: As far as DOT is concerned, we have the hours of service regulation and the entry-level driver training requirement, which would set a minimum threshold for the number of classroom hours and behind-the-wheel training hours a driver must have to qualify for a CDL.

WGT: What is the status of these regulations?

Most Frequently Found CGMP Deviations of Past 24 Months

Duane DeBruyne: They both are currently in rulemaking, and for that reason, I cannot discuss them. The notice, public docket and public comments can all be found on FMCSA’s Web site, though, at www.fmcsa.dot.gov.

WGT: Hours of service has its detractors.

Duane DeBruyne: There are some folks who feel the current rule is too stringent, and others who feel the current rule is too lenient. Other than to say that it is in rulemaking, I can’t comment.

WGT: Do you know when the rulemaking session is expected to finish?

Duane DeBruyne: It is scheduled, and let me repeat, it is scheduled, to be completed before the end of the calendar year.

WGT: Can you comment on the recently proposed revisions of the CGMP regulations at 21 CFR Parts 210-211 regarding cylinder segregation?

FDA: Two proposals were published in the Federal Register, one in April 2006, the other in December 2007. The 2006 proposal creates provisions to better distinguish containers containing different gases to prevent hazardous mix-ups. We expect to finalize these regulations soon.

WGT: How have your agencies changed over the years?

Bob Richard: We are more risk-based. We try to use our resources better to identify problems that present the highest safety risks. We are more collaborative. We are trying to anticipate future technologies. We are most proud of a collaboration with the International Association of Fire Chiefs which will, next year, support a Web portal in which every fire company can get information regarding how to respond to every imaginable kind of incident.

WGT: What is one thing the industry should know about government regulatory bodies?

Bob Richard: I think we share the same safety concerns as the industry and want to ensure that the nation is safe. It’s important that the industry understands the implications of some of these incidents. When serious incidents occur, it becomes difficult for transporters to move their commodities, because if public perception is lost, then we’re going to be pressured to put additional requirements in place that might not be necessary and would make transport even more difficult. We’re here to help, and there are a lot of resources we can offer to help GAWDA members achieve a level of safety that’s appropriate.

WGT: One final question. Most of you are career civil servants. What’s the best part of your job?

Bob Richard: Knowing that we are making a difference every day to make America a safer place.

Agreement all around.

Gases and Welding Distributors Association