Medical Gas Guidelines, Security And Driver Hours Top Agenda For 2003

The 2003 government affairs agenda for GAWDA members includes three major items: new medical gas guidelines from the FDA, new cargo and driver security requirements, and possibly some new requirements for driver hours of service.

FDA Medical Gas Guidelines
For those GAWDA members distributing medical gases, the FDA intends to issue new medical gas guidelines sometime early in 2003. These guidelines will replace the existing medical gas guidelines that were issued in 1989. Although no one outside the FDA has seen the draft guidelines now circulating within the agency, the new guidelines will likely include many of the recommended practices contained in the Fresh Air speeches over the past several years. Duane Sylvia of the FDA Office of Enforcement will make a presentation discussing the new guidelines at the GAWDA Spring Management Conferences in March (Atlanta) and May (Chicago).

The pivotal question is how these new guidelines will be enforced by the FDA. The current guidelines state that they are one means, but not the exclusive means, of meeting a distributor’s obligation to comply with current good manufacturing practice. The FDA has stated that it intends to provide the industry with a 60-day comment period before the new guidelines become effective. GAWDA might request additional time before implementation of the new guidelines if they present substantial differences from the 1989 guidelines.

Cargo and Driver Security
The second significant item on the regulatory agenda includes a variety of potential new requirements affecting cargo and driver security. Some 14 months after the attacks of September 2001, several agencies of the U.S. Government and the Congress have turned their attention to the security of the nation’s hazardous cargo shipments.

The U.S. Customs Service has taken the lead with its Container Security Initiative (CSI), which was begun in January 2002 to enhance the security of the six million containers offloaded at U.S. seaports each year. Under the CSI, Customs will have inspectors at the 20 largest foreign ports to screen and identify high-risk containers before they are shipped to the U.S. At present, seven countries with 11 of the top 20 ports have signed onto the CSI program with the U.S.

According to Customs, CSI has four core elements:

  1. Identify “high-risk” containers. Customs already has criteria and automatic targeting tools for assessing domestic container shipments, and Customs currently assesses every container arriving by water in the U.S. Customs wants to use these procedures earlier, at foreign ports, to conduct assessments before the shipments are carried to the U.S.
  2. Pre-screen containers before they are shipped. Customs wants to conduct security screening at the port of departure rather than the port of arrival.
  3. Use technology to screen high-risk containers, without slowing down international trade. This includes using large-scale X-ray machines and radiation detection devices.
  4. Use more secure containers to ensure the integrity of containers screened overseas.

In addition, as part of the CSI, Customs has issued a final rule to require the advance and accurate presentation of manifest information for cargo destined for the U.S. prior to lading at all foreign ports (67 Federal Register 66318, October 31, 2002). The new manifest requirements went into effect December 2, 2002. Customs has exempted bulk shipments from the prior notice requirements.

Under present Customs regulations, the master of every vessel arriving in the U.S. and required to make entry must have on board the vessel a manifest that complies with Customs requirements; the master must be able to produce the manifest upon demand to a Customs officer. The cargo declaration is one of the documents that comprises the cargo manifest. The declaration must list all of the inward forward cargo on board the vessel regardless of the intended U.S. port of discharge of the vessel. No merchandise may be unladen from a vessel until Customs has issued a permit for its unlading.

It is unlawful to present or transmit any forged, altered or false document or manifest to Customs. The master of a vessel that violates these requirements is subject to civil penalties as well as seizure and forfeiture of the vessel and cargo.

The new rule states that Customs must receive the vessel’s cargo manifest (declaration) from the carrier 24 hours before the related cargo is laden aboard the vessel at the foreign port. The manifest will be filed electronically from the foreign port. The rule also identifies the elements that must be included in the submitted cargo manifest.

In addition, the President has signed the bill to establish the Department of Homeland Security (DHS), which will consolidate 22 separate agencies into a new federal agency with over 170,000 employees. The new law creates four directorates within the DHS. The Border and Transportation Directorate includes the Border Patrol, Customs Service, enforcement functions of the Immigration Service, Coast Guard, and the Transportation Security Administration (TSA), which will remain a separate and distinct entity within the Department.

Transport of Hazardous Materials
The Research and Special Programs Administration (RSPA) of the Department of Transportation (DOT) will continue to regulate the transportation of hazardous materials. In fact, section 1711 of the bill provides that RSPA shall have new authority over the security (as well as the safety) of hazmat transportation. This provision is intended to preclude the TSA from issuing its own regulations pertaining to hazmat transportation security, and to preempt the state and local governments from attempting to regulate hazmat security within their borders. Nevertheless, there is still at least some confusion over the appropriate role of the Transportation Security Administration to regulate hazmat shippers and carriers under its authority over transportation security issues.

There was some speculation when TSA was established as part of the Department of Transportation that it would seize all responsibility for hazmat transportation, but to date that has not occurred. Moreover, there are now two ongoing rulemaking proceedings on hazmat security issues, one applicable to all shippers and carriers, HM-232 (67 Federal Register 22028, May 2, 2002), and another on hazmat shipments by truck, HM-232A (67 Federal Register 46622, July 16, 2002). These rulemakings are under the authority of RSPA and RSPA/Federal Motor Carrier Safety Administration (FMCSA), respectively, without any reference to TSA authority. (A final rule in HM-232 is expected early in 2003 and will likely require each hazmat shipper and carrier to implement a written security plan and to train all employees in the elements of the plan.)

The TSA is drafting Memoranda of Understanding with the various modal administrations within DOT to set out regulatory jurisdiction over transportation security issues and to develop procedures for cooperative activities. TSA officials, however, have stated that they intend to issue security rules for all truck shipments that would require locking of all trailers while in transportation and other basic precautions.

The Federal Motor Carrier Safety Administration (FMCSA) has further postponed its interim final rule to require criminal background checks for drivers who hold a commercial driver’s license with a hazmat endorsement. This rule is mandated by section 1012 of the USA Patriot Act, enacted in October 2001, and requires all drivers of vehicles transporting hazardous materials to undergo a criminal background check using the FBI computer system. CDL drivers who are not American citizens would also undergo a check of their immigration status and a criminal background check using Interpol records. Drivers who present a “security risk,” a term not defined by the statute, would be denied a hazmat endorsement for their CDL by their state motor vehicle licensing agency.

The FMCSA is reportedly in a dispute with the Justice Department over which agency will determine whether a driver/applicant poses a security risk, even though the statute clearly states that the Secretary of Transportation will make that determination. The agencies are also discussing which parties will have access to the information in the FBI computerized criminal records. Although the rule is mandated by statute, it might be several more months before the agencies resolve these issues.

Driver Hours of Service
There are several indications that GAWDA members will be facing a new driver hours of service proposal, or possibly even a final rule, sometime in the new year. Outgoing FMCSA Administrator Joe Clapp stated that he wanted to complete his agency’s review of a new HOS proposal before he left office in December 2002. Once the proposed rule is out of FMCSA, it still must be reviewed in the Office of the Secretary of Transportation and then the Office of Management and Budget before it is published in the Federal Register for comments.

On December 9, 2002, the FMCSA issued its semiannual regulatory agenda, which provides the status of all rulemakings within the agency. The notice stated that the FMCSA intended to publish a revised proposed rule on driver hours of service in March 2003. Usually, the dates set out in DOT’s semiannual agenda have little relation to reality, and there is no legal requirement that the agency meet the stated deadline. DOT Secretary Norman Mineta has said that he wants to see the FMCSA issue a revised rule by that date as well, so there seems to be some internal pressure on the FMCSA to meet the March 2003 date for a new proposal. Of course, the FMCSA would have to consider all of the comments that a new proposal would generate, and a final rule could still be months or years away.

The FMCSA was recently sued by Public Citizen and a number of other safety advocacy groups to force the agency to issue final rules on hours of service and five other rulemakings in Citizens for Reliable and Safe Highways, et al. v. Mineta and the Federal Motor Carrier Safety Administration, No. 02-1363 (D.C. Cir. Filed November 26, 2002). By statute, FMCSA was required to publish a final rule on HOS in 1998, but the agency has ignored the deadline. The lawsuit seeks a court order to require the agency to issue a final rule in the HOS proceeding within 30 days of the order.

If the suit is successful, FMCSA would be compelled to comply with the court order, and GAWDA members might have a final rule on hours of service sooner rather than later.

Gases and Welding Distributors Association
Meet the Author
Richard P. Schweitzer, Esq. is GAWDA’s government affairs and human resources legal consultant, and president of Richard P. Schweitzer, PLLC in Washington, D.C.