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Meetings and Events > Chemical Industry Conference > 2004 Conference Report > Conference Report Chemical Industry Conference 2004Conference ReportThe 2004 Drug Enforcement Administration - Chemical Industry Conference was held on September 14-16, 2004, at the Langham Hotel in Boston, Massachusetts. Boston Division Associate Special Agent-in-Charge (ASAC) Carol Cooper opened the conference by greeting the participants and providing a brief overview of the drug situation in the New England area. She indicated that while methamphetamine abuse had reached the New England area, clandestine drug laboratories and the illicit manufacture of methamphetamine had not yet become the overwhelming problem that it is in other jurisdictions. Ironically, she noted that agents from her office had just seized two clandestine methamphetamine laboratories the week before. ASAC Cooper introduced Patricia M. Good, Chief of the Liaison and Policy Section. Ms. Good greeted the conference participants on behalf of DEA’s Office of Diversion Control and Deputy Assistant Administrator William J. Walker. Ms. Good gave a brief overview of the presentations that were planned and said that these conferences provided a unique opportunity for two-way communication. It was important that attendees participate in the discussions and ask questions to make the conference as productive as possible. Ms. Good introduced Mr. Scott Collier, Chief of the Chemical Control Section. Mr. Collier gave a presentation outlining the domestic regulated chemical situation. The focus of Mr. Collier’s presentation was the trafficking of pseudoephedrine and its effects on the clandestine manufacture of methamphetamine. He further discussed the effects that methamphetamine manufacture and abuse have had on the people living in the United States. He put particular emphasis on the economic and environmental devastation this activity has produced. Details can be found in Mr. Collier’s MS PowerPoint presentation (attached, see file entitled "Collier Presentation"). The next series of speakers discussed the legislative developments regarding pseudoephedrine and its availability for public consumption and diversion into the illicit market. Mr. Stephen Sola, Trial Attorney for the U.S. Department of Justice, spoke regarding the Department’s view on Federal legislation to control pseudoephedrine. He indicated that the Department was of the opinion that each state should address the issue as it best suited that state. Because the severity of the problem varied from area to area, a unified, federal response was unnecessary and undesirable at this time. Details can be found in Mr. Sola’s MS PowerPoint presentation (attached, see file entitled "Sola Presentation"). Dr. John Duncan, Ph.D., Chief Agent, Oklahoma Bureau of Narcotics and Dangerous Drugs Control, spoke regarding recent legislation passed by the State of Oklahoma to control the distribution of pseudoephedrine at the retail level. He indicated that public access to pseudoephedrine products must be controlled. In order to purchase these items, the consumer must present a valid form of identification and fill out a log book maintained by the seller. Individual purchases are limited to three grams in a 30 day period unless a practitioner authorizes more. Dr. Duncan further indicated that grant money had been secured to establish a state wide electronic system to track retail sales of products containing pseudoephedrine. Details can be found in Dr. Duncan’s MS PowerPoint presentation (attached, see file entitled "Duncan Presentation"). The final speaker to address the topic of legislative control of pseudoephedrine was Mr. Kevin Kraushaar, Vice President of Government and Public Affairs for the Consumer Healthcare Products Association (CHPA). Mr. Kraushaar spoke regarding CHPA’s "Meth Watch Program." He explained how his association had developed this program of voluntary compliance to preclude the need for federal or state legislation regarding retail sales of products containing pseudoephedrine. CHPA believes that the governmental control of pseudoephedrine will result in the loss of product availability and will adversely affect the consumer. Mr. Kraushaar stated that when a product is placed behind the counter, where there is little space, the retailer must decide which products to carry and which products to abandon, thereby reducing the consumers’ choices. Because he was unable to attend the remainder of the conference, Mr. Kraushaar took this opportunity to express his association’s point of view regarding DEA’s proposed chemical security regulation. The proposed regulation was discussed later in a conference by Ms. Patricia Good. CHPA and its member companies felt that the proposed requirements were cost prohibitive and would not serve to reduce or prevent the diversion of pseudoephedrine into the illicit market. Because of the volume of product handled by the association’s members, the proposed requirements were entirely too expensive/too restrictive as to be practical for the industry to implement. Mr. Kraushaar indicated that CHPA would be preparing formal comments in response to the proposed regulation that would be submitted to the DEA during the comment period. The day ended with a presentation by Dr. Lori Love, MD, Ph.D., Senior Advisor, Food and Drug Administration (FDA), regarding the FDA ban of ephedrine alkaloid containing products. Dr. Love began by discussing the legislation/regulations that authorize the FDA to control dietary supplements that contain ephedrine alkaloids (ephedrine, pseudoephedrine, methylephedrine, norephedrine and norpseudoephedrine). She further discussed how vague and confusing definitions used in the original regulations had been clarified in subsequent legislation so that products (botanicals, extracts and synthetics) containing ephedrine alkaloids could be brought under control. She spoke about the natural products that contain ephedrine alkaloids and this new authority allowed them to be banned from the U.S. market. Details can be found in Dr. Love’s MS PowerPoint presentation (attached, see file entitled "Love Presentation"). The second day of the conference began with a presentation by Susan Carr, Deputy Chief, DEA’s Drug and Chemical Evaluation Section. Ms. Carr gave an overview of the duties of the Section and its current activities regarding regulated chemicals. Emphasis was placed on rule making regarding chemical mixtures and the control of iodine. By way of background, Ms. Carr discussed the various methods by which methamphetamine is manufactured and the proliferation of clandestine methamphetamine laboratories across the country. Ms. Carr expanded the discussion beyond methamphetamine by introducing the manufacture of cocaine and the chemicals needed for successful production. She discussed the success that DEA has had with restricting access to potassium permanganate. However, just as the success with restricting access to ephedrine led to the use of pseudoephedrine in clandestine laboratories, the success with restricting potassium permanganate has led illicit laboratory operators to switch to sodium permanganate. Details can be found in Ms. Carr’s MS PowerPoint presentation (attached, see file entitled "Carr Presentation"). The next presentation was given by Ms. Patricia M. Good, Chief, DEA’s Liaison and Policy Section. Ms. Good began by digressing from her planned remarks and explaining the recent changes that have taken place within the Office of Diversion Control. She outlined how a number of retirements and reassignments have affected the people that interact with members of industry. First, Ms. Laura Nagel has been replaced by Mr. William Walker as the Deputy Assistant Administrator in charge of the Office of Diversion Control. Next, with the retirement of Mr. Terry Woodworth, Mr. Joseph Rannazzisi has taken the position of Deputy Director. The post of Special Assistant has been filled with Ms. Denise Curry since the retirement of Kenneth Ronald. The position of Chief of the Drug and Chemical Evaluation Section has been filled with Dr. Christine Sannerud since Mr. Frank Sapienza retired. To further complicate the situation, the Office of Diversion Control has just undergone reorganization. The two sections that deal with investigations, the Chemical Control Section under Mr. Scott Collier and the Drug Operations Section under Ms. Elizabeth Willis, have been moved to the Office of Enforcement and no longer report to the Deputy Assistant Administrator. Ms. Good then proceeded with the announced subject of a chemical regulatory update. Of particular interest was the proposed rule on security requirements for handlers of pseudoephedrine, ephedrine, and phenylpropanolamine. DEA is proposing that the security required to handle ephedrine, pseudoephedrine, and phenylpropanolamine be enhanced to the level that is required for Schedule III – V controlled substances. Ms. Good acknowledged that DEA did not fully understand the operation of distributors of these products. This proposed rule has an unusually long comment period (open until October 28, 2004) so that the industry may have time to develop and submit proposals to DEA. This topic generated a substantial amount of discussion, particularly the amount of space needed to store liquid formulations of the products that contain pseudoephedrine, ephedrine, and phenylpropanolamine and the description of the thefts reported in the proposed rule. This prompted Ms. Good to ask that comments be submitted in writing so that they may be considered for incorporation in the final rule. A topic of much less controversy was the proposed rule to remove the blister pack exemption from the record keeping requirements of the Methamphetamine Anti-Proliferation Act (MAPA). Most of the attendees seemed to be in agreement that the blister pack exemption was no longer valid. Details can be found in Ms. Good’s MS PowerPoint presentation (attached, see file entitled "Good Presentation"). Ms. Catherine Gentry, Program Analyst, International Chemical Control Unit, gave the next presentation regarding the international chemical situation and several special international operations in which DEA has participated. Ms. Gentry discussed the need and function of the following activities:
Ms. Gentry discussed the operation and results of each special activity. Details can be found in Ms. Gentry’s MS PowerPoint presentation (attached, see file entitled "Gentry Presentation"). The topic of security and terrorism in the chemical industry was covered by the next two speakers. Mr. Larry Stanton, Unit Chief, Protective Security Division, Department of Homeland Security (DHS), started his presentation by giving a brief overview of the structure and operation of the DHS. Mr. Stanton went on to explain how the chemical industry is an economic asset of the country and therefore a matter of national security concern. Beyond the possibility for a major environmental or social catastrophe, the economic impact of the loss of this industry would be devastating and far reaching. The DHS wants to partner with private industry to insure that security and public safety are satisfied while having the least impact on the operation of the businesses involved. Details can be found in Mr. Stanton’s MS PowerPoint presentation (attached, see file entitled "Stanton Presentation"). This topic was concluded by a presentation from Marybeth Kelliher, Senior Manager, American Chemistry Council. Ms. Kelliher began by giving a brief overview of the American Chemistry Council (ACC). She then went on to describe the Responsible Care© Security Code (RCSC), that the ACC has developed for their members. Ms. Kelliher touched on various security issues and how the RCSC meets or exceeds these requirements. She proposed that the RCSC be accepted as an alternative to the security enhancements that were being set forth in the DEA’s Proposed Rule mentioned earlier in Ms. Good’s presentation. Details can be found in Ms. Kelliher’s MS PowerPoint presentation (attached, see file entitled "Kelliher Presentation"). The final day of the conference began with a presentation by Mr. Mark Via, Information Specialist, DEA, Chemical Control Section. Mr. Via explained that currently, DEA Form 486 (Import/Export Declaration – Chemical) must be filled out and faxed to DEA prior to the transiting of listed chemicals through the United States or by a broker registered in the U.S. DEA is in the process of placing this form on-line and making interactive – able to be filled out and submitted electronically. The test version is up and running and available to those companies that wish to participate in its development. Mr. Via used the hotel’s Internet provider to access the electronic version of DEA Form 486 and provided the attendees with a live demonstration. He created a fictitious company and proceeded to input data. Mr. Via addressed various situations that the attendees might encounter and allowed them to view his input and interaction with the on-line form. Considerable discussion ensured regarding possible errors and the way that the system could check for mistakes. Mr. Via indicated that the system was still being developed and that changes/corrections/enhancements could still be made. Throughout the discussion, Mr. Via emphasized that this was an optional method for submitting the required information. The faxing of paper forms would still be allowed for those companies wishing to do so. A discussion of legal issues by Mr. Charles Trant, DEA, Office of Chief Counsel was the next presentation. This discussion centered on the concept of "know your customer". If a sale is unreasonable, then it is probably illegitimate. As business people, the attendees know the market for their product. DEA is in the process of learning the market for regulated chemicals. Mr. Trant said that DEA has hired a consultant to assist them in determining what makes "good business sense" and what does not. This type of consultant is often hired by different industries to determine where a new retail outlet should be established if it is to be a success. Mr. Trant said that the consultant informed DEA that industry statistics indicate that most people purchase their cough, cold, and allergy medicines from pharmacies and grocery stores, not convenience stores. Accordingly, sales of large quantities of these products to convenience stores and other non-traditional outlets should be considered suspect. Mr. Trant indicated that DEA will continue to vigorously pursue legal action against those members of the industry who consistently disregard these warning signs. During the last session of the day and the conference, Ms. Patricia Good hosted an open discussion where the industry and association members were free to voice their opinions and concerns. As earlier, the discussion centered on the DEA proposed rule regarding chemical security. Many attendees were concerned about the cost of implementing these safeguards, while others were concerned about the proposed 90 day time limit for implementing the required changes. Ms. Good reassured the attendees that their comments would be taken into consideration and that any reasonable, workable alternatives would be included in the final rule. Regarding the time for implementing the change, Ms. Good asked if 180 days (rather than the proposed 90) would be sufficient to accomplish the changes. The majority of attendees were uncertain as to the time required because there would be an unprecedented demand for this type of construction as all registrants tried to meet the deadline. Ms. Good closed the conference by repeating that it is only through open communication that we have been able to forge the working relationship that we enjoy at this time. She encouraged everyone to continue to participate in the process and not be overwhelmed by the challenges that we all face. You will need Acrobat Reader to view PDF files Registration
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