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Regulatory framework for the thermal treatment of various waste streams.

Since 1990, regulations and standards have changed considerably. This article is an update of the regulatory requirements for the thermal treatment of various waste streams. The waste categories covered, along with the laws they are governed under, include: Hazardous waste under Subtitle C of the Resource Conservation and Recovery Act (RCRA) and under the Clean Air Act; municipal solid waste under Subtitle D of the RCRA; medical waste under Subtitle J of the RCRA; Superfund waste under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA); toxic waste under the Toxic Substances Control Act (TSCA); and sludge waste under the Clean Water Act (CWA).

Humans↗

Where is the drug problem?

This article traces the history of drug use from its earliest use to the present time. It treats alcohol and the "other drugs," but deals more with alcohol since this has been the major drug of use. It outlines the many problems associated with use and abuse, the legislation passed as an effort to control these and finally, the effect of the Uniform Alcoholism Act of 1970. This was followed by changing public attitudes toward alcohol and the development of many effective treatment programs, while the "other drug" problem remains unresolved in spite of a similar attempt through the Uniform Controlled Substances Act of 1970.

Alcoholism↗

Schedules of controlled substances: placement of Zopiclone into schedule IV. Final rule.

With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance, zopiclone, including its salts, isomers and salts of isomers into Schedule IV of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of Schedule IV will be applicable to the manufacture, distribution, dispensing, importation and exportation of zopiclone and products containing zopiclone.

Central Nervous System Depressants↗

Schedules of controlled substances: placement of pregabalin into schedule V. Final rule.

This final rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid], including its salts, and all products containing pregabalin into Schedule V of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of Schedule V will be applicable to the manufacture, distribution, dispensing, importation and exportation of pregabalin and products containing pregabalin.

Analgesics↗

EPA use of in vivo germ cell mutagenicity data.

The Toxic Substances Control Act (TSCA) provides the U.S. Environmental Protection Agency, Office of Toxic Substances (EPA, OTS) with the authority to regulate chemical use by requiring testing and use restrictions as appropriate to protect human health. Regulation on the basis of heritable mutation induction is specifically mentioned in the Test Rule section of the law and has also been pursued for new chemical substances. A tiered scheme of mutagenicity testing has been employed and recently revised to assess mutagenicity hazard. In vivo assay systems play key roles at all three levels in the scheme, beginning with the first level of determining intrinsic mutagenicity hazard. Once intrinsic mutagenicity has been identified, the revised scheme requires an assay or assays to assess chemical interaction with gonadal DNA. Finally, the scheme contains tests that permit risk assessment for a chemical. The recently-revised Office of Pesticide Programs (OPP) mutagenicity testing requirements closely parallel those of OTS.

Animals↗

Predicting ready biodegradability of premanufacture notice chemicals.

Chemical substances other than pesticides, drugs, and food additives are regulated by the U.S. Environmental Protection Agency (U.S. EPA) under the Toxic Substances Control Act (TSCA), but the United States does not require that new substances be tested automatically for such critical properties as biodegradability. The resulting lack of submitted data has fostered the development of estimation methods, and the BioWIN models for predicting biodegradability from chemical structure have played a prominent role in premanufacture notice (PMN) review. Until now, validation efforts have used only the Japanese Ministry of International Trade and Industry (MITI) test data and have not included all models. To assess BioWIN performance with PMN substances, we assembled a database of PMNs for which ready biodegradation data had been submitted over the period 1995 through 2001. The 305 PMN structures are highly varied and pose major challenges to chemical property estimation. Despite the variability of ready biodegradation tests, the use of at least six different test methods, and widely varying quality of submitted data, accuracy of four of six BioWIN models (MITI linear, MITI nonlinear, survey ultimate, survey primary) was in the 80+% range for predicting ready biodegradability. Greater accuracy (>90%) can be achieved by using model estimates only when the four models agree (true for 3/4 of the PMNs). The BioWIN linear and nonlinear probability models did not perform as well even when classification criteria were optimized. The results suggest that the MITI and survey BioWIN models are suitable for use in screening-level applications.

Biodegradation, Environmental↗

Current perspectives on anabolic-androgenic steroid abuse.

For the past 40 years anabolic-androgenic steroids have been used by a wide variety of athletes with the hope of improving their training, endurance and performance. Proponents of their use claim that the drugs increase muscle strength and mass, endurance, decrease recovery time between workouts and improve physique. Critics claim that these beneficial effects are due primarily to expectancy and other factors associated with training; many doctors also claim that their use is actually quite dangerous. Regardless of their efficacy, the use and abuse of anabolic-androgenic steroids has escalated such that in 1990 the US Congress enacted the Anabolic Steroids Control Act requiring that anabolic steroids be added to Schedule III of the Controlled Substances Act. This action placed compounds such as testosterone cipionate and nandrolone decanoate in the company of various opioid drugs, amphetamines and barbiturates. As chair of the American Society for Pharmacology and Experimental Therapeutics' Committee on Substance Abuse, Scott Lukas advocates continued research on the effectiveness, toxicity and natural history of anabolic-androgenic steroid abuse.

Anabolic Agents↗

Keeping the lid on: a century of drug regulation and control.

Since the early 1900s, national and international drug control legislation has acted as a key site of contention between important societal actors. Physicians and pharmacists, regulators and drug companies, patients and addicts, and researchers and pharmacologists all attempted to influence formulation and interpretation of the rules that regulate access to addicting but medically useful substances. The 1970 Controlled Substances Act (CSA) consolidated and rationalized previous US domestic legislation and paid careful attention to the international aspects of the issue. Yet the CSA also incorporated long-standing fundamental disputes about who would act as gatekeepers, what criteria would be employed in regulatory decisions, and the basic goals of drug control legislation. Rather than view the CSA as a beginning or an end, it is better conceived as a major milepost in a century-long odyssey of maneuvering among interested parties for advantage in a complex regulatory environment. Instead of providing a definitive authoritative structure to which all parties must adhere, the CSA has served as a vehicle for discernment and continuous renegotiation of essential concepts such as "abuse liability".

Drug Industry↗

United States governmental efforts to improve the regulation of toxic substances.

The U.S.'s efforts to improve its regulation of toxic substances presently have their focus in the administration of the Toxic Substance Control Act (TSSC), the Cancer Policy of the regulatory agencies, and the Drug Regulation Reform Act. By improving interagency communication and cooperation as well as establishing a coherent federal approach to the control of toxic substances with public and industrial input, the U.S. government should significantly strengthen the functioning of its regulatory agencies while decreasing the financial burden for everyone involved.

Carcinogens↗

Legal bases for the control of analgesic drugs.

Governments throughout the world have struggled for decades to ensure the availability of narcotic analgesics for legitimate medical and scientific purposes while controlling the abuse and illegal diversion of such substances. While the international drug-control system has effectively limited illicit trafficking of opioids, concerns remain about its effectiveness in ensuring the availability of these drugs for legitimate purposes. In the United States, federal legislation accommodates the use of controlled substances for medical and scientific purposes more effectively than does state law. Many states' controlled substance laws hinder appropriate opioid prescribing through (a) the use of ill-defined terms, (b) restriction of pain prescriptions to a specific number of dosage units; and/or (c) utilization of multiple-copy prescription programs. A more efficient state approach to monitoring inappropriate schedule II prescribing and dispensing may be through an electronic, computer-based pharmacy point-of-sale system, through which pharmacists can be alerted instantaneously to patients receiving the same drug from multiple pharmacies. In addition, states should consider modifying their approaches to drug abuse by adopting the revised Uniform Controlled Substances Act and/or establishing state pain initiatives.

Analgesics↗

Clarification of registration requirements for individual practitioners. Final rule.

The Drug Enforcement Administration (DEA) is amending its registration regulations to make it clear that when an individual practitioner practices in more than one State, he or she must obtain a separate DEA registration for each State. This amendment will make it easier for practitioners to understand the requirements of the Controlled Substances Act and its implementing regulations.

Drug and Narcotic Control↗

Evolution of attitudes toward occupational health in the U. S. A.

Attitudes toward ill-health associated with workplace are inevitably closely linked to attitudes toward disease occurring generally, and these have evolved remarkably slowly since the Middle Ages. By the nineteenth century in western countries, at least, people considered disease as a retribution for sins against God, or as a result of bad luck. Certainly this attitude was a factor in why the advent of the germ theory was followed only very slowly by measures aimed at preventing infections brought about from water, food, or airborne sources, even when methods for doing so were well understood. Today, attention is directed toward chronic degenerative diseases and cancer, with their long periods of development, and preventive approaches to these diseases are similarly slow to be applied. In part because the U. S. A. is a relatively young country, with a rapid influx of immigrant labor in this century, the contribution of occupations to injury, ill health and disease has been too seldom recognized. Doctors or nurses working in industries have usually focussed their attention on traditional health care techniques. In the U. S. A. there has recently been, however, a change, at least by ordinary citizens, toward recognizing the importance of prevention of disease. In the context of work-related illness, this recognition has been accelerated by recent legislation which makes employers legally responsible for detecting adverse effects on health of workers and the general public arising from their operations. Paradoxically the Occupational Safety and Health Act of 1970 has been less effective in bringing about a change of awareness of occupational disease than has the Toxic Substances Control Act of 1977.(ABSTRACT TRUNCATED AT 250 WORDS)

Accidents, Occupational↗

EPA's requirements for dermal irritation and sensitization testing.

This paper presents an overview of EPA guidelines for dermal irritation and sensitization testing (part of Subdivision F Guidelines) for the registration of pesticide products [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)]. In addition, these data and others may be needed for chemicals submitted for the Premanufacture Notification or testing under Section 4 of the Toxic Substances Control Act (TSCA). The EPA periodically reviews its recommended test procedures and revises them when indicated scientifically.

Animals↗

Authority for practitioners to dispense or prescribe approved narcotic controlled substances for maintenance or detoxification treatment. Final rule.

DEA is amending its regulations to allow qualified practitioners not otherwise registered as a narcotic treatment program to dispense and prescribe to narcotic dependent persons Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. This Final Rule is in response to amendments to the Controlled Substances Act by the Drug Addiction Treatment Act of 2000 (DATA) that are designed to expand and improve treatment of narcotic addiction. This Final Rule is intended to accomplish the goals of DATA while preventing the diversion of Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for maintenance / detoxification treatment.

Certification↗

Schedules of controlled substances: temporary placement of alpha-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine into Schedule I. Final rule.

The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this final rule to temporarily place alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of the CSA. This final action is based on a finding by the DEA Deputy Administrator that the placement of AMT and 5-MeO-DIPT into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this rule, the criminal sanctions and regulatory controls of Schedule I substances under the CSA will be applicable to the manufacture, distribution, and possession of AMT and 5-MeO-DIPT.

Drug and Narcotic Control↗

Exemption of chemical mixtures containing the List I chemicals ephedrine, N-methylephedrine, N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and pseudoephedrine. Final rule.

On September 16, 1998, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) to implement provisions of the Controlled Substances Act (CSA) pertaining to the regulation of chemical mixtures which contain any of 34 listed chemicals. The NPRM was published to implement CSA requirements that only those chemical mixtures identified by regulation be exempt from applicable regulatory controls. The NPRM proposed criteria for the determination of whether a chemical mixture shall qualify for automatic exemption from CSA regulatory controls. Additionally, the NPRM defined an application process by which manufacturers may apply for an exemption for chemical mixtures that do not qualify for automatic exemption. Due to concerns regarding the potential illicit use of chemical mixtures which contain ephedrine, N-methylephedrine, N- methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or pseudoephedrine (as precursor material for the production of methamphetamine and related amphetamines), DEA is hereby finalizing the portion of the NPRM pertaining to these six chemicals. Final regulations for all remaining listed chemicals will be published under separate rulemaking, upon completion of a thorough review of applicable comments.

Dietary Supplements↗

Eszopiclone for the treatment of insomnia.

Eszopiclone, a single-isomer, non-benzodiazepine hypnotic agent, is approved for use in the US for the treatment of insomnia for patients who have difficulty falling asleep (sleep latency) as well as for those who have difficulty staying asleep (sleep maintenance). Efficacy in sleep maintenance has not been consistently demonstrated with previous hypnotics, and long-term efficacy and safety data are lacking for these agents. In clinical trials, eszopiclone 3 mg significantly improved objective and subjective sleep measures in transient and chronic insomnia in adults. Nightly treatment with eszopiclone 1 mg effectively induced sleep in elderly patients and the 2-mg dose effectively induced and maintained sleep. The ability of eszopiclone 2 mg to significantly improve next-day functioning and daytime alertness (as demonstrated by a reduction in the number and duration of naps) in the elderly is an important finding in clinical trials, and is unique to the class of hypnotic agents for the treatment of insomnia. Eszopiclone was well tolerated in clinical trials < or = 12 months duration, with no clinically significant evidence of pharmacological tolerance, rebound insomnia or dependence. The most frequently reported adverse event was unpleasant taste. Eszopiclone is the only non-benzodiazepine sedative-hypnotic (in the Schedule IV class under the Controlled Substances Act) to be evaluated as a long-term treatment for chronic insomnia.

Adult↗

Schedules of controlled substances: rescheduling of buprenorphine from schedule V to schedule III. Final rule.

This final rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to reschedule buprenorphine from a Schedule V narcotic to a Schedule III narcotic under the Controlled Substances Act (CSA). This action is based on a rescheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that buprenorphine meets the criteria of a Schedule III narcotic. The DEA published a proposed rule to reschedule buprenorphine on March 21, 2002 (67 FR 13114). The comment period was extended for an additional 30 days until May 22, 2002 (67 FR 20072). The DEA received ten comments but no requests for hearings. This final action will impose the regulatory controls and criminal sanctions of a Schedule III narcotic on those persons who handle buprenorphine or products containing buprenorphine

Buprenorphine↗