Regulatory Programs

Risk Assessment and Management Commission must report to Congress on the appropriate use and policy implications of risk assessment and risk management in various regulatory programs. 

Regulatory programs tliat promote prevention through mechanisms such as codes, licenses, and permits... 

Gilbertson M. 1997. Great Lakes forensic toxicology and the implications for research and regulatory programs. Environ Toxicol Chem 16 1771-1778. 

Okumura et al reported State regulatory programs for pesticide residues in food crops analyzed by the CDFA. In the multiresidue analysis of several organochlorine pesticides including diphenyl ether herbicides, bifenox, nitrofen and oxyfluorfen, HPLC has also been used. 

By the year 2010, FDA will have a science-based regulatory program that fully implements the DSHEA. The plan addresses safety, labeling, clarification of the differences between drugs and dietary supplements, and enforcement activities. 

As U.S. EPA continues to revise the regulatory program for incinerators in order to adequately protect human health and the environment, the omnibus permitting authority, site-specific risk assessments, and public participation issues have received greater attention. The following discusses both issues in greater detail. 

Looking to the future, some pyrethroids will be tested in the battery of endocrine screening assays being developed for regulatory programs in the US and EU. 

The widespread use of -hexanc as an extractant in the laboratory creates problems in interpreting concentration readings at low levels. Even with good quality control, it may often be impossible to determine whether to attribute a measured value to the actual levels in a sample or to contamination from M-hexanc in the laboratory environment (Otson et al. 1994). For the most part, -hexane is not a common target analyte from water or soil samples. While data based on ambient air samples or sampling in the air of various workplace or residential environments are more numerous, most EPA regulatory programs rely on bulk measurements of total hydrocarbons or total volatile compounds rather than on measurements of specific compounds such as -hexane (Bishop et al. 1994 DeLuchi 1993). 

It is the responsibility of the Central Safety Testing Lab staff to scan test results into the database and to serve as database administrators. 2. It is the responsibility of the Product Safety and Product Regulatory Programs to develop MSDSs and Workplace Precaution Statements. 3. It is the responsibility of the project/process leader to ensure the Survey Sheets have been completed, and that MSDSs or workplace precaution statements have been requested. ... 

The regulatory program must be based upon sound national standards that protect human health and the environment. 

The regulatory program must be designed to be implemented at a state and local level. 

Enhance the consistency and coordination of the FDA s drug quahty regulatory programs, in part, by further integrating enhanced quahty systems approaches into the FDA s business processes and regulatory policies concerning review and inspection activities... 

The hazardous waste regulatory program as we know it today began with the Resource Conservation and Recovery Act (RCRA) in 1976. Since its enactment in 1976, the RCRA has been amended several times, to promote safer solid and hazardous waste management programs (Dennison, 1993). The Used Oil Recycling Act of 1980 and the Hazardous and Solid Waste Amendments of 1984 (HSWA) were the major amendments to the original law. 

While all nations of the world possess the sovereign right to establish their own acceptable levels for pesticide residues in foods, many lack the resources to develop their own regulatory programs and instead rely upon a set of international standards developed by the Codex Alimentarius Commission, frequently referred to as Codex. The Codex international standards are termed maximum residue limits (MRLs) and, like U.S. tolerances, are established primarily as enforcement tools for determining whether pesticide applications are made according to established directions. While many countries have adopted Codex MRLs, others, such as the U.S. and several Asian countries, rely on their own standards. Thus, there is no uniformity among the world with respect to allowable levels of pesticides on foods. A pesticide-commodity... 

Food Safety and Inspection Service of the Department of Agriculture (for meat, poultry, and eggs) and the Department of Transportation. Although laws and regulatory programs vary, most countries have agencies with similar sets of responsibilities. 

The United States has the most extensive environmental regulatory programs that aim to minimize the release of metals into the environment. These regulations seek to control the emission of pollutants from specific industries and to define the emission limits according to the type of industry, the age and size of the plant, and the nature of the processes involved. In addition, different limits are set according to the following criteria best... 

The solid wastes that are RCRA hazardous wastes are those either listed in 40 CFR pt. 261, or exhibit one of the four characteristics [ignitabUity, corrosivity, reactivity, and extraction procedure (EP) toxicity] identified in Part 261 [a more stringent Toxicity Characteristic Leaching Procedure (TCLP) replaced EP in 1986 (51 Federal Regulation 21,648 1986)]. Both the characteristics and the lists sweep many pesticides and pesticide wastes into the RCRA regulatory program. 

A previous Pellston workshop listed the benefits of uncertainty analysis in regulatory programs as follows (Warren-Hicks and Moore 1998) ... 

The NRC issues licenses for the facilities noted and the operators of those facilities. Licenses may also be issued by individual state governments under NRC-approved regulatory programs. There are more than 8500 such licenses under the NRC s jurisdiction and approximately 15,000 under the jurisdiction of Agreement States, which regulate certain radioactive materials under agreements with the NRC. As of 1996, there are 109 licensed commercial nuclear power reactors in the United States, located at 71 sites in 33 states (see Nuclear REACTORS). However, several of these facilities are only partially constructed and further construction has been deferred. There are more than 5300 licensed nuclear power plant operators in the United States, each licensed for a specific reactor. Every operator must be requalified before renewal of a six-year license (14,15). 

---