Constituents policy

As discussed above, the Delaney clause applies to substances proposed for use as food additives, but does not apply to individual constituents of a food additive. Examples of constituents would include residual monomers or catalysts. The constituents policy, subjected to judicial review in Scott v. FDA, 728 F. 2d 322 (6th cir. 1984), states that FDA may consider the potential risks of constituent exposure under the general safety standards set forth in FFDCA. The notification process places the responsibility upon the notifier for addressing the carcinogenic risk of constituent exposure from a proposed use of a food additive. FDA recommends that notifiers include in their food contact notification a safety narrative that addresses the safety of each carcinogenic constituent at any exposure (in addition to the recommendations listed in Table 7.1). This narrative should include an estimate of the potential human cancer risk from the constituent due to the proposed use of the food contact material (FDA, 2002). 

For off-site land disposal of wastes resulting from a CERCLA activity, the program contains two additional requirements. First, the unit in which the wastes are to be disposed must not be releasing hazardous wastes or constituents into groundwater, surface water, or soil. Second, any releases from other units of the facility must be under an approved RCRA corrective action program. This policy assures that wastes shipped off-site from CERCLA sites are sent to environmentally sound waste management facilities. 

U.S. EPA proposed to significantly impact the RCRA hazardous waste identification process through a rulemaking effort called the Hazardous Waste Identification Rules (H WIR). The first rule, HWIR-media, was finalized on November 30,1998, and addressed contaminated media.16 The second rule, HWIR-waste, was finalized on May 16, 2001, and modified the mixture and derived-from rules, as well as the contained-in policy for listed wastes.5 Both the HWIR-media rule and the HWIR-waste rule attempt to increase flexibility in the hazardous waste identification system by providing a regulatory mechanism for certain hazardous wastes with low concentrations of hazardous constituents to exit the RCRA Subtitle C universe. 

For practitioners of in situ technologies, note that U.S. EPA has issued a policy statement that reinjection of contaminated groundwater is allowed under Resource Conservation and Recovery Act (RCRA)35 36 as long as certain conditions are met. This policy is intended to apply to remedies involving in situ bioremediation and other forms of in situ treatment. Under this policy, groundwater may be reinjected if it is treated aboveground prior to reinjection. Treatment may be by a pump-and-treat system or by the addition of amendments meant to facilitate subsurface treatment. Also, the treatment must be intended to substantially reduce hazardous constituents in the groundwater (either before or after reinjection) the cleanup must be protective of human health and the environment and the injection must be part of a response action intended to clean up the environment.37... 

Cefic claims that polymeric materials, reaction intermediates and substances used for R D should not be subject to the REACH evaluation and authorisation process being proposed by the European Commission in its White Paper on future chemicals policy, it is briefly reported. On specific issues, Cefic wants a risk-based approach to chemicals assessment and regulation realistic deadlines for the REACH process and exemption from REACH of finished articles, so that it applies only to substances marketed as substances or as constituents of a preparation. 

REACH. In 2003 the EU Commission proposed a new chemicals policy -REACH (Registration, Evaluation, and Authorisation of Chemicals). The biocides used in AF products are still registered through the BPD, but the other paint constituents as with all other chemical constituents produced or imported > 1 ton/year on the European market will need to be partly or fully risk assessed under REACH. The legislation is expected to enter into force in 2007 (EU, 2003b). 

SECTION 2 = Reactions to President Kennedy s policies and specific opposition from law makers and constituents... 

Over the past several decades there have been increasingly strong demands in Europe and the United States that atmospheric chemistry research be directly useful in developing scientific risk assessments and public policies. For example, one component of the EUROTRAC program (European Experiment on Transport and Transformation of Environmentally Relevant Trace Constituents in the Troposphere) ...is expected to assimilate the scientific results from EUROTRAC and present them in a condensed form, together with recommendations where appropriate, so that they are suitable for use by those responsible for environmental planning and management in Europe (EUROTRAC, 1993). 

Some of EPA s programmatic and policy deficiencies can be ascribed to career civil servants with their own agendas, who manipulate EPA-inexperienced political appointees (most often lawyers). A pertinent example is Dr. Elizabeth Milewski, an EPA mid-level manager who has had primary responsibility for biotech policies in the Office of Pesticides and Toxic Substances. At a 1991 interagency meeting that I attended, she announced that the EPA could not accept a certain scientifically based policy because our constituency won t stand for it. ... 

Two political appointees, D. James Baker, at that time head of the National Oceanic and Atmospheric Administration, and Ro-sina Bierbaum, second in line at the Office of Science and Technology Policy, were made co-chairs of the Committee on Environment and Natural Resources, one of the many constituent committees of the National Science and Technology Council. Baker, in his role as chair, directed a subcommittee of his com-... 

Center for Drug Evaluation and Research (CDER). Manual of Policies and Procedures, MAPP 4512.1. Formal Meetings Between CDER and CDER s External Constituents, March 7,1996. 

FDA policies and procedures for formal meetings with external constituents described in CDER s Manual of Policy and Procedures (MAPP 4512.1) and CBER Standard Operating Procedures and Policies (SOPP) 8101.1... 

FDA, CDER Manual of Policies and Procedures (MAPP) 4512.1, Training and Communications, Formal Meetings between CDER and External Constituents, March 1996 (http //www.fda.gov/cder/). 

The intake of fluoride as a constituent of substances described in FCC monographs, even at the maximum limits established for fluoride, is not expected to significantly add to the human daily fluoride intake from other sources and is well within the various limits described in the Institute of Medicine s committee report. Nonetheless, given that toxicological manifestations have been amply demonstrated for fluoride, as described in the report, the maintenance of fluoride limits in drinking water and food, and thus food additives, appears consistent with sound public health policy. Therefore, the Committee on Food Chemicals Codex considers that maintaining fluoride limits for relevant food additives and ingredients is justified. 

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