predicted, then the Administrator will require that testing be conducted on that substance. See 15 U.S.C.A. §2603. Upon receipt of any data which indicate to the Administrator that there may be a reasonable basis to conclude that a chemical substance will present an unreasonable risk of environmental harm, the Administrator will take steps to reduce that risk. However, these steps may be as minimal as labeling notice requirements or limitations on the use of the substance. See 15 U.S.C.A. §2605(a). Clearly this falls short of the Biological Weapons Convention prohibition on the possession of certain substances. While the Act requires regulation of chemical substances which will present an "unreasonable risk" of injury to health or the environment, that regulation must be "the least burdensome" means for preventing any such risk. (15 U.S.C.A. §2605.) Clearly, the least burdensome "protect[ions]" against the risk posed by biological weapons would not be blanket prohibitions -- as are required by the Convention -- but rather regulations controlling the use, distribution, documentation and disposal of those biological weapons. The Act would therefore require less stringent regulation of biological weapons than the Biological Weapons Convention requires. There are further inadequacies. First, the Act applies only to the "manufacture" and "processing" of substances for "commercial purposes," 15 U.S.C.A. §2604(i); and "manufacture for commercial purpose" is defined as "manufacturing with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer." 40 C.F.R. §704.3. Thus, a governmental unit manufacturing biological weapons would be outside the scope of the Act since its purpose would not be to gain a "commercial advantage." Additionally, the Act specifically exempts from its reporting requirements any person manufacturing or processing substances in small quantities for "scientific experimentation or analysis," or "chemical research on, or analysis . . . including research and analysis for the development of a product." Finally, the Act apparently does not create a civil action under which damages can be recovered. See Johnsen v. Koppers Co., 524 F.Supp. 1182 (N.D. Oh. 1981). 6. Public Health Service Act The Public Health Service Act is codified at 42 U.S.C.A. 201 to 300. Sections 262 and 263a of the Act relate to licensing of biological products and clinical laboratories. Another potentially applicable section was related to genetic disease, but it has been repealed. The two arguably applicable sections of the Act are therefore sections 262 (licensing of biological products) and section 263a (licensing of laboratories). Both sections fail to implement the Biological Weapons Convention. While article IV of the Convention requires measures which will "prohibit and prevent" the development of any agents or toxins that lack any peaceful purpose, the Act merely prohibits interstate traffic of unlicensed toxins. First, with regard to section 262, the Act covers a much more limited range of "biological products" than does the Convention. While the Convention covers agents or toxins which lack a peaceful purpose, the Act covers only agents or toxins "applicable to the prevention, treatment, or cure of diseases or infirmities of man." Since many of the agents with no peaceful purpose will be non-curative in nature, the Act will inadequately implement the Convention with respect to a broad class of biological weapons. The Act also requires that the agents it covers be licensed; it does not, however, ban them as the Convention mandates. Such licenses under §262(d) may be issued upon a showing that agents meet standards of continued safety, purity and potency prescribed in regulations. Second, section 263a merely imposes various reporting requirements for regulation of clinical laboratories. It does not ban laboratories which produce biological weapons as required by the Convention. 7. Federal Insecticide, Fungicide and Rodenticide Act With certain exceptions, this Act, codified at 7 U.S.C.A. 136 et. seq., requires that persons register with the EPA any "pesticides" which are distributed, offered or sold. The term "pesticide" is defined as (1) any substance intended for preventing, repelling, or mitigating any "pest," and (2) any substance intended for use as a plant regulator, defoliant, or desiccant. Biological toxins and agents covered by the Convention seem quite unlike the pesticides described in this Act. Indeed, pesticides are defined as substances intended to repel or mitigate the growth of bacterial organisms. This is evidenced by the fact that a pesticide is defined as a repeller of any "pest," and pest is defined in 40 C.F.R. 162.3 as "(1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacterial organism or other microorganism (except viruses, bacteria, or other microorganisms on or in living man or other living animals) which the Administrator declares to be a pest under section 25(c)(i) of the Act and 40 C.F.R. §162.14 as being injurious to health or environment." Furthermore, biological toxins do not appear in the illustrative list of pesticides at 40 C.F.R. 102.3(ff). The closest categories of "pesticides" listed in the regulations are "biological weed-control agents" (under the term "herbicides") (40 C.F.R. 162.3(ff)(9)(viii)) and "biological insect control agents" (under the term "insecticides") (40 C.F.R. 162.3(ff)(10)(iv)). Clearly, most of the biological toxins and agents covered by the Convention are not "pesticides" since they are neither labelled as such (see 40 C.F.R. 162.3(ff)(12)) nor intended to repel "pests." See 40 C.F.R. §162.4 (status of products or pesticides). Even if some "pesticides" did fall under the Convention's rubric of biological agents, the Act would still fail to properly implement the Convention with respect to those substances. 7 U.S.C.A. §136a merely requires that "pesticides" be registered; it does not prohibit the possession or manufacture of pesticides which have no peaceful purpose. It is significant to note that a court has held the Act not to create a private right of action. See Fiedler v. Clark, 714 F.2d 77 (9th Cir. 1983). Cf. Oregon Environmental Council v. Kanzman, 714 F.2d 901 (9th Cir. 1983) (state residents can sue under Administrative Procedure Act for alleged violations of Federal Insecticide, Fungicide and Rodenticide Act). It is also important to point out that under 7 U.S.C.A. §136p the Administrator may, at his discretion, exempt any Federal or State agency from any provision of the Act if he determines that emergency conditions exist which require such exemption. Furthermore, 7 U.S.C.A. §1360 declares that pesticides and devices intended solely for import will not violate the Act so long as they are prepared in compliance with the foreign purchaser's directions. All of these exceptions display the further inadequacy of this Act as a means for implementing the Convention. In summary, the Federal Insecticide, Fungicide and Rodenticide Act does not implement any portion of the Biological Weapons Convention as required under article IV. Like the other statutes reviewed, this Act is deficient for this purpose in three main respects: (1) it does not cover the biological agents and toxins described by the Convention in article I; (2) it only regulates and does not prohibit the development, production, stockpiling, acquisition and retention of the substances it covers; and (3) it contains numerous exceptions including an exemption for Federal and State agencies. 8. The NIH Guidelines Finally, the Reagan administration has argued that the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules can somehow be said to "implement" the Biological Weapons Convention. However it is quite clear from the "legislative history" of these Guidelines that they were never intended to and do not now address these issues. Indeed, in June of 1982, the Recombinant DNA Advisory Committee (RAC) specifically considered amending the NIH Guidelines so as to address the use of recombinant DNA technology in biological warfare. 47 Fed. Reg. 23,110 (1982). But RAC never adopted that amendment. In fact, the proceedings of RAC's June, 1982 meeting demonstrate that some members of RAC considered an amendment of the Guidelines to be unnecessary and superfluous, because they erroneously believed that the Convention was already effective as U.S. domestic law. See Minutes of the Meeting, June 28, 1982, Recombinant DNA Advisory Committee, Department of Health and Human Services, Public Health Services, National Institutes of Health, at 60. Furthermore, the view was expressed that an amendment might dangerously imply that RAC considered the Convention itself inapplicable to the use of recombinant DNA technology in biological warfare. Id. at 75. Therefore RAC never adopted the amendment, but simply advised the Director of NIH of its position that such uses of recombinant DNA techniques were prohibited under the Convention. Subsequently, in May of 1985, RAC also declined to establish a working group to examine potential military uses of recombinant DNA technology. The RAC members agreed that RAC had neither the mandate nor the resources to investigate such issues. See Discussion on a Proposal to Form a RAC Working Group on Biological Weapons, 8 Recombinant DNA Technical Bulletin 174 (Dec. 1985). Thus RAC never acted so as to implement the Biological Weapons Convention to any extent, but on the contrary specifically refused to undertake any such measures. The American Public Health Association (APHA), representing a combined national and affiliate membership of over 55,000 public health professionals and community health leaders, supports S. 993, the Biological Weapons Anti-Terrorism Act of 1989. APHA has long recognized that there are serious dangers associated with the research, manufacture, storage, and transport of chemical and biological weapons. The Association expressed these concerns in a 1974 policy statement entitled "Chemical and Biological Methods of Warfare," a copy of which is enclosed for your information. As a result of this policy statement, we have consistently supported moratoria on research, development, and use of of all forms of biological and chemical weapons. Despite the support of APHA and several other organizations Given the tremendous potential of biological weapons to cause death and injury through warfare, terrorism, and accidental release, APHA firmly supports any and all efforts to ban these weapons. We applaud you for introducing S. 993, and we strongly urge the Senate Judiciary Committee to consider this important piece of legislation. Thank you. |