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Emerging Roles Of NIH And EPA in the Regulation Of rDNA Technology

Bio/Technology volume 1, pages 757–768 (1983)Cite this article

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References

  1. Committee on Recombinant DNA, “Potential Biohazards of Recombinant DNA Molecules”, Nature 250: 175 (1974); Proc. Nat. Acad. Sci. 71: 2593 (1974); Science 185: 303 (1974).

  2. Fed. Regist. 48: 24556 (1983).

  3. Milewski, E., Editor's Note. Recombinant DNA Tech. Bull. 4: i (1981).

    Google Scholar 

  4. Inside EPA 4, 1 (1983). EPA has already held a meeting and published a draft report on the subject of its regulation of this area under the TSCA. EPA, “Administrator's Toxic Substances Advisory Committee; Meeting”, Fed. Regist. 48: 8342 (1983); Regulation of Genetically Engineered Substances Under TSCA, Chemical Control Division, Office of Toxic Substances, Office of Pesticides and Toxic Substances, Environmental Protection Agency, Washington, D.C. (March 1982). Congress also recently held a hearing on the subject of existing federal authority over the release of R-DNA-containing organisms into environment. M. Sun, Science 221: 136 (1983).

  5. Sects. 2–30, 15 U.S. Code, sects. 2601–2629 (1976 and Supp. V 1981). Hereinafter, all references in the text to TSCA refer to the section numbers as enacted and not to the corresponding U.S. Code sections.

  6. The Administrative Procedure Act specifically states that the reviewing court shall “hold unlawful and set aside agency action, findings, and conclusions found to be hellip; in excess of statutory jurisdiction, authority, or limitations, or short of statutory right. hellip;” 5 U.S. Code, sect. 706(2)(C) (1976).

  7. PHS Act, 42 U.S. Code, sects. 217a and 241 (1976); Charter, Recombinant DNA Advisory Committee, Department of Health and Human Services (1982).

  8. Korwek, E., Food, Drug and Cosm. L. J. 35: 633 (1980), p. 636.

    Google Scholar 

  9. Although DHHS has some authority under Section 361 of the PHS Act to regulate R-DNA materials that cause human disease and are communicable, most types of experimentation would not fall into this category. Because of this limitation, the Sub committee of the Federal Interagency Committee on R-DNA Research concluded that Section 361 lacked the requisite authority for the regulation of all R-DNA work. Sub committee Review of Existing Legislation in Interim Report of the Federal Interagency Committee on Recombinant DNA Research: Suggest ed Elements for Legislation (March 15, 1977), pp. 8–9.

  10. For a review of current state and local laws, see Biotechnology L. Rep. 2: 19 (1983).

  11. Scholtes, P., Biotechnology L. Rep. 2: 91 (1983); G. Karny, U. Tol. L. Rev. 12: 815 (1981), p. 831.

    Google Scholar 

  12. Korwek, E. U. Cinn. L. Rev. 50: 284 (1981), p. 300.

    Google Scholar 

  13. Sect. 26(c), 15 U.S. Code, sect. 2625(c) (1976 and Supp. V 1981). This authority over categories is significant in the R-DNA area because with one action EPA could likely regulate all R-DNA molecules, not just specific ones.

  14. H.R. Rep. No. 94-1341, 94th Cong., 2d Sess., 10 (1976).

  15. Whether R-DNA molecules used to manufacture drugs are within the jurisdiction of TSCA is less clear, because such materials may not fall within the definition of articles subject to the jurisdiction of FDA under the Federal Food Drug and Cosmetic Act. On this point, sec E. Korwek, J. Parenteral Sci. and Tech. 36: 252 (1982), pp. 254–255.

  16. Interim Report (9), p. 32.

  17. Regulation of Genetically Engineered Substances Under TSCA (4), p. 16.

  18. EPA, “Inventory Reporting Regulations”, Fed. Regist. 42: 64572 (1977).

  19. Ibid., p. 64585.

  20. Letter to A. E. Stevenson, Chairman, Sub committee on Science, Technology, and Space, U.S. Senate Committee on Com merce, Science, and Transportation, in Oversight Report, Recombinant DNA Research and its Applications, 95th Cong., 2d Sess., Aug. 1978, p. 88.

  21. Code of Fed. Regs. 40, sect. 710.4(b) (1983).

  22. Substances formed by actual mixing together, such as hydrates, alloys, ceramics, and cements, although they may contain components that occur naturally, are typical examples of mixtures. “Inventory Reporting Regulations” (18), p. 64585.

  23. EPA, “Premanufacture Notification; Pre-manufacture Notice Requirements and Re view Procedures; Final Rules and Notice Form”, Fed. Regist. 48: 21722 (1983), p. 21745, note 1. EPA has as of this writing postponed the effective date of this rule because of industry response. EPA, “Pre-nianufaclurc Nolificatiori, Delay of Regulation”, ibid., p. 31641.

  24. Legislative History of the Toxic Substances Control Act, p. 422 (House Report).

  25. “Inventory Reporting Regulations” (18), p. 64584.

  26. Dow Chemical Co. v. EPA, 605 Fed. Rep., 2nd ser. 673, 686 (3d Cir., 1979).

  27. “Premanufacture Notification” (23), p. 21744.

  28. Once notification is provided, subject chemicals are placed on the Inventory upon submission of a commencement of manufacture notice and no longer are part of the PMN process unless manufactured for a significant new use. Since 1976, EPA has reviewed more than 1,700 new chemicals; nearly one-half of the notices received were during 1982. Toxic Substances Control Act Report to Congress for Fiscal Year 1982, Environmental Protection Agency, p. 4. About 1300 notices are expected in 1984. Pesticide and Toxic Chemicals News, 2 Feb. 1983, p. 14. Overall, EPA has taken action on roughly five percent of the notices. Office of Technology Assessment (OTA), The Information Content of Premanufacture Notices; Background Paper (Government Printing Office, Washington, D.C., 1983).

  29. TSCA Report (28), p. 3. Several classes of bacteria, fungi, yeast, and other microorganisms are listed on the Inventory, as are naturally occurring chemicals, which include those that are unprocessed or processed only by manual, mechanical, or gravitational means (21). Both of these categories of chemical substances therefore do not require premanufacture notification.

  30. “Premanufacture Notification” (23), p. 21746.

  31. The purpose of this exemption is to ensure that R&D is not impeded. 122 Cong. Rec. H8805 (Aug. 23, 1976) (House Debate—Cong. McCollister); ibid., H8819 (House Debate—Cong. Murphy). EPA defines the term “small quantities” to mean those that are no greater than reasonably necessary for R&D purposes and which are used under the supervision of technically qualified individuals. “Premanufacture Notification” (23), p. 21744.

  32. EPA, “Regulatory Impact Analysis: Final Form”, pp. 198–204 (1983).

  33. EPA, “Potassium N,N-Bis (Hydroxyethyl) Cocoamine Oxide Phosphate and Potassium N,N-Bis (Hydroxyethyl) Tallowamine Oxide Phosphate; Proposed Determination of Significant New Uses—Proposed Rule”, Fed. Regist. 48: 7142 (1983).

  34. EPA, “Category of Chemical Substances Known as Chlorinated Naphthalenes; Proposed Determination of Significant New Uses—Proposed Rule”, ibid., p. 20668. EPA recently withdrew a proposed SNUR on another industrial chemical, because the chemical did not present potential risks of sufficient concern to justify agency action. EPA, “N-Methanesulfonyl-p-Toluenesul-fonamide; Withdrawal of Proposed Significant New Use Rule—Termination of Pro posed Rule”, ibid., p. 7148.

  35. Chemical Regulation Reporter, Current Report (Bureau of National Affairs, Aug. 5, 1983), p. 660. A sampling of PMN submissions reveals that about one-half contain any toxicity data, usually in the form of acute oral information. OTA (28). The effectiveness of premanufacture notices therefore has been repeatedly raised too during the recent reauthorization hearings on TSCA. Pesticide and Toxic Chemical News, 27 April 1983, p. 4.

  36. OTA (28), p. 78.

  37. TSCA Report (28), p. 5.

  38. TSCA Chemicals-in-Progress Bulletin 4, 8 (1983). Five were already issued during July. Chemical Regulation Reporter, Current Report (Bureau of National Affairs, July 29, 1983), p. 637.

  39. Pesticide & Toxic Chemical News, 27 July 1983, p. 9.

  40. Klein, E., “Summary of Informal Regulatory Actions—Quarterly Report”, Memo to Don R. Clay, Director, Office of Toxic Sub stances, EPA, July 30, 1982.

    Google Scholar 

  41. Thus far, EPA's testing requirements have focused on only ITC-designated substances, although testing can apparently be required of chemicals not subject to ITC recommendations. The ITC issues a priority list every six months and is currently on its twelfth report. EPA, “Twelfth Report of the Inter-agency Testing Committee to the Administrator; Receipt of Report and Request for Comments Regarding Priority List of Chemicals”, Fed. Regist. 48: 24443 (1983). In this latest report, 5 chemicals were designated for testing and 15 were removed because EPA had responded to the Committee's recommendations. A total of thirty-six chemicals are currently on the list. No final test rules have yet to be promulgated, although since the testing program began in 1977, proposed rules on four chemicals have issued. Chemical Regulation Reporter, Current Report (Bureau of National Affairs, May 13, 1983), p. 307. In 1982, EPA negotiated four test agreements, issued seven decisions not to test, published one pro posed rule and two advanced notices of proposed rule making. TSCA Report (28), p. 7.

  42. The subject of negotiated testing agreements has been controversial; environmental groups argue that TSCA mandates that rules are the exclusive means for accomplishing testing. See EPA, “4-chlorobenzo-trifluoride; Decision to Adopt Negotiated Testing Program”, Fed. Regist. 48: 32730 (1983), pp. 32730–31.

  43. § 5(b)(l)(A)(ii), 15 U.S. Code, sect. 2604(b)(l)(A)(ii) (1976 and Supp. V 1981).

  44. Code of Fed. Regs. 40, part 762 (1983) (chlorofluoroalkanes); ibid., part 763 (as bestos); ibid., part 775 (dioxin) (subject to new rule making at Fed. Regist. 47: 193 (1982)). A partial or total ban is expected on the manufacture and import of a carcinogenic polyurethane hardener and curing agent, EPA, “4,4′-methylene Bis (2-chlor-oaniline); Initiation of Regulatory Investigation,” Fed. Regist. 48: 22954 (1983), p. 339, and a ban on five categories of use of asbestos and a production cap on all other uses, Chemical Regulation Reporter, Cur rent Report (Bureau of National Affairs, Aug. 8, 1983), p. 659.

  45. Fed. Redist. 48: 24556 (1983), p. 24561.

  46. Code of Fed. Regs. 40, sect. 712.20 (1983).

  47. See generally EPA, Chemical Information Reporting Rules; Automatic Reporting, Fed. Regist. 48: 21294 (1983); Chemical Information Rules; Preliminary Assessment Information; Manufacturers Reporting; Amendment Adding ITC Chemicals—Final Rule, ibid., 22694; Preliminary Assessment Information; Addition of Chemicals, ibid., 22697; Manufacturer's Reporting of Additional Chemicals, ibid., 28443.

  48. EPA, “Asbestos Reporting Requirements”, ibid., 47: 33198 (1982).

  49. EPA, “Chlorinated Terphenyl; Submission of Notice of Manufacture or Importation”, ibid., 19419.

  50. EPA, “Records and Reports of Allegations That Chemical Substances Cause Significant Adverse Reactions to Health or the Environment; Recordkeeping and Reporting Procedures”, ibid., 48: 38178 (1983).

  51. Ibid.

  52. EPA, “Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies—Final Rule”, ibid., 38780 (1982). Recently a proposed rule was issued covering the submission of unpublished health and safety studies on six ITC-designated chemicals and one mixture.EPA, “Health and Safety Data Reporting; Submission of Tests and Copies of Health and Safely Studies”, ibid., 28483.

  53. EPA, “TSCA—Notification of Substantial Risk Under Section 8 (e)”, ibid., 43: 11110 (1978).

  54. In 1982, EPA evaluated 45 substantial risk notices, and 76 “for your information” notices, from those who had risk-related information that did not fit the Section 8 (e) criteria. TSCA Report (28), p. 9.

  55. Last year, a Memorandum of Understanding was executed between the U. S. Food and Drug Administration and Department of Agriculture regarding responsibilities of each agency for regulating biotechnology-derived animal products as biologics or drugs. See FDA, “Memorandum of Understanding With the U.S. Dept. of Agriculture, Animal and Plant Health Inspection ServiceNotice,” Fed. Regist. 47: 26458 (1982).

  56. TSCA Bulletin (38), p. 6.

  57. TSCA Report (28), p. 3.

  58. Pesticide & Toxic Chemical News, 16 Feb. 1983, p. 3.

  59. G. Karny (11), p. 821.

  60. Federal preemption can exist under Section 4, when EPA establishes a testing requirement. If the Agency regulates a chemical substance or mixture under Section 5 or 6, no state may adopt a different requirement, unless it is adopted under another federal law or it prohibits use of the substance or mixture other than use in the production of other chemicals. See § 18, 15 U.S. Code, sect. 2617 (1976 and Supp. V 1981).

  61. Chemicals used in or for instant photographic film articles are exempted. See Fed. Regist. 46: 54585 (1981); ibid., 47: 33896 (1982) (proposed exemption for site limited intermediates and low volume substances); ibid., 33924 (proposed exemption for poly mers, but not biopolymers).

  62. Regulation of Genetically Engineered Substances Under TSCA (4).

  63. Dixon, B., BIO/TECHNOLOGY 1: 45 (1983).

    Article  Google Scholar 

  64. Chemical and Engineering News, Aug. 15, 1983, p. 21.

  65. Charter (7).

  66. HHS, “Program to Assess the Risks of Recombinant DNA Research: Proposed First Annual Update”, Fed. Regist. 45: 61874 (1980).

  67. Federal Food, Drug, and Cosmetic Act, sect. 412, 21 U.S. Code, sect. 350a (1976 and Supp. V 1981).

  68. Human applications of genetic engineering could be regulated within the current statutory framework, since gene products would usually be considered drugs subject to regulation by FDA. On this point, see H. Miller, BIO/TECHNOLOGY 1: 382 (1983). It is interesting to note that the Guidelines and past activities of Congress, state, and local authorities have focused on only the R-DN A technique, while other methodologies, such as cell fusion and treatment with mutagens, which can also produce organisms with unusual genotypes, have escaped attention.

  69. The author gratefully acknowledges the helpful discussions with John B. Dubeck and C. Douglas Jarrett; the excellent research assistance of Ilene Ringel Heller; editing and proofing by Joan Cohen, and manuscript preparation by Lee Officer.

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  1. Ph.D., J.D., is associated with the law offices of Keller and Heckman, 1150 17th St., N.W., Washington, D.C., 20036

    Edward L. Korwek

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Korwek, E. Emerging Roles Of NIH And EPA in the Regulation Of rDNA Technology. Nat Biotechnol 1, 757–768 (1983). https://doi.org/10.1038/nbt1183-757

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