No 'killer tomatoes': Easing federal regulation of genetically engineered plants

Food and Drug Law Journal

Volumn 53, Issue 1, 1998, Pages 181-191

  Beach, Judith E ^a  

^a Phelps and McNamara   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FOOD AND DRUG ADMINISTRATION; FOOD INDUSTRY; GENETIC ENGINEERING; LAW; PLANT; REVIEW;

CONSUMER PRODUCT SAFETY; EUROPE; EUROPEAN UNION; FOOD LABELING; FOOD, GENETICALLY MODIFIED; HUMANS; LEGISLATION, FOOD; UNITED STATES; UNITED STATES DEPARTMENT OF AGRICULTURE; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY; UNITED STATES FOOD AND DRUG ADMINISTRATION;

LYCOPERSICON ESCULENTUM;

EID: 0031949244     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (87)

1. Biotechnology of Food, FDA Backgrounder (May 18, 1994).
2. EDUC./COMPLIANCE PROGRAM, FOOD AND DRUG ADMIN., EMERGING TECHNOLOGIES - BIOTECHNOLOGY (1995).
3. David A. Kessler, Remarks on Regulation of Food Biotechnology, Speech to the University of Washington, Seattle, Washington (Apr. 23, 1993).
4. Id.
5. T. Haniotis, First Sec'y Agric., EC Delegation to the United States, The Economics of Agricultural Biotechnology: Differences and Similarities in the U.S. and the EU, Address Before the Integrated Crop Management Conference (Nov. 17-18, 1997), at 1.
6. 62 Fed. Reg. 23,945 (May 2, 1997).
7. European Parliament and Council Regulation 258/97 EC of27 January 1997 on Novel Foods, 1997 O.J. (L 43) 14.2.
8. Special U.S. Trade Nominee Vows to Oppose EU Biotech Food Labeling, FOOD LABELING & NUTRITION NEWS, Sept. 11, 1997, at 10.
9. A "regulated article" is de fined as "[a]ny organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent . . . designated in [7 C.F.R.] § 340.2 and meets the definition of plant pest . . . [or that APHIS] determines is a plant pest or has reason to believe Is a plant pest." 7 C.F.R. § 340.1 (1997).
10. Id. §§ 340.0(a)(1), 340.1.
11. The definition of "plant pest" is taken from the Federal Plant Pest Act, Pub. L. No. 85-36, 71 Stat. 31 (1957) (codified at 7 U.S.C. §§ 147a, 149, 150aa-150jj (1994)), and includes "viruses, or any organisms . . . or any infectious substances, which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants." 7 U.S.C § 150aa(c); 7 C.F.R. § 340.1.
12. 7 C.F.R. §§ 340.0(a)(1), 340.1.
13. EU/US Perspectives on Labeling Genetically Engineered Foods, FOOD CHEM. NEWS, Special Report, at 21.
14. 7 C.F.R. pt. 340.
15. 62 Fed. Reg. at 23,945.
16. 7 C.F.R. §§ 340.0, 340.3.
17. Id. § 340.4.
18. J. Payne, Dir., Biotech. & Sci. Servs., APHIS, Address Before USDA Public Meeting on Simplification of Requirements for Genetically Engineered Organisms (May 28, 1997).
19. Id.
20. 7 C.F.R. § 340.3(b); see APHIS, U.S. DEP'T OF AGRIC., USER'S GUIDE FOR INTRODUCING GENETICALLY ENGINEERED PLANTS AND MICROORGANISMS, Tech. Bull. No. 1783, § VI(rev: 1997)[hereinafter USER'S GUIDE].
21. 7 C.F.R. § 340.3(c); see USER'S GUIDE, supra note 20, § VI.
22. 7 C.F.R. § 340.6
23. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified at 21 U.S.C. §§ 301 et seq. (1994)).
24. Ch. 288, 37 Stat. 309 (codified at 42 U.S.C. §§ 262-263a (1994)).
25. 21 U.S.C. § 342(a)(1).
26. Id. § 348.
27. A comprehensive presentation of initial federal policy on the safety and other aspects of bioengineered research and products was published in the Federal Register. 51 Fed. Reg. 23,302 (June 26, 1986). Therein, FDA, USDA, and EPA published statements of their initial regulatory policies. Although the Coordinated Framework provided direction for agency policies, it did not authorize agency action that could not have otherwise taken place; each agency had to make decisions and issue regulations based on its statutory authority. See Foundation on Economic Trends v. Johnson, 661 F. Supp. 107, 109 (D.D.C. 1986) (court decided that while the Coordinated Framework was not a model of clarity, it was intended to guide policymaking, not to regulate).
28. 21 U.S.C. §§ 321(s), 342, 348.
29. 57 Fed. Reg. 22,984 (May 29, 1992); Statement of Policy; Foods Derived From New Plant Varieties, Q&A Sheet (June 1992).
30. In the 1992 plant policy statement, FDA used the term "substantial similarity," but now is using the term "substantial equivalence" when assessing the safety of foods derived from new plant varieties. 62 Fed. Reg. 18,938, 18,945 n.2 (Apr. 17, 1997).
31. Biotechnology of Food, supra note 1, at 1.
32. CFSAN, FOOD AND DRUG ADMIN., GUIDANCE ON CONSULTATION PROCEDURES FOR FOOD DERIVED FROM NE PLANT VARIETIES, at 1 (Oct. 1997) [hereinafter GUIDANCE].
33. Id.
34. Id.
35. Id. at 2. 36 d. at 2-3.
36. 57 Fed. Reg. at 22,984; GUIDANCE, supra note 32, at 5.
37. CFSAN, FOOD AND DRUG ADMIN., FOODS DERIVED FROM NEW PLANT VARIETIES DERIVED THROUGH RECOMBINANT DNA TECHNOLOGY: FINAL CONSULTATION UNDER FDA's 1992 POLICY (1994-1995).
38. DRAFT UNITED STATES COMMENTS TO THE PROPOSED DRAFT RECOMMENDATIONS ON THE LABELLING OF FOODS OBTAINED THROUGH BIOTECHNOLOGY, AT 3-4 (Proposed Draft Amendment to the General Standard for the Labelling of Prepackaged Foods, at Step 3 of the Procedure app. VI, ¶ 160) (Oct. 10, 1997) [hereinafter DRAFT COMMENTS].
39. 58 Fed. Reg. 25,837 (Apr. 28, 1993). At some time in the future, FDA still is planning to hold a public hearing on labeling issues for foods derived from new plant varieties.
40. 4I 21 U.S.C. § 343(i).
41. 21 C.F.R. § 101.3 (1997).
42. 21 U.S.C. §§ 321(n), 343(a).
43. 57 Fed. Reg. at 22,991.
44. Id.
45. 21 U.S.C. § 343(a); 57 Fed. Reg. at 22,991.
46. Regulation 258/97 EC, supra note 7, at 3. See also FOOD LABELING & NUTRITION NEWS, July 10, 1997, at 3.
47. Commission Regulation 1813/97 of 19 September 1997, 1997 O.J. (L 257) 20.09.
48. Labelling of Genetically Modified Organisms, EC Memo No. 97/110 (Dec. 18, 1997).
49. European Stance on Labeling Genetically Modified Crops Prompts Farm Chemicals Association Response, FOOD LABELING & NUTRITION NEWS, July 17, 1997, at 11.
50. A. Novotny, EU Directive on Labeling Genetically Modified Organisms Creates Confusion for U.S. Industry, Government, FOOD LABELING & NUTRITION NEWS, July 10, 1997, at 3-4.
51. EU May Strengthen Labeling Requirements for Genetically Modified Soybeans and Corn, FOOD LABELING & NUTRITION NEWS, Dec. 11, 1997, at 10-11.
52. Special U.S. Trade Nominee, supra note 8, at 10.
53. CODEX COMM. ON FOOD LABELING, PROPOSED DRAFT RECOMMENDATIONS ON THE LABELING OF FOODS OBTAINED THROUGH BIOTECHNOLOGY (1997).
54. European Council Directive 90/220, 1990 O.J. (L 117) 8.5.
55. DRAFT COMMENTS, supra note 35, at 4.
56. Pub. L. No. 100-532, 102 Stat. 2654 (1988) (codified at 7 U.S.C §§ 136-136y).
57. Pub. L. No. 104-170, 110 Stat. 1489.
58. 21 U.S.C. §§ 346a(c)(2)(A)(ii).
59. Section 2 of FIFRA defines "plant regulator" as "any substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of the plants or the produce thereof." With regard to substances applied to plants, this definition has been interpreted to include, for example, plant hormones (such as auxin, gibberellin, cytokinin, and ethylene). 59 Fed. Reg. 60,496, 60,507 (Nov. 23, 1994).
60. 7 U.S.C. § 136(u).
61. 40 C.F.R. pts. 158, 172 (1997).
62. Id. pts. 158, 162.
63. Novel microbial pesticides (such as genetically modified or nonindigenous microbial pesticides) will be subject to additional data or information requirements on a case-by-case basis depending on the particular microorganism, its parent microorganism, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified. Id § 158.65; see also id. §§ 158.165, 158.170.
64. 7 U.S.C. § 136a.
65. 40 C.F.R. pt. 172.
66. Id. § 172.3(b).
67. Id. § 172.3. EPA has decided that some genetically engineered microbial pesticides warrant a close review before being excluded from EUP requirements at the small-scale testing stage. See 59 Fed. Reg. 45,600 (Sept. 1, 1994). EPA must be notified and obtain prior approval once the research phase requires any type of field trial or when a laboratory does not meet containment standards.
68. 59 Fed. Reg. at 60,509.
69. 7 U.S.C. § 136c.
70. 40 C.F.R. pt 152.
71. Id. § 152.113.
72. Id. § 152.114.
73. 59 Fed. Reg. 60,496, 60,519, 60,535, 60,542, 60,545 (Nov. 23, 1994).
74. 7 U.S.C. § 136u.
75. 59 Fed. Reg. at 60,501.
76. Id. at 60,500-01.
77. Id. Sexual compatibility means that two plants are capable of breeding or "crossing." For example, different types of squash may be sexually compatible.
78. Id.
79. Id. at 60,525-26. Coat pro teins are those ubiquitous substances that encapsulate and protect the genetic material of certain viruses. In some cases, when the genetic material encoding for the coat protein is introduced into a plant's genome, the plant is able to resist subsequent infections by the same virus or related strains (termed "viral coat protein mediated resistance" or "vcp-mediated resistance").
80. 21 U.S.C. § 346a(c). 82 Id. § 346a(c)(2)(A)(ii).
81. 59 Fed. Reg. at 60,521.
82. 59 Fed. Reg. at 60,545.
83. 59 Fed. Reg. at 60,542. EPA has proposed to treat selectable markers as inert ingredients. Id. at 60,543.
84. 59 Fed. Reg. at 60,535. EPA prefers to establish the exemption for Category 1 based on plant pesticides derived from sexually compatible plants. Id. at 60,537.
85. Id. at 60,536-38. EPA has not, however, proposed to exempt from the tolerance requirement plant pesticides either derived from nonfood plants that are not closely related to the recipient plant or that are derived from a nonplant source.
86. 62 Fed. Reg. 27,132, 27,142, 27,149 (May 16, 1997).
87. EU/US Perspectives on Labeling Genetically Engineered Foods, supra note 13, at 3.