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{\title Regulation of Genetically Engineered Food Products:}{\author Faculty Library}{\operator Faculty Library}{\creatim\yr2001\mo2\dy23\hr16\min20}{\revtim\yr2001\mo2\dy23\hr16\min20}{\version2}{\edmins0}{\nofpages1}{\nofwords6003}{\nofchars34220}
{\*\company Harvard Law School Library}{\nofcharsws42024}{\vern113}}\margl1904\margr1911\margt1128\margb1133 \widowctrl\ftnbj\aenddoc\hyphcaps0\viewkind4\viewscale100 \fet0\sectd \sbknone\linex0\headery1200\sectdefaultcl {\*\pnseclvl1
\pnucrm\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl2\pnucltr\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl3\pndec\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl4\pnlcltr\pnstart1\pnindent720\pnhang{\pntxta )}}{\*\pnseclvl5
\pndec\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl6\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl7\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl8\pnlcltr\pnstart1\pnindent720\pnhang
{\pntxtb (}{\pntxta )}}{\*\pnseclvl9\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}\pard\plain \s16\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 Regulation of Genetically Engineered Food Products:
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\f6 A Market-Oriented Perspective
\par }\pard\plain \nowidctlpar\tx204\adjustright {\f6 
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\par }\pard\plain \s18\li4235\nowidctlpar\tx4234\adjustright {\f6 Student TD# 604 0371 6
\par }\pard\plain \nowidctlpar\tx4234\adjustright {\f6 
\par }\pard\plain \s19\li5154\nowidctlpar\tx5153\adjustright {\f6 January 27, 1995
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s20\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
Only twenty years after the landmark Asilomar meeting where scientists discussed the opportunities and possible risks presented by the ability to transfer DNA from one organism to another,' bioengi
neered products have moved outside the confines of the laboratory into commercial uses in the pharmaceutical and food-processing industries. Recent advances in molecular biology and the application of new technologies to the production of food have opened
 the door to a new world of bioengineered food. Agricultural biotechnology}{\f6\super 2 }{\f6 has the potential to "meet the needs of a rapidly growing population and minimize the toxic influences of traditional farming practices on the environment."}{
\f6\super 3}{\f6  Furthermore, it promises to improve human nutritional intake and can even aim to satisfy our desire for novel or exotic foods with aesthetically appealing textures, appearances and tastes. At the same time, however, the public remains

\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\f6\fs18\super 1}{\f6\fs18 Paul Berg et al., }{\b\i\f6\fs18 Asilomar Conference on Recombinant DNA Molecules, }{\b\f6\fs18 188 }{\f6\fs16 SCENCE }{\b\f6\fs18 991 (1975) }{\f1\fs8 . }{
\b\f6\fs18 The Asilomar meeting has been recognized as the beginning of public oversight, rather than mere scientific debate, over recombinant DNA experimentation. }{\b\i\f6\fs18 See generally }{\b\f6\fs18 Judith P. Swazey et al., }{\b\i\f6\fs18 
Risks and Benefits, Rights and
\par }\pard\plain \s22\sl-215\slmult0\nowidctlpar\tx2228\adjustright {\b\i\f6\fs18 Responsibilities:\tab A History of the Recombinant DNA Research Controversy, }{\b\f6\fs18 51 5. CAL. L. REv. 1019 (1978).
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18\super 2}{\f6\fs18 For purposes of this paper, the terms "biotechnology" and }{\b\f1\fs12 a }{\b\f6\fs18 genetic engineering" refer to the ability to ef
fect specific genetic changes via techniques such as recombinant DNA ("rDNA") (i.e., joining together pieces of DNA from different organisms together in vitro), cell fusion (used to create homogeneous antibodies that recognize only one kind of antigen), a
nd recombinant RNA ("rRNA") (the newest techniques in which RNA is modified by inserting segments of foreign RNA). }{\b\i\f6\fs18 Cf. }{\b\f6\fs18 Diane
\par }\pard\plain \s24\sl-215\slmult0\nowidctlpar\tx362\adjustright {\b\f6\fs18 E.\tab Hoffmann, }{\b\i\f6\fs18 The Biotechnology Revolution and its Regulatory Evolution, }{\b\f6\fs18 38 DRAKE }{\b\i\f6\fs18 L. }{\f6\fs16 REV. }{\b\f6\fs18 
471, 471 n.l (1988) (employing this definition); OFFICE }{\f6\fs16 OF TECHNOLOGY ASSESSMENT, cO~\'b6ERCIAL BIOTECHNOLOGY: AN INTERNATIONAL ANALYSIS, }{\b\f6\fs18 3\emdash  4, 503 (1984) (adopting similar definition)
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18\super 3}{\f6\fs18 council on scientific Affairs, Am. Medical Ass'n, }{\b\i\f6\fs18 Biotechnology and the American Agricultural Industry, }{\b\f6\fs18 265 J. AM. M
ED. Ass'N 1429, 1429-34 (1991)
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s25\qc\nowidctlpar\tx720\adjustright {\f6 2
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s16\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
suspicious of the uses to which genetic engineering may be put, as well as somewhat wary of the foods derived from genetically engineered organisms.}{\f6\super 4 }{\f6 Critics of the new technology have long argued that 
recombinant DNA techniques and products derived from them pose significant and ill-understood risks to human health and safety) Against this backdrop, the federal Food and Drug Administration ("FDA") has sought to fulfill its statutory mission to protect 
t
he safety and wholesomeness of the food supply) Because the FDA has chosen to address the novel issues raised by the application of biotechnology to food through existing statutory authority, manufacturers and producers of bioengineered food, as well as o
thers concerned with the availability of safe, nutritious and inexpensive food, have sought clarification from the FDA about how these decades-old standards will be applied. In the near-term future at least, the }{\b\f6\fs18 FDA'S }{\f6 
response, published in l992,~ appears likely to direct commercial efforts at bioengineered foods into channels that may not realize the full benefits of
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s26\li1406\nowidctlpar\tx1405\adjustright {\b\i\f6\fs18 e.g., }{\b\f6\fs18 Michael Schrage, }{\b\i\f6\fs18 Innovation's Growth Industry Lies
\par }\pard\plain \s27\nowidctlpar\tx204\adjustright {\b\i\f6\fs18 Where High Tech and Low Brow Meet, }{\f6\fs16 WASH. POST, Dec. }{\b\f6\fs18 30, 1994, at D2
\par }\pard\plain \s29\sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 (observing that Calgene must constantly assure consumers that its
\par }\pard\plain \s28\fi-720\li720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 genetically engineered "Flavr-Savr" tomatoes are not "Frankenfoods") }{\b\i\f6\fs18\super 5}{\i\f6\fs18 See, e.g., }{\b\f6\fs18 Ruckelshaus, }{\b\i\f6\fs18 
Risk, Science, and Democracy, }{\b\f6\fs18 1 }{\f6\fs16 ISSUES
\par }\pard\plain \s29\sl-215\slmult0\nowidctlpar\tx204\adjustright {\i\f6\fs18 SCI. }{\f6\fs16 TECH. }{\b\f6\fs18 19, 21 (1985) (arguing that the risks inherent
 in biotechnology are the greatest people have ever confronted from advances in the natural sciences); Wald, }{\b\i\f6\fs18 The Case Against Genetic Engineering, }{\b\f6\fs18 16 }{\f6\fs16 SCIENCES 7 }{\b\f6\fs18 (1976).
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18\super 6}{\f6\fs18 This paper will concentrate primarily on the FDA's regulation of foods and food additi
ves produced by biotechnology. It will not discuss the FDA's oversight of genetically engineered drugs, nor will it specifically address the role of other federal and state agencies in regulating biotechnology.
\par }{\fs12 257 }{\b\f6\fs18 Fed. Reg. 22,984 (1992) [hereinafter "FDA Statement").
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s25\qc\nowidctlpar\tx720\adjustright {\f6 3
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s16\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 biotechnology, both from consumerist and marketing perspectives, as quickly and efficiently as possible.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s20\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Part I of this paper briefly explains relevant provisions of the federal Food, Drug and Cosmetic Act}{\f6\super 8 }{\f6 
("FD&C Act") leading up to the analytic framework set forth by FDA in its 1992 statement of policy. Part II discusses the scientific and regulatory climate in which Calgene, a manufacturer of a genetically altered tomato, brought its product to market in 
consultation with the FDA. Part III attempts to place the substantial discretion vested in the }{\b\f6\fs18 FDA }{\f6 
in a broader context as part of the ongoing debate about the safety of genetic engineering. Finally, Part IV explores how the FDA'S positions could inhibit or enhance the development of an active and efficient market for genetically engineered products.

\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s25\qc\nowidctlpar\tx720\adjustright {\f6 I. Basic Statutory Framework of the FD&C Act
\par }\pard\plain \nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s20\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Under current federal law, foods 
and food additives are regulated by the FDA under the FD&C Act. The Act prohibits the introduction or delivery into interstate commerce of "misbranded" or "adulterated" food. Under \'a7 402(a) (1) of the Act,
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s30\fi715\li720\sl-238\slmult0\nowidctlpar\tx720\tx1434\adjustright {\f6 food shall be deemed to be adulterated [i]f it be
ars or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the
\par }\pard\plain \sl-238\slmult0\nowidctlpar\tx720\tx1434\adjustright {\f6 
\par 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 821 U.S.C. \'a75 301-92 (1988 & }{\b\f6\fs18 Supp. 1993).
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 4
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s33\li720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 quantity of such substance in such food does not ordinarily render it injurious to health.}{\f6\super 9}{
\f6  According to \'a7 402(a) (2) (C), a food is deemed
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 adulterated "if it is, or it bears or contains, any food additive which is unsafe within the meaning of \'a7 409." In turn, \'a7
 409 effectively creates a pre-market approval requirement for food additives by providing that a food additive is presumed unsafe unless the additive and its use conform with a regulation prescribing the conditions und
er which such additive may safely be used.'}{\f6\super 0 }{\f6 Finally, \'a7 201(s) defines "food additive" as
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s30\fi715\li720\sl-238\slmult0\nowidctlpar\tx720\tx1434\adjustright {\f6 
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, }{\f1\fs8 . . . }{\f6 
if such substance is not generally recognized, among 
experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures [or, for substances used in food prior to 1958, through experience based on common use] }{\f1\fs8 . . . }{\f6 
to be safe under the conditions of its intended use.'}{\f6\super 1}{\f6 
\par }\pard\plain \sl-238\slmult0\nowidctlpar\tx720\tx1434\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Thus, the FDA may declare a food adulterated and subject to seizure'}{\f6\super 2 }{\f6 
if it includes a poisonous or deleterious substance that either "may render" or "ordinarily render[s]" the food injurious to health, depending on the 
agency's determination of the substance as added or not added. It is clear that the FDA understands the "ordinarily render" clause of \'a7 402(a) (1) to allow greater tolerance of potentially
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\f6 ~21 }{\b\f6\fs18 U.S.C. \'a7 342(a)(1).
\par }{\b\i\f6\fs18 '}{\b\i\f6\fs18\super 1}{\i\f6\fs18 1d. \'a7 }{\b\f6\fs18 348 (also permitting food additives pursuant to certain investigational exemptions)
\par }\pard\plain \s35\li720\nowidctlpar\tx720\adjustright {\b\i\f6\fs18 ''Id. \'a7 }{\f6 321(s).
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 '}{\b\f6\fs18\super 2}{\f6\fs18 Other sanction include injunctive proceedings against the producer or criminal prosecutions.
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx720\adjustright {\f6\fs18 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 5
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 dangerous substances that occur naturally in foods. However, the FDA reg
ards any substance that is not an inherent constituent of food or whose level in food has been increased by human intervention to be "added" within the meaning of \'a7402(a) (1) }{\f6\fs16 {\field{\*\fldinst SYMBOL 183 \\f "Symbol" \\s 8}{\fldrslt
\f3\fs16}}}{\f6\fs16 13 }{\f6 Moreover, the mere presence of an unauthorized food a
dditive or a permitted additive under unauthorized conditions will cause the food to be "adulterated" within the meaning of the FD&C Act. The practical effect of finding a substance to be a food additive is to place the burden of showing safety upon the p
roponent manufacturer, whereas the FDA has the burden of proving by a preponderance of the evidence that the substance is injurious to health.'}{\f6\super 4}{\f6 
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 As far back as 1984, the FDA indicated that it would not seek additional congressional authority to develop guidelines for the regulatory oversight of bioengineered food products.'}
{\f6\super 5}{\f6  The agency confirmed this view in 1986 when it announced that it "need not establish new administrative procedures to deal with generic concerns about biotechnology."'}{\f6\super 6 }{\f6 The refinement o
f recombinant DNA techniques and other forms of genetic engineering, however, contributed to a climate of uncertainty
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 13}{\i\f6\fs18 See }{\b\f6\fs18 United States v. Anderson Seafoods, Inc., 622 F.2d 157 (5th Cir. 1980), }{\b\i\f6\fs18 afff'g }{\b\f6\fs18 
447 F. Supp. 1151, 1155 (D. Fla. 1978) (holding that mercury in fish that had been picked up from the environment could be considered "added" for purposes of \'a7 402)
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18 '}{\b\i\f6\fs18\super 4}{\i\f6\fs18 See }{\b\f6\fs18 United States v. An Article of Food, 678 F.2d 735, 739 (7th Cir. 1982)
\par }{\b\i\f6\fs18\super 15}{\i\f6\fs18 5ee }{\b\f6\fs18 Statement by Frank E. Young, Comm'r of Food and Drugs, before the Subcomm. on Oversight and Investigations of the House Comm.
\par }\pard\plain \s37\sl-221\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 on Energy and Commerce 1 (Dec. 11, 1984) ("FDA does not believe that the use of biotechnological techniques requires any additional laws or regulations.").
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\f6\fs16 1651 }{\b\f6\fs18 Fed. Reg. 23,309 (1986).
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 6
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s16\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 regarding exactly how the FD&C Act's provisions were to be applied to food produced through these techniques.'}{
\f6\super 7}{\f6  Conceptually, was genetic
 engineering to be treated as a more efficient and targeted form of classical hybrid breeding procedures, which had not be subject to any greater regulatory scrutiny, or as the creation and manipulation of organisms in which human intervention had, by def
inition, inserted new additives into the ultimate food products?
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 The }{\b\f6\fs18 FDA'S }{\f6 
articulated position regarding the regulation of biotechnology products as of 1936 did not clarify matters much. After asserting that existing statutory authority would guide the FD
A into the realm of genetically engineered food, the statement held that the "administrative review of products using biotechnology [would be] based on the intended use of each product on a case-by-case ~ Experts advised that it was important to evaluate 
w
hether new procedures resulted in changes in the chemical identity of the ingredient, the introduction into the food supply of new or altered levels of impurities, or an increase in dietary exposure of consumers to the ingredient that was not justified by
 available safety data.'}{\f6\super 9 }{\f6 If the FDA found that the food ingredient manufactured by a new method had been altered significantly, the agency would either conclude that
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\i\f6\fs18\super 17}{\i\f6\fs18 .see, e.g., }{\b\f6\fs18 Steven W. Frank, }{\b\i\f6\fs18 Food Additive Models for the Regulation of Recombinant DN
A Technology Under the Federal Food, Drug, and Cosn~etic Act, }{\b\f6\fs18 45 FOoD DRUG COSM. L.J. 169, 171 (1990)
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 '~51 Fed. Reg. 23,309,
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\f6\fs18 '}{\b\f6\fs18\super 9}{\f6\fs18 See James H. Maryanski, }{\b\i\f6\fs18 
Prospects for the Safety Evaluation of Foods in the United States of America in Connection with Biotechnology }{\b\f6\fs18 (paper presented June 9-10, 1988)
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s38\qc\nowidctlpar\tx725\adjustright {\f6 7
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s16\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
the new ingredient was also "generally regarded as safe" ("GRAS") or that it was not GRAS and was subject to the food additive provisions of \'a7 409 of the FD&C Act.}{\f6\super 20 }{\f6 
The law did not preclude an ingredient produced by recombinant DNA techniques, or other novel methods, from being affirmed as GRAS. However, to be affirmed as GRAS, the food ingredient must be shown to meet the criteria of a GRAS food ingredient, includin
g
 a wide recognition of safety based largely on published information concerning the intended use of the ingredient. Furthermore, these experts cautioned that the microbiological review has a pivotal role in assessing the potential for toxic substances to 
be present in food as a result of genetic modifications.}{\f6\super 2}{\f6 
' As per the FDA's policy, the food manufacturer should adequately identify all of the organisms and vectors used to construct the commercial production strain and characterize fully the introduced ge
netic alterations through techniques such as restriction mapping and nucleotide sequencing to establish the absence of sequences that may code for harmful or unexpected substances.}{\f6\super 22 }{\f6 
Information was also needed to assess whether the production culture produces antibiotics or toxins, and whether the production culture was pathogenic.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 These general guidelines, however, failed to resolve numerous inquiries received by FDA on issues such as whether the agency would conduct pre-market review of new genetically

\par }\pard\plain \s39\sl-215\slmult0\nowidctlpar\tqdec\tx1241\tx1388\adjustright {\f6 \tab }{\b\i\f6\fs18\super 20}{\i\f6\fs18 5ee\tab id.\line \tab }{\i\f6\fs18\super 21}{\i\f6\fs18 5ee\tab id.\line \tab }{\i\f6\fs18\super 22}{\i\f6\fs18 5ee\tab }{
\b\f6\fs18 51 Fed. Reg. 23309 (1986)
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tqdec\tx1241\tx1388\adjustright {\b\f6\fs18 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tqdec\tx1241\tx1388\adjustright {\f6 8
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s16\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
engineered foods, whether and under what conditions such foods would be challenged by FDA when introduced into interstate commerce, whether special labeling would be required for 
these new foods, and what scientific information would be necessary to satisfy FDA that such foods were safe and in compliance with the FD&C Act and other applicable statutes }{\i\f6\fs18 23
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\i\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx204\adjustright {\f6 II. Building upon the Framework: The "Flavr Savr" Tomato
\par }\pard\plain \nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s32\qc\nowidctlpar\tx204\adjustright {\f6 Case and the 1992 Policy Statement
\par }\pard\plain \nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Calgene, one of the larger companies dedicated to the agricultural uses of biotechnology,}{\f6\super 24 }{\f6 
became the first producer to request consultation with the FDA concerning a new plant variety developed by recombinant DNA techniques.}{\f6\super 2~}{\f6 
 Basically, there were two parts to Calgene's regulatory concerns with respect to its "Flavr Savr" tomato, which contained an "antisense" gene sequence that allowed the tomatoes to be picked ripe and then shipped to the consumer without rotting. In April 
o
f 1991, Calgene submitted to the FDA a request for an advisory opinion on the safety of using a common research tool, the kan(r) gene, as a "marker" to facilitate the selection of plants which have been successfully transformed with the desired trait (i.e
.,
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 23}{\i\f6\fs18 5ee }{\b\f6\fs18 57 Fed. Reg. 22,984, 22,984 (1992).
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\f6\fs18\super 24}{\f6\fs18 Robert A. Bohrer, }{\b\i\f6\fs18 Food Products Affected by Biotechnology, }{\b\f6\fs18 55 U.
\par }\pard\plain \s40\nowidctlpar\tx204\adjustright {\f6\fs16 PITT. L. REv. 653, }{\b\f6\fs18 670 (1994).
\par }\pard\plain \nowidctlpar\tx204\adjustright {\b\f6\fs18 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 25}{\i\f6\fs18 5ee }{\b\f6\fs18 57 Fed. Reg. 22,294, 22,985 (1992).
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 9
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 inhibited production of polyglacturonase, the enzyme that causes rotting) }{\f6\fs16 ~26 }{\f6 
Second, Calgene sought the FDA's advice regarding the safety of adding a non-coding, "anti-sense" genetic sequence for the gene that ordinarily produces the enzyme responsible for degrading the cell walls of ripened tomatoes.}{\f6\super 27 }{\f6 
This sequence slows the rate of expression of polyglacturonase, the plant enzyme that causes pectin to degrade, an essential step in the softening of ripe fruit.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 The FDA's response to Calgene's requests and the prevailing uncertainty was embodied in a
 Statement of Policy issued May 29, l992.~ Basically, the statement creates an analytic framework for new varieties of genetically engineered food plants that yields one of three possible outcomes: a position of "no concern"; an admonition to "consult FDA
," which could include both informal regulatory approval as well as the requirement for formal GRAS affirmation or food additive review; or a determination that the new variety is "not acceptable."}{\f6\super 29 }{\f6 
The statement then considers four major classes of genetically-induced effects and the appropriate regulatory treatment for each, which are discussed in greater detail below.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Briefly, one type of bioengineering transformation is to alter the production levels of a protein endogenous to the plant. Such "intra-generic" efforts would include, for
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 26}{\i\f6\fs18 5ee }{\b\f6\fs18 56 Fed. Reg. 20,004 (1991) (FDA requesting comment on Calgene's request)
\par }{\b\i\f6\fs18\super 27}{\i\f6\fs18 5ee }{\b\f6\fs18 57 Fed. Reg. 22,772 (1992).
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\f6\fs16 2857 }{\b\f6\fs18 Fed. Reg. 22,984 (1992).
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 29}{\i\f6\fs18 5ee }{\b\f6\fs18 57 Fed. Reg. at 22,992.
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 10
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
example, the Calgene tomato's inhibition of the production of the rotting enzyme. These cases present the clearest analogy to traditional hybridization efforts, albeit in a much more specifically targeted fashion. Thus, the FDA indicated that its degree o
f concern would depend on whether such changes have an effect on toxicants present in that species and whether the result is a significant change in the nutritional value of that food)}{\f6\super 0 }{\f6 
Where there are no increases in toxicant levels or the changes in the overall nutritional value of the food, the FDA will not require consultation or pre-market approval }{\f1\fs8 \emdash  }{\f6 a "no concern" position.}{\f6\super 3}{\f6 '
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Genetic engineering may also seek to introduce a non-native protein to the plant in order to confer desirable characteristics f
rom the transferor plant or animal on the host plant. If the protein does not have a history of safe use in food and will be found in foods produced from the plant, the FDA will consider the effect of the new protein on levels of any native toxicants that
 may exist as well as the allergenicity and toxicity of the introduced protein.}{\f6\super 32}{\f6 
 Significantly, unless the new protein appears on limited lists of known allergenic proteins or known toxic proteins, the producer of the genetically engineered new variety may
 make its own determination that the food is not one that "may be harmful to human health" and therefore is "generally
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 30}{\i\f6\fs18 5ee }{\b\f6\fs18 57 Fed. Reg. at 22,993 (Figure 1).
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\i\f6\fs18\super 31}{\i\f6\fs18 See id.
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\i\f6\fs18\super 32}{\i\f6\fs18 5ee id. }{\b\f6\fs18 at 22,999\emdash 23,000 (Figure 4).
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s38\qc\nowidctlpar\tx720\adjustright {\f6 11
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s41\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 recognized as safe."}{\f6\super 33 }{\f6 However, if the new protein without a
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s41\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 safe history of safe food usage is likely to be a
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s41\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 "macroconstituent" in the human or animal diet, the FDA will
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 require pre-market consultation and possibly approval as a
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 food additive.}{\f6\super 34}{\f6 
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 The twin questions of G
RAS status and macroconstituent treatment are not trivial to the manufacturer and will likely influence the types of innovation pursued by food manufacturers. Manufacturers favor GRAS status over the food additive petition process for several reasons. Fir
s
t, GRAS status allows the sponsor of an ingredient to decide whether the studies and tests conducted on the substance justify the conclusion that the substance is GRAS. Second, GRAS determinations are generally broader than the very narrow uses permitted 
f
or food additives, and subsequent expanded uses of GRAS substances are obtained more easily. In addition, where the sponsor of an ingredient seeks FDA affirmation of its GRAS status, the FDA review process itself is likely to be quicker and less cumbersom
e.}{\f6\super 35 }{\f6 FDA approval of direct food additives, on the other hand, generally takes between five and seven years.}{\f6\super 36}{\f6 
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par 
\par 
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\i\f6\fs18\super 33}{\i\f6\fs18 See id.; see also }{\b\f6\fs18 Bohrer, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note 24, at 662.
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 34}{\i\f6\fs18 See }{\b\f6\fs18 57 Fed. Reg. 23,000 n.17e.
\par }{\b\f6\fs18\super 35}{\f6\fs18 Bohrer, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note 24, at 658.
\par }{\b\f6\fs18\super 36}{\f6\fs18 coordinated Framework for Regulation of Biotechnology:
\par }\pard\plain \s37\sl-221\slmult0\nowidctlpar\tx204\adjustright {\f6\fs18 Establishment of the Biotechnology science Coordinating Committee, 50
\par Fed. Reg. 47,174, 47,177 (1985), }{\b\i\f6\fs18 cited in }{\b\f6\fs18 Karen Goldman Herman, Comment,
\par }\pard\plain \s27\nowidctlpar\tx204\adjustright {\b\i\f6\fs18 Issues in the Regulation of Bioengineered Food, }{\b\f6\fs18 7 }{\f6\fs16 HIGH TECH. L.J. }{\b\f6\fs18 107,
\par }\pard\plain \s29\sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 124 (1992).
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx204\adjustright {\f6 12
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
The Statement also propounds two questions regarding changes in or additions to the carbohydrates found in a plant variety. First, does the resulting carbohydrate contain any structural features not ordinarily found on f
ood carbohydrates, and, if the carbohydrate is likely to be a macroconstituent of the diet, are there any changes that are likely to affect digestibility or nutritional qualities?}{\f6\super 37}{\f6 
 Although some commentators have noted that the FDA's position will likely mean that new carbohydrates are treated more stringently than new proteins,}{\f6\super 3~ }{\f6\fs18 it }{\f6 
does appear that a genetically engineered carbohydrate similar in structure, digestibility, and nutritional value will avoid FDA pre\-market review.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
\par }\pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
Finally, new or modified fats or oils must be considered under a slightly different framework. For such lipids, the first question is whether the resulting fat or oil will be a macroconstituent of the diet.}{\f6\super 39 }{\f6 
If so, then the manufacturer must consult with the FDA, without regard to whether there are changes in digestibility or nutritional value. Second, the }{\b\f6\fs18 FDA'S }{\f6 
flowcharts articulate a policy decision that if the new or modified lipid is not unusual or toxic, then the producer can make its own determination of safety and avoid pre-market review. }{\i\f6\fs18 40
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\i\f6\fs18 
\par 
\par 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 37}{\i\f6\fs18 See }{\b\f6\fs18 57 Fed. Reg. at 23,001.
\par }\pard\plain \s43\li720\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 39}{\i\f6\fs18 See }{\b\f6\fs18 Bohrer, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note 24.
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 39}{\i\f6\fs18 See }{\b\f6\fs18 57 Fed. Reg. at 23,003 (Figure 6).
\par }\pard\plain \s43\li720\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 40}{\i\f6\fs18 5ee id.
\par }\pard\plain \nowidctlpar\tx720\adjustright {\i\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 13
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
In many cases, therefore, the choice presented to a manufacturer hinges on whether the FDA will require consultation (and potentially a time-consuming food additive petition) or whether the manufacturer will be able to make its own determination of safety
 based on its own testing, often guided by FDA protocols. One striking features of the }{\b\f6\fs18 FDA'S }{\f6 analysis is its use of a "macroconstituent" threshold (e.g., for proteins, carbohydrates, and lipids) }{\f1\fs8 . }{\f6 
The FDA will require pre-market consultation and possibly pr
e-market approval for a new protein that is likely to be a "macroconstituent" in the human diet, even where the protein is not from a donor species commonly allergenic, is not reported to be toxic, and is of the type of protein ordinarily well-digested in
 humans.}{\f6\super 4}{\f6 
' Such concern may be unwarranted; in this case, the manufacturer would appear to be well-equipped to make the determination of safety for itself. On the other hand, as the statement itself indicates, one possible class of proteins that could be co
nsumed at a substantial level comprises the enzymes used as selectable marker genes, introduced into many plants.}{\f6\super 42}{\f6 
 Because the introduction of these proteins may be susceptible to coordination problems among market participants, none of whom individually 
may introduce the marker protein in sufficient quantities to warrant concern, it may be appropriate for the FDA to protect consumer welfare by acting
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 41}{\i\f6\fs18 See id. }{\b\f6\fs18 at 23,000 n.16; Bohrer, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note 24, at 663.
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 42}{\i\f6\fs18 5ee }{\b\f6\fs18 57 Fed. Reg. at 23,000 n.16.
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 14
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s41\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
in this sphere. Ultimately, the better way for the FDA to resolve this question may be to evaluate and add appropriate gene markers to the list of substances considered to be GRAS}{\f6\super 43}{\f6  so as to eliminate uncertainty in this area.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 In May of 1
994, the FDA notified Calgene and other interested parties that it had concluded that "Flavr Savr" tomatoes have not been significantly altered when compared to varieties of tomatoes with a history of safe use.}{\f6\super 44 }{\f6 
At the same time, the FDA took action on the food additive petition}{\f6\super 45}{\f6  that Calgene had filed in July of 1993. The FDA amended the food additive regulations to provide for the safe use of }{\b\f6\fs18 APH(3 }{\f6 
minutes)II as a processing aid in the development of new varieties of tomato, oilseed rape, and cotton.}{\f6\super 46}{\f6 
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Consistent with the thrust of the FDA's 1992 policy statement, the agency did not establish any broad precedent }{\f6\fs16 in its approval of }{\f6 
the Calgene tomato. Indeed, formal rule\-making procedures and guidelines are virtually impossible to frame or implement in t
he context of genetic engineering, which offers the prospect of limitless ability to combine or manipulate an organism's DNA. Because the case-by-case consideration and adjudication of applications of bioengineering to food raises costs and increases dela
y to manufacturers and to the agency, there is a concern, however, that innovation could be slowed or inhibited. Ultimately,
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s44\li720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 43}{\i\f6\fs18 5ee }{\b\f6\fs18 21 C.F.R. \'a7 170.30(d).
\par }{\b\i\f6\fs18 ~See }{\b\f6\fs18 59 Fed. Reg. 26,647 (1994). ~~5B Fed. Reg. 38,429 (1993). }{\b\i\f6\fs18\super 46}{\i\f6\fs18 5ee }{\b\f6\fs18 59 Fed. Reg. 26,700 (1994).
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 15
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s41\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
the success or failure of the FDA's regulatory scheme and, in turn, the success or failure of the bioengineered food industries will rest on how the FDA applies the discretion with which it is vested in allocating resources to the regu
lation of genetically engineered food and how it addresses and is affected by the broader social policies that underlie public concern about genetic engineering.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s41\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 III. Arguments for and against Genetically Engineered Foods
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Beyond the specific statutor
y provisions of the FD&C Act and the interpretations announced by the FDA, it is important to emphasize FDA's substantial discretion and the informal nature of the "consultation" approach adopted by the FDA. The visibility of the FDA'S actions, which are 
w
idely reported on in the media, make the agency a lightning-rod for the interest groups' and the general public's criticisms. Thus, genetic engineering's future in food products must be viewed against the ongoing societal debate over the uses and feared a
buses of bioengineering.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
On the one hand, as recently as 1987, nearly a quarter of the American people harbor moral or religious objections to gene splicing or recombinant DNA to produce hybrid animals and plants.}{\f6\super 47 }{\f6 Some people criticize it as "playing God" with

\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 47}{\i\f6\fs18 See }{\b\f6\fs18 Food and Drug Admin., Office of Tech. Assessment, New Developments in Biotechnology: Background Paper }{\f1\fs8 \emdash  }{\b\f6\fs18 
Public Perceptions of Biotechnology 57 (1987) (24% of Americans who have heard of the techniques say creating hybrids through direct manipulation of DNA is morally wrong; 68% say it is not morally wrong).
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 16
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
living organisms. Although the objections may have become more muted as the technology has grown more established, the popular suspicion of recombinant DNA techniques obviously exerts a powerful hold on Americans' imagination even today, as demonstrated b
y the spectacular success of the 1993 movie }{\i\f6 Jurassic Park. }{\f6 
Even food experts and scientists are not immune. In response to the FDA's statement of policy, one thousand of the nation s top chefs vowed to boycott genetically engineered foods. As one chef expla
ined, "I am not willing to offer my patrons, my family or myself as a testing ground for a new generation of bioengineered foods."}{\f6\super 48}{\f6 
 The existence of such sentiments, despite the FDA's conclusions, suggests that genetic engineering may prove to be an issue that opens up a schism between the FDA and the public, which has long reposed great confidence in the agency.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 Many Americans fear that the risks are not well understood or that genetically engineered organisms, either as food or in the environment, may p
resent unforeseen long-term risks. The 1987 survey mentioned above found that 52% of the public "believes that genetically engineered products are at least somewhat likely to represent a serious danger to people or the environment."}{\f6\super 49}{\f6 

\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
\par 
\par 
\par 
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\i\f6\fs18\super 48}{\i\f6\fs18 5ee }{\b\f6\fs18 Sue Kirchhoff, }{\b\i\f6\fs18 Chefs to Boycott Genetically Engineered Food, }{\b\f6\fs18 Reuter Bus. Rep., July 28, 1992.
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 49}{\i\f6\fs18 See }{\b\f6\fs18 Food and Drug Admin., Office of Tech. Assessment, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note
\par }\pard\plain \s37\sl-221\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 47.
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx204\adjustright {\f6 17
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 The introduction of new proteins into foods or novel }{\f6\fs16 combinations of proteins in foods creates 
}{\f6 the possibility of allergic responses in susceptible individuals. In the absence of labeling requirements, a person would not be able to know that possibly allergenic substances had been introduced into the food. Although the 1992 policy st
atement did not impose a per se requirement of special labeling on genetically altered foods,}{\f6\super 50 }{\f6 the FDA has recently requested comments on whether these foods should be labeled as such.}{\f6\super 5}{\f6 
' Although consumers who demand sufficient information upon which to m
ake an informed choice might favor a label, a useful label that actually identifies the types of genetic engineering (intra-generic versus inter-generic, for example) or the sources of the DNA used would likely create an extremely complex label that few c
onsumers are likely to be able to interpret. Moreover, while public fears linger, any label that alludes to a bioengineered origin may devastate the marketability of the product.}{\f6\super 52}{\f6 
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 Finally, religious or ethical dietary proscriptions may prevent some people from accepting the new technologies. }{\b\f6\fs18 A }{\f6 
moral vegetarian would perhaps be disturbed to learn that an apparent grain product had been genetically altered with
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 50}{\i\f6\fs18 Cf. }{\b\f6\fs18 57 Fed. Reg. at 22,992 (noting that consultation with FDA may result in special labeling required)
\par }{\f6\fs16 5I~g }{\b\f6\fs18 Fed. Reg. 25,837 (1993).
\par }\pard\plain \s46\li720\nowidctlpar\tx720\adjustright {\i\f6\fs18\super 52}{\i\f6\fs18 Cf. Citing Survey, Monsanto Says Any BST Label Will be
\par }\pard\plain \s47\sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\i\f6\fs18 Misleading, }{\f6\fs16 Fooo LABELING NEWS, }{\b\f6\fs18 Apr. 4, 1994 (survey comparing public response to variety of labels found that regardless
 of the apparent innocuousness of the label, 87-97% thought milk from cows not treated with a genetically engineered drug was safer, tastier, or more nutritious than milk from treated cows)
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx204\adjustright {\f6 18
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 animal DNA, for instance. Although the num
ber of DNA nucleotides affected by genetic engineering is infinitesimal compared to the total }{\b\f6\fs18 DNA }{\f6 
in an organism, the dietary dictates of Orthodox Judaism or the moral imperatives of veganism may be difficult to reconcile with these new procedures.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 On the
 other hand, there is no scientific evidence that rDNA alters the toxicity, safety, or allergenicity of foods. Proponents of the new technology identify the many individuals' concerns as stemming from their qualitative assessment of the risks involved as 
new, complex, uncontrollable, and involuntary (to the extent that bioengineered products are not specially labeled) }{\f1\fs8 .~ }{\f6 
The development of plant varieties capable of resisting disease and inhibiting rotting leads to less wasted food, easier transportation, a
nd a commensurate savings of resources. Biotechnology may be employed to enhance crop yields and nutritional contents of foods, which may offer the only way to feed a rapidly expanding world population and to cope with periodic droughts that afflict certa
in regions of the world.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
\par }\pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
Although the controversy over genetic engineering may be simplistically characterized as a debate over the magnitude of the risks and uncertainties involved, the public acceptance and commercial success of bioengineering food produ
cts depends on how the FDA and the food industries are able to address the public's concerns. The next section
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 53}{\i\f6\fs18 See }{\b\f6\fs18 Bohrer, }{\i\f6\fs18 supra }{\b\f6\fs18 note 24.
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 19
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s48\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
examines whether and how the FDA should use its institutional prestige and goodwill with the public to facilitate the marketability of bioengineered foods.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s49\fi-641\li1588\nowidctlpar\tx946\tx1587\adjustright {\f6 IV.\tab Implications for the Development of a Market
\par }\pard\plain \nowidctlpar\tx946\tx1587\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s42\fi715\sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 Many commentators have explored the applicati
on of traditional FDA regulatory structures in the biotechnology arena as well as critiqued the adequacy of this regime to control the emerging new technology. Another approach, however, is to consider the implications of the existing regulatory framework
 
for the introduction to market of new food products obtained through genetic engineering techniques. This section examines the signals and incentives that the FDA's regulatory positions may be establishing for actual and potential market participants, as 
t
hey consider to what kinds of innovative food products they should dedicate their scarce financial and scientific resources. I argue that the current regulatory regime may be inhibiting the introduction of certain types of products that would be likely to
 find a receptive public market. Moreover, the FDA's unwillingness to aggressively counter many of the public's irrational fears of genetic engineering may reduce the incentives of biotechnology food manufacturers to invest
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx714\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 54}{\i\f6\fs18 See, e.g., }{\b\f6\fs18 Bohrer, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note 24; Daniel D. Jones, }{\b\i\f6\fs18 Food Safety
\par }\pard\plain \s50\fi-5760\li5760\nowidctlpar\tx5760\adjustright {\b\i\f6\fs18 Aspects of Gene Transfer in Plants and Animals:\tab Pigs, Potatoes, and
\par }\pard\plain \s29\sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\i\f6\fs18 Pharmaceuticals, }{\b\f6\fs18 43 FooD }{\f6\fs16 DRUG COSM. }{\b\f6\fs18 L.J. 351 (1988); Herman, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note
\par }\pard\plain \s47\sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 36.
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx204\adjustright {\f6 20
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s48\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 in bioengineer foods because of the limited economic return achievable.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s51\fi726\sl-470\slmult0\nowidctlpar\tx725\adjustright {\f6 
The FDA's policy statements regarding how the agency intends to regulate bioengineered food products implicitly favor certain types of relatively conservative "tinkering" at the expen
se of arguably more radical, but not necessarily more dangerous, engineering of food products. In addition to the possibility that the FDA will find itself in a continual struggle to keep pace with the accelerating rate of scientific and technological bre
a
kthroughs, the FDA has outlined its position with respect to four major categories of possible effects of genetic engineering that appear to make it more difficult, expensive and time-consuming for a biotechnology firm to bring a certain types of innovati
ve food product to market, despite several arguments that would support allowing such products to be sold.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx725\adjustright {\f6 
\par }\pard\plain \s51\fi726\sl-470\slmult0\nowidctlpar\tx725\adjustright {\f6 For example, the obligation to consult the FDA with respect to possible allergenics introduced into a product creates the possibility that many firms
 will decide that the extra developmental costs and risks are not worth the risk. Essentially, the pre-market notification and review process may have an }{\i\f6 in terrorarn, }{\f6 
chilling effect on the introduction of certain products. For example, although producers
 may unquestionably sell properly-labeled peanuts and peanut-based products on the market, the 1992 Statement does not explicitly adopt a comparative risk analysis that would look to making the product available, perhaps with a simple
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx725\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s52\qc\nowidctlpar\tx725\adjustright {\f6 21
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s53\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
warning directed to individuals allergic to peanuts, despite its allergenicity to certain consumers in the market.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s54\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Consumers are likely to respond to genetically engineered foods in a manner different from, say, bioengineered drugs. Altho
ugh the demand for food generally is probably rather inelastic (after all, one must consume calories and nutrients, and the purchase of food has a high priority in an individual's budget), the demand for any particular variety of food product is relativel
y
 elastic. The elasticity of genetically engineered foods is particularly high, given the fact that, at least for the near future, bioengineered foods will have very close substitutes in the eyes of most consumers. For example, the "Flavr Savr" tomato comp
e
tes in the market with several ordinary varieties of tomatoes. Contrast the situation with bioengineered drugs, in which a new product's greater efficacy and reduced side effects in treating a particular disease or condition may make the drug unequaled an
d consumers' demand for it far less elastic. Thus, the FDA should be wary of imposing great costs, in the form of regulatory compliance expenses and delay, on manufacturers who seek to introduce genetically engineered food.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s54\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
On the other hand, because the scientific research and technical know-how involved in genetically altering a food source entail substantial costs, the manufacturer needs to be able to recoup his expenses by being able to charge a higher price for the bene
fits of the new product. Calgene's
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s55\qc\nowidctlpar\tx720\adjustright {\b\f6\fs18 22
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
products, for example, provided improved taste because the tomatoes were vine-ripened, rather than artificially ripened by exposure to ethylene gas; they also reduced wholesalers' and retailers' losses due to soft tomatoes damaged during shipment.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s31\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
Given the FDA's unrivaled visibility among government agencies and its unique role in safeguarding the food supply, the FDA can facilitate the development of the bioengineered food industries by continuing
 to assure the public of the safety of these foods. When the Calgene tomato received regulatory approval, approximately five years after it was first created, FDA Commissioner pronounced the vegetable "as safe as any tomato on the market."}{\f6\super 56 }
{\f6 Even as the "Flavr Savr" tomato finally begins to enjoy modest regional sales today, however, Calgene still finds that "[m]anaging consumer ignorance becomes more important than providing a quality innovation."}{\f6\super 57 }{\f6 
In the short term, industry may welcome the FDA's case-by
-case analysis of the first bioengineered foods and the attendant public generated by the process, because FDA approval will help to assuage the public's concerns about safety and boost public confidence in these products. On the other hand, in the longer
 term, industry representatives
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par 
\par }\pard\plain \s56\li720\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 55}{\i\f6\fs18 5ee }{\b\f6\fs18 Bohrer, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note 24, at 671 (noting difference in taste).
\par }\pard\plain \s37\sl-221\slmult0\nowidctlpar\tx204\adjustright {\f6 Of }{\b\f6\fs18 course, }{\f6 the reduction in }{\b\f6\fs18 loss damage would tend to reduce the prices; however, for many other types of genetic engineering that do not affect transporta
tion or disease characteristics, such as true flavor or nutritional hybrids, this effect is negligible.
\par }\pard\plain \s46\li720\nowidctlpar\tx720\adjustright {\i\f6\fs18\super 56}{\i\f6\fs18 Long March of the Tomato, }{\f6\fs16 WASH. PosT, }{\b\f6\fs18 May 21, 1994, at A22.
\par }\pard\plain \s56\li720\nowidctlpar\tx720\adjustright {\b\f6\fs18\super 57}{\f6\fs18 schrage, }{\i\f6\fs18 supra }{\b\f6\fs18 note 4, at D2.
\par }\pard\plain \nowidctlpar\tx720\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s32\qc\nowidctlpar\tx720\adjustright {\f6 23
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s53\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 argue that bioengineered foods should require no more screening than traditionally produced foods.}{\f6\super 58
}{\f6 
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par }\pard\plain \s54\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 The issue of labeling genetically engineered foods as such puts market participants in a difficult dilemma. On the one hand, voluntary labeling of genetic
ally engineered products may justify price differentials over traditional foods. Furthermore, over the long term, it can help to eliminate public concern about these products by highlighting the genetically altered products' nutritional, aesthetic and gus
t
atory equality or superiority to their traditionally produced forerunners. However, the possibility of an unreasoned consumer rejection of genetically engineered foods might prevent any one firm from making the first move. Thus, the question becomes wheth
e
r the FDA should cut through this coordination problem by imposing a labeling requirement on all producers. If the FDA simultaneously uses its public goodwill to disseminate its scientific basis for the safety of bioengineered foods, it may be able to ach
ieve public acceptance of such foods and competitive equality (in fact, competition on nutritional and other merits of the products, rather than on scare tactics) in the marketplace.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par }\pard\plain \s54\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 As the FDA develops regulatory expertise in the particular applications and techniques of biotechnology, the costs of bringing a genetically engineered product to market
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s36\fi720\sl-221\slmult0\nowidctlpar\tx720\adjustright {\b\i\fs18\super 5~}{\i\fs18 See }{\b\f6\fs18 International Food Biotechnology Council, }{\b\i\f6\fs18 Biotechnologies
\par }\pard\plain \s57\sl-221\slmult0\nowidctlpar\tx204\adjustright {\b\i\fs18 and Food: Assuring the Safety of Foods Produced by Genetic Modification, }{\b\f6\fs18 12 }{\fs16 REG. TOXICOLOGY & PHARMACOLOGY }{\b\f6\fs18 xvi, }{\b\i\fs18 cited in }{\b\fs18 
Herman, }{\b\i\f6\fs18 supra }{\b\fs18 note 36, at 126.
\par }\pard\plain \sl-221\slmult0\nowidctlpar\tx204\adjustright {\b\fs18 
\par 
\par 
\par }\pard\plain \s58\qc\nowidctlpar\tx204\adjustright {\f6 24
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s34\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
will likely be reduced. Currently, food manufacturers are likely to hire and train the top researchers and scientists in genetic engineering. As the technology becomes more established and knowledge filters into the agency as }{\b\f6\fs18 it }{\f6 
obtains personnel and experience in these specialized fields, the FDA will perhaps be able to develop more specific protocols and regulations to announce acceptable substances and procedures, for exa
mple, a better idea of the dietary effects, if any, of various genetic markers that may be used throughout the industry. Already, food manufacturers are able to proceed through the FDA notification and consultation phase more quickly because the FDA has p
reviously dealt with analogous substances or vectors)}{\f6\super 9 }{\f6 
In turn, manufacturers could likely reduce the time and resources spent in consultation with the FDA. One could argue, however, that risk and safety assessment is actually an expertise distinct }{\f6\fs16 from }{\f6 and
 better understood than that required for recombinant DNA. The FDA might well be equipped to analyze toxicity and allergenicity data from a substance without necessarily understanding the bioengineering origins of the product. Essentially, this issue stri
kes at the heart of FDA's determination to regulate genetic engineering via its }{\i\f6 products }{\f6 rather than its }{\i\f6 procedures. }{\f6 
However, just as the FDA has adopted what is effectively a process-oriented approach to traditional hybrids (i.e., foods derived from
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s43\li720\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 59}{\i\f6\fs18 See FDA Complete Consultations on Seven New Biotech Products,
\par }\pard\plain \s59\nowidctlpar\tx204\adjustright {\fs16 FOOD cHEMICAL NEWS, }{\b\f6\fs18 Nov. 21, 1994.
\par }\pard\plain \nowidctlpar\tx204\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s60\qc\nowidctlpar\tx204\adjustright {\f6 25
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s53\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
cross-breeding require no special oversight), a partial shift to this type of approach in the rDNA field would likely reduce the barriers to entry and expand the market for genetically engineered foods. Also, an improved understanding of the specific tech
n
iques at work can also allow the FDA to conclude more quickly that certain procedures achieve results (in terms of protein expression) substantially equivalent to approved products and therefore new products can be approved more quickly with no additional
 safety risk)}{\f6\super 0 }{\f6 Thus, accumulated regulatory expertise in this area would also stimulate greater competition for the benefit of consumers.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par }\pard\plain \s54\fi720\sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 Fortunately, to date FDA regulation of genetic engineering has not been driven by the exigencies of addressing a hum
an tragedy due to unsafe or contaminated food. While the agency's 1992 policy statement thoroughly examines a wide variety of scientific knowledge regarding food safety, it has failed to satisfy many consumer advocates, environmentalists, and others in th
e public whose concerns often stem from a lay qualitative perception of the risks of genetic engineering.bI Thus, some have predicted
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx720\adjustright {\f6 
\par 
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\i\f6\fs18\super 30}{\i\f6\fs18 5ee id. }{\b\f6\fs18 (three manufacturers are effectively duplicating the "Flavr5avr" tomato through other genetic mechanisms with t
he same phenotypic expression).
\par }\pard\plain \s21\fi726\sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\i\f6\fs18\super 61}{\i\f6\fs18 5ee, e.g., FDA Scientific Advisers Ponder Regulation of Bioengineered Food, }{\fs16 FOOD CHEMICAL NEWS, }{\b\f6\fs18 
Nov. 14, 1994 (giving examples of consumer advocate and other interest groups criticizing the current FDA position) }{\f1\fs8 . }{\b\f6\fs18 Of course, some scientists also have been outspoken skeptics of the safety of genetic engineering. }{\b\i\f6\fs18 
See }{\b\f6\fs18 note 59 (molecular biologist calling for 50-year moratorium on release of genetically engineered
\par }\pard\plain \sl-215\slmult0\nowidctlpar\tx725\adjustright {\b\f6\fs18 
\par 
\par 
\par }\pard\plain \s58\qc\nowidctlpar\tx725\adjustright {\f6 26
\par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s61\sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 that mounting public pressure on Congress and the FDA may result in additional regulatory oversight.}{\f6\super 
62 }{\f6 Given the inevitable consumer demands for additional sources of novel, nutritious and improved foods, it also seems wise for the FDA to contemplate the implications of its decisions and regulations on the development of the food markets,}{
\f6\super 63 }{\f6 even as it continues its traditional role of safeguarding our food supply.
\par }\pard\plain \sl-470\slmult0\nowidctlpar\tx204\adjustright {\f6 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par }\pard\plain \s29\sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 organisms and returning grant money, because such research is
\par }\pard\plain \s62\nowidctlpar\tx204\adjustright {\b\f1\fs12 a.
\par }\pard\plain \s29\sl-215\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs18 irresponsible" without knowledge of long-term consequences)
\par }\pard\plain \s56\li720\nowidctlpar\tx720\adjustright {\b\i\f6\fs18 ~}{\b\i\f6\fs18\super 2}{\i\f6\fs18 See }{\b\f6\fs18 Bohrer, }{\b\i\f6\fs18 supra }{\b\f6\fs18 note 24, at 666.
\par }\pard\plain \s23\fi720\sl-215\slmult0\nowidctlpar\tx720\adjustright {\b\f6\fs18 b}{\b\f6\fs18\super 3}{\f6\fs18 
The food industry may be greatly affected by apparently small changes in food composition. One commentator has predicted that tomato processors can anticipate savings of $100 million for every one percent increase in the solids content of tomatoes. }{
\b\i\f6\fs18 See }{\b\f6\fs18 Kunimoto, }{\b\i\f6\fs18 Commercial }{\i\f6\fs18 Opportunities in Plant Biotechnology for the Food Industry, }{\b\fs18 Food Tech., }{\b\f6\fs18 Oct. 1986, at 60, }{\b\i\f6\fs18 cited in }{\b\f6\fs18 Frank, }{\b\i\f6\fs18 
supra }{\b\f6\fs18 note 17, at 179.
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