Untitled Document

t .. ' ' 

'The Founda'tion on Economic Trends 

1130 17th St., NW, Suite 630, Washington, DC 20036- (202) 466-2823- Fax (202) 429-9602 

3 November 1993 

Dockets Management Branch 

Food and Drug Administration 

Department of Health and Human Services 

Room 1-23 

12420 Parklawn Drive 

Rockville, Maryland 20857 

To Commissioner Dr. David Kessler: 

Pursuant to 21 C.F.R. Part 10.30, this is a petition submitted 

on behalf of the Foundation on Economic Trends and its president, 

Jeremy Rifkin, requesting that the Food and Drug Administration 

(FDA) postpone all rulings and the issuance of any regulations 

pursuant to Calgene's Food Addinive Petition for Aminoglycoside 3'-

Phosophotransferase II (APH(3')II) in tomatoes, cotton and rapeseed 

pending the completion of the FDA's Statement · of Policy: Foods 

Derived From New Plant Varieties (Docket 92N-0139) . 

STATEMENT OF FACTS 

Calgene is an agribusinelss biotechnology company that is 

developing improved plant varieties and plant products for the 

seed, food and specialty chemical industries. Since its 1991 

request for an FDA Advisory Opi~ion on the status of its FLAVR SAVR 

(TM) tomato, Calgene has sough~ FDA regulatory approval allowing 

for the introduction of genetically altered foods into the 

marketplace. 1 

On January 4, 1993 CalgenJ converted an original Request for 

an Advisory Opinion on the Safety and Use in the Production of 

Genetically Engineered Plants u~ing the kanr Gene (Docket 90A-0416) 

to a Food Additive Petition (FAP) for Aminoglycoside 3'-

Phosphotransferase II (APH(3')II) in Tomatoes, Cotton and Oilseed 

Rape. 2 The FAP seeks FDA appro al for use of APH(3')II, a protein 

1 The FDA is currently reviewing Calgene's August 1991 request for an Advisory Opinion considering the status of the FIA VR 

SAVR (fM) tomato as a food. I 

2 Letter from Donald L. Emlay, Director, Regulatory Affair , Calgene, to Dr. Alan M. Rulis, Director, Office of Premarket 

Approval, Food and Drug Administration, January 4, 1993. 

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used for the purpose of selection during the genetic 

engineering. 

On May 29, 1992, almost eibht months prior to Calgene's FAP, 

the FDA issued its preliminary! proposed Statement of Policy for 

Foods Derived From New Plant Varieties on May 1992 (Statement of 

Policy) (Docket No. 92N-0139) . I The proposed Statement of Policy 

attempts to establish the regulF-tory status of foods derived from 

new plant varieties, including lants developed by newer methods of 

genetic modification. 3 

Upon the initial publication of the proposed Statement of 

Policy, the FDA sought public comments from May 29, 1992 until 

August 27, 1992. 4 On April 28, 1993, the FDA sought additional 

comments on the proposed Statement of Policy. 5 This comment period 

remained open until July 27, 19$ 3. 6 To date, the FDA continues to 

review all comments received during the two notice and comment 

periods and has not yet issued a final Statement of Policy. 

I 

STATEM~NT OF LAW 

I. 21 U.S.C. Section 348. Foo additives -Unsafe food additives; 

exception for conformity with e ' emption or regulation states: 

(c) (1} The Secretary shall -

(a) by order establish a regulation (whether or not 

in accord with that p f oposed by the petitioner) 

prescribing, with respect tio one or more proposed uses of 

the food additive involvej, the conditions under which 

such additives may be saf~ly used (including, but not 

limited to, specifications as to particular food or 

classes of food in or whieh such additive may be used, 

the maximum quantity whic~ may be used or permitted to 

remain in or on such foo~, the manner in which such 

additive may added to or ~sed in or such food, and any 

directions or other labeling or packaging requirements 

for such additive deemed necessary by him to assure the 

safety of such use), and s~all notify the petitioner of 

such order and the reasons for such action. (emphasis 

added) . 

3 57 Fed. Reg. 22984 (Friday, May 29, 1992). 

4 57 Fed. Reg. 23005 (May 29, 1992). 

5 58 Fed. Reg. 25837 (Apri128, 1993). 

6 58 Fed. Reg, 25837, 25841 (April 28, 1993). 

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II. 21 C.F.R. Section 171.100 r egulation based on petition. 

(a) The Commissioner will orward for publication in the 

Federal Register, within 0 days after filing of the 

petition (or within 180 da~s if the time is extended as 

provided for in section ! 409(c) (2) of the Act), a 

regulation prescribing thy conditions under which the 

food additive may be saf ly used (including, but not 

limited to, specifications as to the particular food or 

classes of food in or on wh'ch such additive may be used, 

the maximum quantity that may be used or permitted to 

remain in or on such footl, the manner in which such 

additive may be added to ~ used in or on such food, and 

any directions or othbr labeling or packaging 

re uirements for such addi ive deemed necessar b him to 

assure safety of such use), and prior to the forwarding 

of the order to the Fede al Register for publication 

shall notify the petitione:q of such order and the reasons 

for such action; or by orde~ deny the petition, and shall 

notify the petitioner of uch order and of the reasons 

for such action. I 

III: Administrative Procedure Acl t, 5 U.S.C. Section 706, Scope 

Rev1ew. 

To the extent necessary to decision and when presented, 

the reviewing court shall ecide all relevant questions 

of law, interpret co~stitutional and statutory 

provisions, and determine t he meaning and applicability 

of the terms of an agency action. The reviewing court 

shall --

(2) hold unlawful and set aside agency action, 

findings and conclus1ons found to be -- (A) 

arbitrary, capricious an abuse of discretion, 

or otherwise not in cordance with law. 

of 

A. Action Requested 

Petitions request the FDAI to postpone the issuance of any 

regulations or any and all rulings concerning the FAP for Calgene's 

Aminoglycoside 3'-Phosphotrans erase II (APH(3')II) in Tomatoes, 

Cotton and Oilseed Rape unti ~ final issuance of the agency's 

Statement of Policy: Foods Deriwed From New Plant Varieties. 

B. Statement of Grounds 

I 

The FDA's proposed Statement of Policy was developed to 

address a wide range of questionf pertaining to the introduction of 

genetically altered foods into f he marketplace. Among the issues 

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to be addressed in the Statemen~ of Policy are: whether the agency 

will conduct premarket review .I of these new foods, whether such 

foods introduced into intersta e commerce would be challenged by 

FDA on legal grounds, which new plant varieties might come under 

the jurisdiction of FDA, wha~ scientific information may be 

necessary to satisfy FDA that ch foods are safe and comply with 

law, whether petitions would be f equired by the agency, and whether 

special labeling would be requi~ed. 7 

In addition, in April of ~ is year the FDA sought additional 

comments on its Statement of Pol cy. Among the issues addressed in 

this notice for comment were: ~hether all foods derived from new 

plant varieties developed usingl genetic engineering techniques be 

required to be labeled, should labeling the source of introduced 

DNA be required, under what circumstances is ingredient labeling 

appropriate, how can require~ labeling for food allergy be 

accomplished, what are the prb.ctical difficulties and economic 

impact of labeling genetically ngineered foods, and consideration 

of voluntary labeling. 8 

Currently, the FDA is consibering the comments received during 

these two notice and comment pe iods and will be developing a final 

Statement of Policy which wi l regulate the introduction of 

genetically engineered foods in o the marketplace. 

On January 4, 1993 Calgene submitted a food additive petition 

(FAP) seeks a ruling on APH 3')II, a processing aid in the 

production of transgenic plan s such as tomatoes, cotton and 

rapeseed. The proposed food additive has been used to develop such 

Calgene products as the FLAVR R (TM) , a tomato that contains the 

genetically engineered kanamyci ' resistance gene and a mirror image 

of a tomato gene inhibiting rot. 

The process of genetic alte

1

ration used in products such as the 

FLAVR SAVR (TM) does not always result in predictable 

modifications. The interaction~ between the host organism and the 

synthetic genetic material can e dynamic and complex, and it will 

not always be possible to p t edict the toxic or nutritional 

consequences of the insertion or a particular gene. 

There has already been one case of a genetically engineered 

foodstuff that has produced adly results. The amino acid Ltryptophan, manufactured using g1

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enetically engineered bacteria, has 

been linked with the deaths of least 31 Americans and with more 

7 57 Fed. Reg. 22984 (May 29, 1992). 

8 58 Fed. Reg. 25837 (April 28, 1993). 

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than 1500 serious illnesses. 9 illions of Americans had consumed 

L-tryptophan as a dietary suppl ement for over 30 years, but only 

with the advent of genetic englineering has the ingestion of the 

product had fatal results. To d b.te, the source of the L-tryptophan 

contaminant that caused the d kaths and illnesses has not been 

determined. The FDA has not be n able to rule out the possibility 

that is was the genetic enginee ing process itself that caused the 

deadly contamination of L-tryptdphan. In a recent radio interview, 

the FDA Commissioner admitted t Bat the FDA had not yet been able to 

determine the exact cause of th1e contamination of L-tryptophan. 10 

The Calgene APH(3'}II FAP Leeks an agency ruling on proposed 

additive that will be utilized ~ genetically engineered foods such 

as the FLAVR SAVR tomato. llJnder the FFDCA, the Secretary's 

consideration of this FAP will ddress a number of issues such as 

safety and labeling and usage idelines, that have yet to be fully 

addressed by the agency's S~atement of Policy on New Plant 

Varieties. I 

Under Section 409 of the deral Food, Drug and Cosmetic Act 

(FFDCA} the Secretary of FDA has the statutory discretion to 

promulgate regulations pursuant to "food additive" applications. 11 

Among the issues that may oe contained in the Secretary's 

regulatory response to a FAP arJ the conditions under which such an 

additive may be safely used i f cluding, inter alia, the maximum 

quantity of the additive in que tion, the manner in which such an 

additive may be used, and other packaging or labeling 

requirements. 12 The resolution of these issues are the goal of the 

FDA's attempt to develop a f egulatory policy for addressing 

genetically engineered foods and related proposed additives such as 

APH(3')II. 

Should FDA rule upon the 1 PH(3')II FAP it would be making a 

policy determination on geneticl b lly engineered foods prior to the 

issuance of its final statement of policy. Given the FDA's mandate 

to protect the health and saf¢ty of the American consumer from 

incidents such as the L-trytoph n case, it is imperative that the 

agency establish a comprehensive l regulatory framework to protect 

the public from the risks of food substances that have had no 

history of human consumption. or the FDA to rule on Calgene's FAP 

prior to the finalizing of the Statement of Policy would not only 

contradict FDA's mandate, it I would be an abandonment of the 

9 ~ Raphals, P., "Does Medical Mystery Threaten Bio ch?," ~ 619 (2 Nov. 1990); "FDA's Regulation of the Dietary 

Supplement L-trytophan," 1991: Hearing Before the Human Re ources and Intergovernmental Relations Subcomm., 102d Cong., 1st 

Sess. 54 (statement of Esther Sternberg, M.D., National Institu of Mental Health). 

10 Remarks of Dr. Kessler, Diane Rehm Show, WAMU Radio 88.5 FM (6 May 1992). 

11 21 U.S.CA 348 (1988 & supp. 1992). 

12 21 U.S.CA Section 348(c)(l)(A) (1988 & Supp. 1992). 

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agency's year long mission to tablish a new regulatory policy on 

genetically engineered foods. $uch an action can only be describe 

as arbitrary, capricious, an abilise of discretion, or otherwise not 

in accordance with law. 

C. EnviroJlental rmpact 

The enforcement actions J ere requested will not cause the 

release of any substance i r to the environment. They are 

categorically excluded from the requirement of environmental 

documentation under 21 C.F.R. 25.24 (a) (c) (d). 

D. ceri ification 

We are requesting a response to this petition within (20) 

calendar days. A denial of t * e requests in this petition will 

compel the Foundation to consider litigation in order to achieve 

the full and complete action re~ired to address this arbitrary and 

capricious violation of federj l law that threatens the public 

health and safety. 

The undersigned certify, that, to the best knowledge and 

belief of the undersigned, this petition includes all information 

and views on which the petit on relies, and that it includes 

representative data known to the petitioner which are unfavorable 

to petition. 

Jerem Presid 

Foundation 

~ on Economic Trends 

1130 17th Street, N.W. #630 

Washington, D.C. 20036 

202-466-2823 

lson, III 

ey 

Foundation on Economic Trends 

1130 17th Street, N.W. #630 

Washington, D.C. 20036 

202-466-2823 

6 

Andrew Kimbrell 

Policy Director 

Foundation on Economic Trends 

1130 17th Street, N.W. #630 

Washington, D.C. 20036 

202-466-2823 
... 

The Foundation on Economic Trends 

1130 Seventeenth Street, N.W., Suite #630 

Washington, DC 20036 - (202) 466- 2823 

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