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Citizen Petition Seeking Labeling of Nitrate-Preserved Hot Dogs for Childhood Cancer Risks

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Citizen Petition Seeking Labeling of Nitrate-Preserved Hot Dogs for Childhood

Cancer Risks JoAnn Guest Aug 05, 2005 12:40 PDT

http://www.preventcancer.com/press/petitions/april25_95.htm

 

 

David A. Kessler, M.D.

Commissioner, Food and Drug Administration, Room 1-23

12420 Parklawn Drive

Rockville, MD 20857

 

The undersigned submits on behalf of the Cancer Prevention Coalition,

Inc. (CPC), Samuel S. Epstein, M.D., Chair, and on behalf of the Center

for constitutional Rights, Michael Deutsch, Esq., Legal Director. This

citizen petition is based on accumulating scientific information on

excess risks of childhood brain tumors and leukemia from the consumption

of hot dogs containing nitrite preservatives.

 

The undersigned submits this petition under 21 U.S.C. 321 (n), 361, 362,

and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal

Food, Drug, and Cosmetic Act to request the Commissioner of the Food and

Drug Administration (FDA) to label hot dogs that contain nitrites with a

cancer risk warning.

 

A. Agency Action Requested

 

This petition requests that FDA take the following action:

 

Immediately require nitrite-containing hot dogs to be labelled with

warnings such as hot dogs containing nitrites have been shown to pose

risks of childhood cancer. Pursuant to 21 CFR 10.30 (h) (2), a hearing

at which time we can present our scientific evidence.

 

B. STATEMENT OF GROUNDS

 

Nitrites are widely used as preservatives in hot dogs, besides other

meat products. Nitrites combine with amines naturally present in meat to

form carcinogenic N-nitroso compounds. 1,2,3,4 N-nitrosodimethylamine

has been identified in nitrite-preserved meat products. (5,6) There is

overwhelming evidence on the carcinogenicity of N-nitrosodimmethylamine

in animal experiments.(7) Furthermore, epidemiologic evidence has

associated N-nitroso carcinogens with cancer of the oral cavity, urinary

bladder, esophagus, stomach and brain. (8,9,10)

 

There is substantial evidence on the risks of childhood cancer from the

consumption of meats containing nitrites. (11,12,13) In 1982,

Preston-Martin, et al. found that consumption during pregnancy of meats

cured with sodium nitrite has been associated with development of brain

tumors in the offspring. (14)

 

Recent case-control studies have confirmed the risks of cancer from

consumption of hot dogs. Eating many hot dogs by children, as well

maternal hot dog consumption during pregnancy, has been shown to be

associated with brain cancer and leukemia in children. (15,16,17)

 

Bunin, et al. studied children who were diagnosed with brain cancer

before age six, between 1986 and 1989. Of 53 foods and beverages and

three alcoholic beverages consumed by mothers during pregnancy, only hot

dogs were associated with an excess risk of childhood brain tumor. (1

 

Sarusua and Savitz studied 234 childhood cancer cases in Denver and

found a strong association between the consumption of hot dogs and brain

cancer. Children born to mothers who consumed hot dogs one or more times

per week during pregnancy had approximately double the risk of

developing brain tumors. Children who ate hot dogs one or more times per

week were also at higher risk of brain cancer. In addition, children who

ate hot dogs and took no vitamins, which retard the formation of

N-nitroso carcinogens, were more strongly associated with both acute

lymphocytic leukemia (ALL) and brain cancer. (19) Sarusua and Savitz

concluded:

 

" The results linking hot dogs and brain tumors (replicating an earlier

study) and the apparent synergism between no vitamins and meat

consumption suggest a possible adverse effect of dietary nitrites and

nitrosamines.(20)

 

Peters, et al. studied the relationship between the intake of certain

foods and the risk of leukemia in children from birth to age 10 in Los

Angeles County between 1980 and 1987. The researchers found that

children who ate 12 or more hot dogs per month had approximately nine

times the normal risk for developing childhood leukemia. A strong risk

for childhood leukemia also existed for those children whose fathers'

intake of hot dogs was 12 or more per month. (21) Peters, et al.

concluded:

 

" Our results provide evidence for an association between consumption of

hot dogs and risk of childhood leukemia. Adjustments for all factors

thought to be potential confounders did not affect these associations.

Independent risks were associated with both children's and fathers'

consumption...The findings, if correct, suggest that reduced consumption

of hot dogs could reduce leukemia risks, especially in those consuming

the most. (22)

 

These findings are of particular significance considering a 38 percent

increase in the incidence of brain and nervous system cancers in

children from 1973-1991. (23) Brain tumors account for about one in five

childhood cancers. (24)

 

C. CLAIM FOR CATEGORICAL EXCLUSION

 

A claim for categorical exclusion is asserted pursuant to 21 CFR 25.24

(a) (11).

 

D. CERTIFICATION

 

The undersigned certifies, that, to the best knowledge and belief of the

undersigned, this petition includes all information and views on which

the petition relies, and that it includes representative data and

information known to the petitioner which are unfavorable to the

petition.

 

This petition is submitted by:

 

Samuel S. Epstein, M.D.

Michael Deutsch, Esq. Legal Director, Center for Constitutional Rights,

N.Y.

 

REFERENCES

 

 

Lijinsky, W., Epstein, S., " Nitrosamines as environmental

carcinogens, " Nature " 225(5227):21-12, 1970.

Anonymous. " Nitrates and nitrites in food, " Medical Letter on Drugs &

Therapeutics. 16(1:75-6, 1974

Issenberg, P. " Nitrite, nitrosamines, and cancer, " Federation

Proceedings, 35(6):1322-1326, 1976.

IARC, " Monograph on the evaluation of the carcinogenic risk of chemicals

to humans: some N-nitroso compounds, " 17:36-38, 136-144, 1978.

Ibid.

Issenberg, P., " Nitrite, nitrosamines, and cancer, " Federation

Proceedings 35 (6):1322-1326, 1976.

IARC, " Monograph on the evaluation of the carcinogenic risk of chemicals

to humans: some N-nitroso compounds. "

Fraser, P. " Nitrate and human cancer: A review of the evidence. " Int. J.

Epidemiol, 9:3-11, 1980.

Reed, P. I. " The role of nitrosamines in cancer formation. " Biblthca.

Ntur. Dieta. 37:130-8, 1986.

Craddock, V.M. " Nitrosamines, food and cancer: assessment in Lyon, " Fd.

Chem. Toxic., 28(1):63-65, 1990.

Preston-Martin, S. et al. " N-nitroso compounds and childhood brain

tumors: A case-control study. " Cancer Res. 1982; 42:5240-5.

Bunin, G.R., et al. " Relation between maternal diet and subsequent

primitive neuroectodermal brain tumors in young children. " N. Eng. J.

Med., 3 29-536-41, 1993.

Bunin, G.R., et al. " Maternal diet and risk of astrocytic glioma in

children: a report form the children's cancer group (United States and

Canada), " Cancer Causes & Control. 5:177-87, 1994.

Preston-Martin, S., et al. " N-nitroso compounds and childhood brain

tumors: A case- control study. "

Bunin, G.R., et al. " Maternal diet and risk of astrocytic glioma in

children. "

16. Sarasua, S., Savitz, D. " Cured and broiled meat consumption in

relation to childhood cancer: Denver, Colorado (United States), " Cancer

Causes & Control, 5:141-8, 1994.

Peters, J., et al. " Processed meats and risk of childhood leukemia

(California, USA) " Cancer Causes & Control 5:195-202, 1994.

Bunin, G.R., et al. " Maternal diet and risk of astrocytic glioma in

children. "

Sarasua, S., Savitz, D. " Cured and broiled meat consumption in relation

to childhood cancer. "

Ibid.

Peters, J., Preston-Martin, S., London S., et al. " Processed meats and

risk of childhood leukemia (California, USA) "

Ibid.

Reis, L. et al., " Maternal diet and risk of astrocytic glioma in

children, " 177-87.

_________________

JoAnn Guest

mrsjo-

www.geocities.com/mrsjoguest/Genes

 

 

 

 

AIM Barleygreen

" Wisdom of the Past, Food of the Future "

 

http://www.geocities.com/mrsjoguest/Diets.html

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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