Excerpted from the testimony of

            1.S. G. Srikantia, B.Sc.,.B.B.S., D.Sc.

                    Professor of Food and Nutrition,
                    University of Mysore, India;

                    Former Director,
                    National Institute of Nutrition,
                    Hyderabad, India.

            2.Donald R Louria, Ph.D.,

                    Chairman, Department of
                    Preventive Medicine and Community Health,
                    University of Medicine and Dentistry, New
                  Jersey

            3.George L Tritsch, Ph D

                    Cancer Research Scientist,
                    Roswell Park Memorial Institute,
                    New York State Department of Health

            4.Richard Piccioni, Ph D ,

                    Senior Staff Scientist,
                    Accord Research and Educational Associates
                    New York, NY.



    Excerpt #1.
                          from the testimony of

                S. G. Srikantia, B.Sc.,.B.B.S., D.Sc.

                      Professor of Foods and Nutrition,
                        University of Mysore, India;

                              Former Director,
                      National Institute of Nutrition,
                            Hyderabad, India.


    In response to a request from the Ministry of Health, Government of
    India, to carry out appropriate studies to determine if irradiated wheat
    was safe for consumption, the Institute  [ National Institute of
    Nutrition ]  initiated studies in the year 1973, using a variety of
    experimental animals -- mice, rats and monkeys -- as also some
    undernourished children. They were fed diets which contained
    freshly irradiated wheat , the wheat being incorporated into the diet
    within twenty-one days of being subjected to irradiation.

    During the course of these studies the Institute made several new and
    important observations of practical importance and published them in
    refereed international journals.

        The Institute's Findings

      1.Rats and mice fed diets containing freshly irradiated wheat
          showed increased levels of polyploid cells  [ cells with
          chromosome abnormalities ]  in their bone marrow. This was
          repeatedly observed in several separate experiments.

      2.Normal monkeys and undernourished children fed diets
          containing freshly irradiated wheat showed elevated levels of
          polyploid [ abnormal ]  cells  in circulating lymphocytes
          [white blood cells] . Several months after the irradiated wheat was
          withdrawn, levels of polyploidy returned to normal.

      3.Mice fed freshly irradiated wheat-based diets showed evidence
          of dominant lethal mutation as indicated by increased numbers
          of intrauterine  [ prenatal ]  deaths.

      4.When wheat was stored for twelve weeks after irradiation, and
          then included in the diet, there was neither an increase in the
          number of polyploid cells nor was there evidence of dominant
          lethal mutation.

    The meaning of increased numbers of polyploid cells is not clear ,
    though it is often seen in association with rapidly regenerating tissues
    and with malignancy  [ cancer ] . Whether it signifies either mutational
    or precancerous changes is not certain. But the meaning of
    "dominant lethal mutation" is obvious -- it indicated undesirable
    changes in reproductive performance.

    The explanation for the increased polyploidy and the dominant
    lethal mutation following the ingestion of freshly irradiated wheat,
    is not clear. It is likely to be an effect of a mutagen formed in
    wheat during the process of irradiation. The fact that these effects
    were not seen when stored irradiated wheat was fed, suggests that the
    mutagen is a relatively unstable substance

    Based on these findings the National Institute of Nutrition
    recommended that unconditional clearance of irradiated wheat was
    not warranted and that when subjected to irradiation, wheat should be
    stored for a period of at least twelve weeks prior to being released for
    consumption....

    Questionable Methods

    Recently the Food and Drug Administration, U.S.A.  [ stated that ]
    "The Agency agrees with the conclusions of the Committee of Indian
    Scientists that the studies with irradiated food do not demonstrate that
    adverse effects would be caused by ingestion of irradiated foods."
    (Federal Register 51, April 18, 1986, p 13 385)

    The Committee of Indian Scientists referred to here, is a two-man
    committee which consisted of Dr. P.C. Kesavan and Dr. P.V.
    Sukhatme, whose report, according to the federal register's citation, was
    submitted to the Joint FA0/WHO/IAEA Expert Committee on the
    Wholesomeness of Irradiated Food, held at Geneva in 1976.

    This statement  [ by the U.S. FDA ]  leaves the reader with the
    impression that the  [ Kesavan-Sukhatme ]  report was discussed by the
    Joint Expert Group and that the findings in the report were endorsed by
    it. This would be at variance with the facts because the report was
    NOT submitted to the Joint Expert Group and therefore was never
    discussed . I can vouch for this since I was a member of that Expert
    Group. At that meeting, the  [ earlier ]  findings of the National Institute
    of Nutrition were accepted, as is reflected in the published reports of the
    Proceedings....

    The FDA has now accepted that it was indeed incorrect to have cited
    that the Kesavan-Sukhatme report had been submitted to the Expert
    Group in 1976. It is unfortunate that many of the original readers of the
    Federal Register may not get to know the truth....

    The  [ Kesavan-Sukhatme ]  report was a confidential document. After
    receiving the report, the government of India sent it to the Director,
    National Institute of Nutrition, for his views and comments The
    Institute's Director sent his comments to the government, which was
    also a confidential document. As of today, to the best of my knowledge
    neither of these documents has been made public. It was therefore
    surprising to learn that the FDA has a copy of the confidential
    Kesavan-Sukhatme report, and that it has accepted its findings
    without being aware that the conclusions of that report had been
    questioned. In his comments the Director, National Institute of
    Nutrition, has not only refuted some of the statements made in the
    report, but also provided additional evidence to back up the Institute's
    conclusions....

    The FDA has committed a serious error of judgment. Had it seen
    the Institute's rejoinder to the Kesavan-Sukhatme report, surely, it
    would have been in a better position to evaluate that report....

    It is indeed very strange that aspersions should have been cast on the
    scientific honesty and integrity of the Institute's workers a full ten years
    after the work was published. It is even stranger that the two scientists
    who allegedly made these statements have denied having made them
    when they were approached by me. The person who acted as Chairman
    at the panel discussions has, so far, not responded to my letter. Clearly,
    there is more here than meets the eye. It is very unfortunate that
    attempts are being made to discredit the Institute's work by resorting to
    questionable methods.
    The Institute's Position

    I wish to reiterate that the Institute has NOT withdrawn anything
    which it said earlier on this subject and stands fully behind all that
    it has published. Indeed, its stand has received support from the
    publications of both Renner and Anderson and coworkers. The Institute
    also does not agree with the Kesavan-Sukhatme report. It stands behind
    its statement that eating irradiated wheat-based diets is associated
    with undesirable consequences and reiterates its recommendation that
    should wheat be irradiated for human consumptions it must be stored
    for at least 12 weeks before being released for use.



    Excerpt #2.

                      Donald R Louria, Ph.D.,

                        Chairman, Department of
                Preventive Medicine and Community Health,
            University of Medicine and Dentistry of New Jersey


    I am today urging that adoption of food irradiation be halted until two
    major issues are resolved.

      1.The issue of safety

          It would appear that the FDA gave its approval on the basis
          of five or six studies on rats and dogs. These were selected as
          methodologically sound from a pool of over two thousand
          studies , over four hundred of which appeared potentially good
          enough for preliminary review. Clearly, there are many potential
          biases in selecting such a small number of studies on which to
          base major decisions.

          Two of the studies are in English, three in French, and one in
          German. The two in English were reviewed by five
          epidemiologists and biostatisticians. Their judgment was that
          both studies posed substantial problems in interpretation. In
          one of the two studies, published in 1964, the authors note "in
          many cases statistical comparisons were not possible. However,
          examination of the data intuitively suggests that the differences
          have no real significance."

          In actuality, there were differences between controls and those
          rats given irradiated wheat, but the small number of animals may
          not have permitted statistically significant differences to be found.
          There were unexplained stillbirths in the litters of rats given
          wheat irradiated with twenty thousand rads; recalculation of
          that stillbirth rate shows a significant increase. This study is
          hardly an endorsement for the safety of irradiating food. The
          other study, intensively reviewed, has similar problems with
          statistical significance, unexplained deaths, and abnormalities in
          animals given irradiated foods that are treated dississively and
          virtually ignored.

          So the two studies in English, instead of documenting safety,
          raise questions about the safety of food irradiation.
          Additionally, one of the studies suggests that older animals may be
          more susceptible to adverse effects when eating irradiated foods.

          What about the French and German studies? In two of the
          three French studies, the dose of radiation to food was less than
          fifty thousand rads; this small dosage makes the conclusions
          difficult to apply to the human situation. No specific adverse
          effects were noted. The German study showed no adverse effects
          directly, but showed other adverse effects that will be discussed
          subsequently.

          Taken together, these studies could not possibly establish the
          safety of food irradiation. Indeed, two of the studies suggest the
          technology is not safe.

      2.The effects on the nutritional value of food

          In the 1964 report the authors noted that both controls and those
          fed irradiated wheat were given supplementary vitamins; in part,
          "this was done to avoid the reproductive difficulties that were
          attributed to destruction of vitamin E induced by radiation". In the
          German experiment, in the first year of analysis those animals
          given irradiated foods weighed significantly less than controls
          and showed reproductive defects; both these abnormalities
          were corrected by administration of vitamins, particularly
          vitamin E.

          There are now many other data indicating that irradiation of foods
          can reduce the nutrient value of those foods. Additionally, further
          processing of the food, for example by cooking, may result in
          accelerated nutrient depletion compared to unirradiated foods.

          The supporters of food irradiation treat the potential damage
          to the nutrient value of food as if it were unimportant or
          nonexistent That is a major mistake. If the nutrient value of
          food is reduced, then the argument for food irradiation prolonging
          shelf life is undercut. Surely, it would not make sense to prolong
          shelf life if the foods are nutritionally defective.

    To summarise, I do not believe that irradiated foods have been
    shown to be safe for general consumption. Equally important, the
    effects of irradiation on the nutrient contents of food are not
    established. I believe the prudent action to take is to prohibit the
    irradiation of food until the basic issues are sorted out. To do less would
    be irresponsible.



    Excerpt #3.

                      George L Tritsch, Ph D

                        Cancer Research Scientist,
                      Roswell Park Memorial Institute,
                  New York State Department of Health


    I am speaking as a private citizen, and my opinions are my own, based
    on thirty-three years of experience since my doctorate at Cornell
    Medical College, Rockefeller University, and, since 1959, as a cancer
    research scientist and biochemist at Roswell.

    I am opposed to consuming irradiated food because of the abundant and
    convincing evidence in the refereed scientific literature that the
    condensation products of the free radicals formed during irradiation
    produce statistically significant increases in carcinogenesis, mutagenesis
    and cardiovascular disease in animals and man. I will not address the
    reported destruction of vitamins and other nutrients by irradiation
    because suitable supplementation of the diet can prevent the
    development of such potential deficiencies. However, I cannot protect
    myself from the carcinogenic and other harmful insults to the body
    placed into the food supples and I can see no tangible benefit to be
    traded for the possible increased incidence of malignant disease one to
    three decades in the future.

    Irradiation works by splitting chemical bonds in molecules with high
    energy beams to form ions and free radicals. When sufficient critical
    bonds are split in organisms contaminating a food, the organism is
    killed. Comparable bonds are split in the food. Ions are stable; free
    radicals contain an unpaired electron and are inherently unstable and
    therefore reactive. How long free radicals remain in food treated with a
    given dose of radiation or the reaction products formed in a given food
    cannot be calculated but must be tested experimentally for each food.
    Different doses of radiation will produce different amounts and kinds of
    products.

    The kinds of bonds split in a given molecule are governed by statistical
    considerations. Thus, while most molecules of a given fatty acid, for
    example, may be split in a certain manner, other molecules of the same
    fatty acid will be split differently. A free radical can either combine with
    another free radical to form a stable compound, or it can initiate a
      [chemical]  chain reaction by reacting with a stable molecule to form
    another free radical, et cetera, until the chain is terminated by the
    reaction of two free radicals to form a stable compound. These
    reactions continue long after the irradiation procedure.

    I am bringing this up to give you a rationale for the vast number of new
    molecules that can be formed from irradiation of a single molecular
    species, to say nothing of a complicated mixture as a food. Furthermore
    the final number and types of new molecules formed will depend on the
    other molecules present in the sample. Thus, free radicals originating
    from fats could form new compounds with proteins, nucleic acids
      [DNA] , etc.

    These considerations lead to the following conclusions:

      1.A large number of new molecules is formed. Therefore, irradiation
          is not a process but a means of adding new molecules to food.

      2.Theory cannot predict the nature or number or quantity of the
          new compounds, which will vary with the kind of food, the
          season, and the location in which it is harvested.

      3.Because of the above, extrapolation of the effects of irradiation at
          one dose to higher doses will not be valid for all molecules,
          notwithstanding that in several instances, the formation of volatile
          hydrocarbons from fats has been shown to be related to the dose
          of radiation in a linear fashion.

    The first study I will discuss deals with the danger of irradiation of
    foods which contain unsaturated fats. This is particularly timely since
    the American public is being advised to reduce total fat intake,
    especially intake of saturated fats, because of the excellent correlation
      [with]  cardiovascular disease and some forms of cancer. Unsaturated
    fat consumption is indeed increasing in the United States. When
    poly-unsaturated fats are exposed to one to four kilogray (100-400
    thousand rads) large concentrations of peroxides are formed and a
    concomitant oxidation of benzo-pyrenes to mutagenic benzo-pyrene
    quinones takes place. This response is dose dependent. Unsaturated fats
    such as cod liver oil and mackerel oil showed much greater
    benzo-pyrene quinone formation than saturated fats (like coconut oil) or
    fats containing vitamin E, such as corn oil.

    This recent study of 1986 clearly shows that peroxidation of lipids by
    irradiation produces known carcinogens. Not emphasised in this paper is
    that peroxidation of lipids also results in their cross-link polymerization
    in a manner akin to the drying of oil-based paint These polymers cannot
    be digested by our digestive enzymes and will likely be deposited as
    insoluble plaques in blood vessels. This would have analogous results as
    the deposition of insoluble cholesterol plaque is well known to lead to
    high blood pressure and cardiovascular disease in some individuals. In a
    consensus statement frequently quoted to document the safety of
    irradiated food by proponents the following statement is made:

          "In this research, several anomalies appeared in the test
          animals (for example, hemorrhages, ruptured hearts and
          vitamin deficiencies) but these were related to feeding the
          test animals food they did not customarily eat, and not to
          treating the foods with ionizing energy"

    Hemorrhages and ruptured hearts bring to mind acute and extremely
    high elevation of blood pressure. I would question the prudence of
    instigating a study of feeding animals food they do not customarily eat
    and then dismissing adverse effects for this reason. I do not believe
    such a statement could appear in the refereed scientific literature.

    I would next mention the effects of irradiation on nitrate in foods.
    Irradiation converts nitrate to nitrite in a dose dependent manner.
    Mutagenesis is directly proportional to nitrite concentration. Nitrite is a
    reactive molecule and reacts with nucleic acids and various amino acids
    in protein and forms the known family of carcinogens known as
    nitrosamines. These have been demonstrated to be potent carcinogens
    in man.

    Now let me turn to what I believe to be the most convincing and
    comprehensive group of studies to demonstrate the harmful effects of
    irradiated food. In 1975 were reported the results of feeding five
    malnourished Indian children wheat irradiated with 75,000 rads. This
    wheat produced weight gain, serum albumin, and hemoglobin levels
    indistinguishable from what was found with unirradiated wheat.
    However, four of the five children showed gross chromosomal
    polyploidy four weeks after initiation of the feeding program.
    Chromosome number returned to normal twenty six weeks after the
    feeding was stopped. This is unequivocal evidence of a potent mutagen
    in irradiated wheat. I would remind you that the high lung cancer
    incidence in the United States in 1982-83 was 80 per 100,000, which is
    equivalent to 0.08 percent. In these children, incidence of polyploidy
    was 80 percent  [1000 times larger] .

    Proponents of food irradiation have attempted to dismiss this study
    since only five individuals were involved, but mercifully no one has
    repeated this with greater numbers of children, especially since
    equivalent results were found when irradiated wheat was fed to
    monkeys and rats. In both these studies polyploidy was seen after
    several weeks of feeding and returned to normal about two months after
    feeding irradiated wheat was stopped. In summary, I would be hard put
    to find a group of better studies to demonstrate the mutagenic properties
    of irradiated wheat



    Excerpt #4.

                      Richard Piccioni, Ph D ,

                          Senior Staff Scientist,
                Accord Research and Educational Associates
                              New York, NY.


    Over the past twenty months, a team of biologists, chemists, physicians
    and statisticians in our organisation have carried out an in-depth
    examination of the technical basis of the Food and Drug
    Administration's recent approval of food irradiation processing. We feel
    that there is no assurance in the scientific literature or the arguments of
    the FDA that the widespread irradiation of food will not be a significant,
    if silent, threat to the public health.

    In summary we feel the FDA has adopted scientifically indefensible
    criteria for assessing, and in their view, demonstrating, the safety of
    irradiated foods.

    Treatment of food with ionizing radiation presents issues of food safety
    qualitatively unlike those posed by any other food processing method or
    food additive. The large amount of energy contained in ionising
    radiation provides the potential for exceedingly complex chemical
    transformation of food components including the production of
    mutagenic or carcinogenic substances which were not present or were
    present in far smaller amounts before irradiation. This potential far
    exceeds that of ordinary heat processing, microwave radiation, etc. At
    the same time, because the production of these "radiolytic products"
    takes place within the food itself, it is impossible to design a
    toxicological test in which animals are exposed to exaggerated doses of
    these products the chemical identity of which remains largely unknown.
    Thus toxicologists are limited to biological testing which is thousands of
    times less sensitive than the testing typically required of other chemical
    additives or pesticide residues.

    In 1979, after years of controversy and false starts, radiation food
    processing was reevaluated by a specially appointed FDA committee,
    the BFIFC (Bureau of Foods Irradiated Foods Committee) They
    acknowledged that feeding whole irradiated foods to test animals, even
    after long periods of time, was completely inadequate to assess the
    carcinogenic potential of the radiolytic products present in those foods.
    As an alternative to direct biological testing they proposed acceptance of
    a theoretical calculation of the maximum concentration of radiolytic
    products present in irradiated food -- and made the extraordinary leap of
    faith that parts-per-million residues of unknown substances pose no risk
    when ingested by millions of people over their entire lives.

    Subsequently an FDA task force reiterated the BFIFC recommendations
    and reported the results of an elaborate Review" of the available
    literature on the toxicological testing of irradiated foods - testing which
    they, as well as the BFIFC, agreed was inherently incapable of
    providing definitive evidence of the safety of irradiated food. The five
    studies which have been mentioned by others at this hearing provided,
    according to the Fen itself only the assurance that irradiated food is not
    wildly mutagenic and/or carcinogenic. The task force therefore justified
    its conditional approval of irradiation of fruits and vegetables with up to
    one hundred thousand rads, and spices with up to three million rads, on
    the same theoretical basis as proposed by the BFIFC.

    Proponents of food irradiation commonly claim there are no studies in
    the scientific literature showing mutagenic or carcinogenic activity in
    irradiated foods or food components. In fact, as our own literature
    survey has shown, dozens of such studies exist, observed in a variety of
    biological systems, published by a variety of authors, in a variety of
    peer-reviewed scientific journals, over a period of twenty years.

    In fact, a substantial number of studies can be found in the open
    scientific literature indicating the presence of known mutagens,
    carcinogens, or cytotoxic substances in focd or food components which
    have been irradiated. Furthermore, the radiation chemistry of foods is
    far from fully understood, as evidenced by a steady appearance in the
    literature of studies on new radiolytic products found in various
    irradiated foods (e.g. Simic and Jovanovic, 1986; and ^khlag et al,
    1987) Many of these radiolytic products have not been individually
    tested for mutagenicity or carcinogenicity.

    In short, the available scientific literature provides evidence to make a
    strong presumption of carcinogenicity in some if not all irradiated food.
    The question is one of quantifying the risk.

    Recently, the National Academy of Sciences (1987) identified
    twenty-three pesticides which are responsible for the vast majority of
    the total carcinogenic risk posed by the presence of pesticide residues in
    the U S food supply. Food irradiation would make essentially no
    contribution to the elimination of these pesticides since, of the
    twenty-three, several are herbicides or insecticides applied in the field,
    and the remainder are fungicides, whose replacement by irradiation is a
    highly dubious proposition. In fact irradiation of fruits and vegetables
    may well increase, rather than decrease, the requirement for
    post-harvest application of fungicide, because irradiated products are
    more susceptible to infection by colds and fungi.

    On the question of the use of ionizing radiation to inactivate salmonella
    in poultry, it is important to understand two points:

      1.Doses required for even partial "pasteurisation" of poultry meat
          are far greater than the doses which have been deemed "safe" by
          any of the evidence or arguments provided by the FDA to date.
          All of the concerns of the presence of trace mutagens or
          carcinogens in foods irradiated at "low" doses of 100,000 rads are
          only greater at doses of one million rads, required for even partial
          salmonella inactivation.

      2.Major unresolved microbiological questions arise regarding the
          safety of gamma processing of salmonella-contaminated poultry.
          Much of the virulence of the recent cases of salmonellosis has
          been attributed to the presence of antibiotic resistant strains of the
        pathogens due in turn to the use of these antibiotics in the poultry
          industry. The addition of a highly mutagenic processing procedure,
          namely gamma irradiation, on poultry carcasses still containing low
          levels of antibiotic, is an appalling scenario for the appearance in
          the irradiated food of new, antibiotic resistant strains. This issue
          has received serious but not adequate attention in the scientific
          literature.

    The FDA has also been quick to dismiss concerns that irradiation of
    Aspergillis flavus spores, or the grains upon which this fungus can grow,
    can increase the production of the potent carcinogen aflatoxin, citing
    and dismissing a single study on the subject. In fact, there have been
    several studies showing serious aflatoxin-enhancing effects at or near
    the very doses proposed for the irradiation of grain.

    In summary, the continuing research effort by our organisation indicates
    clearly that recent and pending approvals of food irradiation processing
    by the FDA should be rescinded, and the same degree of caution now
    being expressed by several states and national agencies around the
    world be implemented on a federal level.


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