Center for Food Safety's Comments on
the USDA/FSIS Proposed Irradiation Rule.

FSIS Docket No. 97-076P
Department of Agriculture
Food Safety Inspection Service
Room 102
Cotton Annex
300 12th Street, S.W.
Washington, DC 20250-3700

To Whom It May Concern:

Pursuant to the USDA/FSIS Proposed Rule entitled "Irradiation of
Meat and Meat Products" published at 64 Federal Register 9089 (February 24,
1999), the Center for Food Safety submits the following comments.

The Center for Food Safety (CFS) was established by the
International Center for Technology Assessment (CTA), a 501(c)(3) non-profit
organization, in 1997 to address the impacts of our food production system
on human health, animal welfare and the environment. The four major goals
of CFS include: (1). Ensuring the testing, labeling and regulation of
genetically engineered foods; (2). Preserving strict national organic food
standards; (3). Preventing the potential animal and human health crisis
caused by "mad cow" disease; and (4). Educating the public on the hazards of
industrial agriculture.

Introduction - Irradiation Is Not Proven To Be Safe

The Center for Food Safety (CFS) does not believe irradiation is an
appropriate technology to be used in our food production system. CFS
believes that the technology poses severe drawbacks and limitations that
make the use of irradiation inappropriate. In addition, CFS believes that
irradiation creates legitimate health and environmental concerns which are
unacceptable to the public.

In particular, irradiation has a number of effects on food
(including meat products). Among the major concerns is the ambiguity of its
long-term effects on human health. Molecules that absorb irradiation become
reactive and form ions and free radicals, which react to form chemically
stable radiolytic products (Woods and Pikaev, 1994). A number of radiolytic
free radicals are believed to be unique, or at least more prevalent in,
irradiated foods (Elias and Cohen, 1977). Free radicals are highly reactive
compounds and some have been associated with oncogenicity, mutagenicity and
carcinogenicity. While none of these radiolytic free radicals have been
conclusively determined to be carcinogenic, it is not known whether there
are long-term health effects associated with these irradiation byproducts.
(Murray, 1990). Such uncertainty, however, demands that FSIS act with the
utmost precaution and not allow any irradiated products on the market. As
such, CFS opposes the FSIS's proposal to (1) allow for the irradiation of
hot-boned meat, (2) add ionizing radiation to the list of substances
suitable for controlling food borne pathogens in meat, and meat byproducts.


Comments Concerning Proposed Rule and Labeling

Under the Federal Meat Inspection Act, 21 U.S.C. § 607(c), and the
Poultry Product Inspection Act, 21 U.S.C. § 457, the USDA/FSIS is required
to take action, including the labeling of meat and poultry, to prevent
adulterated, misbranded or unwholesome meat products from reaching the
consumer market. The CFS believes that if the agency allows irradiated
products, including hot-boned meat, to be labeled in a manner inconsistent
with the comments contained below, such action would allow misbranded
products in the marketplace and be violative of law, arbitrary, capricious
and an abuse of discretion in that the agency has exercise it power in a
manner violative of statutory mandate.

(A). FSIS Must Require Labeling With Radura Symbol.

Irradiation changes the flavor, odor, texture, and color of most
foods. Irradiation also degrades the nutrient content in most foods.
Vitamins are particularly sensitive to the effects of ionizing radiation.
Vitamins C and E are particularly susceptible and many B-vitamins, proteins,
and essential amino acids also show measurable losses in irradiated food.
The FDA has recognized that irradiation alters these organoleptic qualities
of in food products. See 51 Fed. Reg. 13376, 13390 (April 18, 1986).

As result, the FSIS is obligated by law to provide consumers with
labeling concerning these changes so that meat and poultry products are not
misbranded. CFS believe that the use of the radura logo along with the
label wording "treated with irradiation" is necessary to meet this legal
burden.

(B). Wording of Label Should Not Be Revised and Labeling Requirement Should
Not Expire.

As the proposed rule notes, the FDA is seeking comment on several
irradiation labeling issues. 64 Fed. Reg. at 9094; See also, 64 Fed. Reg.
7834 (February 17, 1999). The comments requested in the FDA proposed rule
will subsequently impact FSIS labeling. As requested in the FDA regulatory
proposal, CFS opposes any changes to labeling language or an expiration
date for such labeling.

Under the Federal Food Drug and Cosmetic Act (FFDCA) food is deemed
misbranded if its labeling is "false or misleading in any particular." 21
U.S.C. § 343(a)(1) (1992 & Supp. 1997). Further, in accordance with 21
U.S.C. § 321(n) it is provided that:

If an article is alleged to be misbranded
because the labeling or advertising is misleading, then in determining
whether the labeling or advertising is misleading there shall be taken into
account (among other things) not only representations made or suggested by
statement, word, design, device, or any combination thereof, but also the
extent to which the labeling or advertising fails to reveal facts material
in the light of such representations or material with respect to
consequences which may result from the use of the article to which labeling
or advertising relates under the conditions of use prescribed in the
labeling or advertising thereof or under such conditions of use as are
customary.

Use of words such as "cold pasteurization" are inherently misleading
and will be violative of the above controlling statute. "Cold
pasteurization" is a term developed to specifically alter consumer
perception or irradiation. It has no factual basis or scientific basis. The
FFDCA has been interpreted to mandate food labeling in favor of consumer
interests. The courts have "construed Section 343 broadly, since the test is
not the effect of the label on a reasonable consumer, but upon the 'the
ignorant, the unthinking and credulous consumer.'" United States v. Strauss,
999 F.2d 692, 696 (2nd Cir. 1993) (quoting United States v. An Article . . .
Sudden Change, 409 F.2d 734, 740 (2nd Cir. 1969)). The ignorant, unthinking
consumer will have no knowledge of what cold pasteurization means or the
process involved. As such, allowing such labeling on any food, in the
FSIS's case meat and poultry, will be misleading.

Similarly, given the organoleptic changes in irradiate food
products, an expiration date of mandatory requirements would upon expiration
immediately make such unlabeled products adulterated and misbranded under
the FFDCA. While under a different statutory framework, FSIS is well aware
that its mandate under the FMIA and PPIA is, inter alia, to prevent
misbranded products from reaching the consumer market. Therefore, any
alteration in current labeling language similarly would be illegal.

(C). Optional Labeling Statement is Unsupportable.

CFS opposes proposed § 317.14(d) allowing for optional labeling that
indicates specific reductions in microbial pathogens. CFS believes such
statement may induce consumers to purchase irradiated meat and meat products
over non-irradiated products through labeling that would be inherently
misleading.

Despite claims that certain microbial pathogens will be reduced by
irradiation, the presence of two toxins - aflatoxins and botulin - most
likely increase with irradiation. Alfatoxins are produced by a number of
organisms, most notibly Aspergillus flavus and Asperillus parsiticus.
Researchers have noted that aflatoxin production was stimulated in surviving
irradiated Aspergillus (Bullerman, Barnhart and Hartung, 1973). These
results have been replicated numerous times (Murray 1990).

Botulin is the toxin associated with the food poisoning botulism.
It is produced by the irradiation-resistant Clostridium botulinum. Several
incidents and studies have indicated that irradiated seafood has a higher
risk of botulism than non-irradiated seafood (Diehl, 1995 and Murray, 1990).

Additionally, other organisms that are exposed to sublethal levels
of irradiation may cause mutations in those organisms and might evolve into
virulent, radiation-resistant pathogens.

As a result, irradiation may increase the risk of some food borne
illnesses. Therefore, any and all packaging suggesting in any particular
that food borne pathogens have been reduced as a result of irradiation would
be false and misleading to consumers.

USDA/FSIS Proposal Must Be Reviewed Under NEPA.

The National Environmental Policy Act (NEPA) is the "basic national
charter for protection for the environment." 40 C.F.R. § 1500.1. Its
purposes are to "help public officials make decisions that are based on
understanding of environmental consequences, and to take actions that
protect, restore and enhance the environment," and to "insure that
environmental information is available to public officials and citizens
before decisions are made and before actions are taken." Id. at
1500.1(b),(c).

The duties under this section are not "inherently flexible."
Calvert Cliffs Coordinating Comm. Inc. v. U.S. Atomic Energy Comm'n, 449
F.2d 1109 (D.C. Cir. 1971). In fact, "[c]onsideration of administrative
difficulty, delay or economic cost will not suffice to strip the section of
its fundamental importance." Id. The purpose behind NEPA is to "inject
environmental considerations into federal agency's decision making process"
and "to inform the public that the [federal] agency has considered
environmental concerns in its decision making process." Weinberger v.
Catholic Action of Hawaii/Peace Education Project, 454 U.S. 139, 143 (1981).

To accomplish these purposes, NEPA requires all federal agencies to
prepare a "detailed statement" regarding all "major federal actions
significantly affecting the quality of the human environment . . ." 42
U.S.C. § 4332 (2)(C). The USDA/FSIS proposal is a major federal action
designed to liberalize use or irradiation as food processing technique. The
agency even identifies one proposal as "Incentive Labeling for Irradiated
Meat Food Products." 64 Fed. Reg. at 9093. Such a proposal will encourage
greater use of irradiating facilities, and, as result, will expand the
potential environmental impacts associated with irradiation.

Irradiation of food presents significant environmental dangers
associated with irradiation including transporting of radioactive isotopes
to treatment facilities, the dangers of workers exposure in environments
where irradiation chambers are frequently opened, and potential security
problems at irradiation plants. The USDA/FSIS has failed to review these
impacts associated with its proposal and is in violation of NEPA.

Conclusion

For the reasons contained above, the CFS opposes the FSIS Proposed
Rule on the Irradiation of Meat and Meat Products as contained at 64 Federal
Register 9089 (February 24, 1999).

Respectfully submitted,

Joseph Mendelson, III
Legal Director, CFS, http://www.icta.org

Dated: April 23, 1999

References:

Bullerman, L.B., H.M. Branhart and T.E. Hartung. 1973., "Use of Gamma
Irradiation to Prevent Alfatoxin Production in Bread." J. Food. Sci.
38:1238-1240

Diehl, J.F. 1995. Safety of Irradiated Foods (2nd Ed.) New York: Marcel
Dekker.

Elias, P.S. and A.J. Cohen. 1977. Radiation Chemistry of Major Food
Components. New York: Elsevier Biomedical Press.

Murray, D.R. 1990. Biology of Irradiated Food. New York: John Wiley & Sons.