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**S.T.O.P. - Safe Tables Our Priority**

*America's Voice for Safe Food*

3149 Dundee Road #276 Phone /Fax -- 847-831-3032

Northbrook, IL 60062 www.safetables.org

October 17, 2008

Docket Clerk

U.S. Department of Agriculture

Food Safety and Inspection Service

FSIS Docket Room

1400 Independence Avenue, SW

Room 2534

Washington, DC 20250

**[Re: Docket No. FSIS-2008-0028]{.underline}**

**Irradiation as a Processing Aid**

Safe Tables Our Priority (S.T.O.P.) appreciates the opportunity to
submit the following comments in response to the notice of availability
of petition and public meeting published by the Food Safety and
Inspection Service (FSIS) on the petition from the American Meat
Institute (AMI) to recognize the use of low-penetration, low-dose
electron beam irradiation on the surface of chilled beef carcasses as a
processing aid (73 Fed. Reg. 52001 September 2, 2008) (Notice). S.T.O.P.
supports the efforts of FSIS and AMI to advance the idea of an
additional control for *E. coli* O157:H7 in meat products, however we
feel it is necessary to conduct further research in the field before
proceeding with AMI's proposal.

S.T.O.P. is a national, non-profit public health organization dedicated
to preventing illness and death due to pathogens in our food supply by
advocating sound public policy; by building awareness of foodborne
illness risk and its management; and providing victim assistance to
individuals and their families who have experienced foodborne illness.
S.T.O.P. was founded in 1993 in the aftermath of the Jack-In-The-Box *E.
coli* O157:H7 outbreak from contaminated ground beef that occurred in
California and throughout the Pacific Northwest.

S.T.O.P. does not endorse specific technologies. However, throughout
its15-year history S.T.O.P. has embraced and supported the need for
continuous improvement and innovation for [validated]{.underline}
technologies that reduce pathogens in our nation's food supply. Our
comments today reflect neither a pro-irradiation nor anti-irradiation
bias.

In 2005, AMI submitted a citizen's petition to FSIS requesting that the
Agency officially recognize low-dose, low-penetration E-beam irradiation
applied to the surface of chilled beef carcasses as a "processing
aid."[^1] The petition requested that information concerning irradiation
treatment not be required on the label of any products derived from the
carcass. In addition, the petition included only [one]{.underline}
research study supporting AMI's recommendation.[^2] For reasons unknown
to S.T.O.P. FSIS did not move forward on the proposal contained in AMI's
petition.

Despite the length of time that has passed and the failure to act, FSIS
now states, "Based on its consideration of the data and information
contained in the petition, FSIS believes that the petition has
merit."[^3] Due to the time lapse and lack of additional data to support
this claim, S.T.O.P. suggests further consideration be given to the
matter and further research be conducted before proceeding with AMI's
proposal. S.T.O.P. asserts that the sole study used by AMI to support
their proposal is incomplete, not validated and is therefore fatally
flawed.

**[S.T.O.P.'s Policy on Irradiation]{.underline}**

S.T.O.P. recognizes irradiation as a pathogen reduction technology that
could impact the incidence of foodborne illnesses and deaths. We
advocate a comprehensive, farm-to-fork food safety strategy that
incorporates contamination prevention steps and protective actions at
each point along the continuum. S.T.O.P. vehemently opposes the use of
irradiation as a substitute or replacement for any of these
contamination prevention measures and furthermore believes that there is
a lack of data showing the risks and effects of consuming irradiated
food. Because re-contamination can occur after food is irradiated, we
advocate food being irradiated in its final packaging. In addition,
S.T.O.P. supports the right of the consumer to make an informed
purchasing choice through means such as, but not limited to, labeling
that shows that a product has been irradiated.

**[AMI's Petition]{.underline}**

AMI[^4] is requesting that FSIS officially recognize the use of
low-dose, low-penetration electron beam irradiation on beef carcasses as
a "processing aid", thereby exempting any products derived from the
carcass to be labeled as having been irradiated. In essence, AMI, on
behalf of the meat industry, is requesting that FSIS issue an official
label exemption guarantee prior to a thorough examination and/or
production of a prototype that would ensure safety and soundness of the
irradiation process of whole beef carcasses.

Processing aids are used at control points and critical control points
within a plant to reduce microbial contamination of product. S.T.O.P.
believes it is crucial that that these aids be supported by strong
science and proper validation. Therefore, S.T.O.P. has serious concerns
with AMI's petition and study and strongly encourages FSIS to seek
further examination of the process proposed by AMI by requiring a whole
carcass irradiation prototype to be built and properly validated.
Furthermore, failure to conduct this research would set a dangerous
precedent whereby industry's assertions are accepted without adequate
science to support them.

AMI submitted a research study conducted by the USDA Agricultural
Research Center (MARC)[^5] that they contend provide(s) the scientific
evidence to demonstrate that this process:

1\. Is exceptionally effective at reducing levels of *E. coli* O157:H7,

2\. Does not have any effect on organoleptic properties or appearance,

3\. Does not have any lasting effect on shelf life, and

4\. Does not produce significant losses of either macro-or
micro-nutrients.[^6]

While all of these points are important, S.T.O.P. is limiting its
comments to AMI's first contention that carcass irradiation is
"[exceptionally effective at reducing levels of *E. coli*
O157:H7"]{.underline}.[^7]

**[The MARC Research Study]{.underline}**

FSIS has solicited comment on whether data from the MARC study supports
a conclusion that low-dose, low-penetration irradiation produces a
significant surface reduction of *E. coli* O157:H7 on chilled beef
carcasses.[^8] Based on the evidence provided in AMI's petition and the
Notice, S.T.O.P. does not believe that the data supports such a
conclusion.

1\. [The MARC Study Was Not Conducted On Beef Carcasses]{.underline}

Of paramount importance to S.T.O.P. is that AMI's petition centers on
irradiation of [whole carcasses,]{.underline} but the sole research
study used to support their petition was conducted on ["sections of
cutaneous trunci,"]{.underline}[^9] slices of exterior meat tissue in
layman's terms.

By using cutaneous trunci sections instead of whole carcasses, this
study does not address the variability and irregularity of whole beef
carcasses. Dr. Dennis Olson, in a September 2008 interview with
MeatPoultry.com noted,"Carcass irradiation as a processing aid is also a
great concept because all *E. coli* (contamination) occurs on the
slaughter floor. However, to get a uniform dose on such
irregularly-shaped carcasses with large biological variability is a
significant obstacle."[^10]

Because it is unknown if the entire carcass would in fact get a uniform
dose of irradiation, it then leads to the question of whether the
microbial log reductions reported in the MARC study are indicative of
what would occur under actual circumstances of irradiating whole
carcasses and not just sections of tissue as was done in the study.
S.T.O.P. considers this to be the first fatal flaw in AMI's reliance on
the MARC Study as support of its petition.

2.  [The MARC Study Used *E. coli* O157:H7 Strain that Lacked Both Shiga
    Toxins]{.underline}

It is the Shiga toxins within the *E. coli* bacteria that cause it to be
so injurious to human health. However, the MARC Study used
[non-toxigenic]{.underline} *E. coli* O157:H7:

> An *E. coli* O157:H7 strain lacking both Shiga toxins (ATCC43888) was
> used for all inoculations. This strain has growth characteristics
> similar to those of fully toxigenic *E. coli* O157:H7 strains;
> [however to our knowledge there have not been any studies comparing
> the radiation sensitivities of such strains.]{.underline}"[^11]
> (emphasis S.T.O.P.'s).

S.T.O.P. believes that this represents the second fatal flaw of the MARC
Study to support AMI's petition. It has not been scientifically
determined that fully toxigenic *E coli* O157:H7 would respond in the
same way to irradiation as strains lacking both Shiga toxins. Therefore,
S.T.O.P. must question the validity of the microbial log reductions
reported in the MARC Study. It causes us furthermore, to question the
validity in general of a "scientific" study purported to measure the
effects irradiation has on the [toxigenic]{.underline} strain of *E.
coli* O157:H7, that fails to take into consideration the key determinate
that makes it toxigenic to humans, the Shiga toxins.

3.  [MARC Study Methodology]{.underline}

Finally, S.T.O.P. questions certain aspects of the methodology used in
the MARC Study and the resulting conclusions. For example, the MARC
Study notes that, "At the E-beam facility, the cutaneous trunci pieces
were warmed to room temperature before inoculation because when carcass
contamination occurs during the beef harvesting process the surface of
the carcass is warm."[^12] Forty samples were kept as control samples
and another 40 samples were then inoculated; 20 at a "low inoculation"
(3 log cfu/cm²) level and 20 at a "high inoculation" level (6 log
cfu/cm²) of *E. coli* O157:H7 (lacking 2 Shiga toxins). They were then
left at room temperature for one hour to allow attachment. After
attachment the low inoculation level grew to 3.9 logs and the high
inoculation level grew to 7.2 logs.

S.T.O.P. questions whether the hypothesis of bringing tissue samples to
room temperature is a good comparative model to emulate actual slaughter
conditions where the carcass temperature of a freshly-killed steer/cow
is significantly higher. Therefore, we must also question whether the
resulting bacterial log count on whole carcasses, after attachment,
might be significantly higher. This then leads to the question of what
would be the remaining level of *E. coli* O157:H7 on the carcass after a
low-dose treatment of irradiation. The MARC Study simply does not
represent the real world situation of whole carcass irradiation in a
slaughter plant.

S.T.O.P. appreciates the MARC Study for what it is---a study of the
effects of low-dose, low-penetration irradiation on carcass surface cuts
inoculated with *E. coli* O157:H7 lacking both Shiga toxins.

However, we are appalled that the meat industry would ask FSIS, and the
American public, to accept findings that are based on research conducted
on something other than the actual item, inoculated with something other
than the actual pathogen and conducted without the actual equipment, all
within a controlled environment.

**[Labeling]{.underline}**

In S.T.O.P.'s April 26, 1999 written comments regarding FSIS Docket
#97-076P, "Irradiation of Meat and Meat Products" we voiced our concern
that FSIS was not requiring meat and poultry products to be irradiated
in its final packaging and be clearly labeled as such. We noted that
just as there are consumers who will only [want]{.underline} to purchase
irradiated products as a perceived "safer" product, there are others who
[oppose]{.underline} irradiated product on principal.

S.T.O.P. disagrees with the 1999 Final Rule issued by FSIS which calls
for all irradiated meat and poultry products, regardless if done in its
final packaging or merely at an ingredient level in a further processed
product, to be labeled as irradiated.[^13] As stated in our comments,
any meat product not irradiated in its final package is subject to
re-contamination and could lead to a false sense of security to
consumers who interpret irradiated food as being safe.

S.T.O.P. agrees with AMI's submission that it would be misleading to
label product derived from carcasses that have undergone low-dose,
low-penetration irradiation, as "irradiated". All products derived from
these carcasses have multiple opportunities for re-contamination
throughout further production.

However, consumers do have the right to know when making purchasing
decisions. S.T.O.P. encourages FSIS to re-open the issue of labeling in
a broad sense via a transparent public process where all stakeholders
have an opportunity to provide input.

**[Conclusion]{.underline}**

S.T.O.P. appreciates the industry's efforts to advance the idea of an
additional control for *E. coli* O157:H7 in its products via AMI's
petition for carcass irradiation. However, we are disappointed with the
approach and lack of scientific evidence put forth by the industry and
potentially accepted by FSIS as having merit. Scientific claims must be
supported by solid scientific evidence. At this time the research is
incomplete and a clear conclusion cannot be drawn because of the methods
used and the lack of a validated prototype. S.T.O.P. understands that it
would take a large capital investment on the part of industry to pursue
further research. However, this investment is necessary if the industry
wants to proceed in its quest to get low-dose irradiation defined as a
processing aid for beef carcasses.

FSIS has also made it impossible for low-dose, low-penetration
irradiation to be considered as a processing aid through its 1999
regulation requiring meat or meat products containing any amount at all
of irradiated meat to be labeled as "irradiated." S.T.O.P. disagreed
with FSIS in 1999 and still does about this labeling policy. We
encourage FSIS to reconsider this issue as part of a broader discussion
on technologies and labeling through a public process.

Respectfully submitted,

Nancy Donley

President and mother of Alex, *E. coli* O157:H7 victim (1987-1993)

[^1]: American Meat Institute's July 8, 2005 "Re: Citizens Petition To
    Recognize the Use of E-Beam on Carcasses as a Processing Aid." (AMI
    Petition).

[^2]: "Effects of Low-Dose, Los-Penetration Electron Beam Irradiation of
    Chilled Beef Carcass Surface Cuts on *Escherichia coli* O157:H7 and
    Meat Quality". Terrance M. Arthur, Tommy L. Wheeler, Steven D.l
    Shackelford, Joseph M. Bosilevac, Xiangwu Nou, and Mohammad
    Koohmaraie. *Journal of Food Protection, Vol. 68. No. 4. 2005. Pages
    666-672.* (MARC Study).

[^3]: 73 Fed. Reg. 52001

[^4]: "The American Meat Institute (AMI) represents the interests of
    packers and processors of beef, pork, lamb, veal and turkey products
    and their suppliers throughout North America." AMI Petition p. 1.

[^5]: "Effects of Low-Dose, Low-Penetration Electron Beam Irradiation of
    Chilled Beef Carcass Surface Cuts on *Escherichia coli* O157:H7 and
    Meat Quality", Terrance M. Arthur, Tommy L. Wheeler, Steven D.
    Shackelford, Joseph M. Bosilevac, Xiangwu Nou, and Mohammad
    Koohmaraie, *Journal of Food Protection, Vol. 68, No. 4, 2005, Pages
    666-672.*

[^6]: American Meat Institute's July 8, 2005 "Re: Citizens Petition To
    Recognize the Use of E-Beam on Carcasses as a Processing Aid", p. 3.

[^7]: AMI Petition p. 3.

[^8]: 73 Fed. Reg. 52001 p. 52004.

[^9]: MARC Study

[^10]: "Irradiated Meat Needs 'Professional' Health Backing", Bryan
    Salvage, MeatPoultry.com, September 8, 2008.

[^11]: MARC Study

[^12]: MARC Study

[^13]: 64 FR 72168, December 23, 1999.