April 7, 2008

Division of Dockets

Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852

RE: Docket No. 2008-D-0058

Filed electronically [http://www.regulations.gov]{.underline}

Dear Sir or Madam:

On behalf of the non-profit consumer organization Food & Water Watch, I
am writing to oppose the contents of the "Draft Compliance Policy Guide
Sec. 555.320 -- Listeria Monocytogenes." We believe that the relaxation
of the "zero tolerance" standard for this deadly pathogen in foods
creates a dangerous precedent and offers another example of the Food and
Drug Administration (FDA) not addressing the real issue at hand -- its
lack of adequate inspection resources to protect consumers from unsafe
food. Instead of vigorously advocating for additional resources to
address this crisis, the agency is coming up with schemes to avoid
hiring more inspectors that could compromise food safety even further.

We base our opposition on the following substantive points:

1)  As the agency aptly points out, *L. monocytogenes* is widespread in
    the environment. It is found in soil, sewage, and decaying
    vegetation. It is often found in food processing facilities,
    particularly in cool damp areas. *L. monocytogenes* can survive
    longer under adverse environmental conditions than many other
    vegetative bacteria.[^1] This particular pathogen is especially
    harmful to fetuses, neonates who are infected after their mothers
    are exposed to *L. monocytogenes* during pregnancy, the elderly, and
    immuno-compromised consumers. Because this pathogen is pervasive in
    the environment, it requires a rigorous sanitation regime in food
    processing facilities. We believe that a relaxation of the current
    *L. monocytogenes* standard could lead some food processing
    establishments to curtail their sanitation measures since the agency
    will not be scrutinizing establishments that produce products that
    allegedly do not support the growth *of L. monocytogenes*. As even
    some industry representatives pointed out at the March 28, 2008
    public meeting, many food manufacturers have invested substantial
    sums of money to achieve zero-tolerance in their food processing
    facilities and a relaxation of the current standard could lead some
    in the industry to be less vigilant.

2)  The agency points to the relaxation of the "zero-tolerance standard"
    for *L. monocytogenes* for foods that do not support the growth of
    the pathogen that has been adopted by some of our international
    trading partners as another justification for the proposed domestic
    policy shift. We do not agree. The U.S. should not dumb-down our
    food safety standards in the name of facilitating trade. That should
    especially be the case for FDA-regulated imported foods since the
    agency has such a dismal track record of inspecting imported
    foods.[^2] Furthermore, there is evidence that the relaxed standard
    among European Union nations may have spawned an increase in the
    number of human cases of listeriosis.[^3]

3)  We do not feel confident that the proponents of this policy shift
    really comprehend the impact of the change on the agency's field
    personnel and the facilities they inspect. At the March 28, 2008
    public meeting, a representative from Food & Water Watch submitted
    three written questions to agency officials to answer. The questions
    and the responses were as follows:

> Q: How many FDA-regulated food establishments would be impacted by the
> policy change?
>
> A: A lot.
>
> Q: How many dual FDA-USDA regulated food establishments would be
> impacted by the policy change?
>
> A: A lot.
>
> Q: How would the policy change affect the manner in which FDA
> inspectors conducted inspections?
>
> A: It would shift inspection resources to those food establishments
> that produced foods that support the growth of L. monocytogenes.
>
> We do not find the responses to these questions very reassuring. In
> fact, the nebulous answers reinforce our view that FDA headquarters
> officials have no grasp of what is currently going on in the field and
> the new policy will only increase the reliance on industry to police
> itself. Moreover, the message to us from these responses is that FDA
> needs a dramatic increase in the number of field inspectors and the
> relaxation of food safety standards is an unacceptable alternative.

4)  We understand that FDA is responding to an industry petition filed
    in 2004 that requested a change in the current policy. As you know,
    a similar petition filed with USDA's Food Safety and Inspection
    Service (FSIS) was rejected by that food safety agency. In rejecting
    the industry petition, FSIS Assistant Administrator Philip Derfler
    made the following observations:

> "We are concerned...about the limitations of available sampling and
> testing methods and the gaps in knowledge about the survival and
> growth of *L. monocytogenes* on products and its infectious dose for
> humans. We are also concerned about the implications of the changes
> you propose for the maintenance of sanitary operations in meat and
> poultry establishments and for the efficient and effective
> administration of our inspection program."[^4]
>
> It is ironic that the food safety agency with the continuous
> inspection requirement -- FSIS -- is skeptical of relaxing the current
> "zero-tolerance standard" even though its inspection workforce is
> required to visit food establishments at least on a daily basis. Yet
> FDA believes that weakening food safety standards in food
> establishments that receive inspections once every decade is
> acceptable. We believe that FSIS' thinking on this issue is far
> superior to what is being advocated by FDA and provides the most
> protection against contaminated food from entering into commerce.

5)  Finally, we are very concerned about the possible
    cross-contamination this new policy could cause in food
    establishments that fall both within FSIS and FDA jurisdictions. We
    support the views of Dr. Richard Raymond, USDA's Under Secretary for
    Food Safety, which were expressed in a March 27, 2008 letter to Dr.
    Stephen Sundlof, Director of FDA's Center for Food Safety and
    Applied Nutrition:

> "FSIS believes that a policy that permits *L. monocytogenes* in
> products that do not support its growth provides an increased
> opportunity for the pathogen to spread in the environment and
> cross-contaminate products that do support growth of the pathogen. By
> allowing *L. monocytogenes* in the environment, rather than
> controlling it, the organism can form biofilms in processing
> establishments subject to FSIS and FDA jurisdiction and be a source of
> product adulteration, and human illness, over time -- for years, in
> fact."[^5]

For all of the reasons cited above, we believe that the proposed policy
change is foolhardy and can be detrimental to public health.

Sincerely,

![](media/image1.jpeg){width="1.3041666666666667in" height="0.58125in"}

Wenonah Hauter

Executive Director

Food & Water Watch

1616 P St. NW

Washington DC 20036

\(202\) 683-2500

[^1]: See Docket No. FDA-2008-D-0058, "Draft Compliance Policy Guide
    Sec. 555.320 Listeria Monocytogenes; Notice of Public Meeting, 73 FR
    7300.

[^2]: See
    <http://www.fda.gov/oc/oms/ofm/budget/2009/Narratives/1_FOODS.pdf>,
    "ORA Foods Program Activity Data."

[^3]: See http://www.eurosurveillance.org/edition/v13n13/080327_5.asp

[^4]: See http://www.fsis.usda.gov/PDF/Derfler_Letter_091305.pdf

[^5]: See http://www.fsis.usda.gov/PDF/Raymond_Letter_FDa_032708.pdf