August 13, 2004

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

# Room 1061

Rockville, MD 20852

Re: Docket No: 2004N-0264

Dear Sir or Madame:

On behalf of Lopez Foods Inc, we appreciate the opportunity to submit
comments to this very important Advance Notice of Proposed Rulemaking
(ANPRM). 69 Fed. Reg. 42288 (July 14, 2004). After the identification of
bovine spongiform encephalopathy (BSE) in the second indigenous North
American cow, the U.S. Department of Agriculture (USDA) responded
rapidly to implement measures to protect public health. Given what is
known about the epidemiology and characteristically long incubation
period of BSE, additional regulations from the Food and Drug
Administration (FDA) are overdue.

Scientific and epidemiological findings provide more than ample support
for further actions regarding the feed ban in the United States. These
actions are imperative to prevent further recycling of the BSE agent
within the North American cattle herd. The elimination of BSE from the
North American cattle herd would provide safer beef and pharmaceutical
products.

We feel that for the FDA to provide a more comprehensive and protective
feed ban, specified risk materials (SRMs) and deadstock must be removed
from all animal feed and that legal exemptions which allow ruminant
protein to be fed back to ruminants (with the exception of milk) should
be discontinued.[^1]

SRMs, as defined by the USDA, are tissues which, in a BSE infected
animal, are known to either harbor BSE infectivity or to be closely
associated with infectivity. If SRMs are not removed, they may introduce
BSE infectivity and continue to provide a source of animal feed
contamination. Rendering will reduce infectivity but it will not totally
eliminate it. This is significant as research in the United Kingdom has
shown that a calf may be infected with BSE by the ingestion of as little
as .001 gram of untreated brain.

With the current feed ban, it is still possible for cattle to be exposed
to BSE through:

1.  Feeding of materials currently subject to legal exemptions from the
    ban (*e.g*., poultry litter,plate waste)

2.  Cross feeding (the feeding of non-ruminant rations to ruminants) on
    farms; and

3.  Cross contamination of ruminant and non-ruminant feed

A number of authoritative bodies also agree with the position that
removing SRMs and deadstock from all animal feed would reduce the BSE
risk within the US.

[World Health Organization]{.underline}

The World Health Organization (WHO) has issued the following
recommendations for countries with BSE or those where a known exposure
exists:

\"No part or product of any animal which has shown signs of a TSE should
enter any food chain (human or animal).  In particular:\
\
- All countries must ensure the killing and safe disposal of all parts
or products of such animals so that TSE infectivity cannot enter any
food chain.\
\
- **Countries should not permit tissues that are likely to contain the
BSE agent to enter any food chain (human or animal)."**\
\
Report of a WHO Consultation on Public Health Issues related to Human
and Animal Transmissible Spongiform Encephalopathies WHO/EMC/DIS 96.147,
Geneva, 2-3 April 1996 (emphasis added).

[Harvard/Tuskegee BSE Risk Assessment]{.underline}

Per the Executive Summary of its 2001 release, the Harvard/Tuskegee
Study states, "Specific pathways or practices that would contribute the
most to the spread of BSE if it were introduced into the U.S. relate to
compliance with the FDA feed ban and include misfeeding on the farm and
the mislabeling of feed and feed products prohibited for consumption by
cattle. The disposition of cattle that die on the farm would also have a
substantial influence on the spread of BSE if this disease were
introduced into the U.S."

The report continues:

-   "Our evaluation of potential risk mitigation actions highlights
    potential measures to further reduce the already low likelihood that
    BSE could spread to cattle or contaminate human food if it were to
    arise. Prohibiting the rendering of animals that die on the farm,
    possibly of BSE, removes a great deal of potential contamination in
    the animal feed chain and reduces average predicted cases of BSE
    following introduction of ten infected cattle by 77%. Implementation
    of a UK-style ban on specified risk material (*e.g.*, spinal cords,
    brains, vertebral columns) from both human food and animal feed
    reduces the predicted number of BSE cases in cattle by 80% and the
    potential human exposure by 95%."

-   "The disposition of cattle that die on the farm would also have a
    substantial influence on the spread of BSE if the disease were
    introduced." The base case scenario showed that the mean total
    number of ID50s (*i.e*., dosage sufficient to infect 50 percent of
    exposed cattle) from healthy animals at slaughter presented to the
    food/feed system was 1500. The mean total number of ID50s from adult
    cattle deadstock presented to the feed system was 37,000. This
    illustrates the risk of "4D cattle" (*i.e*., deadstock).

Harvard Risk Assessment, 2001, Appendix 3A Base Case.

[Subcommittee to the USDA's Foreign Animal and Poultry Disease Advisory
Committee]{.underline}

An international panel of transmissible spongiform encephalopathy (TSE)
experts appointed by Secretary of Agriculture Ann M. Veneman as a
subcommittee to the Foreign Animal and Poultry Disease Advisory
Committee issued a report in February 2004 which stated:

> "... given the epidemiological evidence indicating that BSE agent
>
> was already circulating in ruminant feed prior to the feed ban in
> 1997, and
>
> the integration of the North American cattle and feed industries,
> strong
>
> consideration should be given to excluding all SRM from **both the
> human food and animal feed supplies**.
>
> "Considering the BSE situation in North America, the subcommittee
> believes
>
> the partial (ruminant to ruminant) feed ban that is currently in place
> is
>
> insufficient to prevent exposure of cattle to the BSE agent."

Secretary's Advisory Committee on Foreign Animal and Poultry Diseases'
Subcommittee on the United States' Response to the Detection of a Case
of Bovine Spongiform Encephalopathy, Report on Measures Relating to
Bovine Spongiform Encephalopathy (BSE) in the United States, 2 February
2004, p. 8 (emphasis added).

In conclusion, we urge the FDA to adhere to the advice of both
international and domestic experts and issue without undue delay
additional regulations prohibiting the inclusion of SRMs and deadstock
in feed for all animals. We further urge FDA to discontinue all of the
exemptions to the existing feed ban (with the exception of the exemption
for milk), which still allow the feeding of ruminant protein to
ruminants.

Respectfully submitted,

Dave Lopez

Assistant Vice President

Purchasing

Lopez Foods Inc.

[^1]: The exemption for milk and milk products from the existing feed
    ban should be retained, because there is no scientific evidence that
    BSE can be transmitted through milk.