December 16, 2005

Re: FDA Proposed Rule: Substances Prohibited from Use in Animal Food or
Feed

Docket No. 2002N- 0273 or RIN 0910-AF46

To Whom it May Concern:

Mad Cow disease scientifically known as Bovine Spongiform
Encephalopathy, has killed nearly 200,000 British and European cattle
since it cropped up on Pitsham Farm and was first known to be identified
in 1985. The human variant of this disease has also claimed 94 lives as
well. What few of us realize is that these tolls could mark the
beginning of something vastly bigger. No one knows for sure just how BSE
first emerged. BSE belongs to the family of disease known as
transmissible spongiform encephalopathies (TSEs). Scientists are only
beginning to understand these afflictions. TSEs are arise spontaneously
in species as varied as sheep, cattle, mink, deer and people. And once
they take hold they can spread. Some TSEs stick to a single species
while others ignore such boundaries. But each of them is fatal and
untreatable, and they all ravage the brain, usually after long latency
periods causing symptoms that can range from dementia to psychosis and
paralysis. If the prevailing theory is right, they're caused not by
germs but by "prions"---normal protein molecules that become infectious
when folded into abnormal shapes. Prions are invisible to the immune
system, yet tough enough to survive harsh solvents and extreme
temperatures. You can freeze them, boil them, soak them in formaldehyde
or carbolic acid or chloroform and most will emerge no less deadly than
they were.

In 1997 the United States banned most mammalian proteins and materials
that can possibly contain prions from cattle feed. Yet exceptions have
existed for blood and blood products, gelatin; inspected, processed, and
cooked meat products for human consumption (such as restaurant plate
waste), milk products; and products containing pork and equine proteins
only. Most mammalian proteins can still be fed to other animals such as
pigs, poultry, and pets. This is simply not acceptable and is totally
irresponsible when this disease is a potential threat to human life.
Especially when it is not definitely known if this infection can through
time be spread from one mammal to another, yet pigs, poultry, and pets
are being feed mammalian proteins which are known to be of high risk to
BSE... this just simply does not make any sense.

The FDA's initial proposal was not approved, as a result, revisions have
been made and a modified proposal is being presented. Note the current
proposal is not as strong as the initial proposal present back in 2004.
The new proposal is to require feed mills to eliminate the brains and
spinal cords of 30-month-old cattle; but this may contribute to the
spread of mad cow if the current mad cow screening process is not
updated. In order to determine if the proposal will be successful; the
screening process must check at least 75% of all cattle.

The FDA' new amended proposal will prohibit the use of certain cattle
origin materials in the food or feed of all animals. These materials
include the following:

-   The brains and spinal cords from cattle of any age not inspected and
    passed for human consumption.

-   The brains and spinal cords from cattle 30 months of age and older

-   The entire carcass of cattle not inspected and passed for human
    consumption, if the brains and spinal cords have not been removed,

-   Tallow that is derived from the materials prohibited by this
    proposed rule that contains more than 0.15 percent insoluble
    impurities, and mechanically separated beef that is derived from
    materials prohibited by this proposed rule.

The United Kingdom was only able to eliminate cases of mad cow in their
cattle by eliminating the use of all mammal material in animal feed.
Although the UK dealt with a much bigger scare of mad cow, the US is
facing a financial strain. Since two cases of mad cow were reported in
the US, Japan will not purchase cattle from the US. Yet Japan is not the
only Country to ban the US; in addition to this Mexico, South Korea, and
Canada have banned us. We need to reassure our citizens and our trading
partners that we are determined to make sure that our cattle are not
infected with mad cow.

**Revision #1**: Cattle feed must be tested more frequently. Government
investigators (from the GAO) say testing is too slow at times to prevent
cattle from eating feed that might be contaminated, just one flaw they
cited in a program to help stop mad cow disease from spreading.

In half the feed samples analyzed, FDA took more than a month to
determine whether banned cattle protein was present. Cattle feed is
eaten quickly after it's manufactured, and the feed may have been
consumed before tests are finished, GAO said. The report examined 989
samples analyzed from August 2003 through June.

Investigators said the agency required no documentation of its reviews
and that FDA said a timeframe for testing is not critical to minimizing
cattle's exposure to potentially contaminated feed.

The program has many weaknesses, according to GAO, the investigative arm
of Congress

Feed safeguards are the most important firewall against mad cow disease.
The only way mad cow disease is known to spread is through feed
containing certain tissue from infected animals. Adding animal protein
to feed is commonly done to speed growth, but the U.S. has banned cattle
protein in cattle feed since 1997.

**Revision \# 2**: All renderers must be reported and certified by the
FDA, in addition to this all Renderers must be test not just a selected
few. The FDA currently only inspects 274 renderers which are reported to
the agency. These firms are the first to handle and process animal
proteins and to send these processed materials to feed mills and/or
protein blenders for use as a feed ingredient. The below mentioned
results are from 185 firms tested of the 274 renderers firms reported to
the FDA.

-   Number of active firms whose initial inspection has been reported to
    FDA -- 274

-   Number of active firms handling materials prohibited from use in
    ruminant feed -- 185 (68% of those active firms inspected)

-   Of the 185 active firms handling prohibited materials, their most
    recent inspection revealed that:

    -   1 firm (0.5%) was classified as OAI

    -   11 firms (5.9%) were classified as VAI

Yet the alarming fact that there is more firms out there that are not
reported to the FDA. It must be made a requirement that all renderers
firms report to the FDA so that the required tests can be conducted not
to just a few but all reported renderers firms. Penalties for such
offenders must be strict and a non-penalized period for non-reported
firms should be in place, this way renderers firms have an opportunity
to come forward with out being at risk of penalization. In addition to
this a reward to firms that have information regarding non-reported
firms should be award, such award should as well be attractive as to
entice reporting of offenders.

**Revision \# 3**: All feed mills producing medicated feed should be
required to be licensed by the FDA. As result of non-compliance to this
revision Feed Mills that actually are not licensed by the FDA and
continue to operate should be banned from processing Cattle feed to any
company whom raises cattle for meat distribution to US customers or any
company that will export meat from the US to any of our trade partners.
We must think of our consumers as well as are trade affiliates,
especially when the well being of an individual is at risk.

During inspections conducted by the FDA on Feed Mills not licensed by
the FDA the following was found:

-   Number of active firms whose initial inspection has been reported to
    FDA -- 5,165

-   Number of active firms handling materials prohibited from use in
    ruminant feed -- 2,036 (39% of those active firms inspected) 

-   Of the 2,036 active firms handling prohibited materials, their most
    recent inspection revealed that:

    -   2 firms (0.1%) were classified as OAI \*

    -   24 firms (1.2%) were classified as VAI \*\*

\*An OAI inspection classification occurs when significant objectionable
conditions or practices were found and regulatory sanctions are
warranted in order to address the establishment\'s lack of compliance
with the regulation. An example of an OAI inspection classification
would be findings of manufacturing procedures insufficient to ensure
that ruminant feed is not contaminated with prohibited material.
Inspections classified with OAI violations will be promptly re-inspected
following the regulatory sanctions to determine whether adequate
corrective actions have been implemented.

\*\* A VAI inspection classification occurs when objectionable
conditions or practices were found that do not meet the threshold of
regulatory significance, but do warrant advisory actions to inform the
establishment of findings that should be voluntarily corrected.
Inspections classified with VAI violations are more technical violations
of the Ruminant Feed Ban. These include provisions such as minor record
keeping lapses and conditions involving non-ruminant feeds.

In comparison to the other firms that are licensed by the FDA these
numbers are way higher. Note the number of firms themselves that are not
licensed are way too high in comparison to those that are not licensed.
Once again, it should be made a requirement that all firms producing
medicated feed; be licensed by the FDA.

**Revision \# 4**: In addition to Revision# 2, all licensed firms must
be inspected more than once a year. As noted above only 39% of
non-licensed firms were actually inspected and only 39% of licensed
firms were inspected as well. This is not sufficient, it only takes one
infected batch cattle of cattle feed to spread BSE/ Mad Cow disease
amongst many cattle. This means that as result all infected cattle can
infect many consumers, which would reflect into a widespread of this
deadly disease. It should be made a requirement that all feed mills be
tested.

**Revision \# 5**: The surveillance program announced by the USDA after
the Washington Mad Cow reporting should be handed to a, non-interest
baring third party inspection agencies overseen by the (GOA) Inspection
agency. Controversy regarding the protocol used USDA's surveillance
program, came about after an incident in Texas, where an animal
exhibiting central nervous systems symptoms was not test. Speculation is
that the USDA is hand picking the cattle, which is tested instead on
selecting at a random order, this way they can control the type of
results that are determined from the testing. Many test are reflecting
false- positive or inconclusive results, which is raising suspicion that
such results are reported according to lower market sensibility. In
other words the USDA is deliberately choosing a relatively rate of
inconclusive and false positive results as means of covering-up possible
discovery of true positive cases that could have a treacherous affect to
the economic and trade performance of the US cattle industry.

**Revision \# 6**: Testing on cattle should be done to all cattle ages
20 months and older, instead of 30 and older. This way we can further
mitigate any risk of this disease spreading. In Japan, such provision
where done soon after a 21month old cow was discovered of being infected
with BSE. At the time when the cow was discovered to have BSE they were
only testing from 30 months and older. Soon after discovery the
government decided to exempt from testing cows aged 20 months or
younger, a far stricter standard than the internationally recognized. To
date, there have been 21 BSE-infected cows found in Japan. But
immediately after the first infected animal was detected, regulations on
cattle feed were strengthened and no Infected cows have been found among
those bred since the tougher rules were adopted. This is further
evidence that our testing ages should be stricter. The benefits to this
revision would be that we could re-open the doors to trade with Japan
and many countries that currently have a ban on our beef products. Not
to mention that we lower the risk of the disease being contacted in the
US.

**Revision #7**: Prohibit the entire carcass of any cattle not inspected
and passed for human consumption that has not been tested for BSE. No
matter if the spinal cord or brain has been removed or not all carcasses
processed for cattle feed must be required to be tested for BSE. This
will also further mitigate the contracting of BSE.

**Revision \# 8**: Tighten and make provision to the law on dietary
supplements included in cattle feed so that it prohibits any supplement
contain the mutant protein found in BSE. Currently the law allows
supplements to contain material from the animal parts most likely to
contain the mutant protein.

**Revision \# 9**: Require doctors and hospitals to report all cases of
Creutzfeldt-jakob to the Centers for Disease Control and prevention.
Creutzfeldt-jakob disease is part of the BSE family and is the known
form of this disease to affect humans. With the assistance of the
medical field reporting such incidents further safeguards and prevention
can be implemented and discovered.

[Comments:]{.underline}

In conducting our study of the new amended proposal we conducted
surveys, which included the public (meat consumers), Center for Diseases
Control, The Center for Food Safety, National renderers Association, as
well as Wild Oats Supermarket were interviewed. The surveys were
conducted in three parts:

-   Survey #1 which was conducted with consumers (meat consumer) to get
    their input in this matter.

-   Survey \# 2 which was conducted with Center for Diseases Control,
    The Center for Food Safety, and Wild Oats.

-   Finally Survey \# 3 with the National Renderers Association, was
    solely used, in addition to our research as a contrary reference to
    our views of this proposal and good indicator why our revisions are
    needed to further perfect this amend proposal being presented to the
    FDA.

In Survey \# 1 the following questions were asked to five different
consumers:

How do feel about cattle feed containing spinal cords and brain matter,
which is feed to cattle which us as consumers eat?

-   Consumer 1 (Female, age: 38, mother of three children, meat
    consumer): I think it is very unhealthy, I would like my family to
    eat the right foods, and I would like my meat to be healthy.

-   Consumer 2 (Female, age: 33, mother of two children): I don't agree
    with this practice. I would like to eat healthier meat.

-   Consumer 3 (Male, age 33, no children, meat consumer): I didn't no
    about that; I think it is gross.

-   Consumer 4 (Male, age 40, father of three children, meat consumer):
    I do not find anything wrong with it as long as it is health. When
    asked if he know that Cattle Feed containing Spinal cord and Brain
    matter increased the risk of meat having BSE/ Mad Cow diseases;
    Consumer 4 answered that he was not aware of that fact. When asked
    how he felt was he was aware of the risk; Consumer 4 answered that
    he was not pleased but trusted that the government would take the
    needed measures to protect the public.

-   Consumer 5 (Male, age 27, no children, meat consumer): I feel
    totally apprehensive that cattle are feed this type of material. It
    does not seem safe for consumers.

Would you be willing to pay more for healthier meat?

-   Consumer 1 (Female, age: 38, mother of three children, meat
    consumer): If it means that the meat will be healthier, sure.

-   Consumer 2 (Female, age: 33, mother of two children, meat consumer):
    Yes I would be willing to pay more.

-   Consumer 3 (Male, age 33, no children, meat consumer): Definitely

-   Consumer 4 (Male, age 40, father of three children, meat consumer):
    Yes sure if it secures my children, my community and myself, I don't
    see why not.

-   Consumer 5 (Male, age 27, no children, meat consumer): I would be
    willing to pay more.

-   

How much more would you be willing to pay?

-   Consumer 1 (Female, age: 38, mother of three children, meat
    consumer): Depends on how much the increase is, but I'd pay up to 3
    dollars more.

-   Consumer 2 (Female, age: 33, mother of two children, meat consumer):
    It all depends, up to 3 dollars more, but I'd really pay whatever it
    takes to be able to eat healthier meat.

-   Consumer 3 (Male, age 33, no children, meat consumer): Maybe a
    dollar to two dollars more a pound.

-   Consumer 4 (Male, age 40, father of three children, meat consumer):
    It all depends. When asked if he'd pay up to a dollar more, consumer
    3 answered that a dollar was a little steep, but he would be willing
    to pay .25 or .50 cents more a pound.

-   Consumer 5 (Male, age 27, no children, meat consumer): Depending on
    how much more, but I would be willing to pay up to a dollar more a
    pound.

In survey \# 2 the following questions were asked to the CDC, CFS, and
Wild Oats Supermarket:

Why have no one raise an alarm about mad cow disease?

-   Center for Disease Control and Protection -Everybody wants to sell
    more beef and nobody is concerned about the public health.

-   The Center for Food and Safety- To protect the cattle ranchers

-   Wild Oats Rep.- Keep the ranchers pretending like the disease do not
    exist.

What do you think can be done to help?

-   Center for Disease Control and Protection - Require testing of all
    cattle over 20 months of age and all animal products from the feed.

-   The Center for Food and Safety -Stop feeding chicken litter to cows
    and using spinal cords material in processing.

-   Wild Oats Rep- Stop sending disease cows into beef products.

Do you think consumers should pay more for beef that omitted the use of
spinal and brain material in cattle feed?

-   Center for Disease Control and Protection -No, USDA and FDA are
    supposed to regulate these issues.

-   The Center for Food and Safety - No, this is just one of the many
    reason why USDA have their jobs.

-   Wild Oats Rep.-No, FDA is supposed to protect the public.

In regards to the above-mentioned Renderers Survey, this in our opinion
was the most eye opening and motivational point to our research. It is a
sad thing to say, but the beef, cattle, and feed industry is only
looking at one aspect of the process and that is their bottom line;
their marginal profit. Knowing the high risk involved and the
possibility of a BSE/ Mad Cow outbreak, as it occurred in Europe, their
main focus is how cheap can they grow it and how quickly can they get it
out to the public, leaving healthier and higher quality in the back
burner. What these industries fail to see is that if they took that
extra step to ensure that the quality of the feed was high and that all
cattle used for consumption was inspected, the public would consumer
more meat. The public in today's day and age is very aware about the
fact that our meat is not the highest quality and that the methods used
in raising cattle is not the most orthodox. As a result many of
Americans have shied way from consuming meat in high volumes, not to
mention the fact the several countries have banned our meat for trade.
It is obvious that if the proposed ruling were to be passed including
the above noted revisions, both the both as well as the meat industries
would triumph. The public would have the ability to consumer a healthier
product resulting in an increase in beef sales and a healthier product
would entice and ensure the trading channels with other countries for
our meat industry. Bottom line this proposed rule is a win/ win
situation for everyone.

Sincerely,

Pablo Lau Jr.

Tammy Lobet

Santino Bella

Carolina Pineira

Dania Quintero

Joan Bispott

Garvin Smith

If you have any questions please do not hesitate to contact us at:
plau24@yahoo.com