> **NOTIFICATION G/SPS/N/USA/933**

***Use of Materials Derived from Cattle in Human Food and Cosmetics***

***- Interim Final Rule -***

**\[Docket No. 2004N--0081\]**

**COMMENTS BY ARGENTINA**

**1- RULE DESCRIPTION**

The interim final rule issued by the Food and Drug Administration (FDA)
prohibits the use of certain cattle material, to address the potential
risk of bovine spongiform encephalopathy (BSE) in human food, including
dietary supplements, and cosmetics.

Prohibited cattle materials include specified risk materials, small
intestine of all cattle, material from non-ambulatory disabled cattle,
material from cattle not inspected and passed for human consumption, and
mechanically separated (MS)(Beef).

Specified risk materials are the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the wings
of the sacrum), and dorsal root ganglia of cattle 30 months and older;
and the tonsils and distal ileum of the small intestine of all cattle.
Prohibited cattle materials do not include tallow that contains no more
than 0.15 percent hexane-insoluble impurities and tallow derivatives.

FDA is taking this action in response to the finding of an adult cow,
imported from Canada, that tested positive for BSE in the State of
Washington.

This action is consistent with the recent interim final rule[^1] issued
in January by the US Department of Agriculture (USDA), on the
prohibition of the use of specified risk materials in human food and
requirements for the disposition of the non-ambulatory disabled cattle.
In the USDA rule, specified risk materials and the carcasses and parts
of non-ambulatory disabled cattle are declared to be inedible, unfit for
human food, their use as human food is prohibited and it is required
that the entire small intestine be removed and disposed of as inedible.

**2- SPS AGREEMENT**

In its **Article 3.1**, the Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement) provides for the Members\'
obligation to base their sanitary and phytosanitary measures on
international standards, guidelines or recommendations, where they
exist.

Notwithstanding this, **Article 3.3** recognizes the Members\' right to
introduce or maintain measures which result in a higher level of
protection than would be achieved by measures based on the relevant
international standards, guidelines or recommendations - assumptions
that will have to be based on scientific evidence.

In turn, under **Article 6.1**, "Members shall ensure that their
sanitary or phytosanitary measures are adapted to the sanitary or
phytosanitary characteristics of the area from which the product
originated and to which the product is destined."

**3- BSE: ARGENTINA\'S SANITARY STATUS**

On June 21 2004, the OIE submitted before the WTO the document
**G/SPS/GEN/501**: Issues of Interest to the SPS Committee Discussed by
the OIE International Committee at the 72^nd^ General Session *-
Communication from World Organization for Animal Health (OIE).*

There, it is informed the adoption of, *inter alia*, Resolution No. XXI
relative to the "Bovine Spongiform Encephalopathy Status of Member
Countries". Thereunder, Argentina is one of the four countries so far
officially recognized by said international organization as
"provisionally free from BSE" in accordance with the provisions of
Article 2.3.13.4 of the Terrestrial Code.

**4- TERRESTRIAL ANIMAL HEALTH CODE (Basado en versión en inglés del
07/09/04, que figura en la página de la OIE)**

The Terrestrial Code sets out BSE-related provisions on trade that make
distinctions by product, or by their origin country or zone. Article
2.3.13.18 also refers to their purpose, establishing that:

1.  From cattle of any age originating from a [**country or** **zone
    with a moderate or a high BSE risk**]{.underline}, the following
    commodities, and any commodity contaminated by them, should not be
    traded for the preparation of food, feed, fertilizers, cosmetics,
    pharmaceuticals including biologicals, or medical devices: tonsils
    and intestine, and protein products derived thereof. Food, feed,
    fertilizers, cosmetics, pharmaceuticals or medical devices prepared
    using these commodities should also not be traded

2.  From cattle originating from a **[country or zone with a moderate or
    a high BSE risk]{.underline}**, that were at the time of slaughter
    over 12 months of age, the following commodities, and any commodity
    contaminated by them, should not be traded for the preparation of
    food, feed, fertilizers, cosmetics, pharmaceuticals including
    biologicals, or medical devices: brains, eyes, spinal cord, skull
    and vertebral column and protein products derived thereof. Food,
    feed, fertilizers, cosmetics, pharmaceuticals or medical devices
    prepared using these commodities should also not be traded.

3.  From cattle originating from a **[country or zone with a minimal BSE
    risk]{.underline}**, that were at the time of slaughter over 30
    months of age, the following commodities, and any commodity
    contaminated by them, should not be traded for the preparation of
    food, feed, fertilizers, cosmetics, pharmaceuticals including
    biologicals, or medical devices: brains, eyes and spinal cord,
    skull, vertebral column and derived protein products. Food, feed,
    fertilizers, cosmetics, pharmaceuticals or medical devices prepared
    using these commodities should also not be traded.

Thus, it is possible to note that there are no determinants established
for imports from BSE provisionally free countries, Argentina\'s
officially-recognized sanitary status.

**5- ARGENTINA\'S COMMENTS**

**A) Comments on the Form**

From a procedural standpoint, Argentina\'s comments to this measure are
the same as those duly submitted in relation to the interim final rule
notified as G/SPS/N/USA/844 - Prohibition of the use of specified risk
materials in human food and requirements for the disposition of the
nonambulatory disabled cattle.

In that sense, the procedure implemented by the US in order to notify
the measure under analysis has not followed the rules of the procedure
recommended to apply the transparency-related obligations set out in the
SPS Agreement (Article 7)[^2] since

-   the measure was not notified before becoming effective as its
    application is immediate and binding for any country wishing to
    export the products included therein to the US, and

-   neither does it correspond to any of the causes that justify the
    application of an urgency measure since this is not a case where the
    US faces problems of urgent sanitary protection or a threat thereof.

**B) Comments on the Substance**

Argentina shares with the US the concern resulting from the BSE case
occurred in the state of Washington. However, we disagree on the
criterion of immediate and binding application of the notified rule to
all countries.

The fact that the sanitary status of exporting countries is not
considered in the rule (Art. 6 - SPSA) leads to the indiscriminate
restriction of the entry of products posing different risk levels.

Ignoring the sanitary status of the country or zone of origin of the
products must not be deemed as a minor issue when, in addition to the
SPS Agreement provision, there is a qualification range in the
Terrestrial Animal Health Code ranking from country or zone free from
BSE, country or zone provisionally free from BSE, country or zone with a
minimal BSE risk, country or zone with a moderate BSE risk, to country
or zone with a high BSE risk. That is, there are five categories of
sanitary status and Argentina enjoys the top one of those so far
recognized.

In Argentina\'s case,

-   both cattle brains and spinal cords are used for human consumption,
    but since 2002 their use for animal feeding has been prohibited as
    an additional risk mitigation measure;

-   the BSE-related ineffectiveness of the distal ileum is associated
    with the lymphoreticular tissue, and it has been detected only in
    bovines that have been experimentally infected;

```{=html}
<!-- -->
```
-   since 10/01/2000, in the entire European Union, it is mandatory to
    withdraw from the human and animal food chains the specified risk
    materials like the spinal cord, brains, eyes, tonsils and part of
    the intestines from cattle; however, under the circular letter
    E3D(03) 532459/jfp dated on October 9 2003 in Brussels, the EU
    accepts the entire small intestine from Argentina;

-   the non-ambulatory cattle that, in being inspected by professionals,
    prove to be so due to evidently traumatic causes are not involved in
    the epidemiological surveillance program implemented in Argentina
    and are used for human consumption.

**6- PETITION BY ARGENTINA**

Bearing in mind these considerations, Argentina thanks for the chance to
submit comments and requires the United States to make the pertinent
modifications to the notified text in order for the notified entry
restrictions to be adjusted to the sanitary status of the exporting
countries, as set out in the IOE Terrestrial Animal Health Code.

Such modifications may be made by excluding from the application scope
of the rule the materials from cattle born and raised in a country free
or provisionally free from BSE as recognized by the IOE, or by
acknowledging the equivalence of the measures implemented by those
countries to those notified by the US on the mitigation of BSE exposure
risks.

[^1]: NOTIFICATION G/SPS/N/USA/844 - Interim final rule - Docket No.
    03-025IF.

[^2]: G/SPS/7/Rev2