Gelatin Manufacturers Institute of America, Inc.

Comments on Proposed Rule

Recordkeeping Requirements for Human Food and Cosmetics Manufactured

From, Processed With, or Otherwise Containing, Material From Cattle

Food and Drug Administration

U.S. Department of Health and Human Services

Docket No. 2004N-0257

August 12, 2004

The Gelatin Manufacturers Institute of America, Inc. (GMIA) is a trade
association whose members include all of the producers of edible,
pharmaceutical and photographic gelatin in the United States and Canada,
and one of the largest Mexican manufacturers.[^1] GMIA members sell
edible gelatin directly to hundreds of food manufacturers and
distributors in the United States and a variety of export markets. GMIA
members also sell gelatin directly to soft gel and hard shell capsule
producers, primarily for use in dietary supplements. GMIA members export
gelatin to many countries around the world for use in dietary supplement
capsules.

The GMIA member companies are totally committed to ensuring that all
gelatin is safe for human consumption and over the years GMIA has
supported FDA on an ongoing basis to assure gelatin safety. The gelatin
industry cooperated in the establishment of and complied with the FDA's
1997 gelatin industry guidance.[^2] In addition, GMIA supported
extensive research studies conducted by highly respected, independent
scientists that have demonstrated that the process of manufacturing
bovine gelatin provides strong additional assurance of gelatin safety.
Data from these studies were presented to the FDA's Transmissible
Spongiform Encephalopathies Advisory Committee (TSEAC) at its meeting in
July, 2003. During this meeting, the TSEAC voted that these data
"demonstrate a reduction in infectivity that is sufficient to protect
human health."[^3]

The FDA is now proposing to take further steps in its ongoing effort to
ensure the safety of human food and cosmetics by requiring manufacturers
to establish and maintain records sufficient to demonstrate that such
products do not contain "prohibited cattle materials." The members of
GMIA, once again, support this effort. As explained further below, GMIA
believes that its members who produce bovine bone gelatin already have
established and maintain records sufficient to demonstrate that gelatin
is not manufactured from, processed with or otherwise contains
"prohibited cattle materials. Furthermore, GMIA members producing bovine
hide gelatin believe that the records requirement in this proposed rule
can be met through current industry record keeping regarding sourcing
hides from healthy animals. This, too, is more fully described below.

[Bovine Bone Gelatin Intended for Use in Food]{.underline}. Gelatin bone
sourced by GMIA member companies for the manufacture of bovine bone
gelatin for food use is obtained from a small number of large U.S. meat
processing companies. These companies are subject to continuous
oversight by the USDA and are in full compliance with the BSE
requirements for cattle materials promulgated by USDA in January 2004.
The cattle materials prohibited by USDA are the same materials
prohibited by the FDA Interim Final Rule.[^4] To the extent that U.S.
bovine bone gelatin manufacturers source from only a few plants, all of
which are USDA approved, it would seem both reasonable and expedient
that documentation by the gelatin manufacturers that their raw materials
were sourced from plants approved and under continuing oversight by USDA
should assure compliance. Thus, records are already in place to document
the source of the gel bone and are sufficient to comply with this
proposed rule.

[Bovine Hide Gelatin Intended for Use in Food.]{.underline} Cattle hides
sourced by GMIA member companies for the manufacture of bovine hide
gelatin for food use are purchased from a small number of tanneries in
the United States. These tanneries are supplied exclusively by
slaughterhouses under continuous oversight by the USDA. GMIA member
companies are also supplied by a few offshore suppliers operating under
the supervision of Veterinary Health Services in regions considered
BSE-free or provisionally free of BSE.

Cattle hides are removed as the first step in processing after the
slaughter of healthy animals. The hides are then immediately taken away
from the production zone where the animal carcass is further processed,
including the removal of SRMs. Thus, any potential for cross
contamination of hides is eliminated. Bovine hide gelatin is considered
safe and free from any and all potential BSE infectivity associated with
cattle material. As set forth on page 30 of the Joint FDA/USDA Advance
Notice of Proposed Rulemaking on Federal Measures to Mitigate BSE Risks:
Considerations for Further Action which was issued on the same date as
this proposed rule: "The OIE also identifies certain commodities that
should not require any BSE-related restrictions, regardless of the BSE
status of the exporting country or zone. For example, the [Terrestrial
Animal Health Code]{.underline} does not recommend any restrictions,
regardless of the BSE status of the country, in trade of . . . gelatin
and collagen coming from hides and skins because these products or
tissues have not demonstrated BSE infectivity in cattle." Records
already maintained by GMIA member companies are sufficient to
demonstrate that their cattle hide raw materials are sourced from
healthy animals slaughtered under the supervision of the USDA or the
Veterinary Health Services of the country source of origin. These
records are sufficient to comply with this proposed rule.

[All Bovine Gelatin Intended for Use in Food.]{.underline} The GMIA does
not believe each individual lot of raw materials or finished product
needs to be accompanied by records. Such a requirement would only add
additional costs without any added public health benefit or protection
for consumers that is not already addressed by FDA's rules and notices.
However, to the extent that FDA insists on a more detailed affirmation,
GMIA proposes that it would be sufficient for a Continuing Letter of
Guarantee to be issued in a blanket form that would cover all materials
provided to gelatin manufacturers and could be renewed on an annual
basis. In turn, customers of bovine gelatin manufacturers would need
only to seek a similar Continuing Letter of Guarantee from their gelatin
supplier.

Thank you in advance for your consideration of the GMIA comments.

Sincerely,

J. Michael Dunn, Ph.D. Karen J. Elam, Ph.D.

Chairman GMIA Consultant

GMIA Regulatory Committee

[^1]: GMIA members include: Atlantic Gelatin/Kraft Foods, Woburn, MA;
    Cangel Inc., Toronto, Ontario; Eastman Gelatine Corporation,
    Peabody, MA; Gelita North America, Sioux City, IA; PB Leiner,
    Davenport, IA and Jericho, NY; Rousselot Inc., Dubuque, IA and
    Waukesha, WI.

[^2]: *Guidance for Industry: The Sourcing and Processing of Gelatin to
    Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy
    (BSE) in FDA-Regulated Products for Hu*. *man Use* (Docket
    No. 97D‑0411, September 1997)

[^3]: FDA website:
    <http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3969t1.htm>.

[^4]: 9 CFR § 310.22; see Federal Register, Vol. 69, pp. 1862 et. seq.,
    January 12, 2004.