[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Rules and Regulations]
[Pages 14012-14013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04869]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. FDA-2004-N-0188] (Formerly 2004N-0081)
RIN 0910-AF47


Use of Materials Derived From Cattle in Human Food and Cosmetics; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or ``we'') is reopening 
the comment period for the interim final rule entitled ``Use of 
Materials Derived From Cattle in Human Food and Cosmetics'' that 
published in the Federal Register of July 14, 2004 (69 FR 42256). The 
interim final rule prohibited the use of certain cattle material to 
address the potential risk of bovine spongiform encephalopathy (BSE) in 
human food, including dietary supplements, and cosmetics. In the 
Federal Register of September 7, 2005 (70 FR 53063), we amended the 
interim final rule to make changes, including providing that the small 
intestine of cattle, formerly prohibited cattle material, could be used 
in human food and cosmetics if the distal ileum was removed by a 
specified procedure or one that the establishment could demonstrate is 
equally effective in ensuring complete removal of the distal ileum. 
Since 2005, peer-reviewed studies have been published showing the 
presence of infectivity in the proximal ileum, jejunum, ileocecal 
junction, and colon of cattle with BSE. Therefore, we are reopening the 
comment period for the interim final rule to give interested parties an 
opportunity to comment on the new studies concerning infectivity in 
parts of the small intestine other than the distal ileum.

DATES: Submit either electronic or written comments by May 3, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Johnny Braddy, Center for Food Safety 
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2131.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of July 14, 2004 (69 FR 42256), FDA 
published an interim final rule entitled ``Use of Materials Derived 
From Cattle in Human Food and Cosmetics.'' The interim final rule 
prohibited the use of certain cattle material to address the potential 
risk of BSE in human food and cosmetics. The interim final rule 
designated the small intestine as prohibited cattle material and 
prohibited its use in human food or cosmetics. In the Federal Register 
of September 7, 2005 (70 FR 53063), we amended the interim final rule 
to allow the use of the small intestine if the distal ileum is removed 
by a procedure that removes at least 80 inches of uncoiled and trimmed 
small intestine as measured from the ceco-colic junction and 
progressing proximally towards the jejunum or by a procedure that the 
establishment can demonstrate is equally effective in ensuring complete 
removal of the distal ileum.
    On January 12, 2004, the U.S. Department of Agriculture, Food 
Safety and Inspection Service (FSIS), issued an interim final rule to 
designate materials that could potentially contain BSE infectivity as 
specified risk materials (SRMs) and prohibit their use for human food 
(see ``Prohibition of the Use of Specified Risk Materials for Human 
Food and Requirements for the Disposition of Non-Ambulatory Disabled 
Cattle''; 69 FR 1862; January 12, 2004). FSIS's interim final rule 
designated the distal ileum as an SRM but required that the entire 
small intestine be removed and disposed of as inedible to ensure the 
effective removal of the distal ileum. On September 7, 2005, FSIS, like 
FDA, amended its interim final rule to permit the use of the entire 
small intestine for human food if the distal ileum is removed by a 
procedure that removes at least 80 inches of the uncoiled and trimmed 
small intestine as measured from the ceco-colic junction and 
progressing proximally towards the jejunum or by a procedure that the 
establishment demonstrates is effective in ensuring complete removal of 
the distal ileum.
    When the FDA and FSIS amendments to the interim final rules were 
published in 2005, BSE infectivity had been demonstrated in lymphoid 
tissue of the distal ileum. In naturally occurring cases, sparse 
immunostaining had also been observed in the myenteric plexus of the 
distal ileum indicating the presence of PrPSc\,\ a TSE-specific protein 
(Ref. 1). Because the myenteric plexus extends throughout the small 
intestine, both FDA and FSIS considered that it was possible that 
infectivity might also exist in the myenteric plexus of the jejunum or 
the duodenum. We stated in our 2005 amendment to our interim final rule 
that if we became aware of data indicating that other portions of the 
small intestine harbored BSE infectivity, we would take action 
appropriate to the public health risk. FSIS stated in its 2005 
amendment to its interim final rule that while it believed that the 
primary tissues of concern for spreading the BSE agent had been 
identified, FSIS would use the results of future studies on BSE to 
further refine its policies with regard to BSE (70 FR 53043 at 53047; 
September 7, 2005). In 2007, FSIS issued a final rule to make permanent 
the interim measures implemented in 2004 and amended in 2005 (72 FR 
38700; July 13, 2007).
    Since we amended our interim final rule in 2005 and FSIS issued its 
final rule in 2007, peer-reviewed studies have been published showing 
the presence of some infectivity in the proximal ileum,

[[Page 14013]]

jejunum, ileocecal junction, and colon of cattle with BSE. The new 
scientific data confirms the presence of limited amounts of BSE 
infectivity in the small intestine outside of the distal ileum of 
classical BSE infected cattle under experimental inoculation and field 
conditions. The infectivity levels reported in these studies were much 
lower than the infectivity levels that were previously demonstrated in 
the distal ileum.
    We have added several peer-reviewed studies (Refs. 2 to 6) to the 
administrative record. We invite comment on those studies.
    Additionally, the European Food Safety authority (EFSA) Panel on 
Biological Hazards (BIOHAZ) has reviewed and evaluated new data as it 
relates to the BSE epidemiological situation in the European Union. We 
have added the EFSA documents to the administrative record as well 
(Refs. 7 and 8). We have evaluated the data from the studies. Only 
trace amounts of infectivity have been found in the proximal ileum, 
jejunum, ileocecal junction, and colon of cattle with naturally 
occurring cases of BSE. We tentatively conclude that the effect of 
these traces of infectivity on the risk of human or ruminant exposure 
to BSE in the United States is negligible. The very low levels of 
infectivity in parts of the intestine other than the distal ileum, the 
sharp decline in the prevalence of BSE worldwide, FDA's BSE-related 
restrictions on the contents of animal food and feed (see 21 CFR 
589.2000 and 589.2001), and the extremely low prevalence of BSE within 
cattle in the United States due to the presence of effective 
mitigations and compliance with international standards suggest that 
the risk from parts of the intestine other than the distal ileum is 
extremely low. We also note that the World Organization for Animal 
Health (formerly known as the Office International des Epizooties or 
``OIE'') has not changed its definition of SRMs to include any part of 
the small intestine in addition to the distal ileum. Based on this 
assessment, we tentatively conclude that requiring the removal of 
additional parts of the small intestine would not provide a measurable 
risk reduction compared to that already being achieved by removal of 
the distal ileum in all cattle and that it would be appropriate to 
finalize our interim final rule without changing any provisions related 
to the small intestine. We invite comment on this tentative conclusion.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. Terry, L.A., S. March, S.J. Ryder, et al., ``Detection of Disease 
Specific PrP in the Distal Ileum of Cattle Exposed Orally to the 
Agent of Bovine Spongiform Encephalopathy,'' Veterinary Record, vol. 
152, pp. 387-392, 2003.
 2. Balkema-Buschmann, A., C. Fast, M. Kaatz, et al., ``Pathogenesis 
of Classical and Atypical BSE in Cattle.'' Preventive Veterinary 
Medicine, vol. 102, pp. 112-117, 2011.
 3. Hoffmann, C., M. Eiden, M. Kaatz, et al., ``BSE Infectivity in 
Jejunum, Ileum and Ileocaecal Junction of Incubating Cattle,'' 
Veterinary Research, vol. 42, p. 21, 2011.
 4. Kimura K. and M. Haritani, ``Distribution of Accumulated Prion 
Protein in a Cow With Bovine Spongiform Encephalopathy,'' The 
Veterinary Record, vol. 162, pp. 822-825, 2008.
 5. Okada H., Y. Iwamaru, M. Imamura, et al. ``Detection of Disease-
Associated Prion Protein in the Posterior Portion of the Small 
Intestine Involving the Continuous Peyer's Patch in Cattle Orally 
Infected With Bovine Spongiform Encephalopathy Agent,'' 
Transboundary and Emerging Diseases, vol. 58(4), pp. 333-343, Aug. 
2011.
 6. Stack M., S.J. Moore, A. Vidal-Diez, et al. ``Experimental 
Bovine Spongiform Encephalopathy: Detection of PrP(SC) in the Small 
Intestine Relative to Exposure Dose and Age,'' Journal of 
Comparative Pathology, vol. 145, pp. 289-301, 2011.
 7. ``European Food Safety Authority (EFSA) Panel on Biological 
Hazards (BIOHAZ),'' EFSA Journal, vol. 1317, pp. 1-9, 2009.
 8. ``European Food Safety Authority (EFSA) Panel on Biological 
Hazards (BIOHAZ),'' EFSA Journal, vol. 9(3), p. 2104, 2011.

    Dated: February 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04869 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P