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Rules and Regulations Federal Register

53043 

Vol. 70, No. 172 

Wednesday, September 7, 2005 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 310 and 318 

[Docket No. 03–025IFA] 

Prohibition of the Use of Specified 

Risk Materials for Human Food and 

Requirements for the Disposition of 

Non-Ambulatory Disabled Cattle 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Interim final rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is amending 

its interim final rule, ‘‘Prohibition of the 

Use of Specified Risk Materials for 

Human Food and Requirements for the 

Disposition of Non-Ambulatory Cattle,’’ 

published in the Federal Register on 

January 12, 2004. The amendments 

permit beef small intestine, excluding 

the distal ileum, to be used for human 

food, provided that such product is 

derived from cattle that were 

slaughtered in an official establishment 

in the United States or in a certified 

foreign establishment from a foreign 

country that is eligible to export beef 

products to the United States. Although 

the distal ileum is the only portion of 

the small intestine in which BSE 

infectivity has been confirmed, the 

January 2004 interim final rule requires 

that the entire small intestine of all 

cattle be removed and disposed of as 

inedible. FSIS is taking this action based 

on the Agency’s evaluation of this issue 

and of the comments received on the 

interim final rule, as well as comments 

received on an advance notice of 

proposed rulemaking published in July 

2004. FSIS has concluded that the distal 

ileum can be effectively removed from 

the rest of the small intestine. FSIS has 

determined that removal of the distal 

ileum in accordance with the 

amendments in this document will 

provide the same level of protection 

from human exposure to the BSE agent 

as does the exclusion of the entire small 

intestine from the human food supply. 

DATES: This interim final rule is 

effective October 7, 2005. Comments on 

this interim final rule must be received 

by November 7, 2005. 

ADDRESSES: FSIS invites interested 

persons to submit comments on this 

amended interim final rule. Comments 

may be submitted by any of the 

following methods: 

• Mail, including floppy disks or CD– 

ROM’s, and hand- or courier-delivered 

items: Send to Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, 300 12th Street, 

SW., Room 102 Cotton Annex, 

Washington, DC 20250. 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Electronic 

mail: 

fsis.regulationscomments@fsis.usda.gov. 

Follow the online instructions at that 

site for submitting comments. 

All submissions received must 

include the Agency name and docket 

number 03–025IFA. 

All comments submitted in response 

to this amended interim final rule, as 

well as research and background 

information used by FSIS in developing 

this document, will be available for 

public inspection in the FSIS Docket 

Room at the address listed above 

between 8:30 a.m. and 4:30 p.m., 

Monday through Friday. The comments 

also will be posted on the Agency’s Web 

site at http://www.fsis.usda.gov/ 

regulations_&_policies/ 

2005_Interim_&_Final_Rules_Index/ 

index.asp. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Daniel Engeljohn, Deputy Assistant 

Administrator, Office of Policy, 

Program, and Employee Development, 

FSIS, U.S. Department of Agriculture, 

1400 Independence Avenue, SW., 

Washington, DC 20250–3700, (202) 205– 

0495. 

SUPPLEMENTARY INFORMATION: 

Background 

On January 12, 2004, FSIS issued a 

series of three interim final rules to 

minimize human exposure to materials 

that scientific studies have 

demonstrated contain the BSE agent in 

cattle infected with the disease. FSIS 

issued the rules in response to the 

diagnosis on December 23, 2003, of BSE 

in an imported dairy cow in Washington 

State. The animal had been imported 

from Canada. One of the rules, 

‘‘Prohibition of the Use of Specified Risk 

Materials for Human Food and 

Requirements for the Disposition of 

Non-ambulatory Disabled Cattle’’ (69 FR 

1826, January 12, 2004) (also referred to 

as ‘‘the SRM interim final rule’’ or ‘‘the 

SRM rule’’), among other things, 

designates certain materials from cattle 

as SRMs, declares that SRMs are 

inedible, and prohibits the use of these 

materials for human food (9 CFR 

310.22(a) and 9 CFR 310.22(b)). The 

SRM rule also requires that 

establishments that slaughter cattle, and 

establishments that process the 

carcasses and parts of cattle, incorporate 

their procedures for the removal, 

segregation and disposition of SRMs 

into their HACCP plans or Sanitation 

SOPs or other prerequisite program (9 

CFR 310.22(d)(1)). 

The materials identified as SRMs in 

the FSIS SRM rule 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 (DRG) of cattle 

30 months of age and older, and the 

distal ileum of the small intestine and 

tonsils from all cattle (9 CFR 310.22(a)). 

FSIS designated these materials as 

SRMs because they have been found to 

contain BSE infectivity at some point 

during the disease incubation period. 

Furthermore, the Agency determined 

that SRMs should be declared as 

inedible because, as stated in the 

preamble to the SRM rule, they present 

a sufficient risk of exposing humans to 

the BSE agent so as to render them 

‘‘unfit for human food’’ within the 

meaning of section 1(m)(3) of the 

adulteration provisions of the Federal 

Meat Inspection Act (FMIA) (21 U.S.C. 

601(m)(3)). For a detailed explanation of 

FSIS’’ rationale for designating these 

tissues as SRMs, including the 

supporting scientific studies, refer to the 

preamble to ‘‘Prohibition of the Use of 

Specified Risk Materials for Human 

Food and Requirements for the 

Disposition of Non-ambulatory Disabled 

Cattle.’’ 

FSIS designated the distal ileum from 

all cattle as an SRM because, in cattle 

infected with BSE under experimental 

conditions, infectivity was confirmed in 

53044 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

the distal ileum in the early stages of the 

disease. To ensure effective removal of 

the distal ileum, FSIS requires that the 

entire small intestine be removed and 

disposed of as inedible (9 CFR 

310.22(a)(3)). However, in the preamble 

to the SRM rule, FSIS noted that beef 

processors may be able to effectively 

remove the distal ileum from the rest of 

the small intestine and requested 

comments on this issue (69 FR 1862, 

1869). 

On July 14, 2004, the Food and Drug 

Administration (FDA) issued an interim 

final rule, ‘‘Use of Materials Derived 

From Cattle in Human Food and 

Cosmetics’’ (also referred to as ‘‘the FDA 

rule’’ or ‘‘the prohibited cattle materials 

rule’’), that extends the measures to 

prevent human exposure to the BSE 

agent issued by FSIS to FDA-regulated 

human food and cosmetics (69 FR 

42255). In its rule, FDA designates 

certain materials from cattle as 

‘‘prohibited cattle materials’’ and 

prohibits the use of such materials for 

human food, including dietary 

supplements, and cosmetics (21 CFR 

189.5 and 21 CFR 700.27). Among the 

materials designated as prohibited cattle 

materials by the FDA are SRMs, the 

small intestine from all cattle, and 

material from cattle not inspected and 

passed for human consumption. 

Materials that were designated as SRMs 

in the FDA rule are the same as the 

materials designated as SRMs by FSIS. 

Although FDA designated the distal 

ileum of the small intestine from cattle 

as an SRM, like FSIS, it prohibits the 

use of the entire small intestine for 

human food. Consistent with the 

amendments to the SRM interim final 

rule that FSIS is issuing in this 

document, FDA intends to issue an 

amendment to its prohibited cattle 

materials rule to permit, under certain 

circumstances, the manufacture and use 

of beef casings derived from beef small 

intestine, excluding the distal ileum, for 

human food and cosmetics. 

Comments Received on Procedures for 

Removal of the Distal Ileum 

In response to the SRM rule, FSIS 

received several comments from beef 

processors, the natural casing industry, 

the beef by-product industry, and 

importers and exporters of natural 

casings and beef by-products on the 

need to exclude the entire small 

intestine from the human food supply. 

On July 14, 2004, APHIS, FSIS, and the 

Food and Drug Administration (FDA) 

issued an Advance Notice of Proposed 

Rulemaking (ANPR), ‘‘Federal Measures 

To Mitigate BSE Risks: Considerations 

for Further Action,’’ (also referred to as 

the APHIS/FSIS/FDA ANPR) that 

provided another opportunity for 

interested parties to comment on which 

portions of the intestine of cattle should 

be removed to prevent potentially 

infective material from entering the 

human food supply (69 FR 42287, 

42296). The comment period for the 

APHIS/FSIS/FDA ANPR closed on 

September 13, 2004. 

Most of the comments submitted to 

the Agency on this issue requested that 

FSIS amend the SRM rule to require the 

removal and disposal of only the distal 

ileum and allow the remaining portion 

of the small intestine to be used for 

human food. As stated by the 

commenters, infectivity has been 

confirmed only in the distal ileum of the 

small intestine of cattle infected with 

BSE under experimental conditions, and 

the technology exists to effectively 

remove the distal ileum from the rest of 

the small intestine. The commenters 

noted that, before the issuance of the 

SRM rule, FSIS had approved a 

standard operating procedure to certify 

the removal of the distal ileum from the 

remaining portions of beef small 

intestine intended for export to Japan. 

As stated by the commenters, the 

procedure approved by FSIS requires 

the removal of at least 80 inches of the 

small intestine as measured from the 

junction of the ileum and the cecum. 

To further support their argument, 

several commenters provided a detailed 

anatomical description of the small 

intestine of cattle, along with pictures 

and diagrams of the anatomy of the 

small intestine, which they asserted can 

be used to develop a model of 

certification of the removal and disposal 

of the distal ileum. According to the 

commenters, this description was 

developed with full scientific oversight 

and has widespread support within the 

beef processing, casing, and beef byproduct industry. 

Many commenters also described, in 

detail, examples of verifiable procedures 

for the effective removal of the distal 

ileum. One procedure described in the 

comments begins with the removal of 

the small intestine from the abomasum. 

Under this procedure, the small 

intestine is separated from the cecum at 

the ileocecal orifice, and the ileum is 

separated from the jejunum at the 

flange. According to the commenters, 

the resulting portion that contains the 

distal ileum would measure 36 to 72 

inches in length depending on the age 

and size of the animal. 

Another procedure described in the 

comments also begins with removal of 

the small intestine from the abomasum, 

except that under this procedure the 

small intestine remains attached to the 

cecum, and the separation is made at a 

point 36 to 80 inches from the cecum, 

leaving behind the remaining edible 

portions of the small intestine. 

According to the commenters, leaving 

the ileum attached to the cecum at this 

initial stage provides an easily verifiable 

point of reference for on-line inspectors. 

The next step in this procedure is to 

separate the 36 to 80 inch portion of the 

intestine that contains the ileum from 

the cecum at the ileocecal orifice, 

leaving the cecum and the large 

intestine for edible use. 

Another commenter described a 

procedure that uses a ‘‘Small Intestine 

Processing Machine’’ that was 

developed in Japan approximately 10 

years ago specifically for the harvest of 

the jejunum of the intestine for export 

to Japan. As presented by the 

commenter, the Small Intestine 

Processing Machine strips the fat from, 

washes, and then splits the jejunum 

lengthwise, and cuts the small intestine 

into sections without leaving any part of 

the distal ileum attached. The 

commenter stated that the harvest 

procedures using the Small Intestine 

Processing Machine require that the 

uncoiled and untrimmed jejunum 

portion of the small intestine be cut at 

least 72 cm or 30 inches from the cecum 

end of the small intestine, which is 

equal to approximately 80 inches of the 

split, washed, and trimmed small 

intestine. According to the commenter, 

this removal procedure exceeds the total 

length of the distal ileum of the small 

intestine and includes a portion of the 

jejunum as a precaution. 

This same commenter stated that the 

harvest procedures for the Small 

Intestine Processing Machine require 

that the entire intestinal tract of the 

digestive system be laid out in full view 

prior to starting the separation process, 

which makes accurate identification and 

removal of the distal ileum possible. 

The commenter provided pictures 

depicting the location of the distal 

ileum, cecum, and jejunum portions of 

the small intestine and noted that as the 

distal ileum joins the cecum, it is 

distinct from the jejunum, duodenum, 

and colon. The commenter also 

explained that as the separation of the 

jejunum (small intestine) is done by the 

Small Intestine Processing Machine, the 

harvest is only completed between the 

initial cut on the cecum end and the 

final cut adjacent to the duodenal 

jejunal flexure. 

Several commenters indicated that 

because of the distinct shape of the 

distal ileum of cattle, FSIS inspection 

program personnel could easily verify 

the effective removal of this portion of 

the small intestine. Furthermore, 

commenters from the natural casing 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53045 

1The international guidelines established by the 

OIE have been revised since FSIS issued the SRM 

interim final rule. The OIE guidelines in the 2005 

Terrestrial Animal Health Code provide for a BSE 

‘‘negligible risk’’ category instead of the ‘‘BSE-free’’

and ‘‘provisionally free’’ categories. 

industry stated that because of its 

physical properties, particularly the fact 

that it has no curve and an irregular 

thick surface, the distal ileum is not 

useable as a natural casing for sausage 

products. Thus, these commenters 

noted, many slaughter establishments in 

the United States and Canada had a 

policy of removing the distal ileum from 

all cattle at the time of slaughter prior 

to the effective date of the SRM rule. 

Furthermore, as stated by the 

commenters, prior to the effective date 

of the SRM rule, slaughter 

establishments in Brazil, Argentina, and 

Uruguay, the three countries that are the 

major exporters of natural casings to the 

United States, had all been able to 

certify the removal of the distal ileum 

using achievable standards when 

requested to do so by their U.S. 

customers. One commenter submitted a 

CD–ROM on ‘‘Details of Beef Casing 

Production in Brazil: Eliminating the 

Distal Ileum,’’ which, according to the 

commenter, demonstrates the distinct 

appearance of the bovine ileum. The 

commenters also noted that Brazil, 

Uruguay, and Argentina are countries 

that are generally recognized as having 

a negligible BSE risk by the 

international community. 

Other Comments on Removal of the 

Small Intestine 

In addition to the comments that 

presented procedures for removing the 

distal ileum, FSIS received other 

comments on whether the entire small 

intestine from cattle should be excluded 

from the human food supply. Some 

commenters, including members of the 

natural casing industry, importers and 

exporters of natural casings and beef byproducts, and foreign countries that 

consider themselves to be ‘‘BSE-free,’’

such as Australia, New Zealand, 

Uruguay, and Argentina, suggested that 

FSIS consider a country’s BSE risk 

status when determining which portions 

of the intestine, if any, should be 

removed and disposed of as inedible. 

Most of these commenters also 

requested that FSIS exempt countries 

recognized as ‘‘BSE-free’’ or 

‘‘provisionally free’’ by the international 

community from all provisions of the 

SRM rule.1

According to the commenters, a 

country’s BSE-free risk status provides 

the same level of protection from human 

exposure to the BSE agent as does 

exclusion of SRMs and beef small 

intestine from the human food supply in 

the United States. In addition, as noted 

by the commenters, such an approach 

would be consistent with guidelines 

established by the World Organization 

for Animal Health (the OIE), which 

recommend that countries restrict the 

importation of beef small intestines and 

other potentially infective materials on 

the basis of the BSE risk classification 

of the region of origin. 

FSIS’ regulations governing the 

importation of meat and meat products 

from foreign countries into the United 

States prohibit the importation of any 

product that is adulterated or 

misbranded, or that does not comply 

with the regulatory requirements that 

would apply to it if it were a domestic 

product (9 CFR 327.3(a)). The FSIS 

import regulations at 9 CFR 327.4(a) 

also require that fresh meat or fresh 

meat by-products consigned to the 

United States from a foreign country be 

accompanied by a foreign meat 

inspection certificate, signed by the 

official authorized by the national 

foreign government to issue inspection 

certificates for meat and meat byproducts exported to the Unites States, 

that certifies, among other things, that 

such products are not adulterated or 

misbranded, and that such products 

have been handled in a sanitary manner 

and are otherwise in compliance with 

requirements equivalent to those in the 

FMIA and its implementing regulations. 

The regulations, 9 CFR 327.3(a) and 9 

CFR 327.4(a), make clear that to be 

eligible for importation into the United 

States, meat products from foreign 

countries must present no greater risk to 

human health than products that were 

produced domestically in the United 

States, and that to achieve the 

appropriate level of public health 

protection, such products must comply 

with regulatory requirements equivalent 

to those required by FSIS. 

Thus, if FSIS were to exempt 

countries with a BSE-free risk status (or 

negligible BSE risk under OIE 

guidelines) from some or all of the 

provisions of the SRM rule, as requested 

by some of the commenters, any 

products eligible for importation into 

the United States would be required to 

comply with 9 CFR 327.3(a) and 9 CFR 

327.4(a), i.e., they could not be 

adulterated or misbranded, and would 

be required to comply with 

requirements that are equivalent to 

those in the FSIS SRM rule. As stated 

above, in response to the confirmation 

of BSE in the cow in Washington State, 

FSIS currently considers the distal 

ileum and all other SRMs from U.S. 

domestic cattle as adulterated under 

section 1(m)(3) of the FMIA. The 

Agency is evaluating whether it is 

appropriate to consider these materials 

adulterated if they originate from a 

country considered to have a BSE-free 

risk status. Until FSIS has an 

opportunity to resolve this issue, the 

Agency has decided that all materials 

designated as SRMs, including the distal 

ileum, should be excluded from the 

human food supply, regardless of their 

country-of-origin. FSIS will continue to 

evaluate the issue, and if the Agency 

determines that an exemption is 

appropriate for countries considered to 

have a BSE-free risk status or negligible 

BSE risk under OIE guidelines, the 

Agency will take appropriate action. 

Other commenters, including a 

private consultant, consumer advocacy 

organization, and members of the 

restaurant industry, recommended that 

FSIS expand the prohibition on the use 

of small intestine from cattle for human 

food to include the entire intestine, both 

large and small. Some of these 

comments noted that while certain 

sections of the intestine were tested 

with no infectivity, not every section of 

the intestine was subjected to the 

bioassay in the pathogenesis studies 

conducted in the United Kingdom. One 

comment asserted that instead of 

assuming that the untested section of 

the intestine are devoid of infectivity, 

FSIS should err on the side of caution 

when it comes to protecting public 

health. 

Some comments, one of them citing 

an unpublished study, mentioned that 

positive immunostaining has been 

identified along the length of the 

intestine, providing evidence for the 

entire intestine to be considered SRM 

under European Union regulations. To 

better understand the implications of 

this finding FSIS contacted the 

commenter to obtain more information 

on the study. The commenter explained 

that the statement that positive 

immunostaining has been identified 

along the length of the intestine was 

based on a misunderstanding of a report 

on a published study. 

The commenter clarified that there are 

published studies in which positive 

immunostaining has been identified in 

the distal ileum portion of the enteric 

nervous system (ENS) of naturally 

infected and experimentally challenged 

cattle with BSE. However, the 

commenter maintained that FSIS should 

designate the entire intestine, both large 

and small, as SRM because the ENS 

runs through the length of the intestinal 

tract and other areas of the ENS from 

naturally occurring cases of BSE have 

not yet been examined for infectious 

prion staining. Thus, stated the 

commenter, if other areas of the 

53046 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

intestinal tract were subjected to 

immunostaining, one might expect to 

find positive immunostaining in 

portions of the intestinal tract other than 

the distal ileum. The commenter also 

noted that, although immunostaining 

was attempted and found negative on 

sections of the intestine other than the 

distal ileum of experimentally 

challenged cattle, this study was 

extremely limited with regard to the 

testing of tissues other than the distal 

ileum (i.e., tissues from 3 calves 

sacrificed 6 months post-exposure). 

Also, as stated by the comments, 

according to the E.U. Scientific Steering 

Committee (SSC), intestine should be 

SRM because infection from BSE comes 

from ingesting contaminated feed and 

slaughterhouse contamination of other 

intestinal areas with matter from the 

ileum cannot be avoided. Many of the 

comments also noted that the 

International Review Team (IRT) 

appointed by the Secretary of 

Agriculture in January 2004 to assess 

the U.S. Government’s response to the 

detection of BSE in the cow in 

Washington State recommended that the 

SRM definition be adjusted to include 

the entire intestine, from pylorus to 

anus, of all cattle. 

After considering these comments, 

FSIS has not changed its conclusion 

that, when the distal ileum is effectively 

removed, beef small intestine that 

complies with the requirements of this 

interim final rule presents no greater 

risk of introducing the BSE agent into 

the human food supply than do other 

beef products permitted for use as 

human food in the United States. As 

discussed below, this conclusion is 

based on the information available to 

the Agency with regard to BSE 

infectivity in the intestine of cattle, 

together with the availability of 

procedures to effectively remove the 

distal ileum. 

FSIS is not aware of any studies in 

which BSE infectivity has been 

confirmed in any portion of the 

intestinal tract of cattle other than the 

distal ileum. The animal studies of TSEs 

that indicate infectivity along the entire 

intestinal tract that the Agency is aware 

of involve animal species other than 

cattle (Ref. 1–6, available for viewing by 

the public in the FSIS docket room). 

Although the data on TSEs in other 

animal species may represent the 

distribution of infectivity in those 

species, these data may not represent 

the distribution of infectivity in cattle as 

evidenced by the studies discussed 

below. 

The Agency recognizes that, based on 

the structure and function of cells that 

make up the gastrointestinal tract of 

mammals, many areas within the 

mammalian gastrointestinal tract could 

theoretically be capable of harboring 

abnormal prions. TSE infectious agents 

that enter susceptible animals through 

oral consumption of infectious material 

appear to gain access to the CNS 

through the nerves that innervate the 

gastrointestinal tract. Infection may 

involve a first step of presentation to 

lymphatic tissues and may also occur by 

direct invasion of nerve endings in the 

intestinal mucosa (Ref. 7, available for 

viewing by the public in the FSIS 

docket room). Both gut-associated 

lymphoid tissue (GALT) and ENS tissue 

are present throughout the intestinal 

tract. 

However, despite this theoretical risk, 

the only bovine GALT found to be 

positive for BSE infectivity thus far has 

been in the Peyers Patches of the distal 

ileum of calves infected with BSE under 

experimental conditions. Two other 

GALT tissues from natural field cases, 

spleen and mesenteric lymph nodes, 

have been subjected to mouse bioassays 

and found to be non-infectious (Ref. 8, 

available for viewing by the public in 

the FSIS docket room). Spleen and 

mesenteric lymph node samples from 

experimentally dosed calves have also 

been subjected to mouse bioassays with 

similar results. 

A component of the ENS is the 

myenteric plexus that courses within 

the length of the intestinal wall (Ref. 9, 

available for viewing by the public in 

the FSIS docket room). Distal ileum 

sections of the intestine from cattle that 

acquired natural field cases of BSE have 

been examined for the presence of 

abnormal prion protien through 

immunostaining, and the ganglion cells 

of the myenteric plexus were found to 

contain abnormal prions in 9 out of 29 

samples (Ref. 10, available for viewing 

by the public in the FSIS docket room). 

Other areas of the ENS system from 

naturally occurring cases of BSE have 

not yet been examined for abnormal 

prion protein through immunostaining. 

Gastrointestinal tissue from BSE field 

cases were subjected to and found noninfective by mouse bioassay include a 

sample of the splanchnic nerve, as well 

as samples of rumen, omasum 

abomasum, proximal small intestine, 

distal small intestine, proximal colon, 

distal colon, and rectum (Ref. 8, 

available for viewing by the public in 

the FSIS docket room). From the U.K. 

pathogenesis studies, in which calves 

were orally dosed with BSE-infectious 

materials, samples of rumen, omasum, 

abomasum, duodenum, and spirial 

colon were found to be non-infective by 

mouse bioassay (Ref. 11, available for 

viewing by the public in the FSIS 

docket room). None of these samples 

have been subjected to a cattle bioassay. 

FSIS is aware of one small experiment 

in which immunostaining was 

attempted on gastrointestinal tissue 

outside of distal ileum. The study 

involved three calves that were orally 

infected with the BSE agent and 

sacrificed six months later. In the study, 

immunostaining was negative in all 

locations tested except for the Peyers 

Patches of the distal ileum (Ref. 10, 

available for viewing by the public in 

the FSIS docket room). 

When it issued the SRM interim final 

rule, FSIS acknowledged that available 

data on the development and 

distribution of tissue infectivity in BSE 

infected cattle are incomplete and that 

additional studies using cattle bioassays 

were being conducted to ensure that low 

levels of infectivity that may not have 

been detected using mouse bioassays are 

not missed (69 FR 1862, 1864–1865, 

January 12, 2005). However, on the basis 

of the findings described above, FSIS 

has concluded that bovine intestinal 

tissues other than the distal ileum are 

either unlikely to contain BSE 

infectivity or contain infectivity below 

the level of detection using the mouse 

bioassay. Furthermore, FSIS has also 

concluded that, due to the availability of 

procedures to remove the distal ileum, 

the fact that infectivity has been 

confirmed only in the distal ileum has 

the most significant implications for 

human health. 

Thus, FSIS has determined that 

designating the distal ileum as SRM is 

a prudent and appropriate measure to 

prevent human exposure to the BSE 

agent in the United States. The Agency 

has also determined that it is not 

necessary to designate the entire small 

intestine or the large intestine as an 

SRM. 

Future research that has been 

recommended by the European SSC 

includes cattle bioassay and more 

sensitive prion detection testing of 

many of the cattle tissues described 

above (Ref. 12, available for viewing by 

the public in the FSIS docket room). 

Stored tissue is available for this 

purpose in the United Kingdom. A 

pathogenesis study underway in 

Germany will also provide tissue from 

cattle incubating BSE for more 

definitive testing (Ref. 13, available for 

viewing by the public in the FSIS 

docket room). 

The Agency supports the need for the 

research being conducted with regard to 

BSE and other TSEs. On March 18, 

2005, the Secretary of Agriculture 

announced that almost $2 million in 

funding has been redirected to enhance 

research on BSE (‘‘Johanns Announces 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53047 

2Once a country is listed in 9 CFR 327.2(b) as 

eligible to export meat and meat products to the 

United States, it must maintain a meat inspection 

system that is equivalent to that of the United 

States. If it does not, FSIS will not permit meat 

products from that country to be imported into the 

United States. FSIS conducts audits of eligible 

foreign countries meat inspection systems at least 

annually. 

Expansion of BSE Research Program and 

Research Initiative to Improve Food 

Safety,’’ USDA press release no. 

0097.05, March 18, 2005). The BSE 

research funds, redirected by USDA’s 

Agricultural Research Service, will be 

used for newly funded BSE projects and 

facilities. Many of these newly funded 

projects involve international 

collaboration with researchers from the 

United Kingdom and other European 

countries. While FSIS believes that the 

primary tissues of concern for spreading 

the BSE agent have been identified, the 

Agency will use the results of futures 

studies on BSE to further refine this 

determination and inform its policies 

with regard to BSE. 

FSIS disagrees with the comment that 

slaughterhouse contamination of other 

intestinal areas with matter from the 

ileum cannot be avoided. As discussed 

earlier in this document, the FSIS SRM 

interim final rule requires that 

establishments develop, implement, and 

maintain written procedures for the 

removal, segregation, and disposition of 

SRMs, and that they incorporate these 

procedures into their HACCP plans, 

Sanitation SOPs or other prerequisite 

programs (9 CFR 310.22(d)(1)). These 

procedures must ensure that all SRMs, 

including the distal ileum, are 

completely removed from the carcass, 

segregated from edible products, and 

disposed of in an appropriate manner as 

prescribed by 9 CFR 314.1 and 9 CFR 

314.3 (i.e., used for inedible rendering, 

incinerated, or denatured). FSIS is 

responsible for ensuring the adequacy 

and effectiveness of the establishment’s 

procedures. 

As stated throughout this document, 

FSIS has determined that beef 

processors have the technology to 

effectively remove the distal ileum from 

the intestine of cattle. Thus, the Agency 

has concluded that when establishments 

incorporate their technologies for 

removing the distal ileum into their 

HAACP plan or Sanitation SOP or other 

prerequisite program, they will be able 

to effectively remove the distal ileum in 

a manner that does not contaminate 

edible materials. 

Amendments to SRM Interim Final 

Rule 

After carefully evaluating this issue 

and the comments submitted on the 

removal of the distal ileum, including 

the anatomical descriptions and 

diagrams of the bovine small intestine, 

as well as the detailed descriptions of 

the procedures for removal of the distal 

ileum, FSIS has concluded that 

processors have the technology to 

effectively remove the distal ileum from 

the rest of the small intestine. Therefore, 

FSIS is amending the SRM interim final 

rule to permit for use as human food 

beef small intestine, excluding the distal 

ileum, derived from cattle slaughtered 

in official U.S. establishments or in 

certified foreign establishments in 

countries listed by FSIS in 9 CFR 

327.2(b) as eligible to export meat 

products to the United States.2 This is 

a requirement that all meat and meat 

food products must comply with to be 

eligible for use as human food in the 

United States. In addition, FSIS will not 

permit natural casings derived from beef 

small intestine, excluding the distal 

ileum, to be used as containers of meat 

food products unless the casings are 

derived from cattle that have been 

inspected and passed in an official U.S. 

establishment or in a certified foreign 

establishment. 

9 CFR 327.1(b) of FSIS’ import 

regulations provides that compliance 

with the conditions of importation 

under FSIS’ regulations does not excuse 

the need for compliance with applicable 

requirements under other laws, 

including the provisions in 9 CFR parts 

94, 95, and 96 of APHIS’ regulations. 

Thus, under the amendments to the 

SRM interim final rule described in this 

document, beef small intestine derived 

from cattle that have been in countries 

listed by APHIS in 9 CFR 94.18(a) as 

regions that present a risk of introducing 

BSE into the United States will continue 

to be subject to importation restrictions 

established by APHIS. APHIS’

regulations at 9 CFR parts 94, 95, and 

96 prohibit or restrict the importation of 

beef products and by-products, as well 

as casings (except stomachs), from cattle 

that have been in any of the regions 

listed by APHIS in 94.18(a). FSIS and 

APHIS work closely together to ensure 

that meat and meat products imported 

into the United States comply with the 

regulatory requirements of both 

agencies. FSIS and APHIS will continue 

to work together to ensure that the 

agencies maintain a consistent policy 

with regard to the importation of beef 

small intestines. 

The amendments to the interim final 

rule also require that establishments 

that process beef small intestine for 

human food have in place procedures to 

ensure that the distal ileum is 

effectively removed. As provided in 9 

CFR 310.22(d)(1), the establishment 

must incorporate these procedures into 

its HACCP plan or Sanitation SOPs or 

other prerequisite program. FSIS has 

concluded that procedures that require 

removal of at least 80 inches of the 

uncoiled and trimmed small intestine as 

measured from the ceco-colic junction 

and progressing proximally towards the 

jejunum comply with this requirement. 

The Agency believes that this standard 

is sufficiently conservative to ensure 

removal of the distal ileum despite 

differences in length of the intestinal 

tract or its segments between breeds or 

variations from animal to animal of the 

same breed. However, establishments 

may propose alternative standards if 

they can demonstrate that such 

standards are as effective as the 

standards described above in ensuring 

that the entire distal ileum is completely 

removed. 

APHIS’ regulations prohibit or restrict 

the importation of most ruminants and 

ruminant products, including beef 

intestines and casings, from countries 

listed by APHIS as presenting a risk of 

introducing BSE into the United States. 

As discussed above, to be eligible for 

importation under FSIS’ regulations, 

beef small intestine must comply with 

both FSIS’ and APHIS’ import 

regulations. 

Jurisdiction 

Under section 1(j) of the FMIA, 

products from cattle that contain meat 

or other portions of the carcass only in 

a relatively small proportion or that 

historically have not been considered by 

consumers as products of the meat food 

industry are not considered ‘‘meat food 

products’’ subject to regulation by FSIS 

(21 U.S.C. 601(j)). Thus, while 

unprocessed bovine small intestine is 

regulated by FSIS as a meat food 

product, stripped and cleaned casings 

derived from the small intestine of cattle 

have historically been regulated by 

FDA. 

As discussed above, FSIS has decided 

to permit for use as human food beef 

small intestine, excluding the distal 

ileum, derived from cattle slaughtered 

in official U.S. establishments or in 

certified establishments in foreign 

countries that FSIS considers eligible to 

export meat and meat products to the 

United States. However, because the 

amendments to the SRM interim final 

rule described in this document are not 

intended to affect the regulatory 

authority of either FSIS or FDA, 

jurisdiction over a product derived from 

small intestine will continue to depend 

on whether the product is considered a 

meat food product as defined in the 

FMIA. Thus, unprocessed beef small 

intestine will continue to be regulated 

53048 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

by FSIS, and stripped and cleaned 

natural casing derived from bovine 

small intestine will continue to be 

regulated by FDA. 

However, although they are regulated 

by FDA, natural beef casings are used as 

containers for certain meat food 

products. Therefore, before FSIS applies 

the mark of inspection to a meat food 

product encased in a natural beef casing 

derived from the small intestine, the 

Agency will require that the 

establishment provide documentation 

that demonstrates that the small 

intestine from which the casing was 

derived complies with the requirements 

in the amendments to the SRM interim 

final rule. 

Small Business Considerations 

One of the reasons that FSIS is at this 

time issuing these amendments to the 

SRM interim final rule to allow the use 

of beef small intestine, excluding the 

distal ileum, for human food is that the 

Agency has received several comments 

in response to the SRM rule and the 

APHIS/FSIS/FDA ANPR from small 

companies that manufacture sausages 

and other products encased in natural 

beef casings, as well as from 

manufacturers of ethnic foods, that 

indicate that the prohibition on the use 

of the entire small intestine for human 

food is having an adverse economic 

impact on small and very small 

businesses. As noted by the 

commenters, beef round casings, which 

are derived from the small intestine of 

cattle, are used in a wide assortment of 

sausage products, as well as in specialty 

sausages. The commenters stated that 

processors can substitute collagen 

casing for some types of sausage made 

from natural beef rounds, but this 

generally results in a lower quality 

product with a decreased market value. 

Although some companies had stocks 

of natural casings from cattle 

slaughtered prior to January 12, 2004, 

the date that the SRM interim final rule 

went into effect, these companies have 

informed FSIS that their existing 

supplies of natural beef casings will 

soon be exhausted. Permitting the use of 

beef small intestine, excluding the distal 

ileum, will relieve some of the 

economic burden that the prohibition 

on the use of the entire small intestine 

for human food has imposed on these 

small entities. 

Summary of the Amendments 

As discussed above, FSIS is amending 

the SRM interim final rule to permit, 

under certain conditions, the use of beef 

small intestine, excluding the distal 

ileum, for human food. As amended, 9 

CFR 310.22(a)(3) will no longer require 

that establishments remove the entire 

small intestine of all cattle and dispose 

of it as inedible. Instead, it will specify 

the conditions under which the small 

intestine from cattle is permitted to be 

used for human food. These conditions 

were described in detail earlier in this 

document. 

The regulations in 9 CFR 318.6(b)(1) 

provide that casings from cattle may be 

used as containers of products provided 

the casings are not derived from the 

small intestine. FSIS is amending 

paragraph (b)(1) to permit casings from 

cattle that are derived from the small 

intestine to be used as containers if the 

small intestine complies with the 

requirements in 9 CFR 310.22(a)(3) as 

amended. The amendments to 

paragraph (b)(1) also require that 

establishments that use casings derived 

from the small intestine of cattle as 

containers for products demonstrate, 

through documentation, that the small 

intestine from which the casing was 

derived complies with the requirements 

in 9 CFR 310.22(a)(3) as amended. 

9 CFR 318.6(b)(8) prohibits small 

intestine from cattle for use in any meat 

food product or for edible rendering. 

FSIS is amending paragraph (b)(8) to 

permit small intestine from cattle to be 

used in a meat food product or for 

edible rendering if it complies with the 

requirements in 9 CFR 310.22(a)(3) as 

amended. 

Effective Date and Opportunity for 

Public Comment 

Because FSIS has already provided 

the public with opportunities to 

comment on the issues raised in this 

document (once in response to the SRM 

interim final rule published on January 

12, 2004 and again in response to the 

APHIS/FSIS/FDA ANPR published on 

July 14, 2004), and because the 

restrictions on the use of the small 

intestine for human food are adversely 

affecting small businesses without 

providing any public health benefits, 

the amendments to the SRM interim 

final contained in this document will 

become effective before the comment 

period closes. FSIS will consider any 

comments received during the comment 

period for this amended interim final 

rule (see DATES above). After that 

comment period closes, the Agency will 

publish another document in the 

Federal Register. The document will 

include a discussion of all comments 

received in response to the SRM interim 

final rule, the APHIS/FSIS/FDA ANPR, 

and the amendments to the SRM interim 

final rule described in this document. It 

will also include any amendments to 

the SRM interim final rule made as a 

result of those comments. 

Executive Order 12866 and Regulatory 

Flexibility Act 

These amendments to the January 12, 

2004 interim final rule have been 

determined to be significant and 

therefore, have been reviewed by the 

Office of Management and Budget. 

The interim final rule of January 12, 

2004 (69 FR 1862) included a 

Preliminary Regulatory Impact Analysis 

(PRIA) that was made available for 

comment on April 7, 2004 (69 FR 

18245). The PRIA indicated that benefits 

of the SRM interim final rule were 

primarily those resulting from the 

reduction in human exposure to BSE 

infectivity and the restoration of beef 

exports. The PRIA estimated that 

designating beef small intestines, 

including the distal ileum, from cattle of 

all ages as a specified risk material did 

not result in a significant reduction in 

potential human exposure to BSE. As 

discussed elsewhere in this document, 

the distal ileum was designated as an 

SRM because BSE infectivity has been 

demonstrated in the distal ileum after 

oral exposure to the BSE agent. 

Although BSE infectivity was not 

demonstrated in the remaining part of 

the small intestine, the interim final rule 

required the removal of the entire small 

intestine to ensure effective removal of 

the distal ileum. Therefore, this action 

does not change the reduction in human 

exposure to BSE estimated in the PRIA. 

The effect of amending the SRM 

interim final rule would be to increase 

the supplies of beef small intestines and 

beef natural casings manufactured from 

beef small intestine (beef casings) that 

do not contain the distal ileum, and 

that, prior to the implementation of the 

SRM rule, were used for human food. 

Although the SRM interim final rule 

designated the distal ileum of all cattle 

as an SRM, to ensure effective removal 

of the distal ileum, it required that the 

entire small intestine be removed and 

disposed of as inedible. Thus, as a result 

of the SRM rule, the supplies of beef 

small intestine and natural casings 

derived from beef small intestine 

produced after the effective date of the 

SRM rule were prohibited for use as 

human food. 

One of the impacts on consumers of 

this prohibition of the use of beef small 

intestine for human food has been the 

loss of food products in marketplaces 

where the only suitable casings are beef 

casings. These types of food products 

that typically use beef casings include 

sausages such as salami, hard salami, 

thuringer, European-type sausages such 

as braunschweiger, metwurst, and 

supressa, basterma, and Arabic 

sausages, some pate ́s, and a variety of 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53049 

other food products largely sold in 

ethnic markets. Suitable substitutes for 

beef casings do not exist or are generally 

inadequate for some of these types of 

food products. For example, cellulosic, 

collagen, fibrous, muslin or synthetic 

casings, or hog or sheep casings are, in 

many cases, not adequate substitutes for 

beef natural casings for use in producing 

some sausages, or some types of 

traditional ethnic products. Another 

impact on consumers of this prohibition 

has been the loss of food products in 

ethnic marketplaces where beef small 

intestines were sold as variety meats, or 

food products were sold that used beef 

small intestines as an ingredient of 

manufactured food products or edible 

rendered food products. Suitable 

substitutes for beef small intestines as 

variety meats do not exist or are 

generally inadequate for some of these 

types of products. 

The PRIA of the SRM interim final 

rule estimated that approximately 160 

million pounds of small intestines, 

including the distal ileum, were 

removed from the human food supply. 

The net revenue lost by excluding the 

entire small intestine from the food 

supply, was estimated to be an average 

of $27.6 million ($20.6 to $34.5 million) 

per year for the food industry, after the 

implementation of the rule. Of the $27.6 

million in net annual revenue lost as a 

result of the interim final rule, the PRIA 

estimated that an average of $16.6 

million ($13.0 to $20.6 million) resulted 

from exclusion of the distal ileum and 

an average of $10.9 million from the 

remaining parts of the small intestine 

(see page 24 of the analysis). Therefore, 

this action is estimated to restore an 

average of $10.9 million ($2.9 to $19.0 

million) in net revenues lost as a result 

of the interim final rule. 

In the PRIA, the Agency estimated, by 

survey, that approximately 47 federallyinspected establishments, that were 

primarily large establishments, were 

affected by the value lost of beef small 

intestines that were used for food 

products and to manufacture beef 

casing. The amendment would allow 

some of these 47 establishments to 

resume their sales of beef small 

intestines, beef casing, and food 

products that use the imported beef 

casings. Thus, some of the 47 

establishments or firms are expected to 

recover some of the value lost through 

these new sales because of the 

amendment. The Agency is unable to 

estimate the number of establishments 

that would resume the sales of beef 

small intestines and their associated 

food products. 

Also, the Agency is unable to estimate 

the number of establishments that used 

beef casings in the production of meat 

products prior to the implementation of 

the SRM interim final rule in January of 

2004. However, it believes that the 

number of domestic establishments 

producing such products was small. As 

discussed elsewhere in this document, 

the Agency has received comments from 

small companies that indicate that the 

prohibition on the use of the entire 

small intestine for human food is having 

an adverse economic impact on some 

small and very small businesses. Most 

of these commenters are manufactures 

of meat food products encased in 

natural beef casing. These amendments 

will help to relieve some of this 

economic burden. However, FSIS is 

unable to determine the number of 

small entities that will benefit from this 

action. 

The economic impact of the measure 

on manufacturers of casings produced 

from other sources is not significant. 

The availability of natural beef casings 

may reduce the demand for some 

cellulosic, collagen, synthetic, or other 

types of casings. However, the reduction 

is not expected to be significant, given 

the long-term trend in the use of these 

types of non-natural casings. 

Therefore, the Agency has determined 

that these amendments to the interim 

final rule will not have a significant 

economic impact on a substantial 

number of small entities, as defined by 

the Regulatory Flexibility Act (5 U.S.C. 

601). 

The PRIA estimated that the SRM 

interim final rule would have a minimal 

impact on U.S. meat production and 

beef prices paid by consumers, because 

these products are a very small amount 

of total beef production. Therefore, 

allowing the small intestine, excluding 

the distal ileum, for use as human food 

as provided in this action will not have 

a significant impact on the food 

industry and consumers. 

The availability of these types of 

casing will reduce the demand for some 

cellulosic, collagen, synthetic, or other 

types of casings. However, the reduction 

is not expected to be significant, given 

the long-term trend in the use of these 

types of non-natural casings. 

Executive Order 12988 

This amendment to the SRM interim 

final rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. In this interim final rule: (1) All 

state and local laws and regulations that 

are inconsistent with this rule will be 

preempted; (2) no retroactive effect will 

be given to this rule; and (3) 

administrative proceedings will not be 

required before parties may file suit in 

court challenging this rule. 

Paperwork Requirements 

The SRM interim final rule included 

a paperwork analysis (61 FR 38862) 

prepared in accordance with the 

Paperwork Reduction Act. FSIS has 

determined that the corrections and 

amendments in this rule do not change 

any information collection burden 

hours. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and in particular 

minorities, women, and persons with 

disabilities, are aware of this amended 

interim final rule, FSIS will announce it 

on-line through the FSIS Web page 

located at http://www.fsis.usda.gov/ 

regulations_&_policies/ 

2005_Interim_&_Final_Rules_Index/ 

index.asp. The Regulations.gov Web site 

is the central online rulemaking portal 

of the United States government. It is 

being offered as a public service to 

increase participation in the Federal 

government’s regulatory activities. FSIS 

participates in Regulations.gov and will 

accept comments on documents 

published on the site. The site allows 

visitors to search by keyword or 

Department or Agency for rulemakings 

that allow for public comment. Each 

entry provides a quick link to a 

comment form so that visitors can type 

in their comments and submit them to 

FSIS. The Web site is located at 

http://www.regulations.gov/. 

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

types of information that could affect or 

would be of interest to our constituents 

and stakeholders. The update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The update 

also is available on the FSIS Web page. 

Through Listserv and the Web page, 

FSIS is able to provide information to a 

much broader, more diverse audience. 

In addition, FSIS offers an e-mail 

subscription service which provides an 

automatic and customized notification 

when popular pages are updated, 

including Federal Register publications 

and related documents. This service is 

available at http://www.fsis.usda.gov/ 

news_and_events/email_subscription/ 

53050 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

and allows FSIS customers to sign up 

for subscription options across eight 

categories. Options range from recalls to 

export information to regulations, 

directives and notices. Customers can 

add or delete subscriptions themselves 

and have the option to password protect 

their account. 

References 

1. Jeffrey, M., S. Ryder, S. Martin, et 

al., ‘‘Oral Inoculation of Sheep With the 

Agent of Bovine Spongiform 

Encephalopathy (BSE). 1. Onset and 

Distribution of Disease-Specific PrP 

Accumulation in Brain and Viscera,’’

Journal of Comparative Pathology, 124: 

280–289, 2001. 

2. Bons, N., S. Lehmann, N. Nishida, 

et al., ‘‘BSE Infection of the Small ShortLived Primate Microcebus Murinus,’’

Comptes Rendus Biologies, 325: 67–74, 

2002. 

3. Herzog, C., N. Sales, N. Etchegaray, 

et al., ‘‘Tissue Distribution of Bovine 

Spongiform Encephalopathy Agent in 

Primate After Intravenous or Oral 

Infection,’’ Lancet, 363: 422–428, 2004. 

4. Jeffrey, M., I. Begara-McGorum, S. 

Clark, et al., ‘‘Occurrence and 

Distribution of Infection-Specific PrP in 

Tissues of Clinical Scrapie Cases and 

Cull Sheep From Scrapie-Affected 

Farms in Shetland,’’ Journal of 

Comparative Pathology, 127: 264–273, 

2002. 

5. Press, C. McL., R. Heggebo, A. 

Espenes, ‘‘Involvement of GutAssociated Lymphoid Tissue of 

Ruminants in the Spread of 

Transmissible Spongiform 

Encephalopathies,’’ Advanced Drug 

Delivery Reviews, 56: 885–899, 2004. 

6. Heggebo, R., C. McL. Press, G. 

Gunnes, ‘‘Distribution and 

Accumulation of PrP in Gut-Associated 

and Peripheral Lymphoid Tissue of 

Scrapie-Affected Suffolk Sheep,’’

Journal of General Virology, 83: 479–

489, 2002. 

7. Baird, A.W., D.P. Campion, L. 

O’Brien, D.J. Brayden, ‘‘Oral Delivery of 

Pathogens from the Intestine to the 

Nervous System,’’ Journal of Drug 

Target, 12(2): 71–8, 2004. 

8. Scientific Steering Committee. SSC 

Update of the Opinion on TSE 

infectivity distribution in ruminant 

tissues (initially adopted on 10–11 

January 2002 and amended on 7–8 

November 2002) following the 

submission of (1) a risk assessment by 

the German Federal Ministry of 

Consumer Protection, Food and 

Agriculture and (2) new scientific 

advice regarding BSE infectivity 

distribution in tonsils. 2002. Health and 

Consumer Protection DirectorateGeneral (EC). 

9. A.L.R. Findlay. Motility of the 

gastrointestinal tract of ruminants. 98. 

Physiological laboratory, University of 

Cambridge. 2004. 

10. Terry L.A., S. Marsh, S.J.Ryder, 

S.A. Hawkins, G.A. Wells, Y.I. Spencer, 

‘‘Detection of Disease-Specific PrP in 

the Distal Ileum of Cattle Exposed 

Orally to the Agent of Bovine 

Spongiform Encephalopathy,’’

Veterinary Record, 152(13): 387–92 

2003. 

11. Wells, G.A.H., M. Dawson, S.A.C. 

Hawkins, et al., ‘‘Infectivity in the Ileum 

of Cattle Challenged Orally to the Agent 

of Bovine Spongiform Encephalopathy,’’

Veterinary Record, 135: 40–41, 1994. 

12. Scientific Steering Committee. 

SSC Opinion on BSE risk of the bovine 

autonomic nervous system (Adopted by 

the Scientific Steering Committee 

Meeting at its meeting of 6–7 March 

2003. Health and Consumer Protection 

Directorate-General (EC). 

13. ProMED mail. BSE, ORAL 

CHALLENGE TRIAL 03). ProMED-mail 

2004 20040524.1384. 2004. 

List of Subjects 

9 CFR Part 310 

Animal diseases, Disposition of 

carcasses, Meat inspection, and Postmortem inspection. 

9 CFR Part 318 

Entry into official establishments, 

Food packaging, Meat inspection, 

Reinspection and preparation of 

products. 

■ For the reasons discussed in the 

preamble, FSIS is amending 9 CFR 

Chapter III as follows: 

PART 310—POST-MORTEM 

INSPECTION 

■ 1. The authority citation for part 310 

continues to read as follows: 

Authority: 21 U.S.C. 601–695; 7 CFR 2.18, 

2.53. 

■ 2. Paragraph (a)(3) of § 310.22 is 

amended by removing the second 

sentence and adding the following 

sentence and paragraphs (a)(3)(i) and (ii) 

in its place: 

§ 310.22 Specified risk materials from 

cattle and their handling and disposition. 

(a) * * * 

(3) * * * The small intestine may be 

used for human food if: 

(i) It is derived from cattle that were 

inspected and passed in an official 

establishment in the United States or in 

a certified foreign establishment in a 

country listed in 9 CFR 327.2(b) as 

eligible to export meat and meat 

products to the United States and it is 

otherwise eligible for importation under 

9 CFR 327.1(b), and 

(ii) 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. 

* * * * * 

PART 318—ENTRY INTO OFFICIAL 

ESTABLISHMENTS; REINSPECTION 

AND PREPARATION OF PRODUCTS 

■ 3. The authority citation for part 318 

continues to read as follows: 

Authority: 7 U.S.C. 38F, 450, 1901–1906; 

21 U.S.C. 601–695; 7 CFR 2.18, 2.53. 

■ 4. Section 318.6 is amended to revise 

paragraphs (b)(1) and (b)(8) to read as 

follows: 

§ 318.6 Requirements concerning 

ingredients and other articles used in 

preperation of products. 

* * * * * 

(b)(1) The only animal casings that 

may be used as containers of product 

are those from sheep, swine, or goats. 

Casings from cattle may be used as 

containers of products. However, if 

casings from cattle are derived from the 

small intestine, the small intestine must 

comply with the requirements in 9 CFR 

310.22(a)(3). Establishments that use 

casings derived from the small intestine 

of cattle as containers for products must 

demonstrate, through documentation, 

that the small intestine from which the 

casing was derived complies with the 

requirements in 9 CFR 310.22(a)(3). 

* * * * * 

(8) Intestines shall not be used as 

ingredients in any meat food product for 

which a standard is prescribed in part 

319 of this subchapter and shall not be 

used in other products unless the 

products are labeled in accordance with 

§ 317.8(b)(3) of this subchapter. When 

small intestine from cattle is used in a 

meat food product or for edible 

rendering, it must comply with the 

requirements in 9 CFR 310.22(a)(3). 

* * * * * 

Done at Washington, DC on: September 1, 

2005. 

Barbara J. Masters, 

Administrator. 

[FR Doc. 05–17683 Filed 9–6–05; 8:45 am] 

BILLING CODE 3410–DM–P