Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53063 

PART 181—NORTH AMERICAN FREE 

TRADE AGREEMENT 

■ 26. The authority citation for part 181 

is revised to read as follows: 

Authority: 19 U.S.C. 66, 1202 (General 

Note 3(i), Harmonized Tariff Schedule of the 

United States), 1624, 3314; 

PART 191—DRAWBACK 

■ 27. The general authority citation for 

part 191 is revised to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 

(General Note 3(i), Harmonized Tariff 

Schedule of the United States), 1313, 1624; 

* * * * * 

Dated: September 1, 2005. 

Robert C. Bonner, 

Commissioner, Bureau of Customs and Border 

Protection. 

[FR Doc. 05–17662 Filed 9–6–05; 8:45 am] 

BILLING CODE 9110–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 189 and 700 

[Docket No. 2004N–0081] 

RIN 0910–AF47 

Use of Materials Derived From Cattle in 

Human Food and Cosmetics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Interim final rule and request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

interim final rule on use of materials 

derived from cattle in human food and 

cosmetics published in the Federal 

Register of July 14, 2004. In the July 14, 

2004, interim final rule, FDA designated 

certain materials from cattle, including 

the entire small intestine, as ‘‘prohibited 

cattle materials’’ and banned the use of 

such materials in human food, 

including dietary supplements, and in 

cosmetics. FDA is taking this action in 

response to comments received on the 

interim final rule. Information was 

provided in comments that persuaded 

the agency that the distal ileum, one of 

three portions of the small intestine, 

could be consistently and effectively 

removed from the small intestine, such 

that the remainder of the small 

intestine, formerly a prohibited cattle 

material, could be used for human food 

or cosmetics. We (FDA) are also 

clarifying that milk and milk products, 

hide and hide-derived products, and 

tallow derivatives are not prohibited 

cattle materials. Comments also led the 

agency to reconsider the method cited 

in the interim final rule for determining 

insoluble impurities in tallow and to 

cite instead a method that is less costly 

to use and requires less specialized 

equipment. FDA issued the interim final 

rule to minimize human exposure to 

materials that scientific studies have 

demonstrated are highly likely to 

contain the bovine spongiform 

encephalopathy (BSE) agent in cattle 

infected with the disease. FDA believes 

that the amended provisions of the 

interim final rule provide the same level 

of protection from human exposure to 

the agent that causes BSE as the original 

provisions. 

DATES: The amendments to the interim 

final rule are effective October 7, 2005. 

Submit written or electronic comments 

on the amendments to the interim final 

rule by November 7, 2005. The Director 

of the Office of the Federal Register 

approves the incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51 of certain publications in 

21 CFR 189.5 and 700.27 as of October 

7, 2005. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2004N–0081, 

by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 2004N–0081 and/or 

RIN number RIN 0910–AF47 in the 

subject line of your e-mail message. 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management, Food 

and Drug Administration (HFA -305), 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the agency name and 

Docket No. or Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received will be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm , including 

any personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Effective Date and Opportunity for 

Public Comment’’ heading of the 

SUPPLEMENTARY INFORMATION in section 

IV of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Buckner, Center for Food Safety 

and Applied Nutrition (HFS–306), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1486. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 14, 2004, FDA issued an 

interim final rule entitled ‘‘Use of 

Materials Derived From Cattle in 

Human Food and Cosmetics’’ (also 

referred to as ‘‘the interim final rule’’), 

to address the potential risk of BSE in 

human food and cosmetics (69 FR 

42256, July 14, 2004). In the interim 

final rule, FDA designated certain 

materials from cattle as ‘‘prohibited 

cattle materials’’ and banned the use of 

such materials in human food, 

including dietary supplements, and in 

cosmetics in §§ 189.5 and 700.27 (21 

CFR 189.5 and 21 CFR 700.27). In the 

interim final rule, FDA designated the 

following as prohibited cattle materials: 

Specified risk materials (SRMs), the 

small intestine from all cattle, material 

from nonambulatory cattle, material 

from cattle not inspected and passed for 

human consumption, and mechanically 

separated (MS)(Beef). The materials 

designated as SRMs were 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 distal ileum 

of the small intestine and tonsils from 

all cattle. The Food Safety and 

Inspection Service (FSIS) of the United 

States Department of Agriculture 

(USDA) designated the same list of 

materials as SRMs in its rule entitled 

‘‘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). In addition, 

FDA provided an alternative standard 

for tallow in its interim final rule. 

Tallow must be produced by either 

excluding prohibited cattle materials or, 

if produced using prohibited cattle 

materials, must contain no more than 

0.15 percent insoluble impurities. 

Tallow derivatives were exempted from 

53064 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

the provisions of FDA’s interim final 

rule. 

The comment period for the interim 

final rule closed on October 12, 2004. 

After reviewing comments received on 

the interim final rule, FDA determined 

that it needed to make some changes 

and clarifications now, rather than 

waiting until we could address all of the 

comments in a final rule. We are 

amending or clarifying the interim final 

rule in the following five areas: 

1. Use of small intestine, 

2. Status of milk and milk products, 

3. Status of tallow derivatives, 

4. Status of cattle hide, and 

5. Testing method cited for 

determining the level of insoluble 

impurities in tallow. 

We are making these amendments to 

the interim final rule in part in response 

to comments indicating uncertainty 

regarding the status of certain products 

under the interim final rule and new 

information regarding removal of the 

distal ileum. 

II. Amendments and Clarifications to 

the Interim Final Rule 

A. Prohibition on the Use of Small 

Intestine From All Cattle 

In the interim final rule of July 14, 

2004, FDA prohibited the use of the 

entire small intestine in human food 

and cosmetics, even though the agency 

(at the time the interim final rule was 

issued) only considered, and currently 

only considers, the distal ileum portion 

of the small intestine to be an SRM. As 

stated in the preamble to the interim 

final rule, FDA prohibited the use of the 

entire small intestine because at the 

time we believed: (1) It would be 

difficult to distinguish one end of the 

small intestine from the other once it 

had been removed from the animal; (2) 

there was a lack of international 

agreement on how much of the small 

intestine should be removed to ensure 

that the distal ileum is separated from 

the remainder of the intestine; and (3) 

given the lack of international 

consensus on the issue, a manufacturer 

or processor would not be able to 

document that the distal ileum was 

adequately removed (69 FR 42256 at 

42259). We requested comments 

addressing our reasons for prohibiting 

use of the entire small intestine and 

solicited specific information on 

whether processors may be able to 

effectively remove just the distal ileum. 

1. Comments Received 

In response to the interim final rule, 

FDA received comments from beef 

processors, the natural casing industry, 

the beef by-product industry, and 

importers and exporters of natural 

casings and beef by-products that 

requested that the agency amend its 

prohibited cattle materials rule to 

prohibit only the distal ileum portion of 

the small intestine for human food and 

cosmetics, rather than the entire small 

intestine. As stated in the comments, 

infectivity has only been confirmed 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 portion from the rest of 

the small intestine. 

Comments also described, in detail, 

examples of verifiable procedures for 

the effective removal of the distal ileum 

portion of the small intestine, which is 

made up of three sections: The 

duodenum, the jejunum, and the 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 caecum 

at the ileocecal orifice, and the ileum is 

separated from the jejunum at the 

flange. According to the comments, the 

resulting segment 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 

caecum. The separation of the nonileum sections of the small intestine 

from the ileum is made at a point 36 to 

80 inches from the caecum, leaving the 

entire ileum of the small intestine 

attached to the caecum. According to 

the comments, leaving the ileum 

attached to the caecum 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 caecum 

at the ileocecal orifice, leaving the 

caecum and the small intestine for 

edible use. 

Another comment noted that, prior to 

December 2003, Japan accepted 

importation of beef casings from the 

United States on the basis of U.S. 

government certified removal of the 

distal ileum from the small intestine. 

The procedure required the removal of 

at least 80 inches of the small intestine, 

measured from the junction of the ileum 

and the caecum, to ensure removal of 

the distal ileum. 

Several comments indicated that, 

because of the distinct shape of the 

distal ileum of cattle, it is easy to verify 

the effective removal of this portion of 

the small intestine. Furthermore, 

comments from the natural casing 

industry stated that, because of the 

distal ileum’s physical properties, 

particularly the absence of a curve and 

an irregular thick surface, the distal 

ileum is not useable as a natural casing 

for sausage products. Thus, these 

comments noted, many slaughter 

establishments in the United States and 

Canada have a policy of removing the 

distal ileum from all cattle at the time 

of slaughter. Furthermore, as stated by 

the comments, slaughter establishments 

in Brazil, Argentina, and Uruguay, the 

three countries that are the major 

exporters of natural casings to the 

United States, have all been able to 

certify the removal of the distal ileum 

using achievable standards when 

requested to do so by their U.S. 

customers. 

In addition to comments requesting 

that only the distal ileum portion of the 

small intestine be prohibited from use 

in human food and cosmetics, we 

received comments stating that the 

entire small intestine or both the small 

and large intestines should be 

considered SRMs. Comments noted that 

the European Union (EU) identifies both 

the small and large intestine as specified 

risk material and prohibits their use in 

food. As stated in comments, this was 

done in the EU because BSE infection is 

associated with absorption of the BSE 

agent from contaminated feed and 

because it is not possible to prevent 

slaughterhouse contamination of other 

intestinal areas with matter from the 

ileum. Comments also cited a study 

showing that the myenteric plexus of 

the distal ileum was positive when 

immunostained in naturally infected 

and experimentally infected cattle. The 

comments noted that, because the 

myenteric plexus runs throughout the 

intestine, the possibility of infectivity in 

other sections of the intestine cannot be 

discounted. Comments also noted that 

the International Review Team (IRT), 

appointed to review BSE prevention 

measures in the United States after the 

discovery of the BSE-positive cow in 

Washington State, recommended that 

the SRM ban be amended to include the 

entire small and large intestines. 

2. Response to Comments 

After considering the comments 

submitted on the removal of the distal 

ileum, FDA has concluded that 

processors have the technology to 

effectively remove the distal ileum 

portion from the rest of the small 

intestine. 

FDA believes that procedures to 

ensure effective removal of the distal 

ileum require that at least 80 inches of 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53065 

the uncoiled and trimmed small 

intestine, as measured from the caecocolic junction and progressing 

proximally towards the jejunum, be 

removed. We believe that these 

procedures ensure removal of the entire 

distal ileum despite differences in 

length of the intestinal tract or its 

segments between breeds or among 

animals of different sizes of the same 

breed. An alternative removal procedure 

may be used if an establishment can 

demonstrate that it is equally effective 

in ensuring that the entire distal ileum 

is completely removed. 

We do not agree with comments that 

stated that the entire small intestine or 

both the small and the large intestine 

should be designated as SRMs. Though 

the EU prohibits the entire intestine 

from use in food, the data that we are 

aware of indicating infectivity along the 

entire intestine is from other species, 

not from cattle infected with BSE or 

other transmissible spongiform 

encephalopathies (TSEs) (Refs. 1 to 6). 

Though the studies in other species 

represent the distribution of infectivity 

in those species, they may not represent 

the distribution of infectivity in cattle 

infected with BSE as evidenced by 

studies with bovine tissue. 

In cattle, infectivity has been found in 

the distal ileum in tissue bioassay from 

cattle experimentally given BSE (Ref. 7; 

see discussion in sections I. E and F of 

the interim final rule). In cattle 

experimentally infected with BSE, 

positive Peyer’s patches were found by 

immunohistochemistry only in the 

distal ileum, and in cattle with naturally 

occurring and experimental BSE, 

positive myenteric plexus neurons were 

found only in the distal ileum (Ref. 8). 

The duodenum of cattle experimentally 

given BSE has not demonstrated 

infectivity when tested by mouse 

bioassay and has been negative for the 

presence of abnormal prions when 

examined by immunohistochemistry 

during all stages in the pathgenesis of 

the disease (Refs. 8 and 9). Few samples 

of jejunum have been tested, but those 

that have been tested were negative for 

the presence of abnormal prions when 

examined by immunohistochemistry 

(Ref. 8). In a bioassay of tissues from 

cattle with naturally-occuring BSE, no 

infectivity was found in the splanchnic 

nerve, rumen, omasum, abomasum, 

proximal small intestine, proximal 

colon, distal colon, and rectum, or even 

in the distal small intestine (Ref. 9). 

The study by Terry and others (Ref. 8) 

indicated that the myenteric plexus of 

the distal ileum contained some 

abnormal prion protein in neurons. This 

tissue extends throughout the small 

intestine, so we cannot completely 

eliminate the possibility that infectivity 

might exist in the jejunum or the 

duodenum. However, that same study 

found no evidence of abnormal prion 

protein in the sections of the duodenum 

and the jejunum examined. Therefore, it 

is likely that, if any infectivity is 

present, it is at levels too low to present 

a public health risk. We realize that the 

studies on tissue infectivity have 

limitations, but we are not aware of 

evidence that intestine other than the 

distal ileum harbors infectivity in cattle 

with BSE. If we become aware of data 

indicating that other portions of the 

small intestine or the large intestine in 

cattle harbor infectivity, we will take 

action appropriate to the public health 

risk presented by the tissues. 

We also do not agree that cross 

contamination of other parts of the 

intestine with infectivity in the distal 

ileum is unavoidable in the 

slaughterhouse. Comments provided 

several methods by which the distal 

ileum can be consistently and 

effectively removed from the rest of the 

small intestine without cross 

contamination during slaughter. We 

agree that, if these methods are properly 

implemented, cross contamination can 

be avoided. 

Finally, we do not agree that we 

should require that the entire intestine 

of all cattle be designated an SRM 

because the IRT recommended it. As 

stated previously in this document, the 

agency does not find that there is 

sufficient evidence to support 

designating the entire intestine as an 

SRM. 

Therefore, we are amending 

§§ 189.5(a)(1) and 700.27(a)(1) to reflect 

that small intestine is a prohibited cattle 

material unless it meets the provisions 

of new §§ 189.5(b)(2) and 700.27(b)(2). 

New §§ 189.5(b)(2) and 700.27(b)(2) 

state that small intestine is not 

considered prohibited cattle material if 

the distal ileum is removed by a 

procedure that verifiably removes at 

least 80 inches of the uncoiled and 

trimmed small intestine as measured 

from the caeco-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. 

These amendments to FDA’s interim 

final rule are consistent with 

amendments that USDA made to its 

interim final rule regarding use of small 

intestine appearing elsewhere in this 

issue of the Federal Register. FDA 

regulates stripped and cleaned casings 

derived from bovine small intestine, and 

USDA’s FSIS regulates unprocessed 

bovine small intestine and ‘‘meat food’’

products made with beef casings. It is 

important to note that natural beef 

casings and other FDA regulated 

products derived from small intestine 

are also subject to FSIS requirements 

when used in FSIS regulated products. 

Specifically, FSIS will not permit 

natural casings derived from beef small 

intestine to be used in meat food 

products unless the casings are derived 

from cattle that have been inspected and 

passed in a U.S. official establishment 

or in a certified foreign establishment. 

B. Status of Milk and Milk Products 

The interim final rule provides that 

no human food or cosmetics shall be 

manufactured from, processed with or 

otherwise contain, prohibited cattle 

materials. Prohibited cattle materials 

include material from cattle not 

inspected and passed for human 

consumption. 

1. Comments Received 

Several comments noted that milk 

and milk products could be viewed as 

products that are not inspected and 

passed because milk is obtained from 

live animals that do not undergo the 

same inspection as cattle during 

slaughter. These comments noted that 

milk and milk products are 

internationally recognized to present a 

negligible risk of transmitting the agent 

that causes BSE and asked that we 

clarify the status of milk and milk 

products under the interim final rule. 

2. Response to Comments 

The interim final rule applies to 

materials from cattle slaughtered on or 

after the effective date and was not 

meant to apply to milk and milk 

products, which come from live cattle. 

Therefore, we are amending 

§§ 189.5(a)(1) and 700.27(a)(1) to clarify 

that milk and milk products are not 

included in the definition of 

‘‘prohibited cattle materials.’’

C. Clarification of the Classification of 

Tallow Derivatives 

The interim final rule defines tallow 

and tallow derivatives and states that 

prohibited cattle materials do not 

include tallow that contains no more 

than 0.15 percent hexane-insoluble 

impurities and tallow derivatives. 

1. Comments Received 

Several comments requested that we 

clarify whether the tallow used as 

starting material for the tallow 

derivatives has to contain no more than 

0.15 percent insoluble impurities in 

order for the tallow derivatives not to be 

included in the definition of 

‘‘prohibited cattle materials.’’

53066 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

2. Response to Comments 

The exemption of tallow derivatives 

from the definition of ‘‘prohibited cattle 

materials’’ does not depend on the 

source tallow for the derivatives. For the 

reasons discussed in the preamble to the 

interim final rule, tallow derivatives 

present a negligible risk of transmitting 

the agent that causes BSE regardless of 

the source tallow. Therefore, all tallow 

derivatives are exempt from the ban on 

the use of prohibited cattle materials in 

human food and cosmetics. 

D. Status of Human Food and Cosmetics 

Derived From Cattle Hide 

The interim final rule provides that 

no human food or cosmetics shall be 

manufactured from, processed with or 

otherwise contain, prohibited cattle 

materials. Prohibited cattle materials 

include products that have not been 

inspected and passed for human 

consumption. Cattle hides, which are 

used as source material for collagen and 

collagen casings, receive antemortem 

but not postmortem inspection in most 

slaughter operations. 

1. Comments Received 

Several comments stated that the 

commenters did not believe that FDA 

meant to designate all cattle hide and 

products derived from hide as 

prohibited cattle material because they 

do not undergo postmortem inspection. 

These comments also pointed out that 

antemortem inspection is when BSE 

might be detected from the behavior or 

appearance of the animal, while 

postmortem inspection is more useful 

for detecting cross contamination among 

parts of the carcass. Comments 

indicated that risk of cross 

contamination by other carcass parts is 

not relevant for the hide because it is 

removed at the beginning of the 

slaughter process. In addition, 

comments noted that cattle hide is 

internationally recognized to be a tissue 

with a negligible risk of transmitting the 

agent that causes BSE, and the World 

Organization for Animal Health (OIE) 

recommends that it be freely traded 

regardless of the BSE risk status of the 

exporting countries. 

2. Response to Comments 

We agree with these comments. It was 

not our intention to designate all 

products derived from cattle hide as 

prohibited cattle materials for use in 

human food and cosmetics. We also 

recognize that cattle hide has been 

determined to be a tissue with negligible 

risk of transmitting the agent that causes 

BSE and that the OIE recommends that 

it be freely traded regardless of the BSE 

risk status of the exporting countries. 

Therefore, we are exempting hides from 

the provisions of the interim final rule 

and are amending §§189.5(a)(1) and 

700.27(a)(1) to clarify that hides and 

hide-derived products are not included 

in the definitions of ‘‘prohibited cattle 

materials.’’ Though we are exempting 

hides from the provisions of the interim 

final rule, manufacturers and processors 

must take precautions to avoid cross 

contamination of hides and other 

nonprohibited cattle material with 

prohibited cattle material during 

slaughter and processing. If hides are 

cross contaminated with prohibited 

cattle material, they will be considered 

adulterated. 

E. Method for Determining the Level of 

Insoluble Impurities in Tallow 

Under the interim final rule 

(§§ 189.5(a)(6) and 700.27(a)(6)), any 

raw materials may be used as the 

starting material for tallow production 

as long as the resulting tallow contains 

no more than 0.15 percent hexane 

insoluble impurities. The interim final 

rule requires that the method for 

‘‘hexane-insoluble matter’’ described in 

the 5th edition of the Food Chemicals 

Codex (FCC) be used to measure 

hexane-insoluble impurities in tallow. 

The interim final rule also states that an 

alternative method may be used if it is 

equivalent to the FCC method. 

1. Comments Received 

We received several comments 

requesting that we specify a different 

method for measuring insoluble 

impurities in tallow. Comments stated 

that the domestic tallow industry 

primarily uses a method of the 

American Oil Chemists’ Society (AOCS) 

to measure insoluble impurities. In 

comparison to the FCC method, 

comments stated that the AOCS method 

is less expensive, requires less solvent 

and has lower solvent disposal costs, 

and does not require specialized 

equipment or supplies. These comments 

requested that FDA approve the AOCS 

method for measuring insoluble 

impurities. 

2. Response to Comments 

FDA agrees that the FCC method is 

more expensive, uses more solvent, and 

requires more specialized equipment 

than other methods currently used by 

industry. In response to comments and 

the information we obtained about the 

various methods, we are amending the 

interim final rule to cite the method for 

measuring insoluble impurities of the 

AOCS (‘‘Insoluble Impurities,’’ AOCS 

Official Method Ca 3a-46) or a method 

equivalent to it in accuracy, precision 

and sensitivity. The AOCS method is 

currently used by the domestic tallow 

industry, uses updated equipment, is 

less expensive to implement, and may 

be more sensitive than the FCC method. 

Reference to the AOCS method in the 

amended interim final rule does not 

exclude use of the FCC method we cited 

in the interim final rule. Any testing 

method may be used that is equivalent 

to the AOCS method. Those wishing to 

use an alternate test are responsible for 

determining that it is equivalent to the 

AOCS method cited in the interim final 

rule as amended here; it is not necessary 

that FDA approve the use of an alternate 

test. 

III. Summary of Amendments to the 

Interim Final Rule 

We are amending §§ 189.5(a)(1) and 

700.27(a)(1) to reflect that small 

intestine is a prohibited cattle material 

unless it meets the provisions of new 

§§ 189.5(b)(2) and 700.27(b)(2). New 

§§ 189.5(b)(2) and 700.27(b)(2) state that 

small intestine is not considered 

prohibited cattle material 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 caeco-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. 

We are amending §§ 189.5(a)(1) and 

700.27(a)(1) to specify that milk and 

milk products and hides and hidederived products are not prohibited 

cattle materials. 

Finally, we are amending 

§§ 189.5(a)(6) and 700.27(a)(6) to 

indicate that tallow, if it is sourced from 

unknown materials, must contain not 

more than 0.15 percent insoluble 

impurities as determined by the method 

‘‘Insoluble Impurities’’ (AOCS Official 

Method Ca 3a-46), AOCS, or another 

method equivalent in accuracy, 

precision, and sensitivity to AOCS 

Official Method Ca 3a-46. 

IV. Effective Date and Opportunity for 

Public Comment 

FDA provided the public with an 

opportunity to comment on the issues 

raised by the interim final rule and 

addressed in this document. These 

amendments to the interim final rule are 

in response to some of those comments. 

These amendments to the interim final 

rule are effective October 7, 2005. FDA 

invites public comment on these 

amendments to the interim final rule. 

The comment period will be 60 days. 

The agency will consider modifications 

to these amendments to the interim final 

rule based on comments made during 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53067 

the comment period. Interested persons 

may submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding these 

amendments to the interim final rule. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

FDA will address other comments 

received in response to the interim final 

rule and comments received in response 

to this amendment in further 

rulemaking. 

V. Executive Order 12866 and 

Regulatory Flexibility Act 

FDA has examined the economic 

implications of this amendment to the 

interim final rule as required by 

Executive Order 12866. Executive Order 

12866 directs agencies to assess all costs 

and benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). Executive Order 

12866 classifies a rule as significant if 

it meets any one of a number of 

specified conditions, including: Having 

an annual effect on the economy of $100 

million, adversely affecting a sector of 

the economy in a material way, 

adversely affecting competition, or 

adversely affecting jobs. A regulation is 

also considered a significant regulatory 

action if it raises novel legal or policy 

issues. FDA has determined that this 

amendment to the interim final rule is 

not an economically significant 

regulatory action. 

FDA has examined the economic 

implications of this amendment to the 

interim final rule as required by the 

Regulatory Flexibility Act (5 U.S.C. 

601–612). If a rule has a significant 

economic impact on a substantial 

number of small entities, the Regulatory 

Flexibility Act requires agencies to 

analyze regulatory options that would 

lessen the economic effect of the rule on 

small entities. FDA has determined that 

this amendment to the interim final rule 

does not have a significant economic 

impact on a substantial number of small 

entities. 

Bovine Small Intestine 

The effect of amending the interim 

final rule will be that FDA regulated 

human food and cosmetics may be 

manufactured from, processed with, or 

otherwise contain small intestine if the 

distal ileum is effectively removed. FDA 

regulates stripped and cleaned casings 

derived from bovine small intestine, and 

USDA’s FSIS regulates unprocessed 

bovine small intestine and ‘‘meat food’’

products made with beef casings. Very 

few, if any, FDA regulated foods use 

beef intestines or beef casings as an 

ingredient. Therefore, the impact on 

FDA regulated food industries as a 

result of this amendment to the final 

rule is expected to be small. In the 

economic analysis of the interim final 

rule, FDA did not estimate any 

opportunity costs for cattle slaughterers 

or manufacturers that used beef small 

intestines and beef natural casings in 

their products because the small 

intestine had already been banned as 

human food by the FSIS interim final 

rule (69 FR 1862, January 12, 2004). 

USDA’s FSIS is amending its interim 

final rule to allow the use of bovine 

small intestine, without the distal 

ileum, in USDA regulated products. 

FDA’s amendment will benefit those 

FSIS regulated manufacturers who use 

beef casings; FDA’s amendment again 

allows this bovine material potentially 

to be used in FSIS regulated products. 

See the FSIS interim final rule (69 FR 

1862; January 12, 2004) and 

accompanying analysis for the cost 

savings associated with the renewed use 

of bovine small intestine in human 

foods products. 

Tallow 

FDA is amending the interim final 

rule to cite the AOCS method for 

measuring insoluble impurities in 

tallow. The domestic tallow industry 

primarily uses the AOCS method to 

measure insoluble impurities in tallow, 

so this change to the rule will reduce 

the burden of having to switch to a new 

measurement standard for many of the 

domestic tallow manufacturers. In 

comparison to the FCC method cited by 

the interim final rule, commenters 

stated that the AOCS method is less 

expensive than the FCC method. Tallow 

producers do not have to use the AOCS 

method if they use another method that 

is equivalent to the AOCS method in 

accuracy, precision, and sensitivity. 

Tallow producers using nonAOCS 

methods that can be validated will 

likely not switch methods and will only 

bear the cost burden of validating that 

their method is equivalent to the AOCS 

method. Tallow producers, who do not 

currently use the AOCS method but 

decide to switch to the method as a 

result of this amendment to the interim 

final rule, will pay a $50 fee to obtain 

the AOCS copyrighted method. 

VI. 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. (FDA has verified the 

Web site addresses, but we are not 

responsible for subsequent changes to 

the nonFDA Web sites after this 

document publishes in the Federal 

Register.) 

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 Short-Lived 

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 ScrapieAffected Farms in Shetland,’’ Journal of 

Comparative Pathology, 127: 264–273, 2002. 

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

‘‘Involvement of Gut-Associated 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. Wells, G. A. H., M. Dawson, S. A. C. 

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

Cattle Challenged Orally With Bovine 

Spongiform Encephalopathy,’’ Veterinary 

Record, 135: 40–41, 1994. 

8. Terry, L. A., S. Marsh, 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, 152: 

387–392, 2003. 

9. Scientific Steering Committee, European 

Commission, ‘‘Update on the Opinion of TSE 

Infectivity Distribution in Ruminant Tissues: 

Initially Adopted by the Scientific Steering 

Committee at its Meeting of January 10–11, 

2002, and Amended at its Meeting of 

November 7–8, 2002, Following the 

Submission of a Risk Assessment by the 

German Federal Ministry of Consumer 

Protection, Food and Agriculture and New 

Scientific Evidence Regarding BSE Infectivity 

Distribution in Tonsils,’’ accessed online at 

http://europa.eu.int/comm/food/fs/bse/ 

scientific_advice08_en.html. 

53068 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

List of Subjects 

21 CFR Part 189 

Food additives, Food packaging, 

Incorporation by reference. 

21 CFR Part 700 

Cosmetics, Packaging and containers, 

Incorporation by reference. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 189 

and 700 are amended as follows: 

PART 189—SUBSTANCES 

PROHIBITED FROM USE IN HUMAN 

FOOD 

■ 1. The authority citation for 21 CFR 

part 189 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348, 371. 

■ 2. Part 189 is amended by revising 

§ 189.5 to read as follows: 

Subpart B—Prohibited Cattle Materials 

Sec. 

§ 189.5 Prohibited cattle materials. 

Subpart B—Prohibited Cattle Materials 

§ 189.5 Prohibited cattle materials. 

(a) Definitions. The definitions and 

interpretations of terms contained in 

section 201 of the Federal Food, Drug, 

and Cosmetic Act (the act) apply to such 

terms when used in this part. The 

following definitions also apply: 

(1) Prohibited cattle materials means 

specified risk materials, small intestine 

of all cattle except as provided in 

paragraph (b)(2) of this section, material 

from nonambulatory disabled cattle, 

material from cattle not inspected and 

passed, or mechanically separated 

(MS)(Beef). Prohibited cattle materials 

do not include tallow that contains no 

more than 0.15 percent insoluble 

impurities, tallow derivatives, hides and 

hide-derived products, and milk and 

milk products. 

(2) Inspected and passed means that 

the product has been inspected and 

passed for human consumption by the 

appropriate regulatory authority, and at 

the time it was inspected and passed, it 

was found to be not adulterated. 

(3) Mechanically Separated 

(MS)(Beef) means a meat food product 

that is finely comminuted, resulting 

from the mechanical separation and 

removal of most of the bone from 

attached skeletal muscle of cattle 

carcasses and parts of carcasses that 

meets the specifications contained in 9 

CFR 319.5, the regulation that prescribes 

the standard of identity for MS 

(Species). 

(4) Nonambulatory disabled cattle 

means cattle that cannot rise from a 

recumbent position or that cannot walk, 

including, but not limited to, those with 

broken appendages, severed tendons or 

ligaments, nerve paralysis, fractured 

vertebral column, or metabolic 

conditions. 

(5) Specified risk material means 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. 

(6) Tallow means the rendered fat of 

cattle obtained by pressing or by 

applying any other extraction process to 

tissues derived directly from discrete 

adipose tissue masses or to other carcass 

parts and tissues. Tallow must be 

produced from tissues that are not 

prohibited cattle materials or must 

contain not more than 0.15 percent 

insoluble impurities as determined by 

the method entitled ‘‘Insoluble 

Impurities’’ (AOCS Official Method Ca 

3a-46), American Oil Chemists’ Society 

(AOCS), 5th Edition, 1997, incorporated 

by reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51, or another 

method equivalent in accuracy, 

precision, and sensitivity to AOCS 

Official Method Ca 3a-46. You may 

obtain copies of the method from AOCS 

(http://www.aocs.org) 2211 W. Bradley 

Ave. Champaign, IL 61821. Copies may 

be examined at the Center for Food 

Safety and Applied Nutrition’s Library, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741–

6030, or go to http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(7) Tallow derivative means any 

chemical obtained through initial 

hydrolysis, saponification, or transesterification of tallow; chemical 

conversion of material obtained by 

hydrolysis, saponification, or transesterification may be applied to obtain 

the desired product. 

(b) Requirements. 

(1) No human food shall be 

manufactured from, processed with, or 

otherwise contain, prohibited cattle 

materials. 

(2) The small intestine is not 

considered prohibited cattle material 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 

caeco-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. 

(c) Records. Manufacturers and 

processors of human food that is 

manufactured from, processed with, or 

otherwise contains, cattle material must 

make existing records relevant to 

compliance with this section available 

to FDA for inspection and copying. 

(d) Adulteration. 

(1) Failure of a manufacturer or 

processor to operate in compliance with 

the requirements of paragraphs (b) or (c) 

of this section renders human food 

adulterated under section 402(a)(4) of 

the act. 

(2) Human food manufactured from, 

processed with, or otherwise containing, 

prohibited cattle materials is unfit for 

human food and deemed adulterated 

under section 402(a)(3) of the act. 

(3) Food additive status. Prohibited 

cattle materials for use in human food 

are food additives subject to section 409 

of the act, except when used as dietary 

ingredients in dietary supplements. The 

use or intended use of any prohibited 

cattle material in human food causes the 

material and the food to be adulterated 

under section 402(a)(2)(C) of the act if 

the prohibited cattle material is a food 

additive, unless it is the subject of a 

food additive regulation or of an 

investigational exemption for a food 

additive under § 170.17 of this chapter. 

PART 700—GENERAL 

■ 3. The authority citation for 21 CFR 

part 700 continues to read as follows: 

Authority: 21 U. S. C. 321, 331, 352, 355, 

361, 362, 371, 374. 

■ 4. Part 700 is amended by revising 

§ 700.27 to read as follows: 

§ 700.27 Use of prohibited cattle materials 

in cosmetic products. 

(a) Definitions. The definitions and 

interpretations of terms contained in 

section 201 of the Federal Food, Drug, 

and Cosmetic Act (the act) apply to such 

terms when used in this part. The 

following definitions also apply: 

(1) Prohibited cattle materials means 

specified risk materials, small intestine 

of all cattle except as provided in 

paragraph (b)(2) of this section, material 

from nonambulatory disabled cattle, 

material from cattle not inspected and 

passed, or Mechanically Separated 

(MS)(Beef). Prohibited cattle materials 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53069 

do not include tallow that contains no 

more than 0.15 percent insoluble 

impurities, tallow derivatives, hides and 

hide-derived products, and milk and 

milk products. 

(2) Inspected and passed means that 

the product has been inspected and 

passed for human consumption by the 

appropriate regulatory authority, and at 

the time it was inspected and passed, it 

was found to be not adulterated. 

(3) Mechanically Separated 

(MS)(Beef) means a meat food product 

that is finely comminuted, resulting 

from the mechanical separation and 

removal of most of the bone from 

attached skeletal muscle of cattle 

carcasses and parts of carcasses that 

meet the specifications contained in 9 

CFR 319.5, the regulation that prescribes 

the standard of identity for MS 

(Species). 

(4) Nonambulatory disabled cattle 

means cattle that cannot rise from a 

recumbent position or that cannot walk, 

including, but not limited to, those with 

broken appendages, severed tendons or 

ligaments, nerve paralysis, fractured 

vertebral column, or metabolic 

conditions. 

(5) Specified risk material means 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. 

(6) Tallow means the rendered fat of 

cattle obtained by pressing or by 

applying any other extraction process to 

tissues derived directly from discrete 

adipose tissue masses or to other carcass 

parts and tissues. Tallow must be 

produced from tissues that are not 

prohibited cattle materials or must 

contain not more than 0.15 percent 

insoluble impurities as determined by 

the method entitled ‘‘Insoluble 

Impurities’’ (AOCS Official Method Ca 

3a-46), American Oil Chemists’ Society 

(AOCS), 5th Edition, 1997, incorporated 

by reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51, or another 

method equivalent in accuracy, 

precision, and sensitivity to AOCS 

Official Method Ca 3a-46. You may 

obtain copies of the method from the 

AOCS (http://www.aocs.org) 2211 W. 

Bradley Ave. Champaign, IL 61821. 

Copies may be examined at the Center 

for Food Safety and Applied Nutrition’s 

Library, 5100 Paint Branch Pkwy., 

College Park, MD 20740, or at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to http://www.archives.gov/federal

_register/code_of_federal_regulations/ 

ibr_locations.html. 

(7) Tallow derivative means any 

chemical obtained through initial 

hydrolysis, saponification, or transesterification of tallow; chemical 

conversion of material obtained by 

hydrolysis, saponification, or transesterification may be applied to obtain 

the desired product. 

(b) Requirements. 

(1) No cosmetic shall be manufactured 

from, processed with, or otherwise 

contain, prohibited cattle materials. 

(2) The small intestine is not 

considered prohibited cattle material 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 

caeco-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. 

(c) Records. Manufacturers and 

processors of cosmetics that are 

manufactured from, processed with, or 

otherwise contain, cattle material must 

make existing records relevant to 

compliance with this section available 

to FDA for inspection and copying. 

(d) Adulteration. Failure of a 

manufacturer or processor to operate in 

compliance with the requirements of 

paragraph (b) or (c) of this section 

renders a cosmetic adulterated under 

section 601(c) of the act. 

Dated: August 31, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17693 Filed 9–6–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. 2003D–0221] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Endotoxin Assay; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) published a final 

rule in the Federal Register of October 

31, 2003 (68 FR 62007). The final rule 

classified the endotoxin assay into class 

II (special controls). The agency 

classified the device into class II 

(special controls) in order to provide 

reasonable assurance of safety and 

effectiveness of the device. FDA is 

amending the agency’s regulations to 

redesignate the section number listed in 

the Code of Federal Regulations (CFR) 

from § 866.3610 to § 866.3210. 

DATES: This rule is effective September 

7, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Freddie M. Poole, Center for Devices 

and Radiological Health (HFZ–440), 

Food and Drug Administration, 2098 

Gaither Rd., Rockville, MD 20850, 240–

276–0496 ext. 1111. 

SUPPLEMENTARY INFORMATION: FDA has 

found that the endotoxin assay 

regulation does not reflect the correct 

section number listed in the CFR. 

Accordingly, FDA is amending the 

regulation in § 866.3610 (21 CFR 

866.3610) to correct the error by 

redesignating the section number from 

§ 866.3610 to 866.3210. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

§ 866.3610 [Redesignated as § 866.3210 ] 

■ 2. Section 866.3610 is redesignated as 

§ 866.3210. 

Dated: August 26, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–17645 Filed 9–6–05; 8:45 am] 

BILLING CODE 4160–01–S