Federal Register / Vol. 73, No. 75 / Thursday, April 17, 2008 / Rules and Regulations 20785 

Region of Origin is the Maritimes, in 

which case entry summary 

documentation must be submitted in 

paper as set forth in paragraph (c) of this 

section): 

(1) Region of Origin. The letter code 

representing a softwood lumber 

product’s Canadian Region of Origin, as 

posted on the Administrative Message 

Board in the Automated Commercial 

System. (For example, the letter code 

‘‘XD’’ designates softwood lumber 

products whose Region of Origin is 

British Columbia Coast. The letter code 

‘‘XE’’ designates softwood lumber 

products whose Region of Origin is 

British Columbia Interior.) 

(2) Export Permit Number—(i) Export 

Permit Number issued by Canada at 

time of filing entry summary 

documentation. The 8-digit Canadianissued Export Permit Number, preceded 

by one of the following letter codes: 

(A) The letter code assigned to 

represent the date of shipment (i.e., ‘‘A’’

represents January, ‘‘B’’ represents 

February, ‘‘C’’ represents March, etc.), 

except for those softwood lumber 

products produced by a company listed 

in Annex 10 of the SLA 2006 or whose 

Region of Origin is the Maritimes, 

Yukon, Northwest Territories or 

Nunavut; 

(B) The letter code ‘‘X’’, which 

designates a company listed in Annex 

10 of the SLA 2006; or 

(C) The letter code assigned to 

represent the Maritimes (code M); 

Yukon (code Y); Northwest Territories 

(code W); or Nunavut (code N), for 

softwood lumber products originating in 

these regions. 

(ii) No Export Permit Number 

required due to softwood lumber 

product’s exempt status. Where an 

Export Permit Number is not required 

because the imported softwood lumber 

product is specifically identified as 

exempt from SLA 2006 export measures 

pursuant to Annex 1A of the Agreement, 

notwithstanding the fact that the exempt 

goods are classifiable in residual 

Harmonized Tariff Schedule of the 

United States provisions otherwise 

listed as covered by the SLA 2006, the 

alpha-numeric code ‘‘P88888888’’ must 

be used in the Export Permit Number 

data entry field on the CBP Form 7501. 

(c) Original Maritime Certificate of 

Origin. Where a softwood lumber 

product’s Region of Origin is the 

Maritimes, the original paper copy of 

the Certificate of Origin issued by the 

Maritime Lumber Bureau must be 

submitted to CBP and the entry 

summary documentation for each such 

entry must be in paper and not 

electronic. The Certificate of Origin 

must specifically state that the 

corresponding CBP entries are for 

softwood lumber products first 

produced in the Maritimes from logs 

originating in the Maritimes or State of 

Maine. 

(d) Recordkeeping. Importers must 

retain copies of export permits, 

certificates of origin, and any other 

substantiating documentation issued by 

the Canadian Government pursuant to 

the recordkeeping requirements set forth 

in part 163 of title 19 to the CFR. 

PART 113—CUSTOMS BONDS 

■ 3. The general authority citation for 

part 113 continues to read as follows: 

Authority: 6 U.S.C. 101, et seq.; 19 U.S.C. 

66, 1623, 1624. 

* * * * * 

§ 113.62 [Amended] 

■ 4. In § 113.62, paragraph (k) is 

amended by: 

■ a. Removing the term ‘‘§ 12.140(a)’’

and adding in its place the term 

‘‘§ 12.140’’; 

■ b. Removing the number ‘‘20’’ and 

adding in its place the number ‘‘10’’; 

and 

■ c. Removing the word ‘‘Customs’’ and 

adding in its place the term ‘‘CBP’’. 

PART 163—RECORDKEEPING 

■ 5. The authority citation for part 163 

continues to read as follows: 

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

1484, 1508, 1509, 1510, 1624. 

■ 6. The Appendix to part 163 is 

amended by removing the listing for 

§ 12.140(c) and adding in its place 

§ 12.140(b) and (c) under section IV to 

read as follows: 

Appendix to Part 163—Interim (a)(1)(A) 

List 

* * * * * 

IV. * * * 

§ 12.140(b) and (c) Canadian-issued 

Export Permit, Certificate of Origin issued 

by Canada’s Maritime Lumber Bureau. 

* * * * * 

W. Ralph Basham, 

Commissioner, U.S. Customs and Border 

Protection. 

Approved: April 10, 2008. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. E8–8095 Filed 4–16–08; 8:45 am] 

BILLING CODE 9111–14–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 its 

regulations on the use of materials 

derived from cattle in human food and 

cosmetics. In these regulations, FDA has 

designated certain materials from cattle 

as ‘‘prohibited cattle materials’’ and has 

banned the use of such materials in 

human food, including dietary 

supplements, and in cosmetics. 

Prohibited cattle materials include 

specified risk materials (SRMs), the 

small intestine of all cattle unless the 

distal ileum is removed, material from 

nonambulatory disabled cattle, material 

from cattle not inspected and passed for 

human consumption, or mechanically 

separated (MS) (Beef). Specified risk 

materials include 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 of age and 

older, and the tonsils and distal ileum 

of the small intestine of all cattle. FDA 

is amending its regulations so that FDA 

may designate a country as not subject 

to certain bovine spongiform 

encephalopathy (BSE)-related 

restrictions applicable to FDA regulated 

human food and cosmetics. A country 

seeking to be so designated must send 

a written request to the Director of 

FDA’s Center for Food Safety and 

Applied Nutrition, including 

information about the country’s BSE 

case history, risk factors, measures to 

prevent the introduction and 

transmission of BSE, and any other 

relevant information. 

DATES: This interim final rule is 

effective July 16, 2008. Submit written 

or electronic comments on this interim 

final rule by July 16, 2008. Submit 

comments on information collection 

issues under the Paperwork Reduction 

Act of 1995 by May 19, 2008 (see the 

‘‘Paperwork Reduction Act of 1995’’

section of this document). 

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20786 Federal Register / Vol. 73, No. 75 / Thursday, April 17, 2008 / Rules and Regulations 

1At the time the comments were submitted, OIE 

classified countries for purposes of BSE into one of 

five categories: ‘‘free,’’ ‘‘provisionally free,’’

‘‘minimal,’’ ‘‘moderate,’’ and ‘‘high risk.’’ OIE 

subsequently revised its categories and now uses 

only three categories: ‘‘negligible,’’ ‘‘controlled,’’

ADDRESSES: You may submit comments, 

identified by Docket No. 2004N–0081 

and RIN 0910–AF47, by any of the 

following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No. and Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see section IV of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov 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–316), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1486. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 14, 

2004 (69 FR 42256), FDA issued an 

interim final rule entitled ‘‘Use of 

Materials Derived From Cattle in 

Human Food and Cosmetics’’ (‘‘the 2004 

IFR’’) to address the potential risk of 

BSE in human food and cosmetics. In 

the 2004 IFR, 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. These restrictions appear in 

§§ 189.5 and 700.27 (21 CFR 189.5 and 

21 CFR 700.27) of FDA’s regulations. 

The 2004 IFR designated the 

following as prohibited cattle materials: 

SRMs, the small intestine from all cattle, 

material from nonambulatory disabled 

cattle, material from cattle not inspected 

and passed for human consumption, or 

MS (Beef). SRMs include 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 of age and older, and the tonsils 

and distal ileum of the small intestine 

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 interim final 

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 the Federal Register of September 

7, 2005 (70 FR 53063), FDA amended 

the 2004 IFR to permit the use of the 

small intestine in human food and 

cosmetics provided the distal ileum 

portion of the small intestine has been 

removed. FDA also clarified that milk 

and milk products, hide and hidederived products, and tallow derivatives 

are not prohibited cattle materials, and 

cited a different method for determining 

impurities in tallow. Also in the Federal 

Register of September 7, 2005 (70 FR 

53043), FSIS published a similar 

amendment to its interim final rule, 

permitting the use of the small intestine 

in human food provided the distal 

ileum is removed. 

II. Amendments to the Interim Final 

Rule’s Provisions on Prohibited Cattle 

Materials 

In the 2004 IFR, FDA requested 

comment on whether materials from 

countries believed to be free of BSE 

should be exempt from the ‘‘prohibited 

cattle materials’’ requirements. FDA 

further solicited comment on what 

standards it should apply in 

determining whether to exempt a 

country and how it should determine 

whether a country meets such standards 

(69 FR 42256 at 42263). FSIS requested 

similar comment on the issue of 

equivalence in applying its BSE 

requirements in an advance notice of 

proposed rulemaking (ANPR) entitled 

‘‘Federal Measures to Mitigate BSE 

Risks: Considerations for Further 

Actions,’’ jointly published by USDA’s 

Animal and Plant Health Inspection 

Service (APHIS) and FSIS, and FDA on 

July 14, 2004 (69 FR 42299–42300). 

A. Comments Received 

In response to FDA’s solicitation on 

this issue, FDA received comments from 

representatives of several foreign 

countries that export cattle materials or 

products derived from such materials 

into the United States and from several 

trade associations. The comments take 

issue with the uniform application of 

FDA’s BSE-related measures to all 

human food and cosmetics imported 

into the United States, without regard to 

the BSE risk status of the originating 

country. Several comments state that 

their countries have a comprehensive 

range of control measures in place to 

prevent the entry and/or amplification 

of the BSE agent. These comments 

maintain that countries classified as 

BSE-free do not present a BSE risk and 

therefore should not be expected to 

comply with FDA’s BSE-related 

restrictions. These comments further 

maintain that U.S. requirements are 

forcing establishments and firms in 

countries considered to be free of BSE 

to carry out costly and unnecessary 

measures that are not scientifically 

justified so that they can export cattle 

materials to the United States. 

These comments also state that 

providing an exemption from BSErelated restrictions for countries 

classified as free of BSE would be 

consistent with guidelines established 

by the World Organization for Animal 

Health (referred to as ‘‘OIE,’’ based on 

its previous name, Office International 

des Epizooties), an international 

standard-setting body with 169 member 

countries, that publishes health 

standards for international trade in 

animal products. These comments state 

that the OIE recommends that countries 

restrict the importation of cattle material 

of potential concern on the basis of the 

BSE risk classification of the country or 

zone of origin. (See Terrestrial Animal 

Health Code, Ref. 1). These comments 

also point out that OIE recommends the 

removal of SRMs for imports from 

countries classified as minimal, 

moderate, and high risk for BSE but not 

for imports from countries with BSEfree status.1 Further, these comments 

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Federal Register / Vol. 73, No. 75 / Thursday, April 17, 2008 / Rules and Regulations 20787 

and ‘‘undetermined’’ risk. Countries previously 

categorized as ‘‘BSE-free’’ or ‘‘provisionally free’’

are now categorized as having ‘‘negligible’’ BSE 

risk. 

2Since these comments were submitted, Canada 

has adopted the OIE BSE risk categorization system 

of negligible, controlled, and undetermined risk. 

The EU is in the process of transitioning from its 

geographical BSE risk (GBR) system, which 

includes four levels of risk, to the OIE 3-tiered risk 

categorization system. 

point out that the World Trade 

Organization Agreement on the 

Application of Sanitary and 

Phytosanitary Measures (the SPS 

Agreement) requires member countries 

to recognize regionalization of diseases 

and not put in place measures that are 

more trade restrictive than necessary to 

achieve public health goals. 

Several of the comments also note 

that Canada and the European Union 

(EU) do not apply all of their BSErelated restrictions to countries 

recognized as BSE-free. For example, EU 

food and cosmetic regulations exclude 

countries that fall within the EU’s 

lowest risk range of BSE risk categories 

from restrictions on the use of SRMs. 

Canada provides a similar exemption 

from its BSE-related restrictions for 

countries it considers to be free from 

BSE.2

One comment suggests that in 

considering the BSE risk status of 

another country, FDA should refer to 

available country assessments already 

completed by USDA’s APHIS in 

carrying out its BSE-related restrictions 

on imports of meat and edible products 

from ruminants (codified at 9 CFR 

94.18), or otherwise rely on criteria 

provided by OIE for determining BSEfree countries. One comment 

recommends that if the assessment is 

conducted by U.S. authorities, it should 

be conducted by a single U.S. agency, 

preferably APHIS, given its prior 

experience in conducting this type of 

assessment. 

B. USDA Amendment 

USDA’s FSIS received similar 

comments in response to its interim 

final rule published on January 12, 

2004, and the ANPR published July 14, 

2004, regarding the application of its 

BSE-related restrictions for imported 

products without taking into account a 

country’s BSE risk status. Based in part 

on these comments, FSIS, in its 

affirmation of interim final rules with 

amendments published on July 13, 2007 

(72 FR 38699), amended its regulations 

to exclude from its definition of SRMs 

those materials from cattle that come 

from foreign countries that can 

demonstrate that their BSE risk status 

can reasonably be expected to provide 

the same level of protection from 

exposure to the BSE agent as does 

prohibiting the use of SRMs in the 

United States. 

C. Response to Comments 

FDA agrees with the views expressed 

by the comments and has determined 

that it is not necessary for all BSErelated restrictions to apply to human 

food and cosmetics regardless of a 

country’s BSE status. FDA’s BSE-related 

restrictions for human food and 

cosmetics are intended to address the 

potential presence of BSE in a country’s 

cattle population. SRMs are prohibited 

because they are the tissues most likely 

to harbor infectivity in cattle with BSE. 

The small intestine is prohibited unless 

the distal ileum portion of the small 

intestine, which is considered an SRM, 

is effectively removed. Material from 

nonambulatory disabled cattle are 

prohibited because evidence has 

indicated that this segment of the cattle 

population is more likely to have BSE 

than healthy-appearing cattle and the 

typical clinical signs of BSE having to 

do with gait and movement cannot be 

observed in nonambulatory cattle. MS 

(Beef) is included in the definition 

because it may contain concentrated 

amounts of the following SRMs: spinal 

cord, dorsal root ganglia, and vertebral 

column. Material from cattle not 

inspected and passed is prohibited 

because they are at higher risk of 

harboring undetected BSE. 

As described in the 2004 IFR, 

epidemiological evidence indicates that 

the BSE epidemic in the United 

Kingdom (U.K.) was a result of 

consumption of animal feed 

contaminated by the BSE agent. The 

spread of BSE outside the U.K. has been 

attributed to the export of BSEcontaminated feed from the U.K. to 

other countries prior to the realization 

of the role of feed in transmitting the 

disease and the implementation of 

restrictions on such trade. However, a 

country may not have engaged in trade 

in animal feed with the U.K. or other 

affected countries, and it may have had 

preventive measures in place for a 

length of time adequate to make the 

chance remote that BSE currently is 

present in its national herds. 

Such a country may be able to 

demonstrate to FDA that its BSE case 

history, risk factors, and measures to 

prevent the introduction and 

transmission of BSE make certain BSErelated restrictions unnecessary. Not 

restricting cattle materials inspected and 

passed for human consumption from 

such a country to be used in human 

food and cosmetics is consistent with all 

applicable statutory standards. Further, 

this approach is consistent with OIE’s 

recommendation that cattle materials 

from negligible risk countries not be 

restricted. 

Material from cattle not inspected and 

passed for human consumption will 

continue to be prohibited, regardless of 

the country of origin. We are retaining 

this provision as a universal 

requirement because the exception for 

designated countries in this amendment 

is predicated on application of a 

country’s food safety controls, including 

inspection of source animals, to human 

food or cosmetics made with cattle 

materials and imported into the United 

States. It is critical to ensuring safety 

that, regardless of the country of origin, 

source cattle have been evaluated and 

determined appropriate for human 

consumption. In addition, applying this 

requirement universally is consistent 

with OIE recommendations, which 

recognize the importance that cattle 

pass antemortem and post-mortem 

inspections even in ‘‘negligible risk’’

countries. 

Therefore, FDA is amending its 

regulations in §§ 189.5 and 700.27 to 

provide that FDA may designate a 

country as not subject to the restrictions 

applicable to human food and cosmetics 

manufactured from, processed with, or 

that otherwise contain SRMs, the small 

intestine of cattle, material from 

nonambulatory disabled cattle, or MS 

(Beef). Cattle materials inspected and 

passed from a designated country will 

not be considered prohibited cattle 

materials and their use will not render 

a human food or cosmetic adulterated. 

The amendment further provides that a 

country seeking to be so designated 

must send a written request to the 

Director of FDA’s Center for Food Safety 

and Applied Nutrition, including 

information about a country’s BSE case 

history, risk factors, measures to prevent 

the introduction and transmission of 

BSE, and other information relevant to 

determining whether SRMs, the small 

intestine of cattle (unless the distal 

ileum has been removed), material from 

nonambulatory disabled cattle, or MS 

(Beef) should be considered prohibited 

cattle materials. 

In its application, the requesting 

country will be expected to provide 

information to FDA on its BSE case 

history, including whether cattle in that 

country have tested positive for BSE, 

and if so, the circumstances and the 

country’s response. In addition, FDA 

will review information that addresses 

the extent to which the requesting 

country has identified and taken into 

account relevant risk factors such as the 

following: 

• Possible presence of BSE in 

indigenous and/or imported cattle; 

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20788 Federal Register / Vol. 73, No. 75 / Thursday, April 17, 2008 / Rules and Regulations 

• Geographic origin of imported 

cattle; 

• Materials used in the production of 

ruminant feed and feed ingredients; and 

• Importation of ruminant feed and 

feed ingredients. 

FDA will consider information 

relating to the possible presence of BSE 

in indigenous and imported cattle in the 

requesting country as well as the 

requesting country’s production and 

importation of ruminant feed and feed 

ingredients. With respect to imported 

cattle, relevant information includes the 

identification of any countries where 

imported cattle were born or raised and 

the dates any cattle were imported. With 

regard to ruminant feed, FDA will 

consider, among other things, how 

ruminant feed was produced in the 

requesting country, including what 

animal origin materials were allowed to 

be included. FDA will also consider 

whether ruminant feed and feed 

ingredients were imported, and if so, the 

source countries and dates of import. 

In addition to reviewing risk factors 

such as those identified previously, 

FDA will assess how the requesting 

country has addressed and managed any 

identified BSE risks through the 

implementation of appropriate measures 

to prevent the introduction and 

transmission of BSE. FDA will consider 

how long such preventive measures 

have been in place and whether they 

have been effectively carried out. 

Examples of preventive measures 

include the following: 

• A prohibition on the use of 

ruminant feed that might carry a risk of 

transmitting the BSE agent; 

• A prohibition on the importation of 

cattle and cattle-derived products that 

might carry a risk of transmitting the 

BSE agent; 

• Surveillance systems for BSE in 

cattle populations with appropriate 

examination of brain or other tissues 

collected for surveillance in approved 

laboratories; 

• Mandatory notification and 

examination of all cattle showing signs 

consistent with BSE; and 

• Protocols or other written 

procedures for investigating potential 

cases of BSE, including ability to trace 

former herdmates of BSE-positive 

animals. 

As part of its evaluation of feed 

restrictions, FDA will consider factors 

including whether appropriate feed 

restrictions are in place and the 

adequacy of enforcement of those 

restrictions (e.g., the frequency of 

facility inspections and level of 

compliance). FDA also will consider a 

requesting country’s import controls for 

cattle material. Such consideration will 

include whether the country effectively 

monitors and controls potential 

pathways of SRMs and other potentially 

infective materials into its country from 

other countries for whom such controls 

are necessary. 

In addition, FDA will consider the 

requesting country’s surveillance and 

monitoring efforts with respect to BSE. 

For example, FDA will evaluate the 

level at which the country performs 

surveillance and monitoring, whether 

tissue samples are collected and 

examined at approved laboratories, and 

whether recognized diagnostic 

procedures and methods are used, such 

as those procedures and methods 

provided in the OIE Manual of 

Diagnostic Tests and Vaccines for 

Terrestrial Animals (Ref. 2). 

FDA also will consider whether the 

country has an ongoing program for 

notification and investigation of all 

cattle showing signs consistent with 

BSE. In evaluating such a program, FDA 

will consider, among other factors, 

whether notification and investigation 

are mandated, whether veterinarians, 

producers, and others involved in cattle 

production have been provided 

sufficient information about BSE, such 

as through an awareness program, and 

whether there are additional measures 

in place to stimulate reporting of 

suspect cattle, such as compensation or 

penalties. 

FDA also will consider a country’s 

written procedures for investigating 

potential cases of BSE. Such a 

consideration will include whether the 

country has written procedures for the 

investigation of suspect animals and 

whether the country has the 

investigative capability to followup 

positive findings by tracing former 

herdmates of animals determined to be 

BSE positive. Finally, FDA also will 

consider any other information relevant 

to determining whether the country 

should be designated under §§ 189.5(e) 

and 700.27(e). 

FDA and the USDA agencies, APHIS 

and FSIS, have different regulatory 

responsibilities with respect to 

preventing BSE and ensuring food 

safety. Further, it is not necessary or 

practical for one of the three agencies to 

conduct every evaluation of a country’s 

BSE status, regardless of the purpose of 

the evaluation. FDA will, however, 

consult with APHIS and FSIS as part of 

its evaluation process. Further, FDA 

will take into consideration available 

risk assessments of other competent 

authorities in conducting its evaluation. 

Though it is not required, a previous 

BSE evaluation by USDA, OIE, or by 

another country or another competent 

authority, will be helpful to FDA in its 

review and may decrease the time 

needed for FDA to make a 

determination. 

Upon completion of its review, FDA 

will provide written notification of its 

decision to the applicant country, 

including the basis for the decision. 

FDA may impose conditions in granting 

a request for designation. Further, any 

designation granted under § 189.5 or 

§ 700.27 will be subject to future review 

by FDA to ensure that the designation 

remains appropriate. As part of this 

process, FDA may ask designated 

countries to confirm that their BSE 

situation and the information submitted 

by them in support of their original 

application remain unchanged. Further, 

FDA may revoke a country’s designation 

if FDA determines that it is no longer 

appropriate. 

FDA will provide further information 

on its evaluation process, the scope of 

the review, and the types of supporting 

information that it would find helpful in 

reviewing a country’s submission at the 

time of the request. 

III. Summary of Amendments to the 

Interim Final Rule 

FDA is amending its regulations in 

§§ 189.5(a) and 700.27(a) by revising the 

definition of ‘‘prohibited cattle 

materials’’ to exclude cattle materials 

inspected and passed for human 

consumption from a country designated 

by FDA under § 189.5(e) or § 700.27(e). 

New §§ 189.5(e) and 700.27(e) provide 

that a country seeking such a 

designation must send a written request 

to the Director, Office of the Center 

Director, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740–3835. 

Further, the request shall include 

information about a country’s BSE case 

history, risk factors, measures to prevent 

the introduction and transmission of 

BSE, and other information relevant to 

determining whether SRMs, the small 

intestine of cattle (unless the distal 

ileum has been removed), material from 

nonambulatory disabled cattle, or MS 

(Beef) should be considered prohibited 

cattle materials. The new sections 

further provide that FDA shall respond 

in writing to any such request and that 

FDA may revoke a country’s designation 

if FDA determines that it is no longer 

appropriate. 

IV. Effective Date and Opportunity for 

Public Comment 

In the 2004 IFR, FDA solicited 

comment on whether materials from 

countries believed to be free from BSE 

should be exempt from the ‘‘prohibited 

cattle materials’’ requirements. FDA 

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Federal Register / Vol. 73, No. 75 / Thursday, April 17, 2008 / Rules and Regulations 20789 

3The OIE ‘‘provisionally free’’ designation is in 

accordance with the 2004 edition (13th edition) of 

the Terrestrial Animal Health Code, and remains in 

effect for Iceland and Paraguay until May 2008. See 

Ref. 3. 

4The data sorted by NAICS code does not allow 

for the separation of beef products that are imported 

from other imported meat products such as pork. 

addresses the comments it received in 

this document. This amendment is 

effective on July 16, 2008. FDA invites 

public comment on the current 

amendment to the interim final rule; 

submit written or electronic comments 

on the interim final rule by July 16, 

2008. The agency will consider 

modifications to the current amendment 

to the interim final rule based on 

comments made during the comment 

period. Interested persons may submit 

to the Division of Dockets Management 

(see ADDRESSES) written or electronic 

comments regarding this document. 

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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA through FDMS only. 

FDA will address other comments 

received in response to the 2004 IFR 

and comments received in response to 

this document in further rulemaking. 

V. Executive Order 12866 and 

Regulatory Flexibility Act 

A. Interim Final Regulatory Impact 

Analysis 

FDA has examined the economic 

impacts of the interim final rule under 

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 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 interim final rule is 

not a significant regulatory action as 

defined by Executive Order 12866. 

1. Need for Regulation 

FDA agrees with FSIS and the 

international community that cattle 

materials imported from countries that 

can demonstrate that their BSE case 

history and their having in place 

effective measures to prevent the 

introduction and transmission of BSE 

may be such that they should not be 

subject to the same BSE-related 

restrictions applied to cattle materials 

imported into the United States from 

other countries. Restricting the 

importation of potentially infective 

materials on the basis of the BSE risk of 

the region of origin is more efficient 

than an approach that does not consider 

a country’s circumstances regarding 

BSE. 

As comments on the 2004 IFR have 

noted, the World Trade Organization 

Agreement on the Application of 

Sanitary and Phytosanitary Measures 

(the SPS Agreement) requires member 

countries to recognize regionalization of 

diseases and not put in place measures 

that are more trade restrictive than 

necessary to achieve public health goals. 

Thus, the uniform application by FDA 

of BSE-related restrictions to all imports 

of food and cosmetic products into the 

United States without taking into 

account a country’s BSE case history, 

risk factors, measures to prevent the 

introduction and transmission of BSE, 

and other relevant information means 

that other countries must implement 

costly and unnecessary measures that 

may not be scientifically justified. 

Providing this exception from certain 

requirements relating to human food 

and cosmetics for designated countries 

is more efficient in the sense that it 

achieves essentially the same protection 

of public health with fewer restrictions 

on the market for cattle-derived 

materials. 

2. Interim Final Rule Coverage 

Foreign countries need to make 

formal application to FDA in order to be 

considered for this exception from the 

provision on prohibited cattle materials 

in §§ 189.5 and 700.27. FDA will make 

a determination as to a country’s request 

based on an evaluation that is carried 

out in consultation with the USDA’s 

APHIS and FSIS. FDA will take into 

consideration relevant technical 

information provided by the requesting 

country with respect to its BSE case 

history, including whether cattle in that 

country have tested positive for BSE, 

and if so, the circumstance and the 

country’s response. In addition, FDA 

will review information that addresses 

the extent to which the requesting 

country has identified and taken into 

account relevant risk factors such as the 

following: 

• The possible presence of BSE in 

indigenous and/or imported cattle; 

• Geographic origin of imported 

cattle; 

• Materials used in the production of 

ruminant feed and feed ingredients; and 

• Importation of ruminant feed and 

feed ingredients. 

FDA will also assess how the requesting 

country has addressed and managed any 

identified BSE risks through the 

implementation of appropriate measures 

to prevent the introduction and 

transmission of BSE, such as the 

following: 

• A prohibition on the use of 

ruminant feed that might carry a risk of 

transmitting the BSE agent; 

• A prohibition on the importation of 

cattle and cattle-derived products that 

might carry a risk of transmitting the 

BSE agent; 

• Surveillance systems for BSE in 

cattle populations with appropriate 

examination of brain or other tissues 

collected for surveillance in approved 

laboratories; 

• Mandatory notification and 

examination of all cattle showing signs 

consistent with BSE; and 

• Protocol or other written 

procedures for investigating potential 

cases of BSE, including ability to trace 

former herdmates of BSE-positive 

animals. 

Number of Countries Affected 

We do not know how many countries 

will take advantage of the option to 

petition FDA for a designation under 

§§ 189.5(e) and 700.27(e). According to 

information from the OIE, countries that 

are officially recognized as having a 

‘‘negligible BSE risk’’ in accordance 

with the requirements of the OIE 

Terrestrial Animal Health Code (16th 

edition 2007) include the following: 

Australia, Argentina, New Zealand, 

Singapore, and Uruguay. Two countries, 

Iceland and Paraguay, are recognized as 

‘‘provisionally free’’3 from BSE. For 

these two categories of countries, OIE 

does not recommend the removal of 

SRMs (Ref. 4). 

Table 1 presents data from the U.S. 

International Trade Commission (Ref. 5) 

showing for 2006 the top 10 exporters 

of meat products4 and animal fats, oils, 

and by-products to the United States. 

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5We assume such measures were necessary to 

continue marketing cattle products following the 

surge of BSE cases in the U.K. and the rulemakings 

that followed. 

6Pay for an employee earning a GS-13 step 7 

adjusted to include locality pay for Washington 

D.C. and surrounding area (Ref. 6). 

TABLE 1.—TOP 10 COUNTRIES EXPORTING SPECIFIED NORTH AMERICAN INDUSTRY CLASSIFICATION

SYSTEM (NAICS) CODE PRODUCTS TO UNITED STATES FOR

2006 

NAICS 3116111—Meat 

Products (Excluding 

Poultry) 

Quantity 

(thousands of 

kilograms)2

Canada 681,899 

Australia 376,585 

New Zealand 211,873 

Uruguay 103,305 

Brazil 83,897 

Denmark 46,652 

Mexico 35,553 

China 28,530 

Argentina 22,353 

Nicaragua 21,303 

NAIC 311613—Animal 

Fats, Oils, & By-Products 

(thousands of 

kilograms)3

Canada 94,306 

New Zealand 32,550 

China 7,809 

Australia 6,807 

Brazil 6,589 

Mexico 2,130 

Colombia 1,826 

Germany 1,642 

Ecuador 1,149 

Japan 1,138 

1The NAIC code 31161 covers the animal 

slaughtering and processing industry. The 

industry is composed of establishments that 

are primarily engaged in one or more of the 

following: (1) Slaughtering animals, (2) preparing processed meats and meat by-products, and (3) rendering and refining animal 

fat, bones, and meat scraps. The subcategory 311611 comprises those establishments primarily engaged in slaughtering animals (except poultry and small game). Establishments that slaughter and prepare 

meats are included in this classification. 

(Ref. 5) We use this data as an indicator of 

the countries that are most likely to petition 

FDA regarding their BSE status. 2These figures do not include exports 

measured in ‘‘clean yield kilograms’’ and 

‘‘pieces.’’ 3These figures do not include exports 

measured in ‘‘grams,’’ ‘‘liters,’’ ‘‘metric tons,’’ 

and ‘‘pieces.’’ 3These figures do not include exports 

measured in ‘‘grams,’’ ‘‘liters,’’ ‘‘metric tons,’’ 

and ‘‘pieces.’’ 

We do not know how many countries 

might petition the FDA. However, 

taking into consideration the previous 

information on countries officially 

recognized as having a negligible BSE 

risk or being provisionally free of BSE 

under OIE, as well as the information in 

table 1 on countries that export large 

amounts of meat products and animal 

fats, oils, and byproducts to the United 

States, we are estimating for this 

analysis that 10 countries may be 

interested in petitioning FDA to be 

excepted from certain BSE-related 

restrictions applicable to human food 

and cosmetics. Our estimate is not 

intended to suggest that all of these 

countries would be able to qualify for a 

designation under §§ 189.5(e) and 

700.27(e). 

3. Costs and Benefits of Exemption 

Provision 

Countries that petition the FDA to be 

designated as excepted from certain 

BSE-related restrictions applicable to 

human food and cosmetics may also 

petition USDA for exclusion from 

USDA’s BSE-related requirements. 

Some of the costs to countries to 

petition FDA may be shared with costs 

to petition USDA because of similarities 

regarding how countries’ products can 

qualify for the exceptions. Even so, we 

will outline here a potential scenario for 

calculating the costs of petitioning FDA 

for an exception from certain provisions 

of the agency’s BSE regulations. 

a. Assumptions and costs associated 

with this interim final rule. We would 

expect countries that wish to petition 

FDA to be excepted from certain BSErelated restrictions applicable to human 

food and cosmetics to have already 

completed a risk assessment and put 

risk management strategies into place.5

Whether these risk assessment and 

mitigation strategies are sufficient for a 

country to be so designated by FDA will 

be determined on a case-by-case basis. 

b. Petition process. We assume 

petitions to FDA for this designation 

would include an already developed 

risk assessment or other technical 

information on the country’s BSE 

situation, a detailed outline of risk 

mitigation strategies, and information 

on the country’s cattle-derived products 

that are exported to the United States. 

The petition is assumed to take 80 hours 

per country for assembly of the 

information and the wage for a 

government employee earning a GS–14 

step 1 (Ref. 6) is used to estimate the 

costs. The cost of assembling a single 

petition is estimated to be about $5,400 

(80 hours x $67.44 per hour including 

overhead). The petition will also be 

reviewed by higher level government 

managers before being sent to the FDA. 

We assume the wage for a high level 

government executive is a GS–15 step 3 

(Ref. 6) and that they will spend 40 

hours reviewing the petition. The cost of 

review by a government manager is 

estimated to be about $3,400 (40 hours 

x $84.62 per hour including overhead). 

Thus, the total cost to each country to 

prepare and submit a petition to FDA to 

be considered for this designation 

would be about $9,000. 

c. Petition review by FDA. It will take 

FDA approximately 80 hours to review 

a petition. The cost of each petition 

review would be about $3,700 (80 hours 

x $45.65 per hour).6

TABLE 2.—TOTAL COST OF INITIAL

PETITION APPLICATION AND REVIEW

Petition Assembly and Review 

per Country 

$9,000 

FDA Review per Petition $3,700 

Total Cost per Country $12,700 

Cost for 10 Countries $127,000 

d. Petition success uncertainty. It is 

possible that some countries that 

petition the FDA to be designated as 

excepted from certain BSE-related 

restrictions applicable to human food 

and cosmetics will not be successful. 

We do not know how likely it will be 

that countries with insufficient BSE risk 

assessment and mitigation strategies 

will petition the FDA. 

e. Future petitions to FDA. It is likely 

that those countries that currently sell a 

significant amount of cattle-derived 

material will be most interested in 

seeking possible relief under this change 

to FDA’s prohibited cattle materials 

requirements. It is possible in the future, 

if new markets for cattle derived 

products develop, that other countries 

may want to petition FDA to be 

designated as not subject to certain BSErelated restrictions applicable to human 

food and cosmetics. We do not attempt 

to forecast new markets for cattle 

derived products here. We also do not 

attempt to forecast the frequency of, or 

estimate the costs associated with, FDA 

review in the future of successful 

petitions. 

f. Future review of successful petitions 

by FDA. Countries that successfully 

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petition the FDA to be designated as 

excepted from certain BSE-related 

restrictions applicable to human food 

and cosmetics will be subject to future 

review by FDA to ensure that their 

designation remains appropriate. As 

part of this process, FDA may ask 

designated countries to confirm that 

their BSE situation and the information 

submitted by them in support of their 

original application remain unchanged. 

FDA may revoke a country’s designation 

if FDA determines that it is no longer 

appropriate. 

FDA has not yet determined the 

method by which the agency will 

conduct these future reviews. One 

possible method would be for FDA to 

send a letter to designated countries 

asking whether there has been a change 

in their status or circumstances relative 

to their BSE history, surveillance, 

import activities, or other relevant 

criteria and then compare any changed 

information with the information that 

was originally submitted. The OIE 

requires that countries it has recognized 

in regard to their BSE status ‘‘should 

annually confirm during the month of 

November whether their status and the 

criteria by which their status was 

recognized have remained unchanged.’’

In some cases, the FDA reviewer might 

rely on this information, if available, in 

conducting a future review of the 

country’s designation. 

We assume it will take FDA and the 

designated country undergoing a review 

in the future about one third the time 

and effort it did when the original 

information was submitted. Thus, if the 

total cost to initially submit a petition 

and have it reviewed by FDA was 

$12,700, then a future review of the 

petition by FDA and the submitting 

country will cost about $4,200 (see 

Table 3). 

TABLE 3.—COST OF FUTURE

REVIEW OF SUCCESSFUL PETITIONS

Submission of Additional Information and Response by 

Country 

$3,000 

FDA Review per Country $1,200 

Total Cost per Country $4,200 

Cost for 10 Countries $42,000 

4. Other Options Considered 

FDA considered the following options 

when examining the costs and benefits 

of this IFR. 

Option 1—Do nothing. 

This option is the baseline for which 

the costs and benefits of other options 

are compared. The costs and benefits of 

this option have already been realized. 

Firms buying and selling cattle-derived 

materials in the United States and other 

countries have found alternatives to 

using products covered by the definition 

of prohibited cattle materials in the 

manufacture of their products. 

Option 2—Amend definition of 

prohibited cattle materials (the chosen 

option). 

The costs and benefits of this option 

are outlined previously. The main 

benefit of this option is that it is more 

efficient than the current regulation 

because it achieves essentially the same 

protection of public health with fewer 

restrictions on the market for cattlederived materials. With this interim 

final rule, FDA can continue to prevent 

the potential introduction and 

transmission of BSE from cattle 

materials from non-designated 

countries, while at the same time 

reducing the restrictions on the market 

for cattle-derived materials from 

designated countries. 

Option 3—Amend the definition of 

prohibited cattle materials to allow 

material from cattle not inspected and 

passed for human consumption for use 

in human food and cosmetics. 

This option is less stringent than 

option 2, which would reduce the costs 

of cattle-derived materials used in the 

manufacture of human food and 

cosmetics, but it would not provide the 

same public health benefits as options 1 

and 2. Material from cattle not inspected 

and passed for human consumption has 

not been approved by a regulatory 

authority (USDA or other) and thus we 

cannot make the determination that, 

among other things, the cattle material 

is from an animal that was evaluated for 

a neurological disorder such as BSE. In 

requiring that material from cattle for 

use in FDA-regulated human food and 

cosmetics be inspected and passed for 

human consumption, we are 

minimizing the risk of exposure to the 

agent that causes BSE, and therefore 

maximizing the protection of public 

health from variant Creutzfeldt-Jakob 

disease, the human disease linked to 

consumption of BSE-infected cattle 

material. 

5. Benefits 

Under this interim final rule, foreign 

countries would have the option of 

demonstrating (through information 

submitted to FDA) that their BSE case 

history, their identifying and taking into 

account relevant risk factors, their 

implementing appropriate measures to 

prevent the introduction and 

transmission of BSE, and any other 

relevant information shows that certain 

BSE-related restrictions, in their case, 

are unnecessary. Countries that 

successfully petition FDA would be able 

to again export human food and 

cosmetics to the United States without 

the removal of the following items: 

• SRMs 

• Small intestine (including the distal 

ileum) 

• Material from nonambulatory 

disabled cattle 

• MS (Beef) 

6. Effect on Food Supply in the United 

States 

We expect this interim final rule 

amendment will increase the 

availability of certain cattle materials 

(and products containing those 

materials) for sale in the United States. 

The most significant gain in supply will 

probably occur from the increased 

availability of FDA-regulated products 

that contain MS (Beef) and material 

from nonambulatory disabled cattle for 

use in human food regulated by FDA. 

Few, if any, human food or cosmetic 

products use SRMs as an ingredient, but 

to the extent that these materials are 

needed, they will again be available in 

the United States. 

B. Final Regulatory Flexibility Analysis 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) (RFA) imposes 

certain requirements with respect to 

Federal rules that are subject to the 

notice and comment requirements of 

section 553(b) of the Administrative 

Procedure Act (5 U.S.C. 551 et seq.) and 

that are likely to have a significant 

economic impact on a substantial 

number of small entities. Unless an 

agency certifies that a proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities, section 603 of the RFA requires 

that the agency present an initial 

regulatory flexibility analysis at the time 

of the publication of the notice of 

proposed rulemaking describing the 

impact of the rule on small entities and 

seeking public comment on such 

impact. Because this rule is being issued 

as an interim final rule, the RFA does 

not apply and FDA is not required to 

either certify that the rule will not have 

a significant impact on a substantial 

number of small businesses or conduct 

an initial regulatory flexibility analysis. 

Also, FDA does not have information on 

how many small firms in foreign 

countries designated by the agency may 

benefit from this rule. Examining the 

effect this interim final rule has on 

small foreign firms is outside the scope 

of the RFA requirements. 

The extent to which small firms 

within the United States are affected by 

this rule is unknown. FDA 

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acknowledges that small U.S. businesses 

that use imported cattle materials in 

manufacture or for sale as final products 

will likely benefit from this rulemaking 

as costs of these inputs are expected to 

decrease as supply increases. Small U.S. 

firms that compete with foreign firms in 

order to supply cattle-derived inputs 

and products to U.S. business and 

markets may be adversely affected if 

foreign firms can more cheaply supply 

these materials and products. FDA seeks 

public comment on the question of 

whether such small U.S. businesses will 

be adversely impacted by this rule. 

C. Unfunded Mandates 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4) 

requires cost-benefit and other analyses 

before any rule making if the rule would 

include a ‘‘Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $127 

million, using the most current (2006) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA has determined 

that this interim final rule does not 

constitute a significant rule under the 

Unfunded Mandates Reform Act. 

VI. Paperwork Reduction Act of 1995 

This interim final rule contains 

information collection requirements that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The title, 

description, and respondent description 

of these provisions are shown in the 

following paragraphs with an estimate 

of the annual recordkeeping burden. 

Included in the estimate is the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing each 

collection of information. 

FDA invites comments on: (1) 

Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Petition To Be Designated as 

Not Subject to Certain BSE-Related 

Restrictions Applicable to FDA 

Regulated Human Food and Cosmetics 

Description: 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, and then 

amended on September 7, 2005. In the 

2004 interim final rule and its 

amendments, 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. Prohibited cattle materials 

include SRMs, the small intestine of all 

cattle unless the distal portion of the 

ileum is removed, material from 

nonambulatory disabled cattle, material 

from cattle not inspected and passed for 

human consumption, and MS (Beef). 

SRMs include 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. Therefore, 

FDA is amending its regulations at 

§§ 189.5 and 700.27 to provide that FDA 

may designate a country as not subject 

to the restrictions applicable to human 

food and cosmetics manufactured from, 

processed with, or that otherwise 

contain SRMs, the small intestine of 

cattle, material from nonambulatory 

disabled cattle, or MS (Beef). The 

interim final rule, as amended, provides 

that these materials, when from cattle 

from a designated country, are not 

considered prohibited cattle materials, 

and their use does not render a human 

food or cosmetic adulterated. The 

amendment further provides that a 

country seeking to be so designated 

must send a written request to the 

Director of FDA’s Center for Food Safety 

and Applied Nutrition, including 

information about a country’s BSE case 

history, risk factors, measures to prevent 

the introduction and transmission of 

BSE, and other information relevant to 

determining whether SRMs, the small 

intestine of cattle (unless the distal 

ileum has been removed), material from 

nonambulatory disabled cattle, or MS 

(Beef) should be considered prohibited 

cattle materials. 

Description of Respondents: Countries 

with firms that would like to use SRMs, 

the small intestine of cattle, material 

from nonambulatory disabled cattle, or 

MS (Beef) in products exported to the 

United States. 

Information Collection Burden Estimate 

FDA estimates the burden for this 

information collection as follows: 

TABLE 4.—ESTIMATED ONE-TIME AND RECURRING REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

189.5 and 700.272 10 1 10 80 800 

189.5(e) and 700.27(e) 10 1 10 26.4 264 

Total one time burden 800 

Total recurring burden 264 

1There are no capital costs or operating and maintenance costs associated with the collection of information under this interim final rule. 2One-time burden. 

One Time Reporting Burden 

There will be a one time burden to 

countries that apply to FDA seeking to 

be designated as not subject to 

restrictions applicable to SRMs, the 

small intestine of cattle, nonambulatory 

disabled cattle, or MS (Beef). We 

estimate that each country that applies 

for an exclusion will spend 80 hours 

putting information together to submit 

to FDA. Table 4 row 3 of this document 

presents the one-time burden expected 

for countries who apply for the 

exclusion. 

Recurring Burden 

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Countries that successfully petition 

the FDA to be designated as excepted 

from certain BSE-related restrictions 

applicable to human food and cosmetics 

will be subject to future review by FDA 

to ensure that their designation remains 

appropriate. As part of this process, 

FDA may ask designated countries from 

time to time to confirm that their BSE 

situation and the information submitted 

by them in support of their original 

application remain unchanged. We 

assume it will take FDA and the 

designated country undergoing a review 

in the future about one third the time 

and effort it did when the information 

was submitted. Table 4 row 4 of this 

document presents the expected 

recurring burden. 

The information collection provisions 

of this interim final rule have been 

submitted to OMB for review. Interested 

persons are requested to fax comments 

regarding information collection by (see 

DATES), to the Office of Information and 

Regulatory Affairs, OMB. To ensure that 

comments on information collection are 

received, OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

Prior to the effective date of this 

interim final rule, FDA will publish a 

notice in the Federal Register 

announcing OMB’s decision to approve, 

modify, or disapprove the information 

collection provisions in this interim 

final rule. An agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

VII. Environmental Impact Analysis 

The agency has determined under 21 

CFR 25.30(h) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VIII. Federalism 

FDA has analyzed this interim final 

rule in accordance with the principles 

set forth in Executive Order 13132. 

Section 4(a) of the Executive Order 

requires agencies to ‘‘construe * * * a 

Federal statute to preempt State law 

only where the statute contains an 

express preemption provision or there is 

some other clear evidence that the 

Congress intended preemption of State 

law, or where the exercise of State 

authority conflicts with the exercise of 

Federal authority under the Federal 

statute.’’ FDA has determined that the 

interim final rule does not contain 

policies that have substantial direct 

effects on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, we conclude that the 

interim final rule does not contain 

policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

IX. 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 FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. World Organization for Animal Health, 

Terrestrial Animal Health Code (2007), 

Chapter 2.3.13, Bovine Spongiform 

Encephalopathy. See also Appendix 3.8.4 

(Surveillance for Bovine Spongiform 

Encephalopathy) and Appendix 3.8.5 

(Factors to Consider in Conducting the 

Bovine Spongiform Encephalopathy Risk 

Assessment Recommended in Chapter 

2.3.13). Accessed online at http:// 

www.oie.int/eng/normes/mcode/ 

en_sommaire.htm. 

2. World Organization for Animal Health, 

Manual of Diagnostic Tests and Vaccines for 

Terrestrial Animals 2004 (updated 2006). 

Accessed online at http://www.oie.int/eng/ 

normes/mmanual/A_summry.htm. 

3. World Organization for Animal Health 

(OIE), Recognition of the Bovine Spongiform 

Encephalopathy Status of Member Countries, 

OIE Resolution No. XXIV, adopted by the 

International Committee of the OIE on May 

22, 2007. See http://www.oie.int/eng/info/ 

en_statesb.htm?eld6, accessed August 30, 

2007. 

4. United States International Trade 

Commission, Interactive Tariff and Trade 

Dataweb, http://dataweb.usitc.gov/, accessed 

April 6, 2007. 

5. NAICS Association, http:// 

www.naics.com/censusfiles/NDEF311.HTM, 

accessed August 27, 2007. 

6. U.S Office of Personnel Management 

Salaries and Wages 2007 General Schedule, 

http://www.opm.gov/oca/07tables/ 

indexGS.asp, accessed on April 11, 2007. 

List of Subjects 

21 CFR Part 189 

Food additives, Food packaging. 

21 CFR Part 700 

Cosmetics, Packaging and containers. 

■ 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, 

381. 

■ 2. Section 189.5 is amended by 

revising paragraph (a)(1) and by adding 

paragraph (e) to read as follows: 

§ 189.5 Prohibited cattle materials. 

(a) * * * 

(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 the following: 

(i) Tallow that contains no more than 

0.15 percent insoluble impurities, 

tallow derivatives, hides and hidederived products, and milk and milk 

products, and 

(ii) Cattle materials inspected and 

passed from a country designated under 

paragraph (e) of this section. 

* * * * * 

(e) Process for designating countries. 

A country seeking designation must 

send a written request to the Director, 

Office of the Center Director, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, at the 

address designated in 21 CFR 5.1100. 

The request shall include information 

about a country’s bovine spongiform 

encephalopathy (BSE) case history, risk 

factors, measures to prevent the 

introduction and transmission of BSE, 

and any other information relevant to 

determining whether specified risk 

materials, the small intestine of cattle 

except as provided in paragraph (b)(2) of 

this section, material from 

nonambulatory disabled cattle, or MS 

(Beef) from cattle from the country 

should be considered prohibited cattle 

materials. FDA shall respond in writing 

to any such request and may impose 

conditions in granting any such request. 

A country designation granted by FDA 

under this paragraph will be subject to 

future review by FDA, and may be 

revoked if FDA determines that it is no 

longer appropriate. 

PART 700—GENERAL 

■ 3. The authority citation for 21 CFR 

part 700 continues to read as follows: 

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20794 Federal Register / Vol. 73, No. 75 / Thursday, April 17, 2008 / Rules and Regulations 

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

361, 362, 371, 374. 

■ 4. Section 700.27 is amended by 

revising paragraph (a)(1) and by adding 

paragraph (e) to read as follows: 

§ 700.27 Use of prohibited cattle materials 

in cosmetic products. 

(a) * * * 

(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 the following: 

(i) Tallow that contains no more than 

0.15 percent insoluble impurities, 

tallow derivatives, hides and hidederived products, and milk and milk 

products, and 

(ii) Cattle materials inspected and 

passed from a country designated under 

paragraph (e) of this section. 

* * * * * 

(e) Process for designating countries. 

A country seeking designation must 

send a written request to the Director, 

Office of the Center Director, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, at the 

address designated in 21 CFR 5.1100. 

The request shall include information 

about a country’s bovine spongiform 

encephalopathy (BSE) case history, risk 

factors, measures to prevent the 

introduction and transmission of BSE, 

and any other information relevant to 

determining whether specified risk 

materials, the small intestine of cattle 

except as provided in paragraph (b)(2) of 

this section, material from 

nonambulatory disabled cattle, or MS 

(Beef) from cattle from the country 

should be considered prohibited cattle 

materials. FDA shall respond in writing 

to any such request and may impose 

conditions in granting any such request. 

A country designation granted by FDA 

under this paragraph will be subject to 

future review by FDA, and may be 

revoked if FDA determines that it is no 

longer appropriate. 

Dated: April 11, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 08–1142 Filed 4–15–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[TD 9393] 

RIN 1545–BF97 

Employer Comparable Contributions to 

Health Savings Accounts Under 

Section 4980G 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains final 

regulations providing guidance on 

employer comparable contributions to 

Health Savings Accounts (HSAs) under 

section 4980G in instances where an 

employee has not established an HSA 

by December 31st and in instances 

where an employer accelerates 

contributions for the calendar year for 

employees who have incurred qualified 

medical expenses. These final 

regulations affect employers that 

contribute to employees’ HSAs and their 

employees. 

DATES: Effective Date: These regulations 

are effective on April 17, 2008. 

Applicability Date: These regulations 

apply to employer contributions made 

for calendar years beginning on or after 

January 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Mireille Khoury at (202) 622–6080. 

SUPPLEMENTARY INFORMATION: 

Paperwork Reduction Act 

The collection of information 

contained in these final regulations has 

been reviewed and approved by the 

Office of Management and Budget in 

accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)) under control number 1545–

2090. The collection of information in 

these final regulations is in Q & A–14. 

This information is needed for purposes 

of making HSA contributions to 

employees who establish an HSA after 

the end of the calendar year but before 

the last day of February or who have not 

previously notified their employer that 

they have established an HSA. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a valid control 

number assigned by the Office of 

Management and Budget. 

Books or records relating to a 

collection of information must be 

retained as long as their contents may 

become material in the administration 

of any internal revenue law. Generally, 

tax returns and tax return information 

are confidential, as required by 26 

U.S.C. 6103. 

Background 

This document contains final Pension 

Excise Tax Regulations (26 CFR part 54) 

under section 4980G of the Internal 

Revenue Code (Code). Under section 

4980G, an excise tax is imposed on an 

employer that fails to make comparable 

contributions to the HSAs of its 

employees. 

On August 26, 2005, proposed 

regulations (REG–138647–04) on the 

comparability rules of section 4980G 

were published in the Federal Register 

(70 FR 50233). On July 31, 2006, final 

regulations (REG–138647–04) on the 

comparability rules were published in 

the Federal Register (71 FR 43056). The 

final regulations clarified and expanded 

upon the guidance regarding the 

comparability rules published in Notice 

2004–2 (2004–2 IRB 296) and in Notice 

2004–50 (2004–33 IRB 196), Q & A–46 

through Q & A–54. See § 601.601(d)(2). 

Q & A–6(b) of the final regulations 

reserved the issue of employees who 

have not established an HSA by the end 

of the calendar year. 

On June 1, 2007, proposed regulations 

(REG–143797–06), were published in 

the Federal Register (72 FR 30501) 

addressing the reserved issue and one 

additional issue concerning the 

acceleration of employer contributions. 

One written public comment on the 

proposed regulations was received, 

which supported the proposed 

regulations. These final regulations 

adopt the provisions of the proposed 

regulations without substantive 

revision. 

Explanation of Provisions and 

Summary of Comments 

Employee Has Not Established HSA by 

December 31 

The proposed and final regulations 

provide a means for employers to 

comply with the comparability 

requirements with respect to employees 

who have not established an HSA by 

December 31, as well as with respect to 

employees who may have established an 

HSA but not notified the employer of 

that fact. The proposed and final 

regulations provide that, in order to 

comply with the comparability rules for 

a calendar year with respect to such 

employees, the employer must comply 

with a notice requirement and a 

contribution requirement. In order to 

comply with the notice requirement, the 

employer must provide all such 

employees, by January 15 of the 

following calendar year, written notice 

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