Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 54083 

comment. In addition, we have 

determined that the South American 

cactus moth is present in the State of 

Mississippi, which we did not include 

in the quarantined area in our proposal 

to establish regulations for South 

American cactus moth. We are 

reopening the comment period on that 

proposal to allow interested persons to 

submit comments on the addition of 

Mississippi to the proposed quarantined 

area, as well as on other aspects of the 

proposal. 

DATES: We will consider all comments 

that we receive on or before October 20, 

2008. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/

component/main?main=DocketDetail&d

=APHIS_2006_0153 to submit or view 

comments and to view supporting and 

related materials available 

electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS 2006 0153, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A 03.8, 4700 

River Road, Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS 

2006 0153. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

http://www.aphis.usda.gov. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Robyn Rose, National Program Lead, 

Emergency and Domestic Programs, 

PPQ, APHIS, 4700 River Rd., Unit 26, 

Riverdale, MD 20737–1236; (301) 734– 

7121. 

SUPPLEMENTARY INFORMATION: 

Background 

The South American cactus moth 

(Cactoblastis cactorum) is a grayishbrown moth with a wingspan of 22 to 

35 millimeters (approximately 0.86 to 

1.4 inches) that is indigenous to 

Argentina, southern Brazil, Paraguay, 

and Uruguay. It is a serious quarantine 

pest of Opuntia spp., and an occasional 

pest of Nopalea spp., Cylindropuntia 

spp., and Consolea spp., four closely 

related genera of the family Cactaceae. 

After an incubation period following 

mating, the female South American 

cactus moth deposits an egg stick 

resembling a cactus spine on the host 

plant. The egg stick, which consists of 

70 to 90 eggs, hatches in 25 to 30 days 

and the larvae bore into the cactus pad 

to feed, eventually hollowing it out and 

killing the plant. Within a short period 

of time, the South American cactus 

moth can destroy whole stands of 

cactus. 

On February 11, 2008, the Animal and 

Plant Health Inspection Service (APHIS) 

published in the Federal Register (73 

FR 7679–7686, Docket No. APHIS– 

2006–0153) a proposal to amend the 

domestic quarantine regulations to 

establish regulations to restrict the 

interstate movement of South American 

cactus moth host material, including 

nursery stock and plant parts for 

consumption, from infested areas of the 

United States. 

In connection with this proposed rule, 

we have prepared an environmental 

assessment (EA) entitled ‘‘Quarantine 

for the South American Cactus Moth, 

Cactoblastis cactorum, in Florida, South 

Carolina, Georgia, Alabama, and 

Mississippi.’’ We are making this 

environmental assessment available to 

the public for review and comment. We 

will consider all comments that we 

receive on or before the date listed 

under the heading DATES at the 

beginning of this notice. 

Since publication of the proposed 

rule, surveys conducted by the 

Mississippi Department of Agriculture 

and Commerce have confirmed the 

presence of South American cactus 

moth in the State of Mississippi. 

Therefore, we have determined that 

Mississippi should be added to the 

proposed list of quarantined areas in 

§ 301.55–3(c). In addition, we would 

like to clarify our intention regarding 

the use of deltamethrin as a treatment. 

Although the ‘‘Background’’ section of 

the proposal listed deltamethrin as an 

acceptable treatment for South 

American cactus moth, the proposed 

regulatory text did not include 

deltamethrin. We do not have efficacy 

data for the use of this chemical on 

South American cactus moth; therefore 

we did not intend to approve 

deltamethrin as a treatment and it 

should not have been included as an 

acceptable treatment in the 

‘‘Background’’ section. 

Comments on the proposed rule were 

required to be received on or before 

April 11, 2008. We are reopening the 

comment period for the proposed rule 

for 30 days following publication of this 

notice. This action will allow interested 

persons to prepare and submit 

comments regarding the proposed 

addition of Mississippi to the list of 

States quarantined for South American 

cactus moth or other aspects of the 

proposed rule. We will also consider all 

comments received between April 11, 

2008, and the date of this notice. 

The environmental assessment, the 

proposed rule, and all previously 

received comments on the proposed 

rule may be viewed on the 

Regulations.gov Web site or in our 

reading room (see ADDRESSES above for 

a link to Regulations.gov and 

information on the location and hours of 

the reading room). You may request 

paper copies of the documents listed 

above by calling or writing to the person 

listed under FOR FURTHER INFORMATION

CONTACT. Please refer to the title of the 

environmental assessment when 

requesting copies. 

The environmental assessment has 

been prepared in accordance with: (1) 

The National Environmental Policy Act 

of 1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.), (2) regulations of the 

Council on Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

Authority: 7 U.S.C. 7701–7772 and 7781– 

7786; 7 CFR 2.22, 2.80, and 371.3. Section 

301.75–15 issued under Sec. 204, Title II, 

Public Law 106–113, 113 Stat. 1501A 293; 

sections 301.75–15 and 301.75–16 issued 

under Sec. 203, Title II, Public Law 106–224, 

114 Stat. 400 (7 U.S.C. 1421 note). 

Done in Washington, DC, this 12th day of 

September 2008. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E8–21816 Filed 9–17–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 94 and 95 

[Docket No. APHIS–2008–0093] 

Bovine Spongiform Encephalopathy; 

Minimal-Risk Regions and Importation 

of Meat, Meat Byproducts, and Meat 

Food Products Derived From Bovines 

30 Months of Age or Older 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 


dwashington3 on PRODPC61 with PROPOSALS
54084 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

ACTION: Request for comments. 

SUMMARY: This document requests 

comment on the removal of the delay of 

applicability of certain provisions of the 

rule entitled ‘‘Bovine Spongiform 

Encephalopathy; Minimal-Risk Regions 

and Importation of Commodities,’’ 

published in the Federal Register on 

January 4, 2005, 70 FR 460–553. The 

delay of applicability was removed in a 

final rule entitled ‘‘Bovine Spongiform 

Encephalopathy; Minimal-Risk Regions; 

Importation of Live Bovines and 

Products Derived from Bovines,’’ 

published in the Federal Register on 

September 18, 2007, 72 FR 53314– 

53379. 

DATES: We will consider all comments 

that we receive on or before November 

17, 2008. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=APHIS– 

2008–0093 to submit or view comments 

and to view supporting and related 

materials available electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS–2008–0093, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS– 

2008–0093. 

Reading Room: You may read any 

comments that we receive on this 

docket, as well as APHIS supporting 

materials referenced in this docket, in 

our reading room. The reading room is 

located in room 1141 of the USDA 

South Building, 14th Street and 

Independence Avenue, SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

http://www.aphis.usda.gov. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Lisa Ferguson, ASEP Director, National 

Center for Animal Health Programs, VS, 

APHIS, 4700 River Road Unit 46, 

Riverdale, MD 20737–1231; (301) 734– 

6188. 

SUPPLEMENTARY INFORMATION: 

Background 

The Animal and Plant Health 

Inspection Service (APHIS) of the U.S. 

Department of Agriculture (USDA or 

Department) regulates the importation 

of animals and animal products into the 

United States to guard against the 

introduction of animal diseases. The 

regulations in 9 CFR parts 93, 94, 95, 

and 96 (referred to below as the 

regulations) govern the importation of 

certain animals, birds, poultry, meat, 

other animal products and byproducts, 

hay, and straw into the United States in 

order to prevent the introduction of 

various animal diseases, including 

bovine spongiform encephalopathy 

(BSE), a chronic degenerative disease 

affecting the central nervous system of 

cattle. 

Nature of BSE 

BSE belongs to the family of diseases 

known as transmissible spongiform 

encephalopathies (TSEs). All TSEs 

affect the central nervous system of 

infected animals. However, the 

distribution of infectivity in the body of 

the animal and mode of transmission 

differ according to the species and the 

TSE agent. In addition to BSE, TSEs 

include, among other diseases, scrapie 

in sheep and goats, chronic wasting 

disease in deer and elk, and CreutzfeldtJakob disease in humans. 

The agent that causes BSE has yet to 

be fully characterized. The theory that is 

most accepted in the international 

scientific community is that the agent is 

an abnormal form of a normal protein 

known as cellular prion protein. The 

BSE agent does not evoke a traditional 

immune response or inflammatory 

reaction in host animals. BSE is 

confirmed by post-mortem examination 

of an animal’s brain tissue, which may 

include detection of the abnormal form 

of the prion protein in the brain tissues. 

The pathogenic form of the protein is 

both less soluble and more resistant to 

degradation than the normal form. The 

BSE agent is resistant to heat and to 

normal sterilization processes. 

BSE is not a contagious disease, and 

therefore is not spread through casual 

contact between animals. Scientists 

believe that the primary route of 

transmission is through ingestion of 

feed that has been contaminated with a 

sufficient amount of tissue from an 

infected animal. This route of 

transmission can be prevented by 

excluding potentially contaminated 

materials from ruminant feed. 

Roles of Different Agencies 

APHIS, an animal health agency 

within USDA, promulgates its 

regulations regarding BSE under the 

authority of the Animal Health 

Protection Act (7 U.S.C. 8301 et seq.), 

which gives the Secretary broad 

discretion to regulate the importation of 

animals and animal products if 

necessary to protect the health of U.S. 

livestock. 

Because variant Creutzfeldt-Jakob 

Disease (vCJD) in humans has been 

linked to exposure to the BSE agent, 

APHIS collaborates with other Federal 

agencies with regulatory responsibility 

for assuring food safety and the 

protection of human health to 

implement a comprehensive 

coordinated U.S. response to BSE. 

Within USDA, protecting human health 

from the risks of BSE is carried out by 

the Food Safety and Inspection Service 

(FSIS), the agency charged with 

responsibility for administering the 

Federal Meat Inspection Act, which was 

enacted to ensure that meat and meat 

food products distributed in commerce 

are wholesome, not adulterated, and 

properly marked, labeled, and packaged. 

The USDA agencies carry out their 

programs in close coordination with the 

following Centers of the Food and Drug 

Administration (FDA) of the U.S. 

Department of Health and Human 

Services: The Center for Veterinary 

Medicine regarding animal feed; the 

Center for Food Safety and Applied 

Nutrition regarding foods other than 

meat, poultry, and egg products; and 

other Centers regarding drugs, biologics, 

and devices containing bovine material. 

These agencies collaborate, issuing 

regulations under their respective 

authorities. 

Tissue Localization 

Some bovine tissues have 

demonstrated infectivity, whereas 

others have not. Most of the information 

on the development and distribution of 

tissue infectivity in BSE-infected cattle 

has been derived from experimental 

pathogenesis studies conducted in the 

United Kingdom (Wells, et al., 1994; 

1996; 1998; 1999; 2005). In these 

studies, cattle were deliberately infected 

with BSE through oral exposure to the 

brain tissue of cattle with confirmed 

BSE. Subsets of the experimentally 

infected cattle were killed at regular 

intervals as the disease progressed. At 

each interval, the tissues of the infected 

cattle were examined for 

histopathological changes consistent 

with BSE and for abnormal prion 

proteins. Also, at each interval, a mouse 

assay was done—i.e., tissues of the BSE 

infected cattle were injected 

intracerebrally and intraperitoneally 

into mice to identify those tissues of 

cattle containing infectivity. 

The pathogenesis studies involved 30 

animals, each of which received a single 

dose of 100g of infected brain at 4 

months of age (Wells, et al., 1994; 1996; 


dwashington3 on PRODPC61 with PROPOSALS
Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 54085 

1 DRG are clusters of nerve cells attached to the 

spinal cord that are contained within the bones of 

the vertebral column. ‘‘DRG’’ as used in this 

document has the same meaning as the term ‘‘dorsal 

spinal nerve root ganglia.’’ Trigeminal ganglia are 

clusters of nerve cells connected to the brain that 

lie close to the exterior of the skull. 

1998; 1999; 2005). This dose is probably 

10–100 times greater than that 

associated with field exposure via feed 

(DEFRA 2005). The studies demonstrate 

that in cattle infected with BSE, the total 

amount of infectivity in the animal, as 

well as the distribution of infectivity in 

the animal’s body, change over time 

(Wells, et al., 1994; 1996; 1998; 1999; 

2005). The highest levels of infectivity 

were detected in the brain and spinal 

cord at the end stages of disease. Some 

cattle exhibited clinical signs of BSE as 

early as 35 months after oral exposure 

to the BSE agent. By 37 months after 

oral exposure, all five animals that were 

still alive demonstrated clinical 

evidence of BSE. Infectivity was found 

in cattle with clinical signs of BSE in 

the brain, spinal cord, dorsal root 

ganglia (DRG),1 trigeminal ganglia, and 

the distal ileum of the small intestine. 

BSE infectivity was demonstrated in 

the brain, spinal cord, and DRG as early 

as 32 months after oral exposure to the 

BSE agent in some cattle (Wells, et al., 

1994; 1996; 1998; 1999; 2005). 

Infectivity was demonstrated in these 

tissues 3 months before animals began 

to develop clinical signs of the disease. 

Infectivity was demonstrated in the 

distal ileum of cattle 6 to 18 months 

after oral exposure to the BSE agent and 

again at 38 months and 40 months after 

oral exposure. A similar, more recent, 

study (Espinosa, et al., 2007) examined 

the infectivity of tissues from these 

same animals by intracerebral 

inoculation of highly sensitive 

transgenic mice overexpressing bovine 

PrP. This study’s findings were similar 

to those of Wells, et al., described above. 

In addition, infectivity in the sciatic 

nerve was found at low levels only after 

30 months from exposure. No detectable 

infectivity was found in the spleen, 

skeletal muscle, blood or urine of 

asymptomatic cattle. 

As explained by the United 

Kingdom’s Department for 

Environment, Food and Rural Affairs 

(DEFRA) and by the European 

Commission’s Scientific Steering 

Committee, a second phase of the 

pathogenesis studies, which used a 

cattle bioassay as an endpoint, was 

conducted to ensure that low levels of 

infectivity that may not have been 

detected in the first phase using the 

mouse bioassay were not missed 

(DEFRA 2006; EC SSC 2002). This 

second phase of the study was 

completed in March 2007 (Gerald Wells, 

personal communication, 2008). 

In the cattle bioassay, tissues from the 

same cattle orally exposed to BSE in the 

earlier pathogenesis studies were 

injected directly into the brain of BSEfree cattle (DEFRA 2005). This method 

is considered to be several hundred-fold 

more sensitive in detecting BSE 

infectivity than the mouse bioassay 

(DEFRA 2005). Preliminary results from 

the cattle bioassay study demonstrate 

that, in addition to the materials that 

were found to contain infectivity when 

the mouse bioassay was used, the 

tonsils of calves 10 months after oral 

exposure to the BSE agent also contain 

infectivity. However, because only one 

of five animals injected with tonsil 

material from infected animals 

developed clinical BSE at 45 months 

post-inoculation, the level of infectivity 

in the tonsils appears to be very low. 

BSE infectivity has not been 

demonstrated in the muscle tissue of 

BSE-infected cattle examined in these 

studies through either the mouse 

bioassay or the cattle assays (Wells 

1996; 2005; personal communication 

2008). All assays of the skeletal muscle 

pools were completed in March 2007 

(Wells, personal communication 2008). 

In addition to these studies on 

experimentally infected cattle, 

distribution of tissue infectivity has also 

been studied in cattle exposed to BSE 

under field conditions. In these animals, 

at the end stages of the incubation 

period with demonstrated clinical signs, 

BSE infectivity has been confirmed by 

mouse bioassay only in the brain, spinal 

cord, and retina of the eye (EC SSC 

2001). 

In a recent study, mice, genetically 

engineered to be highly susceptible to 

BSE and to overexpress the bovine prion 

protein, were inoculated with tissues 

from an end-stage clinically affected 

BSE-infected cow (Buschmann and 

Groschup, 2005). The sensitivity of 

these mice to infection is significantly 

greater than other mice panels used in 

bio-assays, and the sensitivity is even 

greater than that of cattle by 

approximately tenfold. This study 

demonstrated low levels of infectivity in 

the facial and sciatic nerves of the 

peripheral nervous system when 

injected into these highly sensitive 

mice. While this study, and the 2007 

study by Espinosa, et al., produced 

interesting findings that can help further 

characterize the pathogenesis of BSE, 

they cannot be extrapolated into the 

context of the risk presented by natural 

(i.e., field) exposure pathways. The 

findings may be influenced by the 

overexpression of prion proteins in 

these genetically engineered mice. Any 

apparent levels of infectivity are low in 

these extremely sensitive mice and 

would be even lower in other species 

such as cattle. Moreover, the route of 

administration to the mice was both 

intraperitoneal and intracerebral, both 

of which are very efficient routes of 

infection as compared to oral 

consumption. 

Tissues that have demonstrated 

infectivity, and thus are likely to 

contain the infectious BSE agent in 

infected cattle, are brain, tonsil, spinal 

cord, eyes, trigeminal ganglia, DRG, and 

distal ileum. Approximately 90 percent 

of the infectivity is associated with the 

brain, spinal column, DRG, and 

trigeminal ganglia. The remaining 10 

percent is associated with the infectivity 

in the distal ileum. In BSE, as with other 

TSEs, the total amount of infectivity in 

an animal increases throughout the 

incubation period, reaching the highest 

load at the end of that period, very close 

to the death of the animal. Infectivity is 

considered to increase exponentially, 

reaching 4.5 logs less than a clinical 

case at 50 percent of the incubation 

period and 3 logs less than a clinical 

case by 70 percent of the incubation 

period (Comer and Huntly, 2003). 

All of this research has contributed to 

the definition of which tissues should 

be deemed specified risk materials 

(SRMs). Both the types of tissues, and 

the understanding of the progression of 

the infectivity throughout the 

incubation period contribute to the 

definition of SRMs. Affiliated tissues or 

structures such as skull or vertebral 

column are also considered risk 

materials because of the difficulty in 

separating out small tissues such as 

DRG from the vertebral column. The 

risks associated with tissue localization 

can be mitigated by excluding SRMs 

from the food or feed chain or by 

excluding them completely from 

importation. FSIS and FDA regulations 

regarding SRMs are based on this 

scientific knowledge and an 

understanding of the mitigative effects 

of exclusion of SRMs (FSIS, 2004; 

2004a; 2004b; 2005; 2007; FDA, 2004; 

2005; 2007; 2008). 

There are some studies available that 

report finding the presence of the 

abnormal prion protein in various 

tissues (Buschmann and Groschup, 

2005; Masujin et al., 2007). As new 

methods are developed that provide 

increased sensitivity to detect abnormal 

PrP, such demonstrations of the 

presence of abnormal PrP in various 

tissues may continue. However, 

demonstrating the presence of PrPBSE

does not necessarily indicate the 

presence of BSE infectivity, especially if 

no infectivity is demonstrated via the 


dwashington3 on PRODPC61 with PROPOSALS
54086 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

2On September 7, 2005, FSIS published in the 

Federal Register an interim final rule that allowed 

for use as human food, under certain conditions, 

beef small intestine, excluding the distal ileum, 

derived from cattle slaughtered in official U.S. 

establishments or in certified foreign establishments 

in countries listed by FSIS in 9 CFR 327.2(b) as 

eligible to export meat products to the United 

States. 

3On March 2, 2005, Judge Richard F. Cebull of 

the U.S. District Court for the District of Montana 

ordered that the implementation of APHIS’ January 

most direct method available: cattle-tocattle exposure via intracerebral 

inoculation. Therefore, one cannot 

automatically assume that a finding of 

PrPBSE in a tissue means the tissue 

should be considered infectious or 

should be considered an SRM. As noted 

by the World Organization for Animal 

Health (OIE), the international standardsetting organization for guidelines 

related to animal health: 

The availability of experimental infectivity 

data has significantly increased in recent 

years. During the same interval, extremely 

sensitive tests have been developed, 

including those employing highly sensitive 

transgenic mice strains and potentially more 

sensitive laboratory PrP detection methods. 

With the development of such highly 

sensitive methods, the probability of 

detection of PrPBSE in tissues that are not 

currently listed as infectious is increasing. 

However, such findings need to be 

considered in context, and their relevance to 

establishing risk to consumers evaluated 

carefully when the quantity of PrPBSE

detected is potentially below the limit of 

detection of intracerebral cattle to cattle 

bioassay (OIE TAHSC, 2006). 

Within USDA, APHIS and FSIS 

review and consider carefully, on an 

ongoing basis, all BSE research 

regarding the definition of SRMs, as do 

other countries that participate in OIE. 

International guidelines regarding SRM 

definition and removal have not 

changed based on the results of the 

studies noted above that report finding 

the presence of the abnormal prion 

protein in various tissues. U.S. 

regulations regarding SRM removal are 

consistent with international guidelines. 

Prior to 2005, when the APHIS final 

rule on BSE minimal-risk regions (70 FR 

460–553, Docket No. 03–080–3) became 

effective, APHIS’ import regulations 

regarding BSE considered three 

categories of regions with regard to 

BSE—(1) those in which BSE is known 

to exist, (2) those that present an undue 

risk of BSE, and (3) all regions not listed 

in either of the other two categories. 

Imports from BSE-affected regions and 

those considered to present an undue 

risk are governed by the same set of 

restrictions, including a prohibition on 

the importation of meat, meat products, 

and edible products other than meat 

(except for milk and milk products and 

gelatin under certain conditions). All 

other regions were not subject to any 

import restrictions because of BSE. 

Beginning in 2003, APHIS 

commenced a rulemaking process to 

update our BSE regulations to reflect the 

latest scientific data and knowledge of 

the disease. In a document published in 

the Federal Register on November 4, 

2003 (68 FR 62386–62405, Docket No. 

03–080–1), APHIS proposed to establish 

a category of regions that present a 

minimal risk of introducing BSE into 

the United States via live ruminants and 

ruminant products and byproducts, and 

to add Canada to this category. The 

proposal also set forth conditions for the 

importation of certain live ruminants 

and ruminant products and byproducts 

from BSE minimal-risk regions. Among 

the conditions for the importation of 

meat from BSE minimal-risk regions 

was that the meat be derived from 

bovines less than 30 months of age 

when slaughtered. This age restriction 

was a measure to guard against the 

importation of, or contamination of 

meat through contact with, tissues other 

than meat that have the potential of 

containing high levels of BSE 

infectivity. 

On December 25, 2003, less than 2 

weeks before the close of the comment 

period for the proposed rule, a case of 

BSE in a dairy cow of Canadian origin 

in Washington State was verified by an 

international reference laboratory. 

Subsequently, both FSIS and FDA 

implemented significant additional 

measures in the United States to protect 

human health. In addition, APHIS 

commenced an enhanced BSE 

surveillance program to determine the 

incidence of the disease in the United 

States. 

The measures taken by FSIS included 

declaring SRMs to be inedible and 

requiring their removal from cattle at 

slaughter. FSIS designated as SRMs the 

brain, skull, eyes, trigeminal ganglia, 

spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse process of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and DRG of cattle 30 months 

of age or older, and the tonsils and 

distal ileum of the small intestine of all 

cattle. To ensure effective removal of the 

distal ileum, FSIS also required that the 

entire small intestine be removed and be 

disposed of as inedible.2 FSIS also 

required all slaughtering and processing 

establishments to develop, implement, 

and maintain written procedures for the 

removal, segregation, and disposition of 

SRMS. Establishments were specifically 

required to implement procedures to 

address the potential contamination of 

edible materials with SRMs before, 

during, and after entry into the 

establishment. FSIS did not restrict the 

age of cattle eligible for slaughter, 

because the removal of SRMs effectively 

mitigates the BSE risk to humans 

associated with cattle that pass both 

ante-mortem and post-mortem 

inspections (i.e., apparently healthy 

cattle). 

Pursuant to the Federal Meat 

Inspection Act, countries that export 

meat to the United States must 

implement food safety requirements that 

are equivalent to those in place in the 

United States. To be eligible to export 

beef to the United States, a country must 

have in place a system to effectively 

keep SRMs out of the production chain 

and to prevent cross-contamination of 

beef with SRMs. FSIS has determined 

that the SRM requirements 

implemented by Canada in July 2003 are 

equivalent to FSIS’ requirements. 

Additionally, FDA’s feed ban prohibits 

most mammalian protein, including 

ruminant protein, from entering the 

ruminant feed chain in the United 

States. 

On March 8, 2004, we published a 

document in the Federal Register (69 

FR 10633–10636, Docket No. 03–080–2) 

explaining the effects on our proposed 

rule of the detection of BSE in the State 

of Washington in a cow imported from 

Canada and of the additional measures 

taken by FSIS, APHIS, and FDA. That 

document explained why the detection 

of an imported BSE-infected cow did 

not alter the conclusions we had 

reached in our original risk assessment. 

It explained further that, in fact, the 

resulting additional measures put in 

place by FSIS provided a basis for 

removing from the proposed provisions 

an age restriction on cattle from which 

meat would be derived for export to the 

United States. Accordingly, we 

proposed to allow the importation of 

beef derived from cattle of any age. To 

give the public additional time to 

comment on the proposal in light of 

these developments, we reopened and 

extended the comment period for an 

additional 30 days. 

On January 4, 2005, we published in 

the Federal Register (70 FR 460–553, 

Docket No. 03–080–3) a final rule that 

established the criteria for BSE minimalrisk regions, listed Canada as a BSE 

minimal-risk region, and specified 

importation requirements for live 

animals, and meat products and 

byproducts. The final rule allowed the 

importation of meat from bovines of any 

age, as we had proposed on March 8, 

2004. The final rule was scheduled to 

become effective on March 7, 2005.3


dwashington3 on PRODPC61 with PROPOSALS
Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 54087 

4, 2005, final rule be preliminarily enjoined. On 

July 14, 2005, the U.S. States Court of Appeals for 

the Ninth Circuit ordered that the preliminary 

injunction order be vacated and the case remanded 

to the District Court. 

4Requiring that live bovines exported to the 

United States from BSE minimal-risk regions be 

born after the date of effective enforcement of a 

ruminant-to-ruminant feed ban is consistent with 

the standards of the World Organization for Animal 

Health (OIE) for the exportation of live bovines from 

countries classified by the OIE as having either a 

negligible or a controlled BSE risk. We consider 

effective enforcement to have been achieved after 

completion of the initial (or practical) period of 

implementation of a feed ban and after sufficient 

time has elapsed to allow most feed products to 

cycle through the system. The practical 

implementation period, which begins when the 

regulations are initially put in place, can be 

determined by evaluating implementation guidance 

and policies, such as allowing grace periods for 

certain aspects of the industry. In addition, the time 

necessary for initial education of industry and 

training of inspectors must be considered. After the 

practical implementation period is defined, we then 

consider the time necessary subsequent to practical 

implementation to allow most feed products to 

cycle through the system, given the management 

practices in the country. Effective enforcement does 

not necessarily mean that 100 percent compliance 

with the feed ban requirements will be achieved. 

In January 2005, BSE was confirmed 

in two cows in Canada. 

On March 11, 2005, APHIS published 

a document in the Federal Register (70 

FR 12112–12113, Docket No. 03–080–6) 

that, pursuant to an announcement by 

the Secretary of Agriculture on February 

9, 2005, delayed the applicability of the 

provisions of the January 2005 final rule 

as they applied to the importation from 

Canada of the following commodities 

when derived from bovines 30 months 

of age or older when slaughtered: (1) 

Meat, meat food products, and meat 

byproducts other than liver; (2) whole or 

half carcasses; (3) offal; (4) tallow 

composed of less than 0.15 percent 

insoluble impurities that is not 

otherwise eligible for importation under 

9 CFR 95.4(a)(1)(i); and (5) gelatin 

derived from bones of bovines that is 

not otherwise eligible for importation 

under 9 CFR 94.18(c). 

In his February 9, 2005, 

announcement, the Secretary stated that 

because ongoing investigations into the 

recent finds of BSE in Canada in 

animals over 30 months of age were not 

complete, he felt it prudent to delay the 

effective date for allowing imports of 

meat from bovines 30 months of age and 

over. He also indicated that the delay of 

applicability would address concerns 

that the January 2005 final rule allowed 

the importation of meat from bovines 30 

months of age or older, while 

continuing to prohibit the importation 

of live cattle 30 months of age or older 

for processing in the United States. The 

Secretary stated that the Department 

would consider and develop a plan— 

based on the latest scientific 

information and with the protection of 

public and animal health as the highest 

priority—to allow imports of live 

bovines 30 months of age or older. 

In January 2005, an APHIS team 

visited Canada to evaluate the 

epidemiology of the North American 

BSE cases that had been identified at 

that time. This team concluded that the 

information available suggested a 

localized exposure, based on the 

relatively small geographical location, 

the temporal association, and the 

clustering of cases. The team also 

evaluated the likelihood of higher-risk 

animal or feed exposure to the United 

States at that time, and concluded that 

the U.S. feed ban and other mitigations 

had effectively minimized the risk of 

transmission or amplification of the BSE 

agent (USDA, 2005). In addition, also in 

January 2005, USDA sent a team to 

Canada to assess Canada’s feed ban and 

its feed inspection program to determine 

whether the control measures put in 

place by the Canadian Government were 

achieving compliance with that 

country’s regulations. APHIS conducted 

an extensive review of the feed ban in 

Canada and concluded that Canada has 

a robust inspection program, that overall 

compliance with the feed ban in Canada 

was good, and that the feed ban was 

reducing the risk of transmission of BSE 

in the Canadian cattle population 

(USDA, 2005a). 

On January 9, 2007, we published a 

proposed rule in the Federal Register 

(72 FR 1101–1129, Docket No. APHIS– 

2006–0041) to, among other things, 

establish conditions for the importation 

from BSE minimal-risk regions of live 

bovines for any use born on or after a 

date determined by APHIS to be the 

date of effective enforcement of a 

ruminant-to-ruminant feed ban in the 

region of export.4

We conducted an assessment of the 

risk to U.S. livestock of allowing the 

importation of live bovines according to 

the provisions of the proposed rule from 

Canada—currently the only region 

recognized as a BSE minimal-risk region 

by APHIS. That risk assessment 

incorporated and built on information 

from all of the previous analyses, 

including the 2005 reports of the feed 

ban team and the epidemiological 

investigation team. In the risk 

assessment, we evaluated both the 

likelihood of ‘‘release’’ of the BSE agent 

into the United States and the 

likelihood of susceptible animals being 

exposed, given such release. We 

evaluated the pathways by which 

infected Canadian cattle, if imported, 

might expose U.S. cattle to BSE, and the 

likelihood that these pathways might 

lead to the establishment of the disease 

in the U.S. cattle population. We 

concluded that the likelihood of BSE 

exposure and establishment in the U.S. 

cattle population as a consequence of 

imports under the proposed rule was 

negligible. 

In our risk assessment, we explained 

that several steps must occur for BSE to 

be transmitted to cattle in the United 

States from a live bovine imported from 

another country. A BSE-infected bovine 

must be imported into the United States; 

the infected bovine must die or be 

slaughtered; tissues from that animal 

that contain the infectious agent (i.e., 

the SRMs) must be sent to a rendering 

facility; the infectivity present in these 

tissues must survive inactivation in the 

rendering process; the resulting meatand-bone meal containing the abnormal 

prion protein must be incorporated into 

feed; and this feed must be fed to cattle, 

in contravention of FDA regulations, at 

a level adequate to infect the cattle. (The 

amount of infectious material required 

in feed for cattle to become infected is 

dependent on the age of the cattle; 

younger cattle are more susceptible to 

BSE and require less BSE-contaminated 

feed to become infected (Arnold and 

Wilesmith, 2004)). We explained in our 

risk assessment that some of the steps 

could occur in parallel—i.e., without 

the occurrence of other steps—while 

others would need to occur in series. 

Because the impact of any specific step 

would depend on its relationship to 

other steps, its importance to the 

likelihood of BSE transmission, and, in 

turn, the impact of disease mitigation 

measures at each step, cannot be 

understood in isolation from the rest of 

the pathway. 

One component of our risk 

assessment was an estimate of the 

prevalence of BSE in Canada, which 

was conducted using the same methods 

as an earlier estimate of the prevalence 

of BSE in the United States. The results 

of this prevalence estimate were then 

used to inform the subsequent 

considerations and calculations in the 

risk assessment. Because the prevalence 

was not zero—i.e., we concluded and 

acknowledged that BSE is still present 

in Canada at low levels—the risk 

assessment consequently assumed that 

infected animals could be imported into 

the United States under the provisions 

of the proposed rule. Even with this 

assumption, our conclusion that the risk 

of the exposure of U.S. cattle and the 

establishment of BSE in the United 

States was negligible remained 

unchanged. 

On September 18, 2007, we published 

in the Federal Register (72 FR 53314– 

53379, Docket No. APHIS–2006–0041) a 


dwashington3 on PRODPC61 with PROPOSALS
54088 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Proposed Rules 

final rule that adopted the changes to 

the regulations we had proposed in 

January 2007. Additionally, the 

September 2007 final rule removed the 

partial delay of applicability of the 

January 2005 final rule with respect to 

meat and certain meat products and 

byproducts derived from cattle over 30 

months of age. In our September 2007 

final rule, we stated that, subsequent to 

implementation of the partial delay of 

applicability, ‘‘we [had] obtained 

additional information regarding all 

aspects of the issues that prompted the 

delay of applicability and [had] 

conducted additional analyses’’ as 

indicated by the Secretary in February 

2005 to allow imports of live bovines 30 

months of age or older (72 FR 53316). 

As we concluded in our September 

2007 final rule, the risk assessment for 

that final rule demonstrates the 

negligible BSE risk from the importation 

of additional classes of live bovines, 

including those 30 months of age or 

older. As explained previously, the risk 

of transmission of BSE occurs when 

SRMs from infected cattle enter the 

ruminant feed supply in contravention 

of current feed regulations. Since the 

risk is tied to those tissues that contain 

infectivity, if those tissues are excluded 

from import, the risk is mitigated. When 

live cattle are imported, the potential 

exists that, after their death, their SRMs 

could enter the ruminant feed supply. 

Even with this potential, the conclusion 

of the risk assessment was that such 

imports present a negligible risk of 

establishment of BSE in the United 

States. As noted above, one of the 

requirements for the importation of 

meat from bovines is that the SRMS be 

removed from the animals from which 

the meat is derived. In other words, the 

SRMs are excluded from import and 

would not even have the potential to 

enter the risk pathway in the United 

States. Therefore, the conclusion of 

negligible risk related to the importation 

of live older bovines gives further 

support to the conclusion of the risk 

analysis conducted for our January 2005 

final rule regarding meat and meat 

products derived from bovines of any 

age in BSE minimal-risk regions. 

Specifically, the risk is even lower for 

the importation of meat and meat 

products than for live bovines. 

The September 2007 final rule, which 

included the removal of the partial 

delay of applicability of the provisions 

of the January 2005 rule relating to meat 

derived from cattle 30 months of age or 

older, became effective on November 19, 

2007. 

On July 3, 2008, Judge Lawrence L. 

Piersol of the U.S. District Court for the 

District of South Dakota, in response to 

a motion filed in that Court, ordered 

USDA to provide the public with notice 

and a further opportunity to comment 

on the provisions of our January 2005 

final rule regarding the importation of 

beef from bovines 30 months of age or 

older when slaughtered, to consider 

comments made by interested parties, 

and to revise the rule as USDA deems 

necessary. In this document, we are 

providing such notice and further 

opportunity for comment. We will 

consider all comments that we receive 

by November 17, 2008. 

References 

Arnold, M. and J. Wilesmith. (2004). 

Estimation of the Age-Dependent Risk of 

Infection to BSE of Dairy Cattle in Great 

Britain. Preventive Veterinary Medicine. 

66(1): 35–47. 

Buschmann, A. and M. Groschup (2005). 

Highly Bovine Spongiform 

Encephalopathy-Sensitive Transgenic 

Mice Confirm the Essential Restriction of 

Infectivity to the Nervous System in 

Clinically Diseased Cattle. The Journal of 

Infectious Diseases, 192: 934–42. 

September 1. 

Comer, P.J. and P.J. Huntly. (2003). Exposure 

of the human population to BSE 

infectivity over the course of the BSE 

epidemic in Great Britain and the impact 

of changes to the Over Thirty Month 

Rule. Over Thirty Month Rule (OTMR) 

review paper. June. (http:// 

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otmcomer.pdf) 

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Espinosa, J.C., M. Morales, J. Castilla, M. 

Rogers, and J.M. Torres. (2007). 

Progression of prion infectivity in 

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Journal of General Virology 88:1379– 

1383. April. 

European Commission Scientific Steering 

Committee (EC SSC). (2001), ‘‘Opinion 

on TSE Infectivity Distribution in 

Ruminant Tissues (State of Knowledge, 

December 2001)’’ (Adopted January 10– 

11, 2002). (http://europa.eu.int/comm/

food/fs/sc/ssc/out241_en.pdf) 

European Commission Scientific Steering 

Committee (EC SSC). (2002). Update of 

the opinion on TSE infectivity 

distribution in ruminant tissues. 

November. (http://www.europa.eu.int/

comm/food/fs/sc/ssc/out296_en.pdf) 

Food and Drug Administration (FDA) (2004). 

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134, 42255–42274. Interim Final Rule, 

‘‘Use of Materials Derived from Cattle in 

Human Food and Cosmetics.’’ FDA 

Docket No. 2004N–0081. July 14. 

(http://www.fda.gov/OHRMS/DOCKETS/ 

98fr/04–15881.htm) 

Food and Drug Administration (FDA) (2005). 

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172, 533063–53069. Interim Final Rule, 

‘‘Use of Materials Derived from Cattle in 

Human Food and Cosmetics.’’ FDA 

Docket No. 2004N–0081. September 7. 

(http://www.fda.gov/OHRMS/DOCKETS/ 

98fr/05–17693.pdf) 

Food and Drug Administration (FDA) (2007). 

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1582–1619. Proposed Rule, ‘‘Use of 

Material Derived from Cattle in Medical 

Products Intended for Use in Humans 

and Drugs Intended for Use in 

Ruminants.’’ FDA Docket No. 2005N– 

0373. January 12. (http:// 

edocket.access.gpo.gov/2008/pdf/E6– 

22329.htm) 

Food and Drug Administration (FDA) (2008). 

Federal Register Volume 73, Number 81, 

22718–22758. Final Rule, ‘‘Substances 

Prohibited from Use in Animal Food or 

Feed.’’ FDA Docket No. 2002N–0273. 

April 25. (http://edocket.access.gpo.gov/ 

2007/pdf/08–1180.pdf) 

Food Safety and Inspection Service (FSIS) 

(2004). Federal Register Volume 69, No. 

7, 1861–1874. Interim Final Rule, 

‘‘Prohibition of the Use of Specified Risk 

Materials for Human Food and 

Requirements for the Disposition of NonAmbulatory Disabled Cattle,’’ Docket No. 

03–025IF. January 12. (http:// 

www.fsis.usda.gov/OPPDE/rdad/FRPubs/ 

03–025IF.pdf) 

Food Safety and Inspection Service (FSIS) 

(2004a). Federal Register Volume 69, No. 

7, 1874–1885. Interim Final Rule, ‘‘Meat 

Produced by Advanced Meat/Bone 

Separation Machinery and Meat 

Recovery (AMR) Systems,’’ Docket No. 

03–0038IF. January 12. (http:// 

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03–0038IF.pdf) 

Food Safety and Inspection Service (FSIS) 

(2004b). Federal Register Volume 69, 

No. 7, 1885–1891. Interim Final Rule, 

‘‘Prohibition of the Use of Certain 

Stunning Devices Used To Immobilize 

Cattle During Slaughter; Bovine 

Spongiform Encephalopathy 

Surveillance Program; Interim Final 

Rule,’’ Docket No. 01–033IF. January 12. 

(http://www.fsis.usda.gov/OPPDE/rdad/ 

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Food Safety and Inspection Service (FSIS) 

(2005). Federal Register Volume 70, No. 

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Materials for Human Food and 

Requirements for the Disposition of NonAmbulatory Disabled Cattle.’’ Docket No. 

03–025IFA. September 7. (http:// 

frwebgate.access.gpo.gov/cgi-bin/ 

getpage.cgi?position=all&

page=53043&dbname=2005_register) 

Food Safety and Inspection Service (FSIS). 

(2007). Federal Register Volume 72, No. 

134, 38700–38730. Affirmation of 

Interim Final Rules with Amendments, 

‘‘Prohibition of the Use of Specified Risk 

Materials for Human Food and 

Requirements for the Disposition of NonAmbulatory Disabled Cattle; Prohibition 

of the Use of Certain Stunning Devices 

Used to Immobilize Cattle During 

Slaughter.’’ Docket No. 03–025F. July 13. 

(http://www.fsis.usda.gov/Regulations_&


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_Policies/federal_register_publications_&

_related_documents/index.asp) 

Masujin, K., D. Matthews, G.A.H. Wells, S. 

Mohri, and T. Yokoyama. (2007). Prions 

in the peripheral nerves of bovine 

spongiform encephalopathy-affected 

cattle. J. Gen. Virol. (88): 1850–1858; DOI 

10.1099/vir.0.82779–0. 

United States Department of Agriculture 

(USDA). (2005). U.S. Department of 

Agriculture’s Summary of the 

Epidemiological Finding of North 

American BSE Positive Cattle, April. 

(http://www.aphis.usda.gov/newsroom/

hot_issues/bse/background/documents/

bse_epi_report_4–29–05.pdf) 

United States Department of Agriculture 

(USDA). (2005a). Assessment of the 

Canadian Feed Ban, February. (http:// 

www.aphis.usda.gov/newsroom/

hot_issues/bse/background) 

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

R.B. Green, I. Dexter, M.E. Francis, M.M. 

Simmons, A.R. Austin, and M.W. 

Horigan. (1994). Infectivity in the ileum 

of cattle challenged orally with bovine 

spongiform encephalopathy. Vet. Rec. 

135(2): 40–41. 

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

A.R. Austin, R.B. Green, I. Dexter, M.W. 

Horigan, and M.M. Simmons. (1996). 

Preliminary observations on the 

pathogenesis of experimental bovine 

spongiform encephalopathy. In: Bovine 

spongiform encephalopathy: the BSE 

dilemma (Gibbs C.J. Jr., ed.). SpringerVerlag, New York. 

Wells, G.A.H., S.A.C. Hawkins, R.B. Green, 

A.R. Austin, I. Dexter, Y.I. Spencer, M.J. 

Chaplin, M.J. Stack, and M. Dawson. 

(1998). Preliminary observations on the 

pathogenesis of experimental bovine 

spongiform encephalopathy (BSE): an 

update. Vet. Rec. 142: 103–106. 

Wells, G.A.H., S.A.C. Hawkins, R.B. Green, 

Y.I. Spencer, I. Dexter, and M. Dawson. 

(1999). Limited detection of sternal bone 

marrow infectivity in the clinical phase 

of experimental bovine spongiform 

encephalopathy (BSE). Vet. Rec. 144: 

292–294. 

Wells, G.A.H., J. Spiropoulos, S.A.C. 

Hawkins, and S.J. Ryder. (2005). 

Pathogenesis of experimental bovine 

spongiform encephalopathy: pre-clinical 

infectivity in tonsil and observations on 

the distribution of lingual tonsil in 

slaughtered cattle. Vet Rec. 156(13): 401– 

407. 

Wells, G.A.H. (2008). Personal 

communication with APHIS. E-mail. 

January 30. World Organization for 

Animal Health Terrestrial Animal Health 

Standards Commission (OIE TAHSC). 

(2006). Supporting document for Chapter 

2.3.13 of the Terrestrial Animal Health 

Code on Bovine Spongiform 

Encephalopathy. Terrestrial Animal 

Health Standards Commission Report. 

October. (http://www.aataanimaltransport.org/Publications/issues/

4-GS75TAHSCBSE

supportdocOct2006.doc) 

Authority: 7 U.S.C. 450, 7701–7772, and 

8301–8317; 21 U.S.C. 136 and 136a; 31 

U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. 

Done in Washington, DC, this 12th day of 

September 2008. 

Cindy J. Smith, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. E8–21786 Filed 9–17–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF ENERGY 

10 CFR Part 430 

[Docket No. EERE–2008–BT–STD–0012] 

RIN 1904–AB80 

Energy Conservation Standards for 

Residential Refrigerators, RefrigeratorFreezers, and Freezers: Public Meeting 

and Availability of the Framework 

Document 

AGENCY: Office of Energy Efficiency and 

Renewable Energy, Department of 

Energy. 

ACTION: Notice of public meeting and 

availability of the framework document. 

SUMMARY: DOE will hold an informal 

public meeting to discuss and receive 

comments on issues that it will address 

in this rulemaking proceeding. The 

Department is also initiating data 

collection for establishing energy 

conservation standards for residential 

refrigerators, refrigerator-freezers, and 

freezers. The Department also 

encourages written comments on these 

subjects. To inform stakeholders and 

facilitate this process, DOE has prepared 

a draft framework document, available 

at http://www1.eere.energy.gov/ 

buildings/appliance_standards/ 

residential/refrigerators_freezers.html. 

DATES: The Department will hold a 

public meeting on Monday, September 

29, 2008, from 9 a.m. to 5 p.m. in 

Washington, DC. Any person requesting 

to speak at the public meeting should 

submit such request along with a signed 

original and an electronic copy of the 

statements to be given at the public 

meeting before 4 p.m., Monday, 

September 22, 2008. Written comments 

are welcome, especially following the 

public meeting, and should be 

submitted by October 20, 2008. 

ADDRESSES: The public meeting will be 

held at the U.S. Department of Energy, 

Forrestal Building, Room 8E–089, 1000 

Independence Avenue, SW., 

Washington, DC 20585–0121. Please 

note that foreign nationals participating 

in the public meeting are subject to 

advance security screening procedures. 

If a foreign national wishes to 

participate in the public meeting, please 

inform DOE of this fact as soon as 

possible by contacting Ms. Brenda 

Edwards at (202) 586–2945 so that the 

necessary procedures can be completed. 

Stakeholders may submit comments, 

identified by docket number EERE– 

2008–BT–STD–0012 and/or Regulation 

Identifier Number (RIN) 1904–AB80, by 

any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: ResRefFreez–2008–STD– 

0012@hq.doe.gov. Include EERE–2008– 

BT–STD–0012 and/or RIN 1904–AB80 

in the subject line of the message. 

• Mail: Ms. Brenda Edwards, U.S. 

Department of Energy, Building 

Technologies Program, Mailstop EE–2J, 

Framework Document for Refrigerators, 

Refrigerator-Freezers, and Freezers, 

EERE–2008–BT–STD–0012 and/or RIN 

1904–AB80, 1000 Independence 

Avenue, SW., Washington, DC 20585– 

0121. Phone: (202) 586–2945. Please 

submit one signed paper original. 

• Hand Delivery/Courier: Ms. Brenda 

Edwards, U.S. Department of Energy, 

Building Technologies Program, 6th 

Floor, 950 L’Enfant Plaza, SW., 

Washington, DC 20024. Phone: (202) 

586–2945. Please submit one signed 

paper original. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this 

rulemaking. 

Docket: For access to the docket to 

read background documents, a copy of 

the transcript of the public meeting, or 

comments received, go to the U.S. 

Department of Energy, 6th Floor, 950 

L’Enfant Plaza, SW., Washington, DC 

20024, between 9 a.m. and 4 p.m., 

Monday through Friday, except Federal 

holidays. For additional information 

about visiting the Resource Room, 

please call Ms. Brenda Edwards at (202) 

586–2945. Please note that the 

Department’s Freedom of Information 

Reading Room (formerly Room 1E–190 

at the Forrestal Building) no longer 

houses rulemaking materials. 

FOR FURTHER INFORMATION CONTACT: (1) 

Stephen Witkowski, U.S. Department of 

Energy, Office of Energy Efficiency and 

Renewable Energy, Building 

Technologies, EE–2J, 1000 

Independence Avenue, SW., 

Washington, DC 20585–0121. Phone: 

(202) 586–7463. e-mail: 

stephen.witkowski@ee.doe.gov. (2) 

Michael Kido, U.S. Department of 

Energy, Office of General Counsel, GC– 

72, 1000 Independence Avenue, SW., 

Washington, DC 20585–0121. Phone: 

(202) 586–9507. e-mail: 

michael.kido@hq.doe.gov. 

SUPPLEMENTARY INFORMATION: Part A of 

Title III of the Energy Policy and 


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