19952 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

techniques or other forms of information 

technology should be addressed to: Desk 

Officer for Agriculture, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB), 

OIRA_Submission@OMB.EOP.GOV or 

fax (202) 395–5806 and to Departmental 

Clearance Office, USDA, OCIO, Mail 

Stop 7602, Washington, DC 20250– 

7602. Comments regarding these 

information collections are best assured 

of having their full effect if received 

within 30 days of this notification. 

Copies of the submission(s) may be 

obtained by calling (202) 720–8681. 

An agency may not conduct or 

sponsor a collection of information 

unless the collection of information 

displays a currently valid OMB control 

number and the agency informs 

potential persons who are to respond to 

the collection of information that such 

persons are not required to respond to 

the collection of information unless it 

displays a currently valid OMB control 

number. 

Rural Utilities Service 

Title: Public Television Digital 

Transition Grant Program 

OMB Control Number: 0572–0134 

Summary of Collection: The Omnibus 

Appropriations Act (Pub. L. 108–7) 

provided grant funds in the Distance 

Learning and Telemedicine Grant 

Program budget, the Consolidated 

Appropriations Act (Pub. L. 108–199) 

and the Consolidated Appropriations 

Act, 2005 (Pub. L. 108–447) provided 

additional funds for public broadcasting 

systems to meet the digital transition. 

As part of the nation’s transition to 

digital television, the Federal 

Communications Commission (FCC) 

required all television broadcasters to 

initiate the broadcast of a digital 

television signal and to cease analog 

television broadcasts on February 18, 

2009. While stations must broadcast its 

main transmitter signal in digital, many 

rural stations often have translators 

serving small or isolated areas and some 

of these have not completed the 

transition to digital or fully converted 

its production and studio equipment to 

digital. Because the FCC deadline did 

not apply to translators, they are 

allowed to continue broadcasting in 

analog. The digital transition also 

created some service gaps where 

households receiving an analog signal 

cannot receive a digital signal. For these 

reasons the grant program has continued 

past the FCC digital transition deadline 

of June 2009. The Rural Utilities Service 

(RUS) will develop and issue 

requirements for the grant program to 

finance the conversion of television 

services from analog to digital 

broadcasting for public television 

stations serving rural areas. 

Need and Use of the Information: 

Applicants will submit grant 

applications to RUS for review. The 

information will consist of the 

following: Standard Form (SF) 424, 

‘‘Application for Federal Assistance, 

executive summary, evidence of 

eligibility and compliance with other 

Federal statutes and any other 

supporting documentation. RUS will 

use the information to score and rank 

applications for funding. Scoring will 

consist of three categories: Rurality; per 

capita income; and special 

disadvantaging factors facing the 

station’s transition plans. If this 

information is not collected, there 

would be no basis for awarding grant 

funding. 

Description of Respondents: Not-forprofit institutions; State, Local or Tribal 

Government 

Number of Respondents: 40 

Frequency of Responses: Reporting: 

On occasion 

Total Burden Hours: 950 

Charlene Parker, 

Departmental Information Collection 

Clearance Officer. 

[FR Doc. 2011–8491 Filed 4–8–11; 8:45 am] 

BILLING CODE 3410–15–P 

DEPARTMENT OF AGRICULTURE 

Davy Crockett National Forest 

Resource Advisory Committee 

AGENCY: Forest Service, USDA. 

ACTION: Notice of Public Meeting, Davy 

Crockett National Forest Resource 

Advisory Committee. 

SUMMARY: In accordance with the Secure 

Rural Schools and Community Self 

Determination Act of 2000 (Pub. L. 106– 

393), [as reauthorized as part of Public 

Law 110–343] and the Federal Advisory 

Committee Act of 1972 (FACA), the U.S. 

Department of Agriculture, Forest 

Service, Davy Crockett National Forest 

Resource Advisory Committee (RAC) 

meeting will meet as indicated below. 

DATES: The Davy Crockett National 

Forest RAC meeting will be held on May 

5, 2011. 

ADDRESSES: The Davy Crockett National 

Forest RAC meeting will be held at the 

Davy Crockett Ranger Station located on 

State Highway 7, approximately onequarter mile West of FM 227 in Houston 

County, Texas. The meeting will begin 

at 6 p.m. and adjourn at approximately 

8 p.m. A public comment period will 

begin at 7:45 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Gerald Lawrence, Jr., Designated Federal 

Officer, Davy Crockett National Forest, 

18551 State Hwy. 7 E., Kennard, TX 

75847: Telephone: 936–655–2299 ext. 

225 or e-mail at: glawrence@fs.fed.us. 

SUPPLEMENTARY INFORMATION: The Davy 

Crockett National Forest RAC proposes 

projects and funding to the the Secretary 

of Agriculture under Section 203 of the 

Secure Rural Schools and Community 

Self Determination Act of 2000, (as 

reauthorized as part of Public Law 110– 

343). The purpose of the May 5, 2011 

meeting is the following: proposal and 

approval of new Title II and 

Stewardship proposals, deadlines for 

obligating funding, and current project 

status. These meetings are open to the 

public. The public may present written 

comments to the RAC. Each formal RAC 

meeting will also have time, as 

identified above, persons wishing to 

comment and time available, the time 

for individual oral comments may be 

limited. 

Gerald Lawrence, Jr., 

Designated Federal Officer, Davy Crockett 

National Forest RAC. 

[FR Doc. 2011–8503 Filed 4–8–11; 8:45 am] 

BILLING CODE 3410–11–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2005–0044] 

Not Applying the Mark of Inspection 

Pending Certain Test Results 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice; Request for comment. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

its intention to change its procedures 

and withhold a determination as to 

whether meat and poultry products are 

not adulterated, and thus eligible to 

enter commerce, until all test results 

that bear on the determination have 

been received. Inspection program 

personnel periodically sample products 

for adulterants to verify an 

establishment’s regulatory compliance. 

The Agency’s practice has been to allow 

these products to bear the mark of 

inspection, and to enter commerce, even 

though the test results have not been 

received. FSIS has asked, but has not 

required, official establishments to 

maintain control of products 

represented by a sample pending test 

results. 

Because establishments, including 

official import inspection 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19953 

establishments, are not consistently 

maintaining control of product, despite 

FSIS’s request that they do so, 

adulterated product is entering 

commerce. Therefore, FSIS is 

announcing its tentative determination 

not to apply the mark of inspection until 

negative results are available and 

received for any testing for adulterants 

conducted by the Agency. FSIS invites 

comments on this proposed change in 

policy and procedures. FSIS will 

evaluate comments received in response 

to this notice. In a subsequent Federal 

Register notice, FSIS will respond to the 

comments it receives. FSIS will make 

any appropriate changes to the policy 

and procedures based on comments, 

and in that subsequent Federal Register 

notice will announce the effective date 

of the new policy. 

DATES: The Agency must receive 

comments by July 11, 2011. 

ADDRESSES: Comments may be 

submitted by either of the following 

methods: 

Federal eRulemaking Portal: This 

Web site provides the ability to type 

short comments directly into the 

comment field on this Web page or 

attach a file for lengthier comments. Go 

to http://www.regulations.gov. Follow 

the online instructions at that site for 

submitting comments. 

Mail, including diskettes or CD– 

ROMs, and hand-delivered or courierdelivered items: Send to Docket Clerk, 

U.S. Department of Agriculture (USDA), 

FSIS, Room 2–2127, George Washington 

Carver Center, 5601 Sunnyside Avenue, 

Mailstop 5474, Beltsville, MD 20705– 

5474. 

Instructions: All items submitted by 

mail or electronic mail must include the 

Agency name and docket number FSIS– 

2006–0044. Comments received in 

response to this docket will be made 

available for public inspection and 

posted without change, including any 

personal information, to http:// 

www.regulations.gov. 

Docket: For access to background 

documents or to comments received, go 

to the FSIS Docket Room at the address 

listed above between 8:30 a.m. and 4:30 

p.m., Monday through Friday. 

All comments submitted in response 

to this proposal, as well as background 

information used by FSIS in developing 

this document, will be available for 

public inspection in the FSIS Docket 

Room at the address listed above 

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

Monday through Friday. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Edelstein, Director, Policy 

Issuances Division, Office of Policy and 

Program Development, FSIS, U.S. 

Department of Agriculture, Room 6065, 

South Building, 1400 Independence 

Ave., SW., Washington, DC 20250–3700; 

telephone (202) 720–0399; fax (202) 

690–0486. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS is responsible for protecting the 

nation’s meat and poultry supply by 

making sure that it is safe, wholesome, 

not adulterated, and properly labeled 

and packaged. FSIS operates under 

authority provided by the Federal Meat 

Inspection Act (FMIA) (21 U.S.C. 601 et 

seq.) and the Poultry Products 

Inspection Act (PPIA) (21 U.S.C. 451 et 

seq.) (the Acts). These statutes prohibit 

anyone from selling, transporting, 

offering for sale or transportation, or 

receiving for transportation in 

commerce, any adulterated or 

misbranded meat or poultry products 

(21 U.S.C. 610 and 458). 

There are nine parts to the definition 

of ‘‘adulterated’’ in the FMIA and eight 

in the PPIA. Most relevant to product 

testing are subparagraphs (1) and (2)(A) 

of 21 U.S.C. 601(m) and 453(g). 21 

U.S.C. 601(m)(1) and 453(g)(1) provide 

that product is adulterated if it bears or 

contains any poisonous or deleterious 

substance that may render it injurious to 

health. Therefore, a ready-to-eat meat or 

poultry product found positive for a 

pathogen, or a raw ground or other raw 

non-intact beef product found positive 

for E. coli O157:H7, is adulterated under 

these statutory provisions. In addition, 

if food contact surfaces are found 

positive for Listeria monocytogenes, 

ready-to-eat product produced on these 

surfaces is adulterated under 9 CFR 

430.4(a). 21 U.S.C. 601(m)(2)(A) and 

453(g)(2)(A) provide that a meat or 

poultry product is adulterated if it bears 

or contains any added poisonous or 

added deleterious substance by reason 

of administration of any substance to 

the live animal. Therefore, if FSIS tests 

carcasses for residues of animal drugs 

that have been administered to the live 

animal and finds unacceptable levels, 

the product would be adulterated under 

these statutory provisions. FSIS testing 

conducted for pathogens and residues 

that would adulterate product under the 

provisions above are the primary focus 

of the actions outlined in this notice. 

In addition, the term ‘‘adulterated’’ 

includes product from which any 

valuable constituent has been in whole 

or in part omitted or abstracted; for 

which any substance has been 

substituted; or to which any substance 

has been added or mixed or packed so 

as to increase its bulk or weight, reduce 

its quality or strength, or make it appear 

better or of greater value than it is (21 

U.S.C. 601(m)(8) and 453(g)(8)). This 

type of adulteration is referred to as 

‘‘economic adulteration’’. FSIS testing 

that indicates product is economically 

adulterated would be subject to the 

actions outlined in this document. 

However, because FSIS conducts 

minimal testing for economic 

adulteration, this notice does not 

elaborate on such testing. 

The FMIA and PPIA also provide that 

meat and poultry products must bear an 

official inspection legend (21 U.S.C. 

601(n)(12) and 453(h)(12)) in order to 

enter commerce. FSIS must be able to 

determine that product is not 

adulterated in order to apply the mark 

of inspection (21 U.S.C. 606 and 457(a)). 

FSIS inspection personnel conduct a 

range of activities to determine whether 

product is adulterated (9 CFR 417.8). 

Among these activities is testing for 

adulterants. 

FSIS’s practice is to allow meat and 

poultry products to be packaged and 

labeled with the mark of inspection 

pending receipt of results of tests done 

by FSIS. Currently, FSIS requests, but 

does not require, that establishments 

maintain control of all product 

represented by any samples taken until 

the Agency receives the results of the 

sampling. Establishments are not 

required to maintain such control and 

may ship product before test results are 

available. If the establishment 

introduces the product into commerce, 

and the test result for that product is 

positive for a pathogen or other 

adulterant, FSIS will request that the 

establishment recall the product. If the 

establishment refuses to recall the 

product, FSIS will move to detain and, 

if necessary, seize it. 

Reason for This Notice 

The Agency has questioned for some 

time whether it should continue to 

allow product to leave the 

establishment, albeit subject to a recall, 

before relevant test results are received. 

On December 12, 2002, FSIS held a 

public meeting in Washington, DC, to 

both inform the public about the recall 

process and to solicit recommendations 

on recalls from establishments whose 

product is subject to recall, from public 

health agencies, and from those who 

represent the public health interests of 

consumers. The agenda for this meeting 

included a discussion on withholding 

the decision to apply the mark of 

inspection until FSIS test results are 

available. Presenters and commenters 

raised concerns about the effect such a 

policy would have on small and very 

small establishments. FSIS took these 

comments into account in the cost 


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1A summary of the Agency’s analysis of the 

industry guidelines is available electronically at 

http://www.fsis.usda.gov/OPPDE/NACMPI/ 

May2006/Test_and_Hold_Report_NACMPI.pdf. 

benefit analysis of this policy discussed 

below. 

On June 2–3, 2004, FSIS presented a 

subcommittee of the National Advisory 

Committee on Meat and Poultry 

Inspection (NACMPI) with the following 

question for discussion: Should FSIS 

delay a decision on granting the mark of 

inspection to product that has been 

tested by FSIS for the presence of an 

adulterant until it has received the 

results of the testing? The committee 

made a number of recommendations to 

the Agency but was unable to come to 

consensus on the question of not 

applying the mark of inspection until 

FSIS verification test results are 

available. The committee recommended 

that the Agency continue to encourage 

plants to develop a plan for holding 

products when they are sampled for 

adulterants. The committee further 

recommended that FSIS provide 

guidance to plants regarding holding 

products, and that FSIS work with the 

industry on strategies to mitigate some 

of the practical problems associated 

with holding products. 

In June 2005, the Agency again 

requested advice from the NACMPI. The 

Agency asked the committee for 

suggestions on the most effective way to 

provide guidance to industry on holding 

product that has been tested for 

pathogens by FSIS, especially to small 

and very small plants. The Committee 

considered the issue and its impact on 

small and very small establishments and 

made a number of recommendations to 

the Agency. The Committee 

recommended: (a) That FSIS refrain 

from issuing any guidance at that time 

but instead review a draft of voluntary 

guidelines that representatives from 

across the meat and poultry industry 

had written to ensure that they conform 

to applicable laws, regulations, and 

policies; (b) that industry issue its 

guidelines after FSIS review and work 

with the Agency to ensure widespread 

distribution of these guidelines, 

especially to small and very small 

plants; and (c) that FSIS monitor the 

effectiveness of the industry guidance 

on an ongoing basis and take 

appropriate actions, ranging from 

recommendations for improving the 

guidelines to formal Agency action. 

In 2005, the Agency carefully 

considered the committee’s 

recommendations and decided not to 

pursue a change in policy that would 

require establishments to hold product 

pending FSIS test results and to await 

the outcome of the industry-issued 

voluntary guidance on best practices for 

maintaining control of product while 

awaiting FSIS’ test results. The Agency 

made this decision because of the 

difficulties a policy change could 

present for some small and very small 

establishments. 

In September 2005, a coalition of 

trade associations issued a guidance 

document, ‘‘Industry Best Practices for 

Holding Tested Products.’’ This best 

practices document included, among 

many other things, suggestions to aid 

small and very small establishments in 

planning for and maintaining control of 

product pending FSIS pathogen test 

results. FSIS assisted the trade 

associations in disseminating the 

guidance document to all official 

establishments. 

The Agency conducted an initial 

assessment of the voluntary guidance 

document’s effectiveness and presented 

its findings to the NACMPI at its 

meeting on May 23–24, 2006. The 

assessment examined FSIS test data for 

the calendar years 2003 through 2005 

and the first quarter of 2006 and 

grouped the data by establishment size 

and pathogen. This initial assessment 

found that in the first quarter of 2006, 

establishments were holding between 

approximately 80% and 100% of all 

meat and poultry products until 

receiving Agency test results, and that 

establishments of all sizes were 

increasingly holding more product 

pending receipt of Agency test results 

every year between 2003 and 2006, with 

large establishments holding almost all 

tested product every year since 2003. 

The brief, 9-month period from the 

issuance of the industry guidelines was 

not sufficient for the Agency to ascertain 

the effectiveness of these guidelines, 

however.1 The Agency continues to 

monitor verification test results and the 

circumstances that result in recalls. 

Based on evaluation of 2007–2009 data, 

the Agency has noted that 

establishments releasing product into 

commerce before receiving test results 

continues to be a problem. 

In 2007 there were 14 Class I recalls 

as a result of FSIS testing; in 2008 there 

were 19 Class I recalls; and in 2009 

there were 11 Class I recalls. In 2007 

seven of the Class I recalls were for E. 

coli O157:H7 and seven for Listeria 

monocytogenes (Lm). In 2008, seven of 

the Class I recalls were for E. coli 

O157:H7 and twelve for Lm. In 2009, 

eight of the Class I recalls were for E. 

coli O157:H7 and three were for Lm. As 

discussed in the cost and benefits 

discussion below, one such recall was 

associated with two illnesses. There 

were no recalls for Salmonella in Readyto-Eat (RTE) product between 2007– 

2009. These recalls occurred because 

establishments that produced the 

product that tested positive released the 

product into commerce while test 

results were pending. Even though the 

number of Class I recalls went down in 

2009 compared to 2007 and 2008, there 

is still product entering commerce 

before test results are received. FSIS is 

currently analyzing the 2010 recall data. 

2010 data show the proportion of the 

industry (by size) that holds product 

until test results are received to be 

similar to those from the 2006 study. 

These findings have led the Agency to 

conclude that despite voluntary 

compliance efforts, adulterated products 

are continuing to enter commerce and 

that establishments’ failure to hold or 

maintain control of product pending 

FSIS test results endangers public 

health. Not allowing product to move 

into commerce until the results of any 

testing for adulterants done by FSIS 

become available would eliminate this 

concern. 

In June 2008, the American Meat 

Institute (AMI) sent a letter to the Under 

Secretary for Food Safety stating that the 

organization supported the Agency 

requiring companies to hold or control 

product tested by FSIS until the results 

are known. AMI also stated that it did 

not support Agency retention of any 

FSIS tested product. Rather, AMI 

supported requiring a company to 

utilize its own, effective control 

measures to ensure the product is not 

used or distributed for sale before the 

test results are known. 

On October 19, 2009, AMI sent 

another letter to Secretary of Agriculture 

Vilsack again stating that the 

organization supported a policy that 

would require companies to hold or 

control product tested by FSIS until the 

test results are known. 

In March of 2010, the USDA Office of 

Inspector General issued an audit report 

of the FSIS National Residue Program 

for Cattle. In that audit, the OIG 

recommended that establishments 

should not be allowed to release 

potentially adulterated product before 

residue test results are confirmed. The 

proposed change in policies and 

procedures will address that 

recommendation. 

FSIS does have a current policy 

whereby carcasses tested for bovine 

spongiform encephalopathy (BSE) must 

be controlled by the establishment and 

are not permitted to enter commerce 

until test results are received. FSIS 

implemented this policy in response to 

the first discovery of a BSE-positive cow 

in December 2003. FSIS issued a 

Federal Register notice on January 12, 


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Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19955 

2004 (69 FR 1892), announcing that the 

Agency would not apply the mark of 

inspection to any animal carcass tested 

for BSE until after the Agency 

determined that the test results were 

negative. This policy, which continues 

in effect, is consistent with policy and 

procedures that FSIS has tentatively 

decided to implement, as discussed in 

the next section. 

New Policy 

For the reasons discussed above, FSIS 

intends to implement a new policy with 

respect to the application of the mark of 

inspection that would in effect require 

establishments to maintain control of 

product tested for adulterants by FSIS 

and not allow such products to enter 

commerce until negative test results are 

received. Therefore, should FSIS 

implement this new policy, the policy 

would cover non-intact raw beef 

product or intact raw beef product 

intended for non-intact use that is tested 

for E. coli O157:H7. Also, the policy 

would cover any ready-to-eat products 

tested for Listeria monocytogenes, E. 

coli O157:H7, or Salmonella s. 

Similarly, this policy would cover 

ready-to-eat product that passed over 

food contact surfaces that have been 

tested for the presence of Listeria 

monocytogenes and Salmonella, 

pending receipt of negative test results. 

This policy would not cover raw meat 

or poultry products tested for 

Salmonella or other pathogens that FSIS 

has not designated as adulterants in 

those products. 

Should FSIS implement this new 

policy, it would also apply to livestock 

carcasses subject to FSIS testing for such 

veterinary drugs as antibiotics, 

sulfonamides, or avermectins or the feed 

additive carbadox. Because of the 

significant number of poultry carcasses 

in a lot, the economic effect of holding 

such a lot, and because historically, 

FSIS has not seen residue problems in 

poultry tested for residues, such product 

would not need to be held from 

commerce pending negative test results. 

FSIS requests comments on whether 

the policy that product cannot be 

released into commerce before negative 

test results are receive should also apply 

to tests conducted by establishments. 

New Procedures 

FSIS recognizes that the mark of 

inspection is pre-printed on the package 

label of many products, and that it is 

most efficient to allow the product to be 

packaged and labeled with the printed 

mark of inspection as part of the 

production process. FSIS intends to 

continue to allow meat and poultry 

establishments to package and label 

products sampled and tested for 

adulterants with the mark of inspection 

pending negative Agency test results, 

but, if FSIS adopts this change, these 

products will not be able to enter 

commerce until negative test results 

become available. The pre-shipment 

review of records associated with the 

production lot will not be complete 

without the pending test results. Under 

this new policy, FSIS inspection 

program personnel will continue to 

provide each establishment with 

notification before sampling product or 

food contact surfaces to allow the 

establishment time to hold product that 

is represented by the sample. 

Consistent with current policies, 

should FSIS implement this new policy, 

establishments would be able to move 

product to locations other than the 

production facility so long as the 

establishment maintains control of the 

product and maintains the integrity of 

the lot under company seal. If the 

establishment moves the product to 

other locations, it would not be able to 

transfer ownership of the product until 

negative test results become available. 

Inspection program personnel would 

notify the establishment when product 

could move into commerce based on 

negative FSIS test results. 

Considerations for Holding Product 

Tested for Pathogens or Residues 

For E. coli O157:H7, prior to FSIS’s 

sampling, inspection program personnel 

inform the establishment that it is 

responsible for defining the sampled lot. 

Under current policy and under this 

new policy, some factors or conditions 

that the establishment should consider 

in defining the sampled lot include any 

scientific, statistically based sampling 

programs for E. coli O157:H7 that the 

establishment uses to distinguish 

between segments of production; 

Sanitation Standard Operating 

Procedures (Sanitation SOPs) or any 

other prerequisite programs used to 

control the spread of E. coli O157:H7 

cross-contamination between raw beef 

components during production; 

processing interventions that limit or 

control E. coli O157:H7 contamination; 

and the use of beef manufacturing 

trimmings and other raw ground beef 

components or rework carried over from 

one production period to another. 

FSIS does not recognize ‘‘clean-up to 

clean-up’’ alone as a supportable basis 

for distinguishing one portion of 

production of raw beef product from 

another portion of production. Rather, 

establishments should consider whether 

the same source materials are used 

during different production periods. 

For testing of ready-to-eat product or 

contact surfaces for Listeria 

monocytogenes or for testing such 

product for Salmonella, inspection 

program personnel also inform the 

establishment that it is responsible for 

determining the lot. In contrast to E. coli 

O157:H7, for these types of testing, the 

sampled lot is generally considered the 

ready-to-eat product that is produced 

from clean-up to clean-up because the 

product typically undergoes consistent 

cooking and other lethality procedures 

during the production period. 

For livestock carcasses subject to 

scheduled FSIS residue testing or 

residue testing conducted by the 

establishment or other entity, 

establishments would need to hold the 

sampled carcasses under this new 

policy. For this testing, the carcasses 

would not receive the mark of 

inspection until negative test results are 

received. 

Consistent with current policy, under 

this new policy, exporting countries 

would continue to need to complete all 

forms of inspection (including receiving 

lab results) before applying the mark of 

inspection and signing a certificate for 

export of products to the United States. 

Also consistent with current policy, the 

foreign countries would continue to 

certify on official health certificates how 

much product in a shipment represents 

the lot based on the product and its 

processing method (e.g., HACCP 

Processing categories, Product Species). 

Comments Regarding This New Policy 

The National Meat Association 

(NMA), representing seven other trade 

associations: The American Association 

of Meat Processors (AAMP), the Eastern 

Meat Packers Association (EMPA), the 

National Cattlemen’s Beef Association 

(NCBA), the National Turkey 

Association (NTA), the North American 

Meat Processors Association (NMPA), 

and the Southwest Meat Association 

(SMA), submitted a letter in anticipation 

of this notice to FSIS. 

NMA raised a number of issues about 

the prospective adoption of a revised 

FSIS hold and test policy. The letter 

asked how FSIS would address the issue 

of products with a shelf life less than 

the amount of time required to conduct 

the analysis. The letter also asked how 

small and very small establishments 

that produce product for same-day 

delivery would be affected by this 

policy, and how FSIS could justify 

economic impacts such as interruption 

of business and loss of customers. 

FSIS recognizes the concern that some 

very small establishments might lose 

some product because of a short shelf 

life, as well as experience some inability 


srobinson on DSKHWCL6B1PROD with NOTICES
19956 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

2There are three classes of recalls. Class I: A 

health hazard situation where there is a reasonable 

possibility that the use of the product will cause 

serious, adverse health consequences; Class II: A 

health hazard situation where there is a remote 

probability of adverse health consequences from the 

use of the product; and Class III: A situation where 

the use of the product will not cause adverse health 

consequences. 

3 ‘‘Preliminary Regulatory Impact Analysis and 

Initial Regulatory Flexibility Analysis of the 

Proposed Rules to Ensure the Safety of Juice and 

Juice Products’’ (63 FR 24258; May 1, 1998). 

4The annual figure of $15 million is derived by 

summing the total number of FSIS recalls for 2007– 

2009 from Table 1, then multiplying the total by $1 

million which is the average cost per recall for 

industry and government. That figure is then 

divided by 3 to get the annual amount. (14 + 19 + 

11 = 44 * 1M = 44M/3 = $14.7 M per year). 

5 ‘‘Preliminary Regulatory Impact Analysis and 

Initial Regulatory Flexibility Analysis of the 

Proposed Rules to Ensure the Safety of Juice and 

Juice Products’’ (63 FR 24258; May 1, 1998). 

6 Ibid. 

to satisfy customer orders, resulting in 

a short-term disruption in business 

activities. FSIS appreciates the concern. 

However, the Agency believes the new 

policy would not cause significant loss 

of product because FSIS inspection 

program personnel provide 

establishments with notification before 

they collect samples to provide the 

establishment time to plan accordingly. 

Furthermore, establishments may 

produce small production lots when 

they are subject to FSIS testing. In 

addition, many establishments already 

maintain control of product pending test 

results. FSIS welcomes comments on 

additional ways establishments and 

FSIS can address this concern. Also, 

FSIS intends to provide outreach 

activities for small and very small 

establishments, such as Webinars or 

Podcasts, as necessary. FSIS will also 

make compliance guidelines available. 

In addition, NMA asked how FSIS 

will ensure that all products that should 

be held have indeed been held. If the 

policy is adopted after evaluating the 

comments, FSIS will issue necessary 

instructions to its field force on how to 

verify that establishments are 

maintaining control of product pending 

test results for adulterants. Similarly, 

FSIS would develop Agency procedures 

to promptly inform the establishment 

that product is not adulterated and thus 

may enter commerce when negative 

results become available. 

NMA also noted that some recalls 

occur because the establishment did not 

properly hold all products associated 

with a tested sample. FSIS 

acknowledges that this new policy, if 

implemented as planned, will not 

guarantee establishments correctly 

identify the sampled lot. However, FSIS 

will continually evaluate the policy to 

provide updated instructions to 

inspection program personnel and 

guidance to establishments so that lots 

sampled for pathogens by FSIS do not 

enter commerce. 

Finally, the letter asked whether FSIS 

intended to mandate 100% testing at 

establishments that do not currently test 

but receive tested trim, such as raw 

ground beef at grinders. FSIS does not 

require such testing and does not intend 

to require such testing in the future. 

However, all establishments are 

required to conduct on-going 

verification activities to ensure that 

their HACCP plans are effectively 

implemented (9 CFR 417.4(a)(2)). 

I. Expected Benefits of the Action 

The Agency expects benefits from this 

policy to accrue to consumers, 

Government and to industry. 

If an establishment fails to hold a 

product when FSIS tests for a pathogen, 

and the test is positive, the 

establishment will be asked to recall the 

product. Because the pathogens for 

which FSIS does testing represent an 

immediate threat to human health, the 

recall would be classified as a Class I 

recall.2 Table 1 shows Class I recalls 

(2007–2009) for FSIS testing that are 

included in the universe for the Test 

and Hold policy analysis. These recalls 

were for E. coli O157:H7, Listeria 

monocytogenes, and Salmonella in RTE 

product. In 2007 there were 14 Class I 

recalls as a result of FSIS testing; in 

2008 there were 19 Class I recalls; and 

in 2009 there were 11 Class I recalls. In 

2007 seven of the Class I recalls were for 

E. coli O157:H7 and seven for Listeria 

monocytogenes (Lm). In 2008, seven of 

the Class I recalls were for E. coli 

O157:H7 and twelve for Listeria 

monocytogenes (Lm). In 2009, eight of 

the Class I recalls were for E. coli 

O157:H7 and three were for Listeria 

monocytogenes (Lm). There were no 

recalls for Salmonella in Ready-to-Eat 

(RTE) product between 2007–2009 for 

FSIS testing. 

TABLE 1—CLASS 1 RECALLS INCLUDED IN TEST AND HOLD POLICY UNIVERSE DERIVED FROM FSIS TESTS

[2007–2009] 

Year and type E. coli O157:H7 Listeria 

monocytogenes Salmonella Total 

2007: 

FSIS .................................................................................. 7 7 0 14 

2008: 

FSIS .................................................................................. 7 12 0 19 

2009: 

FSIS .................................................................................. 8 3 0 11 

Total ........................................................................... 22 22 0 44 

Note: Data source FSIS recall division. 

If the combination of industry and 

government costs per recall on average 

is $1 million,3 then the total annual cost 

of FSIS recalls could be on average as 

high as $15 million per year.4

Considering costs to retailers as well 

as manufacturers and State, local, and 

Federal authorities, a class I recall may 

cost as much as $3 million to $5 

million.5 Using a conservative estimate, 

if the actual cost of a recall for industry 

and government combined is closer to 

$3 million than $5 million,6 then the 

annual cost of the recall (the benefit of 

avoiding these recalls) could be as high 

as $44.0 million annually. FSIS requests 

comment on these estimates and the 

total costs to industry and government 

associated with USDA Class I recalls. 

In addition to the cost savings 

attributed to avoiding recalls described 

above, firms generally suffer a loss of 

sales, at least temporarily, following a 

Class I or Class II recall. This alone does 

not result in a social cost, but rather a 

social transfer, as other firms will step 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19957 

7Ollinger, Michael, working paper. ‘‘Many 

economists have examined the effects of reputation 

loss and the production of unsafe food. Packman 

(1998) argues that the negative publicity generated 

from a recall can erode prior investments in 

reputation and brand capital. Economists (Thomsen 

and McKenzie, 2001; Pruitt and Peterson; Salin and 

Hooker) found that firms that voluntarily recalled 

contaminated meat and poultry products suffered a 

decline in long run profitability (i.e., significant 

declines in stock prices). A number of studies 

(Piggott and Marsh, 2004; Marsh, Schroeder, and 

Mintert, 2004) determined that adverse meat and 

poultry food safety events led to temporary declines 

in meat and poultry consumption. Thomsen, 

Shiptsova, and Hamm (2006) established that sales 

of branded frankfurter products declined more than 

20 percent after product recalls.’’ 

8Scallan E. Hoekstra RM, Angulo FJ, Tauxe RV, 

Widdowson MA, Roy SL, et al. Foodborne illness 

acquired in the United States—major pathogens. 

Emerg Infect Dis. 2011 Jan: [Epub ahead of print] 

Table 2 of this report provides foodborne STEC 

O157: H7 illnesses at: 63,153, with 90% confidence 

of (17,587–149,631). Table 3 of this report provides 

STEC O157:H7 hospitalizations at 2,138, with 90% 

confidence of (549–4,614) and deaths of 20, with 

90% confidence of (0–113). 

9ERS cost calculator can be found on their Web 

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

10The cost per illness for the seven severity levels 

is between $30 (for an individual who did not 

obtain medical care) and $7.2 million for a patient 

who died from Hemolytic Uremic Syndrome (HUS). 

forward to capture sales lost by the 

recalling firm. However, in addition to 

the resources invested in recalling the 

product, the recalling firm may incur 

additional advertising costs to recapture 

the loss of sales plus the flow of future 

sales, which is a social cost. 

Additionally, there can be a loss of 

reputation for the manufacturer and the 

brand associated with recalls that may 

affect future sales. 

Consumer 

FSIS expects the consumer to benefit 

from: (1) Reduced incidence of 

adulterated product being released into 

commerce, (2) fewer recalls resulting in 

higher confidence and acceptability of 

products, and (3) lower levels of illness. 

This new policy will lead to increased 

consumer confidence and acceptance of 

product through reduced recalls and 

negative press.7

Government 

FSIS expects there to be a reduction 

in the number of recalls, and, therefore, 

the Agency expects to benefit from 

lower Agency costs for recalls and 

recovery of adulterated product because 

of: (1) Reduced inspection program 

personnel activities at Federal 

establishments (2) reduced overtime 

hours for FSIS staff, and (3) reduced 

staff travel to establishments after 

recalls to conduct Food Safety 

Assessments (FSA) and recall 

effectiveness checks. These expenses 

would include air, train, or car travel; 

lodging; and per diem expenses for 

meals. In addition, FSIS should have 

less need to disseminate information 

about food recalls through press releases 

and recall releases. 

Industry 

Under this policy change, the meat 

and poultry processing and slaughter 

industries will benefit from fewer 

recalls and negative press. As the 

number of recalls declines, there will 

likely be: (1) An increase in consumers’ 

confidence, (2) reduced costs for recalls, 

(3) greater consumer acceptance of 

products. 

Initially, preventing adulterated 

product from going into commerce 

should reduce operating costs. 

Operating costs will be lower because 

companies will be less likely to have a 

recall and experience the adverse 

impacts to business reputation as well 

as the product loss associated with a 

recall. Avoiding adverse impacts on 

business reputation is an indirect 

benefit. 

Imported Product 

There were 9 Class I recalls of FSIS 

tested imported product for the 2007– 

2009 (Table 1) time period, 4 for E. coli 

O157:H7 and 5 for Listeria 

monocytogenes. One recall occurred in 

2007 for Lm and eight in 2008 (4 for E. 

coli O157:H7 and 4 for Lm). There are 

no recalls from FSIS testing for 

imported product in 2009. All of these 

recalls are included within the universe 

described in Table 1 and therefore are 

included in the Benefits section within 

this analysis. 

Human Health Benefits 

Introduction 

The Centers for Disease Control and 

Prevention (CDC) has estimated that 

Shiga toxin-producing E. coli O157:H7 

infections cause 63,000 illnesses 

annually in the United States, resulting 

in more than 2,138 hospitalizations and 

20 deaths.8 Economic Research Service 

(ERS) estimates that the annual 

economic cost of illness caused by E. 

coli O157:H7 is $478 million (in 2009 

dollars) for all cases, not just for 

foodborne cases. 

The occurrence of recalls 

demonstrates that pathogens have been 

present on raw meat and poultry 

products distributed in commerce under 

FSIS’ existing approach. These 

pathogens represent a hazard to human 

health. Thus, public health likely will 

benefit because meat and poultry 

products will be held until results of 

pathogen tests are returned as negative. 

If test results are positive, the product 

will be destroyed, or further processed 

to destroy the pathogen, rather than 

having to be recalled. This change will 

thus reduce foodborne pathogens in 

products that are released into 

commerce. The economic health 

benefits are expected to be small relative 

to the economic benefits of avoided 

recalls. 

To reach this conclusion FSIS 

analyzed both the actual illnesses from 

the universe described in Table 1 and 

estimated future illnesses averted as a 

result of this change. We discuss in 

Section A (Potential averted illnesses 

from this policy using actual case data) 

the research conducted by the Economic 

Research Service (ERS) for each of the 

pathogens, E. coli O157:H7, Listeria 

monocytogenes, and Salmonella, as well 

as their associated costs per case.9

A. Potential Averted Illnesses From This 

Policy Using Actual Case Data 

(1) During 2007–2009, there were 22 

recalls for E. coli O157:H7 from FSIS 

testing. None of these recalls resulted in 

any illnesses according to the Office of 

Public Health Science (OPHS) data. The 

ERS estimate excludes a number of 

other potential costs, such as those for 

special education, nursing homes, 

travel, childcare, and pain and suffering. 

Illnesses for E. coli O157:H7 are divided 

into seven severity levels depending on 

whether the patient visits a physician or 

not, develops Hemolytic Uremic 

Syndrome (HUS) or not, develops Endstage renal disease or not, and finally 

whether death occurs. ERS estimates 

$6,510 as the average cost per case.10

(2) During 2007–2009 there were 22 

recalls for Listeria monocytogenes from 

FSIS testing. Only one of these recalls 

was associated with illnesses. In 2008, 

there were two illnesses, one of which 

was fatal, when a customer consumed 

chicken salad that had been released 

into commerce before the FSIS test 

results were returned as positive. We 

know that the cost of Lm illnesses with 

hospitalization ranges from $10,815 

(moderate) to $30,000 (severe). Ninetyfive percent of all hospitalized Lm cases 

are severe. The economic value of a life 

ranges between $6 and $7 million based 

on the value of statistical life (VSL) 

economic literature in 2001 dollars. 

Benefits from averting the two illnesses 

had the establishment held the product 

until the test results returned a positive 

would be $60,000 ($30,000 * 2), or 

$20,000 annually, and the benefit from 

averting the fatality would range from 

$5.7 to $6.8 million. The mid-point of 

the benefit from averting the death is 

$6.25 million or $2.1 million annually. 


srobinson on DSKHWCL6B1PROD with NOTICES
19958 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

11See ‘‘Prevention of Salmonella Enteritidis in 

Shell Eggs During Production, Storage, and 

Transportation’’ (74 FR 33030, July 9, 2009). 

12See Appendix 1: ‘‘Development of model for 

predicting averted illnesses due to E. coli O157:H7 

from Test and Hold’’ and Appendix 2: ‘‘Data used 

in Analysis.’’ A copy of these documents is 

available for viewing in the FSIS Docket Room and 

on the FSIS Web site as related documents 

associated with this docket. 

13OPHS data was used for the model that 

contained illnesses from all recalls and all sources. 

This included Outbreak, Illness, FSIS Test, and 

Establishment Test. This was done only for the 

purpose of estimating the rational expectation of 

future illnesses averted by this policy. 

14 Drugs are used on plants as well as in/on 

animals, so some of the chemicals regulated by EPA 

are drugs (for example antibiotics and antifungals). 

EPA establishes safe methods of use for chemicals 

(drugs, pesticides, fungicides, etc) and sets the 

allowable residual levels in the environment, water 

and air resulting from use, based on the risk to 

people through direct and indirect exposure to the 

residues. 

15See General Accounting Office (GAO) report 

‘‘Chemical Risk Assessment: Selected Federal 

Agencies’ Procedures, Assumptions, and Policies’’, 

GAO–01–810, August 2001. 

16A summary of the FSIS’s analysis is available 

electronically at http://www.fsis.usda.gov/OPPDE/

Actual annual benefits during 2007– 

2009 for Lm would be $2.10 million. 

(3) There were no recalls from FSIS 

testing for Salmonella in RTE product 

during 2007–2009. Research has shown 

that the cost per case of a Salmonella 

illness is $18,000.11

B. Estimated Averted Illnesses From 

This Policy 

FSIS has developed a model 12 to 

estimate annual illnesses averted per 

positive sample, from holding FSIS 

tested product until testing results are 

returned. This model is based on 2007– 

2009 recall data, as well as the OPHS 

illness data occurring from these 

recalls.13 The model estimates expected 

illnesses by accounting for volume of 

product recalled and ‘‘time in days’’ 

between the dates of production of 

adulterated product until the date of 

recall of that adulterated product. If the 

Agency proceeds with this new policy, 

the FSIS model estimated the upper 

95% confidence bound of averted E. coli 

O157:H7 illnesses to be approximately 

2.61 for a three-year period (based on 

the 2007–2009 data). FSIS estimated 

human health benefits, based on 

averting these 2.61 E. coli O157:H7 

illnesses to be approximately $5,664 

annually. ($6,510 * 2.61/3) 

Using similar methodology and an 

estimated number of illnesses of 0.18 for 

Listeria monocytogenes and .57 for 

Salmonella in RTE product, the annual 

cost is $1,800 and $3,420, respectively. 

For the three pathogens, E. coli 

O157:H7, Listeria monocytogenes, and 

Salmonella, human health benefits are 

estimated from the model to be 

approximately $10,884 annually. See 

Table 2. 

TABLE 2—HUMAN HEALTH BENEFITS FROM ACTUAL RECALLS AND ESTIMATED MODEL

[2007–2009] 

Pathogen Cost per CASE Actual CASES 

2007–2009 

Actual annual 

benefit 

2007–2009 

FSIS estimated 

cases averted 

(Model) 

2007–2009 ** 

Annual benefit 

(Model) 

E. coli O157:H7 ..................................... $6,510 0 0 2.61 $5,664 

Listeria Monocytogenes ......................... 30,000 2 $20,000 .18 1,800 

Salmonella ............................................. 18,000 0 0 .57 3,420 

Death (Annual) * ..................................... 6.25 1 2.1 M .............................. ..............................

Total ................................................ .............................. .............................. 2.1 M 3.36 10,884 

* Note: LM is known to have a high death rate and as such one death is included in the expectation of benefits from illnesses averted. The 

cost of 2 LM illnesses ($60,000) is accounted for in the Model. 

** Table 3 of the Model (Appendix) estimates illnesses for 10 years. To make the numbers comparable we used estimated illnesses from the 

model/10 * 3 to derive the numbers in this column. 

Total human health benefits from the 

FSIS model and actual reported 

illnesses combined would be 

approximately $2.11 million annually 

($2.1 M + $10,884). Differences may be 

due to rounding. 

Residue Benefits 

Microbiological hazards are expected 

to drive the cost-benefit analysis 

because they result in an attributable 

short term, low (morbidity) to high 

(morbidity) impact consequences that 

can be realistically estimated. 

The cost-benefit analysis for chemical 

hazards on the other hand is difficult to 

quantify. The negative health effects of 

exposure to low levels of chemicals are 

long term and multifactorial. Single 

exposure to low levels of chemicals or 

cumulative exposure can contribute to 

negative health effects 10, 20, or more 

years later; for example, cancer. Of 

course, over such long periods of time, 

individuals are exposed to a variety of 

hazards making it impossible to 

quantify the contribution of the 

chemical exposure to societal and 

medical costs. The approach for 

conducting a cost benefit analysis for 

single incidents of contamination at 

levels that cause immediate morbidity/ 

mortality, i.e., where the health effects 

are readily attributable to the exposure, 

is comparable to microbiological 

hazards. 

The Environmental Protection Agency 

(EPA) 14 and the Food and Drug 

Administration (FDA) conduct risk 

assessments to establish what level of 

chemical residues are acceptable.15

They consider acute and chronic 

exposure scenarios to set residue limits 

and include a wide margin of safety in 

their calculations. Meat, poultry, and 

egg products with chemical residues 

that exceed the tolerances or other 

limits set, or for which no scale level 

has been set, by EPA and FDA are 

adulterated and unsafe for human 

consumption. 

Summary of Benefits 

The annual benefits from this policy 

change come from: 

(1) Reduced costs of recalls, $15 

million to $44 million, 

(2) Actual averted death, $2.1 million 

as shown in Table 2 and 

(3) Estimated Averted illnesses for E. 

coli O157:H7, Listeria moncytogenes 

and Salmonella of $10,884 as shown in 

Table 2. 

Total benefits from this policy change 

are estimated to range between $17.1 

million and $46.1 million annually. 

II. Expected Costs of the Action 

FSIS prepared a paper in September, 

2006 to provide data on trends in the 

industry practice of holding meat and 

poultry products pending results of 


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Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19959 

NACMPI/May2006/Test_and_Hold_Report

_NACMPI.pdf. 

FSIS microbiological testing.16

Identifying trends in industry holding 

practices provides a context and 

baseline for any future evaluation of the 

effects of holding product pending test 

results. FSIS examined test data for the 

calendar years 2003 through 2005, as 

well as data for the first eight months of 

2006, and grouped data by 

establishment size and pathogen. 

Specifically, FSIS examined the hold/ 

release information included with FSIS 

testing results for the following 

pathogens in five different groups: 

(1) E. coli O157:H7 in raw, non-intact 

beef produced by domestic official 

establishments,17 (2) E. coli O157:H7 in 

domestically-produced ready-to-eat 

(RTE) meat and poultry; (3) Salmonella 

in domestically-produced RTE meat and 

poultry; (4) Listeria monocytogenes (Lm) 

in domestically-produced RTE meat and 

poultry; and (5) Lm on food-contact 

surfaces in establishments that produce 

RTE meat and poultry products. 

A. Domestic Product 

(1) Micro Testing 

FSIS found the following results of 

meat and poultry product being held by 

establishments prior to receiving FSIS 

test results. Table 3 shows the results by 

establishment size for the first 8 months 

of year 2006 for the five test groups 

described above. 

TABLE 3—PERCENT OF PRODUCT BEING HELD BY ESTABLISHMENT SIZE FOR 2006 JAN–AUG

[In percent] 

Large Small Very small Unknown 

Group 1 ............................................................................................................ 100 83 79 57

Group 2 ............................................................................................................ 100 93 88 100 

Group 3 ............................................................................................................ 100 90 82 93

Group 4 ............................................................................................................ 99 91 82 93 

Group 5 ............................................................................................................ 100 97 88 — 

Group 1: Percent of raw, non-intact beef Products held after Agency E. coli O157:H7 Sampling. 

Group 2: Percent of RTE Products held after Agency E. coli O157:H7 Sampling. 

Group 3: Percent of RTE Products held after Agency Salmonella Sampling. 

Group 4: Percent of RTE Products held after Agency Lm Product Sampling. 

Group 5: Percent of RTE Products held after Agency Lm Food Contact Surface Sampling. 

Note: This data is the latest available data for product held in establishments from FSIS testing. Study by the Office of Program, Evaluation, 

Enforcement, and Review (OPEER.). 

Based on evaluation of recent data, 

the Agency has noted that 

establishments releasing product into 

commerce before receiving test results 

continues to be a problem. 

However, using the percentage 

numbers from Table 3 for the first eight 

months of 2006 will provide a basis for 

establishing the costs for 2007–2009 to 

hold product until test results are 

returned. 

Table 4 shows the number of 

Federally inspected meat and poultry 

establishments by establishment size 

and illustrates in columns 3 and 4, 

based on the results from Table 3, the 

number of establishments currently 

holding product, as well as the number 

of establishments that will need to hold 

product as a result of this policy change. 

TABLE 4—FEDERAL INSPECTED MEAT/POULTRY ESTABLISHMENTS. 

Establishment size Number of 

establishments * Holds product Does not hold product 

(1) (2) (3) (4) 

LARGE ....................................................................................................................... 362 362 0 

SMALL ....................................................................................................................... 2,366 1,964–2,295 71–402 

VERY SMALL ............................................................................................................ 2,900 2,291–2,552 348–609 

UNKNOWN ................................................................................................................ 578 329–578 0–249 

TOTAL ................................................................................................................ 6,206 4,946–5,787 419–1,260 

* Source: Performance Based Inspection System (PBIS) 1/3/2008. There has been no substantial change in establishment numbers. 

The data provided in Table 3 are used to calculate the number of establishments holding product (column 3) and the number of establishments not holding product (column 4). 

Across establishment size, between 

79 percent and 100 percent of 

establishments already hold product 

pending test results and between zero 

and 21 percent will need to hold 

product pending test results. 

Based on the percentage results 

shown in Table 4, FSIS assumes for cost 

purposes only that all 362 large 

establishments are holding all tested 

product for results. Approximately 71– 

402 small establishments, 348–609 very 

small establishments, and between 0 

and 249 unknown size establishments 

do not hold tested product and will be 

affected by this new policy. Table 4, 

column 4 shows the range of 

establishments that will have to hold 

product pending negative test results 

before FSIS will award the USDA mark 

of inspection. A total of between 419 

and 1,260 federally inspected meat and 

poultry establishments will be affected 

by this policy change. There will be no 

additional costs to any of the large 

establishments as they are assumed to 

hold all tested product. FSIS expects 


srobinson on DSKHWCL6B1PROD with NOTICES
19960 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

17 In this paper, FSIS did not examine results 

from the recently initiated FSIS baseline testing of 

beef trim for E. coli O157:H7 and Salmonella. 

that among the remaining 

establishments that do not hold tested 

product, there will be an adjustment of 

lot size to accommodate necessary 

storage capacity at the establishment 

prior to an FSIS test. 

FSIS conducted further research on 

all FSIS tests conducted in the year 

2007. Combining the percentages of 

product held from Table 3 and the 

estimates of common lot sizes from the 

following Table 5, FSIS reached certain 

conclusions about the additional 

pounds of product that would need to 

be held by the small and very small 

establishments, which is shown in 

Table 6. 

TABLE 5—ESTIMATED LOT SIZES BY ESTABLISHMENT SIZE

Establishment size Lot (pounds) size 

produced 

Average lot (pounds) 

size tested * 

LARGE ..................................................................................................................................... 2,000–30,000 2,000 

SMALL ..................................................................................................................................... 1,000–10,000 1,000 

VERY SMALL .......................................................................................................................... 50–2,000 50–60 

Source: Common Industry Practice and expert elicitation. 

* Tested lots are smaller than typical production lot sizes. 

FSIS estimates the common industry 

practice for average lot sizes tested to be 

approximately 2,000 pounds at large 

establishments, 1,000 pounds at small 

establishments, and between 50–60 

pounds at very small establishments. As 

a result of the above lot size estimations, 

there may be a certain number of small 

and very small establishments that will 

incur costs relative to additional storage 

(recurring costs) or for capital 

equipment (one-time costs), in order to 

hold tested product. 

TABLE 6—ADDITIONAL COST PER ESTABLISHMENT TO HOLD ESTIMATED POUNDS OF PRODUCT

Lbs to be held by 

establishment 

Days product to 

be held 

Cost per 

establishment 

store product 

LARGE ....................................................................................................................... 0 3–8 $0 

SMALL ....................................................................................................................... 4,511 3–8 5,000 

V/SMALL .................................................................................................................... 1,329 3–8 1,000 

UNKNOWN ................................................................................................................ 1,011 3–8 1,000 

Source: FSIS/OPEER/OCIO data. 

Cost per commercial freezer @ $5,000 per 300 cu. ft. for small establishments. Cost of stand-up freezer for very small establishments @ 

$1,000. 

Factors affecting this cost impact 

include: (1) The amount of product 

needed to be handled and placed into 

storage; (2) the average number of days 

of storage; (3) the number of times per 

year that tests occur; and (4) the cost per 

day in handling and storage. 

The costs shown in Table 6 would 

predominately be one-time capital 

expenditures to purchase freezers for 

storage of tested product. There would 

be a small amount of electricity charges 

to operate the refrigeration units, but we 

do not anticipate that they would be 

significant. Labor costs would also be 

minimal to accommodate the additional 

product stored. Additionally, FSIS 

recognizes the concern of some very 

small establishments that they could 

lose some product because of the 

product’s short shelf life, and that an 

establishment could experience some 

inability to satisfy customer orders, 

resulting in a short-term disruption in 

business activities.18 FSIS does not have 

sufficient information to include costs 

associated with this disruption in the 

analysis, but we request comments on 

these costs and on additional ways 

establishments and FSIS can address the 

effect this policy may have on small and 

very small establishments that produce 

product with a short shelf life. 

Table 7 combines the results of tables 

4, 5 and 6 and shows that the estimated 

total costs to all small and very small 

(and unknown) establishments that do 

not hold product domestically would 

range between $703,000 and $2.87 

million. 

TABLE 7—TOTAL ONE-TIME COST PER ESTABLISHMENT SIZE

Establishment size 

Number establishments 

affected 

Table 5 

(col. 1) 

Cost/Est. to store 

product 

Table 7 

(column 4) 

One-time total cost to 

hold product * Annualized 7%–10 years 

Large ................................................ 0 $0 $0 $0 

Small ................................................ 71–402 5,000 $355K–$2.01M $50,541–$299,000 

Very Small ....................................... 348–609 1,000 $348K–$609K $49,545–$86,700 

Unknown .......................................... 0–249 1,000 $0–$249K $0–$17,227 


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Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19961 

19Beef price data provided by the Economic 

Research Service, USDA. The data is for 90% lean 

beef, not carcasses and can be interpreted as cents 

per pound or dollars per cwt of product. 

20Estimation of worst case business loss for dairy 

cows: Total number of animals selected for dairy 

cows (300) * 4 (number of chemicals sampled) * 

average lbs of animal (609) = total lbs to be held 

* price difference per lb. from fresh to frozen 

($0.054) 

21Estimation of worst case business loss for 

roaster pigs: Total number of animals selected for 

roaster pigs 300 * 4 (number of chemicals sampled) 

* average lbs of animal (70) = total lbs to be held 

* price per lb. ($1.10) 

TABLE 7—TOTAL ONE-TIME COST PER ESTABLISHMENT SIZE—Continued 

Establishment size 

Number establishments 

affected 

Table 5 

(col. 1) 

Cost/Est. to store 

product 

Table 7 

(column 4) 

One-time total cost to 

hold product * Annualized 7%–10 years 

Total .......................................... 419–1,260 ........................................ $703,000–$2.87 M $100,000–$408,600 

* NOTE: Total cost to hold product is result of # of Establishments affected * cost/Est to store product. 

(2) Residue Testing 

The National Residue Program (NRP) 

consists of two sampling plans: 

Domestic and import. These plans are 

further divided to facilitate the 

management of chemical residues such 

as veterinary drugs, pesticides, and 

environmental contaminants in meat, 

poultry, and egg products. The domestic 

sampling plan includes both a 

scheduled sampling program that is 

derived statistically by an interagency 

(FSIS, EPA, and FDA) technical team 

and by inspector-generated sampling in 

which samples are collected by in-plant 

veterinarians when they suspect an 

animal presented for slaughter may have 

violative levels of chemical residues. 

The import re-inspection sampling plan 

verifies the equivalence of inspection 

systems of exporting countries. FSIS 

inspectors collect samples randomly 

from imported products, and the 

intensity of sampling increases when 

products fail to meet U.S. requirements. 

Residue Costs 

In CY 2008, under the National 

Residue Plan, there were 22,709 FSIS 

residue samples completed. An 

additional 135,552 inspector-generated 

samples were taken. The number of 

samples includes those taken in-plant, 

taken from show animals, taken by 

inspectors or OPEER personnel as part 

of their regular work, and as part of state 

programs. 

The average range of days between a 

sample arriving at the lab and the report 

being available is generally 3–10 

working days. Some screen results are 

available the same day by Kidney 

Inhibition Swab (KIS) tests, while other 

tests may take longer than 10 days. 

The Agency does not anticipate any 

substantial cost impact from additional 

storage space requirements for FSIS 

residue testing. For establishment 

residue testing, the establishment as 

part of its HACCP program should 

already be holding any tested carcasses. 

The Agency asks for comments on 

possible additional storage space 

requirements. 

Products will have a reduced shelflife at retail as a result of carcasses being 

held pending FSIS and establishment 

test results. Some beef product that has 

been residue tested and held for three to 

ten days will lose freshness and will 

need to be frozen. Over the past nine 

years, on average, the difference in fresh 

vs. frozen beef prices is approximately 

$0.054 a pound.19 The worst case 

scenario for loss of business revenue for 

dairy cows, used for beef estimation 

purposes, would be approximately 

$39,500.20 While these lost revenue 

estimates are a worst case scenario, we 

also estimate the range for reduced beef 

sales to be between $19,700 and 

$39,500. The Agency requests 

comments on reduced sales. 

Additionally, roaster pig carcasses 

could go rancid and would also need to 

be frozen. Some product will go to 

secondary markets, such as renderers, 

pet foods, and fertilizer product. For 

roaster pigs, we estimate a worst case 

scenario loss of business at 

approximately $92,400.21 The lower 

estimate for roaster pigs is $46,200. The 

Agency requests comments on reduced 

sales revenues. 

TABLE 8—LOSS OF REVENUES FOR DOMESTIC BEEF AND ROASTER PIGS DUE TO RESIDUE TEST AND HOLD POLICY

Establishment size Beef number of 

establishments Beef $$ lost 

Roaster pigs 

number of 

establishments 

Roaster pigs 

$$ lost 

Large ........................................................................................ 132 $1,264 4 $601 

Small ........................................................................................ 810 7,900 85 13,860 

Very Small ............................................................................... 3,164 30,099 467 77,616 

Unknown .................................................................................. 25 237 2 323 

Total .................................................................................. 4,131 39,500 558 92,400 

Source of data: Data Analysis Integration Group (DAIG) and Office of Policy and Program Development (OPPD)/Risk Management Division. 

B. Imported Product 

Imported Re-Inspection Sampling Plan 

Import Inspection Personnel are to 

sample imported ready-to-eat (RTE) 

meat and poultry products produced in 

foreign establishments. Analyses will 

include Listeria monocytogenes and 

Salmonella testing for all RTE products, 

and E. coli O157:H7 for cooked beef 

patties and dry or semi-dry fermented 

sausages. 

Ready-to-eat cooked meat or poultry 

product is subjected to microbial 

sampling at the port-of-entry. This 

includes any product that is intended to 

be consumed without any further safety 

preparation steps. Import inspection 

personnel do not sample products for 

Listeria monocytogenes or Salmonella 

that are labeled with cooking 


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22The storage cost data was not robust, therefore 

a cost + 10% range was cited. Adding the 10% 

leads to a storage cost of $832,242. 

instructions or ‘‘Not Fully Cooked’’. 

These products are not considered RTE 

and are not sampled under this 

program. 

Table 9 describes the two different 

types of tests that are conducted on 

imported product, (1) micro testing, and 

(2) residue testing (column 1). Column 

2 shows the number of samples where 

product was held, while column 3 

shows the number of samples where the 

product was not held. Column 4 shows 

the number of samples for which the 

available data do not show whether or 

not the product was held. Column 5 is 

the total of all tests taken on imported 

product (sum of columns 2, 3 & 4). 

Column 6 is the percentage of tested 

product that is currently being held. 

TABLE 9—PERCENT OF IMPORTED PRODUCT HELD THAT HAS BEEN FSIS TESTED

[By lots] 

Type Held Not held Not indicated Total 

Percentage 

product 

currently held 

(1) (2) (3) (4) (5) (6) 

Micro .................................................................................... 1,994 1,799 88 3,881 51.4 

Residues .............................................................................. 2,320 2,490 493 5,303 43.7 

Source: FSIS International Policy Division. 

Table 10 shows the type of samples 

(column 1) and the number of FSIS 

samples taken (column 2). The average 

lot size derived by dividing the total 

pounds of product presented for import 

in 2008 by the total lots presented for 

import in 2008 is shown in column 3 

(3,270,643,817/210,592). Column 4 and 

5 are percentage of product currently 

held and percentage of product to be 

held. Column 6 and 7 represent the total 

pounds to be held and the cost of 

holding that product. The cost of 

holding imported product when this 

policy becomes effective will range from 

approximately $757,000 to $832,000.22

The Agency asks for comments on costs 

of storage. 

TABLE 10—COST TO HOLD IMPORTED FSIS TESTED PRODUCT

Type Number of 

FSIS samples 

Average lot 

size 

Percent 

product now 

held 

Additional percent of product 

to be held * 

Total pounds 

to be held 

Cost for 

holding 

product 

(1) (2) (3) (4) (5) (6) (7) 

Microbial ................................................... 3,881 15,530 51.4 48.6 29,292,158 $292,922 

Residue .................................................... 5,303 15,530 43.7 56.3 46,366,197 463,662 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 756,584 

Note: Cost is based on storage of product for up to 30 days @ $.01/pound. 

Source: FSIS—International Policy Division. 

* Column 5 is the additional percentage of product that will need to be held once this policy becomes effective. (100%¥column 4 percentage) 

Summary of Annual Costs: 

Total Domestic Product—$100,000– 

$408,600. 

Loss of Business Revenue—$66,000– 

$131,900. 

Total Import Product—$757,000– 

$832,000. 

Total Cost: $923,000–$1.4 million. 

Estimated annual benefits range 

between $17.1 million and $46.1 

million and exceed the estimated costs. 

Annual net benefits range between 

$16.2 million and $44.7 million. 

USDA Nondiscrimination Statement 

The U.S. Department of Agriculture 

(USDA) prohibits discrimination in all 

its programs and activities on the basis 

of race, color, national origin, gender, 

religion, age, disability, political beliefs, 

sexual orientation, and marital or family 

status. (Not all prohibited bases apply to 

all programs.) Persons with disabilities 

who require alternative means for 

communication of program information 

(Braille, large print, audiotape, etc.) 

should contact USDA’s Target Center at 

202–720–2600 (voice and TTY). 

To file a written complaint of 

discrimination, write USDA, Office of 

the Assistant Secretary for Civil Rights, 

1400 Independence Avenue, SW., 

Washington, DC 20250–9410 or call 

202–720–5964 (voice and TTY). USDA 

is an equal opportunity provider and 

employer. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that minorities, women, and 

persons with disabilities are aware of 

this document, FSIS will announce it 

online through the FSIS Web page 

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

regulations_&_policies/ 

Federal_Register_Notices/index.asp. 

FSIS will also make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

types of information that could affect or 

would be of interest to constituents and 

stakeholders. The Update is 

communicated via Listserv, a free 

electronic mail subscription service for 

industry, trade and farm groups, 

consumer interest groups, health 

professionals, and other individuals 

who have asked to be included. The 

Update is available on the FSIS Web 

page. Through the Listserv and the Web 


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23Recalls cited in Table 1 in the main report do 

not include all E. coli O157:H7 recalls. Rather, 

Table 1 includes only those recalls based on FSIS 

or establishment E. coli O157:H7 positive test 

results. The data used for modeling include all 

recalls of relevant FSIS regulated product besides 

those indentified in Table 1 of the main report, such 

as recalls resulting from outbreaks or state 

laboratory testing. 

page, FSIS is able to provide 

information to a much broader and more 

diverse audience. In addition, FSIS 

offers an e-mail subscription service that 

provides automatic and customized 

access to selected food safety news and 

information. This service is available at: 

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

news_and_events/email_subscription/. 

Options range from recalls to export 

information to regulations, directives, 

and notices. Customers can add or 

delete subscriptions themselves, and 

have the option to password-protect 

their accounts. 

Done at Washington, DC, on: April 5, 2011. 

Alfred V. Almanza, 

Administrator. 

Appendix 1 

FSIS is planning to require product to be 

held when FSIS test for pathogens. 

(E coli O157:H7 in ground and trim beef 

products, and Salmonella and Listeria 

monocytogenes (LM) in ready-to-eat (RTE) 

products), until the test result is reported 

negative. Benefits from averted illnesses from 

this policy thus would accrue if it were the 

case that instead of holding tested product 

that was contaminated, the product was 

released before a positive result was found 

and portions of that product would have 

been consumed, which would have led to 

illness. It takes 6 days before samples are 

confirmed to contain E. coli O157:H7 (1 day 

for sending the sample from the 

establishment to the laboratory and 5 days 

once the sample arrives in the laboratory); for 

the other two pathogens it takes 8 days. The 

expected decreased risk of illness (the 

estimated benefits) to consumers by the 

execution of this policy is estimated by 

modeling the observed relationship of 

reported illnesses due to E. coli O157:H7, 

Listeria monocytogenes (LM) and Salmonella 

associated with recent recalls (2007–2009), 

with the number of days before the recall and 

the amount of product associated with the 

recall. From this model, the expected number 

of illnesses that would occur for product 

recalled x days after sampling can be 

estimated. There are many assumptions 

implicit in the model, for example, the 

recalled volume might not reflect the actual 

volume of product for which consumers were 

exposed. One would expect, though, that the 

longer time between the recall date and 

manufactured date, the more the exposure 

and thus the greater opportunity for illness 

from the product. Thus, it is expected that 

illnesses would increase if volume increases 

or days before recall increase, given 

everything else being equal; that is, the 

number of illnesses is an increasing function 

of volume and days. In Appendix 2 are the 

data used in the analysis, consisting of 75 

cases, within 2007–2009, for which product 

volume, days between manufactured and 

recall dates, and illnesses associated with the 

recall were available.23

Besides estimates of illnesses associated 

with potential recalls, there are 4 factors that 

need to be accounted for in estimating the 

potential benefits that would be realized from 

the test and hold policy: 

(1) The number of establishments that 

would not be holding product if not for the 

policy; 

(2) The volume of the product being held; 

(3) The number of tests expected to be 

conducted, yearly; and 

(4) The expected proportion of tests that 

would be positive. 

Another assumption made is that large 

establishments (as determined from FSIS’ 

HACCP size classification) already hold 

product when it is being tested and thus this 

policy will not result in averted illnesses 

from this sector of the industry. It is only 

assumed that some HACCP-size small and 

very small establishments will need to hold 

product that otherwise would not have, and 

thus will have averted illnesses as a result of 

this policy. 

Regarding the proportion of tests expected 

to be positive, the proportion could be a 

function of the volume of product per test 

that is held. However, a test consists of an 

analysis of a certain amount of material, 

which is assumed constant; thus for 

modeling the potential benefits, it is assumed 

that this proportion is independent of 

volume. The percentage of positive test 

results that would be seen in the future is 

assumed to be equal to that observed for the 

years 2007–2009 (up to the middle of 

November). The percentage of positive 

results depends upon the HACCP size of the 

establishment (Table 1) as well as the 

particular test. For LM, since FSIS tests 

multiple samples per ‘‘unit’’ (unit = a 

collection of samples for product and food 

contact surfaces, excluding other 

environment samples), the results below 

report the percentage of units that had at 

least one positive result, since even one 

positive result from these samples leads to a 

determination of an adulterated product that 

would be subject to recall. 

TABLE 1—NUMBERS OF TESTS AND NUMBERS AND PERCENTS POSITIVE BY HACCP SIZE AND TEST-TYPE, FROM 2007– 

2009 (MID-NOVEMBER), COVERING 34.5 MONTHS, FOR ALL FSIS’ TESTS ON GROUND AND TRIM BEEF FOR E. coli 

O157:H7 AND READY-TO-EAT (RTE) PRODUCT FOR SALMONELLA AND LISTERIA MONOCYTOGENES (LM) 

Size 

E. coli O157:H7 Salmonella LM * Other LM 

Test Positive Test Positive Test Positive Test Positive 

Small ................................ 17,772 115 17,898 7 671 19 17,630 90 

.................... 0.65% .................... 0.039% .................... 2.83% .................... 0.51% 

Very small ........................ 20,313 74 12,821 10 125 6 12,735 41 

.................... 0.36% .................... 0.078% .................... 4.80% .................... 0.32% 

* LM numbers refer to the number of units (set of product and food contact surface samples, from which any positive would lead to declaration 

of product adulteration). 

For LM, estimating the number of tests 

and percent of those that would be 

positive and lead to held product, the 

numbers for the two types of LM 

sampling are added together. Thus, for 

example, for the small size 

establishments, it is assumed that there 

are 17,630 + 671 tests for Lm of which 

90 + 19 of them were positive. 

For Salmonella and Listeria testing, it 

is assumed that the number of samples 

used in the past would remain the same. 

In this case, the number of positive 

results that would lead to holding 

product that otherwise would not have 

been is determined by just multiplying 

the number of test times the expected 

percentage of positive results, times a 

factor that represents the fraction of 

establishments that would not be 

holding product if not for this rule. This 

percentage is taken from Table 4 of the 

main report, which provides the 

percentages of establishments by 

HACCP size category that hold product 

for the different types of sampling. As 

mentioned above, it is assumed that all 

large establishments would hold 

product and thus do not contribute in 

the analysis presented here. For 

Salmonella, the assumed percentages of 

the tested small and very small 

establishments that hold product are 

90% and 82% respectively (Table 4 of 

the main report). For LM, since either a 

positive result for a food contact surface 


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or product leads to recall, the lower 

percentages establishments holding 

product of the groups associated with 

LM testing from Table 4 of the main 

report are assumed. That is, it is 

assumed that percentages of the tested 

small and very small establishments 

that hold product are 91% and 82% 

respectively (Table 4 of the main report, 

group 4). Thus the number of positive 

samples over a 10-year period 

associated with product that would not 

have been held if not for the proposed 

regulation is 10Q(1-w)12/34.5 where Q 

is the number of positive results for 34.5 

months given above in Table 1, and w 

is the fraction of establishments that 

already hold product (Table 4 of the 

main report). 

For E. coli O157:H7 sampling, since 

FSIS’ sampling plan calls for sampling 

each establishment once a month, the 

number of establishments assumed are 

the number that are being sampled 

presently. There are 570 and 884 small 

and very small size establishments, 

respectively, that were sampled. From 

Table 4 of the Notice it is assumed that 

17% and 21% of them, respectively, are 

not presently holding product. In 

addition 5 establishments were sampled 

for which the size was not known for 

which (from Table 4 of the main report) 

is assumed that an expected 43% did 

not hold product. These 5 

establishments are assumed to be 

distributed between the small and very 

small establishments by the ratio of 570/ 

(884 + 570). Thus, after calculations, it 

is assumed that 98 small and 187 very 

small establishments presently do not 

hold product for E. coli O157:H7 

sampling. Since for E. coli O157:H7 

testing, it is assumed that every 

establishment will be tested once a 

month, for 10 years, the expected 

number of positive tests in the next 10 

years per establishment is 10(12)p, 

where p equals 0.65% for small 

establishments and 0.36% for very small 

establishments (Table 1 above). This 

number is multiplied by the number of 

establishments assumed involved, 

which would be equal to 98 for the 

small establishments and 187 for the 

very small establishments to derive the 

expected number of positive tests in a 

10-year period, K. 

Regarding the number of pounds that 

would be held, FSIS policy permits the 

number of pounds likely to be subjected 

to being tested and held to be small 

since the establishment will be given 

prior notification of the test and will, 

most likely, prepare smaller amounts of 

product for testing. As discussed in the 

economic analysis (Table 6), it is 

anticipated that, for small 

establishments, the product volume 

held would be on average 1000 pounds, 

and for very small establishments, the 

held volume will be on average 50–60 

pounds. In the analysis, 60 pounds was 

used. 

The estimated number of averted 

illnesses is estimated by multiplying the 

expected number of positive results in 

10 years times the expected number of 

illnesses averted per positive test 

resulting in a recall x days after the 

manufacturing date, where x equals 6 

for E. coli O157:H7 and equals 8 for the 

other two pathogens. For modeling this 

expected number of averted illnesses, as 

mentioned above, it is assumed that 

number of illnesses associated with a 

positive test is an increasing function of 

the volume of the recalled product and 

the days after the initial manufactured 

date of the product. Specifically, a 

general model considered was: 

where v = volume, x = days, g is a 

function with parameters: a, b, c, * * *, 

whose values are to be estimated from 

the data in the appendix, and e is 

random variable, with expected value 

equal to 0, and standard deviation equal 

to s. Estimated values were obtained 

using the non-linear mixed effects 

model of PC–SAS version 9.1 (PROC 

NLMIXED). For this procedure, e is 

assumed to be distributed as a normal 

distribution, since this is the only 

option permitted. The procedure 

maximizes the marginal likelihood 

function, integrated over the 

distribution of e. Thus λ is distributed 

as a lognormal distribution, and the 

expected value of the number of 

illnesses, given v and x, is 

The benefit for a given volume, 

B(v, x), and days before recall, x, is 

obtained by: 

where K is the number of expected 

positive tests for the next 10 years for 

product that would not be held if not for 

the requirement. For small HACCP size 

establishments, it is assumed v = 1000 

pounds; for very small size 

establishment, v = 60 pounds. And as 

mentioned above, for E. coli O157:H7, 

x = 6 days and for Salmonella and LM, 

x = 8 days. 

Comparisons of models used to 

estimate g and s are based on the loglikelihood ratio test, where the 

distribution of the difference of 

statistics, L = ¥2 log(likelihood), for 

two models being compared is 

approximated by the appropriate chisquare distribution. 

To help determine the form of g, the 

function of independent variables 

associated with the variable ‘days’ 

between the date of manufacturing and 

recall and the volume of the recalled 

product, Figure 1 presents graphs of the 

natural logarithm of the ratio of the 

number of illnesses divided by product 

volume, ln(illnesses/volume), versus 

days (right side) and versus the natural 

logarithm of days + 1, ln(days +1) (left 

side). When the number of illnesses was 

0, the value assigned was ¥14. The 

smooth lines are spline curve, 


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constructed using the default options of 

the S-Plus® for Windows, version 8.1. 

The graph on the right indicates the 

high degree of influence the data point 

with days = 365 could have on a model 

predicting number of illnesses using 

days as an independent variable. This 

point would have less influence if 

ln(days+1) were used instead of days as 

an independent variable. 

Figure 2 provides a graph of 

ln(#illness/(days+1)) versus ln(volume). 

When the number of illnesses is zero, a 

value of ¥5.5 was assigned. The dark 

smoothed line is the quadratic fit; the 

dashed-dotted red line is the curve 

derived from fitting: a + ln(be¥cln(v) + 

cebln(v)

), a function borrowed from one 

used to describe cell population growth 

assuming two phases: A lag phase and 

an exponential phase. 

These figures suggest a model for 

estimating the number of illnesses as a 

function of ln(volume) and ln(days+1) 

be based on a Poisson regression with 

log-link a function of ln(days+1) and 

ln(volume), plus a random error 

(Equation 1). It is assumed that g is the 

full quadratic function of these 

variables: 

where b, c, d, e, and f are constants, and 

a depends upon the pathogen. For the 

full model in Equation 4, the model has 

9 parameters (including s) since there 

are three ‘‘intercepts’’ being estimated, 

one for each pathogen. 

Table 2 presents differences of values 

of L for selected models from the value 

obtained from the full quadratic model 

given in Equation 4, excluding the 2 

outlier data points identified. All 

models converged by the Gconvergence criterion (gradient) using 

the default quasi-Newton optimization 

technique. 

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BILLING CODE 3410–DM–C 

TABLE 2—L = ¥2 LOG(LIKELIHOOD) FOR SELECTED MODELS FROM THE VALUE OBTAINED FROM THE FULL QUADRATIC

MODEL GIVEN IN EQUATION 4. MODELS ARE DESIGNATED BY FREE PARAMETERS NOT ASSIGNED TO BE ZERO, IN

EQUATION 4 

Model Number of 

parameters 

L = ¥2 log 

likelihood 

Linear model (a, b, c, s) .......................................................................................................................................... 6 208.8 

(a, b, c, d, s) ............................................................................................................................................................ 7 207.8 

(a, b, c, f, s) ............................................................................................................................................................. 7 207.2 

(a, b, c, e, s) * .......................................................................................................................................................... 7 206.6 

(a, b, c, d, f, s) ......................................................................................................................................................... 8 207.4 

(a, b, c, d, e, s) ........................................................................................................................................................ 8 206.7 

(a, b, c, e, f, s) ......................................................................................................................................................... 8 206.6 

Full model ................................................................................................................................................................ 9 206.6 

* Model M1. 

From Table 2, it appears that the linear 

model provides the best fitting 

parsimonious model. The model that 

includes e ¥ the coefficient of the 

square of ln(x+1), decreases L by 2.22, 

with 1 degree of freedom, which under 

normal theory would be significant with 

p-value equal to 0.136. The value of e 

was estimated to be negative; however 

the term cln(x+1) + e[ln(x+1)] 2 is greater 

than zero for x < 4989 which is well 

outside the range of concern. Thus, for 

our purposes, the function g (Equation 

4) for M1 is an increasing function of 

the variable days in the region of 

concern, and thus can be used. Because 

the p-value is not large, this model 

cannot be rejected, thus an estimate 

associated with this model, M1, is also 

considered in order to help evaluate the 

range of uncertainty of the estimates and 

to see the impact of the more 

complicated model. Table 3 provides 

the estimates of averted illnesses. 

TABLE 3—ESTIMATED ILLNESSES AND TOTAL AVERTED COSTS (TAC) OVER 10 YEARS TOGETHER WITH UPPER 95% 

CONFIDENCE LIMIT FOR THE TWO MODELS CONSIDERED. ESTIMATES DERIVED USING MIXED EFFECT MODEL WITH

ASSUMPTION OF LOGNORMAL DISTRIBUTION (SEE EQUATIONS 2 AND 3) 

Statistic Estimate linear 

model 

Upper 95% 

limit linear 

model 

Estimate M1 

model 

Upper 95% 

limit M1 model 

Tot ill for Sal .................................................................................................... 0.7 1.9 0.5 1.7 

Tot ill for LM ..................................................................................................... 0.3 0.6 0.4 1.0 


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TABLE 3—ESTIMATED ILLNESSES AND TOTAL AVERTED COSTS (TAC) OVER 10 YEARS TOGETHER WITH UPPER 95% 

CONFIDENCE LIMIT FOR THE TWO MODELS CONSIDERED. ESTIMATES DERIVED USING MIXED EFFECT MODEL WITH

ASSUMPTION OF LOGNORMAL DISTRIBUTION (SEE EQUATIONS 2 AND 3)—Continued 

Statistic Estimate linear 

model 

Upper 95% 

limit linear 

model 

Estimate M1 

model 

Upper 95% 

limit M1 model 

Tot ill for E coli ................................................................................................. 5.6 8.7 4.0 10.6 

The residuals of these models do not 

appear to be normally distributed, based 

on the QQ plots (for both the linear and 

model M1) given in Figure 3, with 

occasional large residuals. The QQ plots 

take on the appearance it does because 

of many results with no illnesses. 

However, the models provide estimated 

values of λ (Equation 1) that are close to 

the actual illnesses, thus, conditionally, 

the goodness-of-fit, as determined by the 

closeness of the estimated value of λ 

and the number of illnesses is good. 

Using a chi-square approximation, of 

the square of the difference between the 

estimated λ and the actual number of 

illnesses, divided by λ, for the linear 

model, the sum of these terms over the 

75 observations is 14.3; for all recalls for 

which the illnesses are reported as zero, 

the largest estimated value of λ is 1.04, 

which is not inconsistent; the largest 

difference is about 2, which occurs for 

a recall that reported 11 illnesses for 

which the estimated value of λ is 9.06. 

This data point is the one with the 

largest residual (top right corner of the 

top graph of Figure 3). For the model 

M1, the chi-square statistic is slightly 

larger (20.4 because for one recall with 

1 reported illness, the estimated value of 

λ is 0.06 (whereas for the linear model 

the estimated value of λ is 0.10); thus 

the chi-square statistic associated with 

this observation is large, causing the 

larger chi-square statistic compared to 

that for the linear model. 

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BILLING CODE 3410–DM–C 

In conclusion, the estimates of the 

averted illnesses are highly uncertain 

because of the small number of data 

points and the high degree of variability 

of these data, leading to statistical 

uncertainty regarding the predicted 

number of illnesses given a model and 

uncertainty regarding the best model to 

use for estimating the number of averted 

illnesses. However, from the above 

models, it appears that, with 95% 

confidence, the expected number of 

illnesses would be, on average, no more 

than about 1 illness per year averted, 

over the 10 years, with expected total 

averted costs as much as about 

$120,000, depending upon the model 

used. 

These estimates though reflect (only) 

expectations, and do not include the 

possibilities of averted cost for a given 

expected value. There is a distinct 

probability that one of these averted 

illnesses could result in severe, long 


srobinson on DSKHWCL6B1PROD with NOTICESEN11AP11.004</GPH>
Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19969 

term illness, or death. In that case the 

averted costs would be substantially 

larger than the expected costs that are 

being estimated above. 

Appendix 2: Data Used in Analysis 

Assigned days before recall Volume 

(lbs) 

Reported 

illnesses Pathogen 

4 ........................................................................................................................................................... 50 0 E coli. 

4 ........................................................................................................................................................... 65 0 E coli. 

4 ........................................................................................................................................................... 375 0 E coli. 

6 ........................................................................................................................................................... 128 0 E coli. 

6 ........................................................................................................................................................... 219 0 E coli. 

6 ........................................................................................................................................................... 345 0 E coli. 

6 ........................................................................................................................................................... 884 0 E coli. 

6 ........................................................................................................................................................... 1900 0 E coli. 

6 ........................................................................................................................................................... 4663 0 E coli. 

6 ........................................................................................................................................................... 6152 0 E coli. 

7 ........................................................................................................................................................... 75 0 E coli. 

7 ........................................................................................................................................................... 925 0 E coli. 

9 ........................................................................................................................................................... 26669 0 E coli. 

10 ......................................................................................................................................................... 4240 0 E coli. 

11 ......................................................................................................................................................... 780 0 E coli. 

13 ......................................................................................................................................................... 13275 0 E coli. 

14 ......................................................................................................................................................... 16743 0 E coli. 

17 ......................................................................................................................................................... 13150 0 E coli. 

22 ......................................................................................................................................................... 1560 0 E coli. 

26 ......................................................................................................................................................... 1084384 0 E coli. 

30 ......................................................................................................................................................... 68670 0 E coli. 

50 ......................................................................................................................................................... 2340 0 E coli. 

50 ......................................................................................................................................................... 4200 0 E coli. 

50 ......................................................................................................................................................... 20460 0 E coli. 

52 ......................................................................................................................................................... 420 0 E coli. 

56 ......................................................................................................................................................... 39973 0 E coli. 

88 ......................................................................................................................................................... 3516 0 E coli. 

55 ......................................................................................................................................................... 5920 1 E coli. 

123 ....................................................................................................................................................... 173554 1 E coli. 

45 ......................................................................................................................................................... 95927 2 E coli. 

8 ........................................................................................................................................................... 107943 5 E coli. 

64 ......................................................................................................................................................... 188000 6 E coli. 

72 ......................................................................................................................................................... 95898 6 E coli. 

14 ......................................................................................................................................................... 259230 8 E coli. 

30 ......................................................................................................................................................... 3300000 8 E coli. 

43 ......................................................................................................................................................... 117500 9 E coli. 

58 ......................................................................................................................................................... 845000 10 E coli. 

42 ......................................................................................................................................................... 2758 11 E coli. 

72 ......................................................................................................................................................... 129000 17 E coli. 

65 ......................................................................................................................................................... 380000 20 E coli. 

51 ......................................................................................................................................................... 5700000 27 E coli. 

47 ......................................................................................................................................................... 545699 29 E coli. 

45 ......................................................................................................................................................... 153630 33 E coli. 

365 ....................................................................................................................................................... 21700000 40 E coli. 

63 ......................................................................................................................................................... 1360000 42 E coli. 

43 ......................................................................................................................................................... 5300000 54 E coli. 

Assigned days before recall Volume 

(lbs) 

Reported 

illnesses Pathogen 

6 ........................................................................................................................................................... 1591 0 LM. 

7 ........................................................................................................................................................... 16 0 LM. 

7 ........................................................................................................................................................... 285 0 LM. 

7 ........................................................................................................................................................... 290 0 LM. 

7 ........................................................................................................................................................... 4535 0 LM. 

7 ........................................................................................................................................................... 6970 0 LM. 

8 ........................................................................................................................................................... 130 0 LM. 

8 ........................................................................................................................................................... 172 0 LM. 

8 ........................................................................................................................................................... 290 0 LM. 

8 ........................................................................................................................................................... 750 0 LM. 

8 ........................................................................................................................................................... 39514 0 LM. 

10 ......................................................................................................................................................... 6907 0 LM. 

11 ......................................................................................................................................................... 872 0 LM. 

11 ......................................................................................................................................................... 70400 0 LM. 

12 ......................................................................................................................................................... 140 0 LM. 

13 ......................................................................................................................................................... 930 0 LM. 

14 ......................................................................................................................................................... 207 0 LM. 

15 ......................................................................................................................................................... 5250 0 LM. 

22 ......................................................................................................................................................... 564 0 LM. 

40 ......................................................................................................................................................... 2268 0 LM. 


srobinson on DSKHWCL6B1PROD with NOTICES
19970 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

Assigned days before recall Volume 

(lbs) 

Reported 

illnesses Pathogen 

47 ......................................................................................................................................................... 28610 0 LM. 

52 ......................................................................................................................................................... 3590 0 LM. 

72 ......................................................................................................................................................... 1 0 LM. 

136 ....................................................................................................................................................... 2184 0 LM. 

137 ....................................................................................................................................................... 3780 0 LM. 

137 ....................................................................................................................................................... 10368 0 LM. 

192 ....................................................................................................................................................... 286320 2 LM. 

61 ......................................................................................................................................................... 466236 14 Sal. 

63 ......................................................................................................................................................... 825769 42 Sal. 

[FR Doc. 2011–8408 Filed 4–8–11; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Hiawatha East Resource Advisory 

Committee 

AGENCY: Forest Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: The Hiawatha East Resource 

Advisory Committee will meet in Sault 

Ste. Marie, Michigan. The committee is 

meeting as authorized under the Secure 

Rural Schools and Community SelfDetermination Act (Pub. L. 110–343) 

and in compliance with the Federal 

Advisory Committee Act. The purpose 

is to hold the first meeting of the newly 

formed committee. 

DATES: The meeting will be held on May 

5, 2011, and will begin at 6 p.m. 

ADDRESSES: The meeting will be held at 

Best Western Sault Ste. Marie, 4281 I– 

75 Business Spur, Sault Ste. Marie, MI 

49783. Written comments should be 

sent to Janel Crooks, Hiawatha National 

Forest, 2727 North Lincoln Road, 

Escanaba, MI 49829. Comments may 

also be sent via e-mail to 

HiawathaNF@fs.fed.us, or via facsimile 

to 906–789–3311. 

All comments, including names and 

addresses when provided, are placed in 

the record and are available for public 

inspection and copying. The public may 

inspect comments received at Hiawatha 

National Forest, 2727 North Lincoln 

Road, Escanaba, MI. Visitors are 

encouraged to call ahead to 906–786– 

4062 to facilitate entry into the building. 

FOR FURTHER INFORMATION CONTACT: 

Janel Crooks, RAC coordinator, USDA, 

Hiawatha National Forest, 2727 North 

Lincoln Road, Escanaba, Michigan 

49862; (906) 786–4062; E-mail 

HiawathaNF@fs.fed.us. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

between 8 a.m. and 8 p.m., Eastern 

Standard Time, Monday through Friday. 

SUPPLEMENTARY INFORMATION: The 

meeting is open to the public. The 

following business will be conducted: 

(1) Introductions of all committee 

members, replacement members and 

Forest Service personnel. (2) Selection 

of a chairperson by the committee 

members. (3) Receive materials 

explaining roles of the RAC and process 

for considering and recommending Title 

II projects; and (4) Public Comment. 

Persons who wish to bring related 

matters to the attention of the 

Committee may file written statements 

with the Committee staff before or after 

the meeting. 

Dated: April 4, 2011. 

Stevan J. Christiansen, 

Designated Federal Officer. 

[FR Doc. 2011–8506 Filed 4–8–11; 8:45 am] 

BILLING CODE 3410–11–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

West Virginia Resource Advisory 

Committee 

AGENCY: Forest Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: The West Virginia Resource 

Advisory Committee will meet in 

Elkins, West Virginia. The committee is 

meeting as authorized under the Secure 

Rural Schools and Community SelfDetermination Act (Pub. L. 110–343) 

and in compliance with the Federal 

Advisory Committee Act. The purpose 

is for the committee to consider new 

project proposals. 

DATES: The meeting will be held on 

April 21, 2011, and will begin at 1 p.m. 

ADDRESSES: The meeting will be held at 

the Monongahela National Forest 

Supervisor’s Office, 200 Sycamore 

Street, Elkins, WV 26241. Written 

comments should be sent to Kate 

Goodrich-Arling at the same address. 

Comments may also be sent via e-mail 

to kgoodricharling@fs.fed.us, or via 

facsimile to 304–637–0582. 

All comments, including names and 

addresses when provided, are placed in 

the record and are available for public 

inspection and copying. The public may 

inspect comments received at 

Monongahela National Forest, 200 

Sycamore Street, Elkins, WV 26241. 

FOR FURTHER INFORMATION CONTACT: Kate 

Goodrich-Arling, RAC coordinator, 

USDA, Monongahela National Forest, 

200 Sycamore Street, Elkins, WV 26241; 

(304) 636–1800; E-mail 

kgoodricharling@fs.fed.us. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

between 8 a.m. and 8 p.m., Eastern 

Standard Time, Monday through Friday. 

SUPPLEMENTARY INFORMATION: The 

meeting is open to the public. The 

following business will be conducted: 

(1) Review and approval or amendment 

of notes from previous meeting (2) 

Consider new project proposals; and (3) 

Public Comment. Persons who wish to 

bring related matters to the attention of 

the Committee may file written 

statements with the Committee staff 

before or after the meeting. 

Dated: April 4, 2011. 

Clyde N. Thompson, 

Designated Federal Officer. 

[FR Doc. 2011–8505 Filed 4–8–11; 8:45 am] 

BILLING CODE 3410–11–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Madera County Resource Advisory 

Committee 

AGENCY: Forest Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: The Madera County Resource 

Advisory Committee will be meeting in 

North Fork, California on April 20th 

2011. The purpose of the meeting will 

be to review the funding schedule for 

projects identified for approval at the 


srobinson on DSKHWCL6B1PROD with NOTICES