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9772 

Notices Federal Register

Vol. 71, No. 38 

Monday, February 27, 2006 

This section of the FEDERAL REGISTER 

contains documents other than rules or 

proposed rules that are applicable to the 

public. Notices of hearings and investigations, 

committee meetings, agency decisions and 

rulings, delegations of authority, filing of 

petitions and applications and agency 

statements of organization and functions are 

examples of documents appearing in this 

section. 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. 04–026N] 

Salmonella Verification Sample Result 

Reporting: Agency Policy and Use in 

Public Health Protection 

AGENCY: Food Safety and Inspection 

Service, USDA. 


ACTION: Notice and response to 


comments. 


SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

changes in how it uses the results from 

its Salmonella verification sampling 

program for meat and poultry 

establishments to enhance public health 

protection. The Agency is also changing 

how it reports these results. These 

actions follow an April 2003 FSIS 

Federal Register Notice asking for 

public comment on whether and how 

Agency policy could be improved. This 

Notice responds to the comments 

received and presents the Agency’s 

views on the issues raised in the 2003 

Notice. 

FSIS will begin adding results from 

individual Salmonella verification 

sample tests to reports the Agency 

regularly makes to meat and poultry 

establishments that have asked to be 

informed of various test results. These 

Salmonella sample results will be sent 

to establishments as soon as they 

become available. FSIS will begin 

posting quarterly nationwide data for 

Salmonella, presented by product class, 

on the Agency Web site. 

Moreover, the Agency will assess each 

completed Salmonella sample set in 

light of either existing regulatory 

standards or recently-published baseline 

study results, as appropriate. FSIS 

expects to take follow-up action, which 

may include scheduling of another 

sample set or assessing the design and 

execution of the food safety system, 

based on how a plant’s performance 

compares to the existing regulatory 

standard or nationwide baseline results 

and to the presence of serotypes of 

Salmonella that are common causes of 

human illness. 

To further encourage industry process 

control efforts, the Agency is providing 

a new compliance guideline containing 

information that FSIS has found to be 

relevant to control of Salmonella, 

particularly for poultry. 

FSIS intends to monitor closely the 

percent positive in verification samples 

month-by-month over the course of a 

full calendar year, beginning in 2006. 

After one year FSIS will evaluate these 

data, reassess how it reports Salmonella 

results for each class of products, and 

consider making additional changes in 

how it reports and publishes results. 

ADDRESSES: FSIS invites interested 

persons to submit comments on this 

notice. Comments may be submitted by 

any 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. 

FSIS prefers to receive comments 

through the Federal eRulemaking Portal. 

Go to http://www.regulations.gov and, 

in the ‘‘Search for Open Regulations’’ 

box, select ‘‘Food Safety and Inspection 

Service’’ from the agency drop-down 

menu, then click on ‘‘Submit.’’ In the 

Docket ID column, select the FDMS 

Docket Number to submit or view 

public comments and to view 

supporting and related materials 

available electronically. After the close 

of the comment period, the docket can 

be viewed using the ‘‘Advanced Search’’ 

function in Regulations.gov. 

• Mail, including floppy disks or CD– 

ROMs, and hand-or courier-delivered 

items: Send to Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, 300 12th Street, 

SW., Room 102 Cotton Annex, 

Washington, DC 20250. 

• Electronic mail: 

fsis.regulationscomments@fsis.usda.gov. 

All submissions received must 

include the Agency name and docket 

number 04–026N. 

All comments submitted in response 

to this Notice, as well as research and 

background information used by FSIS in 

developing this document, will be 

posted to the regulations.gov Web site. 

The background information and 

comments also 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. 

DATES: Effective Date: May 30, 2006. 

FOR FURTHER INFORMATION: For further 

information contact Daniel Engeljohn, 

Ph.D., Deputy Assistant Administrator 

for Office of Policy, Program and 

Employee Development, FSIS, U.S. 

Department of Agriculture, Room 3147, 

South Building, 14th and Independence 

SW., Washington DC 20250–3700; 

telephone (202) 205–0495, fax (202) 

401–1760, e-mail: 

daniel.engeljohn@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On July 25, 1996, FSIS published 

‘‘Pathogen Reduction; Hazard Analysis 

and Critical Control Point (PR/HACCP) 

Systems’’ (61 FR 38806). This final rule 

established, among other measures, 

pathogen reduction performance 

standards for Salmonella bacteria for 

certain slaughter establishments and for 

establishments producing certain raw 

ground products. The performance 

standards are codified at 9 CFR 

310.25(b)(1) and 381.94(b)(1). These 

performance standards are based on the 

prevalence of Salmonella found by the 

Agency’s nationwide microbiological 

baseline studies, which were conducted 

before the PR/HACCP rule was adopted 

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

Baseline_Data/). The performance 

standards set a maximum number of 

Salmonella-positive samples allowable 

per sample set. Raw product classes 

covered by performance standards are 

carcasses of cows/bulls, steers/heifers, 

market hogs, broilers (young chickens), 

and ground beef, ground chicken, and 

ground turkey. 

FSIS selected Salmonella as the target 

organism because it is one of the most 

common causes of foodborne illness 

associated with meat and poultry 

products; it is present to varying degrees 

in all major species; and interventions 

targeted at reducing the presence of this 

pathogen may be beneficial in reducing 

contamination by other enteric 

pathogens. 

The sampling and testing of carcasses 

and raw products for Salmonella is 

conducted by FSIS. The Agency verifies 

that establishments are meeting the 

Salmonella standards by having federal 

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inspection personnel collect product 

samples from individual establishments 

over the course of a defined number of 

sequential days of production to 

complete a sample set. The product 

samples are sent to FSIS laboratories for 

analysis. The number of samples in a 

sample set varies by product class. The 

maximum number of positive samples 

allowed in a set is based on data from 

the nationwide baseline studies. The 

standards were defined on a product 

class basis so that an establishment 

operating at the baseline level would 

have an 80% chance of meeting the 

standard. 

An initial sample set or a set that 

follows a passed set is termed an ‘‘A’’ 

set; other codes (such as ‘‘B’’, ‘‘C’’, and 

‘‘D’’) represent sample sets collected 

from establishments in follow-up testing 

after a failed set. All code ‘‘A’’ sample 

sets are collected at randomly selected 

establishments, while code ‘‘B,’’ ‘‘C,’’ 

and ‘‘D’’ sets are collected at 

establishments that failed a previous set. 

Generally, all establishments within a 

product class are tested by FSIS once 

annually for the ‘‘A’’ set. However, 

establishments that fail the performance 

standard are scheduled for a follow-up 

sample set after the establishment takes 

corrective action (i.e, the ‘‘B,’’ ‘‘C,’’ and 

‘‘D’’ sets) resulting in one or more 

additional sample sets annually. 

The overall percentage of positive 

results for Salmonella in ‘‘A’’ samples 

has been used to track progress in 

addressing control of Salmonella. These 

aggregate data are based on large 

numbers of test results. Although they 

provide a useful estimate of Salmonella 

control, FSIS verification sampling is 

not designed to estimate national 

prevalence of Salmonella by class of 

products. A ‘‘true’’ prevalence can only 

be derived from randomly selected 

samples in a nationwide baseline study 

designed within the boundaries of a 

specified statistical confidence level. 

To date, with a few exceptions, the 

Agency has reported Salmonella test 

results to an establishment only when a 

sample set is completed. The Agency 

has also published aggregate yearly data 

from ‘‘A’’ sets, by product class (e.g., 

steers/heifers, broilers, ground beef) and 

plant size as defined in the PR/HACCP 

final rule (large, small, and very small). 

FSIS has initiated an evaluation of 

how it uses and reports test results from 

its Salmonella sampling program. In a 

Federal Register Notice of April 16, 

2003, we asked for comments on our 

established policy for reporting sample 

results (68 FR 18593–18596; http:// 

www.fsis.usda.gov/ 

Regulations_&_Policies/ 

2005_Notices_Index/index.asp). In 

evaluating its policy, the Agency had 

concluded that there would be value in 

making public more information about 

Salmonella sampling results than just 

the annual reports. Additionally, in 

response to that notice, several 

establishments stated that there would 

be significant value in receiving the 

results of individual samples. 

As the Agency considered the 

comments on the 2003 Notice and how 

best to proceed, FSIS was influenced by 

recent epidemiological data from the 

Centers for Disease Control and 

Prevention (CDC) that have raised 

concern. In recent years, overall human 

infections from Salmonella serotypes 

have decreased only slightly, from an 

incidence of approximately 16 cases per 

100,000 persons in the reference period 

1996–98 to 14.7 cases per 100,000 

persons in 2004. To put this information 

in context, USDA and FSIS recognize 

the U.S. Department of Health and 

Human Services National Food Safety 

Objectives—‘‘Healthy People 2010’’— 

(http://www.healthypeople.gov/ 

document/tableofcontents.htm as 

appropriate for guiding strategic 

planning for public health. Healthy 

People 2010 set a goal for 2010 of 6.8 

cases/100,000 persons, which is less 

than half the rate of current incidence. 

FSIS recognizes that raw meat and 

poultry are not the only contributors to 

the disease burden associated with 

Salmonella. However, when the 

serotypes of Salmonella present on raw 

meat and poultry are considered, 

particularly in comparison to those 

commonly associated with human 

illness, FSIS believes that Salmonellacontaminated raw meat and poultry are 

important sources of this pathogen. 

Furthermore, while CDC data show 

the incidence of human Salmonella 

Typhimurium (S. Typhimurium) 

infection as decreasing by 41% between 

the 1996–98 baseline and 2004, the 

incidence of two other leading 

serotypes, S. Enteritidis and S. 

Heidelberg, did not change significantly. 

Human infection incidence from S. 

Newport increased by 41%. Moreover, 

microbial resistance to antibiotics 

associated with serotypes of Salmonella 

may be increasing. This change has been 

particularly noted with S. Newport, 

which has emerged in recent years. (See 

‘‘Preliminary FoodNet Data on the 

Incidence of Infection with Pathogens 

Transmitted Commonly Through 

Food—10 Sites, United States, 2004’’ 

from Morbidity and Mortality Weekly 

Review, CDC, April 15, 2005, 352–356; 

available at http://www.medscape.com/ 

viewarticle/503230.) Importantly, these 

same Salmonella serotypes and others 

also commonly associated with human 

illness have been found in samples of 

raw meat and poultry collected by FSIS. 

Recent Agency data have shown the 

percentage positive in Salmonella ‘‘A’’ 

sets of broilers (young chickens) from 

establishments of all sizes increasing 

from 11.5% in 2002 to 12.8% in 2003 

to 13.5% in 2004. Although the overall 

percentage of positive samples in 

verification testing is still below the 

nationwide baseline prevalence figures, 

this persistent upward trend in positive 

verification samples provides reason for 

concern, particularly because of the 

associated increased exposure of the 

public to serotypes of Salmonella that 

are commonly associated with human 

illness. [See http://www.fsis.usda.gov/ 

ophs/haccp/salm6year.htm.] Other 

product classes have not shown such a 

persistent upward trend, and the 

percentage of positive verification 

samples has declined for all three beef 

product classes. 

FSIS has found through assessments 

of food safety systems, in establishments 

that failed to meet the performance 

standard that these establishments have 

flaws in the design and execution of 

their control procedures. Establishments 

with an elevated percentage of samples 

positive for Salmonella in verification 

testing have not adequately addressed 

the following specific issues: design 

flaws in HACCP plans and Sanitation 

Standard Operating Procedures, failure 

to execute the food safety system as 

designed, failure to ensure that 

corrective actions are effective, and 

failure to reassess the food safety system 

once changes are made. 

FSIS has evidence, based on its 

experience with establishments that 

failed one or more Salmonella sets that 

then implemented corrective actions 

and came into compliance, that, when 

properly addressed in the 

establishment’s food safety system, 

Salmonella levels in regulatory samples 

can be controlled. For example, Agency 

data show that those establishments 

performing well—e.g., with percent 

positive Salmonella samples at or less 

than 50% of a relevant standard or 

baseline for at least five consecutive 

sets—do so with remarkable consistency 

and predictability. Conversely, 

establishments with higher percent 

positive results show much greater 

variability and inconsistency in their 

sample results. Not only do 

establishments that have had at least 

one sample set in which the percent of 

positive samples was greater than 50% 

of the Salmonella standard have a 

higher average of percent positive 

Salmonella samples, but, as a group, 

such establishments also repeatedly 

exceed 50% of the standard. Most of 

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these establishments maintain an 

elevated average percentage of positive 

Salmonella samples until FSIS conducts 

a food safety assessment and identifies 

food safety system design and execution 

weaknesses to the establishments. Based 

on experience, FSIS has found that once 

these establishments implement 

effective control measures as part of 

their HACCP system, they demonstrated 

an ability to maintain good control of 

Salmonella. These patterns show that 

Salmonella in regulatory sample results 

can be controlled consistently through 

efforts by establishments to maintain 

process control. These HACCP-related 

efforts, particularly in broiler 

operations, mirror the outcomes realized 

by the beef industry for control of 

Escherichia coli O157:H7 (E. coli 

O157:H7) when the beef industry began 

implementing better process control for 

this pathogen. 

For all these reasons, the Agency has 

concluded that it needs to re-direct its 

Salmonella verification sampling 

program to ensure that it is useful in 

providing enhanced public health 

protection. 

Agency Decisions 

FSIS is announcing several steps to 

increase public health protection. First, 

the Agency will add results from 

individual Salmonella verification 

sample tests to reports the Agency 

regularly makes to meat and poultry 

establishments that have asked to be 

informed of various test results. These 

Salmonella sample results will be sent 

to establishments as soon as they 

become available. The National 

Advisory Committee on Microbiological 

Criteria for Foods has noted that 

Salmonella test results are useful 

measures of process control, and 

establishments using Statistical Process 

Control (SPC) may find this timely 

information to be particularly helpful in 

gauging the effectiveness of their 

process control measures. 

The Agency will also begin posting 

quarterly, rather than annually, 

nationwide Salmonella data by product 

class on the Agency Web site. 

As soon as possible in 2006, FSIS will 

issue instructions to inspection program 

personnel and begin conducting 

sampling in establishments slaughtering 

young turkeys, the subject of a recentlypublished baseline study (see 70 FR 

8058, February 17, 2005; http:// 

www.fsis.usda.gov/ 

Regulations_&_Policies/ 

2005_Notices_Index/index.asp). These 

baseline data will provide a useful guide 

for FSIS Salmonella verification testing 

of turkey carcasses and evaluation of 

process control by turkey slaughter 

establishments, which the Agency has 

expected to control Salmonella levels 

on carcasses even in the absence of a 

performance standard. FSIS will use the 

baseline results to guide its testing of 

turkey carcasses in the same manner 

that it will use the existing regulatory 

standards to guide its testing of broilers 

and other classes of raw products. 

Tables A and B show existing 

Salmonella performance standards and 

recently-developed microbiological 

baseline guidance results for young 

turkeys and geese. 

TABLE A.—SALMONELLA PERFORMANCE STANDARDS 

[See 9 CFR 310.25 and 381.94] 

Product class 

Performance 

standard 

(percent 

positive for 

Salmonella) 

Number 

of 

samples 

tested (n) 

Maximum 

number of 

positives to 

achieve 

standard 

Steers/heifers ........................................................................................................................................... 1.0% 82 1 

Cows/bulls ................................................................................................................................................ 2.7% 58 2 

Ground beef ............................................................................................................................................. 7.5% 53 5 

Market hogs ............................................................................................................................................. 8.7% 55 6 

Fresh pork sausages ............................................................................................................................... NA NA NA 

Broilers ..................................................................................................................................................... 20.0% 51 12 

Ground chicken ........................................................................................................................................ 44.6% 53 26 

Ground turkey .......................................................................................................................................... 49.9% 53 29 

Turkeys .................................................................................................................................................... NA NA NA 

TABLE B.—SALMONELLA BASELINE GUIDANCE RESULTS FOR YOUNG TURKEYS AND GEESE 

Product class/method 

Baseline 

prevalence 

(percent 

positive for 

Salmonella) 

Number 

of 

samples 

in set 

Maximum 

number of 

positives 

Young turkey carcasses/sponge ............................................................................................................. 19.6% 56 13 

Goose carcasses/sponge ........................................................................................................................ 13.7% 54 9 

Each completed sample set result will 

be recorded in one of three categories in 

relation to the standard or baseline 

guideline: 

Category 1. Consistent Process Control 

for Salmonella Reduction. 50% or less 

of the performance standard or baseline 

guidance, demonstrating the best 

control for this pathogen. 

Category 2. Variable Process Control 

for Salmonella Reduction. From 51% of 

the performance standard or regulatory 

guideline to the performance standard 

or baseline guidance, demonstrating 

intermediate control for this pathogen. 

Category 3. Highly Variable Process 

Control for Salmonella Reduction. 

Greater than the performance standard 

or baseline guidance, demonstrating the 

least control for this pathogen. 

Selection of the Category 1 versus 

Category 2 criteria was based, in part, on 

the long-term evidence from regulatory 

samples collected between 1998 and 

2004 that there is a statistically 

significant difference in the likelihood, 

calculated as an odds ratio, of serotypes 

of Salmonella that are common causes 

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of human illness in the U.S., based on 

the high frequency of these serotypes in 

products from establishments in 

Category 2 compared to those in 

Category 1. FSIS has identified many of 

the most common serotypes of human 

illness in broiler samples. These 

serotypes include Salmonella 

Heidelberg, Typhimurium, Enteritidis, I 

4,[5],12:i:-, Montevideo, Newport, and 

Infantis. 

FSIS believes that targeting its 

Salmonella sampling according to these 

categories will enable it to maximize the 

effective use of its resources. Since 

establishments that have not 

implemented effective process controls 

for Salmonella may fluctuate between 

categories until process control is 

assured, FSIS expects to consider the 

results of at least two consecutive 

sample sets before categorizing the 

establishment. By using more than one 

sample set to make this categorization, 

FSIS will have a good basis on which 

to assess process control. Furthermore, 

FSIS expects to use the most recent 

sample set result, regardless of whether 

the sample set was an ‘‘A,’’ ‘‘B,’’ or other 

set result, plus its next result in 

effecting this approach. FSIS expects to 

assess the utility of this decision 

criterion at least annually. 

An individual establishment with 

results in Category 1 for at least its last 

two sets will be considered by the 

Agency to have demonstrated sustained 

good control of Salmonella presence in 

its product over time. Thus, barring 

special circumstances (for example, 

eliminating an antimicrobial treatment 

during the production process), such an 

establishment will be tested no more 

than once a year, but at least once every 

two years, unless it gets a result that 

puts it in Category 2 or 3. As stated 

earlier, until now, an establishment not 

exceeding the performance standard 

generally was not scheduled for more 

than one sample set annually. 

Once any establishment receives a 

result from FSIS testing for Salmonella 

that puts it in either Category 2 or 3, 

FSIS likely will subject the 

establishment to retesting at any time. 

However, establishments in Category 3 

should expect that the retesting will be 

sooner and more frequent within a 

calendar year than that for 

establishments in Category 2. Moreover, 

the Agency will evaluate Category 2 and 

3 establishments on a case-by-case basis 

and determine any further actions to 

take, which may include increased 

sampling (e.g., at rehang, at pre-chill, 

and at post-chill to gather information 

about changes in the microbiological 

profile during the same production 

process), expedited serotyping, 

enhanced verification of the 

establishment’s food safety programs 

(e.g., intensified focus on sanitation 

procedures and record keeping), and 

assessment of the establishment’s food 

safety system. Importantly, 

establishments in Category 2 and 3 that 

demonstrate an inability to control for 

the on-going presence of serotypes of 

Salmonella known to be associated with 

common human illness will receive 

greater attention by FSIS regarding the 

verification of the establishment’s food 

safety programs. 

FSIS data indicate that increased 

Agency scrutiny through food safety 

assessments and verification testing 

leads to improved plant performance in 

controlling Salmonella. (See Fulfilling 

the Vision: Initiatives in Protecting 

Public Health, USDA/FSIS, July 2004; 

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

Fulfilling_the_Vision.pdf). Less frequent 

sampling of those establishments that 

have a relatively low percent positive of 

Salmonella samples will free Agency 

resources for application to 

establishments that are not performing 

as well. 

In addition, FSIS is providing a new 

compliance guideline particularly 

related to the broiler industry 

containing information that FSIS has 

found to be relevant to the control of 

Salmonella. This compliance guideline 

will be available on the Agency Web site 

and as a document in the FSIS docket 

room. The document will present 

information on control measures that 

can help reduce the prevalence of 

Salmonella. 

FSIS will also be obtaining more 

timely Salmonella serotype information 

for each positive test result from its 

verification program and may intensify 

testing or scrutiny via a food safety 

assessment of establishments that 

produce product with serotypes of 

epidemiological concern. Serotype 

identification requires additional 

analysis and thus is not likely to be 

available when establishments receive 

their initial sample results, but serotype 

information will be made available by 

FSIS to establishments as soon as 

possible. FSIS will also publish annual 

aggregate results for serotypes. 

As soon as possible, FSIS will pursue 

sub-typing, including pulsed-field gel 

electrophoresis of Salmonella found in 

the FSIS testing program. In addition, 

FSIS expects to further assess the 

current procedures in place for phagetyping pathogens found in regulatory 

samples. The Agency expects to pursue 

mechanisms to further share this 

important public health-related 

information with public health partners 

such as CDC, the Food and Drug 

Administration, and the States in order 

to find timely ways to compare subtypes 

of Salmonella with strains from other 

public health surveillance systems. 

Furthermore, the Agency will be 

conducting baseline studies for 

Salmonella and other pathogens and 

indicator organisms among specific 

product classes. These baseline studies 

will be statistically designed to measure 

the national prevalence of 

microorganisms on regulated raw 

products and to ascertain whether 

continuous improvement for pathogen 

reduction is evident, as intended by the 

PR/HACCP final rule. New baseline 

studies will be used to inform risk 

management policies, and could 

provide support for new performance 

standards or baseline guidance. Isolates 

from positive samples, particularly for 

pathogens, are expected to be serotyped 

and analyzed for patterns of resistance 

to antibiotic drugs. 

FSIS is exploring the information 

systems enhancements needed to 

implement fully these risk-based 

policies for Salmonella sampling. 

The main Agency focus will be on 

control of Salmonella in slaughter and 

combined slaughter/processing 

establishments because these operations 

have direct control over this pathogen 

during sanitary dressing and further 

processing. While grinders are certainly 

of interest to FSIS, the best way to 

control Salmonella levels in ground 

product is through control over the 

Salmonella levels in the source 

materials. Thus, the slaughter and 

slaughter/processing combination plants 

are the Agency’s first concern, but 

policy for grinders will be assessed 

during that year as well. 

Further Agency Considerations 

FSIS intends to monitor the 

Salmonella percent positive in 

verification samples by product class 

over the course of a full year beginning 

in July 2006. The Agency’s current 

thinking is that if the percent positive of 

Salmonella in verification samples over 

that one-year period for the great 

majority of establishments (e.g., 90%) in 

a specific product class is not at or 

below half the performance standard/ 

baseline guidance level (i.e., Category 

1), FSIS will consider whether there are 

further actions that should be taken to 

ensure that establishments improve 

their control of Salmonella and further 

enhance public health protection. 

For example, FSIS would consider 

actions that would provide an incentive 

to industry to improve controls for 

Salmonella. One approach that FSIS has 

considered and favors is posting on the 

Agency Web site the ‘‘A’’ set results 

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from the completed Salmonella sample 

sets for each establishment producing 

that product class, identified by 

establishment name and number. 

Publishing the results of these FSIS 

Salmonella analyses, which have been 

used by the Agency as one component 

for assessing establishment 

performance, could serve as a valuable 

support to an establishment’s process 

control efforts. 

A study by USDA’s Economics 

Research Service (ERS) has shown that 

increased public information on food 

safety performance measures can offer 

incentives to establishments to invest in 

process control by helping them realize 

benefits from their investments, and 

thus spur industry innovation in food 

safety (see Food Safety Innovations in 

the United States: Evidence from the 

Meat Industry by Elise Golan, Tanya 

Roberts, Elisabete Salay, Julie Caswell, 

Michael Ollinger, and Danna Moore, 

AER–831, USDA/ERS, April 2004; 

http://www.ers.usda.gov/publications/ 

aer831/). FSIS believes that this study 

has relevance regarding the Salmonella 

strategy articulated above relative to 

publishing establishment-specific 

information associated with Salmonella 

control. For example, a further 

processor of ground product who 

purchased carcasses from a slaughter 

operation would not know whether the 

carcass was produced with the best or 

worst safety procedures, even though 

the procedures were in compliance with 

the minimum regulatory requirements. 

This situation reduces incentives by 

manufacturers of the source material 

(e.g., carcasses) to invest in food safety 

innovation. By addressing this 

asymmetry, that is, providing more 

information about the process control 

performance of establishments related to 

Salmonella, FSIS believes it would be 

providing the appropriate incentive for 

the meat and poultry slaughter industry 

to attain consistent, good control for 

Salmonella. FSIS is especially 

interested in receiving comment on this 

approach to ensuring pathogen 

reduction in all raw products regulated 

by FSIS. 

The Agency will also consider other 

actions, such as modifying its approach 

to inspection, if widespread industry 

performance provides a basis for 

reducing Agency concern about control 

for pathogens in classes of raw product. 

For example, the Agency is aware that 

limits on linespeeds are a concern to 

both the young poultry slaughter and 

the hog slaughter industries. If 

widespread action within these 

industries controlled Salmonella 

contamination such that the Agency, in 

its testing of carcasses, consistently 

found industry-wide results at half or 

below half the current standard/baseline 

guidance, FSIS would be prepared to 

consider allowing the industries to 

study whether linespeeds could be 

increased above the current regulatory 

limits. FSIS also would be interested in 

any impact that such changes may have 

on other regulatory obligations of the 

establishments and the Agency, as well 

as other pathogens of public health 

concern (e.g., Campylobacter), 

particularly as the industries seek to 

demonstrate continuous improvement 

in their performance over time. Such 

studies could be conducted through 

existing regulatory provisions for a 

waiver of the meat and poultry 

regulations (9 CFR 303.2 and 381.3). 

Although FSIS has an establishmentspecific approach for inspection, FSIS 

believes that, ultimately, it will take an 

industry-wide effort to ensure that there 

is effective Salmonella control in raw 

classes of product. FSIS experience with 

the beef industry regarding control for E. 

coli O157:H7 ultimately resulted in an 

industry-wide approach to reassess their 

HACCP plans in order to ensure that 

each establishment had effective food 

safety systems. FSIS requests comment 

on these potential actions and any other 

incentives that would be useful in 

encouraging control of Salmonella. 

Response to Comments on the Federal 

Register Notice of April 16, 2003 

In deciding how to proceed, the 

Agency considered the nine comments 

that it received on the April 2003 

Notice. 

Reporting to Establishments 

Four comments supported reporting 

individual sample results to 

establishments as they become 

available. Two comments suggested that 

establishments should receive 

individual sample results if they request 

them. 

FSIS response: The Agency agrees 

with these comments. Receiving 

individual sample results soon after the 

samples are taken will help 

establishments in their assessment of 

why a production lot of product 

resulted in a positive sample. An 

establishment will be able to determine 

whether it had a problem on the day in 

question, or whether positives are 

associated with a particular supplier. 

On balance, therefore, it now seems 

clear that making the information 

available to establishments will be of 

value to the establishments in 

determining a prompt and appropriate 

response. Accordingly, FSIS will add 

results from individual Salmonella 

verification sample tests to reports that 

the Agency regularly makes to meat and 

poultry establishments that have asked 

to be informed of various test results. 

Posting Individual Sample Results on 

the Agency Web Site 

Three comments opposed posting 

individual sample results to the Web, 

and one comment opposed posting 

results in general. 

FSIS response: The Agency agrees 

that posting individual sample results 

(as opposed to completed sample set 

results) to the Web would be of little 

value to consumers, industry, or public 

health officials. Moreover, it would 

impose a significant burden on the 

Agency. 

Posting Completed Sample Set Results 

on the Agency Web Site 

Two comments specifically supported 

posting completed sample set results on 

the Agency Web site, identified by 

establishment. Two comments 

suggested publishing aggregate data 

only, either monthly or quarterly, and 

one of these comments asked that data 

be presented by FSIS Inspection 

District. 

FSIS response: The Agency has 

concluded that posting quarterly 

nationwide data for Salmonella, 

presented by product class, on the 

Agency Web site is most appropriate at 

this time. Doing so will provide 

consumers with more timely, 

meaningful information about overall 

industry performance in protecting 

public health. FSIS believes that posting 

completed sets, in aggregate, would be 

appropriate because sample sets, as a 

measure of controlling and reducing 

harmful bacteria on raw meat and 

poultry, are intended to enable FSIS and 

the establishment to verify the 

effectiveness of an establishment’s 

HACCP controls in reducing harmful 

bacteria as measured by the presence of 

Salmonella. 

Freedom of Information Act (FOIA) 

Exemption 

One comment supported the Agency’s 

long-standing position that Salmonella 

sample results should be exempt from 

disclosure under the FOIA. One 

comment stated that FOIA exemptions 

do not apply to Salmonella sample 

results. 

FSIS response: The Agency agrees 

that it has treated Salmonella sample 

results as pre-decisional and has 

exempted such results from disclosure 

under FOIA. FOIA exemptions are 

generally permissive and are left to the 

appropriate discretion of the Agency 

involved. When FSIS makes individual 

sample results available to 

hsrobinson on PROD1PC70 with NOTICES

Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices 9777 

establishments, as described herein, the 

results can no longer be considered predecisional. Given the potential value in 

making sample-by-sample test results 

available, as described above, FSIS has 

decided that it is reasonable to include 

individual Salmonella verification 

sample results in reports to those 

establishments that request various 

sample results and to make completed 

set results, in aggregate and quarterly, 

available on the Agency Web site. 

Salmonella as Basis for Performance 

Standard 

Two comments questioned the 

appropriateness of Salmonella as an 

indicator organism or as the basis for a 

performance standard, noting that 

Salmonella occurs in food products 

other than the meat, poultry, and eggs 

regulated by FSIS. 

FSIS response: FSIS notes that the 

National Advisory Committee on 

Microbiological Criteria for Foods in its 

report of August 8, 2002 (Final— 

Response to the Questions Posed by 

FSIS Regarding Performance Standards 

with Particular Reference to Ground 

Beef Products; http://www.fsis.usda.gov/ 

OPHS/NACMCF/2002/rep_stand2.pdf) 

concluded that Salmonella test results 

are useful measures of process control. 

The Agency also notes its concern 

regarding recent increases in Salmonella 

positives in some raw product classes 

and in human infections from certain 

Salmonella serotypes that are associated 

with meat and poultry. FSIS, 

furthermore, will be obtaining 

Salmonella serotype information for 

each positive test result from its 

verification program in a more timely 

manner and will consider intensifying 

testing and scrutiny of establishments 

that produce products with serotypes of 

epidemiological concern. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and, in particular, 

minorities, women, and persons with 

disabilities are aware of this notice, 

FSIS will announce it on-line through 

the FSIS Web page located at http:// 

www.fsis.usda.gov/ 

regulations_&_policies/ 

2006_Notices_Index/index.asp. The 

Regulations.gov Web site is the central 

online rulemaking portal of the United 

States government. It is being offered as 

a public service to increase participation 

in the Federal government’s regulatory 

activities. FSIS participates in 

Regulations.gov and will accept 

comments on documents published on 

the site. The site allows visitors to 

search by keyword or Department or 

Agency for rulemakings that allow for 

public comment. Each entry provides a 

quick link to a comment form so that 

visitors can type in their comments and 

submit them to FSIS. The Web site is 

located at http://www.regulations.gov/. 

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

types of information that could affect or 

would be of interest to our constituents 

and stakeholders. The update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The update 

also is available on the FSIS web page. 

Through Listserv and the web page, 

FSIS is able to provide information to a 

much broader, more diverse audience. 

In addition, FSIS offers an email 

subscription service which provides an 

automatic and customized notification 

when popular pages are updated, 

including Federal Register publications 

and related documents. This service is 

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

news_and_events/email_subscription/ 

and allows FSIS customers to sign up 

for subscription options across eight 

categories. Options range from recalls to 

export information to regulations, 

directives and notices. Customers can 

add or delete subscriptions themselves 

and have the option to password protect 

their account. 

Done at Washington, DC, on February 21, 

2006. 

Barbara J. Masters, 

Administrator. 

[FR Doc. 06–1783 Filed 2–22–06; 1:15 pm] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2006–0001] 

Codex Alimentarius Commission: 

Meeting of the Codex Committee on 

General Principles 

AGENCY: Office of the Under Secretary 

for Food Safety, USDA. 

ACTION: Notice of public meeting and 

request for comments. 

SUMMARY: The Office of the Under 

Secretary for Food Safety, U.S. 

Department of Agriculture (USDA) is 

sponsoring a public meeting on March 

21, 2006. The objective of the public 

meeting is to provide information and 

receive public comments on agenda 

items and draft United States positions 

that will be discussed at the 23rd 

Session of the Codex Committee on 

General Principles (CCGP) of the Codex 

Alimentarius Commission (Codex), 

which will be held in Paris, France, 

April 10–14, 2006. The Under Secretary 

for Food Safety recognizes the 

importance of providing interested 

parties the opportunity to obtain 

background information on the 23rd 

Session of CCGP and to address items 

on the agenda. 

DATES: The public meeting is scheduled 

for Tuesday, March 21, 2006 from 1 

p.m. to 4 p.m. 

ADDRESSES: The public meeting will be 

held in Room 107–A, Jamie Lee Whitten 

Building, U.S. Department of 

Agriculture, 1400 Independence 

Avenue, SW., Washington, DC 20250. 

Documents related to the 23rd Session 

of the CCGP will be accessible via the 

World Wide Web at the following 

address: http:// 

www.codexalimentarius.net/web/ 

current. 

FSIS invites interested persons to 

submit comments on this notice. 

Comments may be submitted by any 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. 

FSIS prefers to receive comments 

through the Federal eRulemaking Portal. 

Go to http://www.regulations.gov and, 

in the ‘‘Search for Open Regulations’’ 

box, select ‘‘Food Safety and Inspection 

Service’’ from the agency drop-down 

menu, then click on ‘‘Submit.’’ In the 

Docket ID column, select the FDMS 

Docket Number FSIS–2006–0001 to 

submit or view public comments and to 

view supporting and related materials 

available electronically. 

• Mail, including floppy disks or CD– 

ROMs, and hand- or courier-delivered 

items: Send to Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, 300 12th Street, 

SW., Room 102 Cotton Annex Building, 

Washington, DC 20250. 

• Electronic mail: 

fsis.regulationscomments@fsis.usda.gov. 

All submissions received must include 

the Agency name and docket number 

FSIS–2006–0001. All comments 

submitted in response to this notice, as 

well as research and background 

information used by FSIS in developing 

this document, will be posted to the