This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

75187

Vol. 65, No. 232

Friday, December 1, 2000

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

7 CFR Part 319

[Docket No. 98–103–2]

Importation of Artificially Dwarfed

Plants in Growing Media From the

People’s Republic of China

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice of reopening and

extension of comment period.

SUMMARY: We are reopening and

extending the comment period for our

proposed rule that would amend our

regulations to allow artificially dwarfed

(penjing) plants of the genera Buxus,

Ehretia (Carmona), Podocarpus,

Sageretia, and Serissa to be imported

into the United States from the People’s

Republic of China in an approved

growing medium subject to specified

growing, inspection, and certification

requirements. This action will allow

interested persons additional time to

prepare and submit comments.

DATE: We invite you to comment on

Docket No. 98–103–1. We will consider

all comments that we receive by

December 20, 2000.

ADDRESSES: Please send four copies of

your comment (an original and three

copies) to: Docket No. 98–103–1,

Regulatory Analysis and Development,

PPD, APHIS, Suite 3C03, 4700 River

Road, Unit 118, Riverdale, MD 20737–

1238. Please state that your comment

refers to Docket No. 98–103–1.

You may read any comments that we

receive on this docket in our reading

room. The reading room is located in

room 1141 of the USDA South Building,

14th Street and Independence Avenue

SW., Washington, DC. Normal reading

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

Monday through Friday, except

holidays. To be sure someone is there to

help you, please call (202) 690–2817

before coming.

APHIS documents published in the

Federal Register, and related

information, including the names of

organizations and individuals who have

commented on APHIS dockets, are

available on the Internet at http://

www.aphis.usda.gov/ppd/rad/

webrepor.html.

FOR FURTHER INFORMATION CONTACT: Mr.

Wayne D. Burnett, Senior Import

Specialist, Phytosanitary Issues

Management Team, PPQ, APHIS, 4700

River Road Unit 140, Riverdale, MD

20737–1236; (301) 734–6799.

SUPPLEMENTARY INFORMATION:

Background

On September 20, 2000, we published

in the Federal Register (65 FR 56803–

56806, Docket No. 98–103–1) a

proposed rule to amend our regulations

governing the importation of plants and

plant products to allow artificially

dwarfed (penjing) plants of the genera

Buxus, Ehretia (Carmona), Podocarpus,

Sageretia, and Serissa to be imported

into the United States from the People’s

Republic of China in an approved

growing medium subject to specified

growing, inspection, and certification

requirements.

Comments on the proposed rule were

required to be received on or before

November 20, 2000. We are reopening

and extending the comment period on

Docket No. 98–103–1 for an additional

30 days. This action will allow

interested persons additional time to

prepare and submit comments. We will

consider all comments that we received

between September 20, 2000, and

December 20, 2000.

Further, interested persons may now

obtain the qualitative, pathway-initiated

pest risk assessment for this action,

titled ‘‘Pest Risk Assessments, Penjing

Plants from China,’’ on the APHIS web

site at: http://www.aphis.usda.gov/ppq/

pim/.

Authority: Title IV, Pub. L. 106–224, 114

Stat. 438, 7 U.S.C. 7701–7772; 7 U.S.C. 166

and 450; 21 U.S.C. 136 and 136a; 7 CFR 2.22,

2.80, and 371.3.

Done in Washington, DC, this 21st day of

November 2000.

Craig A. Reed,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 00–30597 Filed 11–30–00; 8:45 am]

BILLING CODE 3410–34–U

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 381 and 424

[Docket No. 98–062P]

Performance Standards for On-line

Antimicrobial Reprocessing of PreChill Poultry Carcasses

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Proposed rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is proposing

to amend its poultry products

inspection regulations to allow, on a

voluntary basis, the on-line reprocessing

of pre-chill carcasses that are accidently

contaminated with digestive tract

contents during slaughter. FSIS is

proposing that, to permit this on-line

reprocessing of visibly contaminated

birds, the treated carcasses must meet

pre-chill performance standards for

Salmonella and E. coli that are

significantly lower than the existing

criteria for verifying process control for

E. coli and the pathogen reduction

performance standards for Salmonella

for chilled poultry. The proposed

change will allow contaminated poultry

carcasses, including turkeys, to remain

on the main processing line for

treatment, rather than having to be

moved off the main line. Birds with no

visible contamination may undergo the

same antimicrobial treatment, but they

will remain subject to the Agency’s

pathogen reduction performance

standards and process control criteria

already in place for raw chilled product.

Birds whose entire carcass is affected

with contamination or are mutilated

will not be permitted to be processed

on-line. Under this proposal,

establishments doing on-line

antimicrobial reprocessing will need to

do so in accordance with the Hazard

Analysis and Critical Control Point

(HACCP) system requirements in 9 CFR

part 417. This proposed rule is in

response to petitions from Rhodia Inc.,

of Cranbury, New Jersey, and Alcide

Corporation of Redmond, Washington.

DATES: Comments must be received on

or before January 30, 2001.

ADDRESSES: Submit written comments

to the FSIS Docket Clerk, Room 102,

Cotton Annex Building, 300 12th Street,

75188 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules

SW., Washington, DC 20250–3700.

Interested persons are requested to

submit an original and two copies of

comments concerning this proposal.

Written comments should be sent to the

Docket Clerk at the address shown

above and should refer to Docket

Number 98–062P. Copies of all

comments submitted in response to this

proposal will be available for public

inspection in the FSIS Docket Room

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

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations &

Inspection, Office of Policy, Program

Development, and Evaluation, FSIS, at

(202) 205–0699 or FAX (202) 401–1760.

SUPPLEMENTARY INFORMATION: FSIS is

responsible for ensuring that poultry

products distributed in commerce are

wholesome, not adulterated, and

properly marked, labeled, and packaged.

Under the Poultry Products Inspection

Act (PPIA) (21 U.S.C. 451–470), FSIS

provides mandatory inspection of

poultry and poultry products

distributed in interstate and foreign

commerce and in designated States and

U.S. territories. Inspection of poultry

slaughtering establishments is intended

to ensure that fresh, ready-to-cook

poultry and parts are not adulterated or

misbranded.

Poultry Reprocessing

FSIS estimates that 2 percent of

inspected poultry carcasses are

reprocessed. This estimate is based on

approximately two years of in-plant data

collection and represents the national

average. The Agency requires that

poultry with cut, contaminated surfaces

be reprocessed by trimming, and poultry

with uncut, contaminated inner surfaces

be reprocessed by trimming alone or in

combination with other methods, such

as washing or vacuuming. After viscera

removal, the contaminated carcasses are

hung on a designated area of the retain

rack. Carcasses are then transferred to

the reprocessing station where they are

suspended to prevent contamination

during trimming and washing. The

crops are removed, and external carcass

surfaces are thoroughly washed. The

contaminant is removed, and the

reprocessed carcass is rinsed with water

containing 20 ppm chlorine. After

further examination by plant personnel,

clean carcasses are lotted and made

available for reinspection by FSIS

inspectors. Carcasses found by the FSIS

inspectors to be not adulterated are

passed for human consumption.

Reprocessing procedures must be

submitted in writing to FSIS. FSIS field

personnel are authorized to grant

approvals for reprocessing stations to

include 60-day provisional approvals

(experimental under section 381.3(b)) to

permit method development and data

accumulation via MPI Bulletin 78–40

(‘‘Disposition of Contaminated Poultry

Carcasses,’’ 3/28/78). Provisional

approvals can be refused or revoked if

the establishment cannot maintain

consistently effective results. Final

approvals must be based in part upon

data from 20 consecutive days of

successful operations.

The statutory basis for poultry

reprocessing is section 6(c) of the PPIA

(21 U.S.C. 455(c)) which provides that

carcasses, parts, and products that may

by reprocessing be made not

adulterated, need not be condemned

and destroyed if reprocessed under the

supervision of an inspector and found to

be not adulterated. The methods used to

reprocess carcasses have changed over

time. In the early 1960’s, FSIS

prohibited reprocessing by washing of

poultry carcasses. This meant that

contamination had to be removed by

trimming. As a practical matter, the

entire back of contaminated carcasses

often had to be cut out and discarded.

In 1975, an Agriculture Research

Service (ARS) study showed that the

microbial profile of thoroughly washed

carcasses previously contaminated with

digestive tract contents was no different

than the microbial profile of

uncontaminated birds. Industry

responded by requesting that FSIS

permit contamination to be removed by

washing. Industry also supplied data to

demonstrate that washing also removed

visible specks of internal contamination.

Citing newer technology that made

the present procedure of trimming

‘‘unsuitable,’’ on August 19, 1977, the

Food Safety and Quality Service (now

FSIS) proposed (42 FR 41873) to permit

the reprocessing of internally

contaminated carcasses if two

conditions were met. First, each

establishment must receive approval

from FSIS of the off-line reprocessing

procedure (trimming, vacuuming, or

washing singly or in various

combinations) and equipment. Second,

the surface of each reprocessed carcass

must be treated with a chlorinated water

solution. A final rule, issued on March

8, 1978 (43 FR 12846), reduced the

chlorine requirements from 50 ppm to

20 ppm and clarified some information

about the areas designated for

reprocessing.

During the 1970’s and 1980’s, the

industry made significant technological

advances and increased its process

control capabilities. The development of

automated evisceration equipment and

improvements in genetics, nutrition

health, and flock management permitted

the poultry industry to present uniform

lots of birds to inspectors faster than

inspectors could inspect them using

traditional methods. In the 1980’s, the

Agency developed new inspection

procedures, including New Line Speed

(NELS) and Streamlined Inspection

System (SIS) for chickens and the New

Turkey Inspection (NTI) system, which

shifted quality control responsibilities

to the plant and relied more heavily on

monitoring and verification than in the

past. Inspection was now conducted in

two distinct phases—a post-mortem

inspection phase and a reinspection

phase.

Under the current regulations, any

carcass of poultry accidently

contaminated during slaughter with

digestive tract contents will not be

condemned if promptly reprocessed in

a designated area off-line under the

supervision of an inspector and found to

be not adulterated. Under provisions of

§ 381.91, carcasses of poultry

contaminated with volatile oils, paints,

or any other substance that renders the

carcass adulterated will be condemned.

In addition, any organ or other part of

a carcass that has been accidentally

mutilated in the course of processing

will be condemned, and if the whole

carcass is affected, the whole carcass

will be condemned.

Advantages of On-Line Versus Off-Line

Reprocessing

Although FSIS’ regulations require

any visibly contaminated poultry

carcass to be reprocessed at an approved

reprocessing station away from the main

processing line, there has been concern

that pathogenic organisms may be

spread by the off-line reprocessing

technique (Beuchat, LR, and JH Ryu,

Produce Handling and Process

Practices, 1997). This technique

involves a significant amount of product

handling and provides an opportunity

for cross-contamination.

On-line reprocessing of pre-chill

poultry would provide great benefits to

poultry slaughtering establishments.

Production rates could increase

considerably if such reprocessing were

permitted. An increase in annual

revenues resulting from an increase in

the production rate would more than

offset any one-time investment for the

purchase and installation of equipment

needed to reprocess on-line.The Agency

does not foresee that any establishment

would need to reduce its linespeeds as

a result of on-line reprocessing,

although the FSIS inspector-in-charge

has discretion to reduce linespeeds,

when necessary.

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules 75189

The benefits to be derived from online reprocessing include substantial

reductions in pathogens on dressed,

ready-to-cook poultry. A reduction in

contamination, coupled with an

antimicrobial treatment, would result in

reduced microbial loads on dressed

poultry carcasses. Because carcasses

without visible contamination would

undergo the antimicrobial treatment if

reprocessing was done on-line, most

poultry products would benefit from online reprocessing. There would be

added assurance that reprocessed

poultry are free of contamination and

unlikely to be a cause of cross

contamination when introduced into the

chiller system.

Industry is aware of the potential

benefits to be derived from on-line

reprocessing. Consequently, over the

last several years, companies have been

exploring various methodologies. The

first to come forward with data from

trials performed at five plants (Choctow

Maid, Carthage, MS; Perdue Farms,

Rockingham, NC; Wayne Farms, Jack,

AL; Choctow Foods, Forrest, MS; and

Amick Farms, Batesburg, SC) was

Rhodia, Inc., whose system uses

trisodium phosphate (TSP). Rhodia’s

data show that its on-line reprocessing

system can achieve pathogen levels

significantly lower than the Agency

pathogen reduction performance

standards and process control

verification criteria.

In addition, Alcide Corporation has

developed the SanovaTM Continuous

On-line Processing (COP) antimicrobial

intervention process for poultry, which

uses acidified sodium chlorite. FSIS is

aware that other companies in addition

to Rhodia and Alcide are doing in-plant

testing and may soon be coming forward

with data on the effectiveness of their

antimicrobial systems.

TSP as a Processing Aid

Rhodia Inc., Rhone-Poulenc, Inc., its

parent company, and Stauffer Chemical

Company, its predecessor company,

have conducted tests on the efficacy of

various processes using solutions of

food-grade TSP as a processing aid on

raw meat and poultry carcasses for the

purpose of reducing the numbers and

prevalence of various pathogenic

microorganisms. TSP is listed by the

Food and Drug Administration (FDA) as

generally recognized as safe (GRAS) for

multiple-purpose use in accordance

with good manufacturing practices

(GMP) (21 CFR 182.1778). As part of the

testing of TSP, numerous laboratory,

plant, and commercial trials have been

conducted pre-chill and post-chill in

slaughtering operations for beef and

poultry (chicken and turkey) and for

poultry giblets.

The trials tested both TSP spray/

drench systems using inside/outside

birdwashers (IOBW) and TSP

immersion/application techniques using

a drag through tank. Each of the

commercial plant trials consistently

demonstrated the efficacy of TSP in

reducing prevalence and levels of

Aerobic Plate Counts (APC’s),

Campylobacter, E. coli, and

Enterobacteriaceae on meat and poultry.

The efficacy of a TSP rinse combined

with a chlorine rinse in reducing the

prevalence and levels of pathogenic

bacteria on poultry is well documented

by Rhodia. From the data submitted by

Rhodia, it appears that APC’s can be

reduced up to 1.5 log10 cycles (i.e., just

less than 99 percent); Campylobacter

prevalence can be reduced from 78.6

percent to 41.6 percent, a 37 percent

reduction; E. coli and

Enterobacteriaceae can be reduced to

below the level of detection; and

Salmonella can be reduced to below 1

percent of the total number of birds

sampled.

Petition for Approval of TSP on Raw,

Chilled Poultry Carcasses

In 1992, Rhone-Poulenc petitioned

FSIS for approval of the use of TSP on

raw, chilled poultry carcasses. The

petitioner included data in its petition

to demonstrate that the use of TSP is

effective in reducing the prevalence of

bacteria, including pathogenic bacteria,

on raw, chilled poultry products. FSIS

evaluated the petitioner’s request and

concluded that the treatment leaves

virtually no residues in or on the

product.

FSIS also determined that the use of

TSP requested by the petitioner was

suitable for its intended purpose as an

antimicrobial processing aid, and that

the use of this substance on raw, chilled

poultry carcasses at the stated level

would not render the treated product

adulterated, misbranded, or otherwise

not in accordance with the requirements

of the PPIA. In a final rule issued on

July 29, 1996 (61 FR 39273), FSIS

amended the poultry products

inspection regulations (formerly in

§ 381.147; now in the table in

§ 424.21(c)) to add ‘‘antimicrobial

agents’’ as a new class of substance for

use on poultry products and to include

TSP as an approved antimicrobial agent

whose use is limited to raw, chilled

poultry carcasses.

In-Plant Trials of On-Line Reprocessing

Because of the antimicrobial efficacy

demonstrated by TSP on chilled poultry

in commercial poultry slaughter

operations, Rhodia requested and

received authorization from FSIS to

conduct in-plant trials of the use of TSP

for on-line reprocessing of pre-chill

carcasses. FSIS regulations

(§ 381.91(b)(1) and (2)) require that the

carcasses be reprocessed off-line under

the supervision of an FSIS inspector.

Under the FSIS-approved protocol, a

TSP treatment using an IOBW for the

on-line reprocessing was tested. In the

first stage of the approved protocol,

visible contamination was removed

from carcasses prior to zero tolerance

verification by using one or more IOBW

with a water spray containing 20 ppm

chlorine. In the second stage, carcasses

passed through another IOBW where a

TSP antimicrobial rinse was applied.

Two separate phases of sampling took

place in each trial at five plants. Phase

1 was conducted over a 4-week period

and involved extensive sampling, in

part, to verify proper startup of the

system. Phase 2 was conducted over an

8-week period and involved collecting a

lesser number of samples on a random

basis.

The trials were conducted within the

following operating parameters:

(1) There was strict compliance with

FSIS regulatory policy, including the

zero tolerance for fecal matter (9 CFR

381.65(e)), and with the existing prechill finished product standards (9 CFR

381.76, Table 1).

(2) Birds whose entire carcass was

affected with contamination were not

eligible for on-line reprocessing with

TSP. These carcasses were reprocessed

off-line in accordance with 9 CFR

381.91.

(3) The temperature of the TSP

treatment solution did not exceed the

carcass temperature at the time of

treatment, and the treatment solution

was applied by spraying/drenching

carcasses up to 15 seconds.

(4) The TSP concentration levels were

between 8 and 12 percent, with a

critical limit of not less than 8 percent.

The 960 samples generated at each

plant were divided equally among three

sampling points. ‘‘A’’ samples were

taken randomly from ‘‘normal’’ on-line

fully eviscerated carcasses with no

visible contamination before they

underwent the first IOBW rinse for online reprocessing. The ‘‘A’’ samples,

therefore, can be considered the control

samples because they represented the

actual bacterial load on carcasses

proceeding on-line during days the

sampling was conducted. ‘‘B’’ samples

were taken from visibly contaminated

carcasses that would normally have

been reprocessed off-line but that were

marked and allowed to be reprocessed

on-line. ‘‘C’’ samples were obtained

75190 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules

from carcasses after they were

reprocessed off-line, where they

underwent procedures such as

vacuuming, washing, or trimming,

singly or in combination, and treated

with chlorinated water. All samples

were frozen and shipped to laboratories

for analysis by AOAC/BAM analytical

methods.

Results of Trials

The data submitted to FSIS in support

of Rhodia’s petition show that the

combined effects of the TSP and

chlorine rinses substantially reduced

the average APC’s and

Enterobacteriaceae counts and the

prevalence of Campylobacter, E. coli,

and Salmonella on treated sample

carcasses. Specifically, the data show

that:

• On-line TSP reprocessing achieved

a 1 log10 greater reduction in average

APC’s than normally reprocessed online carcasses before the chiller (‘‘A’’

samples) and a one-half log greater

reduction in average APC’s than off-line

reprocessed carcasses before the chiller

(‘‘C’’ samples).

• The average prevalence of

Campylobacter on normal on-line

carcasses before the chiller (‘‘A’’

samples) was 78 percent, and the

average prevalence was 80 percent for

off-line carcasses before the chiller (‘‘C’’

samples). There was a 32 percent

reduction in Campylobacter prevalence

for TSP reprocessed birds. (There were

no Campylobacter samples tested in

Phase 2 of the trials).

• On-line TSP reprocessing resulted

in less than a 1.0 percent prevalence for

E. coli. On-line carcasses in the control

group (‘‘A’’ samples) had an average E.

coli prevalence of 97 percent before the

chiller, and off-line reprocessed

carcasses (‘‘C’’ samples) averaged a 22

percent prevalence rate before the

chiller.

• TSP on-line reprocessing reduced

the prevalence for Enterobacteriaceae to

1.0 percent of carcasses. The average

prevalence of Enterobacteriaceae on

normal on-line pre-chilled carcasses

(‘‘A’’ samples) was 98 percent, and the

average prevalence was 81 percent for

off-line reprocessed pre-chilled

carcasses (‘‘C’’ samples).

• Salmonella prevalences were based

on more than 1,200 samples each of the

normal on-line carcasses, the TSP online reprocessed carcasses, and the offline reprocessed carcasses. Less than 0.5

percent of the on-line carcasses treated

with chlorine and TSP rinses were

positive for Salmonella. On-line prechilled carcasses (‘‘A’’ samples)

averaged a prevalence of 30 percent, and

off-line reprocessed pre-chilled

carcasses (‘‘C’’ samples) averaged a 22

percent prevalence.

Establishing a Pathogen Reduction

Standard for On-Line Reprocessing

Systems

In its petition, as noted above, Rhodia

presented data from frozen samples that

showed that the TSP rinse, in

combination with a chlorinated water

system, achieved substantial microbial

load reduction on treated carcasses.

Rhodia Inc., asked that FSIS amend its

rules to provide for the on-line

reprocessing of poultry with a substance

or reprocessing system that has

demonstrated, with statistically

significant validating data generated

under conditions of in-plant trial tests,

the ability to reduce the pre-chill

prevalence of Salmonella to less than

0.5 percent and to reduce the pre-chill

prevalence of E. coli to less than 1.0

percent on frozen samples.

The on-line reprocessing of carcasses

would occur after FSIS post-mortem

inspection (in non-HACCP Inspection

Models project plants) and the removal

from the slaughter/processing line of

carcasses extensively contaminated with

digestive tract content or fecal material,

condemned poultry carcasses, and parts

or organs that are obviously

unwholesome or unfit for human food.

The removal of processing defects

(nonconformances such as digestive

tract contents, lungs, hair, feathers,

bruises, scabies, airsacculitis, and others

listed in § 381.76) is unchanged by this

proposed rule and would continue to

occur before on-line antimicrobial

processing and before carcasses enter

the chiller tank.

Under this proposal, carcasses with

visible digestive tract contamination,

including fecal contamination, would be

permitted to remain on-line and would

be treated with an antimicrobial agent

before entering the chiller. Carcasses

with extensive digestive tract

contamination would continue to be

eligible for reprocessing off-line but

would not be eligible for on-line

reprocessing.

FSIS is not proposing the specific prechill Salmonella and E. coli standards

because, at this time, various

antimicrobial treatments have been

demonstrated to have differing effects.

FSIS does intend to establish one or

more pre-chill performance standards

that establishments using on-line

reprocessing with an antimicrobial

treatment will be required to meet. FSIS

invites comment, especially in the form

of additional data, on the specific

performance standards that

establishments should be required to

meet.

E. coli continues to be the best

microbial indicator for fecal

contamination. Salmonella is the most

frequently occurring foodborne

pathogen, and it is widely associated

with raw poultry. Because E. coli

contamination is largely preventable,

and because the current E. coli and

Salmonella requirements contained in

§ 381.94 were met or exceeded in the

commercial on-line reprocessing trials,

FSIS believes that these organisms

would be appropriate for pre-chill

performance standards for reprocessing

on line.

Under provisions of the HACCP final

rule, FSIS requires all poultry slaughter

establishments to test carcasses for

generic E. coli using an AOAC approved

method of analysis to verify process

control for fecal contamination. The rule

establishes testing frequencies based on

production levels. The HACCP final rule

does not require establishments to

conduct their own testing for

Salmonella, but FSIS tests product and

reports the results to establishments.

FSIS has published guide books for

sampling for both E. coli and

Salmonella (footnotes 1 and 3 in

§ 381.94). The guidebooks are available

in the Docket Room (See ADDRESSES)

and on the FSIS web page at http://

www.fsis.usda.gov. FSIS believes that

establishments operating on-line

antimicrobial reprocessing systems for

pre-chilled carcasses should follow the

guidelines for sample collection for the

pre-chill pathogen reduction

performance standards for E. coli and

Salmonella in accordance with

footnotes 1 and 3 in 9 CFR 381.94.

Campylobacter

In 1999, the National Advisory

Committee on Meat and Poultry

Inspection requested that the National

Advisory Committee for Microbiological

Criteria for Foods evaluate options for

defining a performance standard for

Campylobacter. Campylobacter is the

most frequent cause of bacterial

foodborne illness in the United States.

It is estimated that between 60 and 80

percent of chilled whole birds sampled

at processing facilities are contaminated

with the microorganism. The National

Advisory Committee for Microbiological

Criteria for Foods expressed concern in

defining a Campylobacter standard, in

part, because of the paucity of data on

the relationship among Campylobacter,

other microorganisms (e.g., Salmonella

and generic E. coli), and poultry. For

example, there are no available on-farm

or slaughter intervention strategies

designed to eliminate Campylobacter,

and a new method developed by the

Agricultural Research Service to detect

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules 75191

and quantify Campylobacter has not yet

been fully assessed and compared

against the current method used by

FSIS. Consequently, FSIS believes that

there are insufficient data to establish a

performance standard for

Campylobacter as part of this proposed

rulemaking for on-line antimicrobial

reprocessing of pre-chill poultry

carcasses. However, FSIS is interested

in establishing such a standard for this

pathogen and is seeking comment and

data regarding this issue.

Alcide’s Petition for Acidified Sodium

Chlorite

In January 1999, FSIS granted interim

approval to the Alcide Corporation of

Redmond, Washington, to permit the

use of SanovaTM equipment using

acidified sodium chlorite as an

antimicrobial treatment for reducing

microbial levels on raw poultry

carcasses. The Agency’s approval did

not extend to the use of the equipment

and acidified sodium chlorite for online reprocessing of contaminated

poultry. FSIS stated in the January 1999

letter that it would eventually add the

substance to the chart specifying the

food ingredients approved for use in the

preparation of meat and poultry

products under the heading

‘‘Antimicrobial agents’’ for pre-chilled

poultry carcasses at § 424.21(c).

In November 1999, FSIS received a

petition from Alcide requesting that the

Agency conduct rulemaking to approve

the use of its SanovaTM continuous online processing (COP) system, which

uses acidified sodium chlorite as an

antimicrobial treatment for on-line

reprocessing of contaminated poultry.

The process can be used in conjunction

with an IOBW, but an IOBW is not a

requirement of the system. The COP

system features a spray cabinet to

deliver an antimicrobial treatment of

acidified sodium chlorite (500 to 1200

ppm sodium with citric acid) to poultry

carcasses before the carcasses are

chilled.

FSIS intended to initiate rulemaking

to amend the chart to include acidified

sodium chlorite until a recent final rule

(64 FR 72168) and a Memorandum of

Understanding with the Food and Drug

Administration (FDA) on the listing of

food ingredients (MOU; FDA/FSIS

Regarding the Listing of Food

Ingredients and Sources of Radiation

Used in the Production of Meat and

Poultry Products, January 2000) were

issued. The documents provide that

FDA will list in its regulations in title

21 of the Code of Federal Regulations

(CFR) all food ingredients and sources

of radiation that are safe for use in the

production of meat and poultry

products. FSIS, through a separate

rulemaking activity, intends to delete

the chart in § 424.21(c), and the contents

of the chart will be appended to 21 CFR.

Meanwhile, FDA amended its food

additive regulations to provide for the

safe use of acidified sodium chlorite as

a antimicrobial agent in the processing

of red meat carcasses (63 FR 11118), on

red meat parts and organs (65 FR 1776),

in poultry processing (64 FR 26841),

and on poultry carcass parts (65 FR

16312).

Alcide also requested that any

regulatory proposal on performance

standards for on-line reprocessing of

poultry be deferred until FSIS has had

the opportunity to evaluate Alcide’s

petition. The Agency has reviewed

Alcide’s petition and the accompanying

data. The Agency’s review of the test

results from Alcide indicates that the

COP system achieves an average

reduction in Salmonella prevalence of

27.27 percent, and an average reduction

of Campylobacter prevalence of 25.6

percent. Alcide’s samples were fresh

and chilled, not frozen. Of the 1,070

post-COP treated carcasses sampled in

the five establishments, an average of 34

percent were negative for E. coli, and 66

percent were positive. Assuming that 10

or fewer cells of E. coli are considered

as a limit of detection, the estimated

prevalence in the sampling is 26.4

percent. If the samples were frozen,

Alcide estimated that freezing would

reduce the number of organisms in a

sample by 1 log10 (i.e., 90 percent)

resulting in only 5.4 percent of the

samples having a count greater than 10.

Unlike the Rhodia data that were

quantitative and focused on absolute

levels of reduction (i.e., less than 0.5

percent of the treated samples were

positive for Salmonella), Alcide’s data

documented degrees of reduction (i.e.,

there was an average reduction by 27.27

percent of the prevalence of Salmonella

on the treated samples). Alcide’s data

appear to document statistically

significant food safety enhancements

achieved at the five test establishments,

without establishing specific numerical

performance standards as Rhodia did

through its petition. Therefore, at this

time, the Agency has not been able to

equate the results of the data from the

two petitions. Nonetheless, because the

Agency has decided to go forward with

this rulemaking, it has granted the

Alcide petition, in part, except for the

company’s request to use nonquantitative performance standards.

FSIS is seeking public comment on

performance standard levels and hopes

to receive further data that are relevant

to this issue. It also seeks comment on

whether is is possible to equate the

Rhodia and Alicde data.

National Chicken Council Data

Meanwhile, a third set of data was

submitted to the Agency by the National

Chicken Council (NCC). The NCC

conducted testing in five establishments

regarding the commercial application of

TSP. The NCC data, like the Rhodia

data, show that on-line antimicrobial

reprocessing is superior to off-line

reprocessing, and that the prevalence of

E. coli and Salmonella can be reduced

considerably. In contrast to the Rhodia

data, however, the NCC data show that

freezing the samples has an impact on

the prevalence and counts of E. coli and

results in lower numbers. Although the

prevalence of Salmonella was lower in

frozen samples than in refrigerated

samples in the NCC study, the

difference between frozen and

refrigerated samples was not statistically

significant. NCC asserted that its

sampling (1,840 samples were analyzed

for Salmonella spp, and 1,320 were

analyzed for E. coli) demonstrated that

the that the 0.5 percent pre-chill

performance standard for Salmonella

and the 1.0 percent pre-chill

performance standard for E. coli were

not achievable following TSP

application in commercial operations.

NCC’s study was conducted in four

stages. Carcass rinses of whole birds

were performed at three designated sites

along the production line: pre TSP (post

IOBW), post TSP, and post-chill. The

sample types included ‘‘visually clean/

no TSP,’’ ‘‘visually contaminated/with

TSP,’’ and ‘‘visually contaminated/offline reprocessed/no TSP.’’ All carcass

rinses were tested for the presence or

absence of E. coli and Salmonella using

validated rapid screening methods.

Carcass rinses were kept chilled on wet

ice or refrigerated until transported to

the laboratory. Frozen samples were

held on dry ice for 18 to 24 hours and

thawed before setting. Positive results

were confirmed biochemically and

serologically.

Because the NCC data results are

substantially different from the Rhodia

data, the Agency is seeking comment on

what should be the new pre-chill

performance standards in order to

balance public health benefits for

consumers and achievable goals that

encourage establishment participation.

The Agency also is seeking comments

on the issue of the effect freezing has on

samples and any other aspects of the

NCC data. The data are available in the

FSIS Docket Room and on the FSIS web

page.

The NCC data point out another

factor. Currently, even in plants where

75192 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules

TSP or the Sanova system is in use,

birds that are grossly contaminated, and

then reprocessed off-line, enter the

chiller without the TSP or Sanova

treatment. This fact is significant

because there is sometimes a higher

prevalence of Salmonella in these plants

post-chill than pre-chill. Thus, FSIS

requests comment on whether it should

include, as a condition for permitting

on-line reprocessing, that all birds

entering the chiller, including those

reprocessed off-line, be treated with the

antimicrobial intervention.

Environmental Impact

There are increasing environmental

concerns associated with the use of

nutrients, particularly nitrogen,

phosphorus, and potassium, in

agricultural systems. In response to the

growing body of evidence about the

relationship among solid nutrient

loadings, nutrient transport off-sites,

and surface and ground water quality,

USDA’s Natural Resources Conservation

Service (NRCS) and other Federal

agencies have revised their policies for

delivering nutrient management and

issued new technical guidelines.

In agriculture, the greatest focus is on

the inputs of nutrients in the form of

fertilizers that exceed outputs of

nitrogen and phosphorus in the form of

crops and manure production. High

densities of poultry plants in some areas

in the United States have generated

concerns about manure production

exceeding the needs of crops to which

the manure is applied. The density of

animals on the land is directly related

to nutrient flows to aquatic ecosystems.

In addition, there is a concern about

the introduction of additional

substances into the agricultural

production process, particularly in view

of NRCS’s stated goal of reducing

nutrients used in agricultural

production. However, the waste water of

the more than 80 poultry establishments

that are engaged in on-line reprocessing

operations with TSP is handled

routinely by existing water treatment

systems or recycled as by-products

without entering the plant’s systems,

municipal water systems, or the ground

water.

However, would establishments

operating under more restrictive state

environmental laws and regulations

incur additional costs as a result of online reprocessing operations? Are such

operations restricted in some States?

FSIS would like the public to comment

on the environmental impacts

associated with on-line reprocessing

operations.

Request for Comments

FSIS has decided to publish this

proposed rule and to solicit comments

on the exact performance standard that

it should adopt. Although the Agency is

not now proposing specific performance

levels, FSIS is giving the public an

opportunity to comment on and provide

data that would support adopting a

particular performance level as the

standard.

The Agency is aware that not all

antimicrobial substances or processing

systems for poultry pre-chill may be

capable of attaining the pathogen

reduction levels Rhodia claims to have

achieved in its trials. FSIS is proceeding

with this proposal because it considers

pathogen reduction to be one of its

primary goals, and data supplied to date

appear to show significant

improvements in the ability to reduce

microbial contamination of poultry.

FSIS remains open to considering other

new technologies or treatments, and

alternate standards, in developing a

final rule. In recent years, trials with

TSP and other substances have

proliferated. FSIS would like to

accommodate any technology that is

safe and will significantly reduce the

prevalence of E. coli, Salmonella, and

other microorganisms on poultry

carcasses pre-chill.

In developing an appropriate

standard, the Agency believes that

poultry contaminated with digestive

tract contents must be held to a more

rigid pathogen reduction standard than

product that is not visibly contaminated

because digestive tract contents are a

source of pathogens and other

microorganisms. Furthermore, physical

removal of visible contamination does

not necessarily remove significant levels

of these pathogens and other

microorganisms, as evidenced by the

Rhodia trials involving off-line

reprocessed pre-chill carcasses.

Persuasive data that support specific

performance standards for on-line

reprocessed visibly contaminated

poultry pre-chill will be the basis for the

final rule. The Agency would like

public consideration of the following

questions: Should the performance

standards be based on organisms other

than E. coli and Salmonella? What is the

appropriate standard if chilled (i.e., not

frozen) samples are submitted for

laboratory analysis?

It is important to emphasize that

Rhodia used frozen, not chilled,

laboratory samples in its in-plant trials.

Data obtained by Rhodia on the effects

of freezing whole carcass rinse samples

indicated that there was no difference

between frozen or chilled TSP treated

samples. All TSP treated samples were

negative for E. coli, Enterobacteriaceae,

and Salmonella. These results are based

on a 2-day split sampling and testing

study at a plant conducting on-line

reprocessing using TSP. A copy of these

results is available to the public for

review in the FSIS Docket Room (See

ADDRESSES). No data were obtained

regarding frozen Campylobacter

samples. Campylobacter cells are

sensitive to freezing and generally die

off when subjected to temperatures at or

below freezing.

If adopted, the performance standards

should not only significantly improve a

single establishment’s performance but

also should lower the national baseline,

compelling improvements in process

control and pathogen reduction by all

establishments. FSIS is interested in

hearing from the poultry industry,

industry-related organizations, the

scientific community, academia,

consumers, consumer groups, and other

interested persons before developing a

final rule.

The Proposed Rule

FSIS is proposing to amend the

poultry products inspection regulations

at 9 CFR 381.91 by adding a new

subsection (c) that would allow poultry

carcasses contaminated with digestive

tract contents during slaughter to

remain on the main processing line

along with uncontaminated carcasses

for treatment with an antimicrobial

agent before the chiller. FSIS also is

proposing to amend the chart in 9 CFR

424.21(c) to extend the use of

antimicrobial agents to pre-chill poultry

carcasses.

Because FSIS is proposing to hold the

visibly contaminated carcasses to more

rigorous performance standards than

apply to other birds, plants would need

to establish verification and validation

procedures as part of their HACCP

system requirements. As part of the

plant’s on-going verification procedures,

FSIS expects that plants will identify

the visibly contaminated carcasses to

distinguish them from the

uncontaminated carcasses before the

birds proceed down the processing line

in order that the visibly contaminated

carcasses can be sampled separately

from the other birds after the treatment.

Furthermore, FSIS expects that plants

will identify an appropriate sampling

frequency for verification as part of the

HACCP system requirements.

In addition, in accordance with

§ 417.5(a)(1), establishments will need

to include in their hazard analyses

validating data, generated under

conditions of in-plant commercial

operations, demonstrating that the onVerDate 11<MAY>2000 09:25 Nov 30, 2000 Jkt 194001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\01DEP1.SGM pfrm03 PsN: 01DEP1
Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules 75193

line reprocessed contaminated poultry

carcasses achieve the proposed pre-chill

standards that FSIS adopts.

Establishments would establish critical

control points for the use of the

antimicrobial treatment based on the

determinations that they make as part of

their reassessment.

FSIS is not proposing to change the

requirement in § 381.65(e) that carcasses

contaminated with visible fecal material

not enter the chilling tank or to change

the finished product standards in

§ 381.76(b)(3). In addition, under the

proposed regulation, on-line

reprocessed carcasses, as well as the online non-contaminated carcasses, must

comply with the criteria for verifying

process control (E. coli testing) and with

the pathogen reduction performance

standards for Salmonella in accordance

with § 381.94 of the poultry regulations.

The Agency emphasizes that this

proposal would neither mandate on-line

reprocessing by all establishments nor

establish the use of specific equipment

and antimicrobial aids to reprocess prechilled poultry carcasses on-line.

Finally, the Agency requests

comments on amending the chart in

§ 424.21(c) to extend the use of

trisodium phosphate to ‘‘pre-chill’’

poultry carcasses.

Cost of the Proposal

The economic impact of this rule is

likely to be minimal because of the

voluntary nature of the practice this

proposal would authorize. An

establishment will use on-line

reprocessing if it is consistent with the

objectives of the firm, conforms with

plant configuration, provides increased

efficiency in achieving product

standards, improves product

characteristics, and other factors. The

poultry industry is highly competitive;

an increase in product price by a single

producer is likely to result in a loss of

market share. A firm is not likely to

purchase new equipment that will

increase overall production costs or

reduce profits.

The cost for a poultry plant to adopt

an acceptable on-line reprocessing

system will vary from plant to plant and

will be contingent on the location,

physical structure, and age of the plant

and the adaptability of the equipment.

Available information indicates that the

capital cost per line ranges from $10,000

to more than $55,000, with an average

cost of $35,600, which is close to the

manufacturer’s estimate for a single line

cost of $30,000.

Operating costs associated with online reprocessing systems also can vary

significantly as a result of plant size,

number of lines, processing capacity,

plant configuration, and other factors.

Rhodia estimates that the TSP

application cost will be about 0.2 cents

per pound for an average chicken

slaughter plant. The application of other

antimicrobial substances may vary

slightly in cost. Plant data suggest that

total annual operating costs, which

include labor, water softener, TSP, and

water, are very close to the

manufacturer’s estimate. Available

information suggests annual operating

costs of about $125,000 per line for an

average plant. Costs associated with offline reprocessing would be expected to

decline following installation of on-line

reprocessing equipment because of

reduced labor and other operating

requirements. Available data suggest the

decrease in operating costs because of

reduced off-line reprocessing is about

$70,000 per line, somewhat more than

half of the increase in operating costs

associated with TSP on-line

reprocessing. The available plant

information suggests that about twothirds of the plants would not

experience any change in sewage

treatment. The remaining third would

be required to perform additional

treatment at the plant to meet discharge

limits. Two-thirds of the plants would

show no change in water use, while the

remaining plants will have to increase

use by 1 to 2 gallons per bird, or about

10 percent.

For the average plant, the net present

value of capital costs and the net change

in operating costs of TSP on-line

reprocessing is about $1.2 million over

a 10-year period using a discount rate of

7 percent. Based on the assumptions

that the average plant processes about

200,000 birds per day, that an average

bird has a dressed weight of 3.6 pounds,

and the plant operates an average of 255

days per year over the next 10 years, the

increase in total production costs is

slightly more than .2 cents per pound.

The capital costs amortized over a 10-

year period are minimal on a per pound

basis. The costs to the poultry

processing industry would accrue to

plants engaged in slaughter, either

exclusively or in combination with

processing. In 1996, there were 281

federally inspected plants of this

description. Only one Federal-State

cooperative inspection plant is currently

engaged in poultry slaughter. If all such

plants voluntarily install an on-line

reprocessing system, the total cost to the

poultry industry would be about $345

million over a 10-year period.

The cost of a TSP on-line reprocessing

system represents an insignificant

portion of the retail price per pound of

poultry. If there is any increase in the

retail price of poultry, it will be modest

and offset by consumer confidence that

the product presents lower microbial

risks.

Cost Impact on Small Entities

The impact of the proposed rule on

small establishments is likely to be

minimal given that it is voluntary. A

firm will adopt the practice if it is

consistent with its objectives. The

limited evidence available does not

indicate that small firms would be at a

disadvantage if on-line reprocessing

were a uniformly accepted practice. The

initial capital costs and net change in

operating costs do not appear to be

related to plant size. In addition, the

magnitude of the costs, $1.2 million

over 10 years, would not represent a

significant share of overall costs for

small firms.

Request for Comments on Economic

Impact

The Agency would like comment

from the public and especially from

poultry firms that are currently engaged

in TSP or acidified sodium chlorite

reprocessing on the costs presented in

this document. Are the economic

assumptions valid? Do the decreases in

operating costs for reduced off-line

reprocessing appear to be reasonable?

The Agency expects that on-line

reprocessing will provide

establishments with considerable

economic advantages related to cost

savings gained from no longer having to

reprocess birds off-line. What levels of

savings would accrue to plants adopting

on-line reprocessing operations? How

much will the proposed new standards

for Salmonella and E. coli, if

implemented, contribute to higher costs

for product sampling? If the pathogen

reduction standards become tighter, can

compliance costs be expected to

increase? Because adopting on-line

reprocessing is voluntary, the amounts

of the increase are difficult to

determine. FSIS also would like to hear

from the public about whether the

Agency should consider deleting the

provisions for off-line reprocessing in

§ 381.91(b)(1) and (2) if on-line

reprocessing is implemented. FSIS

would like comments on the economic

impact on both large and small

establishments if such actions were

taken.

Industrial Hygiene Survey

At the request of FSIS, because of

concerns raised by in-plant inspectors,

an industrial hygiene survey was

conducted in 1999 by an independent

firm to evaluate potential dermal,

ocular, respiratory, or other exposure of

inspectors to TSP while working with

75194 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules

TSP-treated poultry or around TSP

treatment facilities. The study did not

address TSP exposure to plant

employees, whose job activities differ

significantly from those of inspection

employees. Based on interviews and

observations of inspectors and sampling

results, the risk of bodily contact with

significant quantities of TSP solution is

minimal for slaughter line inspectors.

They are not present when the TSP

solution is prepared and inspect and

handle the birds prior to TSP

application. This indicates no alkalinity,

TSP contact, or dermal hazard. The

survey results also show no respiratory

or ocular hazard from ambient TSP dust

or mist in the plant.

Other inspectors who perform a

variety of tasks throughout the plant

may come into contact with small

quantities of TSP solution when

conducting pre-chill finished product

standard checks and Acceptable Quality

Level (AQL) giblet checks. There is also

the potential for transient ocular

exposure. The survey recommends the

mandatory use of safety glasses when

performing activities where exposure to

TSP occurs and PVC or natural rubber

gloves when handling poultry post TSP

application. It encourages the

consideration of barrier creams on a

voluntary basis, routine washing at

signs of TSP solution contact, and

awareness of emergency lavage for

accidental eye contact. The study

recommends that federally inspected

establishments provide emergency

eyewashes within a limited distance

from TSP use areas and training

regarding these recommendations.

Rhodia Inc. conducted a later study in

June 1999 to monitor the effects of TSP

exposure on both plant and inspection

employees at four locations in 46 plants.

The study concluded that there were no

safety risks to either plant or inspection

employees from exposure to TSP. Food

Safety Benefits of On-line Reprocessing.

Scientific and public concern about

microbiological contamination of

poultry products has expanded from the

processing of such products to

conditions under which poultry are

slaughtered to pre-slaughter poultry

production. FSIS has encouraged the

scientific community and the industry

to develop slaughter and processing

methods and treatments that would

yield raw poultry products that are as

free as practicable of pathogenic

bacteria.

The use of TSP and other

antimicrobial rinses would not

eliminate the need for continued careful

handling of raw poultry products.

However, by allowing the visibly

contaminated carcasses to remain online, all carcasses are subject to further

rinsing and antimicrobial treatment. The

result will be lesser risks because of

reduced pathogen prevalence on

contaminated poultry carcasses. Not

handling contaminated carcasses in offline reprocessing may reduce the risk of

foodborne pathogens from crosscontamination of the contaminated

carcasses.

Executive Order 12866

FSIS has determined that this

regulatory proposal is not a significant

rule under Executive Order 12866 and,

therefore, it has not undergone review

by the Office of Management and

Budget.

Alternatives

Executive Order 12866 requires that

FSIS identify and assess alternative

forms of regulation. FSIS considered

two alternatives to this proposed rule:

(1) Not proposing to allow for the online reprocessing of contaminated

carcasses and (2) proposing to require

plants to perform on-line reprocessing

of pre-chill contaminated carcasses and

establishing specific numerical

performance standards that the

reprocessed poultry must meet using a

mandated antimicrobial treatment or

process. FSIS rejected both alternatives

for the reasons explained below.

Failing To Propose

FSIS is committed to reducing the

levels of microbial pathogens in poultry

products. On-line reprocessing of

poultry in commercial trials using

solutions of TSP/chlorine and acidified

sodium chlorite has been shown to be

a highly effective method of reducing

the microbial levels of raw poultry to

levels substantially below the

performance standards and criteria

established by the pathogen reduction/

HACCP final rule.

Mandating Procedures, Materials, and

Methods

FSIS is proposing to give all

establishments the option of adopting

on-line reprocessing of visibly

contaminated birds. By not mandating

that all plants adopt on-line

reprocessing, FSIS is recognizing that

there are other solutions to reducing

bacterial loads that may be more

appropriate and cost-effective for small

plants. There are many possible

solutions for pathogen reduction of raw

poultry and poultry products, and the

industry continues to seek out new

products and equipment that will be

effective.

Pathogen reduction is central to the

FSIS food safety strategy. However,

eliminating as many prescriptive or

command-and-control regulations as

possible also is an important part of the

overall strategy for updating and

improving inspection in light of

HACCP. Therefore, there will be no

mandate proposed for establishments to

use TSP or any other substance as the

antimicrobial reprocessing aid.

Various substances have undergone

trials to determine their potential as

antimicrobial processing agents. Such

substances include acidified sodium

chlorite; organic acids such as lactic,

acetic, and formic acids; chlorine

dioxides; and ozone. Plants will be free

to use other products that have

demonstrated their efficacy in reducing

levels of microorganisms in in-plant

commercial trials. This is consistent

with the Agency’s strategy of

encouraging the industry to take

advantage of new technology to reduce

the risks associated with the

consumption of meat and poultry

products.

Executive Order 12988

This proposed rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. This proposed rule

would provide for the on-line

reprocessing of poultry carcasses

accidently contaminated with digestive

tract contents during slaughter.

States and local jurisdictions are

preempted under the PPIA from

imposing any requirements with respect

to federally inspected premises and

facilities, and operations of such

establishments, that are in addition to,

or different from, those imposed under

the PPIA. States and local jurisdictions

also are preempted under the PPIA from

imposing any marking, labeling,

packaging, or ingredient requirements

on federally inspected poultry products

that are in addition to, or different than,

those imposed under the PPIA. States

and local jurisdictions, however, may

exercise concurrent jurisdiction over

poultry products that are misbranded or

adulterated under the PPIA or, in the

case of imported products, which are

not at such an establishment after their

entry into the United States. States and

local jurisdictions also may make

requirements or take other actions that

are consistent with the PPIA, with

respect to any other matters regulated

under the PPIA.

Under PPIA provisions, States that

maintain poultry inspection programs

must impose requirements on State

inspected products and establishments

that are at least equal to those required

under the PPIA. These States, however,

may impose more stringent

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules 75195

requirements on such State-inspected

products and establishments.

Additional Public Notification/Request

for Comments

FSIS has considered the potential

civil rights impact of this proposed rule

on minorities, women, and persons with

disabilities. FSIS anticipates that this

proposed rule will not have a negative

or disproportionate impact on

minorities, women, or persons with

disabilities. However, proposed rules

generally are designed to provide

information and receive public

comments on issues that may lead to

new or revised Agency regulations or

instructions. Public involvement in all

segments of rulemaking and policy

development is important.

Consequently, in an effort to better

ensure that minorities, women, and

persons with disabilities are aware of

this proposed rule and are informed

about the mechanism for providing their

comments, FSIS will announce it and

provide copies of this Federal Register

publication in the FSIS Constituent

Update.

FSIS provides a weekly FSIS

Constituent Update, which is

communicated via fax to more than 300

organizations and individuals. In

addition, the update is available on line

through the FSIS web page located at

http://www.fsis.usda.gov. The update is

used to provide information regarding

FSIS policies, procedures, regulations,

Federal Register notices, FSIS public

meetings, recalls, and any other types of

information that could affect or would

be of interest to our constituents/

stakeholders. The constituent fax list

consists of industry, trade, and farm

groups, consumer interest groups, allied

health professionals, scientific

professionals, and other individuals that

have requested to be included. Through

these various channels, FSIS is able to

provide information to a much broader,

more diverse audience. For more

information and to be added to the

constituent fax list, fax your request to

the Congressional and Public Affairs

Office, at (202) 720–5704.

Paperwork Requirements

FSIS has reviewed the paper and

recordkeeping requirements in this

proposed rule in accordance with the

Paperwork Reduction Act.

Establishments choosing to reprocess

poultry on-line using an antimicrobial

treatment before the chiller will need to

do so in accordance with 9 CFR Part

417. Accordingly, establishments will

reassess their HACCP plans as

prescribed in § 417.4(a)(3). Also, in

accordance with § 417.5(a)(1),

establishments will need to generate

and maintain validating data, generated

under conditions of in-plant commercial

operation, demonstrating that the

reprocessing substance or system

resulted in product that meets any

performance standard that FSIS adopts.

Based on the determinations

establishments make as part of their

reassessments, they may establish

critical control points for the use of the

antimicrobial treatment.

Estimate of Burden: The Agency

estimates that it will take 8 hours for

establishments to reassess their HACCP

plans and to prepare the validating data

they will include in their hazard

analysis. For purposes of this paperwork

analysis, FSIS will assume that all

establishments will establish a critical

control point for the use of the

antimicrobial treatment. Accordingly,

an establishment will spend about 5

minutes a day (250 days) completing

one monitoring record and 2 minutes a

day filing the record for one HACCP

plan.

Respondents: Meat and poultry

product establishments.

Estimated Number of Respondents:

80.

Estimated Number of Responses per

Respondent: 1 for HACCP reassessment;

250 for monitoring records, and 250 for

filing the record.

Estimated Total Annual Burden on

Respondents: 2,974.

Copies of this information collection

assessment can be obtained from Lee

Puricelli, Paperwork Specialist, FSIS,

USDA, Room 109 Cotton Annex

Building, Washington, DC 20250–3700.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the Agency,

including whether the information will

have practical utility; (b) the accuracy of

the Agency’s estimate of the burden of

the proposed collection of information,

including the validity of the method and

assumption used; (c) ways to enhance

the quality, utility, and clarity of the

information to be collected; (d) ways to

minimize the burden of the collection of

information on those who respond,

including through use of appropriate

automated, electronic, mechanical, or

other technological collection

techniques or other forms of information

technology. Comments may be sent to

Mr. Puricelli at the address above and

to the Desk Officer for Agriculture,

Office of Information and Regulatory

Affairs, Office of Management and

Budget (OMB), Washington, DC 20253.

List of Subjects in 9 CFR Parts 381 and

424

Poultry and poultry products.

For the reasons discussed in the

preamble, FSIS is proposing to amend 9

CFR part 381 as follows:

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

1. The authority citation for part 381

continues to read as follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C.

451–470, 7 CFR 2.18, 2.53.

2. Section 381.91 would be amended

by adding paragraph (c) to read as

follows:

§ 381.91 Contamination.

* * * * *

(c) In lieu of the provisions in

paragraph (b) of this section, any

poultry carcass contaminated during

slaughter with digestive tract contents

may remain on the main processing/

slaughter line and be reprocessed while

on-line through use of an antimicrobial

technique, in accordance with the

Hazard Analysis and Critical Control

Point (HACCP) system requirements in

part 417 of this chapter. Validating data,

generated under conditions of in-plant

commercial operations, must

demonstrate that the visibly

contaminated carcasses that are

reprocessed on-line meet the pre-chill

performance standard of: ____. Birds

whose entire carcass is contaminated by

digestive tract contents under paragraph

(b)(1) of this section or birds that have

been mutilated under paragraph (a) of

this section may not remain on the main

processing/slaughter line and may not

be reprocessed using the on-line

antimicrobial technique.

PART 424—PREPARATION AND

PROCESSING OPERATIONS

3. The authority citation for 9 CFR

part 424 continues to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53.

4. The table in § 424.21(c) would be

amended by adding an entry for

‘‘Antimicrobial agents for use as

secondary additives’’ after the entries

for ‘‘Antimicrobial agents’’ to read as

follows:

§ 424.21 Use of food ingredients and

sources of radiation.

* * * * *

(c) * * *

75196 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Proposed Rules

Class of

substance Substance Purpose Products Amount

*******

Antimicrobial agents for

use as secondary additives.

Trisodium phosphate ........ To reduce microbial levels

during reprocessing.

Raw, chilled or pre-chilled

poultry carcasses.

8 to 12%; in conjunction

with a water spray containing 20 ppm chlorine;

solution to be maintained between 45–55°F

after chilling and applied

by spraying chilled or

pre-chilled carcasses for

up to 15 seconds in accordance with 21 CFR

182.1778.

*******

* * * * *

Done at Washington, DC, on: November 22,

2000.

Thomas J. Billy,

Administrator.

[FR Doc. 00–30497 Filed 11–30–00; 8:45 am]

BILLING CODE 3410–DM–P

DEPARTMENT OF ENERGY

Office of Energy Efficiency and

Renewable Energy

10 CFR Part 430

[Docket Number EE–RM/STD–00–550]

RIN 1904–AB08

Energy Conservation Standards for

Distribution Transformers

AGENCY: Office of Energy Efficiency and

Renewable Energy, Department of

Energy.

ACTION: Proposed rule; notice of

extension of comment period.

SUMMARY: On October 6, 2000, the

Department of Energy (DOE or

Department) published a Notice of

public workshop and availability of the

Framework Document for Distribution

Transformer Efficiency Standards. 65 FR

59761. The document announced that

December 1, 2000, would be the closing

date for receiving public comments and

information on the matters addressed in

the Framework Document and on other

matters relevant to consideration of

energy conservation standards for

distribution transformers. On November

1, 2000, during the public workshop on

the energy efficiency rulemaking

process for distribution transformers,

several stakeholders requested that the

comment period be extended. The

Department agrees to extend the

comment period closing date until

January 16, 2001.

DATES: Comments must be received on

or before January 16, 2001.

ADDRESSES: Written comments are

welcome. Please submit written

comments to: Ms. Geraldine Paige, U.S.

Department of Energy, Office of Energy

Efficiency and Renewable Energy,

‘‘Energy Conservation Program for

Consumer Products: Energy

Conservation Standards for Distribution

Transformers, Docket No. EE–RM/STD–

00–550’’, EE–41, 1000 Independence

Avenue, SW., Washington, DC 20585–

0121. Telephone: (202) 586–9130;

Telefax: (202) 586–4617. You should

label comments both on the envelope

and on the documents, and submit them

for DOE receipt by January 16, 2001.

Please submit one signed copy and a

computer diskette (WordPerfect 8) or 10

copies (no telefacsimiles). The

Department will also accept

electronically-mailed comments, by email to Geraldine.Paige@ee.doe.gov, but

you must supplement such comments

with a signed hard copy.

FOR FURTHER INFORMATION CONTACT: Carl

Adams, U.S. Department of Energy,

Office of Energy Efficiency and

Renewable Energy, EE–41, 1000

Independence Avenue, SW.,

Washington, DC 20585–0121, (202) 586–

9142, e-mail: carl.adams@ee.doe.gov, or

Edward Levy, Esq., U.S. Department of

Energy, Office of General Counsel, GC–

72, 1000 Independence Avenue, SW.,

Washington, DC 20585, (202) 586–9507,

e-mail: Edward.Levy@hq.doe.gov.

Issued in Washington, DC, on November

27, 2000.

Dan W. Reicher,

Assistant Secretary Energy Efficiency and

Renewable Energy.

[FR Doc 00–30641 Filed 11–30–00; 8:45 am]

BILLING CODE 6450–01–P

DEPARTMENT OF THE TREASURY

Office of the Comptroller of the

Currency

12 CFR Part 8

[Docket No. 00–29]

RIN 1557–AB90

Assessment of Fees; National Banks;

District of Columbia Banks

AGENCY: Office of the Comptroller of the

Currency, Treasury.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Office of the Comptroller

of the Currency (OCC) proposes to

amend its assessment regulation to

clarify that the OCC has authority to

charge a national bank when the OCC

conducts a special examination of a

third party that provides services to the

bank. The proposal applies in the same

way to a District of Columbia bank and

to a Federal branch or agency.

DATES: Comments must be received by

January 2, 2001.

ADDRESSES: Please direct your

comments to: Communications

Division, Office of the Comptroller of

the Currency, 250 E Street, SW., Third

Floor, Washington, DC 20219,

Attention: Docket No. 00–29; Fax

number (202) 874–5274 or Internet

address: regs.comments@occ.treas.gov.

Comments may be inspected and

photocopied at the OCC’s Public

Reference Room, 250 E Street, SW.,

Washington, DC, between 9 a.m. and 5

p.m. on business days. You can make an

appointment to inspect comments by

calling (202) 874–5043.

FOR FURTHER INFORMATION CONTACT:

Mitchell E. Plave, Senior Attorney,

Legislative and Regulatory Activities

Division, (202) 874–5090.