Use of Trisodium Phosphate on Raw, Chilled Poultry Carcasses

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. 92-026F]

RIN 0583-AB65

Use of Trisodium Phosphate on Raw, Chilled Poultry Carcasses

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the

poultry products inspection regulations to permit the application of

trisodium phosphate (TSP) on raw, chilled poultry carcasses passed for

wholesomeness. The TSP solution will be permitted as an antimicrobial

agent on such poultry carcasses at a level of 8 to 12 percent. The

solution must be maintained at a temperature of 45 deg.F to 55 deg.F

and applied by spraying or dipping carcasses for up to 15 seconds.

Tests conducted by industry and FSIS have shown that the use of TSP, at

the above-stated concentration, temperature, and duration, reduces

microbial populations on raw, chilled poultry surfaces.

EFFECTIVE DATE: August 28, 1996.

ADDRESSES: Copies of the studies, reports, letters, and publications

referenced in this docket are available for public inspection in the

FSIS Docket Room, USDA, 14th and Independence Avenue, SW., Room 4352,

South Agriculture Building, Washington, DC 20250.

FOR FURTHER INFORMATION CONTACT:

Dr. William O. James, Director, Slaughter Inspection Standards and

Procedures Division, Science and Technology, Food Safety and Inspection

Service, U.S. Department of Agriculture, Washington, DC 20250; (202)

720-3219.

SUPPLEMENTARY INFORMATION:

Background

FSIS was petitioned by Rhone-Poulenc, Inc., Cranbury, New Jersey,

to permit the use of food-grade TSP as a processing aid in post-chill

poultry slaughter operations. TSP is listed in the Food and Drug

Administration (FDA) regulations as generally recognized as safe (GRAS)

for multiple-purpose use in accordance with good manufacturing

practices (21 CFR 182.1778). The petitioner requested the use of a

treatment solution consisting of TSP dissolved in water to a

concentration of 10 percent, plus or minus 2 percent (8 to 12 percent).

The petitioner requested exposure of the poultry to the TSP treatment

solution for no more than 15 seconds, with the TSP treatment solution

being maintained at 50 deg.F, plus or minus 5 deg.F (45 deg.F to 55

deg.F).

The petitioner included data in its petition demonstrating that the

use of TSP is effective in reducing the levels of bacteria, including

pathogenic bacteria, found on raw, chilled poultry carcasses. FSIS also

conducted studies to determine the efficacy of TSP on raw, chilled

poultry carcasses. These studies demonstrate that the use of TSP on

raw, chilled poultry carcasses results in statistically significant

reductions in the levels of bacteria.

Additionally, FDA evaluated the petitioner's request for the use of

TSP as a processing aid in poultry and concluded that the treatment

leaves no residues on the product which could be harmful to consumers.

Therefore, in an August 25, 1992, letter to Rhone-Poulenc, Inc., FDA

approved the use of TSP as a processing aid on raw poultry, under

conditions to be established by FSIS.

FSIS determined that use of TSP requested by the petitioner was

suitable for the intended purpose 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 Poultry Products Inspection Act.

On January 5, 1994, FSIS proposed to amend the poultry products

inspection regulations at 9 CFR 381.147(f)(4) to add antimicrobial

agents as a new class of substance for use on poultry products, and to

add TSP as an approved antimicrobial agent. FSIS proposed to permit the

use of TSP on raw, chilled poultry carcasses at a level of 8 to 12

percent. The TSP treatment solution would be maintained at 45 deg.F to

55 deg.F, and would be applied either by spraying or dipping the raw,

chilled poultry carcasses for up to 15 seconds.

Discussion of Comments

FSIS received 21 comments in response to the proposed rule. All but

2 commenters favored the proposal. In general, those favoring the

proposal stated that TSP treatment reduces bacterial levels on poultry

carcasses and decreases consumer exposure to pathogens. They believed

food-grade TSP has been proved safe. The following is a discussion of

the relevant issues raised in all of the comments.

One commenter believed FDA's GRAS affirmation of TSP did not apply

to the hydrous formulation of AvGard, a proprietary name for food-grade

TSP.

In a 1979 proposed rule, FDA specifically defined TSP as containing

``* * * 1 or 12 molecules of water of hydration'' (44 FR 74845, 74857).

AvGard contains 12 molecules of hydration and, therefore, is included

in the definition of TSP. Citing the report of the Select Committee on

GRAS Substances, FDA concurred that ``there is no evidence in the

available information on * * * sodium phosphate, tribasic [TSP] * * *

that demonstrates, or suggests reasonable grounds to suspect, a hazard

to the public when they [GRAS phosphates] are used at levels that are

now current or might reasonably be expected in the future'' (44 FR

74851-52).

It is within FDA's purview to affirm the multiple purpose GRAS

status of TSP, which FDA did in the previously noted August 25, 1992,

letter to Rhone-Poulenc. The Food Chemicals Codex, 3rd edition,

specifically lists anhydrous and hydrous formulations of TSP as meeting

the specifications for TSP.

[[Page 39274]]

One commenter questioned the validity of FSIS's TSP study conducted

in April 1992. Since the control and treated carcass bacterial counts

were low, this commenter wondered whether the results were

representative.

A statistically valid number of carcasses were randomly selected by

FSIS personnel over four consecutive days in April, 1992. Routine FSIS

quality control checks on the ability of the nutrient broth, agar, and

reagents to recover microorganisms were within normal limits. These

routine FSIS quality control checks verified the accuracy of the

results from the April 1992 study.

Additional data submitted with the petition, and available during

the comment period, demonstrated statistically significant reductions

of bacteria, including Salmonella, on poultry carcasses following post-

chill immersion in TSP. The data showed that Salmonella prevalence

after TSP treatment was consistently reduced from levels as high as 31

percent to levels below the laboratory limit of detection. Comparable

results were obtained whether the samples were refrigerated or frozen.

Similar results were found using prevalence or most probable number.

Inoculation studies with Salmonella typhimurium showed a reduction

between 95 and 100 percent. The Bender/Brodsky patented process for TSP

application references similar test results.

Independent scientific studies [1],[2] also demonstrate the

efficacy of TSP in reducing Salmonella on raw, chilled poultry

carcasses. A study on the effect of TSP on Salmonella typhimurium,

Campylobacter jejuni, E. coli 0157:H7, and Listeria monocytogenes

showed that TSP not only reduced bacterial counts on raw poultry, but

could potentially be used to reduce bacterial counts on other foods and

on food and non-food contact surfaces. [3]

Therefore, FSIS has determined that information submitted by the

petitioner, in the Agency's own studies, and in the scientific

literature substantiates the efficacy of TSP as an antimicrobial agent

on raw, chilled poultry carcasses.

On commenter questioned the petitioner's results due to unknown

testing methodology and asked whether FSIS will seek comment on the

experimental protocol.

Before any chemical not listed in 9 CFR 381 can be tested in

official poultry establishments, the proposed conditions of use are

reviewed by FSIS scientists. Only after acceptance of the testing

protocol by FSIS may a trial begin. Since these trials are conducted in

official establishments, supervised by FSIS personnel, and designed to

address FSIS information requirements, FSIS does not routinely seek

outside comment on the testing protocols.

One commenter questioned the relationship between the proposed

conditions of TSP use (8-12 percent solution maintained at a

temperature between 45 deg.F and 55 deg.F, and applied for up to 15

seconds) and the supporting studies.

FSIS and industry studies referenced in the proposed rule

demonstrate TSP efficacy against bacteria, including pathogenic

bacteria, at concentrations as low as 6 percent and temperatures as low

as 42 deg.F. The most consistent results were achieved at TSP

concentrations of 8-12 percent. Although efficacy of TSP is primarily

related to solution concentration, not solution temperature, an upper

55 deg.F temperature limit for post-chill TSP use is consistent with

the general chilling requirements in 9 CFR 381.66(b)(1), which permits

a maximum internal temperature of 55 deg.F in processing operations,

providing other requirements are met. Fifteen seconds was the time

necessary to adequately apply the TSP to raw, chilled poultry carcasses

on a moving line.

This commenter also asked whether these supporting studies used

AvGard, a proprietary name for food-grade TSP. All TSP studies

referenced in this docket used AvGard.

One commenter suggested TSP use may increase or decrease moisture

absorption in poultry carcasses. Under current industry practice,

broiler carcasses are chilled for approximately 60 minutes in immersion

chillers. FSIS and petitioner studies have demonstrated the additional

15 second application of TSP does not result in moisture violations. As

part of the poultry chilling process, poultry carcasses may gain

moisture up to the levels permitted in 9 CFR 381.66(d). Poultry

establishments using TSP are not exempted from the moisture absorption

and retention limits contained in 9 CFR 381.66(d). Federal

establishments applying TSP to raw, chilled poultry will include the

TSP application in their washing, chilling, and draining method as

outlined in 9 CFR 381.66(d)(8).

One commenter questioned the petitioner's claim that virtually no

residue remains on or in treated poultry carcasses. The commenter

referenced an abstract from an Agricultural Research Service (ARS)

study, ``Effect of TSP on Salmonella Attached to Chicken Skin'' that

seemed to refute the petitioner's claim. That abstract incorrectly

stated that a high residual skin pH indicated the presence of TSP

residue. In response to peer-review of the study, that assertion was

removed when the study was published in the Journal of Food Protection.

Testing carcasses for pH does not directly correlate with phosphate

residues. FSIS monitors meat and poultry for chemical residues by using

specific analytical tests for the chemical residue in question. The

1993 FSIS Food Chemistry Guidebook recommends the quimociac method for

phosphate determinations in meat and poultry. This analytical method

determines phosphate levels within 0.05 percent. The petitioner used

the FSIS recommended quimociac method, and, therefore, FSIS accepted

the petitioner's results of virtually no residue.

One commenter asked whether use of an ``* * * FSIS approved drag

through tank and attendant pump and filtration unit * * *,'' as

mentioned in the petition from Rhone-Poulenc, would be required. This

commenter also requested information on the significance of such

equipment.

FSIS believes that requiring specific application equipment would

not afford establishments sufficient flexibility in meeting good

manufacturing practices (GMP) for TSP application. The Agency believes

that the regulations in 9 CFR 381.53, regarding use of equipment in

official establishments, are sufficient to ensure that the proper

equipment is used for TSP application.

The equipment used was not significant in the results of the

studies. However, it is unlikely that establishments, using current

industry practices, will be able to apply TSP as a dip to raw, chilled

poultry on a moving line without use of a drag-through tank. The

process used in the studies is patented by Rhone-Poulenc, Inc.

One commenter expressed five concerns regarding the occupational

safety of TSP. First, this commenter referenced U.S. Coast Guard and

U.S. Department of Housing and Urban Development documents describing

non-food-grade TSP as potentially hazardous to worker safety.

These references referred to use of non-food-grade TSP as a paint

stripper on ocean vessels and for lead paint abatement in buildings.

This commenter did not document any hazards from the use of food-grade

TSP. TSP has been safely used for decades in a variety of food

manufacturing establishments producing processed cheeses, breakfast

cereals, and snack foods.

Second, the commenter referenced TSP workplace environmental

exposure limits from the American Industrial

[[Page 39275]]

Hygiene Association, an industry group without regulatory authority,

and incorrectly stated that the Occupational Safety and Health

Administration (OSHA) does not have general exposure limits for TSP.

Although OSHA does not list air contaminant limits specifically for

TSP, OSHA considers TSP a ``Particulate not otherwise regulated''

(PNOR) (29 CFR 1910.1000 Table Z-1). Additionally, OSHA has regulatory

authority over worker and workplace safety, including those in

federally inspected establishments. The OSHA regulations contained in

Title 29, Code of Federal Regulations, address worker and workplace

safety regarding the use of TSP.

Third, this commenter inquired about the nature of any

communication regarding TSP between OSHA and FSIS.

The OSHA workplace safety levels for TSP as a PNOR are clearly

codified in the above-referenced regulations, and FSIS has confirmed

with OSHA that TSP is regulated as a PNOR.

Fourth, this commenter referred to U.S. Coast Guard recommendations

for protective respiratory equipment for workers using non-food-grade

TSP, even though OSHA does not specifically require the use of such

protective respiratory equipment.

OSHA regulations state, in part, that accepted engineering control

measures, such as adequate ventilation, where feasible, may be

sufficient to prevent atmospheric contamination (29 CFR 1910.134).

To evaluate the safety of TSP use, FSIS contracted for industrial

hygiene studies at two federally inspected establishments that are

using TSP under interim approval. Because of the alkalinity of TSP,

these studies recommended use of protective eyeware and gloves for FSIS

employees monitoring the TSP application equipment. No medically

substantiated occupational illness related to TSP use was documented

from those two studies. Three TSP commercial poultry trials and 30 in-

plant demonstrations, totaling more than 1,000 combined days of TSP use

or testing, demonstrated no documented worker or workplace problems as

a result of working in, around, or with food-grade TSP treatment

facilities or TSP-treated product. As a result of the FSIS-initiated

industrial hygiene studies, FSIS requires establishment management to

provide FSIS employees with protective clothing or equipment. The

establishment's ``Material Safety Data Sheet,'' as required under OSHA

regulations, specifies the conditions under which establishment

management must provide protective gear. FSIS employees have access to

the Material Safety Data Sheet. The necessity of using protective

equipment, such as eye wear or latex gloves, will depend on OSHA

requirements (29 CFR 1910.133) and specific methods of TSP application

in individual establishments.

Fifth, this commenter expressed concern over the lack of a specific

antidote for any TSP-related industrial overexposure (e.g., dermal,

oral, ocular, or respiratory exposure).

In fact, most substances do not have specific antidotes for

overexposure. Therapy for most excessive exposures entails symptomatic

treatment. As with all chemicals, especially those used in an

industrial environment, caution should be exercised in handling.

Protective equipment suitable for the specific application and access

to means for diluting accidental chemical exposure, such as eyewashes

and emergency showers, are commonly available.

One commenter expressed concern regarding the effect of TSP, an

orthophosphate compound, on the environment, and referenced the

Comprehensive Environmental Response, Compensation, and Liability Act

(CERCLA, Title 42 U.S.C. 9601 et seq.) and U.S. Department of

Transportation (DOT) requirements for notification of TSP release into

the environment.

TSP (sodium phosphate, tribasic) is classified as a Category D

hazardous substance under CERCLA (40 CFR 302.4). Category D substances,

being the safest of five hazardous substance categories, are subject to

CERCLA notification only for releases of 5,000 pounds. DOT regulations

(49 CFR 172.101, App. A), which are based on the Superfund Amendments

and Reauthorization Act of 1986 (Public Law 99-499), have an identical

requirement for reporting releases of 5,000 pounds of TSP into the

environment. This commenter also inquired about any communication and

coordination between the U.S. Environmental Protection Agency (EPA),

DOT, and FSIS on this rule. FSIS contacted EPA to affirm that CERCLA

notification for TSP was 5,000 lbs. and that individual states regulate

industrial effluent either directly or indirectly.

One commenter believed the disposal of TSP as an animal-feed

ingredient should be required by FSIS to minimize the potential for

phosphate release into the environment.

FDA, not FSIS, has the authority to determine whether TSP can be

disposed of by conversion into an animal-feed ingredient. In a July 13,

1992, letter to Rhone-Poulenc, Inc., FDA stated the conditions under

which it would permit TSP to be converted into an animal feed, and

stated that it will consider, on a case-by-case basis, requests for the

use of other by-products from the permitted recovery process.

Additionally, State and local authorities have the authority to

promulgate standards for phosphate discharge into the environment.

Establishment effluent is regularly monitored by State or local

officials with statutory authority over effluent discharge.

Another commenter questioned the safety of eating animals that have

consumed calcium phosphate derived from the conversion of spent TSP.

No supporting documentation accompanied that comment. FDA stated in

a July 9, 1992, letter to Rhone-Poulenc that precipitation of spent TSP

with tricalcium phosphate forms calcium phosphate in accordance with

the Association of American Feed Control Officials definition. FDA

partially based its decision allowing this conversion of spent TSP into

calcium phosphate on the known safety of the commonly used feed

additive calcium phosphate to humans and animals. FSIS is not aware of

any published study suggesting that use of calcium phosphate in animal

feeds is a human health hazard.

One commenter questioned the safe environmental disposal of TSP and

referenced a United Nations (U.N.) Environment Programme data profile

for chemicals, but incorrectly stated this document reflected U.N.

standards for TSP disposal. This U.N. document specifically states that

it does not necessarily reflect the views or official policies of the

U.N. Environment Programme. The U.N. data profiles for chemicals is

intended to be used by those professionally engaged in the management

of waste. The referenced data profile should not be considered on its

own merit, but merely as part of an integrated body of scientific

evidence. Local and state governments, not U.N. data profiles, have

statutory authority over phosphate release by official establishments.

One commenter raised questions regarding pre-chill uses of TSP.

Uses of TSP, other than those discussed in the proposed rule, as

appropriate, will be handled through separate rulemakings.

Three commenters noted that use of TSP should not be a substitute

for current inspection practices. FSIS agrees and views the use of TSP

as an addition to, not a substitute for, effective inspection and

process control.

One commenter stated that regular end-product testing should be

[[Page 39276]]

conducted to ensure the effectiveness of TSP.

FSIS does not currently plan to conduct routine microbiological

monitoring of TSP-treated product. Previously referenced studies

demonstrate the efficacy of TSP when applied with the FSIS-accepted

concentration, time, and temperature. Industry and FSIS will monitor

the TSP application process to ensure adherence to good manufacturing

practices.

One commenter preferred use of ``alternate methods to reduce

microorganisms,'' such as trimming contamination, slowing line speeds,

and utilizing air chilling, rather than either utilizing the current

method of immersion chilling or applying TSP. This commenter did not

provide evidence in support of these ``alternate methods.'' FSIS is

aware of several studies regarding these alternate methods. [4], [5],

[6], [7] None demonstrates that removing contamination solely by

trimming or line-speed reductions lowers levels of microorganisms on

poultry carcasses.

Regarding air chilling, studies conducted by the Commission of the

European Communities, [8] using birds from the same flock, showed that

immersion-chilled and air-chilled poultry carcasses had similar numbers

of Salmonella. However, unlike these alternate methods, use of a TSP

solution has demonstrated statistically significant reductions in

bacteria, including pathogenic bacteria, on poultry carcasses.

J. E. Thomson et al. [9] concluded that commercial immersion

chilling of broilers, with properly used equipment and adequate water

replacement, can reduce bacterial counts to lower levels than air-blast

chilling. Air-blast chilling does not significantly reduce bacterial

counts. Air chilling in chill-rooms or by continuous air-blast requires

low scald temperatures to minimize surface drying and does not have the

advantage of the washing effect of submersion chilling. Air chilling

does not reduce levels of Campylobacter contamination dramatically,

presumably because the carcass does not dry-out sufficiently on all

parts of the surface, either inside or out. Air-chilled carcasses are

always likely to have higher bacterial levels than those chilled in a

properly controlled immersion chiller. [10] Incidence of Campylobacter

jejuni/coli can be reduced significantly in establishments using

chlorinated chiller water, however the prevalence rates for this

organism have been reported in the range of 50 to 100 percent. [9]

The findings of most researchers indicate there is a potential for

cross-contamination during immersion chilling, but with properly used

equipment, and adequate chlorinated water replacement, the washing

effect of commercial immersion chilling of broilers will reduce total

bacterial counts. [11], [12], [13], [14] K.N. May [15] collected data

that found immersion chilling sanitary with reduction in total

bacterial counts. The work of Busta et al. [16] indicates that the

number of birds contaminated with pathogens is also reduced by

immersion chilling. J.E. Thomson et al. [17] and W.O. James et al. [13]

demonstrated that chlorination of chiller water reduced or eliminated

Salmonella cross-contamination. R.M. Blood and B. Jarvis [18] showed

that bacterial levels were inversely related to the amount of fresh

replacement water along with chlorine at 30-50 ppm added to the

chillers.

The commenter's concern over immersion chilling cannot be supported

by carefully conducted research on properly operated equipment. In the

few reports showing cross-contamination of microorganisms during

immersion chilling, one or more of the following existed: extremely

high level of initial carcass contamination, low water overflow rates,

and absence of chlorination. Air chilling is less efficient and does

not improve the sanitary quality of the carcasses. [19]

Lastly, a commenter stated that the use of TSP should be indicated

on the product label. TSP is classified by FDA as a multiple purpose

GRAS substance. TSP is a processing aid, not an ingredient, and it

leaves virtually no residue on or in poultry carcasses. FDA exempts

from label declaration requirements, at 21 CFR 101.100(a)(3)(ii)(c),

processing aids added for technical or functional effect at processing,

but not present in the finished food at significant levels and which do

not have any technical or functional effect in that food. Therefore,

declaring TSP on product labels is not required. However, as with an

optional labeling statements, FSIS would evaluate, on a case-by-case

basis, requests for optional labeling statements about the purpose of

TSP. Such statements must not be false or misleading.

On December 29, 1995, FSIS published in the Federal Register the

proposed rule, ``Substances Approved for Use in the Preparation of Meat

and Poultry Products,'' (60 FR 67459). The rule proposes to amend the

meat and poultry inspection regulations to harmonize and improve the

efficiency of the procedures used by FSIS and the FDA for reviewing and

approving the use of substances in meat and poultry products. Under the

proposed procedures, FSIS would no longer issue its own regulations

listing substances it finds suitable for use in meat and poultry

products. Instead, by agreement between USDA and the FDA, future FDA

regulations would specify whether a substance approved for use in foods

under the Federal Food, Drug, and Cosmetic Act (FFDCA) may be used in

or on meat or poultry products. Current FDA regulations that approve

the use of substances in foods generally, and do not preclude meat and

poultry uses, will confer authority to use such substances in meat and

poultry products unless expressly prohibited by USDA regulation.

Requests for meat and poultry uses of substances not permitted

under title 9 or title 21 of the Code of Federal Regulations (CFR)

would have to be made to FDA in the form of a petition for FDA

approval. Therefore, FDA simultaneously published its proposed rule,

``Substances Approved for Use in the Preparation of Meat and Poultry

Products; Food Standards of Identity, Quality and Fill of Container;

Common or Usual Name Regulations,'' (60 FR 67490). FDA's rule proposes

to amend FDA regulations governing the review of petitions for the

approval of food additives to provide for simultaneous review of such

petitions by FSIS when meat or poultry product uses are indicated. This

would permit FDA listings to specify whether, and if so under what

conditions, such substances may be used in USDA-inspected meat and

poultry products. Such listings would eliminate the need for separate

FSIS rulemaking.

FSIS would limit any future, substance-specific rulemaking to

prohibitions or limitations on meat or poultry uses of specific

substances that may be necessary to protect the public under the

Federal Meat Inspection Act (FMIA) or Poultry Products Inspection Act

(PPIA). FSIS would continue to provide evaluations upon request as to

whether substances permitted for general use under current regulations

are suitable for specific uses in meat and poultry products.

FSIS proposes to adopt the position that substances that are listed

in title 21, CFR, Parts 182 and 184, as generally recognized as safe

(GRAS) for use in food generally, with no limitation other than good

manufacturing practice, would be accepted by USDA as GRAS for use in

meat, meat food products, and poultry products generally, unless

otherwise restricted for such use by regulation in title 9, CFR. Other

GRAS substances currently permitted for general food use would be

evaluated by

[[Page 39277]]

FSIS as to their suitability for specified uses in meat food products

and poultry products on a case-by-case basis, in consultation with FDA

as appropriate.

Until that proposed rulemaking is complete and final rule issued,

FSIS will continue to initiate individual rulemaking to add substances

to its table of approved substances.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been determined to be not significant for purposes of

Executive Order 12866 and therefore has not been reviewed by the Office

of Management and Budget.

The Administrator, FSIS, determined this rule will not have a

significant economic impact on a substantial number of small entities.

The rule will permit establishments voluntary use of TSP.

Establishments choosing to use TSP as an antimicrobial agent will

incur a one-time expense for the necessary equipment and an ongoing

cost for purchasing TSP. In the proposed rule, the cost for equipment

was estimated at $45,000 per processing line, and the cost for the TSP

at \1/2\ cent per bird. Since the proposed rule was published,

additional analysis of the estimated cost of the equipment and of the

TSP has provided minor changes to the cost estimations. The cost for

equipment is now estimated to be $40,000 per processing line, and the

cost for the TSP is estimated to average about 0.3 cents per broiler

and 1.4 cents per turkey.

Executive Order 12778

This rule has been reviewed under Executive Order 12778, Civil

Justice Reform. This rule will provide for the use of TSP as an

antimicrobial treatment on raw, chilled poultry carcasses passed for

wholesomeness.

States and local jurisdictions are preempted under the Poultry

Products Inspection Act (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 than,

those imposed under the PPIA. States and local jurisdictions are also

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 may, however, exercise

concurrent jurisdiction over poultry products that are outside official

establishments for the purpose of preventing the distribution of

poultry products that are misbranded or adulterated under the PPIA or,

in the case of imported articles, which are not at such an

establishment, after their entry into the United States. States and

local jurisdictions may also make requirements or take other actions

that are consistent with the PPIA, with respect to any other matters

regulated under the PPIA.

Under the PPIA, 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

may, however, impose more stringent requirements on such State-

inspected products and establishments.

In the event of its adoption, no retroactive effect will be given

to this rule, and applicable administrative procedures must be

exhausted before any judicial challenge to the application of these

provisions. Those administrative procedures are set forth in 9 CFR

381.35.

List of Subjects in 9 CFR Part 381

Poultry and poultry products.

For the reasons set forth in the preamble, FSIS is amending the

poultry products inspection regulations as follows:

PART 381--MANDATORY POULTRY PRODUCTS INSPECTION

1. The authority citation for part 381 continues to read as

follows:

Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR

2.18, 2.53.

2. In Table 1 of Sec. 381.147(f)(4), a new class of substance,

``Antimicrobial agents,'' is added, and the substance ``Trisodium

phosphate'' is added to the new class of substance, to read as follows:

Sec. 381.147 Restrictions on the use of substances in poultry

products.

* * * * *

(f) * * *

(4) * * *

----------------------------------------------------------------------------------------------------------------

Class of substance Substance Purpose Products Amount

----------------------------------------------------------------------------------------------------------------

* * * * * *

*

Anti-microbial agents Trisodium phosphate... To reduce microbial Raw, chilled poultry 8 to 12 percent;

levels. carcasses. solution to be

maintained at

45 deg.F. to

55 deg.F. and

applied by

spraying or

dipping

carcasses for

up to 15

seconds in

accordance with

21 CFR

182.1778.

* * * * * *

*

----------------------------------------------------------------------------------------------------------------

Done at Washington, DC, on: July 20, 1996.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

References

1. Tamblyn, K.C., et al. (1993) Utilization of the Skin

Attachment Model (SAM) to Determine the Antibacterial Activity of

Potential Carcass Treatments. Poultry Science. 72 supplement

(1):298.

2. Dickens, J.A., et al. (1993) The Effect of Dipping Processed

Broiler Carcasses in a Trisodium Phosphate Solution on Total

Aerobes, Enterobacteriaceae, and Inoculated Salmonella. Poultry

Science. 72 supplement (1):S35.

3. Somers, E.B.; Schoeni, J.L.; and Wong, A.C.L. (1994) Effect

of trisodium phosphate on biofilm and planktonic cells of

Campylobacter jejuni, escherichia coli 0157:H7, Listeria

monocytogenes and Salmonella typhimurium. International Journal of

Food Microbiology. 22:269-276.

4. Brewer, R.L.; James, W.O.; and Prucha, J.C. (1995) Poultry

Processing Line Speeds as Related to Bacteriologic Profile of

Broiler Carcasses. Journal of Food Science. Volume 60, No. 5.

5. Blankenship, L.; Bailey, J.; and Cox, N. (1993) Broiler

Carcass Reprocessing, A Further Evaluation. Journal of Food

Protection. Volume 56.

6. Blankenship, L., Cox, N., and Craven, S. (1975) Comparison of

the Microbiological Quality of Inspection-Passed and Fecal

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[FR Doc. 96-19132 Filed 7-26-96; 8:45 am]

BILLING CODE 3410-DM-M