[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Rules and Regulations]
[Pages 39273-39278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19132]


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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 
Contamination-Condemned Broiler Carcasses. Journal of Food Science. 
Volume 40.
    7. Waldroup, A.; Rathgerber, B.; and Hierholzer, R. (1993) 
Effects of Reprocessing on Microbiological Quality of Commercial 
Prechill Broiler Carcasses. Applied Poultry Science, Inc.
    8. Commission of the European communities (1976) Evaluation of 
the Hygienic Problems Related to the Chilling of Poultry Carcasses. 
Series: Information on Agriculture. No. 22.

[[Page 39278]]

    9. Thomson, J.E.; Cox, N.A.; Whitehead, W.K.; Mercuri, A.J.; and 
Juven, B.J. (1975) Bacterial counts and weight changes of broiler 
carcasses chilled commercially by water immersion and air-blast. 
Poultry Science. 54, 1452-1460.
    10. Mead, G.C. (1989) Processing of Poultry, Chapter 6--Hygiene 
Problems and Control of Process Contamination. 183-220.
    11. Bailey, J.S., Thomson, J.E., Cox, N.A. (1987) The 
Microbiology of Poultry Meat Products. Academic Press, Inc. 193-211.
    12. James, W.O.; Williams, W.O. Jr.,; Prucha, J.C.; Johnston, 
R.; and Christensen, W. (1992) Profile of selected bacterial counts 
and Salmonella prevalence on raw poultry in a poultry slaughter 
establishment. Journal of American Veterinarian Medical Association. 
200:57-59.
    13. James, W.O.; Brewer, R.L.; Prucha, J.C.; Williams, W.O.; and 
Parham, D.R. (1992) Effects of chlorination of chill water on the 
bacteriologic profile of raw chicken carcasses and giblets. Journal 
of American Veterinarian Medical Association. 200:60-63.
    14. Waldroup, A.L.; Rathgeber, B.M.; and Forsythe, R.H. (1992) 
Effects of six modifications on the incidence and levels of spoilage 
and pathogenic organisms on commercially processed postchill 
broilers. Journal Applied Poultry Research. 1:225-234.
    15. May, K.N. (1974) Changes in microbial numbers during final 
washing and chilling of commercially slaughtered broilers. Poultry 
Science. 53:1282-1285.
    16. Busta, F.F.; Kottola, E.A.; Arnold, E.A.; and Hagberg, M.M. 
(1973) Incidence and control of unwanted microorganisms in turkey 
products. Research Report to Minnesota Turkey Research and Market 
Development Board.
    17. Thomson, J.E.; Bailey, J.S.; Cox, N.A.; Posey, D.A.; and 
Carson, M.O. (1979) Salmonella on broiler carcasses as affected by 
fresh water input rate and chlorination of chiller water. Journal of 
Food Protection. Vol. 42, No. 12, pp 954-955.
    18. Blood, R.M. and Jarvis, B. (1974) Chilling of poultry: the 
effects of process parameters on the level of bacteria in spin-
chiller waters. Journal of Food Technology. 9, 157-169.
    19. Brant, A.W. (1974) The current status of poultry chilling in 
Europe. Poultry Science. 53:1291-1295.

[FR Doc. 96-19132 Filed 7-26-96; 8:45 am]
BILLING CODE 3410-DM-M