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