[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)]
[Proposed Rules]
[Pages 551-554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-104]
[[Page Unknown]]
[Federal Register: January 5, 1994]
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DEPARTMENT OF AGRICULTURE
9 CFR Part 381
[Docket No. 92-026P]
RIN 0583-AB65
Use of Trisodium Phosphate on Raw, Chilled Poultry Carcasses
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: FSIS is proposing to amend the poultry products inspection
regulations to permit the application of trisodium phosphate (TSP) on
raw, chilled poultry carcasses passed for wholesomeness. TSP would be
permitted as an antimicrobial agent on such poultry carcasses at a
level of 8 to 12 percent. The TSP treatment solution would 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 have shown that the use of TSP at a level of 8 to 12 percent
reduces microbial populations on raw, chilled poultry surfaces. This
proposed rule is in response to a petition filed by Rhone-Poulenc,
Inc., Cranbury, New Jersey.
DATES: Comments must be received on or before March 7, 1994.
ADDRESSES: Written comments to: Policy Office, Attn: Diane Moore, room
3171, South Agriculture Building, Food Safety and Inspection Service,
U.S. Department of Agriculture, Washington, DC 20250. Oral comments, as
provided under the Poultry Products Inspection Act (PPIA), should be
directed to Dr. William O. James at (202) 720-3219. (See also
``Comments'' under supplementary information.)
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:
Executive Order 12866
FSIS has determined that this regulatory action is not a
significant rule under Executive Order 12866. It would not likely
result in a rule that may (1) have an annual effect on the economy of
$100 million or more or adversely affect in a material way the economy,
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. This proposed rule would 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 would be given
to this proposed 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.
Effect on Small Entities
The Administrator, FSIS, has determined that the proposed rule
would not have a significant impact on a substantial number of small
entities. The proposed rule would permit the use of TSP at the
establishment's option.
Establishments that decide to use TSP as an antimicrobial agent on
their products would incur a one-time expense for the necessary
equipment and an ongoing cost for purchasing TSP. The cost for the
treatment equipment would be approximately $45,000 per processing line.
The cost for the TSP would average about \1/2\ cent per bird.
The production of ready-to-cook poultry containing lower amounts of
bacteria than such poultry now available would contribute to the
national effort to reduce the incidence of pathogenic bacteria in
foods. Most consumers are willing to pay more for poultry products that
are raised or processed in a way that reduces the levels of Salmonella
on such products.\1\ Therefore, the market for TSP-treated poultry
carcasses would likely attract most consumers who desire additional
protection from harmful microorganisms. In turn, poultry establishments
that market TSP-treated poultry carcasses could benefit from increased
sales.
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\1\Rhone-Poulenc Food Buyer Telephone Survey, January 1993. A
copy of this survey is available for public inspection in the office
of the FSIS Hearing Clerk.
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Comments
Interested persons are invited to submit comments concerning this
proposal. Written comments should be sent to the Policy Office at the
address shown above and should refer to Docket Number 92-026P. Any
person desiring opportunity for oral presentation of views, as provided
under the PPIA, should make such request to Dr. James at (202) 720-3219
so that arrangements may be made for such views to be presented. A
record will be made of all such oral comments. Copies of all comments
submitted in response to this proposal will be available for public
inspection in the Policy Office between 9 a.m. and 12:30 p.m. and
between 1:30 and 4 p.m., Monday through Friday.
Background
FSIS is responsible for assuring that poultry products distributed
in commerce are wholesome, not adulterated, and properly marked,
labeled, and packaged. Under the PPIA (21 U.S.C. 451-470), FSIS
provides mandatory inspection of poultry and poultry products shipped
in interstate and foreign commerce, as well as in designated States.
Continuous inspection of poultry slaughtering establishments is
intended to assure that fresh, ready-to-cook poultry carcasses and
parts are free of visible signs of disease and contamination. FSIS
inspectors examine the outside, inside, and viscera of all birds
presented for inspection.
Because raw poultry furnish a rich medium for the potential growth
of both beneficial and harmful microorganisms, it has been assumed
traditionally that a certain level of microbial activity on the surface
tissues of raw poultry was unavoidable. Consequently, poultry slaughter
inspection activities have focused on the organoleptic detection of
poultry diseases or other abnormalities in carcasses and parts that
would render the products adulterated or unwholesome.
Over the years, scientific and public concern about microbiological
contamination of poultry products has expanded from the processing of
such products to conditions under which poultry are slaughtered, and
even to preslaughter poultry production. FSIS has encouraged the
scientific community and the regulated industry to develop slaughtering
and processing methods and treatments that would yield raw poultry
products that are as free as practicable of pathogenic bacteria. The
control of miscrooganisms on raw poultry has been given a high priority
on FSIS's research agenda.
Researchers estimate that from 6.5 million to 33 million Americans,
or 3 to 14 percent of the population, become ill each year from
consumption of foods containing microorganisms. An estimated 9,000 of
these illnesses result in death, or 4 in 100,000 people. Chapter 4 of a
1985 report by the National Research Council/National Academy of
Sciences, Meat and Poultry Inspection: The Scientific Basis of the
Nation's Program, recommended, in part, that the poultry inspection
program be refocused to place greater emphasis on microbiological and
chemical testing.\2\ Since the issuance of that report, FSIS has given
greater priority to microbiological and chemical testing.
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\2\A copy of Chapter 4 of this report is available for public
inspection in the office of the FSIS Hearing Clerk. Page 53 contains
the referenced recommendation.
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Among the diseases caused by foodborne microorganisms, the one
receiving the most publicity in recent years has been salmonellosis.
This common human intestinal disorder was estimated to cost Americans
approximately $1 billion in 1987.
Much of the concern about Salmonella in the food supply has focused
on chicken. FSIS has encouraged and permitted the industry to use
technologies such as counterflow scalders, chlorinated inplant water,
and ionizing radiation to reduce Salmonella and other pathogenic
bacteria.
Rhone-Poulenc, Inc., Petition
FSIS has been 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.\3\ 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.).
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\3\A copy of this petition is available for public inspection in
the office of the FSIS Hearing Clerk.
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The petitioner supplied data demonstrating that the use of TSP,
under the parameters addressed above, is effective in reducing the
levels of bacteria, including pathogenic bacteria, found on raw,
chilled poultry carcasses. Immediately after chilling, poultry
carcasses that have been passed for wholesomeness enter the TSP
treatment system. Chilled poultry carcasses are either sprayed with or
dipped in the TSP treatment solution for no more than 15 seconds. The
concentration of TSP used in various studies conducted by or for the
petitioner ranged from 8 to 12 percent in water, at temperatures
ranging from 45 deg. F. to 55 deg. F.
Data from the petitioner included results of studies conducted by
the Pennsylvania State Sensory Laboratory for Rhone-Poulenc, Inc., on
consumer acceptability of cooked poultry derived from TSP-treated
poultry carcasses. These studies show no significant difference in
taste or appearance between cooked poultry from TSP-treated poultry
carcasses and cooked poultry from untreated poultry.
The petitioner also provided study results concerning moisture
pickup and residue findings in poultry carcasses treated with TSP.
According to these study results, the moisture pickup in TSP-treated
poultry carcasses does not exceed regulatory limits for moisture
absorption as prescribed in 9 CFR 381.66(d)(5). Residue findings ranged
from -0.25 percent to 0.11 percent, showing that virtually no residue
of the TSP solution remains on or in the treated poultry carcasses.
FSIS Studies on TSP
FSIS also conducted studies to determine the efficacy of TSP on
raw, chilled poultry carcasses.\4\ These studies show that the use of
TSP on raw, chilled poultry carcasses results in statistically
significant reductions in the levels of bacteria. Summary statistics of
bacterial plate counts were used in all statistical analyses based on
the arithmetic average and statistical significance was determined
through nonparametric procedures using the relative rank of values.
Analyses of 256 carcass-rinse samples collected at a federally
inspected establishment over 4 days indicated that carcasses had
average aerobe plate counts of 328 before TSP application, and 78 after
application; Enterobacteriaceae counts of 25.5 before TSP application,
and 2.7 after application; and Escherichia coli counts of 10.1 before
TSP application, and 0.2 after treatment. Although these particular
studies found no salmonellae in untreated or treated carcasses,
preliminary results from industry group testing show that TSP is also
effective in reducing salmonellae on raw poultry. Studies on moisture
absorption resulting from the use of TSP found no inconsistencies with
data furnished by the petitioner.
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\4\A copy of the study results is available for public
inspection the office of the FSIS Hearing Clerk. After carcasses had
been chilled and hung on a moving shackle line, they were dipped for
15 seconds in an 8 percent) plus or minus 2 percent) TSP solution at
a temperature of 7.7 deg.C. (plus or minus 2 deg.C.) (42 deg.F.
to 49.5 deg.F.).
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Food Additive Status
TSP is listed in the Food and Drug Administrated (FDA) regulations
as generally recognized as safe (GRAS) for multiple purpose use in
accordance with good manufacturing practice (21 CFR 182.1778).
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 that could be harmful to consumers. Therefore,
in an August 25, 1992, letter, FDA approved the use of TSP as a
processing aid on raw poultry, under conditions to be established by
FSIS.\5\
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\5\A copy of FDA's approval letter is available for public
inspection in the office of the FSIS Hearing Clerk.
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The Proposal
The Administrator has determined that (1) the use of TSP on raw,
chilled poultry carcasses is in compliance with applicable FDA
requirements, (2) its use is functional and suitable for the intended
purpose, (3) the substance is used at the lowest acceptable level to
consistently achieve the desired reduction of pathogenic bacteria as
determined in specific cases, and (4) the use of this substance on raw,
chilled poultry carcasses at the stated level will not render the
treated product adulterated, misbranded, or otherwise not in accordance
with the requirements of the PPIA.
Therefore, FSIS is proposing 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. As requested by the
petitioner, TSP would be permitted for use on raw, chilled poultry
carcasses passed for wholesomeness 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 no more than 15 seconds. FSIS has determined,
through review of the petitioner's data and its own study results, that
15 seconds is the maximum time necessary to coat all surfaces of the
poultry carcasses with the TSP solution. FSIS is proposing the
application of TSP by spraying, as well as by dipping, to permit the
use of any existing spraying equipment in establishments, and thus
reduce the costs incurred by establishments to set up the TSP treatment
system.
Although the use of TSP would not eliminate the need for continuing
careful handling of raw poultry products, TSP treatment on raw, chilled
poultry carcasses would reduce the levels of bacteria that may be
present on raw poultry carcasses.
TSP leaves virtually no residue on or in the carcass of treated
poultry that would require the labels of such treated product to show
the presence of TSP. Therefore, poultry producers opting to use TSP
would not be required to revise their product labels.
List of Subjects in 9 CFR Part 381
Poultry and poultry products.
For the reasons set forth in the preamble, FSIS is proposing to
amend the poultry products inspection regulations as follows:
PART 381--MANDATORY POULTRY PRODUCTS INSPECTION
1. The authority citation for part 381 would continue to read as
follows:
Authority: 7 U.S.C. 450, 21 U.S.C. 451-470, 7 CFR 2.17, 2.55.
2. In Table I of Sec. 371,147(f)(4), a new class of substance
titled ``Antimicrobial agents'' would be added and the substance
``Trisodium phosphate'' would be 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) * * *
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Class of substance Substance Purpose Products Amount
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****** *
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.
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Done at Washington, DC, on December 27, 1993.
Eugene Branstool,
Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-104 Filed 1-4-94; 8:45 am]
BILLING CODE 3410-DM-M
