[Code of Federal Regulations]
[Title 9, Volume 2, Parts 200 to end]
[Revised as of January 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.147]
[Page 533-540]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND
INSPECTION SERVICE,
DEPARTMENT OF AGRICULTURE
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart O--Entry of Articles Into Official Establishments; Processing
Inspection and Other Reinspections; Processing Requirements
Sec. 381.147 Restrictions on the use of substances in poultry products.
(a) All ingredients and other substances used in the processing or
handling of poultry products at official establishments shall be such as
will not result in adulteration or misbranding of the poultry products.
(b) Poultry products and poultry broth used in the processing of
poultry products shall have been processed in the United States only in
an official establishment, or imported from a foreign country listed in
Sec. 381.196(b), and inspected and passed, in accordance with the
regulations. Detached ova and offal shall not be used in the processing
of any poultry products, except that poultry feet may be processed for
use as human food when handled in a manner approved by the Administrator
in specific cases, and detached ova may be used in the processing of
poultry products if the processor demonstrates that such ova comply with
the requirements under the Federal Food, Drug, and Cosmetic Act.
(c) Liquid, frozen, and dried egg products used in the processing of
any poultry product shall have been prepared under inspection and be so
marked in accordance with the Egg Products Inspection Act.
(d)(1) Carcasses, parts thereof, meat and meat food products of
cattle, sheep, swine, goats, or equines may be used in the processing of
poultry products only if they were prepared in the United States only in
an official meat packing establishment, or imported, and were inspected
and passed, in accordance with the Federal Meat Inspection Act, and the
regulations under such Act (subchapter A of this chapter) and are so
marked.
(2) Pork from carcasses or carcass parts, used as an ingredient in
poultry products, that has been found free of trichinae, as described
under Sec. 318.10 (a)(2), (e) and (f) of the Federal meat inspection
regulations (9 CFR 318.10 (a)(2), (e) and (f)), is not required to be
treated for the destruction of trichinae.
(3) Poultry products containing pork muscle tissue which the
Administrator determines at the time the labeling for the product is
submitted for approval in accordance with part 381 of the regulations in
subchapter C, or upon subsequent reevaluation of the product, would be
prepared in such a manner that the product might be eaten rare or
without thorough cooking because of the appearance of the finished
product or otherwise, shall be effectively heated, refrigerated, or
cured to destroy
[[Page 534]]
any possible live trichinae, as prescribed in Sec. 318.10(c) of the
Federal meat inspection regulations (9 CFR 318.10(c)), at the official
establishment where such products are prepared. In lieu of such
treatment of poultry products containing pork, the pork ingredient may
be so treated.
(e) [Reserved]
(f)(1) No substance may be used as an ingredient or otherwise in the
processing of any raw or cooked poultry product unless its use is
approved as shown in Table 1 of paragraph (f)(4) of this section, or
elsewhere in this part, or by the Administrator in specific cases.
(2) Approval of new substances or new uses or new levels of use of
approved substances may be granted if:
(i) The substance has been previously approved by the Food and Drug
Administration (FDA) for use in poultry or poultry products as a food
additive, color additive or as a substance generally recognized as safe
and is listed in title 21 of the Code of Federal Regulations, parts 73,
74, 81, 172, 173, 182, or 184.
(ii) Its use is in compliance with applicable FDA requirements; and
(iii) The Administrator has determined that:
(A) The use of the substance will not render the product in which it
is used adulterated or misbranded or otherwise not in compliance with
the Act; and
(B) Its use is functional and suitable for the product and it is
permitted for use at the lowest level necessary to accomplish the
desired technical effect as determined in specific cases.
(3) Whenever the Administrator determines that approval of a new
substance or a new use or new level of use of an approved substance
should be granted in accordance with pararaph (f)(1) of this section,
the Administrator shall issue a final rule amending Table 1 of paragraph
(f)(4) of this section to include the additional substance or new use of
the substance, and any technical effect or change in the level of use of
the substance.
(4) No poultry product shall bear or contain any substance which
would render it adulterated or misbranded, or which is not approved in
part 381 or by the Administrator in specific cases.
Table I
[See footnotes at end of this table]
----------------------------------------------------------------------------------------------------------------
Class of substance Substance Purpose Products Amount
----------------------------------------------------------------------------------------------------------------
Acidifiers........ Acetic acid............ To adjust acidity...... Various \3\............ Sufficient for
purpose.\4\
Citric acid............ ......do............... ......do............... Do.
Glucono delta-lactone.. ......do............... ......do............... Do.
Lactic acid............ ......do............... ......do............... Do.
Phosphoric acid........ ......do............... ......do............... Do.
Tartaric acid.......... ......do............... ......do............... Do.
Antifoaming agent. Methyl polysilicone.... To retard foaming...... Soups.................. 10 ppm.
..................... ..................... Rendered fats.......... 10 ppm.
..................... ..................... Curing pickle.......... 50 ppm.
Antimicrobial Trisodium phosphate.... To reduce microbial Raw, chilled poultry 8 to 12 percent;
agents. 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.
Antioxidants and BHA (butylated To retard rancidity.... Various................ 0.01 percent
oxygen hydroxyanisole). based on fat
interceptors. content. (0.02
percent in
combination with
any other
antioxidant
listed in this
table based on
fat content.)
BHT (butylated ......do............... ......do............... Do.
hydroxytoluene).
Propyl gallate......... ......do............... ......do............... 0.01 percent
based on fat
content. (0.02
percent in
combination with
any other
antioxidant
listed in this
table, except
TBHQ, based on
fat content.)
[[Page 535]]
TBHQ (tertiary ......do............... ......do............... 0.01 percent
butylhydroquinone). based on fat
content. (0.02
percent in
combination only
with BHA and/or
BHT based on fat
content.)
Tocopherols............ ......do............... ......do............... 0.03 percent
based on fat
content. (0.02
percent in
combination with
any other
antioxidant
listed in this
table, except
TBHQ, based on
fat content.)
Binders and A mixture of sodium To bind poultry pieces. Ground and formed raw Sodium alginate
extenders. alginate, calcium or cooked poultry not more than
carbonate, lactic pieces. 0.8%, calcium
acid, and calcium carbonate not
lactate. more than 0.15%,
lactic acid and
calcium lactate,
in combination,
not more than
0.6% of product
formulation.
Added mixture
may not exceed
1.55% of product
at formulation.
The mixture must
be added in dry
form.
Algin.................. To extend and stabilize Various................ Sufficient for
product. purpose.
Carrageenan............ ......do............... ......do............... Do.
Carboxymethyl cellulose ......do............... ......do............... Do.
(cellulose gum).
Enzyme (rennet) treated To bind and extend Various................ Sufficient for
calcium reduced dried product. purpose.
skim milk and calcium (Calcium lactate
lactate. required at rate
of 10 percent of
binder.)
Enzyme (rennet) treated ......do............... ......do............... Sufficient for
sodium caseinate and purpose.
calcium lactate. (calcium lactate
required at rate
of 25 percent of
binder.)
Gelatin................ ......do............... ......do............... Sufficient for
purpose in
accordance with
21 CFR 172.5.
Gums, vegetable........ ......do............... ......do............... Do.
Methyl cellulose....... To extend and to ......do............... 0.15 percent.
stabilize product
(also carrier).
Isolated soy protein... To bind and extend ......do............... Sufficient for
product. purpose.
Sodium caseinate....... ......do............... ......do............... 3 percent in
cooked product,
2 percent in raw
product; in
accordance with
21 CFR 172.5 and
182.1748.
Tapioca dextrin........ ......do............... ......do............... Sufficient for
purpose in
accordance with
21 CFR 184.1277.
Wheat gluten........... ......do............... ......do............... Sufficient for
purpose in
accordance with
21 CFR 184.1322.
Whey (dried)........... ......do............... ......do............... Do.
Xanthan gum............ To maintain: Uniform Various, except Do.
viscosity; suspension uncooked products or
of particulate matter; sausages or other
emulsion stability; products with a
freeze-thaw stability. moisture limitation
established by subpart
P of this part.
Chilling media.... Salt (NaCl)............ To aid in chilling..... Raw poultry products... 700 lbs. to
10,000 gals. of
water.\1\
Coloring agents Annatto, Carotene...... To color products...... Various................ Sufficient for
(natural). purpose.
Coloring agents Coal tar dyes (FD&C To color products; to ......do............... Do.
(artificial). certified), Titanium whiten products. Salads and spreads..... 0.05 percent.
dioxide.
[[Page 536]]
Curing Ascorbic acid.......... To accelerate color Cured poultry; cured, 75 oz to 100 gal
accelerators; fixing. comminuted poultry pickle at 10
must be used only products. percent pump
in combination level; \3/4\ oz
with curing to 100 lb of
agents. poultry product;
10 percent
solution to
surfaces of the
product prior to
packaging. (The
use of such
solution shall
not result in
the addition of
a significant
amount of
moisture to the
product.)
Erythorbic acid........ ......do............... ......do............... Do.
Fumaric acid........... ......do............... Cured, comminuted 0.065 percent (or
poultry or poultry 1 oz to 100 lb)
products. of the weight of
the poultry or
poultry
byproducts,
before
processing.
Sodium ascorbate....... ......do............... ......do............... 87.5 oz to 100
gal pickle at 10
percent pump
level; \7/8\ oz
to 100 lb of
poultry product;
10 percent
solution to
surfaces of
product prior to
packaging. (The
use of such
solution shall
not result in
the addition of
a significant
amount of
moisture to the
product.)
Sodium erythorbate..... ......do............... ......do............... Do.
Citric acid or sodium ......do............... ......do............... May be used in
citrate. cured products
to replace up to
50 percent of
the ascorbic
acid or sodium
ascorbate that
is used.
Curing agents..... Sodium or potassium Source of nitrite...... ......do............... 7 lb to 100 gal
nitrate. pickle; 3\1/2\
oz. to 100 lb or
poultry product
(dry cure); 2\3/
4\ oz to 100 lb
of chopped
poultry meat.
Sodium or potassium To fix color........... Cured products......... 2 lb to 100 gal
nitrite. (Supplies of pickle at 10
sodium nitrite and percent pump
potassium nitrite and level; 1 oz to
mixtures containing 100 lb of
them must be kept poultry product
securely under the (dry cure); \1/
care of a responsible 4\ oz to 100 lb
employee of the chopped poultry
establishment. The meat. The use of
specific nitrite nitrites,
content of such nitrates, or
supplies must be known combination
and clearly marked shall not result
accordingly.). in more than 200
ppm of nitrite,
calculated as
sodium nitrite,
in finished
product.
Emulsifying agents Acetylated To emulsify product.... Various................ Sufficient for
monoglycerides. purpose.
Diacetyl tartaric acid ......do............... Rendered poultry fat or Do.
esters of mono- and a combination of such
diglycerides. fat with vegetable fat.
Glycerol-lacto ......do............... ......do............... Do.
stearate, oleate or
palmitate.
Lecithin............... To emulsify product Various................ Do.
(also as antioxidant).
Mono- and diglycerides To emulsify product.... ......do............... Do.
(glycerol palmitate,
etc.).
Polysorbate 80 To emulsify product.... Various................ 1 percent when
(polyoxyethylene (20) used alone. If
sorbitan monooleate). used with
polysorbate 60,
the combined
total shall not
exceed 1
percent.
[[Page 537]]
Propylene glycol mono- ......do............... Rendered poultry fat or Sufficient for
and diesters of fats a combination of such purpose.
and fatty acids. fat with vegetable fat.
Polysorbate 60 ......do............... ......do............... 1 percent when
(polyoxyethylene (20) used alone. If
sorbitan monostearate). used with
polysorbate 80,
the combined
total shall not
exceed 1
percent.
Flavoring agents; Artificial smoke To flavor product...... Various................ Sufficient for
protectors and flavoring.. purpose.
developers.
Smoke flavoring........ ......do............... ......do............... Do.
Autolyzed yeast extract ......do............... ......do............... Do.
Citric acid............ To protect flavor...... ......do............... Do.
Corn syrup solids; corn To flavor product...... ......do............... Do.
syrup; glucose syrup.
Disodium inosinate..... ......do............... ......do............... Do.
Disodium guanylate..... ......do............... ......do............... Do.
Hydrolyzed plant ......do............... ......do............... Do.
protein.
Malt syrup............. ......do............... ......do............... Do.
Milk protein ......do............... ......do............... Do.
hydrolysate.
Monosodium glutamate... ......do............... ......do............... Do.
Monoammonium glutamate. ......do............... ......do............... Do.
Sodium sulfoacetate ......do............... ......do............... 0.5 percent.
derivative of mono and
diglycerides.
Sugars approved ......do............... ......do............... Sufficient for
(surcose and dextrose). purpose.
Potassium lactate...... To flavor product...... Various poultry and Not to exceed 2
poultry food products, percent of
except infant formula formulation; in
and infant food. \3\ accordance with
21 CFR 184.1639.
Sodium lactate......... ......do............... ......do............... Not to exceed 2
percent of
formulation; in
accordance with
21 CFR 184.1768.
Sodium Acetate......... To flavor product...... Various................ Not to exceed
0.12 percent of
formulate in
accordance with
21 CFR 184.1721.
Sodium Diacetate....... To flavor product...... Various................ Not to exceed 0.1
percent of
formulate in
accordance with
21 CFR 184.1754.
Gases............. Carbon dioxide solid To cool product or Various................ Do.
(dry ice). facilitate chopping or
packaging.
Carbon dioxide liquid.. Contact freezing....... ......do............... Do.
Nitrogen............... To exclude oxygen from ......do............... Do.
sealed containers.
Nitrogen liquid........ Contact freezing....... ......do............... Do.
Miscellaneous..... Sodium bicarbonate..... To neutralize excess Rendered fat, soups, Do.
acidity; cleaning curing pickle.
vegetables.
Calcium propionate..... To retard mold growth.. Fresh pie dough........ 0.3 percent of
calcium
propionate or
sodium
propionate
alone, or in
combination,
based on weight
of the flour
used.
Sodium hydroxide....... To decrease the amount Poultry food products May be used only
of cooked out juices. containing phosphates. in combination
with phosphate
in a ratio not
to exceed one
part sodium
hydroxide to
four parts
phosphate.
[[Page 538]]
Sodium propionate...... To retard mold growth.. Fresh pie dough........ 0.3 percent of
calcium
propionate or
sodium
propionate
alone, or in
combination,
based on weight
of the flour
used.
Disodium phosphate..... To decrease the amount Poultry food products 0.5 percent of
of cooked out juices. except where otherwise total product.
prohibited by the
poultry products
inspection regulations.
Monosodium phosphate... ......do............... ......do............... Do.
Sodium metaphosphate, ......do............... ......do............... Do.
insoluble.
Sodium polyphosphate, ......do............... ......do............... Do.
glassy.
Sodium tripolyphosphate ......do............... ......do............... Do.
Sodium pyrophosphate... ......do............... ......do............... Do.
Sodium acid ......do............... ......do............... Do.
pyrophosphate.
Dipotassium phosphate.. ......do............... ......do............... Do.
Monopotassium phosphate ......do............... ......do............... Do.
Potassium ......do............... ......do............... Do.
tripolyphosphate.
Potassium pyrophosphate ......do............... ......do............... Do.
Tricalcium phosphate... To preserve product Mechanically deboned Not to exceed 2
color during chicken to be percent of the
dehydration process. dehydrated. weight of the
mechanically
deboned chicken
prior to
dehydration, in
accordance with
21 CFR 182.1217.
Sodium citrate buffered To inhibit the growth Cured and uncured, Not to exceed 1.3
with citric acid to a of micro-organisms and processed whole-muscle percent of the
pH of 5.6. retain product flavor poultry food products, formulation
during storage. e.g., chicken breasts. weight of the
product in
accordance with
21 CFR 184.1751.
Poultry scald Alpha-hydro-omega- To remove feathers..... Poultry carcasses...... Not to exceed
agents; must be hydroxy-poly 0.05% by weight
removed by (oxyethylene) poly in scald water.
subsequent (oxypropylene)
cleaning (minimum 15 moles)
operations. poly (oxyethylene)
block copolymer
(polyoxamer).
Dimethylpolysiloxane... ......do............... ......do............... Sufficient for
purpose.
Dioctyl sodium ......do............... ......do............... Do.
sulfosuccinate.
Dipotassium phosphate.. ......do............... ......do............... Do.
Ethylenediamine- ......do............... ......do............... Do.
tetraacetic acid
(sodium salts).
Lime (calcium oxide, ......do............... ......do............... Do.
calcium hydroxide).
Polyoxyethylene (20) ......do............... ......do............... Not to exceed
sorbitan monooleate. 0.0175% in scald
water.
Potassium hydroxide.... ......do............... ......do............... Sufficient for
purposes.
Propylene glycol....... ......do............... ......do............... Do.
Sodium acid phosphate.. ......do............... ......do............... Do.
Sodium bicarbonate..... ......do............... ......do............... Do.
Sodium carbonate....... ......do............... ......do............... Do.
[[Page 539]]
Sodium dodecylbenzene- ......do............... ......do............... Do.
sulfonate.
Sodium-2-ethylhexyl ......do............... ......do............... Do.
sulfate.
Sodium ......do............... ......do............... Do.
hexametaphosphate.
Sodium hydroxide....... ......do............... ......do............... Do.
Sodium lauryl sulfate.. ......do............... ......do............... Do.
Sodium phosphate (mono- ......do............... ......do............... Do.
, di-, tribasic).
Sodium pyrophosphate... ......do............... ......do............... Do.
Sodium sesquicarbonate. ......do............... ......do............... Do.
Sodium sulfate......... ......do............... ......do............... Do.
Sodium tripolyphosphate ......do............... ......do............... Do.
Tetrasodium ......do............... ......do............... Do.
pyrophosphate.
Sodium tripolyphosphate ......do............... ......do............... Do.
Sodium pyrophosphate... ......do............... ......do............... Do.
Sodium acid ......do............... ......do............... Do.
pyrophosphate.
Proteolytic Aspergillus oryzae..... To soften tissue....... Raw poultry muscle Solutions
enzymes. tissue of hen, cock, consisting of
mature turkey, mature water and
duck, mature goose, approved
and mature guinea. proteolytic
enzyme applied
or injected into
raw poultry
tissue shall not
result in a gain
of more than 3
percent above
the weight of
the untreated
product.
Aspergillus flavus ......do............... ......do............... Do.
oryzze group.
Bromelin............... ......do............... ......di............... Do.
Ficin.................. ......do............... ......do............... Do.
Papain................. ......do............... ......do............... Do.
Radiation Sources. Ionizing radiation For control of food- Fresh or frozen, Minimum absorbed
sources as approved in borne pathogens uncooked, packaged dose of 1.5
21 CFR 179.26(a) poultry products that kiloGray (150
are: (1) Whole kilorads) to a
carcasses or maximum absorbed
disjointed portions of dose of 3.0
such carcasses that kiloGray (300
are "ready-to-cook," kilorads).
which includes such
poultry products as
fresh or frozen,
uncooked ground, hand-
boned, and skinless
poultry, (2)
mechanically separated
poultry--a finely
comminuted ingredient
produced by the
mechanical deboning of
poultry carcasses or
parts of carcasses
Synergists (used Citric acid............ To increase Poultry fats........... 0.01 percent
in combination effectiveness of alone or in
with antioxidants. combination with
antioxidants). antioxidants in
poultry fats.
Malic acid............. ......do............... ......do............... Do.
Monoisopropyl citrate.. ......do............... ......do............... 0.01 percent
poultry fats.
Phosphoric acid........ ......do............... ......do............... 0.01 percent.
Monoglyceride citrate.. ......do............... ......do............... 0.02 percent.
[[Page 540]]
Tenderizing agents Aspergillus oryzae..... To soften tissue....... Raw poultry muscle Solutions
tissue of hen, cock, consisting of
mature turkey, mature water and
duck, mature goose, approved
and mature guinea. proteolytic
enzymes applied
or injected into
raw poultry
tissue shall not
result in a gain
of more than 3
percent above
the weight of
the untreated
product.
Aspergillus ......do............... ......do............... Do.
flavusoryzae group.
Bromelin............... ......do............... ......do............... Do.
Ficin.................. ......do............... ......do............... Do.
Papain................. ......do............... ......do............... Do.
Potassium chloride..... ......do............... ......do............... Not more than 3
percent of a 2.0
molar solution.
Magnesium chloride..... ......do............... ......do............... Not more than 3
percent of a 0.8
molar solution.
Calcium chloride....... ......do............... ......do............... Not more than 3
percent of a 0.8
molar solution.
Potassium, magnesium or ......do............... ......do............... A solution of
calcium chloride. approved
inorganic
chlorides alone
or in
combination,
applied or
injected into
raw poultry
muscle tissue
shall not result
in a gain of
more than 3
percent above
the weight of
the untreated
product.
----------------------------------------------------------------------------------------------------------------
\1\ Special labeling requirements are prescribed in Sec. 381.120 for raw poultry products chilled in a medium
with more than 70 lbs. of salt to 10,000 gals. of water.
\2\ [Reserved]
\3\ Information as to the specific products for which use of this substance is approved may be obtained upon
inquiry addressed to the Standards and Labeling Division, Meat and Poultry Inspection Technical Services, Food
Safety and Inspection Service, U.S. Department of Agriculture, South Building, 14th Street and Independence
Avenue SW., Washington, DC 20250.
\4\ Provided, that its use is functional and suitable for the product and it is permitted for use at the lowest
level necessary to accomplish the desired technical effect as determined in specific cases prior to label
approval under Sec. 381.32.
[37 FR 9706, May 16, 1972]
Editorial Note: For Federal Register citations affecting
Sec. 381.147, see the List of CFR Sections Affected in the Finding Aids
section of this volume.
