Section

[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.10]

[Page 246-256]

TITLE 9--ANIMALS AND ANIMAL PRODUCTS

CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE

PART 318_ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION
OF PRODUCTS--Table of Contents

Subpart A_General

Sec. 318.10 Prescribed treatment of pork and products containing pork
to destroy trichinae.

(a)(1) All forms of fresh pork, including fresh unsmoked sausage
containing pork muscle tissue, and pork such as bacon and jowls, other
than those covered by paragraph (b) of this section, are classed as
products that are customarily well cooked in the home or elsewhere
before being served to the consumer. Therefore, the treatment of such
products for the destruction of trichinae is not required.
(2) Pork from carcasses or carcass parts that have been found free
of trichinae as described under paragraph (e) or (f) of this section is
not required to be treated for the destruction of trichinae.
(b) Products named in this paragraph, and products of the character
hereof, containing pork muscle tissue (not including pork hearts, pork
stomachs, and pork livers), or the pork muscle tissue which forms an
ingredient of such products, shall be effectively heated, refrigerated,
or cured to destroy any possible live trichinae, as prescribed in this
section at the official establishment where such products are prepared:
Bologna, frankfurter, vienna, and other cooked sausage; smoked sausage;
knoblauch sausage; mortadella; all forms of summer or dried sausage,
including mettwurst; flavored pork sausages such as those containing
wine or similar flavoring materials; cured pork sausage; sausage
containing cured and/or smoked pork; cooked loaves; roasted, baked,
boiled, or cooked hams, pork shoulders, or pork shoulder picnics;
Italian-style hams; Westphalia-style hams; smoked boneless pork shoulder
butts; cured meat rolls; capocollo (capicola, capacola); coppa; fresh or
cured boneless pork shoulder butts, hams, loins, shoulders, shoulder
picnics, and similar pork cuts, in casings or other containers in which
ready-to-eat delicatessen articles are customarily enclosed (excepting
Scotch-style hams); breaded pork products; cured boneless pork loins;
boneless back bacon; bacon used for wrapping around patties, steaks and
similar products; and smoked pork cuts such as hams, shoulders, loins,
and pork shoulder picnics (excepting smoked hams, and smoked pork
shoulder picnics which are specially prepared for distribution in
tropical climates or smoked hams delivered to the

[[Page 247]]

Armed Services); ground meat mixtures containing pork and beef, veal,
lamb, mutton, or goat meat and other product consisting of mixtures of
pork and other ingredients, which the Administrator determines at the
time the labeling for the product is submitted for approval in
accordance with part 317 of the regulations in this subchapter 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. Cured
boneless pork loins shall be subjected to prescribed treatment for
destruction of trichinae prior to being shipped from the establishment
where cured.
(c) The treatment shall consist of heating, refrigerating, or
curing, as follows:
(1) Heating. (i) All parts of the pork muscle tissue shall be heated
according to one of the time and temperature combinations in the
following table:

------------------------------------------------------------------------
Minimum internal temperature
--------------------------------------------------
Degrees Minimum time
Degrees fahrenheit centigrade
------------------------------------------------------------------------
120.................................. 49.0 21 hours.
122.................................. 50.0 9.5 hours.
124.................................. 51.1 4.5 hours.
126.................................. 52.2 2 hours.
128.................................. 53.4 1 hour.
130.................................. 54.5 30 minutes.
132.................................. 55.6 15 minutes.
134.................................. 56.7 6 minutes.
136.................................. 57.8 3 minutes.
138.................................. 58.9 2 minutes.
140.................................. 60.0 1 minute.
142.................................. 61.1 1 minute.
144.................................. 62.2 Instant.
------------------------------------------------------------------------

(ii) Time and temperature shall be monitored by a calibrated
recording instrument that meets the requirements of paragraph (d) of
this section, except for paragraph (c)(1)(iv).
(iii) The time to raise product temperature from 60 [deg]F. to 120
[deg]F shall not exceed 2 hours unless the product is cured or
fermented.
(iv) Time, in combination with temperatures of 138 [deg]F to 143
[deg]F, need not be monitored if the product's minimum thickness exceeds
2 inches (5.1 cm) and refrigeration of the product does not begin within
5 minutes of attaining 138 [deg]F (58.9 [deg]C).
(v) The establishment shall use procedures which insure the proper
heating of all parts of the product. It is important that each piece of
sausage, each ham, and other product treated by heating in water be kept
entirely submerged throughout the heating period; and that the largest
pieces in a lot, the innermost links of bunched sausage or other massed
articles, and pieces placed in the coolest part of a heating cabinet or
compartment or vat be included in the temperature tests.
(2) Refrigerating. At any stage of preparation and after preparatory
chilling to a temperature of not above 40 [deg]F. or preparatory
freezing, all parts of the muscle tissue of pork or product containing
such tissue shall be subjected continuously to a temperature not higher
than one of those specified in table 1, the duration of such
refrigeration at the specified temperature being dependent on the
thickness of the meat or inside dimensions of the container.

Table 1--Required Period of Freezing at Temperature Indicated
------------------------------------------------------------------------
Temperature [deg]F. Group 1 (Days) Group 2 (Days)
------------------------------------------------------------------------
5 20 30
-10 10 20
-20 6 12
------------------------------------------------------------------------

(i) Group 1 comprises product in separate pieces not exceeding 6
inches in thickness, or arranged on separate racks with the layers not
exceeding 6 inches in depth, or stored in crates or boxes not exceeding
6 inches in depth, or stored as solidly frozen blocks not exceeding 6
inches in thickness.
(ii) Group 2 comprises product in pieces, layers, or within
containers, the thickness of which exceeds 6 inches but not 27 inches,
and product in containers including tierces, barrels, kegs, and cartons
having a thickness not exceeding 27 inches.
(iii) The product undergoing such refrigeration or the containers
thereof shall be so spaced while in the freezer as will insure a free
circulation of air between the pieces of meat, layers, blocks, boxes,
barrels, and tierces in order that the temperature of the meat
throughout will be promptly reduced to not higher than 5 [deg]F., -10
[deg]F., or -20 [deg]F., as the case may be.

[[Page 248]]

(iv) In lieu of the methods prescribed in Table 1, the treatment may
consist of commercial freeze drying or controlled freezing, at the
center of the meat pieces, in accordance with the times and temperatures
specified in Table 2.

Table 2--Alternate Periods of Freezing at Temperatures Indicated
------------------------------------------------------------------------
Maximum internal temperature
--------------------------------------------------
Degrees Minimum Time
Degrees Fahrenheit centigrade
------------------------------------------------------------------------
0................................... -17.8 106 hours.
-5................................... -20.6 82 hours.
-10.................................. -23.3 63 hours.
-15.................................. -26.1 48 hours.
-20.................................. -28.9 35 hours.
-25.................................. -31.7 22 hours.
-30.................................. -34.5 8 hours.
-35.................................. -37.2 \1/2\ hour.
------------------------------------------------------------------------

(v) During the period of refrigeration the product shall be kept
separate from other products and in the custody of the Program in rooms
or compartments equipped and made secure with an official Program lock
or seal. The rooms or compartments containing product undergoing
freezing shall be equipped with accurate thermometers placed at or above
the highest level at which the product undergoing treatment is stored
and away from refrigerating coils. After completion of the prescribed
freezing of pork to be used in the preparation of product covered by
paragraph (b) of this section the pork shall be kept under close
supervision of an inspector until it is prepared in finished form as one
of the products enumerated in paragraph (b) of this section or until it
is transferred under Program control to another official establishment
for preparation in such finished form.
(vi) Pork which has been refrigerated as specified in this
subparagraph may be transferred in sealed railroad cars, sealed
motortrucks, sealed trailers, or sealed closed containers to another
official establishment at the same or another location, for use in the
preparation of product covered by paragraph (b) of this section. Such
vehicles and containers shall be sealed and transported between official
establishments in accordance with Sec. 325.7 of this subchapter.
(3) Curing--(i) Sausage. The sausage may be stuffed in animal
casings, hydrocellulose casings, or cloth bags. During any stage of
treating the sausage for the destruction of live trichinae, except as
provided in Method 5, these coverings shall not be coated with paraffin
or like substance, nor shall any sausage be washed during any prescribed
period of drying. In the preparation of sausage, one of the following
methods may be used:

Method No. 1. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After being stuffed, sausage having a diameter not
exceeding 3\1/2\ inches, measured at the time of stuffing, shall be held
in a drying room not less than 20 days at a temperature not lower than
45 [deg]F., except that in sausage of the variety known as pepperoni, if
in casings not exceeding 1\3/8\ inches in diameter measured at the time
of stuffing, the period of drying may be reduced to 15 days. In no case,
however, shall the sausage be released from the drying room in less than
25 days from the time the curing materials are added, except that
sausage of the variety known as pepperoni, if in casings not exceeding
the size specified, may be released at the expiration of 20 days from
the time the curing materials are added. Sausage in casings exceeding
3\1/2\ inches, but not exceeding 4 inches, in diameter at the time of
stuffing, shall be held in a drying room not less than 35 days at a
temperature not lower than 45 [deg]F., and in no case shall the sausage
be released from the drying room in less than 40 days from the time the
curing materials are added to the meat.
Method No. 2. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After being stuffed, sausage having a diameter not
exceeding 3\1/2\ inches, measured at the time of stuffing, shall be
smoked not less than 40 hours at a temperature not lower than 80
[deg]F., and finally held in a drying room not less than 10 days at a
temperature not lower than 45 [deg]F. In no case, however, shall the
sausage be released from the drying room in less than 18 days from the
time the curing materials are added to the meat. Sausage exceeding 3\1/
2\ inches, but not exceeding 4 inches, in diameter at the time of
stuffing, shall be held in a drying room, following smoking as above
indicated, not less than 25 days at a

[[Page 249]]

temperature not lower than 45 [deg]F., but in no case shall the sausage
be released from the drying room in less than 33 days from the time the
curing materials are added to the meat.
Method No. 3. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After admixture with the salt and other curing materials
and before stuffing, the ground or chopped meat shall be held at a
temperature not lower than 34 [deg]F. for not less than 36 hours. After
being stuffed, the sausage shall be held at a temperature not lower than
34 [deg]F. for an additional period of time sufficient to make a total
of not less than 144 hours from the time the curing materials are added
to the meat, or the sausage shall be held for the time specified in a
pickle-curing medium of not less than 50[deg] strength (salometer
reading) at a temperature not lower than 44 [deg]F. Finally, sausage
having a diameter not exceeding 3\1/2\ inches, measured at the time of
stuffing, shall be smoked for not less than 12 hours. The temperature of
the smokehouse during this period at no time shall be lower than 90
[deg]F.; and for 4 consecutive hours of this period the smokehouse shall
be maintained at a temperature not lower than 128 [deg]F. Sausage
exceeding 3\1/2\ inches, but not exceeding 4 inches, in diameter at the
time of stuffing shall be smoked, following the prescribed curing, for
not less than 15 hours. The temperature of the smokehouse during the 15-
hour period shall at no time be lower than 90 [deg]F., and for 7
consecutive hours of this period the smokehouse shall be maintained at a
temperature not lower than 128 [deg]F. In regulating the temperature of
the smokehouse for the treatment of sausage under this method, the
temperature of 128 [deg]F. shall be attained gradually during a period
of not less than 4 hours.
Method No. 4. The meat shall be ground or chopped into pieces not
exceeding one-fourth of an inch in diameter. A dry-curing mixture
containing not less than 2\1/2\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After admixture with the salt and other curing materials
and before stuffing, the ground or chopped sausage shall be held as a
compact mass, not more than 6 inches in depth, at a temperature not
lower than 36 [deg]F. for not less than 10 days. At the termination of
the holding period, the sausage shall be stuffed in casings or cloth
bags not exceeding 3\1/3\ inches in diameter, measured at the time of
stuffing. After being stuffed, the sausage shall be held in a drying
room at a temperature not lower than 45 [deg]F. for the remainder of a
35-day period, measured from the time the curing materials are added to
the meat. At any time after stuffing, if the establishment operator
deems it desirable, the product may be heated in a water bath for a
period not to exceed 3 hours at a temperature not lower than 85 [deg]F.,
or subjected to smoking at a temperature not lower than 80 [deg]F., or
the product may be both heated and smoked as specified. The time
consumed in heating and smoking, however, shall be in addition to the
35-day holding period specified.
Method No. 5. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After being stuffed, the sausage shall be held for not
less than 65 days at a temperature not lower than 45 [deg]F. The
coverings for sausage prepared according to this method may be coated at
any stage of the preparation before or during the holding period with
paraffin or other substance approved by the Administrator.
Method No. 6. (A) Basic requirements. The meat shall be ground or
chopped into pieces not exceeding three-fourths of an inch in diameter.
A dry-curing mixture containing not less than 3.33 pounds of salt to
each hundredweight of the unstuffed sausage, excluding the weight of dry
ingredients, shall be thoroughly mixed with the ground or chopped meat.
After the curing mixture has been added, the sausage shall be held for
two time periods, a holding period and a drying period. The holding
period will be for a minimum of 48 hours at a room temperature not lower
than 35 [deg]F. This holding period requirement may be fulfilled totally
or in part before the drying period and then the remainder, if any,
after the drying period or as an extension of the drying period. During
the drying period, the sausage shall be held in a drying room at a
temperature not lower than 50 (10.0 [deg]F. (10.0 [deg]C) for a period
of time determined by Tables 3A, 3B, and 4. The length of the drying
period, established in (c)(3)(i)(A), may be modified as provided in
paragraphs (c)(3)(i)(B) and (c)(3)(i)(C) of this section.

Table 3A--Sausage Drying Room Times by Method No. 6
------------------------------------------------------------------------
Days in
Diameter of casing at time of stuffing\1\ drying
room\2\
------------------------------------------------------------------------
Up to:
1 inches................................................... 14
1\1/2\ inches.............................................. 15
2 inches................................................... 16
2\1/2\ inches.............................................. 18
3 inches................................................... 20
3\1/2\ inches.............................................. 23
4 inches................................................... 25
4\1/2\ inches.............................................. 30
5 inches................................................... 35

[[Page 250]]

5\1/2\ inches.............................................. 43
6 inches................................................... 50
------------------------------------------------------------------------
\1\ The drying room times for flattened or oval sausages shall use a
diameter derived by measuring the circumference and dividing by 3.14
(pi).
\2\ Drying room time may be modified as set forth in Tables 3B and 4.

(B) Reduction in Drying Room Time. During the holding period, the
sausage may be smoked or fermented. If the temperature is increased to
70 [deg]F. (21.1 [deg]C) or higher, while the sausage is being held
after adding curing materials but before the drying period, the
subsequent drying room times prescribed for this method may be reduced
according to the schedule in Table 3B. No interpolation of values is
permissible.

Table 3B--Percentage Reduction in Drying Room Time (Table 3A) Permitted by Holding Times and Temperatures Prior to Drying \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Minimum Temperature \2\
---------------------------------------------------------------------------------------------------
70 75 80 85 90 95 100 105 110 120
Minimum Time [deg]F [deg]F [deg]F [deg]F [deg]F [deg]F [deg]F [deg]F [deg]F [deg]F
---------------------------------------------------------------------------------------------------
21.1 23.9 26.7 29.5 32.2 35.0 37.9 40.6 43.3 48.9
[deg]C [deg]C [deg]C [deg]C [deg]C [deg]C [deg]C [deg]C [deg]C [deg]C
--------------------------------------------------------------------------------------------------------------------------------------------------------
24 hours............................................ 4 5 8 10 15 23 37 57 90 \3\ 100
48 hours............................................ 9 12 18 25 35 49 88 \3\ 100 \3\ 100 100
72 hours............................................ 14 19 28 39 55 74 \3\ 100 100 100 100
96 hours............................................ 19 26 38 53 75 98 100 100 100 100
120 hours........................................... 24 33 48 67 95 \3\ 100 100 100 100 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the
required total drying time. Example: Sausage stuffed in 3 diameter casing requires 20 days in the drying room (from Drying Room Times,
Table 3A). If allowed to ferment, after addition of curing materials, at 80 [deg]F. for 48 hours, the 20 day drying time may be reduced 18% (from
Table 3B). Eighteen percent of 20 day equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room,
therefore, will be 17 days.
\2\ Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-protein ratio of
2.3:1 or less. Internal product temperature shall be used for all other sausages.
\3\ Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no drying room period is
required for products so treated.

(C) Reduced Salt Content--Drying Room Times. Salt content of less
than 3.33 pounds for each hundredweight of sausage formulation,
excluding dry ingredients, (such as salts, sugars, and spices), may be
permitted provided the drying time is increased according to the
schedule contained in Table 4.

Trichina Treatment of Sausage by Method No. 6;

Table 4--Reduced Salt Content--Drying Room Times
[Required percentage increase in drying room time (table 3A) for added
salt of less than 3.33 pounds per hundredweight of sausage]
------------------------------------------------------------------------
Increase
in drying
Minimum pounds of salt added to sausage \1\ room time
\2\
------------------------------------------------------------------------
3.3.......................................................... 1
3.2.......................................................... 4
3.1.......................................................... 7
3.0.......................................................... 10
2.9.......................................................... 13
2.8.......................................................... 16
2.7.......................................................... 19
2.6.......................................................... 22
2.5.......................................................... 25
2.4.......................................................... 28
2.3.......................................................... 31
2.2.......................................................... 34
2.1.......................................................... 37
2.0.......................................................... 40
------------------------------------------------------------------------
\1\ Calculate the salt content for column 1 as follows: Multiply the
pounds of salt in the sausage formulation by 100. Then divide this
number by the total weight of sausage formulation minus the weight of
dry ingredients and round down to the next lowest 0.1%. Percents may
be substituted for pounds.
Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. wine, 1
lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium
nitrite total weight is 127.872 lbs.

(3.56x100)/(127.872-3.56-2-.8-.012)=356/121.5=2.93

Therefore, the sausage drying time must be increased by 13 percent.
\2\ In computing the days to be added to the required total drying time,
fractions shall be rounded to the next higher whole number and added
to the required total drying time. Example: Sausage stuffed in 3\1/2\
inch diameter casing requires 23 days in the drying room (from Drying
Room Times). If the quantity of salt added per hundredweight of
sausage is 2 pounds instead of 3.33 pounds, the drying room time must
be increased by 40 percent (from Reduced Salt Content-Drying Room
Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to
the 23 days to equal 33 days. The total drying time required in the
drying room, therefore, will be 33 days.

Method No. 7, Dry Sausages. (A) General Requirements. The
establishment shall use meat

[[Page 251]]

particles reduced in size to no more than 1/4 inch in diameter. The
establishment shall add a curing mixture containing no less than 2.7
pounds of salt per hundred pounds of meat and mix it uniformly
throughout the product. The establishment shall hold, heat, and dry the
product according to paragraph (B) or (C) below.
(B) Holding, Heating, and Drying Treatment, Large Sausages. Except
as permitted in (C) below, the establishment shall subject sausages in
casings not exceeding 105 mm in diameter, at the time of stuffing, to
all of the following minimum chamber temperatures and time periods.

Treatment Schedule for Sausages 105 Millimeters (4\1/8\ Inches) or Less
in Diameter
------------------------------------------------------------------------
Minimum chamber temperature
------------------------------------------------- Minimum time (hours)
([deg]F) ([deg]C)
------------------------------------------------------------------------
50 10 12
90 32.2 1
100 37.8 1
110 43.3 1
120 48.9 1
125 51.7 7
------------------------------------------------------------------------

Following the preceding treatment, the establishment shall dry the
sausages at a temperature not lower than 50 [deg]F (10 [deg]C) for not
less than 7 days.
(C) Heating and Drying Treatment, Small Sausages. Alternatively, the
establishment may subject sausages in casings not exceeding 55 mm in
diameter, at the time of stuffing, to all of the following minimum
chamber temperatures and time periods.

Treatment Schedule for Sausages 55 Millimeters (2\1/8\ Inches) or Less
in Diameter
------------------------------------------------------------------------
Minimum chamber temperature
------------------------------------------------- Minimum time (hours)
([deg]F) ([deg]C)
------------------------------------------------------------------------
50 10 12
100 37.8 1
125 51.7 6
------------------------------------------------------------------------

Following the preceding heat treatment, the establishment shall dry the
sausages at a temperature not lower than 50 [deg]F (10 [deg]C) for not
less than 4 days.

(ii) Capocollo (capicola, capacola). Boneless pork butts for
capocollo shall be cured in a dry-curing mixture containing not less
than 4\1/2\ pounds of salt per hundredweight of meat for a period of not
less than 25 days at a temperature not lower than 36 [deg]F. If the
curing materials are applied to the butts by the process known as
churning, a small quantity of pickle may be added. During the curing
period the butts may be overhauled according to any of the usual
processes of overhauling, including the addition of pickle or dry salt
if desired. The butts shall not be subjected during or after curing to
any treatment designed to remove salt from the meat, except that
superficial washing may be allowed. After being stuffed, the product
shall be smoked for a period of not less than 30 hours at a temperature
not lower than 80 [deg]F., and shall finally be held in a drying room
not less than 20 days at a temperature not lower than 45 [deg]F.
(iii) Coppa. Boneless pork butts for coppa shall be cured in a dry-
curing mixture containing not less than 4\1/2\ pounds of salt per
hundredweight of meat for a period of not less than 18 days at a
temperature not lower than 36 [deg]F. If the curing mixture is applied
to the butts by the process known as churning, a small quantity of
pickle may be added. During the curing period the butts may be
overhauled according to any of the usual processes of overhauling,
including the addition of pickle or dry salt if desired. The butts shall
not be subjected during or after curing to any treatment designed to
remove salt from the meat, except that superficial washing may be
allowed. After being stuffed, the product shall be held in a drying room
not less than 35 days at a temperature not lower than 45 [deg]F.
(iv) Hams and pork shoulder picnics. In the curing of hams and pork
shoulder picnics, one of the methods below shall be used. For
calculating days per pound, the establishment shall use the weight of
the heaviest ham or picnic in the lot.

Method No. 1. The hams and pork shoulder picnics shall be cured by a
dry-salt curing process not less than 40 days at a temperature no lower
than 36 [deg]F. The products shall be laid down in salt, not less than 4
pounds to each hundredweight of product, the salt being applied in a
thorough manner to the lean meat of each item. When placed in cure, the
products may be pumped with pickle if desired. At least once during the
curing process, the products shall be overhauled (turned over for the
application of additional cure) and additional salt applied, if
necessary, so that the lean meat of each item is thoroughly covered.
After removal from cure, the products may be soaked in water at a
temperature not higher than 70 [deg]F for not more than 15 hours, during
which time the water may be changed once, but they shall not be

[[Page 252]]

subjected to any other treatment designed to remove salt from the meat
except that superficial washing may be allowed. The products shall
finally be dried or smoked at a time and temperature not less than a
combination prescribed in Table 5 of Method No. 3.
Method No. 2. [Reserved]
Method No. 3. (A) Curing. (Other than bag curing): Establishments
shall cure hams and shoulders by using a cure mixture containing not
less than 70 percent salt by weight to cover all exposed muscle tissue
and to pack the hock region. Total curing time consists of a mandatory
cure contact time and an optional equalization time.
(B) Cure Contact Time. This is the cure contact period, during which
the establishment shall keep exposed muscle tissue coated with the cure
mixture at least 28 days but for no less than 1.5 days per pound of ham
or shoulder. Overhaul is optional so long as the exposed muscle tissue
remains coated with curing mixture.
(C) Equalization. The establishment may provide an equalization
period after the minimum cure contact period in (B) above to permit the
absorbed salt to permeate the product's inner tissues. Equalization is
the time after the excess cure has been removed from the product at the
end of the cure contact period until the product is placed in the drying
room and the drying period begins. The total curing time (equalization
plus cure contact) shall be at least 40 days and in no case less than 2
days per pound of an uncured ham or shoulder.
(D) Removing Excess Cure. After the required cure contact period,
the establishment may remove excess cure mixture from the product's
surface mechanically or by rinsing up to 1 minute with water, but not by
soaking.
(E) Bag Curing. Bag curing is a traditional ham curing technique in
which the manufacturer wraps the ham and all of the cure mixture
together in kraft paper then hangs them individually. The paper keeps
the extra cure mixture in close contact with the product making
reapplication of salt unnecessary, and it protects the product from
mites and insects. Establishments may employ the bag curing method as an
alternative to (A) through (D) above. An establishment which elects to
use the bag curing method shall apply a cure mixture containing at least
6 pounds of salt per 100 pounds of uncured product. The establishment
shall rub the curing mixture into the exposed muscle tissue, pack the
hock region with the curing mixture, and use uncoated wrapping paper to
wrap the product together with any remaining curing mixture. The bag
cured product shall remain wrapped throughout the curing period and may
or may not remain wrapped during the drying period. In any case, the
curing period shall be at least 40 days but not less than 2 days per
pound of an uncured ham or shoulder. After curing, the cured product
shall be exposed to a drying time and temperature prescribed in Table 5.
(F) Curing Temperature. During the curing period the establishment
shall use one of the following procedures:
(1) The establishment shall control the room temperature at not less
than 35 [deg]F (1.7 [deg]C) nor greater than 45 [deg]F (7.2 [deg]C) for
the first 1.5 days per pound of an uncured ham or shoulder, and not less
than 35 [deg]F (1.7 [deg]C) nor greater than 60 [deg]F (15.6 [deg]C) for
the remainder of the curing period.
(2) The establishment shall monitor and record daily product
temperature. The room temperature need not be controlled but days on
which the product temperature drops below 35 [deg]F (1.7 [deg]C) shall
not be counted as curing time. If the product temperature exceeds 45
[deg]F (7.2 [deg]C) within the first period of 1.5 days per pound of an
uncured ham or shoulder or if it exceeds 60 [deg]F (15.6 [deg]C) for the
remainder of the curing period, the establishment shall cool the product
back to the 45 [deg]F (7.2 [deg]C) maximum during the first period or 55
[deg]F (12.8 [deg]C) maximum during the remainder of the period.
(3) The establishment shall begin curing product only between the
dates of December 1 and February 13. The room temperature need not be
controlled, but the establishment shall monitor and record daily room
temperatures, and days in which the room temperature drops below 35
[deg]F (1.7 [deg]C) shall not be counted as curing time.
(G) Drying. After the curing period, establishments shall use one of
three procedures for drying:
(1) The establishment shall subject the product to a controlled room
temperature for a minimum time and minimum temperature combination
prescribed in Table 5 or for a set of such combinations in which the
total of the fractional periods (in column 4 of Table 5) exceeds 1.5.
(2) Establishments using uncontrolled room temperatures shall
monitor and record the internal product temperature. The drying period
shall be complete when, from the days which can be counted as curing
time, one of the time/temperature combinations of Table 5 is satisfied
or when the total of the fractional values for the combinations exceeds
1.5.
(3) Establishments using uncontrolled room temperatures shall dry
the product for a minimum of 160 days including the entire months of
June, July, and August. This procedure is obviously dependent on local
climatic conditions and no problem exists with respect to current
producers who use this procedure. Future applicants shall demonstrate
that their local monthly average temperatures and the local monthly
minimum temperatures are equal to or warmer than the normal average
temperatures and

[[Page 253]]

normal minimum temperatures compiled by the National Oceanic and
Atmospheric Administration for Boone, North Carolina, station 31-0977,
1951 through 1980.

Monthly Temperatures ([deg]F) for Boone NC, 1951-1980
----------------------------------------------------------------------------------------------------------------
Jan. Feb. Mar. Apr. May June July Aug. Sep.
----------------------------------------------------------------------------------------------------------------
Normal average temperatures
----------------------------------------------------------------------------------------------------------------
32.2 34.1 41.3 51.2 59.1 65.1 68.3 67.5 61.6
---------------------------------------------------------
Normal minimum temperatures
----------------------------------------------------------------------------------------------------------------
22.8 24.2 30.8 39.6 48.1 54.7 58.5 57.6 51.6
----------------------------------------------------------------------------------------------------------------

Drying Times and Temperatures for Trichina Inactivation in Hams and
Shoulders

Table 5--Minimum Drying Days at a Minimum Temperature*
------------------------------------------------------------------------
Minimum Drying Temperature Fractional
-------------------------------------------- Minimum days period for
Degrees at drying one day of
Degrees fahrenheit centigrade temperature drying
------------------------------------------------------------------------
130........................... 54.4 1.5 .67
125........................... 51.7 2 .50
120........................... 48.9 3 .33
115........................... 46.1 4 .25
110........................... 43.3 5 .20
105........................... 40.6 6 .17
100........................... 37.8 7 .14
95............................ 35.0 9 .11
90............................ 32.2 11 .091
85............................ 29.4 18 .056
80............................ 26.7 25 .040
75............................ 23.9 35 .029
------------------------------------------------------------------------
* Interpolation of these times or temperatures is not acceptable;
establishments wishing to use temperatures or times not in this Table
shall first validate their efficacy as provided by 318.10(c)(4) of
this section.

Method No. 4. (A) Cure: Establishments shall cure hams and shoulders
by using a cure mixture containing not less than 71.5 percent salt by
weight to cover all exposed muscle tissue and to pack the hock region.
Establishments may substitute potassium chloride (KCl) for up to half of
the required salt on an equal weight basis.
(B) Curing. Establishments shall apply the cure at a rate not less
than 5.72 pounds of salt and KCl per hundred pounds of fresh meat. The
cure shall be applied in either three or four approximately equal
amounts (two or three overhauls) at separate times during the first 14
days of curing.
(C) Cure Contact Time. Establishments shall keep the product in
contact with the cure mixture for no less than 2 days per pound of an
uncured ham or shoulder but for at least 30 days. Establishments shall
maintain the curing temperature at no less than 35 [deg]F (1.7 [deg]C)
during the cure contact time.
(D) Equalization. After the cure contact period, establishments
shall provide an added equalization period of no less than 1 day per
pound of an uncured ham or shoulder but at least 14 days. Equalization
is the time after the excess cure has been removed from the product, the
end of the cure contact period, and before the drying period begins.
Establishments may substitute additional cure contact days for an equal
number of equalization days.
(E) Removing Excess Cure. After the required cure contact period,
the establishment may remove excess cure mixture from the product's
surface mechanically or by rinsing up to 1 minute with water, but not by
soaking.
(F) Drying. After the curing period, establishments shall use one of
the controlled temperature methods for drying listed in Method No. 3 of
this subparagraph.
Method No. 5 (A) Curing. The establishment shall cure the ham to a
minimum brine concentration of 6 percent by the end of the drying
period. Brine concentration is calculated as 100 times the salt
concentration divided by the sum of the salt and water concentrations.

Percent brine = 100 x [salt] / ([salt] + [water])

The Agency will accept the brine concentration in the biceps femoris
as a reasonable estimate of the minimum brine concentration in the ham.
(B) Drying and Total Process Times. The establishment shall dry the
cured ham at a minimum temperature of 55 [deg]F (13 [deg]C) for at least
150 days. The total time of drying plus curing shall be at least 206
days.
(C) Ensuring an Acceptable Internal Brine Concentration. (1) To
establish compliance, the establishment shall take product samples from
the first 12 lots of production as follows: From each lot,
(i) One sample shall be taken from each of 5 or more hams;
(ii) Each sample shall be taken from the biceps femoris. As an
alternative to the use of the biceps femoris, the Agency shall consider
other method(s) of sampling the dry-cured hams to determine the minimum
internal brine concentration, as long as the establishment proposes it
and submits data and other information to establish its sufficiency to
the Director of the Processed Products Inspection Division;

[[Page 254]]

(iii) Each sample shall weigh no less than 100 grams;
(iv) The samples shall be combined as one composite sample and
sealed in a water vapor proof container;
(v) The composite sample shall be submitted to a laboratory
accredited under the provisions of Sec. 318.21 to be analyzed for salt
and water content using methods from the ``Official Methods of Analysis
of the Association of Official Analytical Chemists (AOAC),'' 15th
Edition, 1990, Section 983.18 (page 931) and Section 971.19 (page 933)
which are incorporated by reference. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250 or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. If
the time between sampling and submittal of the composite sample to the
accredited laboratory will exceed 8 hours, then the establishment shall
freeze the composite sample immediately after the samples are combined;
(vi) Once the laboratory results for the composite sample are
received, the manufacturer shall calculate the internal brine
concentration by multiplying the salt concentration by 100 and then
dividing that figure by the sum of the salt and water concentrations;
(vii) Compliance is established when the samples from the first 12
lots of production have a minimum internal brine concentration of 6
percent. Lots being tested to establish compliance shall be held until
the internal brine concentration has been determined and found to be at
least 6 percent. If the minimum internal brine concentration is less
than 6 percent, the lot being tested shall be held until the
establishment brings the lot into compliance by further processing.
(2) To maintain compliance, the establishment shall take samples,
have the samples analyzed, and perform the brine calculations as set
forth above from one lot every 13 weeks. Lots being tested to maintain
compliance shall not be held. If the minimum internal brine
concentration is less than 6 percent in a lot being tested to maintain
compliance, the establishment shall develop and propose steps acceptable
to FSIS to ensure that the process is corrected.
(3) Accredited laboratory results and the brine calculations shall
be placed on file at the establishment and available to Program
employees for review.
Method No. 6 (A) Curing. The establishment shall cure the ham to a
minimum brine concentration of 6 percent by the end of the drying
period. Brine concentration is calculated as 100 times the salt
concentration divided by the sum of the salt and water concentrations.

Percent brine = 100 x [salt] / ([salt] + [water])

The Agency will accept the brine concentration in the biceps femoris
as a reasonable estimate of the minimum brine concentration.
(B) Drying and Total Process Times. The establishment shall dry the
cured ham at a minimum temperature of 110 [deg]F (43 [deg]C) for at
least 4 days. The total time of drying plus curing shall be at least 34
days.
(c) Ensuring an Acceptable Internal Brine Concentration.
(1) To establish compliance the establishment shall take product
samples from the first 12 lots of production as follows: From each lot,
(i) One sample shall be taken from each of 5 or more hams;
(ii) Each sample shall be taken from the biceps femoris. As an
alternative to the use of the biceps femoris, the Agency will consider
other methods of sampling the dry-cured hams to determine internal brine
concentration, as long as the establishment proposes it and submits data
and other information to establish its sufficiency to the Director of
the Processed Products Inspection Division;
(iii) Each sample shall weigh no less than 100 grams;
(iv) The samples shall be combined as one composite sample and
sealed in a water vapor proof container;
(v) The composite sample shall be submitted to a laboratory
accredited under the provisions of Sec. 318.21 to be analyzed for salt
and water content using methods from the ``Official Methods of Analysis
of the Association of Official Analytical Chemists (AOAC),'' 15th
Edition, 1990, section 983.18 (page 931) and section 971.19 (page 933)
which are incorporated by reference. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250 or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/

[[Page 255]]

code--of--federal--regulations/ibr--locations.html. If the time between
sampling and submittal of the composite sample to the accredited
laboratory will exceed 8 hours, then the establishment shall freeze the
composite sample immediately after the samples are combined;
(vi) Compliance is established when the samples from the first 12
lots of production have a minimum internal brine concentration of 6
percent. Lots being tested to establish compliance shall be held until
the internal brine concentration has been determined and found to be at
least 6 percent. If the minimum internal brine concentration is less
than 6 percent, the lot being tested shall be held until the
establishment brings the lot into compliance by further processing.
(2) To maintain compliance, the establishment shall take samples,
have the samples analyzed, and perform the brine calculations as set
forth above from one lot every 13 weeks. Lots being tested to maintain
compliance shall not be held. If the minimum internal brine
concentration is less than 6 percent in a lot being tested to maintain
compliance, the establishment shall develop and propose steps acceptable
to FSIS to ensure that the process is corrected.
(3) Accredited laboratory results and the brine calculations shall
be placed on file in the establishment and available to Program
employees for review.

(v) Boneless pork loins and loin ends. In lieu of heating or
refrigerating to destroy possible live trichinae in boneless loins, the
loins may be cured for a period of not less than 25 days at a
temperature not lower than 36 [deg]F. by the use of one of the following
methods:

Method No. 1. Application of a dry-salt curing mixture containing
not less than 5 pounds of salt to each hundredweight of meats.
Method No. 2. Application of a pickle solution of not less than
80[deg] strength (salom eter) on the basis of not less than 60 pounds of
pickle to each hundredweight of meat.
Method No. 3. Application of a pickle solution added to the dry-salt
cure prescribed as Method No. 1 in this subdivision (v) provided the
pickle solution is not less than 80[deg] strength (salometer).
After removal from cure, the loins may be soaked in water for not
more than 1 hour at a temperature not higher than 70 [deg]F. or washed
under a spray but shall not be subjected, during or after the curing
process, to any other treatment designed to remove salt.
Following curing, the loins shall be smoked for not less than 12
hours. The minimum temperature of the smokehouse during this period at
no time shall be lower than 100 [deg]F., and for 4 consecutive hours of
this period the smokehouse shall be maintained at a temperature not
lower than 125 [deg]F.
Finally, the product shall be held in a drying room for a period of
not less than 12 days at a temperature not lower than 45 [deg]F.

(4) The Administrator shall consider additional processing methods
upon petition by manufacturers, and shall approve any such method upon
his/her determination that it can be properly monitored by an inspector
and that the safety of such methods is adequately documented by data
which has been developed by following an experimental protocol
previously reviewed and accepted by the Department.
(d) General instructions: When necessary to comply with the
requirements of this section, the smokehouses, drying rooms, and other
compartments used in the treatment of pork to destroy possible live
trichinae shall be suitably equipped, by the operator of the official
establishment, with accurate automatic recording thermometers. Circuit
supervisors are authorized to approve for use in sausage smokehouses,
drying rooms, and other compartments, such automatic recording
thermometers as are found to give satisfactory service and to disapprove
and require discontinuance of use, for purposes of the regulations in
this subchapter, any thermometers (including any automatic recording
thermometers) of the establishment that are found to be inaccurate or
unreliable.
(e) The requirements for using the pooled sample digestion technique
to analyze pork for the presence of trichina cysts are:
(1) The establishment shall submit for the approval of the Regional
Director its proposed procedure for identifying and pooling carcasses,
collecting and pooling samples, testing samples (including the name and
address of the laboratory), communicating test results, retesting
individual carcasses, and maintaining positive identification and clear
separation of pork found to be trichina-free from untested pork or
trichina-positive pork.
(2) The establishment shall use the services of a laboratory
approved by the Administrator for all required testing. Such approval
shall be based on adequacy of facilities, reagents, and

[[Page 256]]

equipment, and on demonstration of continuing competency and reliability
in performing the pooled sample digestion technique for trichinae.
(3) The establishment shall sample no less than 5 grams of diaphragm
muscle or tongue tissue from each carcass or no less than 10 grams of
other muscle tissue. Samples may be pooled but a pool shall not consist
of more than 100 grams of sample. Sampling and sample preparation are
subject to inspection supervision.
(4) Pork or products made from tested pork shall not be released as
trichina free from the official establishment without treatment until
the inspector in charge receives a laboratory report that the tested
pork is free of trichina cysts.
(f) Approval of other tests for trichinosis in pork. The
Administrator shall consider any additional analytical method for
trichinosis upon petition by a manufacturer, and may approve that method
upon the determination that it will detect at least 98 percent of swine
bearing cysts present at a tissue density equal to or less than one cyst
per gram of muscle from the diaphragm pillars at a 95 percent confidence
level. Any such petitions shall be supported by any data and other
information that the Administrator finds necessary. Notice of any
approval shall be given in the Federal Register, and the approved method
will be incorporated into this section.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 31517; Nov. 15, 1973; 39
FR 40580, Nov. 19, 1974; 50 FR 5229, Feb. 7, l985; 50 FR 48075, Nov. 21,
1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, June 22, 1992; 57 FR
33633, July 30, 1992; 57 FR 56440, Nov. 30, 1992]