Section

[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2007]

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

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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 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.

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.

[[Page 248]]

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.

(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

[[Page 249]]

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 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

[[Page 250]]

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

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.

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

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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 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.

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

[[Page 252]]

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

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.

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

[[Page 253]]

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 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.

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

[[Page 254]]

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.

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;

(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.

[[Page 255]]

(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.

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)