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 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.

(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		Minimum time
Degrees fahrenheit	Degrees centigrade	Minimum time
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 °F. to 120 °F shall not exceed 2 hours unless the product is cured or fermented.

(iv) Time, in combination with temperatures of 138 °F to 143 °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 °F (58.9 °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 °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 °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 °F., −10 °F., or −20 °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		Minimum Time
Degrees Fahrenheit	Degrees centigrade	Minimum Time
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 § 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 31/3 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 31/2 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 °F., except that in sausage of the variety known as pepperoni, if in casings not exceeding 13/8 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 31/2 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 °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 31/3 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 31/2 inches, measured at the time of stuffing, shall be smoked not less than 40 hours at a temperature not lower than 80 °F., and finally held in a drying room not less than 10 days at a temperature not lower than 45 °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 31/2 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 °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 31/3 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 °F. for not less than 36 hours. After being stuffed, the sausage shall be held at a temperature not lower than 34 °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° strength (salometer reading) at a temperature not lower than 44 °F. Finally, sausage having a diameter not exceeding 31/2 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 °F.; and for 4 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 128 °F. Sausage exceeding 31/2 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 °F., and for 7 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 128 °F. In regulating the temperature of the smokehouse for the treatment of sausage under this method, the temperature of 128 °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 21/2 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 °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 31/3 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 °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 °F., or subjected to smoking at a temperature not lower than 80 °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 31/3 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 °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 °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 °F. (10.0 °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.

(B) Reduction in Drying Room Time. During the holding period, the sausage may be smoked or fermented. If the temperature is increased to 70 °F. (21.1 °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.

(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;

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.

Following the preceding treatment, the establishment shall dry the sausages at a temperature not lower than 50 °F (10 °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.

Following the preceding heat treatment, the establishment shall dry the sausages at a temperature not lower than 50 °F (10 °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 °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 °F., and shall finally be held in a drying room not less than 20 days at a temperature not lower than 45 °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 °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 °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 °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 °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.

(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 °F (1.7 °C) nor greater than 45 °F (7.2 °C) for the first 1.5 days per pound of an uncured ham or shoulder, and not less than 35 °F (1.7 °C) nor greater than 60 °F (15.6 °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 °F (1.7 °C) shall not be counted as curing time. If the product temperature exceeds 45 °F (7.2 °C) within the first period of 1.5 days per pound of an uncured ham or shoulder or if it exceeds 60 °F (15.6 °C) for the remainder of the curing period, the establishment shall cool the product back to the 45 °F (7.2 °C) maximum during the first period or 55 °F (12.8 °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 °F (1.7 °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.

Table 5—Minimum Drying Days at a Minimum Temperature*

Minimum Drying Temperature		Minimum days at drying temperature	Fractional period for one day of drying
Degrees fahrenheit	Degrees centigrade	Minimum days at drying temperature	Fractional period for one day of 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 °F (1.7 °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 × [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 °F (13 °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;

(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 § 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 × [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 °F (43 °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 § 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) 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.

(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 °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° strength (salometer) 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° 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 °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 °F., and for 4 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 125 °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 °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 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.

Code of Federal Regulations

[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, 1985; 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]