3 OF COLD CUTS – EMULSIFIED SAUSAGESnmis.gov.ph/attachments/article/11/Code of RCPPHCC.pdf · 3...
Transcript of 3 OF COLD CUTS – EMULSIFIED SAUSAGESnmis.gov.ph/attachments/article/11/Code of RCPPHCC.pdf · 3...
Draft RCP as of June 15, 2010
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RECOMMENDED CODE OF PRACTICE FOR THE PROCESSING AND HANDLING 2
OF COLD CUTS – EMULSIFIED SAUSAGES 3
4
1. SCOPE 5
6
This Code of Practice is concerned with the receipt of raw materials and ingredients, 7
preparation and processing of emulsified sausages as defined in this Code, in order to 8
conform with the required standards stated in PNS/FDA No. ___. Standards for Cold 9
Cuts – Emulsified Sausages. The product shall be prepared from emulsified meat, 10
and then cooked to make the product ready-to-eat. This Code is intended to provide 11
guidelines to achieve compliance with the standards for emulsified sausages packed 12
in any suitable container. 13
14
2. DEFINITION OF TERMS 15
16
For the purpose of this Code, the following definitions apply: 17
18
Casing – a tubular membrane, natural or manufactured, shirred or in loose form, 19
stretchable or unstretchable, permeable or impermeable to gas or liquid, may be 20
edible or non-edible. 21
22
Cold cuts – pre-cooked or ready-to-eat meat products such as sausages and meat 23
loaves that are usually served or consumed cold or unheated. 24
25
Comminution – a general term for the process of particle size reduction. This may 26
include cutting, chopping, grinding, milling and other physical treatment. 27
28
Container – any form of packaging material, which completely or partially encloses 29
the food (including wrappers). A container may enclose the food as a single item or 30
several units or types of prepackaged food when such is presented for sale to the 31
consumer. 32
33
Current Good Manufacturing Practices (cGMP) – a quality assurance system 34
aimed at ensuring that products are consistently manufactured, packed or repacked or 35
Draft RCP as of June 15, 2010
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held to a quality appropriate for the intended use. It is thus concerned with both 36
manufacturing and quality control procedures. 37
38
Edible casing – it is a casing or tubing prepared from collagen, cellulose, or food-39
grade synthetic material or from natural sources (e.g., hog or sheep intestines) that 40
contain the sausage mix (CODEX STAN 192-1995 (Rev. 5-2004)). Edible casings are 41
casings that do not have to be removed before consumption and are fit to be 42
consumed together with the sausage mix. 43
44
Emulsion – In sausage products, the emulsion is a semi-fluid mixture of comminuted 45
meat, water, spices, and curing agents, with the combination of solubilized protein and 46
water forming a capsule around the fat globules. 47
48
Extenders – refer to any non-meat ingredient added to reduce formulation cost, 49
improve emulsion stability and other technological purposes. 50
51
Fat caps – refer to unbound fat molecules that have accumulated on the surface and 52
ends of the sausage due to emulsion breakdown resulting from overchopping of 53
ingredients or the presence of excess fat. 54
55
Flavor and flavoring substances – substances which are added to impart flavor 56
which are either natural, nature identical or artificial flavoring substances. 57
(a) natural flavor – these flavoring substances derived through appropriate physical 58
processes from spices, herbs, fruit or fruit juices, vegetable or vegetable juices, edible 59
yeast, bark, bud, root, leaf or plant materials, meat, fish, poultry, eggs, dairy products 60
or fermentation products thereof. 61
(b) nature-identical flavoring substances – these are substances chemically derived 62
from aromatic materials or obtained synthetically, which are chemically identical to 63
substances present in' natural products intended for human consumption. 64
(c) artificial flavoring substances – these are substances that impart flavor but which 65
have not been identified in natural products or natural sources of flavorings. 66
67
Food – any substance, whether processed, semi-processed or raw, which is intended 68
for human consumption, and includes drink, chewing gum and any substance which 69
has been used in the manufacture, preparation or treatment of “food” but does not 70
include cosmetics or tobacco or substances used only as drugs. 71
Draft RCP as of June 15, 2010
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72
Food Additives – any substance the intended use of which results or may reasonably 73
be expected to result, directly or indirectly, in its becoming a component or otherwise 74
affecting the characteristics of any food (including any substance intended for use in 75
producing, manufacturing, packing, processing, preparing, treating, packaging, 76
transporting, or holding food; and including any source of radiation intended for any 77
such use), if such substance is not generally recognized, among experts qualified by 78
scientific training and experience to evaluate its safety, as having been adequately 79
shown through scientific procedures to be safe under the conditions of the intended 80
use (R.A. 3720. Food, Drugs and Cosmetic Act). 81
82
Food and Drug Administration or FDA – formerly known as Bureau of Food and 83
Drug (BFAD) of the Department of Health (DOH); which was renamed in accordance 84
to RA 9711 (Food and Drug Administration (FDA) Act of 2009). 85
86
Food Standard – a regulatory guideline that defines the identity of a given food 87
product (i.e. its name and the ingredients used for its preparation) and specifies the 88
minimum quality factors and, when necessary, the required fill of the container. It may 89
also include specific labeling requirements other than or in addition to the labeling 90
requirements generally applicable to all prepackaged foods. 91
92
Ingredient - any substance including food additive, used as a component in the 93
manufacture or preparation of a food and present in the final product in its original or 94
modified form. 95
96
Label – includes any tag, brand, mark, pictorial, or other descriptive script, written, 97
printed, marked, embossed or impressed on, or attached to the container. 98
99
Labeling – any written, printed or graphic matter (1) upon any article or any of its 100
container or wrappers and/or (2) accompanying the packaged food. 101
102
Lot – food produced during a period of time and under more or less the same 103
manufacturing condition indicated by a specific code. 104
105
Meat – it is fresh, chilled, or frozen edible carcass including offal derived from food 106
animals (Joint DA-NMIS and DOH-FDA A.O. 01 s.2009). Skeletal & non-skeletal 107
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muscle tissues may include beef (cattle), carabeef (carabao or water buffaloes), pork, 108
poultry (chicken, duck, turkey), lamb/mutton (sheep), and chevon (goat). For the 109
purpose of this standard, meat shall also come from other meat sources such as fish, 110
shellfish, and other seafoods. 111
112
Moisture content - the percentage weight of water in relation to the dry weight of the 113
product. 114
115
Mould – any rigid metal or inert material of any shape or form used as container 116
during cooking of cold cuts. 117
118
Packaging – the process of packing that is part of the production cycle applied to a 119
bulk product to obtain the finished product. Any material, including painted material, 120
employed in the packaging of a product including any outer packaging used for 121
transportation of shipment. Packaging materials are referred to as primary or 122
secondary according to whether or not they are intended to be in direct contact with 123
the product. 124
125
Processing aids – these are additives that are used in the processing of food to 126
achieve a specific technological purpose and which may or may not result in the 127
presence of residues or derivatives in the final product (BFAD A.O. No. 88-A s. 1984) 128
129
Potable water – it is the water fit for human consumption and potability determined by 130
health authorities cited in Philippine National Standards for drinking water 131
(Department of Health-Administrative Order No. 2007-0012: Philippine National 132
Standards for Drinking Water 2007) 133
134
Sausage – it is fresh or preserved meat, chopped or comminuted fine, to which has 135
been added salt and spices and may contain sugar, seasoning, saltpeter (potassium 136
or sodium nitrate) potassium or sodium nitrite, with or without binder (BFAD A.O. 154 137
s. 1971). Sausage is comminuted seasoned meat that has been stuffed into casings, 138
and may have undergone smoking, curing, fermentation and heating (FAO, 1985). 139
140
Spices – refer to any aromatic vegetable substance in whole, broken, ground or in 141
any other form, except those other substances which have been traditionally regarded 142
as food. 143
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144
Water Activity – it is the ratio of vapor pressure of water in the food substrate to the 145
vapor pressure of pure water at the same temperature (Jay et. al., 2005). It is also a 146
measure of water available for chemical reactions and microbial growth (Fennema, 147
1996). 148
149
3. RAW MATERIALS, INGREDIENTS AND PACKAGING MATERIAL 150
REQUIREMENTS 151
152
3.1 Raw materials and ingredients. Raw materials for processing shall not contain 153
parasites, microorganisms, toxins, and decomposed or extraneous substances. 154
155
3.1.1 Basic Ingredients 156
157
Meat. Meat to be used shall be sound, clean, and fit for human consumption. Meat 158
should have a meat inspection mark or certificate of inspection by the NMIS and/or 159
authority for the meat source, to confirm their suitability for processing. 160
161
Water. Only clean, potable water (Annex A) shall be used for the preparation and for 162
all the pretreatment and processing steps of emulsified sausage production. 163
164
Non-potable water may be used only for operations not in direct contact with the food 165
materials provided that this does not pose a hazard to health as determined and 166
approved by the official agency having the jurisdiction over it. 167
168
Spices and Flavorings. All spices and flavor/flavoring substances used shall be 169
certified as food grade by the Food and Drugs Administration (FDA). 170
171
Salt. Salt to be used should be fine or coarse sodium chloride (NaCl) available from 172
natural sources or manufactured as food grade, and meets the purity requirements as 173
specified in Section 4.1 of the Implementing Rules and Regulations of the ASIN Law, 174
Republic Act (RA) 8172, an Act Promoting Salt Iodization Nationwide. 175
176
Fat. Fat to be used should come from any edible and food-grade vegetable and 177
animal fat source, and must comply with applicable food standards. 178
179
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180 3.1.2 Optional Ingredients 181
182
Binders and extenders. These may include soy proteins, cereal flours and other 183
suitable food-grade materials complying with applicable food standards 184
185
Curing agents. Curing agents used must comply with the regulations set for food 186
additives (BFAD Bureau Circular No. 016 s.2006. Updated List of Food Additive) and 187
other applicable food standards 188
189
Other food ingredients. These ingredients must be of food-grade quality and comply 190
with applicable food standards required by FDA and/or authority. 191
192
3.1.3. Casings 193
Casings used may be edible or non-edible, must be of food grade-quality, and should 194
conform to food standards required by FDA, NMIS, and/or authority. 195
196
3.2 Packaging materials. The packaging materials should be appropriate for the product 197
to be packed and for the expected conditions of handling during distribution and 198
storage. These should provide the products adequate protection from contamination 199
and should be sufficiently durable to withstand mechanical, chemical and thermal 200
stresses encountered during processing and normal distribution. All packaging 201
materials must be clean and free from defects that may affect the product or package 202
integrity. These shall be stored in a clean and sanitary manner. 203
204
4. HYGIENE 205
206
It is recommended that the products covered by the provisions of this code of practice 207
should be processed and handled according to the appropriate sections of 208
Recommended Code of Practice – General principles of Food Hygiene (CAC/RCP 1-209
1969 (Rev. 4, 2003)), the Recommended International Code of Practice for Fresh 210
Meat (CAC/RCP 11-1976), the Recommended International Code of Hygienic Practice 211
for Processed Meat and Poultry Products (CAC/RCP13-1976 (Rev. 1-1985)), Code of 212
Practice for Fish and Fishery Products (CAC/RCP 52-2003; Rev.4-2008) and/or BFAD 213
A.O. No. 153 s. 2004 - Revised Guidelines on Current Good Manufacturing Practice In 214
Manufacturing, Packing, Repacking, or Holding Food, covering the plant facilities and 215
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operations requirement including the construction and layout of processing plant, 216
hygienic facilities, equipment, utensils and working surfaces. 217
218
5. PREPARATION AND PROCESSING 219
220
The preparation of emulsified sausages is described from the receipt of raw materials 221
until the packing operations. The production process should be supervised by 222
personnel with adequate technical training and experience. 223
224
5.1 Preparation of Raw Materials and Ingredients 225
226
5.1.1 Meat 227
228
Receipt 229
Meat from any food animal, poultry, fish, shellfish or seafood species shall only be 230
accepted if it is sound and suitable for processing, according to the requirements 231
stipulated in sub-subsection 3.1.1. Those found with contamination should be 232
rejected. Special precautions must be taken to reject meat showing signs of 233
deterioration and spoilage. 234
235
Inspection and sorting 236
The meat shall be inspected and sorted according to meat source (species), meat 237
parts or cuts, and intended use of the meat pieces. 238
239
If prepackaged meat pieces or mechanically deboned meat is to be used as raw 240
material, choose only those contained in clean, non-toxic, and properly labeled 241
packaging materials. 242
243
Storage/holding 244
Fresh meat must be kept chilled at temperatures of 0° to 4°C, while frozen meat 245
must be kept at -18°C or below. 246
247
Meat held for processing should be stored in a suitable type of container and must be 248
protected from domestic animals, parasites, chemical or microbiological 249
contaminants, debris, and dust. Meat may be placed in corrosion resistant trays. 250
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Cartons may also be used as long as appropriate inner lining is used or if the meat is 251
individually wrapped. 252
253
The containers should be arranged to allow adequate air circulation and to prevent 254
drip from one meat piece from falling onto another piece. Conditions in the storage 255
and holding areas such as temperature and humidity should be regulated to prevent 256
spoilage and contamination. 257
258
Regular inspection of the storage facility should be done to avoid infestation. 259
Temperature and humidity levels conducive to spoilage and contamination should be 260
avoided. 261
262
Washing and/or sanitizing 263
Meat may be washed to remove dirt, dust, and filth that might contaminate the 264
meat, or water may be used to facilitate thawing of frozen meat. Water used for 265
washing, thawing, and rinsing should be of potable quality. 266
267
5.1.2 Optional Ingredients 268
269
Receipt 270
Optional ingredients and casings to be used in the preparation of emulsified 271
sausages shall conform to the requirements stipulated in sub-subsections 3.1.2, and 272
3.1.3. Whenever applicable, certificates of analyses (COA) from ingredient suppliers 273
shall be secured to confirm their suitability for processing. Ingredients shall be 274
rejected if they do not conform to the requirements and are found to have signs of 275
deterioration, decomposition, or contamination to an extent which renders them unfit 276
for human consumption. 277
278
Storage/Holding 279
Optional ingredients shall be in closed containers as protection against infestation by 280
domestic animals, parasites, filth, and chemical and microbiological contaminants. 281
Storage requirements such as temperature and humidity may vary depending on the 282
ingredient, and these should be provided accordingly by the storage facilities to be 283
used. 284
285
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Stored stocks of ingredients should be used on a “first in-first out” (FIFO) or a “first to 286
expire-first to use” (FEFU) basis. 287
288
5.2 Processing Operations 289
290
5.2.1. Preparation of meat 291
If frozen meat is used, the thawing process should take place in conditions that 292
minimize contamination and microbial growth. Frozen meat may be thawed in air or 293
by immersing in water. Time and temperature conditions must be controlled to 294
minimize microbial growth and allow the product to thoroughly thaw out. Chilled 295
meat and thawed meat must be kept at 0° to 4°C while waiting for further processing. 296
297
5.2.2. Grinding/comminution 298
The meat shall be comminuted to smaller, uniformly-sized particles through the use 299
of a meat grinder, a food processor, or a silent cutter. Comminution must be 300
performed in a way that minimizes contamination and prevents overchopping of 301
meat. Overchopping of meat may result to protein strands that are too short, and 302
would affect the emulsification process. 303
304
5.2.3 Blending and emulsification 305
Ground or comminuted meat is mixed or blended with non-meat ingredients including 306
spices and flavorings, salt, and curing agents. Water in the form of crushed ice or ice 307
water is gradually added throughout the process to dissolve the dry ingredients, 308
control the temperature of the mixture, and to facilitate the formation of the meat 309
emulsion. The amount of added water in the formulation should not exceed 10% of 310
the total product weight. 311
312
Fat is gradually added during the latter part of the mixing process to prevent fat 313
rendering. Excessive fat in the formulation may cause the formation of fat caps in the 314
finished product. 315
316
The blending and emulsification process should be controlled to avoid overmixing. 317
Overmixing of ingredients may Increase the temperature of the meat mixture that can 318
coagulate protein before the meat emulsion is formed and/or cause the partial 319
rendering of fat. 320
321
Draft RCP as of June 15, 2010
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5.2.4 Shaping 322
Shaping may be accomplished by either stuffing and linking, or moulding: 323
324
Stuffing and Linking. The meat emulsion is stuffed into casings by hand, through a 325
screw feed or by using an automatic stuffing machine. Care must be observed not to 326
use too much pressure that will damage the casings, and at the same time, the 327
sausage mix must completely and compactly fill the casings to prevent air pockets 328
from forming. 329
330
Emulsified sausages that have large diameters are filled into individual casings that 331
have the ends sealed with strings or metal clips. On the other hand, emulsified 332
sausage that use casings with smaller diameter and longer strand are further divided 333
into segments that are uniform in size and length. This may be accomplished by 334
twisting the casing or tying with a string to create sausage links. 335
336
Moulding. The meat emulsion is filled into moulds, which will give the product its 337
shape in lieu of a casing and will serve as container during the cooking process. 338
339
5.2.5 Other Treatments 340
341
Drying/Reddening. After stuffing and linking, sausages in casings are allowed to 342
stand at room temperature for 1 to 2 hours. This is to allow the casings to dry, and 343
give time for curing to occur before the product is subjected to smoking. 344
Drying/reddening may also be accomplished by placing the products inside a warm 345
smokehouse kept at 50°C without smoke. Drying the casing will depend on the 346
size/diameter of the sausage and may range from 15 minutes to one hour. 347
348
Sufficient time and temperature must be employed to allow reddening or curing to 349
proceed if the product will not be subjected to smoking. For products that utilize 350
impermeable casings or moulds, the products are allowed to stand at ambient 351
temperature for one to two hours to allow time for curing. 352
353
Smoking. Emulsified sausages may or may not be smoked. Using raw sawdust, 354
emulsified sausages are smoked at temperatures ranging from 65° to 75°C for 30 to 355
60 minutes or until the desired product color is obtained. The relative humidity of the 356
Draft RCP as of June 15, 2010
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smokehouse should be maintained at around 80%, since very low humidity can dry 357
out the product while excessively high humidity dilutes the effect of smoke. 358
359
Liquid smoke, a water soluble compound with smoke flavor, is also available, and 360
can be sprayed or applied to the sausage surface. 361
362
5.2.6 Cooking 363
Cooking of emulsified sausages may be done inside a smokehouse, through the use 364
of ovens, or by immersion of the product in heated water. 365
366
Cooking temperatures may vary with the method of cooking. Water sprays may have 367
temperatures of 80° to 82°C, while cooking vats may have temperatures of 74° to 368
80°C. Cooking time ranges from 15 to 20 minutes or until the internal product 369
temperature reaches a minimum of 70°C. 370
371
For products that are not smoked, the cooking process may take a longer period of 372
time before the minimum internal temperature is achieved. Also, instead of using 373
cooking vats and water sprays, some products may be baked in an oven. The typical 374
baking/cooking temperature for meat loaves and similar products is 150°C for 2 to 3 375
hours. 376
377
5.2.7 Cooling 378
Cooling of cooked sausages is done through immersion in cold water bath or cold 379
water spraying. 380
381
5.3 Packing 382
Packing can be done either mechanically or manually. It is important to standardize 383
filling for economic reasons. Gas-packing or vacuum-packing may be done. The 384
room temperature of the packing area should be maintained at 10°C or below. 385
386
5.4 Closing or Sealing of Containers 387
Seams and other closures shall be sealed air-tight to meet the requirements of the 388
processors. 389
390
The seal area of flexible containers must be free of food material and wrinkles. 391
Sealing temperature and pressure shall conform to the sealing equipment to be used. 392
Draft RCP as of June 15, 2010
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393
5.5 Coding of Sealed Containers 394
Coding of sealed container shall be indelible with details of production date and time, 395
batch code, product code, the product line in which product is packed, the 396
manufacturing plant and other information necessary for product traceability. Where 397
the container does not permit the code to be embossed or inked, the label shall be 398
legibly perforated or otherwise marked, and securely affixed to the product container. 399
400
5.6 Post-Process Container Handling 401
Emulsified sausages must be kept at chilled (0° to 4°C) or frozen conditions (below 402
-18°C). Fluctuations in storage temperature that will expose the product to freeze-403
thaw cycles should be avoided. The repeated freezing and thawing process can 404
cause deterioration of the product quality. 405
406
Mechanical shocks leading to breakage of semi-rigid containers due to container 407
abuse must be avoided. These occur by knocking against each other during 408
conveying, packaging and labeling operations, among others. Flexible 409
containers/pouches shall be handled singly rather than in bunches, and care must be 410
exercised so as to prevent damage by roughened contact surfaces. 411
412
6. FOOD ADDITIVES 413
414
6.1. Food additives when used shall be in accordance with the regulations established by 415
the Food and Drugs Administration (B.C. No.2006-016 Updated List of Food 416
Additives), the Codex Alimentarius Commission (CAC/STAN 192-1995, Rev. 5 417
(2004)), and/or authority for these products. The following food additives listed in, but 418
not limited to, Table 1, may be used for the manufacture of emulsified sausages. 419
420
6.2 All others that have not been included in the above list (Table 1) shall be allowed as 421
carry over provided they are approved by the FDA regulation (B.C. No. 016 s. 2006; 422
Updated List of Food Additives) and shall be in accordance to Section 5.2 of the 423
“Principle Relating to the Carry-Over of Food Additives into Foods (CAC/Volume 1, 424
1991). These additives include those that are used for raw materials and other 425
ingredients such as edible casings. Table 2 shows the list of additives that may be 426
used for edible casings. 427
428
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429 430 431 Table 1. Food Additives for Emulsified Sausages. (BFAD B.C. No.016 s. 2006. 432 Updated List of Food Additives) 433
Function Additive Maximum allowable level Antioxidants BHA 200 mg/kg (Fat or oil basis)*
BHT 100 mg/kg (Fat or oil basis)* Gallate, Propyl 200 mg/kg * Tertiary Butylhydroquinone (TBHQ)
100 mg/kg (Fat or oil basis)*
Tocopherols 3000 mg/kg* Color Allura Red AC 25 mg/kg**
Annatto extracts 50 mg/kg (As total bixin or norbixin)** Canthaxanthin 15 mg/kg ** Carmines 100 mg/kg ** Carotenes, vegetable 20 mg/kg ** Carotenoids 20 mg/kg ** Curcumin 20 mg/kg ** Erythrosine 30 mg/kg * Grape Skin Extract GMP (For use in glaze, coatings, or
decorations for fruit, vegetables, meat, or fish) **
Iron Oxides GMP (For use in glaze, coatings, or decorations for fruit, vegetables, meat, or fish) **
Ponceau 4R 200 mg/kg **
Sunset Yellow CF 500 mg/kg (For use in glaze, coatings, or decorations for fruit, vegetables, meat, or fish) **
Tannic Acid (Tannins, food grade)
10 mg/kg*
Emulsifier/ Stabilizer
Diacetyltartaric and fatty acid esters of glycerol
GMP **
Polysorbates 10000 mg/kg * Propylene Glycol Alginate 5000 mg/kg * Stearoyl-2-Lactylates 4000 mg/kg ** Sucroglycerides 5000 mg/kg (Fat or oil basis) ** Sucrose Esters of Fatty Acids
5000 mg/kg (Fat or oil basis) **
Flavor Enhancer
Saccharin 500 mg/kg **
Humectant Phosphates 1100 mg/kg (As phosphorus)* Preservative EDTAs 35 mg/kg (As anhydrous calcium disodium
EDTA) ** Nitrates 365 mg/kg (As residual NO3 ion)** Nitrites 134 mg/kg (As residual NO2 ion) * Sodium Diacetate 1000 mg/kg * Sorbates 2000 mg/kg (As sorbic acid) * Sulphites 500 mg/kg (As residual SO2) **
* For food category system: 8.3. Processed comminuted meat, poultry and game products ** For food subcategory:8.3.2.Heat-treated processed comminuted meat, poultry, and game products
434 435
436 437 438
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439 Table 2. Food Additives for Edible Casings (BFAD B.C. No.016 s. 2006. Updated List of 440 Food Additives*) 441
Function Additive Maximum allowable level Antioxidant Ascorbyl Esters 5000 mg/kg (As ascorbyl stearate)
Tocopherols 5000 mg/kg Color Allura Red AC 500 mg/kg (For use in glaze, coatings or
decorations for fruit, vegetables, meat or fish) Annatto extracts 60 mg/kg (As total bixin or norbixin) Canthaxanthin GMP Carmines 500 mg/kg (For use in glaze, coatings, or
decorations for fruit, vegetables, meat, or fish) Carotenes, vegetable GMP Carotenoids 500 mg/kg (For use in glaze, coatings, or
decorations for fruit, vegetables, meat, or fish) Curcumin 500 mg/kg (For use in glaze, coatings, or
decorations for fruit, vegetables, meat, or fish) Erythrosine GMP Fast Green FCF GMP (Surface treatment; For decoration,
stamping, marking or branding the product) Grape Skin Extract GMP Iron Oxides 1000 mg/kg (Ready-to-eat basis) Orange B 150 ppm
Ponceau 4R 500 mg/kg (For use in glaze, coatings, or decorations for fruit, vegetables, meat, or fish)
Sunset Yellow CF 500 mg/kg (For use in glaze, coatings, or decorations for fruit, vegetables, meat, or fish)
Emulsifier/ Stabilizer
Diacetyltartaric and fatty acid esters of glycerol
GMP
Dioctyl Sodium Sulfosuccinate 200 mg/kg Polysorbates 1500 mg/kg Propylene Glycol Alginate 20000 mg/kg Sorbitan Esters of Fatty Acids 3500 mg/kg Sucrose Esters of Fatty Acids 5000 mg/kg (Fat or oil basis)
Humectant Phosphates 1100 mg/kg (As phosphorus) Preservative Hydroxybenzoates, p- 36 mg/kg (As p-hydroxybenzoic acid)
Nitrates 146 mg/kg (As residual NO3 ion) Nitrites 134 mg/kg (As residual NO2 ion) Sorbates GMP (As sorbic acid) Sulphites 500 mg/kg (As residual SO2)
*For food category system: 8.4. Edible casings (e.g. sausage casings)
442
443 7. LABELLING 444
445
7.1 Each container shall be labeled and marked with the following information in accordance 446
with BFAD A.O. 88-B s. 1984 (Rules and regulations Governing the Labeling of 447
Prepackaged Food Products distributed in the Philippines): 448
449
(a) The product shall be known as “sausage” or “emulsified sausage”. It may be labeled 450
by common names that include but are not limited to “hotdog”, “frankfurter”, 451
Draft RCP as of June 15, 2010
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“bologna”, and “Vienna sausage”, provided that the product conforms to the accepted 452
standard formulation and process. For sausages utilizing only one meat source, the 453
label may also indicate the species or type of meat source used, such as “fish”, 454
“chicken”, “turkey”, or “beef”. Additional description may be printed with the product 455
name to provide classification for premium, regular, and value products. 456
(b) The complete list of ingredients and food additives used in the preparation of the 457
product in descending order of proportion. 458
(c) The net content by weight in the metric system. Other systems of measurement 459
required by importing countries shall appear in parenthesis after the metric system 460
unit. 461
(d) The name and address of the manufacturer, packer and/or distributor of the food. 462
(e) Open date marking 463
The words “Best/Consume Before/Expiry Date” indicating end of period at which the 464
product shall retain its optimum quality attributes at defined storage conditions. 465
(f) Lot or code number identifying product lot. 466
(g) The words “Product of the Philippines”, or the country of origin if imported. 467
(h) Directions for use; 468
Directions for use should be indicated on the label. The label should indicate that 469
non-edible casings should be removed from the product before consumption. 470
(i) Storage instructions; and 471
(j) Additional requirements 472
A pictorial representation of the product and/or raw materials used placed on the 473
label should not mislead the consumer with respect to the product and/or raw 474
material so illustrated. 475
476
7.2 Nutrition Labeling 477
Nutrition labeling shall conform to the established regulations of FDA and/or authority for 478
this commodity. 479
480
8. QUALITY ASSURANCE 481
482
8.1 Inspection of Finished Products 483
All processed products shall be inspected before labeling and casing and defective 484
products shall be withdrawn or rejected. The company must have an approved policy and 485
procedures based on the BFAD A.O. No. 153 s. 2004 - Guidelines, Current Good 486
Manufacturing Practices in Manufacturing, Packing, Repacking or Holding Food. 487
Draft RCP as of June 15, 2010
16
488
8.2 Record Keeping 489
Permanent and legible dated records of time, temperature code mark and other pertinent 490
details shall be kept concerning each load. Such records are essential as a check on 491
processing operations. 492
493
Written records of all container closure examinations shall specify the code lot, the date 494
and time of container closure inspections, the measurements obtained and all the 495
corrective actions taken. 496
497
Records shall be maintained identifying initial distribution of the finished product to 498
facilitate, if necessary, the segregation of specific food lots that may have been 499
contaminated or otherwise unfit for intended use. 500
501
All process deviations involving failure to satisfy the minimum requirements of the process 502
shall be recorded detailing those deviations and the actions taken. 503
504
8.3 Good Manufacturing Practices (GMP) 505
Processing establishments shall have developed, documented and implemented 506
prerequisite programs based on Food and Drugs Administration’s Current Good 507
Manufacturing Practices (cGMP) and Hygiene Control. An effective GMP and Hygiene 508
Control program will decrease the number of critical control points that a manufacturer 509
must face during the hazard analysis of the product/process. 510
511
9. STORAGE AND TRANSPORT OF FINISHED PRODUCT 512
513
Storage and transport conditions of the finished product shall be such that the integrity of 514
the product container, and the safety and quality of the product are not adversely affected. 515
516
Cases and cartons must be of proper size so that the containers fit snugly and are not 517
subject to damage from movement within the case. They must be strong enough to 518
withstand normal transport. 519
520
Chilled products must be kept at 0° to 4°C while frozen products must be kept at below 521
-18°C. Extreme fluctuations in temperature and humidity during storage and transport of 522
the product must be avoided to prevent product deterioration. 523
Draft RCP as of June 15, 2010
17
524
10. LABORATORY CONTROL PROCEDURES 525
526
Each food processing establishment shall have access to laboratory control of both the 527
processes used and the finished products. All food ingredients and food products declared 528
unfit for human consumption by the laboratory shall be rejected. 529
530
Representative samples for each lot or batch shall be taken to assess the safety and 531
quality of the product. 532
533
Microbiological laboratory shall be separated from the processing area. No pathogens 534
shall be handled within the premises of manufacturing plant. 535
536
Laboratory procedures for quality control of the processes and the product must follow 537
recognized or standard methods for easy interpretation of results. 538
539
11. END PRODUCT SPECIFICATIONS 540
541
Appropriate methods shall be used for sampling analysis and determinations to meet the 542
following specifications: 543
1. To the extent possible in good manufacturing practices, the products shall be free 544
from any objectionable characteristics. 545
2. The product shall not contain any toxic substances originating from microorganisms 546
and chemicals. 547
3. The product shall be free from chemical pollutants in amounts which may pose 548
hazard to health. 549
4. The product shall comply with the requirements set forth by the Food and Drugs 550
Administration, and the Codex Alimentarius Commission on Pesticide Residues and 551
Food Additives. 552
553
12. REFERENCES 554
555
A.O. No. 88-A s. 1984. Regulatory Guidelines Concerning Food Additives. Bureau of Food 556
and Drugs. Department of Health. Alabang, Muntinlupa City, Philippines. 557
558
Draft RCP as of June 15, 2010
18
A.O. No. 153 s. 2004. Guidelines, Current Good Manufacturing Practice in Manufacturing, 559
Packing, Repacking or Holding Food. Bureau of Food and Drugs. Department of Health. 560
Alabang, Muntinlupa City, Philippines. 561
562
A.O. No. 154 s. 1971. Regulation B-4 Definition and Standards of Identity for Food 4.14 563
Meat and Meat Products, 4.14.01 Sausages. Bureau of Food and Drugs. Department of 564
Health. Alabang, Muntinlupa City, Philippines. 565
566
Archer, G.P. and C.J. Kennedy. 1998. Maximising Quality and Stability of Frozen Foods: 567
A Producers Guide to the State of the Art. Report no 2. EU Concerted action CT96-1180. 568
Accessed: 9 June 2010. Available at: <http://www.nutrifreeze.co.uk/Documents/ 569
Maximising%20Quality.pdf> 570
571
Association of Analytical Chemists. Official Methods of Analysis Manual. 16th ed., 1995. 572
AOAC International. 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2417. 573
U.S.A. 574
575
B.C. No. 01-A s. 2004. Guidelines for the Assessment of Microbiological Quality of 576
Processed Foods. Bureau of Food and Drugs. Department of Health. Alabang, Muntinlupa 577
City, Philippines. 578
579
B.C. No. 016 s. 2006. Updated List of Food Additives. Bureau of Food and Drugs. 580
Department of Health. Alabang, Muntinlupa City, Philippines. 581
582
Essien, E. 2003. Sausage Manufacture: Principles and Practice. Woodhead Publishing 583
Ltd. Cambridge, England. 584
585
FAO/WHO Codex Alimentarius Commission Manual. 1995. Codex Alimentarius 586
Commission. Food and Agriculture Organization. Viale delle Terme di Caracalla, 00100 587
Rome, Italy. 588
589
Food, definition. ALINORM 04/27/41, para. 88 and Appendix VI. 2005. Codex Alimentarius 590
Commission. Food and Agriculture Organization. Viale delle Terme di Caracalla, 00100 591
Rome, Italy. 592
593
Draft RCP as of June 15, 2010
19
FSIS. 2009. Hot Dogs and Food Safety. Accessed 19 March 2010. Available at: 594
<http://www.fsis.usda.gov/pdf/hot_dogs_and_food_safety.pdf> 595
596
Heinz, G. and P. Hautzinger. 2007. Meat Processing Technology: for Small- and Medium- 597
Scale Producers. Food and Agriculture Organization of the United Nations: Regional office 598
for Asia and the Pacific. Bangkok, Thailand. 599
600
Joint DA-NMIS and DOH-FDA A.O. 01 s.2009. Delineation of Functions and Shared 601
Responsibilities in the Regulation of Meat Products. National Meat Inspection Service. 602
Department of Agriculture. Visayas Ave., Diliman, Quezon City. 603
604
M.C. no. 09 s. 2008. Guidelines on the Assessment of Microbiological Quality of Fresh, 605
Chilled, and Frozen Meat. National Meat Inspection Service. Department of Agriculture. 606
Visayas Ave., Diliman, Quezon City. 607
608
New Zealand Food Safety Authority. Draft Code of Practice: Production of Processed 609
Meats. Accessed: 9 June 2010. <http://www.nzfsa.govt.nz/consultation/processed-meat-610
cop-part1-4/part-3-process-control/index.htm> 611
612
Philippine National Standards No. 991:1993. Agricultural and Other Food Products – 613
Bottled Drinking Water Specifications. Bureau of Product Standards. Department of Trade 614
and Industry. Makati City, Philippines. 615
616
Philippine National Standards/Bureau of Agriculture and Fisheries Product Standards No. 617
83:2009. Beef Primal Cuts. Bureau of Product Standards. Department of Trade and 618
Industry. Makati City, Philippines. 619
620
Philippine National Standards/Bureau of Agriculture and Fisheries Product Standards No. 621
41:2008. Pork Cuts. Bureau of Product Standards. Department of Trade and Industry. 622
Makati City, Philippines. 623
624
R.A. 3720. Food, Drugs and Cosmetic Act. Bureau of Food and Drugs. Department of 625
Health. Alabang, Muntinlupa City, Philippines. 626
627
Savic, I.V. 1985. Small-scale Sausage Production. Food and Agriculture Organization of 628
the United Nations. Rome, Italy. 629
Draft RCP as of June 15, 2010
20
630
USDA/FSIS/AFDO. 1999. Safe Practices for Sausage Production: Distance Learning Course 631
Manual. Accessed 22 March 2010. Available at: < http://www.midwesternresearch.com/PDF/ 632
SausageFSIS.pdf>. 633
634
USFDA. 2001. Bacteriological Analytical Manual. Accessed 24 June 2010. Available at: 635
http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalM636
anualBAM/default.htm>. 637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
653
654
655
656
657
658
659
660
661
662
663
664
665
Draft RCP as of June 15, 2010
21
ANNEXA666 Standard Parameters and Values for Drinking Water 667
Philippine National Standards for Drinking Water 2007 (DOH AO 2007-0012) 668 669
Table 1. Standard values for bacteriological quality 670 Parameter Value/Unit Point of Compliance
Total Coliform < 1.1 MPN/100 ml Service Reservoir Water treatment works Consumers’ taps Refilling stations Water haulers Water vending machines
Fecal Coliform < 1.1 MPN/100 ml Service Reservoir Water treatment works Consumers’ taps Refilling stations Water haulers Water vending machines Point sources - Level 1
Heterotropic Plate Count < 500 CFU/ml Service Reservoir Water treatment works Consumers’ taps nearest meter Refilling stations Water vending machines
671 Table 2. Standard values for Physical and Chemical Quality for Acceptability Aspects for 672
Drinking Water 673
674 675 Table 3. Standard Values for Organic and Inorganic Chemical Constituents of Health 676 Significance in Drinking Water 677
Constituents Maximum Level (mg/L) or Characteristic
Constituents Maximum Level (mg/L) or Characteristic
Taste No objectionable taste Hydrogen Sulfide 0.05 Odor No objectionable odor Iron 1.0 Color Apparent = 10 color units
True = 5 color units Manganese 0.4
Turbidity 3 NTU pH 6.5 – 8.5 Aluminum 0.2 Sodium 200 Chloride 250 Sulfate 250 Copper 1.0 Total Dissolved
Solids 500
Hardness 300 as CaCO3 Zinc 5.0
Inorganic Chemicals
Constituents Maximum Level (mg/L) Constituents Maximum Level (mg/L) Antimony 0.02 Fluoride 1.0 Arsenic 0.05 Lead 1.01 Barium 0.7 Mercury (total) 0.001 Boron 0.5 Nickel 0.02 Cadmium 0.003 Nitrate 50 Chromium (Total) 0.05 Nitrite 3.0 Cyanide (Total) 0.07 Selenium 0.01
Draft RCP as of June 15, 2010
22
678 679 680
681 682 683 684 685 686 687 688 689 690 691
Organic Chemicals
Constituents Maximum Level (mg/L)
Constituents Maximum Level (mg/L)
Benzene 0.01 Ethylbenzene 0.30 Carbon tetrachloride 0.004 Nitrilotriacetic acid (NTA) 0.20 1,2-Dichlorobenzene 0.1 Polyaromatic hydrocarbons
(PAHs) 0.20
1,4-Dichlorobenzene 0.5 Polynuclear aromatic 0.0007 1,2-Dichloroethane 0.003 Tetrachloroethene 0.02 1,1-Dichloroethene 0.05 Styrene 0.04 1,2-Dichloroethene 0.07 Tetrachloroethene 0.70 Dichloromethane 1.0 Trichloroethene 0.07 Di(2-ethyhexyl) phthalate
1.01 Vinyl chloride 0.0003
Edetic Acid (ADTA) 0.001 Xylene 0.5 Organic Pesticides
Constituents Maximum Level (ug/L)
Status in the Philippines
Aldrin and Dieldrin (combined) 30.0 Banned Atrazine 0.03 Registered Carbofuran 2.0 Registered Chlordane 7.0 Banned DDT ** 0.2 Banned 1,2-Dibromo-3-chloropropane (DBCP) 1.0 Banned 2,4-Dichlorophenoxyacetic acid (2,4-D) 1.0 Registered Endrin 30. Banned 1,2-Dibromomethane (Ethylene dibromide) 0.6 Banned Heptachlor and Heptachlor epoxide (combined) 0.03 Banned Lindane 2.0 Restricted MCPA (4-(2-methyl-4-chloro) phenoxyl acetic acid
2.0 Registered
Pendimethalin 20.0 Registered Pentachlorophenol (PCP) 9.0 Banned
Draft RCP as of June 15, 2010
23
692
ANNEXB693 Determination of Crude Protein Content 694
(AOAC 981.10; Block Digestion Method) 695
696 A. Reagents 697 (a) Catalyst tablets.-containing 3.5 g K2SO4 and 0.175 g HgO. 698 (b) Boric acid solution.-4%. Dissolve 4 g H3BO3 in H2O containing 0.7 mL 0.1% alcoholic 699 solution of methyl red and 1.0 mL 0.1% alcoholic solution of bromocresol green, and dilute 700 to 100 mL with H2O. 701 (c) Sodium hydroxide-sodium thiosulfate solution.-Dissolve 2000 g NaOH and 125 g 702 Na2S2O3 in H2O and dilute to 5 L (ca 5o mL is used per analysis). 703 (d) Hydrochloric acid standard solution.- o.2N ( 936.15 [see A.1.o6]). 704 (e) Hydrogen peroxide. – 3o-35%. 705 (f) Sulfuric acid.-concentrated. 706 707 B. Equipment 708 (a) Digestion block and associated glassware.-Tecator Ds-6 or Ds-2o (Tecator), or 709 equivalent. 710 (b) Distillation unit and associated glassware.-Kjeltec 1oo3 (Tecator), or equivalent. 711 712 C. Determination 713 Accurately weigh ca 2 g well-ground and mixed sample on 7 cm N-free filter paper (e.g., 714 whatman 541), fold, and transfer to 250 mL digestion tube. Place tubes in fume hood and 715 add 2 or 3 boiling stones, 2 catalyst tablets, 15 mL H2SO4, and slowly 3 mL 3o-35% 716 H2O2. Let reaction subside and place tubes in block digestor preheated at 410°. (Digestor 717 must be placed in perchloric acid fume hood or be equipped with exhaust system. Boiling 718 concentrated acid is very corrosive and also emits corrosive fumes. Rapid addition of 3o-719 35% H2O2 may cause the reaction to become violent.) Digest at 410° until mixture is clear, 720 ca 45 min. Remove tubes and let cool ca 1o min. Do not let precipitate form; if precipitate 721 forms, reheat. Carefully add 5o-75 mL H2O. 722 723 Place NaOH-Na2S2O3 solution in alkali tank of steam distillation unit. Make sure that 5o-75 724 mL is dispensed from unit before conducting distillation. Attach digestion tube containing 725 diluted digest to distillation unit. Place 25o mL receiving flask containing 25 mL H3BO3 726 solution with mixed indicator on receiving platform, with tube from condenser extending 727 below surface of absorbing solution. Steam distil until 100-125 mL collects (absorbing 728 solution turns green from liberated NH3). Remove digestion tube and receiving flask from 729 unit. Titrate absorbing solution with 0.2 N Hcl to neutral gray end point and record volume 730 acid required to 0.01 mL. Titrate reagent blank similarly. 731 732 D. Computation: 733 % N = ( vA – vB ) x 1.4oo7 x N /g sample 734 % Protein = ( vA – vB ) x 1.4oo7 x N x 6.25/g sample 735 where vA and vB = volume standard acid required for sample and blank, respectively; 736 1.4007 = milliequivalent weight N x 1oo(%); N = normality of standard acid; and 6.25 = 737 protein factor for meat products (16% N). 738 739
740
741
Draft RCP as of June 15, 2010
24
742
ANNEXC743 744
Determination of Moisture Content 745 (AOAC 950.46b; Air Drying) 746
747 748 --First Action 749 --Final Action 1991 750 751 1. With lids removed, dry sample containing ca 2 g dry material 16 –18 h at 100 – 102° in 752
air oven (mechanical convection preferred). Use covered Al dish ≥50 mm diameter 753 and ≤4o mm deep. Cool in desiccator and weigh. Report loss in weight as moisture. 754 755
2. With lids removed, dry sample containing ca 2 g dry material to constant weight (2 – 4 756 h depending on product) in mechanical convection oven or in gravity oven with single 757 shelf at ca 125°. Use covered Al dish ≥50 mm diameter and ≤4o mm deep. Avoid 758 excessive drying. Cover, cool in desiccator, and weigh. Report loss in weight as 759 moisture. (Dried sample is not satisfactory for subsequent fat determination.) 760
761 762
763
764
765
766
767
768
769
770
771
772
773
774
775
776
777
778
779
780
781
Draft RCP as of June 15, 2010
25
782
ANNEXD783 784
Determination of Crude Fat 785 (AOAC 960.39) 786
787 788 A. Sample Drying 789 790 1. Weigh 3 – 4 g sample by difference into thimble containing small amount of sand. Mix 791
with glass rod, place thimble and rod in 50 mL beaker, and dry in oven 6 h at 100 – 792 102° or 1.5 h at 125°. Proceed as in (B); or 793
2. Weigh 3 – 4 g sample by difference into small disposable Al dish, add sand, and mix, 794 spreading mixture on bottom of dish with glass or Al paddle. Dry with paddle as in (1). 795 Roll edges of dish and insert with paddle into thimble. Proceed as in B. 796 797
B. Determination: 798
(Large amounts H2O-soluble components such as carbohydrates, urea, lactic acid, 799 glycerol, and others may interfere with extraction of fat; if present, extract 2 g sample on 800 small paper in funnel with five 20 mL portions H2O prior to drying for ether extraction. 801 Caution: see Appendix B, safety notes on monitoring equipment, distillation, and diethyl 802 ether.) 803 804 1. Extract ca 2 g sample, dried as in (A), with anhydrous ether. Use thimble with porosity 805
permitting rapid passage of ether. Extraction period may vary from 4 h at condensation 806 rate of 5 – 6 drop/s to 16 h at 2 – 3 drop/s. Petroleum ether, 945.16A (see 27.4.04), 807 may be used instead of anhydrous ether, if desired. 808 809
2. Dry extract to constant weight at 100°, cool, and weigh. 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828
Draft RCP as of June 15, 2010
26
829
ANNEXE830 Determination of Water Activity (AOAC 978.18) 831
832 A. Principle 833 Water activity, aw, is ratio of vapor pressure of H2O in product to vapor pressure of pure H2O at 834 same temperature. It is numerically equal to 1/100 of relative humidity (RH) generated by product 835 in closed system. RH can be calculated from direct measurement of 836 partial vapor pressure or dew point or measured indirectly by sensors whose physical or electric 837 characteristics are altered by RH to which they are exposed. Instruments are checked or 838 calibrated on basis of RH generated by standard salt slushes. 839 840 B. Instruments and Systems 841 (Select 1 of following instruments or systems to perform test. Each has different application 842 limitations because of interferences from other volatile components of products being measured. 843 check with instrument manufacturer for more specific limitations.) 844 845 (a) Change in electrical conductivity of immobilized salt solution. – Instrument available from 846
Beckman Industrial, Rosemount Analytical Div., 89 Commerce Rd, Cedar Grove, NJ 07009; 847 Nova Sina AG, Andreastrasse 7-11, CH 8050, Zurich,Switzerland; Rotronic Instrument Corp., 848 160 E. Main St, Huntington, NY 11743. Immobilized salt sensors are affected by polyols such 849 as glycerol and glycol and by volatile amines 850
(b) Change in electrical capacitance of polymer thin films. – Instrument available from General 851 Eastern Instruments, 50 Hunt St, Watertown, MA 02172. Polymer thin film sensors are affected 852 by CH3COOH. 853
(c) Dew point by chilled mirror technique. – Instrument available from EG&G, Environmental 854 Equipment Division, 217 Middlesex Turnpike, Burlington, MA 01803 or General Eastern 855 Instruments. Dew point measurements can be affected by condensables with lower critical 856 temperature than H2O. 857
(d) Longitudinal change in dimensions of water-sorbing fiber. – Instrument available from G Lufft 858 Metallbarometerfabrik, D-7, Postfach 692, Neue Weinsteige 22, Stuttgart, Germany. 859
(e) Partial water vapor pressure by manometric system. – Partial H2O vapor pressure 860 measurements can be made useless by living products that respire, such as grains or nuts; by 861 active fermentation; or by products that expand excessively when subjected to high vacuum. 862
(f) Relative weight of moisture sorbed by anhydrous hydrophilic solid, e.g., microcrystalline 863 cellulose.-see J. Agr. Food chem. 22, 326(1974). 864
865 C. Apparatus and Reagents 866 (As needed for instrument or system selected.) 867 868 (a) Dew point instrument. – Equipped to measure temperature to ±0.1°. See 978.18B(c). 869 (b) Forced-draft cabinet. – Constant temperature, set to maintain 25 ± 1°; capacity ≥0.06 m3 (2 cu ft); 870
with access port to accommodate instrument sensor leads. Use in conjunction 871 with (c). 872
(c) Insulated box with cover. – Large enough to hold test container, (e), and small enough to fit in 873 forced-draft cabinet, (b); with access port to accommodate instrument sensor leads. Protect 874 test container from short-term temperature fluctuations. 875
(d) Manometric system. – Sensitive to pressure differential of ± 0.01 mm Hg (1.33 Pa). See 876 978.18B(e). 877
(e) Test containers. – 120 or 240 mL (4 or 8 oz) wide-mouth or Mason glass jars with Al- or Teflon-878 lined screw caps and gaskets. Check integrity of cap seals and sensor leads by any means 879 available, e.g., ability of system to hold vacuum, using Tesla coil. 880
(f) Water bath. – Capable of maintaining temperature constant within 0.1° at 25±1°; capacity 881 sufficient to hold measuring chamber of selected apparatus. 882
(g) Hydrophilic solid. – Microcrystalline cellulose, Type PH-101 (FMC Corp.,Pharmaceutical and 883 Bioscience Division, 1735 Market St, Philadelphia, PA 19103, or equivalent). 884
Draft RCP as of June 15, 2010
27
(h) Reference salts. – ACS reagent grade, fine crystal. see Table 978.18. 885
886 D. Preparation of Reference Salt Slushes 887 888 Place selected reference salt in test container to depth of ca 4 cm for more soluble salts (lower aw), 889 to depth of ca 1.5 cm for less soluble salts (higher aw), and to intermediate depth for intermediate 890 salts. Add H2O in ca 2 mL increments, stirring well with spatula after each addition, until salt can 891 absorb no more H2O as evidenced by free liquid. Keep free liquid to minimum needed to establish 892 saturation of salt with H2O. Slushes are ready for use upon completion of mixing, and are usable 893 indefinitely (except for some high aw salts susceptible to bacterial attack), if contained in manner to 894 prevent substantial evaporation losses. Some slushes, e.g., NaBr, may solidify gradually by crystal 895 coalescence, with no effect on aw. 896 897 E. Calibration 898 899 Select ≥ 5 salts to cover aw range of interest or range of sensor being used. Measure humidity 900 generated by each salt slush in terms of instrument readout, as in 978.18F. Plot readout against aw 901 values given in Table 978.18 for selected salts, using cross-section paper scaled for reading to 902 0.001 aw unit. Draw best average smooth line through plotted points. Use this calibration line to 903 translate sensor instrument readout of samples to aw or to check vapor pressure or dew point 904 instruments for proper functioning. 905 906 F. Determination 907 908 Place calibration slush or sample in forced-draft cabinet, (b), or H2O bath, (f), until temperature is 909 stabilized at 25±1°. Transfer salt slush or sample to test container, (e), seal container with sensing 910 device attached, and place in temperature control device. Use volume of sample or slush >1/20 911 total volume sample container plus any associated void volume of sensing system, but not so 912 much as to interfere with operation of system. Record instrument response at 15, 30, 60, and 120 913 min after test container is placed in temperature control device, or record response on strip chart. 914 Two consecutive readings, at indicated intervals, which vary by <0.01 aw unit are evidence of 915 adequately close approach to equilibrium. Continue readings at 60-min intervals, if necessary. 916 Convert last reading to aw by calculation from physical measurements or by reference to calibration 917 line. Make all measurements within range of calibration points; do not extrapolate calibration line. 918 Make all measurements in same direction of change, and, if required by properties of sensor, 919 expose sensor to controlled RH below ambient before starting each measurement. 920 921 922 923 924
925
Draft RCP as of June 15, 2010
28
926
ANNEXF927 Determination of Aerobic Plate Count 928
Conventional Plate Count Method (USFDA, 2001) 929
A. Equipment and materials 930 1. Work area, level table with ample surface in room that is clean, well-lighted (100 931
foot-candles at working surface) and well-ventilated, and reasonably free of dust 932 and drafts. The microbial density of air in working area, measured in fallout pour 933 plates taken during plating, should not exceed 15 colonies/plate during 15 min 934 exposure. 935
2. Storage space, free of dust and insects and adequate for protection of equipment 936 and supplies 937
3. Petri dishes, glass or plastic (at least 15 x 90 mm) 938 4. Pipets with pipet aids (no mouth pipetting) or pipettors, 1, 5, and 10 ml, graduated 939
in 0.1 ml units 940 5. Dilution bottles, 6 oz (160 ml), borosilicate-resistant glass, with rubber stoppers or 941
plastic screw caps 942 6. Pipet and petri dish containers, adequate for protection 943 7. Circulating water bath, for tempering agar, thermostatically controlled to 45 ± 1°C 944 8. Incubator, 35 ± 1°C; milk, 32 ± 1°C 945 9. Colony counter, dark-field, Quebec, or equivalent, with suitable light source and grid 946
plate 947 10. Tally register 948 11. Dilution blanks, 90 ± 1 ml Butterfield's phosphate-buffered dilution water (R11); 949
milk, 99 ± 2 ml 950 12. Plate count agar (standard methods) (M124) 951 13. Refrigerator, to cool and maintain samples at 0-5°C; milk, 0-4.4°C 952 14. Freezer, to maintain frozen samples from -15 to -20°C 953 15. Thermometers (mercury) appropriate range; accuracy checked with a thermometer 954
certified by the National Institute of Standards and Technology (NIST) 955
956
B. Procedure for analysis of frozen, chilled, precooked, or prepared foods 957
Using separate sterile pipets, prepare decimal dilutions of 10-2, 10-3, 10-4, and others as 958 appropriate, of food homogenate (see Chapter 1 for sample preparation) by transferring 10 959 ml of previous dilution to 90 ml of diluent. Avoid sampling foam. Shake all dilutions 25 times 960 in 30 cm (1 ft) arc within 7 s. Pipet 1 ml of each dilution into separate, duplicate, 961 appropriately marked petri dishes. Reshake dilution bottle 25 times in 30 cm arc within 7 s 962 if it stands more than 3 min before it is pipetted into petri dish. Add 12-15 ml plate count 963 agar (cooled to 45 ± 1°C) to each plate within 15 min of original dilutionPour agar and 964 dilution water control plates for each series of samples. Immediately mix sample dilutions 965 and agar medium thoroughly and uniformly by alternate rotation and back-and-forth motion 966 of plates on flat level surface. Let agar solidify. Invert solidified petri dishes, and incubate 967 promptly for 48 ± 2 h at 35°C. Do not stack plates when pouring agar or when agar is 968 solidifying. 969
970 971
972 973
Draft RCP as of June 15, 2010
29
ANNEXG974 Isolation of Salmonella (USFDA, 2001) 975
A. Sample Preparation (For meats, meat substitutes, meat by-products, animal substances, 976 glandular products, and meals (fish, meat, bone)). 977
Aseptically weigh 25 g sample into sterile blending container. Add 225 ml sterile lactose broth and 978 blend 2 min. Aseptically transfer homogenized mixture to sterile wide-mouth, screw-cap jar (500 979 ml) or other appropriate container and let stand 60 ± 5 min at room temperature with jar securely 980 capped. If mixture is powder or is ground or comminuted, blending may be omitted. For samples 981 that do not require blending, add lactose broth and mix thoroughly; let stand for 60 ± 5 min at room 982 temperature with jar securely capped. 983
Mix well by swirling and determine pH with test paper. Adjust pH, if necessary, to 6.8 ± 0.2. Add up 984 to 2.25 ml steamed (15 min) Tergitol Anionic 7 and mix well. Alternatively, use steamed (15 min) 985 Triton X-100. Limit use of these surfactants to minimum quantity needed to initiate foaming. Actual 986 quantity will depend on composition of test material. Surfactants will not be needed in analysis of 987 powdered glandular products. Loosen jar caps 1/4 turn and incubate sample mixtures 24 ± 2 h at 988 35°C. Continue as in B., below. 989
B. Isolation of Salmonella 990
1. Tighten lid and gently shake incubated sample. 991
Guar gum and foods suspected to be contaminated with S. Typhi. Transfer 1 ml 992 mixture to 10 ml selenite cystine (SC) broth and another 1 ml mixture to 10 ml TT broth . 993 Vortex. 994
All other foods. Transfer 0.1 ml mixture to 10 ml Rappaport-Vassiliadis (RV) medium 995 and another 1 ml mixture to 10 ml tetrathionate (TT) broth. Vortex. 996
2. Incubate selective enrichment media as follows: 997
Foods with a high microbial load. Incubate RV medium 24 ± 2 h at 42 ± 0.2°C 998 (circulating, thermostatically-controlled, water bath). Incubate TT broth 24 ± 2 h at 43 ± 999 0.2°C (circulating, thermostatically-controlled, water bath). 1000
Foods with a low microbial load (except guar gum and foods suspected to be 1001 contaminated with S. Typhi). Incubate RV medium 24 ± 2 h at 42 ± 0.2°C (circulating, 1002 thermostatically controlled, water bath). Incubate TT broth 24 ± 2 h at 35 ± 2.0°C. 1003
Guar gum and foods suspected to be contaminated with S. Typhi. Incubate SC and 1004 TT broths 24 ± 2 h at 35°C. 1005
3. Mix (vortex, if tube) and streak 3 mm loopful (10 µl) incubated TT broth on bismuth 1006 sulfite (BS) agar, xylose lysine desoxycholate (XLD) agar, and Hektoen enteric (HE) agar. 1007 Prepare BS plates the day before streaking and store in dark at room temperature 1008 until streaked. 1009 4. Repeat with 3 mm loopful (10 µl) of RV medium (for samples of high and low microbial 1010 load foods) and of SC broth (for guar gum). 1011 5. Refer to 994.04 in Official Methods of Analysis (1) for option of refrigerating incubated 1012 sample preenrichments and incubated sample selective enrichments (SC and TT broths 1013 only) of low moisture foods. This option allows sample analyses to be initiated as late as 1014 Thursday while still avoiding weekend work. 1015
Draft RCP as of June 15, 2010
30
6. Incubate plates 24 ± 2 h at 35°C. 1016 7. Examine plates for presence of colonies that may be Salmonella. 1017 8. Lightly touch the very center of the colony to be picked with sterile inoculating needle 1018
and inoculate TSI slant by streaking slant and stabbing butt. Without flaming, inoculate 1019 LIA slant by stabbing butt twice and then streaking slant. Since lysine decarboxylation 1020 reaction is strictly anaerobic, the LIA slants must have deep butt (4 cm). Store picked 1021 selective agar plates at 5-8°C. 1022
9. Incubate TSI and LIA slants at 35°C for 24 ± 2 h. Cap tubes loosely to maintain 1023 aerobic conditions while incubating slants to prevent excessive H2S production. 1024 Salmonella in culture typically produces alkaline (red) slant and acid (yellow) butt, with 1025 or without production of H2S (blackening of agar) in TSI. In LIA, Salmonella typically 1026 produces alkaline (purple) reaction in butt of tube. Consider only distinct yellow in butt 1027 of tube as acidic (negative) reaction. Do not eliminate cultures that produce 1028 discoloration in butt of tube solely on this basis. Most Salmonella cultures produce H2S 1029 in LIA. Some non- Salmonella cultures produce a brick-red reaction in LIA slants. 1030
10. All cultures that give an alkaline butt in LIA, regardless of TSI reaction, should be 1031 retained as potential Salmonella isolates and submitted for biochemical and serological 1032 tests. Cultures that give an acid butt in LIA and an alkaline slant and acid butt in TSI 1033 should also be considered potential Salmonella isolates and should be submitted for 1034 biochemical and serological tests. Cultures that give an acid butt in LIA and an acid 1035 slant and acid butt in TSI may be discarded as not being Salmonella . Test retained, 1036 presumed-positive TSI cultures as directed in D-11, below, to determine if they are 1037 Salmonella species, including S. arizonae. If TSI cultures fail to give typical reactions 1038 for Salmonella (alkaline slant and acid butt) pick additional suspicious colonies from 1039 selective medium plate not giving presumed-positive culture and inoculate TSI and LIA 1040 slants as described in D-8, above. 1041
11. Apply biochemical and serological identification tests to: 1042
a. Three presumptive TSI cultures recovered from set of plates streaked from RV 1043 medium (or SC broth for guar gum), if present, and 3 presumptive TSI agar cultures 1044 recovered from plates streaked from TT broth, if present. 1045
b. If 3 presumptive-positive TSI cultures are not isolated from one set of agar plates, test 1046 other presumptive-positive TSI agar cultures, if isolated, by bioche mical and 1047 serological tests. Examine a minimum of 6 TSI cultures for each 25 g analytical unit or 1048 each 375 g composite. 1049
1050 1051 1052 1053 1054
1055 1056 1057 1058 1059 1060 1061 1062 1063
Draft RCP as of June 15, 2010
31
1064
ANNEXH1065 Determination of E.Coli Count 1066
(Enumeration of Escherichia coli and the Coliform Bacteria (USFDA, 2001)) 1067
Conventional Method for coliforms, fecal coliforms and E. coli 1068
A. Equipment and materials 1069
1. Covered water bath, with circulating system to maintain temperature of 45.5 ± 0.2°C. Water 1070 level should be above the medium in immersed tubes. 1071
2. Immersion-type thermometer, 1-55°C, about 55 cm long, with 0.1°C subdivisions, certified by 1072 National Institute of Standards and Technology (NIST), or equivalent 1073
3. Incubator, 35 ± 1.0°C 1074 4. Balance with capacity of >2 kg and sensitivity of 0.1 g 1075 5. Blender and blender jar 1076 6. Sterile graduated pipets, 1.0 and 10.0 mL 1077 7. Sterile utensils for sample handling 1078 8. Dilution bottles made of borosilicate glass, with polyethylene screw caps equipped with Teflon 1079
liners. Commercially prepared dilution bottles containing sterile Butterfield's phosphate buffer 1080 can also be used. 1081
9. Quebec colony counter, or equivalent, with magnifying lens 1082 10. Longwave UV light [~365 nm], not to exceed 6 W. 1083 11. pH meter 1084
B. Media and Reagents 1085
Brilliant green lactose bile (BGLB) broth, 2% (M25) 1086 Lauryl tryptose (LST) broth (M76) 1087 EC broth (M49) 1088 Levine's eosin-methylene blue (L-EMB) agar (M80) 1089 Butterfield's phosphate-buffered water (R11) or equivalent diluent (except for shellfish) 1090 Lauryl tryptose MUG (LST-MUG) broth (M77) 1091 Peptone Diluent, 0.1% (R56) 1092
MPN - Presumptive test for coliforms, fecal coliforms and E. coli 1093
Weigh 50 g food into sterile high-speed blender jar. (see Chapter 1 and current FDA compliance 1094 programs for instructions on sample size and compositing) Frozen samples can be softened by 1095 storing it for <18 h at 2-5°C, but do not thaw. Add 450 mL of Butterfield's phosphate-buffered water 1096 and blend for 2 min. If <50 g of sample are available, weigh portion that is equivalent to half of the 1097 sample and add sufficient volume of sterile diluent to make a 1:10 dilution. The total volume in the 1098 blender jar should completely cover the blades. 1099
Prepare decimal dilutions with sterile Butterfield's phosphate diluent. Number of dilutions to be 1100 prepared depends on anticipated coliform density. Shake all suspensions 25 times in 30 cm arc or 1101 vortex mix for 7 s. Do not use pipets to deliver <10% of their total volume. Transfer 1 mL portions 1102 to 3 LST tubes for each dilution for at least 3 consecutive dilutions. Hold pipet at angle so that its 1103 lower edge rests against the tube. Let pipet drain 2-3 s. Not more than 15 min should elapse from 1104 time the sample is blended until all dilutions are inoculated in appropriate media. 1105
NOTE: Use 5-tube MPN for analysis of shellfish and shellfish harvest waters. 1106
Incubate LST tubes at 35°C. Examine tubes and record reactions at 24 ± 2 h for gas, i.e., 1107 displacement of medium in fermentation vial or effervescence when tubes are gently agitated. Re-1108
Draft RCP as of June 15, 2010
32
incubate gas-negative tubes for an additional 24 h and examine and record reactions again at 48 ± 1109 2 h. Perform confirmed test on all presumptive positive (gas) tubes. 1110
MPN - Confirmed test for coliforms 1111
From each gassing LST tube, transfer a loopful of suspension to a tube of BGLB broth, avoiding 1112 pellicle if present. Incubate BGLB tubes at 35°C and examine for gas production at 48 ± 2 h. 1113 Calculate most probable number (MPN) of coliforms based on proportion of confirmed gassing 1114 LST tubes for 3 consecutive dilutions. 1115
MPN - Confirmed test for fecal coliforms and E. coli 1116
From each gassing LST tube from the Presumptive test, transfer a loopful of each suspension to a 1117 tube of EC broth (a sterile wooden applicator stick may also be used for these transfers). Incubate 1118 EC tubes 24 ± 2 h at 45.5 °C and examine for gas production. If negative, reincubate and examine 1119 again at 48 ± 2 h. Use results of this test to calculate fecal coliform MPN. To continue with E. coli 1120 analysis, proceed to Section F under Enumeration of Escheria coli and the Coliform Bacteria of the 1121 USFDA Bacteriological Analytical Manual (2001). The EC broth MPN method may be used for 1122 seawater and shellfish since it conforms to recommended procedures (1). (Caution: see Note 1123 below). 1124
NOTE: Fecal coliform analyses are done at 45.5± 0.2°C for all foods, except for water testing and 1125 in shellfish and shellfish harvest water analysis, which uses an incubation temperature of 44.5± 1126 0.2°C. 1127
1128 1129 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142 1143 1144 1145 1146 1147 1148 1149 1150 1151 1152 1153
Draft RCP as of June 15, 2010
33
1154
ANNEXI1155 Determination of Staphylococcus aureus 1156 (Direct Plate Count Method (USFDA, 2001)) 1157
1158
A. Equipment and materials 1159 1. Same basic equipment as for conventional plate count (Chapter 3). 1160 2. Drying cabinet or incubator for drying surface of agar plates 1161 3. Sterile bent glass streaking rods, hockey stick or hoe-shaped, with fire-polished ends, 1162
3-4 mm diameter, 15-20 cm long, with an angled spreading surface 45-55 mm long. 1163
B. Media and reagents 1164 1. Baird-Parker medium (M17) 1165 2. Trypticase (tryptic) soy agar (TSA) (M152) 1166 3. Brain heart infusion (BHI) broth (M24) 1167 4. Coagulase plasma (rabbit) with EDTA 1168 5. Toluidine blue-DNA agar (M148) 1169 6. Lysostaphin (Schwartz-Mann, Mountain View Ave., Orangeburg, NY 10962) 1170 7. Tryptone yeast extract agar (M165) 1171 8. Paraffin oil, sterile 1172 9. 0.02 M phosphate-saline buffer (R61), containing 1% NaCl 1173 10. Catalase test (R12) 1174 1175 C. Preparation of sample 1176 (see Chapter 1 of USFDA/CFSAN Baceriological Analytical Manual, 2001). 1177 1178 D. Isolation and enumeration of S. aureus 1179 1180 1. For each dilution to be plated, aseptically transfer 1 ml sample suspension to 3 plates 1181 of Baird-Parker agar, distributing 1 ml of inoculum equitably to 3 plates (e.g., 0.4 ml, 0.3 1182 ml, and 0.3 ml). Spread inoculum over surface of agar plate, using sterile bent glass 1183 streaking rod. Retain plates in upright position until inoculum is absorbed by agar (about 1184 10 min on properly dried plates). If inoculum is not readily adsorbed, place plates upright 1185 in incubator for about 1 h. Invert plates and incubate 45-48 h at 35°C. Select plates 1186 containing 20-200 colonies, unless only plates at lower dilutions (>200 colonies) have 1187 colonies with typical appearance of S. aureus. Colonies of S. aureus are circular, smooth, 1188 convex, moist, 2-3 mm in diameter on uncrowded plates, gray to jet-black, frequently with 1189 light-colored (off-white) margin, surrounded by opaque zone and frequently with an outer 1190 clear zone; colonies have buttery to gummy consistency when touched with inoculating 1191 needle. Occasionally from various foods and dairy products, nonlipolytic strains of similar 1192 appearance may be encountered, except that surrounding opaque and clear zones are 1193 absent. Strains isolated from frozen or desiccated foods that have been stored for 1194 extended periods frequently develop less black coloration than typical colonies and may 1195 have rough appearance and dry texture. 1196 1197 2. Count and record colonies. If several types of colonies are observed which appear to 1198 be S. aureus on selected plates, count number of colonies of each type and record counts 1199 separately. When plates of the lowest dilution contain <20 colonies, these may be used. If 1200 plates containing >200 colonies have colonies with the typical appearance of S. aureus 1201 and typical colonies do not appear at higher dilutions, use these plates for the 1202
Draft RCP as of June 15, 2010
34
enumeration of S. aureus, but do not count nontypical colonies. Select > 1 colony of each 1203 type counted and test for coagulase production. Add number of colonies on triplicate 1204 plates represented by colonies giving positive coagulase test and multiply by the sample 1205 dilution factor. Report this number as number of S. aureus/g of food tested. 1206 1207 E. Coagulase test 1208
Transfer suspect S. aureus colonies into small tubes containing 0.2-0.3 ml BHI broth and 1209 emulsify thoroughly. Inoculate agar slant of suitable maintenance medium, e.g., TSA, with 1210 loopful of BHI suspension. Incubate BHI culture suspension and slants 18-24 h at 35°C. 1211 Retain slant cultures at room temperature for ancillary or repeat tests in case coagulase 1212 test results are questionable. Add 0.5 ml reconstituted coagulase plasma with EDTA (B-4, 1213 above) to the BHI culture and mix thoroughly. Incubate at 35°C and examine periodically 1214 over 6 h period for clot formation. Only firm and complete clot that stays in place when 1215 tube is tilted or inverted is considered positive for S. aureus. Partial clotting, formerly 2+ 1216 and 3+ coagulase reactions, must be tested further (4). Test known positive and negative 1217 cultures simultaneously with suspect cultures of unknown coagulase activity. Stain all 1218 suspect cultures with Gram reagent and observe microscopically. A latex agglutination test 1219 (AUREUS TESTTM, Trisum Corp., Taipei, Taiwan) may be substituted for the coagulase 1220 test if a more rapid procedure is desired. 1221
1222 1223
1224 1225 1226
1227