3 OF COLD CUTS – EMULSIFIED SAUSAGESnmis.gov.ph/attachments/article/11/Code of RCPPHCC.pdf · 3...

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Draft RCP as of June 15, 2010 1 1 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

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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1

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

2

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

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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

Draft RCP as of June 15, 2010

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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

Draft RCP as of June 15, 2010

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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

15

“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

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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

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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

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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

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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