Header:
TEXAS ADMINISTRATIVE CODE
TITLE 25. HEALTH SERVICES
PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229. FOOD AND DRUG
SUBCHAPTER N. CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMA
Date:
08/31/2009
Document:
25 TAC § 229.219 (2011)
§ 229.219. Production and Process Controls
All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with good public health and sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Testing procedures shall be used where necessary to identify sanitation failures or possible food contamination by chemicals, microbes, or extraneous materials. All food that has become contaminated to the extent that it is adulterated within the meaning of the Act shall be rejected, or if permissible, treated or processed to eliminate the contamination.
(1) Raw materials and other ingredients.
(A) Food including raw ingredients and finished product shall be obtained from an approved source.
(B) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of sanitary quality for its intended use. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to contamination or deterioration of food.
(C) Raw materials and other ingredients shall either: not contain levels of microorganisms that may produce food poisoning or other disease in humans; or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the Act. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.
(D) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations, guidelines, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or may be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.
(E) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or material shall comply with applicable Food and Drug Administration regulations, guidelines, and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination.
(F) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at a temperature and relative humidity and in a manner to prevent the food from becoming adulterated within the meaning of the Act. Material scheduled for rework shall be identified as such.
(G) Frozen raw materials and other frozen ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the Act.
(H) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.
(2) Manufacturing operations.
(A) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing. As necessary, equipment shall be taken apart for thorough cleaning.
(B) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. Compliance with this requirement may be accomplished by careful monitoring of physical factors such as time, temperature, humidity, a w , pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.
(C) The internal temperature of potentially hazardous foods during transport and storage shall be maintained at or below 41 degrees Fahrenheit as appropriate for the food using methods, that include refrigeration, pre-chilled insulated coolers, dry ice, or storage on ice made from potable water. The method used must maintain the required temperature for the entire length of time the food is in transport or storage.
(i) Frozen foods shall be kept frozen at all times.
(ii) Shell eggs, after initial packing, must be transported and stored at a temperature of 45 degrees Fahrenheit or less. If the United States Department of Agriculture and the U.S. Food and Drug Administration determine by law that a lower temperature must be maintained, the lower temperature shall prevail.
(iii) The temperature of molluscan shellfish from the harvester through the original shellfish dealer shall be maintained in accordance with §§ 241.58 - 241.60 of this title (relating to Molluscan Shellfish). Raw molluscan shellfish shall be adequately iced or refrigerated at 45 degrees Fahrenheit or less during all subsequent distribution, storage, processing, and sale.
(iv) Hot foods shall be maintained at 135 degrees Fahrenheit (60 degrees Celsius) or above.
(v) Acid or acidified foods shall be heat treated to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.
(D) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling a w that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, must be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the Act.
(E) Work-in-process shall be handled in a manner that protects against contamination.
(F) Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary.
(G) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.
(H) Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.
(I) Food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and confirmed to be safe within the meaning of the Act before being incorporated into other food.
(J) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, soaking, tempering, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by cleaning and sanitizing all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.
(K) Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of sufficient operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of sanitary quality for its intended use.
(L) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following:
(i) using ingredients free of contamination;
(ii) employing adequate heat processes where applicable;
(iii) using proper time and temperature controls;
(iv) providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them;
(v) cooling to a sufficient temperature during manufacturing; or
(vi) disposing of batters at appropriate intervals to protect against the growth of microorganisms.
(M) Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:
(i) use of a quality control operation in which the control points are identified and controlled during manufacturing;
(ii) proper cleaning and sanitizing of all food-contact surfaces and food containers;
(iii) using materials for food containers and food-packaging materials that are safe and suitable for their intended use;
(iv) providing physical protection from contamination, particularly airborne contamination; and
(v) using sanitary handling procedures.
(N) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of a w for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:
(i) monitoring the aw of food;
(ii) controlling the soluble solids-water ratio in finished food; and
(iii) protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the a w of the food does not increase to an unsafe level.
(O) Acid food, acidified food, and similar food that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or both of the following practices:
(i) monitoring the pH of raw materials, food in process, and finished food; and
(ii) controlling the amount of acid or acidified food added to low-acid food.
(P) Reduced oxygen packaging. Manufacturers performing reduced oxygen packaging:
(i) shall maintain Standard Operating Procedures (SOPs) that:
(I) limit the shelf life of foods to not more than 14 calendar days from the date the food is packaged to the date the food is consumed or the original manufacturer's "sell by" or "use by" date, whichever comes first, except as described in clause (vi) of this subparagraph;
(II) describe how the packages shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:
(-a-) "use by" and provide a date that is within 14 calendar days of packaging or provide a date as allowed by clause (v) of this subparagraph; and
(-b-) keep the food refrigerated at 41 degrees Fahrenheit or below;
(III) require employees that contact foods with bare hands to wash hands properly or utilize proper utensils;
(IV) designate raw food and ready to eat food areas and place physical barriers or effective methods that minimize the risk of cross-contamination between raw foods and ready-to-eat foods and restrict access to the food processing equipment to personnel who are trained to operate the equipment and understand the risks of cross-contamination;
(V) describe cleaning and sanitization procedures for food-contact surfaces; and
(VI) describe the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:
(-a-) concepts required for safe operation;
(-b-) equipment and facility; and
(-c-) procedures specified in clauses (i)(II) - (V) and (iii) - (vii) of this subparagraph;
(ii) shall maintain records that document employee training. Records documenting training must be maintained for at least one year after the employee leaves the company or is moved to other duties that do not include vacuum packaging. The records must be available at the packaging facility or corporate offices for review by the regulatory authority;
(iii) shall maintain food processing records for at least one year from the time the food is packed. The records must be available at the facility or corporate offices for review by the regulatory authority. The records must contain the following information:
(I) the identity of the food that is packaged;
(II) the date the food was packaged; and
(III) the name of the operator performing the food packaging;
(iv) shall limit the types of foods that are packaged to a food that does not support the growth of Clostridium botulinum because it complies with one of the following:
(I) has a water activity (aw ) of 0.91 or less;
(II) has a hydrogen ion concentration (pH) of 4.6 or less;
(III) is a meat or poultry product cured at a food processing plant regulated by the U.S. Department of Agriculture or the department, and is received in an intact package; or
(IV) is a food with a high level of competing organisms such as raw meat or poultry;
(v) food products, other than those specified in clause (iv) of this subparagraph may be vacuum packaged if the firm provides written documentation of product testing such as shelf life studies of the product under the same storage and packaging conditions or scientific studies of the product which must be the same species, market form, packaging, and holding conditions that prove the reduced oxygen packaged product will not support the growth of Clostridium botulinum;
(vi) the shelf life of a vacuum packaged product may be extended past the 14 day shelf life limit as specified in clause (i)(I) of this subparagraph if the firm provides written documentation of product testing such as shelf life studies of the product under the same storage and packaging conditions or scientific studies of the product which must be the same species, market form, packaging, and holding conditions that prove the extended shelf life of the reduced oxygen packaged product will not support the growth of Clostridium botulinum, Listeria and Salmonella; and
(vii) fish shall not be packaged in reduced oxygen packaging unless the fish is frozen before, during, and after packaging unless the firm is subject to §§ 229.121 - 229.129 of this title (relating to Seafood HACCP).
(Q) Unshelled pecans shall be thoroughly cleaned to remove foreign matter before cracking. After cleaning, unshelled pecans shall be sanitized.
(R) When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.
(S) Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.
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