Source: https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=25&pt=1&ch=229&rl=222
Timestamp: 2020-05-27 00:54:55
Document Index: 43014618

Matched Legal Cases: ['§229', '§241', 'art 123', 'art 117', 'art 123', '§117', '§424', '§229', 'art 123', '§133', '§133', '§133', '§117']

RULE §229.222 Production and Process Controls
(1) All operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspections, transporting, and segregating) must be conducted in accordance with adequate sanitation principles.
(2) Quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable.
(6) All food that has become contaminated to the extent that it is adulterated must be rejected, treated or processed to eliminate the contamination.
(b) Raw materials and other ingredients.
(1) Food, including raw ingredients and finished product, must be obtained from an approved source.
(2) Raw materials and other ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and must be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Raw materials must be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food must be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not cause allergen cross-contact or increase the level of contamination of the food.
(3) Raw materials and other ingredients must either: not contain levels of microorganisms that may render the food injurious to the health of humans; or they must be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.
(4) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins must comply with current Food and Drug Administration regulations for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food.
(5) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material must comply with applicable Food and Drug Administration regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food.
(6) Raw materials, other ingredients, and rework must be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination and must be held at a temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such.
(7) Frozen raw materials and other frozen ingredients must be kept frozen. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
(8) Liquid or dry raw materials and other ingredients received and stored in bulk form must be held in a manner that protects allergen cross-contact and against contamination.
(9) Raw materials and other ingredients that are food allergens, and rework that contains food allergens, must be identified and held in a manner that prevents allergen cross-contact.
(c) Manufacturing operations.
(1) Equipment and utensils and finished food containers must be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. In so far as necessary, equipment must be taken apart for thorough cleaning.
(2) All food manufacturing, processing, packaging, packing and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food.
(A) Time/temperature controlled for safety foods must be maintained at an internal temperature of 41 degrees Fahrenheit or below.
(B) Frozen foods must be kept frozen at all times.
(C) Shell eggs, after initial packing, must be transported and stored at the lower of 45 degrees Fahrenheit or as required by The United States Department of Agriculture.
(D) The temperature of molluscan shellfish from the harvester through the original shellfish dealer must be maintained in accordance with 25 TAC §§241.57- 241.60 of this title (relating to Molluscan Shellfish). Raw molluscan shellfish must be adequately iced or refrigerated at 45 degrees Fahrenheit or less during all subsequent distribution, storage, processing, and sale.
(E) Hot foods must be maintained at an internal temperature of 135 degrees Fahrenheit (60 degrees Celsius) or above.
(F) Seafood intended for wholesale distribution must comply with temperature requirements specified in 21 Code of Federal Regulations Part 123.
(G) Milk received directly from a facility under the jurisdiction of the Pasteurized Milk Ordinance must be received at an internal temperature of 45 degrees F or below. Further storage and transportation of the milk must be maintained at an internal 41 degrees or below.
(4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms must be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated.
(5) Work-in-process and rework must be handled in a manner that protects against allergen cross-contact, contamination, and the growth of undesirable microorganisms.
(6) Effective measures must be taken to protect finished food from allergen cross-contact and from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contaminated food. Food transported by conveyor must be protected against contamination.
(7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or other food must be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact and against contamination.
(A) Must be disposed of in a manner that protects against the contamination of other food; or
(B) If the adulterated food is capable of being reconditioned, it must be:
(i) reconditioned using a method that has been proven to be effective; or
(ii) reconditioned and reexamined and subsequently found not to be adulterated before being incorporated into other food.
(11) Heat blanching, when required in the preparation of food capable of supporting microbial growth, must be affected 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. Growth and contamination by thermophilic microorganisms in blanchers must be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing.
(13) Filling, assembling, packaging, and other operations must be performed in such a way that the food is protected against allergen cross-contact, contamination, and the growth of undesirable microorganisms.
(14) Food such as, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms must be processed to and maintained at a safe moisture level.
(15) Food such as acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms, must be monitored and maintained at a pH of 4.6 or below. Acid or acidified foods must be heat treated to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.
(16) Modified Atmosphere Packaging. Manufacturers using Modified Atmosphere Packaging:
(A) Except for a facility that is subject to 21 Code of Federal Regulations Part 117, Subchapter C Hazard Analysis and Risk-Based Preventive Controls or the product being produced is subject to 21 Code of Federal Regulations Part 123, Fish and Fishery Products, a facility that packages a Time/Temperature Control for Safety (TCS) food using a modified atmosphere packaging method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes.
(B) a facility that packages TCS food using a modified atmosphere packaging method must implement a food safety plan that contains the information specified under 21 Code of Federal Regulations §117.135 a(1)-c(3) and that:
(i) identifies the food to be packaged;
(ii) except as specified under subparagraphs (C) and (D) of this paragraph, requires that the packaged food shall be maintained at 5 degrees Celsius (41 degrees Fahrenheit) or less and meet at least one of the following criteria:
(III) is a meat or poultry product cured at a food processing plant regulated by the USDA or the department using substances specified in 9 Code of Federal Regulations §424.21, use of food ingredients and sources of radiation, and is received in an intact package; or
(iii) describes how the packages shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:
(I) maintain the food at 5 degrees Celsius (41 degrees Fahrenheit) or below; and
(II) discard the food if within 30 calendar days of its packaging it is not served for on-premises consumption, or consumed if served or sold for off-premises consumption;
(iv) limits the refrigerated shelf life to no more than 30 calendar days from packaging to consumption, except the time the product is maintained frozen, or the original manufacturer's "sell by" or "use by" date, whichever occurs first;
(C) a facility that packages TCS food using a modified atmosphere packaging method must ensure individuals performing modified atmosphere packaging have the appropriate training and documentation as required by §229.212 of this title (relating to Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food).
(D) Except for fish that is frozen before, during, and after packaging, a facility may not package fish using a modified atmosphere packaging method unless the product is subject to 21 Code of Federal Regulations Part 123, Fish and Fishery Products;
(E) Cheese. A facility that packages cheese using a Modified Atmosphere Packaging method must:
(i) limit the cheeses packaged to those that are commercially manufactured in a food processing plant with no ingredients added in a facility other than the original food processing plant and that meet the Standards of Identity as specified in 21 Code of Federal Regulations §133.150, Hard cheeses, 21 Code of Federal Regulations §133.169 Pasteurized process cheese or 21 Code of Federal Regulations §133.187 Semisoft cheeses;
(ii) have a food safety plan that contains the information specified under 21 Code of Federal Regulations §117.135 a(1)-c(3); and