TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 229. FOOD AND DRUG

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (DSHS), adopts the repeal of §§229.61 - 229.73, concerning Juice Hazard Analysis Critical Control Point (HACCP) Systems without changes; §§229.121 - 229.129, concerning Seafood HACCP without changes; the repeal of §§229.210 - 229.222, concerning Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food without changes; new §§229.210 - 229.212, §229.214 - 229.223 and 229.225, concerning Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food without changes; and new §229.803 and §229.807, concerning Sanitary Transportation of Human Food without changes to the proposed text as published in the March 3, 2017, issue of the Texas Register (42 TexReg 971). The sections will not be republished.

Sections 229.213, 229.224, 229.801, 229.802 and 229.804 - 229.806 are adopted with changes to the proposed text as published in the March 3, 2017, issue of the Texas Register (42 TexReg 971) and will be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the repeals and new §§229.210 - 229.225 is to update the rules based on the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 21 Code of Federal Regulations Part 117 (PC rule) and Sanitary Transportation of Human and Animal Food (Sanitary Transportation rule) adopted by U.S. Food and Drug Administration in September 2015 and April 2016 respectively. The PC Rule and Sanitary Transportation rule were promulgated under the authority granted by the Food Safety Modernization Act. These new rules align our state rules with the PC and Sanitary Transportation rules. The incorporation of the federal PC Rule into the new rules were accomplished in two ways. First, Subparts A and B of the federal PC rule were incorporated in the language of the state rules in new §§229.211 - 229.225. Second, Subparts C, D, F, and G of the PC rule were adopted by reference in the new §229.210(d)(19). These rules will comply with Texas Health and Safety Code, §431.244, requiring DSHS to provide more transparency on which specific federal rules apply to industry and are enforced by DSHS as state rules adopted under Texas Health and Safety Code, §431.241 and §431.244. Section 229.210 lists each part of the Code of Federal Regulations that is a state rule.

The PC rule requirements specified in §229.210(d)(19) phase in over a three-year period as follows: very small businesses as defined by §229.211(74) - September 17, 2018; small businesses as defined by §229.211(65) - September 18, 2017; and all other business types upon the effective date of §§229.210 - 229.225.

The Sanitary Transportation rule requirements phase in over a two-year period as follows: small businesses as defined by §229.802(17) - April 6, 2018; and all other business types upon the effective date of §§229.801 - 229.807.

New §§229.210 - 229.225 include requirements for training food safety staff, perform hazard analyses on products produced, adopt a food safety plan, and institute preventive controls to mitigate identified hazards. The rules include requirements for risk-based environmental monitoring, product testing, and a supply chain program appropriate to the specific foods. In addition, the rules contain specific requirements for companies manufacturing products under modified atmosphere packaging. These requirements build on practices currently required under state and federal law.

The purpose of the new §§229.801 - 229.807 is to comply with new 21 CFR Part 1 Subpart O, (Sanitary Transportation Rule), adopted by U.S. Food and Drug Administration in April 2016. This was promulgated under the authority granted by the Food Safety Modernization Act. The new sanitary transportation rules include requirements for vehicles and transportation equipment, operations, training, and recordkeeping.

The rules are in compliance with Government Code, §2001.039, requiring state agencies to review and consider each rule for readoption. Sections 229.210 - 229.222 have been reviewed and DSHS has determined that reasons for adopting the sections continue to exist because rules on this subject are required by statute and provide guidance for the DSHS; however, revisions to the rules are necessary as outlined in this preamble.

COMMENTS

The 60-day comment period ended May 2, 2017.

During this period, DSHS received comments regarding the proposed rules from four commenters, including the Farm and Ranch Freedom Alliance. The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of comments. A summary of the comments relating to the rules and DSHS's responses follows.

Comment: A commenter asked if the definition of "animal food" listed in §229.802(2) is subject to Subchapter GG, Sanitary Transportation.

Response: DSHS agrees the inclusion of animal food in §§229.801 -229.807 is confusing as animal food is not covered under these state rules. DSHS has revised the rule and removed the definition of "animal food" in §229.802(2).

Comment: A representative from the Farm and Ranch Freedom Alliance commented that the preamble mentions "applying" for an exemption. The commenter's understanding is that no application is necessary. Producers who have a Tester-Hagan exemption simply submit a sworn statement that they qualify, and keep their records to prove it. The commenter asked if DSHS is going to require anything more or different.

Response: DSHS agrees with this comment. There is no requirement to apply for a qualified facility exemption. Facilities must meet the requirements detailed in §229.211(52) - (53) to qualify for an exemption from portions of 21 CFR Part 117 as detailed in §229.213(a). Facilities that qualify must comply with the requirements detailed in 21 CFR Subpart D. No change was made as a result of the comment.

Comment: Concerning §229.212, a commenter stated that the new training requirements can increase the cost of food production due to the cost needed for training and difficulty obtaining employees who have fulfilled requirements. Small businesses in food production have a small cost to profit ratio, therefore enacting these rules can put businesses and individuals out of employment due to the barrier cost of these training requirements.

Response: DSHS declines to make any change to the training requirements. The training requirements language in §229.212 only applies to facilities subject to 21 CFR Part 117. Facilities that are exempt from 21 CFR Part 117 but still required to comply with state food manufacturing rules are not subject to this training requirement. Companies that are subject to 21 CFR Part 117 are required to comply with this regulation at the federal level. Eliminating or amending the training requirements will not reduce any burden for facilities as the rule is already in place at the federal level.

Comment: A commenter was concerned that if the government is going to propose additional regulations on cross contact for allergens, it should provide free or low cost (less than $100/year) inspections and subsequent certifications for non-contaminated food products or food production facilities. If the certification is for a food production facility, the certifications should be valid for any business/food products that are produced in said facility.

Response: DSHS declines to make any changes to the allergen cross contact requirements. Only companies utilizing food allergens defined in §229.211(24) are required to take steps to mitigate allergen cross contact. Undeclared allergens cause over 30% of the recalls nationwide. In addition, even a miniscule amount of a protein/allergen can trigger allergic symptoms ranging from mild reactions to death. DSHS is required to collect a fee to recover the costs of conducting an inspection under Texas Health and Safety Code, §431.204.

Comment: A commenter stated that food businesses are self-motivated to provide sanitary transportation of food. A food manufacturer's biggest fear is making a customer sick from food borne illness because of the associated moral and financial costs. Requiring expensive changes to food delivery vehicles will prevent small businesses from being formed. No business that bootstraps or starts with small capital can afford to have a commercial food delivery vehicle when starting up.

Response: DSHS declines to make any changes to the sanitary transportation rules in §§229.801 - 229.807 as a result of this comment. The rules follow the same applicability requirements as the 21 CFR Part 1 Subpart O. Companies that are subject to 21 CFR Part 117 are required to comply with this regulation at the federal level. By eliminating or amending the training requirements will not reduce any burden for facilities as the rule is already in place at the federal level.

Comment: A commenter stated that it appears that there is a conflict between an exemption in the Texas Health and Safety Code, Chapter 431, §431.044(d), which exempts carriers from all other provisions of the Chapter 431 and the proposed new 25 TAC Chapter 229, Subchapter GG, §§229.801 - 229.807.

Response: DSHS agrees with the commenter that using the word "carrier" rather than the phrase "vehicle used to transport food" causes confusion. While DSHS has the authority to inspect vehicles being used to transport or hold food in commerce under Texas Health and Safety Code, §431.042, DSHS does not have the authority to inspect parcel delivery services, such as USPS, under Texas Health and Safety Code, §431.044. In order to maintain consistency with the use of terms and phrases in §§229.801 - 229.807 and Texas Health and Safety Code, §431.044, the proposed definition of "carrier" has been divided into three definitions for clarification as follows.

-§229.802(3) Carrier--Any person who transports food while operating as a parcel delivery service.

-§229.802(9) Food transporter--Any person who physically moves food by vehicle in commerce within the United States; and excludes carriers as defined in this subchapter.

-§229.802(22) Vehicle Used To Transport Food--A vehicle used to transport or hold food in commerce within Texas.

In proposed §229.802(3), the word "carrier" was originally defined as "A person who physically moves food by motor vehicle in commerce within the United States. The term carrier does not include any person who transports food while operating as a parcel delivery service."

Replacing the word "carrier(s)" with "food transporter(s)" in §229.801, §229.802 and §§229.804 - 229.806 does not substantively change the rules. By placing "carrier" in a separate definition only for parcel delivery services and using the phrase "food transporter" solely for moving food, the substance of all the rules remains the same.

A minor edit was made to §229.213(k)(1)(D) to include the word "title" to complete the rule reference as "§229.211 of this title." Edits were made in §229.224(c) and (d) to replace the word "licensee" with "facility" for consistency throughout the rules in Subchapter N.

SUBCHAPTER E. JUICE HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) SYSTEMS

25 TAC §§229.61 - 229.73

The repeals are authorized by Texas Health and Safety Code, §431.241 and §431.244, which provide DSHS with the authority to adopt rules for efficient enforcement and adopt rules under the Federal Act; Government Code, §531.0055; and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001. Review of §§229.210 - 229.222 implements Government Code, §2001.039.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on July 13, 2017.

TRD-201702633

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: August 2, 2017

Proposal publication date: March 3, 2017

For further information, please call: (512) 776-6972


SUBCHAPTER H. SEAFOOD HACCP

25 TAC §§229.121 - 229.129

The repeals are authorized by Texas Health and Safety Code, §431.241 and §431.244, which provide DSHS with the authority to adopt rules for efficient enforcement and adopt rules under the Federal Act; Government Code, §531.0055; and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001. Review of §§229.210 - 229.222 implements Government Code, §2001.039.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on July 13, 2017.

TRD-201702634

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: August 2, 2017

Proposal publication date: March 3, 2017

For further information, please call: (512) 776-6972


SUBCHAPTER N. CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

25 TAC §§229.210 - 229.222

The repeals are authorized by Texas Health and Safety Code, §431.241 and §431.244, which provide DSHS with the authority to adopt rules for efficient enforcement and adopt rules under the Federal Act; Government Code, §531.0055; and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001. Review of §§229.210 - 229.222 implements Government Code, §2001.039.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on July 13, 2017.

TRD-201702636

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: August 2, 2017

Proposal publication date: March 3, 2017

For further information, please call: (512) 776-6972


25 TAC §§229.210 - 229.225

The new sections are authorized by Texas Health and Safety Code, §431.241 and §431.244, which provide DSHS with the authority to adopt rules for efficient enforcement and adopt rules under the Federal Act; Government Code, §531.0055; and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001. Review of §§229.210 - 229.222 implements Government Code, §2001.039.

§229.213.Exemptions.

(a) Except as provided by 21 Code of Federal Regulations Part 117 Subparts E, C and G does not apply to a qualified facility. Qualified facilities are subject to the modified requirements in 21 Code of Federal Regulations, §117.201.

(b) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to activities that are subject to 21 Code of Federal Regulations Part 123, Fish and Fishery Products, at a facility if you are required to comply with, and are in compliance with, Part 123 with respect to such activities.

(c) 21 Code of Federal Regulations Part 117 Subparts C and G of this part do not apply with respect to activities that are subject to 21 Code of Federal Regulations Part 120, Hazard Analysis and Critical Control Point (HACCP) Systems, at a facility if you are required to comply with, and are in compliance with, Part 120 with respect to such activities.

(d) Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.

(1) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to activities that are subject to 21 Code of Federal Regulations Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, at a facility if you are required to comply with, and are in compliance with 21 Code of Federal Regulations Part 113 with respect to such activities.

(2) The exemption in paragraph (1) of this subsection is applicable only with respect to the microbiological hazards that are regulated under 21 Code of Federal Regulations Part 113.

(e) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to any facility with regard to the manufacturing, processing, packaging, or holding of a dietary supplement that is in compliance with the requirements of 21 Code of Federal Regulations Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, and the Federal Food, Drug, and Cosmetic Act, §761, Serious Adverse Event Reporting for Dietary Supplements.

(f) 21 Code of Federal Regulations Part 117 Subparts C and G of do not apply to activities of a facility that are subject to the Federal Food, Drug, and Cosmetic Act, §419, Standards for Produce Safety.

(g) Low Risk packing or holding activity/food combinations.

(1) The exemption in paragraph (3) of this subsection applies to packing or holding of processed foods on a farm mixed-type facility, except for processed foods produced by drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), the packing and holding of which are within the "farm" definition in §229.211 of this title (relating to Definitions). Activities that are within the "farm" definition, when conducted on a farm mixed-type facility, are not subject to the requirements of 21 Code of Federal Regulations Part 117 Subparts C and G and therefore, do not need to be specified in the exemption.

(2) For the purposes of paragraph (3) of this subsection and subsection (h)(3) of this section, the following terms describe the foods associated with the activity/food combinations. Several foods that are fruits or vegetables are separately considered for the purposes of these activity/food combinations (i.e., coffee beans, cocoa beans, fresh herbs, peanuts, sugarcane, sugar beets, tree nuts, seeds for direct consumption) to appropriately address specific hazards associated with these foods and/or processing activities conducted on these foods.

(A) Dried/dehydrated fruit and vegetable products includes only those processed food products such as raisins and dried legumes made without additional manufacturing/processing beyond drying/dehydrating, packaging, and/or labeling.

(B) Other fruit and vegetable products includes those processed food products that have undergone one or more of the following processes: acidification, boiling, canning, coating with things other than wax/oil/resin, cooking, cutting, chopping, grinding, peeling, shredding, slicing, or trimming. Examples include flours made from legumes (such as chickpea flour), pickles, and snack chips made from potatoes or plantains. Examples also include dried fruit and vegetable products made with additional manufacturing/processing (such as dried apple slices; pitted, dried plums, cherries, and apricots; and sulfited raisins). This category does not include dried/dehydrated fruit and vegetable products made without additional manufacturing/processing as described in subparagraph (A) of this paragraph. This category also does not include products that require time/temperature control for safety (such as fresh-cut fruits and vegetables).

(C) Peanut and tree nut products includes processed food products such as roasted peanuts and tree nuts, seasoned peanuts and tree nuts, and peanut and tree nut flours.

(D) Processed seeds for direct consumption include processed food products such as roasted pumpkin seeds, roasted sunflower seeds, and roasted flax seeds.

(E) Dried/dehydrated herb and spice products includes only processed food products such as dried intact herbs made without additional manufacturing/processing beyond drying/dehydrating, packaging, and/or labeling.

(F) Other herb and spice products includes those processed food products such as chopped fresh herbs, chopped or ground dried herbs (including tea), herbal extracts (e.g., essential oils, extracts containing more than 20 percent ethanol, extracts containing more than 35 percent glycerin), dried herb- or spice-infused honey, and dried herb or spice-infused oils and/or vinegars. This category does not include dried/dehydrated herb and spice products made without additional manufacturing/processing beyond drying/dehydrating, packaging, and/or labeling as described in subparagraph (E) of this paragraph. This category also does not include products that require time/temperature control for safety, such as fresh herb-infused oils.

(G) Grains include barley, dent or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for oil extraction (such as cotton seed, flax seed, rapeseed, soybeans, and sunflower seed).

(H) Milled grain products include processed food products such as flour, bran, and corn meal.

(I) Baked goods include processed food products such as breads, brownies, cakes, cookies, and crackers. This category does not include products that require time/temperature control for safety, such as cream-filled pastries.

(J) Other grain products include processed food products such as dried cereal, dried pasta, oat flakes, and popcorn. This category does not include milled grain products as described in subparagraph (H) of this paragraph or baked goods as described in subparagraph (I) of this paragraph.

(3) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to on-farm packing or holding of food by a small or very small business, and 21 Code of Federal Regulations §117.201 does not apply to on-farm packing or holding of food by a very small business, if the only packing and holding activities subject to the Federal Food, Drug, and Cosmetic Act, §418 that the business conducts are the following low-risk packing or holding activity/food combinations-i.e., packing (or re-packing) (including weighing or conveying incidental to packing or re-packing); sorting, culling, or grading incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of:

(A) baked goods (e.g., bread and cookies);

(B) candy (e.g., hard candy, fudge, maple candy, maple cream, nut brittles, taffy, and toffee);

(C) cocoa beans (roasted);

(D) cocoa products;

(E) coffee beans (roasted);

(F) game meat jerky;

(G) gums, latexes, and resins that are processed foods;

(H) honey (pasteurized);

(I) jams, jellies, and preserves;

(J) milled grain products (e.g., flour, bran, and corn meal);

(K) molasses and treacle;

(L) oils (e.g., olive oil and sunflower seed oil);

(M) other fruit and vegetable products (e.g., flours made from legumes; pitted, dried fruits; sliced, dried apples; snack chips);

(N) other grain products (e.g., dried pasta, oat flakes, and popcorn);

(O) other herb and spice products (e.g., chopped or ground dried herbs, herbal extracts);

(P) peanut and tree nut products (e.g., roasted peanuts and tree nut flours);

(Q) processed seeds for direct consumption (e.g., roasted pumpkin seeds);

(R) soft drinks and carbonated water;

(S) sugar;

(T) syrups (e.g., maple syrup and agave syrup);

(U) trail mix and granola;

(V) vinegar; and

(W) any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form).

(h) Low risk manufacturing/processing activity/food combinations.

(1) The exemption in paragraph (3) of this subsection applies to manufacturing/processing of foods on a farm mixed-type facility, except for manufacturing/processing that is within the "farm" definition. Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), are within the "farm" definition. In addition, treatment to manipulate ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling the treated raw agricultural commodities, without additional manufacturing/processing, is within the "farm" definition. In addition, coating intact fruits and vegetables with wax, oil, or resin used for the purpose of storage or transportation is within the "farm" definition. Activities that are within the "farm" definition, when conducted on a farm mixed-type facility, are not subject to the requirements of 21 Code of Federal Regulations Part 117 Subparts C and G and therefore, do not need to be specified in the exemption.

(2) The terms in subsection (g)(2) of this section describe certain foods associated with the activity/food combinations in paragraph (3) of this subsection.

(3) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to on-farm manufacturing/processing activities conducted by a small or very small business for distribution into commerce, and 21 Code of Federal Regulations §117.201 does not apply to on-farm manufacturing/processing activities conducted by a very small business for distribution into commerce, if the only manufacturing/processing activities subject to the Federal Food, Drug, and Cosmetic Act, §418 that the business conducts are the following low-risk manufacturing/processing activity/food combinations:

(A) boiling gums, latexes, and resins;

(B) chopping, coring, cutting, peeling, pitting, shredding, and slicing acid fruits and vegetables that have a pH less than 4.2 (e.g., cutting lemons and limes), baked goods (e.g., slicing bread), dried/dehydrated fruit and vegetable products (e.g., pitting dried plums), dried herbs and other spices (e.g., chopping intact, dried basil), game meat jerky, gums/latexes/resins, other grain products (e.g., shredding dried cereal), peanuts and tree nuts, and peanut and tree nut products (e.g., chopping roasted peanuts);

(C) coating dried/dehydrated fruit and vegetable products (e.g., coating raisins with chocolate), other fruit and vegetable products except for non-dried, non-intact fruits and vegetables (e.g., coating dried plum pieces, dried pitted cherries, and dried pitted apricots with chocolate are low-risk activity/food combinations but coating apples on a stick with caramel is not a low-risk activity/food combination), other grain products (e.g., adding caramel to popcorn or adding seasonings to popcorn provided that the seasonings have been treated to significantly minimize pathogens, peanuts and tree nuts (e.g., adding seasonings provided that the seasonings have been treated to significantly minimize pathogens), and peanut and tree nut products (e.g., adding seasonings provided that the seasonings have been treated to significantly minimize pathogens);

(D) drying/dehydrating (that includes additional manufacturing or is performed on processed foods) other fruit and vegetable products with pH less than 4.2 (e.g., drying cut fruit and vegetables with pH less than 4.2), and other herb and spice products (e.g., drying chopped fresh herbs, including tea);

(E) extracting (including by pressing, by distilling, and by solvent extraction) from dried/dehydrated herb and spice products (e.g., dried mint), fresh herbs (e.g., fresh mint), fruits and vegetables (e.g., olives, avocados), grains (e.g., oilseeds), and other herb and spice products (e.g., chopped fresh mint, chopped dried mint);

(F) freezing acid fruits and vegetables with pH less than 4.2 and other fruit and vegetable products with pH less than 4.2 (e.g., cut fruits and vegetables);

(G) grinding/cracking/crushing/milling baked goods (e.g., crackers), cocoa beans (roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., raisins and dried legumes), dried/dehydrated herb and spice products (e.g., intact dried basil), grains (e.g., oats, rice, rye, wheat), other fruit and vegetable products (e.g., dried, pitted dates), other grain products (e.g., dried cereal), other herb and spice products (e.g., chopped dried herbs), peanuts and tree nuts, and peanut and tree nut products (e.g., roasted peanuts);

(H) labeling baked goods that do not contain food allergens, candy that does not contain food allergens, cocoa beans (roasted), cocoa products that do not contain food allergens), coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, honey (pasteurized), jams/jellies/preserves, milled grain products that do not contain food allergens (e.g., corn meal) or that are single-ingredient foods (e.g., wheat flour, wheat bran), molasses and treacle, oils, other fruit and vegetable products that do not contain food allergens (e.g., snack chips made from potatoes or plantains), other grain products that do not contain food allergens (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), peanut or tree nut products, (provided that they are single-ingredient, or are in forms in which the consumer can reasonably be expected to recognize the food allergen(s) without label declaration, or both (e.g., roasted or seasoned whole nuts, single-ingredient peanut or tree nut flours)), processed seeds for direct consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola (other than those containing milk chocolate and provided that peanuts and/or tree nuts are in forms in which the consumer can reasonably be expected to recognize the food allergen(s) without label declaration), vinegar, and any other processed food that does not require time/temperature control for safety and that does not contain food allergens (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form);

(I) making baked goods from milled grain products (e.g., breads and cookies);

(J) making candy from peanuts and tree nuts (e.g., nut brittles), sugar/syrups (e.g., taffy, toffee), and saps (e.g., maple candy, maple cream);

(K) making cocoa products from roasted cocoa beans;

(L) making dried pasta from grains;

(M) making jams, jellies, and preserves from acid fruits and vegetables with a pH of 4.6 or below;

(N) making molasses and treacle from sugar beets and sugarcane;

(O) making oat flakes from grains;

(P) making popcorn from grains;

(Q) making snack chips from fruits and vegetables (e.g., making plantain and potato chips);

(R) making soft drinks and carbonated water from sugar, syrups, and water;

(S) making sugars and syrups from fruits and vegetables (e.g., dates), grains (e.g., rice, sorghum), other grain products (e.g., malted grains such as barley), saps (e.g., agave, birch, maple, palm), sugar beets, and sugarcane;

(T) making trail mix and granola from cocoa products (e.g., chocolate), dried/dehydrated fruit and vegetable products (e.g., raisins), other fruit and vegetable products (e.g., chopped dried fruits), other grain products (e.g., oat flakes), peanut and tree nut products, and processed seeds for direct consumption, provided that peanuts, tree nuts, and processed seeds are treated to significantly minimize pathogens;

(U) making vinegar from fruits and vegetables, other fruit and vegetable products (e.g., fruit wines, apple cider), and other grain products (e.g., malt);

(V) mixing baked goods (e.g., types of cookies), candy (e.g., varieties of taffy), cocoa beans (roasted), coffee beans (roasted), dried/dehydrated fruit and vegetable products (e.g., dried blueberries, dried currants, and raisins), dried/dehydrated herb and spice products (e.g., dried, intact basil and dried, intact oregano), honey (pasteurized), milled grain products (e.g., flour, bran, and corn meal), other fruit and vegetable products (e.g., dried, sliced apples and dried, sliced peaches), other grain products (e.g., different types of dried pasta), other herb and spice products (e.g., chopped or ground dried herbs, dried herb- or spice-infused honey, and dried herb- or spice-infused oils and/or vinegars), peanut and tree nut products, sugar, syrups, vinegar, and any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form);

(W) packaging baked goods (e.g., bread and cookies), candy, cocoa beans (roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, honey (pasteurized), jams/jellies/preserves, milled grain products (e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit and vegetable products (e.g., pitted, dried fruits; sliced, dried apples; snack chips), other grain products (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), peanut and tree nut products, processed seeds for direct consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola, vinegar, and any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form);

(X) pasteurizing honey;

(Y) roasting and toasting baked goods (e.g., toasting bread for croutons);

(Z) salting other grain products (e.g., soy nuts), peanut and tree nut products, and processed seeds for direct consumption; and

(AA) sifting milled grain products (e.g., flour, bran, corn meal), other fruit and vegetable products (e.g., chickpea flour), and peanut and tree nut products (e.g., peanut flour, almond flour).

(i) Alcoholic beverages.

(1) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to alcoholic beverages at a facility that meets the following two conditions:

(A) Under the Federal Alcohol Administration Act (27 United States Code 201 et seq.) or Chapter 51 of Subtitle E of the Internal Revenue Code of 1986 (26 United States Code 5001 et seq.) the facility is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States, or is a foreign facility of a type that would require such a permit, registration, or approval if it were a domestic facility; and

(B) Under the Federal Food, Drug, and Cosmetic Act, §415, the facility is required to register as a facility because it is engaged in manufacturing, processing, packing, or holding one or more alcoholic beverages.

(2) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to food that is not an alcoholic beverage at a facility described in paragraph (1) of this subsection, provided such food:

(A) is in prepackaged form that prevents any direct human contact with such food; and

(B) constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.

(j) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.

(k) Exemptions to Subchapter N.

(1) Except as provided by paragraph (2) of this subsection, Subchapter N of this chapter does not apply to any of the following:

(A) "farms;"

(B) fishing vessels that are not subject to the registration requirements of 21 Code of Federal Regulations Part 1, Subpart H in accordance with 21 Code of Federal Regulations §1.226(f);

(C) establishments solely engaged in the holding and/or transportation of one or more raw agricultural commodities;

(D) activities of "farm mixed-type facilities" as defined under mixed-type facility in §229.211 of this title that fall within the definition of "farm;" or

(E) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts except in the case where the nut is cracked and/or shelled and is intended to be consumed raw (without additional manufacturing/processing, such as roasting nuts).

(2) If a "farm" or "farm mixed-type facility" dries/dehydrates raw agricultural commodities that are produce as defined in 21 Code of Federal Regulations Part 112, to create a distinct commodity, Subchapter N of this chapter applies to the packaging, packing, and holding of the dried commodities. Compliance with this requirement may be achieved by complying with Subchapter N of this chapter or with the applicable requirements for packing and holding in 21 Code of Federal Regulations Part 112.

§229.224.Good Warehousing Practice.

(a) Plant and grounds.

(1) Storage and transportation of food must be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container.

(2) Food storage facilities must be properly constructed and maintained. All walls, ceilings, and floors must be intact to preclude entry of vermin and environmental contaminants.

(3) Doors and loading docks must be tight-fitting and kept closed at all times when not in use, or adequately screened during normal operating hours to prevent entry of rodents, birds, or other pests.

(4) Outer premises, including trash receptacles, and non food storage areas must be kept clean and free of odors, debris, high weeds, or standing water which could harbor or attract vermin.

(5) Adequate lighting of at least 108 lux (10 foot candles) must be provided to facilitate cleaning and inspection of food storage areas.

(b) Sanitary facilities.

(1) Toilet Facilities. Each warehouse facility must provide employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and in good repair. Toilet facilities must be equipped with a hand washing sink with running water of at least 100 degrees Fahrenheit, hand cleaning agent, and single service towels or an air drying device.

(2) Handwashing Facilities:

(A) For warehouse facilities that have direct hand contact with food, the facility must provide hand-washing facilities separate from the toilet facilties designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. Facilities that utilize conventional handwashing must provide a conventional handwashing sink, hot running water of at least 100 degrees Fahrenheit, hand cleaning agent, and individual disposable towels, continuous towel system that supplies a user with a clean towel, or an air drying device.

(B) For warehouse facilities with no direct hand contact with food, hand-washing facilities separate from toilet facilities are not required.

(C) Wastewater must be disposed of in a manner approved by the regulatory authority.

(c) Sanitary operations.

(1) Food including raw ingredients and finished food products must be obtained from an approved source.

(2) All foods, including refrigerated and frozen foods, must be stored to prevent direct contact with the floor and away from walls to help prevent contamination by vermin (rodents and insects for example) and moisture, and to facilitate cleaning and inspection.

(3) All food packaging material that are intended to come in direct contact with food must be stored to prevent direct contact with the floor.

(4) Food storage facilities and transportation vehicles must be kept free of rodents, insects, birds, and other pests which may contaminate food which includes:

(A) no evidence of pest activity in non-food areas;

(B) no evidence of pest activity in food storage areas; and

(C) no evidence of pest activity in or on food products, food packaging or food preparation utensils, equipment or devices.

(5) Damaged, distressed, and infested foods and food packaging material must be stored in a designated "morgue area", adequately separated from undamaged foods and must be disposed of in a timely manner to preclude further contamination.

(6) Food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding.

(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) Seafood intended for wholesale distribution must comply with temperature requirements specified 21 Code of Federal Regulations Part 123, Seafood Safety.

(F) Milk received directly from a facility under the jurisdiction of the PMO 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.

(7) During warehousing and transporting, all chemicals must be properly stored and physically separated from foods to preclude contamination.

(8) Food storage facilities and transportation vehicles operated under the control of the facility must be kept clean and free of excessive dust, dirt, spillage, and other debris, including excess moisture.

(9) Food transport vehicles must be operated in compliance with federal regulations pertaining to back-hauling.

(10) Each incoming lot must be examined at the time of receipt and contaminated or adulterated foods must not be accepted.

(11) Swollen, leaking, and/or severely dented containers of food must be segregated and promptly placed in the "morgue area" and further contamination, attraction of vermin, or sale prior to reconditioning must be prevented.

(12) Only pesticides approved by the Environmental Protection Agency (EPA) for use in a food warehouse and/or food processing facility may be used. Pesticides must be used only according to label directions. Rodenticides must be placed inside enclosed bait boxes or other approved receptacles. Only a licensed pesticide applicator may apply restricted use pesticides.

(d) Other provisions.

(1) Distressed foods salvaged by the facility must be salvaged in accordance with §§229.541 - 229.555, 229.571 - 229.584, 229.601 - 229.614, and 229.631 - 229.644 of this title (relating to Regulation of Food, Drug, Device, and Cosmetic Salvage Establishments and Brokers).

(2) Food wholesalers engaged in the receipt and distribution of over-the-counter or prescription drugs must comply with §229.251 of this title (relating to Minimum Standards for Licensure).

(3) The facility must keep accurate distribution records so that any foods found to be unfit for human consumption may be recalled expeditiously.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on July 13, 2017.

TRD-201702637

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: August 2, 2017

Proposal publication date: March 3, 2017

For further information, please call: (512) 776-6972


SUBCHAPTER GG. SANITARY TRANSPORTATION OF HUMAN FOODS

25 TAC §§229.801 - 229.807

The new sections are authorized by Texas Health and Safety Code, §431.241 and §431.244, which provide DSHS with the authority to adopt rules for efficient enforcement and adopt rules under the Federal Act; Government Code, §531.0055; and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001. Review of §§229.210 - 229.222 implements Government Code, §2001.039.

§229.802.Definitions.

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise. Those definitions and interpretations of terms of the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431, are also applicable when used in this subchapter.

(1) Adequate--That which is needed to accomplish the intended purpose in keeping with good public health practice.

(2) Bulk vehicle--A tank truck, hopper truck, cargo tank, portable tank, freight container, or hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.

(3) Carrier--Any person who transports food while operating as a parcel delivery service.

(4) Cross-contact--The unintentional incorporation of a food allergen into food.

(5) Farm--Means:

(A) Primary production farm. A primary production farm is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term "farm" includes operations that, in addition to these activities:

(i) pack or hold raw agricultural commodities;

(ii) pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in clause (iii)(II)(-a-) of this subparagraph; and

(iii) manufacture/process food, provided that:

(I) all food used in such activities is consumed on that farm or another farm under the same management; or

(II) any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:

(-a-) drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);

(-b-) treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and;

(-c-) packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or

(B) secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described in subparagraph (A)(ii) and (iii) of this paragraph.

(6) Food allergen--A major food allergen is:

(A) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.

(B) A food ingredient that contains protein derived from a food specified in subparagraph (A) of this paragraph, except the following:

(i) any highly refined oil derived from a food specified in subparagraph (A) of this paragraph and any ingredient derived from such highly refined oil.

(ii) a food ingredient that is exempt under United States Code Title 21 Chapter 9, Subchapter IV, §343(w)(6) and (7).

(7) Food contact substance--Any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.

(8) Food not completely enclosed by a container--Any food that is placed into a container in such a manner that it is partially open to the surrounding environment. Examples of such containers include an open wooden basket or crate, an open cardboard box, a vented cardboard box with a top, or a vented plastic bag. This term does not include food transported in a bulk vehicle as defined in this subchapter.

(9) Food Transporter--Any person who physically moves food by vehicle in commerce within the United States; and excludes carriers as defined in this subchapter.

(10) Full-time equivalent employee--A term used to represent the number of employees of a business entity for the purpose of determining whether the business is a small business. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a whole number, round down to the next lowest whole number.

(11) Loader--A person that loads food onto a motor or during transportation operations.

(12) Non-covered business--A shipper, loader, receiver, or food transporter engaged in transportation operations that has less than $500,000, as adjusted for inflation, in average annual revenues, calculated on a rolling basis, during the 3-year period preceding the applicable calendar year. For the purpose of determining an entity's 3-year average revenue threshold as adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011.

(13) Operating temperature--A temperature sufficient to ensure that under foreseeable circumstances of temperature variation during transport, e.g., seasonal conditions, refrigeration unit defrosting, multiple vehicle loading and unloading stops, and type of food product, the operation will meet the requirements of §229.804(a)(3) of this title (relating to Transportation Operations).

(14) Pest--Any objectionable animals or insects including birds, rodents, flies, and larvae.

(15) Receiver--Any person who receives food at a point in the United States after transportation, whether or not that person represents the final point of receipt for the food.

(16) Shipper--A person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a food transporter or multiple food transporters sequentially.

(17) Small business--A business employing fewer than 500 full-time equivalent employees except that for food transporters by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to §229.801(a) of this title (relating to Purpose and Scope) having less than $27,500,000 in annual receipts.

(18) Transportation--Any movement of food in by motor vehicle or in commerce within the United States.

(19) Transportation equipment--Equipment used in food transportation operations, e.g., bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and unloading systems. Transportation equipment also includes a trailer not attached to a tractor.

(20) Transportation operations--All activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment. Transportation operations do not include any activities associated with the transportation of food that is completely enclosed by a container except a food that requires temperature control for safety, compressed food gases, food contact substances, human food byproducts transported for use as animal food without further processing, or live food animals except molluscan shellfish. In addition, transportation operations do not include any transportation activities that are performed by a farm.

(21) Vehicle--A land conveyance that is motorized, e.g., a motor vehicle, which is used in transportation operations.

(22) Vehicle Used To Transport Food--A vehicle used to transport or hold food in commerce within Texas.

§229.804.Transportation Operations.

(a) General requirements.

(1) Unless stated otherwise in this section, the requirements of this section apply to all shippers, food transporters, loaders, and receivers engaged in transportation operations. A person may be subject to these requirements in multiple capacities, e.g., the shipper may also be the loader and the food transporter, if the person also performs the functions of those respective persons as defined in this subchapter. An entity subject to this subchapter (shipper, loader, food transporter, or receiver) may reassign, in a written agreement, its responsibilities under this subchapter to another party subject to this subchapter. The written agreement is subject to the records requirements of §229.806(d) of this title (relating to Records).

(2) Responsibility for ensuring that transportation operations are carried out in compliance with all requirements in this subchapter must be assigned to competent supervisory personnel.

(3) All transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming adulterated during transportation operations including:

(A) Taking effective measures such as segregation, isolation, or the use of packaging to protect food from contamination by raw foods and nonfood items in the same load.

(B) Taking effective measures such as segregation, isolation, or other protective measures, such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations.

(C) Taking effective measures to ensure that food that requires temperature control for safety is transported under food specific adequate temperature control.

(4) The type of food, and its production stage, e.g., raw material, ingredient or finished food, must be considered in determining the necessary conditions and controls for the transportation operation.

(5) Shippers, receivers, loaders, and food transporters, which are under the ownership or operational control of a single legal entity, as an alternative to meeting the requirements of subsections (b), (d), and (e) of this section may conduct transportation operations in conformance with common, integrated written procedures that ensure the sanitary transportation of food consistent with the requirements of this section. The written procedures are subject to the records requirements of §229.806(e) of this title.

(6) If a shipper, loader, receiver, or food transporter becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food adulterated during transportation, the food shall not be sold or otherwise distributed, and these persons must take appropriate action including, as necessary, communication with other parties to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food adulterated.

(b) Requirements applicable to shippers engaged in transportation operations.

(1) Unless the shipper takes other measures in accordance with paragraph (3) of this subsection to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, i.e., that will prevent the food from becoming adulterated, the shipper must specify to the food transporter and, when necessary, the loader, in writing, all necessary sanitary specifications for the food transporter's vehicle and transportation equipment to achieve this purpose, including any specific design specifications and cleaning procedures. One-time notification shall be sufficient unless the design requirements and cleaning procedures required for sanitary transport change based upon the type of food being transported, in which case the shipper shall so notify the food transporter in writing before the shipment. The information submitted by the shipper to the food transporter is subject to the records requirements in §229.806(a) of this title.

(2) Unless the shipper takes other measures in accordance with paragraph (5) of this subsection to ensure that adequate temperature control is provided during the transportation of food that requires temperature control for safety under the conditions of shipment, a shipper of such food must specify in writing to the food transporter, except a food transporter who transports the food in a thermally insulated tank, and, when necessary, the loader, an operating temperature for the transportation operation including, if necessary, the pre-cooling phase. One-time notification shall be sufficient unless a factor, e.g., the conditions of shipment, changes, necessitating a change in the operating temperature, in which case the shipper shall so notify the food transporter in writing before the shipment. The information submitted by the shipper to the food transporter is subject to the records requirements in §229.806(a) of this title.

(3) A shipper must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, adequate to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, i.e., will prevent the food from becoming unsafe during the transportation operation. Measures to implement these procedures may be accomplished by the shipper or by the food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title.

(4) A shipper of food transported in bulk must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, adequate to ensure that a previous cargo does not make the food unsafe. Measures to ensure the safety of the food may be accomplished by the shipper or by the food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title.

(5) The shipper of food that requires temperature control for safety under the conditions of shipment must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, to ensure that the food is transported under adequate temperature control. Measures to ensure the safety of the food may be accomplished by the shipper or by the food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title and must include measures equivalent to those specified for food transporters under subsection (e)(1) - (3) of this section.

(c) Requirements applicable to loaders engaged in transportation operations.

(1) Before loading food not completely enclosed by a container onto a vehicle or into transportation equipment the loader must determine, considering, as appropriate, specifications provided by the shipper in accordance with subsection (b)(1) of this section, that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, e.g., it is in adequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation. This may be accomplished by any appropriate means.

(2) Before loading food that requires temperature control for safety, the loader must verify, considering, as appropriate, specifications provided by the shipper in accordance with subsection (b)(2) of this section, that each mechanically refrigerated cold storage compartment or container is adequately prepared for the transportation of such food, including that it has been properly pre-cooled, if necessary, and meets other sanitary conditions for food transportation.

(d) Requirements applicable to receivers engaged in transportation operations. Upon receipt of food that requires temperature control for safety under the conditions of shipment, the receiver must take steps to adequately assess that the food was not subjected to significant temperature abuse, such as determining the food's temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors.

(e) Requirements applicable to food transporters engaged in transportation operations. When the food transporter and shipper have a written agreement that the food transporter is responsible, in whole or in part, for sanitary conditions during the transportation operation, the food transporter is responsible for the following functions as applicable per the agreement:

(1) A food transporter must ensure that vehicles and transportation equipment meet the shipper's specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation.

(2) A food transporter must, once the transportation operation is complete and if requested by the receiver, provide the operating temperature specified by the shipper in accordance with subsection (b)(2) of this section and, if requested by the shipper or receiver, demonstrate that it has maintained temperature conditions during the transportation operation consistent with the operating temperature specified by the shipper in accordance with subsection (b)(2) of this section. Such demonstration may be accomplished by any appropriate means agreeable to the food transporter and shipper, such as the food transporter presenting measurements of the ambient temperature upon loading and unloading or time/temperature data taken during the shipment.

(3) Before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for use for the transportation of food that requires temperature control for safety under the conditions of the shipment during transportation, a food transporter must pre-cool each mechanically refrigerated cold storage compartment as specified by the shipper in accordance with subsection (b)(2) of this section.

(4) If requested by the shipper, a food transporter that offers a bulk vehicle for food transportation must provide information to the shipper that identifies the previous cargo transported in the vehicle.

(5) If requested by the shipper, a food transporter that offers a bulk vehicle for food transportation must provide information to the shipper that describes the most recent cleaning of the bulk vehicle.

(6) A food transporter must develop and implement written procedures subject to the records requirements of §229.806(b) of this title that:

(A) Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the food transporter provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition as required by §229.803(b) of this title (relating to Vehicles and Transportation Equipment);

(B) Describe how it will comply with the provisions for temperature control in paragraph (2) of this subsection; and

(C) Describe how it will comply with the provisions for the use of bulk vehicles in paragraphs (4) and (5) of this subsection.

§229.805.Training.

(a) When the food transporter and shipper have agreed in a written contract that the food transporter is responsible, in whole or in part, for the sanitary conditions during transportation operations, the food transporter must provide adequate training to personnel engaged in transportation operations that provides an awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems, and the responsibilities of the food transporter under this subchapter. The training must be provided upon hiring and as needed thereafter.

(b) Food transporters must establish and maintain records documenting the training described in subsection (a) of this section. Such records must include the date of the training, the type of training, and the person(s) trained. These records are subject to the records requirements of §229.806(c) of this title (relating to Records).

§229.806.Records.

(a) Shippers must retain records.

(1) That demonstrate that they provide specifications and operating temperatures to food transporters as required by §229.804(b)(1) and (2) of this title (relating to Transportation Operations) as a regular part of their transportation operations for a period of 12 months beyond the termination of the agreements with the food transporters.

(2) Of written agreements and the written procedures required by §229.804(b)(3) - (5) of this title for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.

(b) Food transporters must retain records of the written procedures required by §229.804(e)(6) of this title for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.

(c) Food transporters must retain training records required by §229.805(b) of this title (relating to Training) for a period of 12 months beyond when the person identified in any such records stops performing the duties for which the training was provided.

(d) Any person subject to this subchapter must retain any other written agreements assigning tasks in compliance with this subchapter for a period of 12 months beyond the termination of the agreements.

(e) Shippers, receivers, loaders, and food transporters, which operate under the ownership or control of a single legal entity in accordance with the provisions of §229.804(a)(5) of this title, must retain records of the written procedures for a period of 12 months beyond when the procedures are in use in their transportation operations.

(f) Shippers, receivers, loaders, and food transporters must make all records required by this subchapter available to a duly authorized individual promptly upon oral or written request.

(g) All records required by this subchapter must be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records.

(h) Except for the written procedures required by §229.804(e)(6)(A) of this title, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The written procedures required by §229.804(e)(6)(A) of this title must remain onsite as long as the procedures are in use in transportation operations. Electronic records are considered to be onsite if they are accessible from an onsite location.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on July 13, 2017.

TRD-201702638

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: August 2, 2017

Proposal publication date: March 3, 2017

For further information, please call: (512) 776-6972