<<Prev Rule

Texas Administrative Code

Next Rule>>
TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER NCURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
RULE §229.213Exemptions

(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);

Cont'd...

Next Page

Link to Texas Secretary of State Home Page | link to Texas Register home page | link to Texas Administrative Code home page | link to Open Meetings home page