Section 11-37-65 - Processes and controls(a) General. (1) All operations in the manufacturing, processing, packing, and holding of hemp products and components (including receiving, inspecting, transporting, and segregating) shall be conducted in accordance with adequate sanitation principles.(2) Appropriate quality control operations shall be employed to ensure that hemp products are suitable for consumption by humans or animals or for topical application to the skin or hair, as applicable, and that packaging materials are safe and suitable.(3) Overall sanitation of the facility shall be under the supervision of one or more competent individuals assigned responsibility for this function.(4) Adequate precautions shall be taken to ensure that production procedures do not contribute to allergen cross-contact or to contamination from any source.(5) Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible allergen cross-contact and contamination.(6) All components and in-process materials that have become contaminated to the extent that they are adulterated shall be rejected, or if appropriate, treated or processed to eliminate the contamination.(b) Ingredients. (1) Ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into hemp products and shall be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Ingredients shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying hemp products or components shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying hemp products or components if it does not cause allergen cross-contact or increase the level of contamination of the hemp product or component.(2) Ingredients shall either not contain levels of microorganisms that may render the hemp product injurious to the health of humans, or they shall be treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.(3) Ingredients susceptible to contamination with aflatoxins or other natural toxins shall not be adulterated before these ingredients are incorporated into a finished hemp product.(4) Ingredients and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall be examined and, based on examination results, shall not be adulterated before these ingredients are incorporated into a finished hemp product.(5) Ingredients and rework shall be held in bulk or in containers designed and constructed so as to protect against mix-ups, allergen cross-contact, and contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the ingredients or hemp product from becoming adulterated. Material scheduled for rework shall be identified as such.(6) Frozen ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the ingredients from becoming adulterated.(7) Liquid or dry ingredients received and stored in bulk form shall be held in a manner that protects against allergen crosscontact and against contamination.(8) Ingredients that are allergens, and rework that contains allergens, shall be identified and held in a manner that prevents allergen cross-contact.(9) Water used as an ingredient shall be: (A) Of a defined quality;(B) Unaffected by materials used in the water treatment equipment;(C) Tested or monitored regularly to verify that it meets applicable chemical, physical, and microbiological specifications for quality; and(D) Supplied by a system set up to avoid stagnation and risks of contamination that is routinely cleaned and sanitized according to an appropriate SOP that ensures no biofilm build-up.(c) Manufacturing operations.(1) Equipment, utensils, and containers shall be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.(2) All hemp product manufacturing, processing, packing, and holding shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen crosscontact, contamination, and deterioration.(3) Hemp products and components that can support the rapid growth of undesirable microorganisms shall be held at temperatures that will prevent the hemp product or component from becoming adulterated during manufacturing, processing, packing, and holding.(4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling a. that are taken to destroy or prevent the growth of undesirable microorganisms shall be adequate under the conditions of manufacture, handling, and distribution to prevent hemp products or components from being adulterated.(5) Work-in-process and rework shall be handled in a manner that protects against allergen cross-contact, contamination, and growth of undesirable microorganisms.(6) Effective measures shall be taken to protect finished hemp products from allergen crosscontact and from contamination by ingredients, other components, or refuse. When ingredients, other components, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contamination of hemp products. Hemp products or components transported by conveyor shall be protected against allergen cross-contact and against contamination as necessary.(7) Equipment, containers, and utensils used to convey, hold, or store components, work-in-process, rework, or other hemp products shall be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact and against contamination.(8) Adequate measures shall be taken to protect against the inclusion of metal or other extraneous material in hemp products.(9) Hemp products and components that are adulterated:(A) Shall be disposed of in a manner that protects against the contamination of other hemp products and components; or(B) If an adulterated component is capable of being reconditioned, it shall be: (i) Reconditioned (if appropriate) using a method that has been proven to be effective; or(ii) Reconditioned (if appropriate) and reexamined and subsequently found not to be adulterated before being incorporated into other hemp products.(10) All operations in the manufacturing, processing, packing, and holding of hemp products and components shall be performed so as to protect hemp products and components against allergen cross-contact, contamination, and the growth of undesirable microorganisms. Hemp products and components shall be protected from contaminants that may drip, drain, or be drawn into them.(11) Heat blanching, when required in the preparation of hemp products or components capable of supporting microbial growth, shall be effected by heating the hemp product or component to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling it or passing it to subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers shall be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing as necessary.(12) Hemp products and components that rely principally on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level.(13) Hemp products and components that rely 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.(14) When ice is used in contact with hemp products or components, it shall be made from water that is safe and of adequate sanitary quality in accordance with section 11-37-63(1) and manufactured in accordance with current good manufacturing practice.[Eff 8/9/21; am and comp 2/24/2022] (Auth: HRS § 328G-4) (Imp: HRS § 328G-4)