Haw. Code R. § 11-850-116 - Processes and controls
(a) General.
(1) All operations in the production and
storage of cannabis, manufactured cannabis products, and components shall be
conducted in accordance with adequate sanitation principles.
(2) Appropriate quality control operations
shall be employed to ensure that cannabis and manufactured cannabis products
are suitable for human consumption 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 cannabis,
components, and in-process materials that have become contaminated shall be
rejected, or if appropriate and allowed under section
11-850-135 (h)
(1), 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 manufactured cannabis 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 cannabis, manufactured cannabis
products/ or components shall be safe and of adequate sanitary quality. Water
may be reused for washing, rinsing, or conveying cannabis, manufactured
cannabis products, or components if it does not cause allergen cross-contact or
increase the level of contamination of the cannabis, manufactured cannabis
product, or component.
(2)
Ingredients shall either not contain levels of microorganisms that may render
the manufactured cannabis 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 contaminated.
(3) Ingredients susceptible to contamination
with aflatoxins or other natural toxins shall not be contaminated before these
ingredients are incorporated into a manufactured cannabis 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 contaminated
before these ingredients are incorporated into a manufactured cannabis
product.
(5) Ingredients and rework
shall be stored in bulk or in containers designed and constructed so as to
protect against mix- ups, allergen cross-contact, and contamination and shall
be stored at such temperature and relative humidity and in such a manner as to
prevent the ingredients or manufactured cannabis product from becoming
contaminated. Material scheduled for reprocessing 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 contaminated.
(7) Liquid or dry ingredients received and
stored in bulk form shall be stored in a manner that protects against allergen
cross-contact and against contamination.
(8) Ingredients that are allergens, and
rework that contains allergens, shall be identified and stored 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 standard operating procedure 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
cannabis and manufactured cannabis product production and storage shall be
conducted under such conditions and controls as are necessary to minimize the
potential for the growth of microorganisms, allergen cross-contact,
contamination, and deterioration.
(3) Components that can support the rapid
growth of undesirable microorganisms shall be stored at temperatures that will
prevent the component from becoming contaminated during production and
storage.
(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 shall be adequate
under the conditions of production, storage, and distribution to prevent
cannabis, manufactured cannabis products, or components from being
contaminated.
(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 cannabis and manufactured cannabis products
from allergen cross-contact 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 cannabis or manufactured cannabis products. Cannabis,
manufactured cannabis 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 or store cannabis, components,
work-in-process, rework, or other manufactured cannabis products shall be
constructed, handled, and maintained during production and storage 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 cannabis or manufactured cannabis products.
(9) Cannabis, manufactured cannabis products,
and components that are contaminated:
(A)
Shall be disposed of in a manner that protects against the contamination of
other cannabis, manufactured cannabis products, and components; or
(B) If the contaminated cannabis,
manufactured cannabis product, or component is allowed to be reprocessed under
section 11-850-135 (h)
(1), it may be:
(i) Reprocessed using a method that has been
proven to be effective; or
(ii)
Reprocessed and reexamined and subsequently found not to be contaminated before
being incorporated into other manufactured cannabis
products.
(10)
All operations in the production and storage of cannabis, manufactured cannabis
products, and components shall be performed so as to protect cannabis,
manufactured cannabis products, and components against allergen cross-contact,
contamination, and growth of undesirable microorganisms. Cannabis, manufactured
cannabis 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 manufactured cannabis products or components capable of
supporting microbial growth, shall be effected by heating the manufactured
cannabis 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) Cannabis and
manufactured cannabis 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) Manufactured cannabis
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
cannabis, manufactured cannabis products, or components, it shall be made from
water that is safe and of adequate sanitary quality in accordance with section
11-850-114 (1)
and manufactured in accordance with current good manufacturing
practice.
Notes
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