Haw. Code R. § 11-37-65 - Processes and controls
(a) General.
(1) All operations in the manufacturing,
processing, packing, and holding of crude extract, manufactured 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 manufactured 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 crude extract or manufactured 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 crude extract, manufactured hemp
products, or components shall be safe and of adequate sanitary quality. Water
may be reused for washing, rinsing, or conveying crude extract, manufactured
hemp products, or components if it does not cause allergen cross-contact or
increase the level of contamination of the crude extract, manufactured hemp
product, or component.
(2)
Ingredients shall either not contain levels of microorganisms that may render
the crude extract or manufactured 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 crude
extract or manufactured 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 crude extract or
manufactured 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,, crude extract, or manufactured
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 cross-contact 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 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
cross-contact, contamination, and deterioration.
(3) Crude extract, manufactured hemp
products, and components that can support the rapid growth of undesirable
microorganisms shall be held at temperatures that will prevent the crude
extract, manufactured 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 aw that are taken to destroy or prevent the
growth of undesirable microorganisms shall be adequate under the conditions of
processing, manufacture, handling, and distribution to prevent crude extract,
manufactured 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 crude extract or manufactured hemp 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
crude extract or manufactured hemp products. Crude extract, manufactured 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 crude extract, manufactured hemp products,
components, work-in-process, or rework 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 crude extract or manufactured hemp products.
(9) Crude extract, manufactured hemp
products, and components that are adulterated:
(A) Shall be disposed of in a manner that
protects against the contamination of other crude extract, manufactured hemp
products, and components; or
(B) If
an adulterated crude extract, manufactured hemp product, or 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 crude extract or a manufactured hemp product.
(10) All operations in
the manufacturing, processing, packing, and holding of crude extract,
manufactured hemp products, and components shall be performed so as to protect
crude extract, manufactured hemp products, and components against allergen
cross-contact, contamination, and the growth of undesirable microorganisms.
Crude extract, manufactured 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 crude extract, manufactured hemp products, or components capable
of supporting microbial growth, shall be effected by heating the crude extract,
manufactured 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 processing or 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) Crude extract, manufactured 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) Crude extract,
manufactured 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 crude
extract, manufactured 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.
Notes
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