18 AAC 32.070 - Raw milk and raw milk product production and sales
(a) A producer must register with the
department prior to conducting activity under this section or producing new raw
milk or raw milk product since the prior registration or renewal. To register,
a producer must
(1) submit a form provided by
the department;
(2) identify the
producer's intended sales method as direct-to-consumer, market, or both
methods;
(3) confirm that the
producer has read and understands this section;
(4) provide an example of the label that
meets the requirements of (e)(4) of this section that will be used for each
type of raw milk or raw milk product container intended to be sold;
and
(5) obtain a registration
number from the department.
(b) A producer of sheep, goat, or cow raw
milk or raw milk product intended for human consumption may sell the raw milk
or raw milk product direct-to-consumer or through markets under this section if
(1) the producer owns the sheep, goat, or cow
that produced the raw milk to be sold or processed into raw milk
product;
(2) the producer has
engaged the services of a licensed veterinarian who provides veterinary
services to the raw milk producing animal, including routine physical
examinations and medical prescriptions or treatments, as directed by the
licensed veterinarian;
(3) the
producer has knowledge about each raw milk producing animal, animal care
requirements under
18 AAC 36.500, husbandry, the
health of each raw milk producing animal, and of facilities at which raw milk
and raw milk product is produced or stored;
(4) raw milk and raw milk product sold under
this section are not distributed interstate;
(5) raw milk or raw milk product that is sold
at a location other than the premises at which the raw milk or raw milk product
was produced is transported in containers that meet the requirements set out
under (e) of this section and maintained at a temperature below 40°
Fahrenheit until accepted by a consumer or market;
(6) the producer, when selling raw milk or
raw milk product direct-to-consumer, displays to consumers, on a placard or
sign that is posted conspicuously at the point of sale, the statement "THIS
PRODUCT IS NOT SUBJECT TO ROUTINE STATE INSPECTION" and
(7) raw milk and raw milk product is not
sold, donated, or served in a food processing establishment or food service; in
this paragraph, "food processing establishment" and "food service" have the
meanings given in
18 AAC 31.990.
(c) The producer of sheep, goat,
or cow raw milk or raw milk product shall provide the information described
under (b)(3) of this section upon a request made by the department and may
provide the information described under (b)(3) of this section upon a request
made by a consumer or a market.
(d)
A producer who obtains a registration number from the department under (a)(5)
of this section must re-register annually, not later than January 15.
(e) The producer shall provide containers for
raw milk and raw milk product that
(1) are
filled in a sanitary manner on premises;
(2) are made of food-grade material, which
includes
(A) glass that is cleaned and
sanitized on the premises; or
(B)
single-use plastic;
(3)
if requiring a lid, the lid
(A) must be
designed to be used with the container and be made of foodgrade
material;
(B) must be clean and
affixed in a sanitary manner;
(C)
must be tamper resistant; and
(D)
may not be reused;
(4)
are clearly labeled with labels that do not contain marks or words that are
misleading as to the contents of the container and that include
(A) the words "RAW MILK" or "RAW MILK
PRODUCT" in letters at least one-quarter inch tall;
(B) the statement "ATTENTION: This product
has not been pasteurized and, therefore, may contain harmful bacteria that can
cause serious illness. Infants, children, the elderly, women who are pregnant,
and persons with weakened immune systems are at highest risk, KEEP REFRIGERATED
TO 40°F OR BELOW the word "ATTENTION" must be in letters at least
one-quarter inch tall and the remainder of the statement must be
legible;
(C) the net volume of the
contents of the container;
(D) if
raw milk, the milk production date and the statement "CONSUME WITHIN FOUR DAYS
OF PRODUCTION DATE" or, if raw milk product, the product production date and a
consume-by date that is appropriate to the specific product as determined by
the producer according to industry standards, and the statement "CONSUME-BY
DATE IS DETERMINED BY THE PRODUCER";
(E) the producer's registration number
assigned by the department under this section;
(F) the name and physical address of the
premises where the product was produced;
(G) whether the raw milk or raw milk product
is produced from cow, goat, or sheep;
(H) if a raw milk product, each ingredient,
listed in descending order of predominance; and
(I) the words "ALLERGEN WARNING: Milk" and
any other allergen identified in the federal requirements adopted by reference
under 18 AAC
31.011(a).
(f) The producer shall ensure that
(1) raw milk is cooled to 40° Fahrenheit
not later than two hours after the start of milking;
(2) the temperature of the raw milk is
maintained at 40° Fahrenheit or lower once it is cooled as set out under
(1) of this subsection or until used in processing raw milk product;
(3) the temperature of raw milk product is
maintained appropriately according to the product type during production and
maintained at a temperature of 40° Fahrenheit or lower after
production;
(4) the refrigeration
unit where raw milk and raw milk product is stored is capable of maintaining an
internal temperature of 40° Fahrenheit, is equipped with a working and
calibrated thermometer, and the interior temperature of the refrigeration unit
is kept at 40° Fahrenheit or lower; a producer must check and document the
temperature of a refrigeration unit where raw milk and raw milk product is
stored at least daily, as set out under (o)(4) of this section;
(5) equipment used for milking is cleaned in
accordance with the equipment manufacturer's recommendation and equipment is
used according to its intended purpose;
(6) packaging and lids are stored in a manner
that prevents damage and contamination;
(7) each consumer that purchases the
producer's raw milk or raw milk product is offered, at the point of sale, the
opportunity to voluntarily provide contact information so that the producer may
notify the consumer in the event of a suspected or confirmed foodbome illness
or product recall that affects or might affect the raw milk or raw milk product
purchased by the consumer; and
(8)
the premises where raw milk or raw milk product being produced includes
(A) at least one toilet room, that is
maintained, kept clean, and has toilet paper provided;
(B) a handwashing sink located within or
adjacent to the exit of a toilet room that is kept clean and equipped with
(i) hot and cold running water;
(ii) hand soap; and
(iii) disposable single-use towels or a
hot-air drying device; and
(C) a wastewater system that disposes of
wastewater in an approved manner under 18 AAC 72. (g) Raw milk and raw milk
product may not contain any drug residue. The producer shall follow
veterinarian prescriptions and withdrawal times for any drug or chemical
compound that is administered to a raw milk producing animal.
(h) A producer may not
sell raw milk to a consumer or market later than four days after the production
date of the raw milk.
(i) A
producer may not sell raw milk product to a consumer or market later than the
consume by date appropriate to the specific product as determined by the
producer.
(j) A producer may not
sell or distribute raw milk or raw milk product that is adulterated, as set out
under AS
17.20.020, to a consumer or market.
(k) The producer shall conduct routine
screening of raw milk producing animals for mastitis and disease, as
recommended by the veterinarian providing veterinary services to the raw milk
and raw milk product-producing animal or animals.
(l) A producer may not sell or distribute raw
milk or raw milk product from an animal showing signs of mastitis or
disease.
(m) The department or a
producer may test raw milk and raw milk product. If any testing of raw milk or
raw milk product is conducted, the producer
(1) shall immediately report results showing
antibiotic residue or pathogens that may contaminate the raw milk producing
animal, or that may negatively impact the quality of the raw milk or raw milk
product to be sold under this section to the department;
(2) shall destroy raw milk or raw milk
product in a manner recommended by the department or repurpose the raw milk or
raw milk product for a use other than human consumption after consultation with
the department; if the raw milk or raw milk product test results show bacteria
or adulteration that may negatively impact the quality of the raw milk or raw
milk product, the producer shall record and maintain this information as set
out under (o)(3) of this section.
(n) A producer may not sell raw milk or raw
milk product that
(1) contains aerobic
bacteria exceeding 20,000 per milliliter (20,000/ml);
(2) has somatic cell counts exceeding
(A) 500,000/ml for cow or sheep; or
(B) 1,000,000/ml for goat; or
(3) contains any of the following
pathogenic bacteria:
(A)
Listeria
monocytogenes,
(B)
Salmonella spp.;
(C)
Campylobacter spp.;
or
(D) Shiga toxin producing
Escherichia coli (STEC), including E coli
O157:H7.
(o) Except as set out under (5) of this
subsection, a producer shall maintain records at the production premises for
not less than two years; the producer shall provide the records upon a request
made by the department and may provide the records upon a request made by a
consumer or market. The records under this subsection must include:
(1) routine and non-routine physical
examinations of raw milk producing animals, including examinations for
mastitis, disease, and other care, as administered by a licensed veterinarian;
records for routine and non-routine physical examinations must include the
reason for the examination, the outcome, and any medication prescribed to the
animal examined;
(2) raw milk and
raw milk product quality tests as conducted under (m) of this
section;
(3) test results for
bacterial counts or adulteration in raw milk and raw milk product as described
under (m) of this section, and what was done with the raw milk or raw milk
product;
(4) the hourly temperature
of raw milk and raw milk product during processing and storage, as required
under (f)(1) - (3) of this section, and the daily temperature of the
refrigeration unit required under (f)(4) of this section; (5) the consumer
contact list of persons that purchased raw milk or raw milk product and
voluntarily provided contact information, as described under (f)(7) of this
section, which includes the date the raw milk or raw milk product was
purchased; the producer must maintain the consumer contact list at the
production premises for not less than one month following the date of
purchase.
(p) In
addition to the requirements set out under (a) - (o) of this section, a
producer selling raw milk or raw milk product through a market must
(1) collect a four-to-six-ounce sample from
every milking, labeled with the date collected, and kept refrigerated at
40° Fahrenheit or lower for 14 days to allow for traceback in the event of
a public complaint, foodbome illness, or animal disease outbreak;
(2) ensure that the premises includes
(A) a facility for animal housing that is
separated from other facilities on the premises by floor-to-ceiling walls and
has overhead protection;
(B) a
facility for milking that
(i) is separated
from the rest of the premises by floor-to-ceiling walls, has overhead
protection, is constructed of material that is cleanable, and is kept clean and
in good repair;
(ii) has a
handwashing sink equipped with hot and cold running water, hand soap, and
disposable single-use towels or a hot-air drying device;
(iii) has a second sink that is used
exclusively for washing, rinsing, and sanitizing equipment, utensils, and other
items that contact raw milk during the milking process and is equipped with hot
and cold running water; and (iv) uses potable water or water from an approved
public water system;
(C)
a facility for raw milk and raw milk product processing where all bottling,
packaging, and other processing is required to take place; and
(i) is separated from the rest of the
premises by floor-to-ceiling walls, is fully enclosed, has solid doors and
windows, and has overhead protection;
(ii) has walls, overhead protection, and
floors that are made of materials that are cleanable and are kept clean and in
good repair;
(iii) has a
handwashing sink equipped with hot and cold running water, hand soap, and
disposable single-use towels or a hot-air drying device;
(iv) has a second sink that is used
exclusively for washing, rinsing, and sanitizing equipment, utensils and other
items that contact raw milk or raw milk products during bottling, packaging,
and processing;
(v) has
food-contact surfaces that are constructed of materials that do not allow the
migration of deleterious substances or impart colors, odors, or tastes to raw
milk or raw milk products;
(vi) has
a utility sink or other approved fixture used exclusively for cleaning the
processing facility; and
(vii) uses
potable water or water from an approved public water system;
(3) minimize bare hand
contact with raw milk or raw milk product, utilizing disposable gloves if
appropriate;
(4) take reasonable
precautions to ensure that each employee with an infected wound or a disease
communicable by food is not working at the premises in any capacity that might
contaminate raw milk or raw milk product or raw milk or raw milk product
contact surfaces; and
(5) ensure
utensils, equipment, and other product contact surfaces are washed, rinsed, and
sanitized in accordance with
18 AAC 31.422 -
18 AAC 31.424.
(q) A market selling raw milk or
raw milk product under this section must
(1)
register with the department by
(A)
completing a form provided by the department;
(B) confirming to have read and understand
this section; and
(C) obtaining
from the department a registration number, which is required to sell raw milk
or raw milk product under this section;
(2) re-register annually not later than
January 15; (3) ensure raw milk or raw milk product is obtained through a
producer holding a current registration from the department as set out under
(a)(5) of this section;
(4) ensure
the raw milk or raw milk product is appropriately labelled, as described in
(e)(4) of this section;
(5) display
to consumers, on a placard or sign that is conspicuously posted where raw milk
or raw milk product is exhibited for sale, the statement "THIS PRODUCT IS NOT
SUBJECT TO ROUTINE STATE INSPECTION";
(6) ensure that the temperature of raw milk
or raw milk product is received and held at 40° Fahrenheit, as described
under (f)(2) - (4) of this section;
(7) provide, at the point of sale, an
opportunity for consumers to provide contact information for recall purposes,
as described under (f)(7) of this section; the market must maintain the
consumer contact list for not less than one month following the date of
purchase; and
(8) ensure raw milk
or raw milk product is separated from pasteurized products.
(r) If a consumer complaint is
reported to the department, or a foodbome illness or animal disease outbreak is
suspected, the department may conduct inspections or audits at the premises at
which raw milk or raw milk product is produced, with or without prior notice,
to assess compliance with this section, including
(1) inspecting the premises;
(2) examining and making copies of labels and
records;
(3) observing
procedures;
(4) obtaining
samples;
(5) collecting samples and
conducting tests;
(6) interviewing
employees; and
(7) taking
photographs.
(s) In
addition to complying with
AS
17.20.230, if the department finds, or has
cause to believe, that raw milk or raw milk product is adulterated under
AS
17.20.020, misbranded under
AS
17.20.040, or in violation of this section,
the department may
(1) require that a
producer detain the raw milk or raw milk product under
AS
17.20.230; detention under is subject to the
following procedures:
(A) the department will
(i) issue a notice of detention and inform
the producer of the conditions to be met for the detention to be terminated;
and
(ii) affix, or instruct the
producer to affix, to the raw milk or raw milk product container a tag reading
"DETAINED", or other appropriate marking that gives notice that the raw milk or
raw milk product has been detained;
(B) if, after issuing a notice of detention,
the department finds that the raw milk or raw milk product is not adulterated,
misbranded, or in violation of this section, the department will terminate the
detention and notify the producer;
(C) a producer may not take an action with
respect to raw milk or raw milk product detained under this subsection without
department approval;
(2)
upon a finding that the raw milk or raw milk product is adulterated under
AS
17.20.020, misbranded under
AS
17.20.040, or in violation of this section,
notify the producer of the necessary corrective action; corrective action may
include requiring the producer to destroy or reuse the raw milk or raw milk
product, as directed by the department;
(3) require a producer to destroy the raw
milk or raw milk product if it violates standards set out in (n) of this
section or if it was handled under the same conditions as other products found
to violate those standards;
(4) in
addition to requiring detention or destruction of the raw milk or raw milk
product under this subsection, take any other actions authorized under AS 03.05
and AS 17.20, including revoking the producer' registration under (a)(5) of
this section, ordering product recall, and issuing an order to stop sale;
and
(5) at the time of the finding
or cause for belief, or any time thereafter, require that the producer provide
timely notification of the department's action to all affected and potentially
affected markets and consumers who voluntarily provided contact information on
the consumer contact lists required under (o)(5) and (q)(7) of this
section.
(t) A person
subject to this section may seek an informal review under
18 AAC 15.185 of a final decision
by the department or an adjudicatory hearing under AS 44.62 (Administrative
Procedure Act); an adjudicatory hearing may be requested by submitting a
request to the commissioner not later than 30 days after the notice of the
department's final decision; upon receipt of a timely request for adjudicatory
hearing, the commissioner may refer the matter to the office of administrative
hearings (AS 44.64.010) for a hearing and
recommended decision under 2 AAC 64 to the commissioner or the commissioner's
designee if the designee is a person other than the person who issued the
contested decision.
(u) Nothing in
this section relieves a producer from complying with other statutes and
regulations as applicable to non-raw milk or non-raw milk product.
(v) In this section,
(1) "consumer" means someone who purchases
raw milk or raw milk product from a producer or market;
(2) "destroy" or "destruction" means disposal
in a manner that precludes human or animal consumption;
(3) "market" includes a food establishment
where food commodities are offered for retail sale to consumers and intended
for off-premises consumption that has a current permit issued under 18 AAC 31
and is registered by the department to sell raw milk and raw milk product;
"market" includes the following:
(A)
convenience stores;
(B) grocery
stores; and
(C) the grocery
portions of supermarkets;
(4) "premises" means the contiguous land or
property under the control of the producer, including facilities and their
contents, structures and interior surfaces, accessories and attachments,
vehicles, food-contact surfaces, food, supplies, water supply, wastewaster
system, and plumbing;
(5)
"producer: means a person who owns a milk-producing animal, and produces and
sells raw milk or raw milk product derived from the milk of the milk-producing
animal;
(6) "raw milk" and "raw
milk product" means raw milk, or a dairy product made from raw milk, that has
not been pasteurized and is not regulated as Grade "A" milk under
18 AAC 32.020; raw milk products
are limited to yogurt, kefir, cheese, ice cream, cream, and butter.
Notes
Authority:AS 03.05.020
AS 03.05.011
AS 03.05.030
AS 03.05.040
AS 03.05.050
AS 03.05.090
AS 17.20.005
AS 17.20.040
AS 17.20.050
AS 17.20.040
AS 17.20.050
AS 17.20.070
AS 17.20.072
AS 17.20.180
AS 17.20.190
AS 17.20.230
AS 17.20.240
AS 17.20.250
AS 17.20.260
AS 17.20.270
AS 17.20.280
AS 17.20.300
AS 44.46.020
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