18 Alaska Admin. Code § 32.070

Current through October 17, 2024
Section 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.

18 AAC 32.070

Eff. 3/26/2023, Register 245, April 2023

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