DAR File No. 39779

Agriculture and Food, Regulatory Services

Rule R70-330

Raw Milk for Retail

Notice of Proposed Rule

(Amendment)

DAR File No.: 39779
Filed: 09/29/2015 02:41:14 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The rule governs the sale of raw milk in the state. The changes are for clarification and to comply with changes made to the Utah Dairy Act, H.B. 104 (2015 General Session).

Summary of the rule or change:

The rule previously prohibited cow-sharing, the law has since been changed to allow for such practices and the rule is being changed to reflect those changes. In addition, there are some formatting changes that were made to make the rule easier to read and understand. Some terms were more clearly defined and processes were clarified.

State statutory or constitutional authorization for this rule:

• Title 4, Chapter 5
• Section 4-3-2
• Subsection 4-2-2(i)

Anticipated cost or savings to:

the state budget:

There are no cost or savings associated with the rule changes. Cow-sharing was previously not allowed by state law, and the department has no regulatory authority over the practice. The other changes made to the rule do not add additional requirements they only add clarity to what has previously been expected.

local governments:

There are no requirements made on local government in the changes to the rule.

small businesses:

The changes add no new requirements on those businesses affected by the rule. There will be neither a cost nor a savings to those affected by the rule.

persons other than small businesses, businesses, or local governmental entities:

The changes to the rule are to align the rule with state code and to clarify already existing practices. There are no requirements added or taken away in the proposed changes.

Compliance costs for affected persons:

The change to this rule does not require additional measures from those affected. It does clarify processes and definitions. It will have no fiscal impact on businesses nor individuals.

Comments by the department head on the fiscal impact the rule may have on businesses:

The changes to this rule do not require additional measures from those affected. It does clarify processes and definitions. The changes will have no fiscal impact on businesses nor individuals.

LuAnn Adams, Commissioner

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Agriculture and Food
Regulatory Services
350 N REDWOOD RD
SALT LAKE CITY, UT 84116-3034

Direct questions regarding this rule to:

• Kathleen Mathews at the above address, by phone at 801-538-7103, by FAX at 801-538-7126, or by Internet E-mail at kmathews@utah.gov
• Travis Waller at the above address, by phone at 801-538-7150, by FAX at 801-538-7124, or by Internet E-mail at twaller@utah.gov
• Scott Ericson at the above address, by phone at 801-538-7102, by FAX at 801-538-7126, or by Internet E-mail at sericson@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

11/16/2015

This rule may become effective on:

11/23/2015

Authorized by:

LuAnn Adams, Commissioner

R70. Agriculture and Food, Regulatory Services.

R70-330. Raw Milk for Retail.

R70-330-1. Authority.

[A.]1) Promulgated under the authority of Section 4-3-2.

[B.]2) [Scope: ]This rule establishes the requirements for the manufacture, production, distribution, holding, delivery, storage, offering for sale and sale of raw milk for retail.

[C. History: The Utah Department of Agriculture and Food, with the concurrence of the U.S. Food and Drug Administration (FDA) strongly advises against the consumption of raw milk. There are numerous documented outbreaks of milkborne disease involving Salmonella and Campylobacter infections directly linked to the consumption of un-pasteurized milk. Cases of raw milk associated campylobacteriosis have been reported in the states of Arizona, California, Colorado, Georgia, Kansas, Maine, Montana, New Mexico, Oregon, Pennsylvania, and Utah. An outbreak of salmonellosis, involving 50 cases was confirmed in Ohio in 2002. Recent cases of Escherichia coli (E. coli) 0157:H7, Listeria monocytogenes, and Yersinia enterocolitica infections have also been attributed to raw milk consumption.

]

R70-330-2. Definitions.

[A.]1) "Raw milk" means milk [as defined by law ]that has not been pasteurized, or heat treated. The word milk shall be interpreted to include the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one or more healthy hoofed mammals.

[B.]2) "Properly staffed" means a person or persons on premise available to sell milk, exchange money, and lock and secure the retail store.

[C.]3) "Department" means the Utah Department of Agriculture and Food.

 

R70-330-3. Permits.

A permit shall be required to manufacture, distribute, sell, deliver, hold, store or offer for sale raw milk. Such permit shall be suspended when these rules or applicable sections of the Utah Dairy Act, Utah Code Annotated (UCA), Vol. 1, Title 4, Chapter 3, are violated.[Cow-share programs, as defined in the Utah Dairy Act, shall not be allowed, either in conjunction with a permitted raw for pasteurization dairy, a permitted raw milk for retail dairy, or in lieu of a permit to sell raw milk for retail.]

 

R70-330-4. Building and Premises Requirements.

1) The building and premises requirements at the time of the issuance of a new permit shall be the same as the current Grade A building guidelines.

2) In addition[to these guidelines], there shall be separate rooms provided for :

[(1)]a) packaging and sealing of raw milk[,];

[(2)]b) the washing of returned multi-use containers ;[when applicable,] and

[(3)]c) a sales room for the sale of raw milk in a properly protected area that is not located in any of the milk handling rooms[.]

i) [T]these rooms shall meet or exceed the construction standards of a Grade A milkhouse.[If the Raw for Retail dairy also raises chickens ,or other poultry, for meat and/or eggs, their housing and movement shall be restricted to areas that do not include the milkhouse, milk barn and their immediate surroundings, the corrals and alleys where there is normally cows or goats, and other locations where there is normal cow or goat traffic. They shall also be restricted from areas normally considered traffic areas of the raw milk customers.]

3) Animals which are not used for the production of milk shall be restricted from the:

a) milkhouse;

b) milk barn;

c) areas immediately surrounding the milkhouse and milk barns;

d) areas where cow or goat normal traffic; and

e) areas where milk customers are located.

 

R70-330-5. Sanitation and Operating Requirements.

[A.]1) Sanitation and operating requirements of all raw milk facilities shall be the same as that required on a Grade A dairy farm producing milk for pasteurization. Milk packaging areas and container washing areas at the raw milk facilities shall meet the requirements for Grade A pasteurized milk processing plants.

2) Milk not handled in a manner required by this rule shall be deemed adulterated and shall not be sold.

[B.]3) All milk shall be cooled to 50 degrees F. or less within one hour of the commencement of milking and to 41 degrees F. or less within two hours after the completion of milking.

[C.]a) The blend temperature after the first milking and subsequent milkings shall not exceed 50 degrees.[Milk not handled in the manner required in this subsection and subsection "B" above shall be deemed adulterated and shall not be sold.]

[1.]4) All raw for retail farm bulk milk tanks put into use on or after August 7, 2007 shall be equipped with an approved temperature-recording device, in addition to the indicating thermometer. Daily temperature logs shall be maintained for bulk milk tanks in use prior to August 7, 2007.

[2.]5) The recording [device]thermometer shall be:

a) in compliance with the current technical specification in the Pasteurized Milk Ordinance;

b) operated continuously;

c) [and be ]maintained in a properly functioning manner;[. Circular recording charts shall not overlap.]

d) installed near the milk storage tank; and

e) accessible to the department

[3. The recording device shall be verified as accurate every six (6) months and documented in a manner acceptable to the department.

] [4.]5) Recording thermometer charts shall[be]:

a) properly identify the producer, date, and signature of the person removing the chart; and

b) be maintained on the premises for a minimum of six (6) months and available to the department

i) circular recording charts shall not overlap.

[5. The recording thermometer shall be installed near the milk storage tank and accessible to the department.

6. The recording thermometer shall comply with the current technical specifications in the Pasteurized Milk Ordinance for tank recording thermometers.

7. The recording thermometer charts shall properly identify the producer, date, and signature of the person removing the chart.

] [D.]6) The temperature of the milk at the time of bottling shall not exceed 41 degrees F.

[E.]7) The sale and delivery of raw milk shall be made on the premise where the milk is produced and packaged, or at a self-owned, properly staffed, retail store.

a) Sanitation and construction requirements of the facilities used as self-owned, retail stores shall be the same as those contained in the Wholesome Food Act, Title 4, Chapter 5.

b) Transportation shall be done by the producer with no intervening storage, change of ownership, or loss of physical control.

i) The temperature of the milk shall be maintained at 41 degrees F or below. Each display case shall have a properly calibrated thermometer, and a daily temperature log shall be maintained and made accessible to the Department.

[F.]8) Raw milk brick cheese, when held at no less than 35 degrees F. for 60 days or longer, may be sold at retail stores or for wholesale distribution, at locations other than the premise where the milk was produced.

[G.]9) Except as provided [in part (F) ]above, all products made from raw milk [including, but not limited to, cottage cheese, buttermilk, sour cream, yogurt, heavy whipping cream, half and half, butter, and ice cream ]shall not be allowed for sale in Utah.

[H.]10) Milk that has been heat treated, shall not be labeled as "Raw Milk" for retail sale.

[I.]11) Inspections of the self-owned retail store shall be performed no less than four times per year to insure compliance with the sanitation, construction, and cooling requirements as set forth in the Wholesome Food Act, Title 4, Chapter 5.

 

R70-330-6. Bacteriological Standards.

[A.]1) The bacterial standards for [unpackaged ]raw milk[, packaged raw milk sold on premise and packaged raw milk sold at a self-owned retail store] shall be a bacterial count of no more than 20,000 per ml. and a coliform count of no more than 10 per ml.

[B.]2) The department shall suspend a permit issued under Section 4-3-8 if two out of four consecutive samples or two samples in a 30-day period violate the sample limits established in [R70-330-6(A)]this rule.

 

R70-330-7. [Testing]Raw Milk for Retail Testing.

[A. Raw Milk for Retail Testing.

] [1.]1) Unpackaged Raw Milk

[a.]a) The Department shall:

i) collect a representative sample of milk from each Raw for Retail farm bulk tank once each month[. All samples shall be delivered];

ii) deliver all samples to the State Dairy Testing Laboratory[.]; and

iii) administer [T]tests [shall include]including those prescribed for Raw Milk for Pasteurization as found in the Pasteurized Milk Ordinance[, and in addition shall include added water, and/or other adulterants].

[b.]b) The Somatic Cell Count (SCC) in unpackaged raw milk for retail shall not exceed 400,000 cells per milliliter (ml) for cows, and not to exceed 1,500,000 cells per ml for goats.

c) When[ever] three out of five samples fail to meet this standard in a 5-month period, the Department shall suspend the raw for retail permit. The suspension shall remain effective until a sample result meets the standard. A temporary permit shall be issued at that time. The permit shall be fully reinstated when three of five samples meet the standard in a five-month period.

[2.]2) Packaged Raw Milk sold on Premise

[a.]a) [It shall be the responsibility of the Department to]The department shall:

i) collect a representative sample of packaged raw milk once each month[.];[All samples shall be delivered]

ii) deliver samples to the State Dairy Testing Laboratory[. Tests shall include]; and

iii) administer tests including those prescribed for Grade "A" Pasteurized milk as found in the Pasteurized Milk Ordinance.

[3.]3) Packaged Raw Milk sold at Self-Owned Retail Stores

[a.]a) [It shall be the responsibility of the]The producer shall:[to]

i) have a sampler certified by the Department [to ]collect a sample from each batch of milk;

ii) [and ]submit [it]the sample to the State Dairy Laboratory or a certified independent laboratory to be tested for Antibiotic Drug Residue, Standard Plate Count (SPC) and Coliform Count[. All]; and

iii) withhold all milk from the sampled batch [shall be withheld ]from sale until the results of the tests are known.

b) When[ever] a sample result exceeds the standard in any of the prescribed categories[,] the producer shall:

[(i)]i) [the producer shall ]not allow the milk to enter into commerce ;

ii) recall all milk from the failed batch already in commerce; and

iii) [shall ]dispose of the milk in a manner agreeable to the Department.[The producer may sell raw milk from batches that were produced earlier and whose testing results met the standards.

b. The producer shall recall all milk from the failed batch that is already in commerce.]

[c.]c) The producer shall keep[A database shall be kept and made] and make available [for review by]to both the [Utah Department of Agriculture and Food]department and the Utah Department of Health a database of all customers, which shall include :

i) names,

ii) addresses,[and]

iii) telephone numbers of customers,

iv) dates of purchases , and

v) amounts of milk purchased.

[d.]d) If another agency's epidemiological investigation finds probable cause to implicate a raw for retail dairy in a milkborne illness outbreak, the Raw for Retail Permit may be suspended by the Department until such time as milk samples are pathogen free when analyzed by the Department or other Department approved testing laboratories, and until an inspection can be performed at the facility by a Compliance Officer from the Department.

[B. Animal Health Tests.

]

R70-330-8. Animal Health.

[1. General herd health examination.

] [a.]1) [Whenever the USDA/APHIS has determined Utah is "Certified Free" of a zoonotic disease relative to an animal species which is milked for human or animal consumption, no testing for that disease in that species shall be required.]No testing for disease shall be required when the USDA/APHIS has determined Utah is "Certified Free" of a zoonotic disease relative to an animal species which is milked for human or animal consumption.

[b.]2) Testing shall be required[Whenever] when USDA/APHIS has determined that Utah is not "Certified Free" of a zoonotic disease .[relative to an animal species which is milked for human or animal consumption, testing shall be conducted, as follows:]

a) Tests shall be conducted in the following manner:

[(i). Prior]i) each animal shall be examined by a veterinarian prior to inclusion in a raw milk supply,

ii) [and each six months thereafter, all animals shall be examined by a veterinarian.]examination by veterinarians shall be conducted every six months;

iii) [Each]each animal in the herd must be positively identified as an individual[. This]

iv) the examination shall include an examination of the milk by a method recommended by the Pasteurized Milk Ordinance, and

vi) the test shall include a statement of the udder health of each animal, and a general systemic health evaluation.

[(ii).]b) [Tuberculosis testing.]Tuberculosis tests shall be conducted in the following manner:

i) [Prior to inclusion in a raw milk supply,]each animal shall have been tested for tuberculosis within 60 days prior to the beginning of milk production ;

ii) [and]each animal shall be retested for tuberculosis once each year [thereafter.]; and

iii) [All positively]all positive reacting animals shall be sent to slaughter in accordance with R58-10 and R58-11.

[(iii).]c) [Brucellosis testing. ]Each bovine animal from which raw milk for retail is produced shall be positively identified as a properly vaccinated animal or shall be negative to the official blood test for brucellosis within 30 days prior to the beginning of each lactation.

i) All positively reacting animals shall be sent to slaughter in accordance with R58-10 and R58-11.

ii) Goats and sheep shall be tested once each year for brucellosis with the official blood test and all positively reacting animals shall be sent to slaughter in accordance with R58-10 and R58-11.

[(iv).]3) [Bulk tank milk testing. ]All [bovine raw milk for retail shall be ]bulk tank shall be tested at least four times yearly with the brucella milk ring test.

a) If such brucella ring test is positive for brucellosis, [then ]each animal in the herd shall be tested with the official blood test and any reactors found shall be immediately sent to slaughter in accordance with R58-10 and R58-11.

[(v).]4) This section shall not apply whenever the Utah State Veterinarian has determined that an animal species in Utah which is milked for human or animal consumption is not at risk for a specific zoonotic disease.

[C. Personnel Health.

]

R70-330-9. Personnel Health.

1) Each employee of the dairy [working]involved in the milk handling operation shall obtain a valid medical examination health card signed by a physician and approved by the department once each year and shall hold a valid food handler's permit.

2) No person shall work in a milk handling operation if infected from any contagious illness or if they have on their hands or arms any exposed infected cut or lesion.

3) [If there is any question in this regard, the]The department may ask for an additional certification from a physician that [this]a person is free from disease which may be transmitted by milk.

 

R70-330-[8]10 . Packaging and Labeling.

[A. Label Requirements.

] 1) The label shall meet the requirements outline in the Utah Dairy Act.

2) [The consumer containers]In addition:

a) Containers for raw milk for retail shall be furnished by the permittee and shall be labeled with the following[information]:

[1.]i) marked as "Raw Milk"[The common or usual name of the product] without grade designation[. The common name for raw milk is "Raw Milk".];

ii) [If]if it is other than cow's milk, the word "milk" shall be preceded with the name of the animal, i.e., "Raw Goat Milk"[.];

[2.]iii) [The]the name, address, and zip code of the place of production and packaging[.];

[3.]iv) [Proper indication of the ]volume of the product[either on the container itself or on the label.];

[4. Nutritional labeling information when applicable.

] [5.]v) The phrase: "Raw milk, no matter how carefully produced, may be unsafe ",[.", shall appear on the label in a conspicuous place. The]the height of the smallest letter shall be no less than one eighth inch[.]; and

[6.]vi) The phrase: "Keep Refrigerated",[shall also appear on the label with] the height of the smallest letter no less than one eighth inch[.]; and

[7. The shelf life labeling of bottled raw milk shall include a pull date, expiration date, or best-if-used-by date, and shall be displayed and clearly visible on raw milk. Raw milk shall not be sold after the pull date, expiration date, or best-if-used-by date has expired, and the date shall not be more than nine days after packaging.

] [8.]vii) [Other provisions of labeling laws in effect in Utah relative to dairy/food products also apply. On the primary panel ]the words "raw" and "milk" shall be the same size lettering.

[B.]3) Products not labeled as required shall be deemed misbranded.

 

R70-330-9. Limitations on Raw Milk Distribution.

[A.]1) Raw milk distribution to the public for human consumption is limited to the following circumstances:

[1.]a) A [raw milk ]producer may sell raw milk [to the public ]on the producer's farm [if]after the producer obtains a raw for retail permit from the department, and

[2.]b) A [raw milk ]producer may sell raw milk [to the public ]at the producer's self-owned off-premise retail store [if ]after the producer obtains a raw for retail permit from the department.

[3. A raw milk producer may distribute raw milk to members of the producer's immediate family on the producer's farm.

] [B.]2) Other methods or circumstances whereby raw milk is distributed to the public for human consumption, including the giving away of samples, are prohibited.

 

KEY: dairy inspections, raw milk

Date of Enactment or Last Substantive Amendment: [November 13, 2013]2015

Notice of Continuation: March 16, 2011

Authorizing, and Implemented or Interpreted Law: 4-3-2