DEPARTMENT OF AGRICULTURE

[Filed February 15, 2019, 3:19 p.m.]

Preproposal statement of inquiry was filed as WSR 18-16-116.

Title of Rule and Other Identifying Information: Chapter 16-101 WAC, Washington state milk and milk products standards.

Hearing Location(s): On March 29, 2019, at 10:00 a.m., at the Washington State Department of Agriculture, Natural Resources Building, Conference Room 259, 1111 Washington Street S.E., Olympia, WA 98504.

Date of Intended Adoption: April 5, 2019.

Submit Written Comments to: Gloriann Robinson, Agency Rules Coordinator, P.O. Box 42560, Olympia, WA 98504-2560, email wsdarulescomments@agr.wa.gov, fax 360-902-2092, by March 29, 2019.

Assistance for Persons with Disabilities: Contact Angela Starr, division coordinator, phone 360-902-1967, fax 360-902-2087, TTY 800-833-6388, email astarr@agr.wa.gov, by March 22, 2019.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The department is proposing to amend chapter 16-101 WAC by:

Adoption of the 2017 revisions enables Washington state to remain uniform with other states so that milk and milk products produced in this state meet the latest standards and will assist in continued acceptance of Washington state milk and milk products shipped into other states. These revisions ultimately protect consumers from contaminated and adulterated milk products.


•	Adopting the 2017 Revision of the "Grade "A" Pasteurized Milk Ordinance" (PMO);
•	Adopting the 2017 Revision of the "Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments";
•	Adopting the 2017 Revision of the "Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers";
•	Adopting the 2017 Revision of the "Evaluation of Milk Laboratories";
•	Updating exceptions to PMO that conflict with state law; and
•	Revising the language in WAC 16-101-800 to remove the "question and answer" format and improve readability without changing its meaning.

Reasons Supporting Proposal: RCW 15.36.021 authorizes the department to, by rule, adopt PMO and supplemental documents by reference to establish requirements for Grade A pasteurized and Grade A raw milk. Chapter 16-101 WAC was last revised in 2013 whereby the department adopted the 2011 versions of PMO and other related documents. Since that time, the four national consensus code documents were revised in 2017 to include changes based on the federal Food and Drug Administration's (FDA) preventive controls for human foods regulation that was developed under the federal Food Safety Modernization Act. FDA encourages states to adopt the most recent PMO in order to promote uniformity with other states and ultimately to protect consumers from milk borne diseases.

Adoption of the 2017 revisions will ensure that our department is meeting the latest national standards which in turn will assist with our industry's ability to market and move milk and milk products into interstate commerce. The raw milk labeling revision is strictly reformatting the language into the same standardized rule language format as the other WAC sections.

Statutory Authority for Adoption: RCW 15.36.021.

Statute Being Implemented: Chapter 15.36 RCW.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state department of agriculture, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Lucy Severs, 1111 Washington Street S.E., Olympia, WA 98504, 360-725-5761.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is not required under RCW 34.05.328. The Washington state department of agriculture is not a listed agency under RCW 34.05.328 (5)(a)(i).

This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:

Is exempt under RCW 19.85.025(3) as the rules are adopting or incorporating by reference without material change federal statutes or regulations, Washington state statutes, rules of other Washington state agencies, shoreline master programs other than those programs governing shorelines of statewide significance, or, as referenced by Washington state law, national consensus codes that generally establish industry standards, if the material adopted or incorporated regulates the same subject matter and conduct as the adopting or incorporating rule; and rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect.

Is exempt under RCW 19.85.025(3)/34.05.310 (4)(c) and (d).

Explanation of exemptions: Adoption of national consensus codes, as referenced by state law, without material change is exempt from completing a small business economic impact statement (SBEIS) under RCW 19.85.025(3)/34.05.310 (4)(c). Clarifying language in WAC 16-101-800 without changing its effect is exempt from completing an SBEIS under RCW 19.85.025(3)/34.05.310 (4)(d).

AMENDATORY SECTION(Amending WSR 13-03-046, filed 1/10/13, effective 2/10/13)

WAC 16-101-701Standards for the production of milk and milk products.

(1) With the exception of the portions identified in subsection (2) of this section, the department adopts the Grade "A" Pasteurized Milk Ordinance, ((2011))2017 Revision, United States Public Health Service/Food and Drug Administration, as additional Washington state standards for the production of milk and milk products including Grade A condensed and dry milk products and condensed and dry whey products under chapter 15.36 RCW.

(2) The department does not adopt the following portions of the Grade "A" Pasteurized Milk Ordinance, ((2011))2017 Revision:

(a) Grade "A" Pasteurized Milk Ordinance - ((2011))2017 Revision.

PMO Page No.		Excepted Portion
((Pages 12-13)) Page 16	•	Section 3, Permits, paragraph ((4))6, which begins with "The regulatory agency shall suspend …"
	•	Section 3, Permits, paragraph ((5))7, which begins with "Upon notification …"
((Page 24)) Pages 28-29	•	Section 6, The Examination of Milk and/or Milk Products, paragraph ((5))9, which begins with "Whenever two (2) of the last four (4) consecutive …"
Page ((29))34		Section of Table 1 entitled "GRADE "A" RAW MILK AND MILK PRODUCTS FOR PASTEURIZATION, ULTRA-PASTEURIZATION ((OR)), ASEPTIC PROCESSING AND PACKAGING, OR RETORT PROCESSED AFTER PACKAGING"
	•	(("))Under Temperature: "Cooled to 10°C (50°F) or less within four (4) hours or less of the commencement of the first milking and to 7°C (45°F) or less within two (2) hours after the completion of milking. Provided that the blend temperature after the first milking and subsequent milkings does not exceed 10°C (50°F)."
		Note: Milk sample submitted for testing cooled and maintained at 0°C (32°F) to ((4.4))4.5°C (40°F), where sample temperature is ˃ 4.5°C (40°F) but ((<))≤7.0°C (45°F) and less than three (3) hours after collection has not increased in temperature;
	•	Under Bacterial Limits((,)): Only the sentence … "Individual producer milk not to exceed 100,000 per mL prior to commingling with other producer milk."
Pages 34-35		Under Somatic Cell Count: "individual producer milk not to exceed 750,000 per mL … *Goat milk 1,500,000 mL."

(b) Standards for Grade "A" Raw Milk for Pasteurization, Ultra-pasteurization ((or)), Aseptic Processing and Packaging or Retort Processed After Packaging.

PMO Page No.	Excepted Portion
Page (((52)))59	Item 18r. "Raw Milk Cooling" paragraph 1, which begins with "Raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging or retort processed after packaging shall be cooled …"
Page ((53))59	((Ir.))I. "Administrative Procedures", ((paragraph))item 1 only

(c) Standards for Grade "A" Pasteurized, Ultra-pasteurized ((and)), Aseptically Processed ((Milk)) and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products.

PMO Page No.	Excepted Portion
Page ((111))119	Item 18p. "Bottling, Packaging and Container Filling", under Public Health Reason, first sentence only which begins with "Manual bottling, packaging, and container filling …"
Page ((111))119	Item 18p. "Administrative Procedures", item number 2 only.
Page ((113))121	Item 19p. "Capping, container closure and sealing and Dry Milk Product Storage", Administrative Procedures, item number 1 only.
Page ((126))134	Sections 15 (Enforcement), 16 (Penalty), and 17 (Repeal and Date of Effect)

(d) Appendix E: Examples of 3-out-of-5 Compliance Enforcement Procedures.

PMO Page No.	Excepted Portion
Pages ((202-203))209-210	All of Appendix E

(3) The department does adopt the following somatic cell count standards to be: Individual producer bovine cow milk not to exceed 400,000 per mL; and goat, sheep, and all other species milk not to exceed 1,000,000 per mL.

AMENDATORY SECTION(Amending WSR 13-03-046, filed 1/10/13, effective 2/10/13)

WAC 16-101-716Procedures for certification of interstate milk shippers.

The department adopts the Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments ((2011))2017 Revision as Washington state procedures for the certification of interstate milk shippers.

AMENDATORY SECTION(Amending WSR 13-03-046, filed 1/10/13, effective 2/10/13)

WAC 16-101-721Methods for making sanitation ratings of milk shippers.

The department adopts the Methods of Making Sanitation Ratings of Milk Shippers ((2011))and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers 2017 Revision, United States Health and Human Services Public Health Service/Food and Drug Administration as Washington state methods for ratings of interstate milk shippers.

AMENDATORY SECTION(Amending WSR 13-03-046, filed 1/10/13, effective 2/10/13)

WAC 16-101-726Standard for the accrediting of milk laboratories.

The department adopts the Evaluation of Milk Laboratories ((2011))2017 Revision United States Health and Human Services Public Health Service/Food and Drug Administration as the Washington state standard for accrediting milk laboratories and certified industry supervisors who request certification and approval for uniform collection and testing required for compliance with the Grade "A" Pasteurized Milk Ordinance.

AMENDATORY SECTION(Amending WSR 13-03-046, filed 1/10/13, effective 2/10/13)

WAC 16-101-731Availability of the publications adopted by the department in this chapter.

(1) The Grade "A" Pasteurized Milk Ordinance, ((2011))2017 Revision, United States Public Health Service/Food and Drug Administration, the Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments, ((2011))2017 Revision, the Methods of Making Sanitation Ratings of Milk Shippers, ((2011))and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers 2017 Revision, United States Department of Health and Human Services Public Health Services/Food and Drug Administration, and the Evaluation of Milk Laboratories, ((2011))2017 Revision, United States Department of Health and Human Services Public Health Service/Food and Drug Administration can be obtained at((: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MilkSafety/NationalConferenceonInterstateMilkShipmentsNCIMSModelDocuments/default.htm))https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk/ucm2007966.htm.

(2) For information regarding the contents and application of these publications, contact the Food Safety and Consumer Services Division at the Washington State Department of Agriculture, P.O. Box 42560, Olympia, WA 98504-2560 or FSCS@agr.wa.gov.

AMENDATORY SECTION(Amending WSR 97-19-045, filed 9/11/97, effective 10/12/97)

WAC 16-101-800Raw milk warning labels.

(1) ((What authority does the department have to require warning labels on retail raw milk containers?)) This rule is ((being)) promulgated under authority of RCW 15.36.021(1) and ((69.04.398(3).

(2) To what does this rule apply? The labeling requirements in this rule apply))15.130.120 and applies to containers of raw milk intended for sale to consumers in the state of Washington.

(((3) Why is the Washington state department of agriculture adopting warning label requirements for retail raw milk sales? The department is adopting this rule))(2) The purpose is to inform consumers about possible harm that may occur from consuming raw milk that contains harmful microorganisms((.

(4) What purpose will this rule serve? The purpose of this rule is))and to warn purchasers about known hazards associated with the consumption of raw milk so that they may make informed choices about buying these products.

(((5) What warning label must be on raw milk containers? The))(3) A raw milk container must bear the following labeling: WARNING: This product has not been pasteurized and may contain harmful bacteria. Pregnant women, children, the elderly and persons with lowered resistance to disease have the highest risk of harm from use of this product.

(((6) What are the specific requirements for warning labels on raw milk?))(4) The raw milk warning labels must meet the following requirements:

(a) The warning label type size must be consistent with the type size of other required labeling, but not less than one-sixteenth inch in height.

(b) The warning label must be conspicuous and in contrasting color from other labeling.

(d) The warning label must be clearly readable.