WSR 12-23-050

PROPOSED RULES

DEPARTMENT OF AGRICULTURE


[ Filed November 16, 2012, 1:00 p.m. ]

     Original Notice.

     Preproposal statement of inquiry was filed as WSR 12-18-031.

     Title of Rule and Other Identifying Information: The department is proposing revisions to chapter 16-101 WAC, Washington state milk and milk products standards, by replacing the 2007 pasteurized milk ordinance (PMO), the 2007 procedures document, the 2007 methods for making sanitation ratings document and the 2005 evaluation of milk laboratories document with the most current 2011 version of the documents, including the revision of the somatic cell count of milk to ensure that milk and milk products produced in this state meet the latest national standards and to assist in continued acceptance of Washington state milk and milk products shipped to other states and countries.

     Hearing Location(s): Washington State Department of Agriculture, Natural Resources Building, Room 259, 1111 Washington Street S.E., Olympia, WA 98504-2560, on January 3, 2013, at 10:00 a.m.

     Date of Intended Adoption: January 10, 2013.

     Submit Written Comments to: Julie Carlson, P.O. Box 42560, Olympia, WA 98504-2560, e-mail jcarlson@agr.wa.gov, fax (360) 902-2087, by January 3, 2013, 5:00 p.m.

     Assistance for Persons with Disabilities: Contact Julie Carlson by December 27, 2012, TTY (800) 833-6388.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Revision of chapter 16-101 WAC, Washington state milk and milk products standards includes: Amending WAC 16-101-701 to adopt the 2011 revision of the PMO and update exceptions to the PMO (those portions that conflict with Washington state law) and to establish the somatic cell count for individual producer bovine cow milk not to exceed 400,000 per mL; WAC 16-101-716 to adopt the 2011 procedures document; WAC 16-101-721 to adopt the 2011 methods for making sanitation ratings document; WAC 16-101-726 to adopt the 2011 evaluation of milk laboratories document; and WAC 16-101-731 to update where the PMO and other related documents can be obtained.

     Statutory Authority for Adoption: RCW 15.36.021.

     Statute Being Implemented: Chapters 15.36 and 34.05 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: Claudia Coles, 1111 Washington Street, Olympia, WA 98504-2560, (360) 902-1905.

     A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

     Overview: The division of food safety and consumer services within Washington state department of agriculture (WSDA) is proposing amending chapter 16-101 WAC under the authorization of chapters 15.36 and 34.05 RCW. Recently WSDA was petitioned by two major dairy product producers (Darigold Inc., and Safeway) along with the Washington State Dairy Federation to establish more stringent standards for somatic cell counts in milk from individual dairy cow milk producers than the current standards established by FDA in the Grade A PMO. New stricter quality standards being implemented and proposed by global customers require milk and milk products produced in Washington state to meet these new standards. This request is to ensure continued sales in export and domestic markets for milk and milk products produced in Washington state.

     The proposed rule amendment includes:


• Reestablishing the current tolerance level for somatic cell counts in dairy cow milk from the current standard of 750,000 per mL to 400,000 per mL.
• Adoption of the 2011 PMO.

     The provisions of this proposed rule amendment would apply to all four hundred eighty-five licensed dairy cow farm operations in Washington state as defined under chapter 15.36 RCW.

     The following small business economic impact statement (SBEIS) was prepared in compliance with the Regulatory Fairness Act, RCW 19.85.040, and provides an analysis of the proposed rule amendment impact on small businesses compared to large businesses. The intent of the proposed rule amendment is to provide clarity to business owners from a regulatory perspective and support future sales and exports of dairy cow milk and milk products.

     Citizens Affected by This Proposal: WSDA is the responsible agency for licensing and inspecting dairy cow milk operations and monitoring the quality of dairy cow milk produced by licensed dairies and processed within Washington state. Currently there are just over four hundred eighty-five licensed dairy cow milk operations in Washington state that would fall under this rule. Over ninety percent of the licensed dairy cow milk farms impacted under this proposed rule would be considered small businesses (employing fifty or fewer employees).

     Cost Survey Examination: This proposal to chapter 16-101 WAC was presented to WSDA by two major dairy processors and the Washington State Dairy Federation which represents dairy farmers within Washington state. The proposal was discussed and shared with the Washington State Dairy Federation board of directors, Washington state dairy products commission and major dairy cow milk processors. Additionally, the proposal was shared and discussed with raw milk producers by conference call. Assumptions on impacts to these small businesses are based on discussions with stakeholders, dairy processors and dairy producers.

     Costs of Complying with this Proposed Rule: This proposed rule amendment will ensure dairy cow milk and related milk products produced and processed in Washington state will be eligible to be exported to overseas markets. Over the past five years exports of dairy products produced and processed in Washington state have been a key part of ensuring markets for dairy cow milk produced and processed in Washington state. Loss of export markets could have a negative impact on net incomes to both dairy cow milk processors and producers. This proposal will also ensure Washington state remains in compliance with FDA requirements for the shipment of dairy cow milk out of Washington state by adoption of the most current (2011 revision) of the PMO. This proposed rule amendment should not create any additional costs for dairy cow milk operations, as over ninety-seven percent of licensed dairy cow milk producers are already meeting the proposed somatic cell count limit of 400,000 per mL. Both dairy cow milk processors and WSDA food safety and consumer services division staff are working with the small number of dairy cow milk producers who have exceeded the proposed limit on somatic cell counts to assist them in meeting this proposal in the future. Low somatic cell counts are a sign of healthy cattle and promote a longer shelf life for dairy cow milk and milk products. The proposed rule amendment is designed to provide regulatory clarity, maintain current and future export markets, not create a reduction or loss of sales, and will not require the addition or loss of jobs in order for dairy cow milk producers to be in compliance.

     Considerations to Reduce Impact to Small Business: The agency reviewed the following potential impacts to small businesses and identified where possible reductions in impacts could be found.


• Reducing, modifying, or eliminating regulatory requirements.
o The rule proposal will ensure continued exports and interstate sales of dairy cow milk and products produced and/or processed in Washington state.
• Simplifying, reducing or eliminating recordkeeping and reporting requirements.
o The proposed rule clearly defines standards for somatic cell counts and procedures for certification of interstate shipments of milk.
• Reducing the frequency of inspections.
o Inspections of dairy processors and producers including sampling of dairy cow milk will be conducted only on a routine bases [basis] unless concerns related to the operation has [have] been noted during an inspection or reported to the agency.
• Delaying compliance timelines.
o The agency will follow all provisions of chapter 43.05 RCW in providing technical assistance and clear timelines for compliance to the business owner.
• Reducing or modifying fine schedules for compliance.
o The rule proposal will not change or modify the current compliance schedule implemented when compliance actions are taken.

     From input received by stakeholders, dairy cow milk producers and dairy cow milk processors the agency has provided in the proposed rule amendment clear guidelines and definitions for compliance with the key objective to provide clarity and to limit costs to the business associated with regulatory compliance.

     Conclusion: The intent of the proposed rule amendment is to assist the dairy cow milk industry in promoting current and future sales including exports of dairy cow milk and milk products produced and/or processed in Washington state. An analysis of this rule proposal noted this proposal will impose minor or no costs to dairy cow milk licensees. Businesses affected by the rule proposal will not lose revenue or need to eliminate jobs.

     On the contrast this rule proposal will position the dairy cow milk industry to be able to maintain and increase export sales of dairy cow milk products, with the possibility of creating more jobs and increasing revenues for licensees in the future. The goal of this proposed rule is to provide these small businesses with a stable and predictable business climate.

     A copy of the statement may be obtained by contacting Julie Carlson, P.O. Box 42560, Olympia, WA 98504-2560, phone (360) 902-1880, fax (360) 902-2087, e-mail jcarlson@agr.wa.gov.

     A cost-benefit analysis is not required under RCW 34.05.328. WSDA is not a listed agency under RCW 34.05.328 (5)(a)(i).

November 16, 2012

Kirk Robinson

Assistant Director

OTS-5137.1


AMENDATORY SECTION(Amending WSR 08-24-073, filed 12/1/08, effective 1/1/09)

WAC 16-101-701   Standards 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, ((2007)) 2011 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, ((2007)) 2011 Revision:

     (a) Grade "A" Pasteurized Milk Ordinance - ((2007)) 2011 Revision.


PMO Page No. Excepted Portion
Pages ((11-12)) 12-13 • Section 3, Permits, paragraph 4, which begins with "The regulatory agency shall suspend..."
• Section 3, Permits, paragraph 5, which begins with "Upon notification..."
Page 24 • Section 6, The Examination of Milk and Milk Products, paragraph 5, which begins with "Whenever two (2) of the last four (4) consecutive..."
Page ((28)) 29 Section of Table 1 entitled "GRADE "A" RAW MILK AND MILK PRODUCTS FOR PASTEURIZATION, ULTRA-PASTEURIZATION OR ASEPTIC PROCESSING"
• "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 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°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."

     (b) Standards for Grade "A" Raw Milk for Pasteurization, Ultra-pasteurization or Aseptic Processing.


PMO Page No. Excepted Portion
Page ((51)) (52) Item 18r. "Raw Milk Cooling" paragraph 1, which begins with "Raw milk for pasteurization shall be cooled..."
Page((s 51-52)) 53 Ir. "Administrative Procedures", paragraph 1 only

     (c) Standards for Grade "A" Pasteurized, Ultra-pasteurized and Aseptically Processed Milk and Milk Products.


PMO Page No. Excepted Portion
Page 111 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 Item 18p. "Administrative Procedures", item number 2 only.
Page 113 Item 19p. "Capping, container closure and sealing and Dry Milk Product Storage", Administrative Procedures, item number 1 only.
Page ((125)) 126 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 ((198-199)) 202-203 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.

[Statutory Authority: RCW 15.36.21 [15.36.021] and chapter 15.36 RCW. 08-24-073, § 16-101-701, filed 12/1/08, effective 1/1/09.]


AMENDATORY SECTION(Amending WSR 08-24-073, filed 12/1/08, effective 1/1/09)

WAC 16-101-716   Procedures 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 ((2007)) 2011 Revision as Washington state procedures for the certification of interstate milk shippers.

[Statutory Authority: RCW 15.36.21 [15.36.021] and chapter 15.36 RCW. 08-24-073, § 16-101-716, filed 12/1/08, effective 1/1/09. Statutory Authority: RCW 15.36.021(3). 00-21-012, § 16-101-716, filed 10/6/00, effective 11/6/00; 96-22-059, § 16-101-716, filed 11/4/96, effective 12/5/96.]


AMENDATORY SECTION(Amending WSR 08-24-073, filed 12/1/08, effective 1/1/09)

WAC 16-101-721   Methods for making sanitation ratings of milk shippers.   The department adopts the Methods of Making Sanitation Ratings of Milk Shippers ((2007)) 2011 Revision, United States Health and Human Services Public Health Service/Food and Drug Administration as Washington state methods for ratings of interstate milk shippers.

[Statutory Authority: RCW 15.36.21 [15.36.021] and chapter 15.36 RCW. 08-24-073, § 16-101-721, filed 12/1/08, effective 1/1/09. Statutory Authority: RCW 15.36.021(3). 00-21-012, § 16-101-721, filed 10/6/00, effective 11/6/00; 96-22-059, § 16-101-721, filed 11/4/96, effective 12/5/96.]


AMENDATORY SECTION(Amending WSR 08-24-073, filed 12/1/08, effective 1/1/09)

WAC 16-101-726   Standard for the accrediting of milk laboratories.   The department adopts the Evaluation of Milk Laboratories ((2005)) 2011 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.

[Statutory Authority: RCW 15.36.21 [15.36.021] and chapter 15.36 RCW. 08-24-073, § 16-101-726, filed 12/1/08, effective 1/1/09. Statutory Authority: RCW 15.36.021(3). 96-22-059, § 16-101-726, filed 11/4/96, effective 12/5/96.]


AMENDATORY SECTION(Amending WSR 08-24-073, filed 12/1/08, effective 1/1/09)

WAC 16-101-731   Availability of the publications adopted by the department in this chapter.   (1) The Grade "A" Pasteurized Milk Ordinance, ((2007)) 2011 Revision, United States Public Health Service/Food and Drug Administration, can be purchased from the Superintendent of Documents, U.S. Printing Office, Washington, D.C.

     (2) The following publications can be obtained by writing the Center for Food Safety and Applied Nutrition, Director, Office of Constituent Operations, Industry Activities Staff, HFS-S65 200 "C" Street, S.W., Washington, D.C. 20204:

     • The Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments, ((2007)) 2011 Revision.

     • The Methods of Making Sanitation Ratings of Milk Shippers, ((2007)) 2011 Revision, United States Department of Health and Human Services Public Health Services/Food and Drug Administration.

     • The Evaluation of Milk Laboratories, ((2005)) 2011 Revision, United States Department of Health and Human Services Public Health Service/Food and Drug Administration.

[Statutory Authority: RCW 15.36.21 [15.36.021] and chapter 15.36 RCW. 08-24-073, § 16-101-731, filed 12/1/08, effective 1/1/09.]