WSR 14-24-077 PROPOSED RULES DEPARTMENT OF HEALTH [Filed November 26, 2014, 2:44 p.m.]
Original Notice.
Proposal is exempt under RCW 34.05.310(4) or 34.05.330(1).
Title of Rule and Other Identifying Information: WAC 246-282-005 Sanitary control of shellfish—Minimum performance standards, amending the rule to reference the 2013 version of the National Shellfish Sanitation Program (NSSP) guide for the Control of Molluscan Shellfish (guide).
Hearing Location(s): Department of Health, TC3 Room 229, 243 Israel Road S.E., Tumwater, WA 98501, on January 6, 2015, at 11:00 a.m.
Date of Intended Adoption: January 13, 2015.
Submit Written Comments to: Brandy Brush, P.O. Box 7824, Olympia, WA 98504, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2257, by January 6, 2015.
Assistance for Persons with Disabilities: Contact Brandy Brush by December 30, 2014, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The United States Food and Drug Administration (FDA) requires all shellfish-producing states to follow the most current version of the NSSP guide in order to place molluscan shellfish into interstate commerce. The rule currently references the 2011 NSSP guide, leaving the current rules out-of-date. The proposed rule updates the reference to the 2013 version of the NSSP guide.
Reasons Supporting Proposal: The FDA oversees a cooperative program between the shellfish-producing states and the shellfish industry for the production and processing of shellfish consistent with the NSSP guide. The FDA evaluates each state's shellfish sanitation control program to ensure compliance with the NSSP guide. Therefore, an update to WAC 246-282-005 is needed so that Washington state remains compliant with the NSSP guide and molluscan shellfish products from the state can continue to be placed into interstate commerce.
Chapter II.
A new paragraph @.02 Shellfish Related Illness Associated with Vibrio parahaemolyticus - Redefining how to address illness and outbreaks.
@.06 Vibrio parahaemolyticus Control Plan is now @.07 Vibrio parahaemolyticus Control Plan - Format change.
Chapter VIII.
@.02 Shellstock Time to Temperature Controls.
I. Shellstock intended for a validated pathogen reduction process where refrigeration would reduce efficacy of the process (and appropriately labeled with name of the receiving dealer) is exempt from the requirements in Chapter VIII. @.02 A. (1) and (2). This change allows product that is going to be subject to a postharvest process to reduce Vibrio, to be exempt from cooling, if the cooling would make the postharvest processing less efficient.
.02 Shellstock Harvesting and Handling.
F. (7)(a) When shellstock are harvested from one harvest area on a single day by a single harvester or aquaculture leaseholder, multiple containers may be utilized on a wrapped pallet, in a tote, in a net brailer, in a single boat, vehicle, conveyance or other container and the unit tagged with a single tag in accordance with the requirements of Section .02 F. This change makes a boat load, or vehicle load, if harvested from the same area on the same day eligible for a bulk tag.
F. (7)(b)(ii)(ii) Number of individual containers in the unit or an estimate of the total weight, volume or count. This change allows the harvester to estimate or approximate counts, weights or volume instead of exact counts or measurements.
Chapter XI-XV.
Moved the requirement for Ice to "come from a facility sanctioned by the Authority or the appropriate regulatory agency" from XI, XII, XIII, XIV, XV. .02 E. Protection of Adulterants (4) (c) to XI, XII, XIII, XIV, XV. .02 A. Safety of Water for Processing and Ice Production (2)(b). This moves the requirement for ice to come from an approved facility from item 12 Protection of Adulterants to item 8, Safety of Water for Processing and Ice Production on the Shellfish inspection form.
Chapter XIII. .01 B. (5)
Product intended for relay, wet storage or depuration, or either geoduck clams (Panopea generose), or Mercenaria sp which are being cooled utilizing an Authority approved tempering plan are exempt from the requirement listed above in .01 B. (4) above. [C] Added geoduck clams (Panopea generose) to the exemption for shellstock shipping critical control point requirements. The lower temperatures listed in Chapter XIII @ 01.B(4) would cause significant mortality in the animal. There is no record of geoduck clams being associated with vibriosis; laboratory testing of geoduck clams in 2007 by DOH revealed no detected presence of Vibrio parahaemolyticus.
Guidance Documents Section IV.
Chapter III added:
.08 Icing, Cold Water Dips and Ice Slurries for Cooling Shellstock.
.09 Irradiation Pre-labeling Guidance.
Chapter IV added:
.05 Template for Submission of Post-Harvest Process Validation Studies.
.06 Vibrio cholera.
Statutory Authority for Adoption: RCW 69.30.030.
Statute Being Implemented: RCW 69.30.030.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Department of health, governmental.
Name of Agency Personnel Responsible for Drafting: Brandy Brush, 243 Israel Road S.E., Tumwater, WA 98501, (360) 236-3342; Implementation and Enforcement: Darin Klein, 243 Israel Road S.E., Tumwater, WA 98501, (360) 236-3341.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(c), a small business economic impact statement is not required for proposed rules that adopt or incorporate by reference - without material change - federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or 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.
A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iii) exempts rules that adopt or incorporate by reference without material change federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or 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.
November 25, 2014
Dennis E. Worsham
Deputy Secretary
for John Wiesman, DrPH, MPH
Secretary
AMENDATORY SECTION (Amending WSR 14-09-003, filed 4/3/14, effective 5/4/14)
WAC 246-282-005 Minimum performance standards.
(1) Any person engaged in a shellfish operation or possessing a commercial quantity of shellfish or any quantity of shellfish for sale for human consumption must comply with and is subject to:
(a) The requirements of the U.S. Food and Drug Administration National Shellfish Sanitation Program (NSSP), Guide for the Control of Molluscan Shellfish (((2011)) 2013) (copies available through the U.S. Food and Drug Administration, Shellfish Sanitation Branch, and the Washington state department of health, office of shellfish and water protection);
(b) The provisions of 21 Code of Federal Regulations (C.F.R.), Part 123 - Fish and Fishery Products, adopted December 18, 1995, by the United States Food and Drug Administration, regarding Hazard Analysis Critical Control Point (HACCP) plans (copies available through the U.S. Food and Drug Administration, Office of Seafood, and the Washington state department of health, office of food safety and shellfish programs); and
(c) All other provisions of this chapter.
(2) If a requirement of the NSSP Model Ordinance or a provision of 21 C.F.R., Part 123, is inconsistent with a provision otherwise established under this chapter or other state law or rule, then the more stringent provision, as determined by the department, will apply.
|