WSR 16-17-011 EXPEDITED RULES DEPARTMENT OF AGRICULTURE [Filed August 4, 2016, 4:40 p.m.]
Title of Rule and Other Identifying Information: Chapter 16-167 WAC, Intrastate commerce in foods, this rule adopts federal regulations adopted under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq. This rule making is to update the chapter which was last revised May 24, 1999.
NOTICE
THIS RULE IS BEING PROPOSED UNDER AN EXPEDITED RULE-MAKING PROCESS THAT WILL ELIMINATE THE NEED FOR THE AGENCY TO HOLD PUBLIC HEARINGS, PREPARE A SMALL BUSINESS ECONOMIC IMPACT STATEMENT, OR PROVIDE RESPONSES TO THE CRITERIA FOR A SIGNIFICANT LEGISLATIVE RULE. IF YOU OBJECT TO THIS USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Henri Gonzales, Agency Rules Coordinator, Washington State Department of Agriculture (WSDA), P.O. Box 42560, Olympia, WA 98504-2560, e-mail WSDARulesComments@agr.wa.gov, AND RECEIVED BY October 25, 2016.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: After congress passed the Food Safety Modernization Act (FSMA) in 2011, the U.S. Food and Drug Administration (FDA) released a number of revised and new federal code of regulations necessary to implement FSMA in late 2015 and again in 2016. Revision to chapter 16-167 WAC, Intrastate commerce in foods, is necessary to remain uniform with federal regulations so that food produced in Washington may be freely shipped in interstate and international commerce and to ultimately protect consumers from contaminated, adulterated, and/or misbranded food.
Reasons Supporting Proposal: Chapter 16-167 WAC, Intrastate commerce in foods, the agency is amending the rule to adopt recent changes to federal regulations regarding food safety in order to better protect public health and promote uniformity with other states.
Statutory Authority for Adoption: RCW 69.04.740, 69.07.020, 69.10.055, 15.36.021, 69.22.020, and chapter 34.05 RCW.
Rule is necessary because of federal law, [no further information supplied by agency].
Name of Proponent: WSDA, governmental.
Name of Agency Personnel Responsible for Drafting: Claudia G. Coles, Olympia, Washington, (206) 321-1124; Implementation and Enforcement: Lucy Severs, Olympia, Washington, (360) 725-5761.
Agency Comments or Recommendations, if any, as to Statutory Language, Implementation, Enforcement, and Fiscal Matters: The agency is conducting this rule making to update our chapter 16-167 WAC to be consistent with newly revised and new federal food safety regulations that FDA has issued. Uniformity with the federal rules are [is] necessary to ensure WSDA is implementing and using enforcement requirements that are also meeting the new FSMA rule changes that FDA has issued so our state food producers can both move products within the state and in the domestic and international arena. Uniformity with the federal requirements is also important for partnership and funding opportunities with the federal government such as the FDA manufactured food regulatory standards program and our rapid response team program.
August 24, 2016
Candace A. Jacobs
Assistant Director
Food Safety and
Consumer Services Division
AMENDATORY SECTION (Amending WSR 99-12-020, filed 5/24/99, effective 6/24/99)
WAC 16-167-010 ((Purpose and authority.)) General.
(1) Consistent with the concept of uniformity where possible with the federal regulations adopted under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq. ((the following federal regulations are specifically made applicable to all persons subject to chapters 69.04 and 69.07 RCW by virtue of RCW 69.04.392, 69.04.394, 69.04.396 and 69.04.398. Although those regulations are automatically applicable to all persons subject to chapters 69.04 and 69.07 RCW, the department is nevertheless adopting as its own rules the following existing regulations of the federal government published in the Code of Federal Regulations revised as of the dates stated in the rule.
(2) The purpose of this rule is to adopt the following portion of the federal regulations promulgated under Title 21 C.F.R., Title 40 C.F.R. and FDA Compliance Policy Guidelines as Washington standards for food safety to ensure uniformity with United States standards and to protect the consuming public from possible harm due to the purchase or consumption of adulterated or misbranded food.
(3) These rules are promulgated under authority of RCW 69.04.392, 69.04.394, 69.04.396, 69.04.398 and 69.07.020)), this chapter adopts the version of the referenced federal rule current at the time this rule becomes effective.
(2) To promote continued uniformity with federal rules; amendments to the federal rules referenced in this chapter are hereby incorporated and enforceable under this chapter upon the effective date of the federal amendment provided:
(a) The director of the Washington state department of agriculture or his or her authorized representative (director) gives notice of the federal rule amendment at the time it is published as a final rule in the Federal Register;
(b) The notice is published, at a minimum, in the state register and on the agency's web site; and
(c) The director has not otherwise determined that the amendment should not be adopted as provided in subsection (3) of this section.
(3) If the director determines that a proposed amendment to a federal rule referenced in this chapter should not be adopted, the director shall initiate rule making under chapter 34.05 RCW to amend this chapter to reflect the version of the federal rule, if any, effective under this chapter.
AMENDATORY SECTION (Amending WSR 99-12-020, filed 5/24/99, effective 6/24/99)
WAC 16-167-020 Pesticide chemicals.
The following federal regulations are adopted as Washington tolerances for pesticide chemicals: 40 C.F.R. ((Revised as of July 1, 1998.
(1))) Chapter I Part((s)) 180 - Tolerances and Exemptions ((from Tolerances)) for Pesticide Chemical((s in or on Raw Agricultural Commodities)) Residues in Food.
(((a))) (1) Subpart A - Definitions and Interpretative Regulations.
(((b))) (2) Subpart C - Specific Tolerances.
(((2) Part 185 - Tolerances for Pesticides in Food.
(3) Part 186 - Tolerances for Pesticides in Animal Feeds.))
AMENDATORY SECTION (Amending WSR 99-12-020, filed 5/24/99, effective 6/24/99)
WAC 16-167-030 Food additives.
The following federal regulations prescribing the conditions under which such food additives may safely be used are adopted as Washington food additive regulations. 21 C.F.R. Chapter ((1 Revised as of April 1, 1998)) I.
(1) Part 170 - Food Additives.
(2) Part 172 - Food Additives Permitted for Direct Addition to Food for Human Consumption.
(3) Part 173 - Secondary Direct Food Additives Permitted in Food for Human Consumption.
(4) Part 174 - Indirect Food Additives: General.
(5) Part 175 - Indirect Food Additives: Adhesives and Components of Coatings.
(6) Part 176 - Indirect Food Additives: Paper and Paperboard Components.
(7) Part 177 - Indirect Food Additives: Polymers.
(8) Part 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers.
(9) Part 179 - Irradiation in the Production, Processing and Handling of Food.
(10) Part 180 - Food Additives Permitted in Food ((on an Interim Basis)) or in Contact with Food on an Interim Basis Pending Additional Study.
(11) Part 181 - Prior-Sanctioned Food Ingredients.
(12) Part 182 - Substances Generally Recognized as Safe.
(13) Part 184 - Direct Food Substances Affirmed as Generally Recognized as Safe.
(14) Part 186 - Indirect Food Substances Affirmed as Generally Recognized as Safe.
(15) Part 189 - Substances Prohibited From Use in Human Food.
AMENDATORY SECTION (Amending WSR 99-12-020, filed 5/24/99, effective 6/24/99)
WAC 16-167-040 Color additives.
The following federal regulations prescribing the use or limited use of such color additives are adopted as Washington color additive regulations. 21 C.F.R. Chapter ((1 Subchapter A-General Revised as of April 1, 1998)) I.
(1) Part 70 - Color Additives.
(2) Part 73 - Listing of Color Additives Exempt From Certification.
(3) Part 74 - Listing of Color Additives Subject to Certification.
(4) Part 81 - General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs and Cosmetics.
(5) Part 82 - Listing of Certified Provisionally Listed Colors and Specifications.
AMENDATORY SECTION (Amending WSR 99-12-020, filed 5/24/99, effective 6/24/99)
WAC 16-167-050 General requirements.
The following ((federal regulations concerning food)) provisions of 21 C.F.R. Chapter I are adopted as Washington requirements for regulating food in intrastate commerce.
(1) ((21 C.F.R. Chapter 1)) The following parts in Subchapter A-General ((Revised as of April 1, 1998)).
(a) Part 1 - General Enforcement Regulations.
(i) Subpart A General Provisions.
(ii) Subpart B General Labeling Requirements.
(iii) Subpart O Sanitary Transportation of Human and Animal Food.
(b) Part 2 - General Administrative Rulings and Decisions.
(i) Subpart A General Provisions.
(ii) Subpart B Human and Animal Foods.
(c) Part 7 - Enforcement Policy.
(2) ((21 C.F.R. Chapter 1)) All parts of Subchapter B-Food for Human Consumption, ((Revised as of Federal Register: July 8, 1998, (Volume 63, Number 130) Page 37030-37056.
(a) Part 100 - General.
(b) Part 101 - Food Labeling.
(c) Part 102 - Common or Usual Name for Nonstandardized Foods.
(d) Part 104 - Nutritional Quality Guidelines for Foods.
(e) Part 105 - Foods for Special Dietary Use.
(f) Part 106 - Infant Formal Quality Control Procedures.
(g) Part 107 - Infant Formula.
(h) Part 108 - Emergency Permit Control.
(i) Part 109 - Unavoidable Contaminants in Food for Human Consumption and Food Packaging Material.
(j) Part 110 - Current Good Manufacturing Practice in Manufacturing. Packing and Holding Human Food.
(k) Part 111 - Current Good Manufacturing Practices for Dietary Supplements.
(l) Part 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.
(m) Part 114 - Acidified Foods.
(n) Part 123 - Fish and Fishery Products.
(o) Part 129 - Processing and Bottling Bottled Drinking Water.
(p) Part 130 - Food Standards: General.
(q) Part 131 - Milk and Cream.
(r) Part 133 - Cheeses and Related Cheese Products.
(s) Part 135 - Frozen Desserts.
(t) Part 136 - Bakery Products.
(u) Part 137 - Cereal Flours and Related Products.
(v) Part 139 - Macaroni and Noodle Products.
(w) Part 145 - Canned Fruits.
(x) Part 146 - Canned Fruit Juices.
(y) Part 150 - Fruit Butters, Jellies, Preserves and Related Products.
(z) Part 152 - Fruit Pies.
(aa) Part 155 - Canned Vegetables.
(bb) Part 156 - Vegetable Juices.
(cc) Part 158 - Frozen Vegetables.
(dd) Part 160 - Eggs and Egg Products.
(ee) Part 161 - Fish and Shellfish.
(ff) Part 163 - Cacao Products.
(gg) Part 164 - Tree Nut and Peanut Products.
(hh) Part 165 - Beverages.
(ii) Part 166 - Margarine.
(jj) Part 168 - Sweeteners and Table Syrups.
(kk) Part 169 - Food Dressings and Flavorings)) except for Part 119.
AMENDATORY SECTION (Amending WSR 97-02-036, filed 12/26/96, effective 1/26/97)
WAC 16-167-900 ((Where can)) Access to publications adopted ((by WSDA)) under this chapter ((be obtained?)).
(1) ((Title 21 C.F.R. and Title 40 C.F.R. can be purchased from the Superintendent of Documents, U.S. Printing Office, Mail Stop SSOP, Washington D.C. 20402-9328.
(2) The compliance policy guidelines 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 SW, Washington D.C. 20204.
(3) Information can also be obtained from FDA's homepage at HTTP://WWW.FDA.GOV/FDAHOMEPAGE.HTML)) Electronic access to Titles 21 and 40 C.F.R. is available at https://www.gpo.gov/fdsys/search/home.action. Print copies of the titles can be purchased from the U.S. Government Bookstore online at https://bookstore.gpo.gov/catalog/laws-regulations/code-federal-regulations-cfrs-print or, if you do not have electronic access, contact the U.S. Government Publishing Office, P.O. Box 979050, St. Louis, MO 63197-9000; phone 1-866-512-1800.
(2) Electronic access to the FDA's Manual of Compliance Policy Guides is available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm. If you do not have electronic access, contact the Food and Drug Administration, 1093 New Hampshire Avenue, Silver Spring, MD 20993-0002; phone 1-888-463-6332.
REPEALER
The following section of the Washington Administrative Code is repealed:
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