WSR 98-04-076

EXPEDITED ADOPTION

DEPARTMENT OF AGRICULTURE

[Filed February 4, 1997, 10:05 a.m.]

Title of Rule: Chapter 16-167 WAC, Intrastate commerce in foods, this rule adopts the federal regulations covering food additives, colors, labeling, food standards, good manufacturing practices, pesticide tolerances and compliance policy guidelines.

Purpose: To adopt the federal regulations covering food in interstate commerce as state rules for uniformity. This will ensure that food produced and processed in Washington state meets the United States food safety and labeling standards. This rule will update the 1995 regulations adopted previously by adopting the newest 1997 regulations.

Statutory Authority for Adoption: RCW 69.04.392, 69.04.394, 69.04.396, 69.04.398, and 69.07.020.

Statute Being Implemented: Intrastate commerce in food, drugs and cosmetics, chapter 69.04 RCW.

Summary: Adopts latest published federal regulations covering food additives, colors, food standards, current good manufacturing practices, food handling, pesticide tolerances and FDA compliance policy guidelines. This will ensure that Washington state standards are consistent with the federal requirements, help protect consumers from unsafe food, and ensure the flow in interstate commerce.

Reasons Supporting Proposal: Uniformity with federal regulations for food safety and to facilitate the sale and movement of goods in interstate/international commerce.

Name of Agency Personnel Responsible for Drafting and Implementation: Verne E. Hedlund, 1111 Washington Street, Olympia, WA 98504-2560, (360) 902-1860; and Enforcement: Michael Donovan, 1111 Washington Street, Olympia, WA 98504-2560, (360) 902-1883.

Name of Proponent: Washington State Department of Agriculture, governmental.

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

Explanation of Rule, its Purpose, and Anticipated Effects: In accordance with the stated purpose of RCW 69.04.398 which is for uniformity with federal laws and regulations this rule adopts the federal regulations that govern the production, processing and sale of foods in interstate commerce as a state rule. These regulations cover among other things, food additives, colors, labeling, current good manufacturing practices, standards of identity, testing requirements, thermal processing of low acid food, acidified food processing, infant formulas, seafood HACCP, dairy product standards, food enrichment, pesticide tolerances in food and animal food and compliance policy guidelines.

The purpose of adopting these federal regulations is uniformity, food safety and to facilitate the flow of Washington products in interstate/international commerce.

The anticipated effects are that applying the same requirements will help ensure safety of food products, and to ensure that the foods produced and processed in Washington state will be in compliance with the national standards and requirements. Again this will facilitate their acceptance and movement in interstate and international commerce.

Proposal Changes the Following Existing Rules: This rule change updates the adoption of the federal regulation to the current 1997 regulations. Changes since 1995 include new EPA pesticide tolerances for human and animal food, the addition of current good manufacturing practices for dietary supplements, labeling for fluid milk products i.e., low fat, skimmed and nonfat has been changed to reflect the requirements under the Nutritional Labeling and Education Act (effective January 1, 1998), the compliance policy guidelines have been reviewed and updated by FDA since they were last adopted. 21 CFR Part 103 Quality Standards for Food With No Identity Standards has been removed.

THIS RULE IS BEING PROPOSED TO BE ADOPTED USING 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 RULE BEING ADOPTED USING THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Verne E. Hedlund, Washington State Department of Agriculture, 1111 Washington Street, P.O. Box 42560, Olympia, WA 98504-2560, AND RECEIVED BY April 4, 1998.

February 4, 1998

Candace A. Jacobs, DVM

Assistant Director

AMENDATORY SECTION (Amending Order 6012, filed 12/26/96, effective 1/26/97)

WAC 16-167-010 Purpose and authority. (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 April 1, ((1996)) 1997.

(2) The purpose of this rule is to adopt the following portion of the federal regulations promulgated under Title 21 CFR, Title 40 CFR 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.

[Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.396, 69.04.398 and 69.07.020. 97-02-036 (Order 6012), 16-167-010, filed 12/26/96, effective 1/26/97. Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.398 and 69.07.020. 95-02-017 (Order 5065), 16-167-010, filed 12/27/94, effective 1/27/95.]

AMENDATORY SECTION (Amending Order 6012, filed 12/26/96, effective 1/26/97)

WAC 16-167-020 Pesticide chemicals. The following federal regulations are adopted as Washington tolerances for pesticide chemicals: 40 CFR Revised as of July 1, ((1995)) 1997.

(1) Parts 180 - Tolerances and Exemptions from Tolerances for Pesticide Chemicals in or on Raw Agricultural Commodities.

(a) Subpart A - Definitions and Interpretative Regulations.

(b) Subpart C - Specific Tolerances.

(2) Part 185 - Tolerances for Pesticides in Food.

(3) Part 186 - Tolerances for Pesticides in Animal Feeds.

[Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.396, 69.04.398 and 69.07.020. 97-02-036 (Order 6012), 16-167-020, filed 12/26/96, effective 1/26/97. Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.398 and 69.07.020. 95-02-017 (Order 5065), 16-167-020, filed 12/27/94, effective 1/27/95.]

AMENDATORY SECTION (Amending Order 6012, filed 12/26/96, effective 1/26/97)

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 CFR Chapter 1 Revised as of April 1, ((1996)) 1997.

(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 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.

[Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.396, 69.04.398 and 69.07.020. 97-02-036 (Order 6012), 16-167-030, filed 12/26/96, effective 1/26/97. Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.398 and 69.07.020. 95-02-017 (Order 5065), 16-167-030, filed 12/27/94, effective 1/27/95.]

AMENDATORY SECTION (Amending Order 6012, filed 12/26/96, effective 1/26/97)

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 CFR Chapter 1 Subchapter A-General Revised as of April 1, ((1996)) 1997.

(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 Provisionally Listed Colors and Specifications.

[Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.396, 69.04.398 and 69.07.020. 97-02-036 (Order 6012), 16-167-040, filed 12/26/96, effective 1/26/97. Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.398 and 69.07.020. 95-02-017 (Order 5065), 16-167-040, filed 12/27/94, effective 1/27/95.]

AMENDATORY SECTION (Amending Order 6012, filed 12/26/96, effective 1/26/97)

WAC 16-167-050 General requirements. The following federal regulations concerning food are adopted as Washington requirements for regulating food in intrastate commerce.

(1) 21 CFR Chapter 1 Subchapter A-General Revised as of April 1, ((1996)) 1997.

(a) Part 1 - General Enforcement Regulations.

(i) Subpart A General Provisions.

(ii) Subpart B General Labeling Requirements.

(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 CFR Chapter 1 Subchapter B-Food for Human Consumption.

(a) Part 100 - General.

(b) Part 101 - Food Labeling.

(c) Part 102 - Common or Usual Name for Nonstandardized Foods.

(d) ((Part 103 - Quality Standards for Foods With no Identity Standards.

(e))) Part 104 - Nutritional Quality Guidelines for Foods.

(((f))) (e) Part 105 - Foods for Special Dietary Use.

(((g))) (f) Part 106 - Infant Formal Quality Control Procedures.

(((h))) (g) Part 107 - Infant Formula.

(((i))) (h) Part 108 - Emergency Permit Control.

(((j))) (i) Part 109 - Unavoidable Contaminants in Food for Human Consumption and Food Packaging Material.

(((k))) (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.

[Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.396, 69.04.398 and 69.07.020. 97-02-036 (Order 6012), 16-167-050, filed 12/26/96, effective 1/26/97. Statutory Authority: RCW 69.04.392, 69.04.394, 69.04.398 and 69.07.020. 95-02-017 (Order 5065), 16-167-050, filed 12/27/94, effective 1/27/95.]

AMENDATORY SECTION (Amending Order 5065, filed 12/27/94, effective 1/27/95)

WAC 16-167-060 Compliance policy guidelines. The following compliance policy guidelines are adopted as Washington regulations for regulating food in intrastate commerce. Food and Drug Administration Compliance Policy Guides revised as of August 1996.

(((1) Chapter 1 Beverage.

(2) Chapter 2 Baked Goods.

(3) Chapter 3 Food Storage.

(4) Chapter 4 Processed Grain.

(5) Chapter 5 Candy and Sugar.

(6) Chapter 6 Dairy.

(7) Chapter 7 Egg Industry.

(8) Chapter 8 Fish and Seafood.

(9) Chapter 9 Condiment Industry.

(10) Chapter 10 Fruit.

(11) Chapter 12 Nut.

(12) Chapter 13 Edible Oil.

(13) Chapter 14 Vegetable.

(14) Chapter 16 Multiple Food.

(15) Chapter 17 Food Related.

(16) Chapter 18 Dietary Food.

(17) Chapter 20 Food - General.

(18) Chapter 27 Color.

(19) Chapter 41 Pesticides.

(20) Chapter 51 Inspectional.)) Chapter 5 - Foods, Colors and Cosmetics.

(1) Subchapter 500 - Additives.

(2) Subchapter 505 - Bakery Products.

(3) Subchapter 510 - Beverages.

(4) Subchapter 515 - Candy and Sugar.

(5) Subchapter 520 - Canned Foods.

(6) Subchapter 525 - Condiment Industry.

(7) Subchapter 527 - Dairy.

(8) Subchapter 530 - Dietary Supplements.

(9) Subchapter 535 - Edible Oils.

(10) Subchapter 537 - Egg Industry.

(11) Subchapter 540 - Fish and Seafood.

(12) Subchapter 545 - Food Related.

(13) Subchapter 550 - Fruits.

(14) Subchapter 555 - General.

(15) Subchapter 562 - Labeling.

(16) Subchapter 565 - Meat and Poultry.

(17) Subchapter 570 - Nut.

(18) Subchapter 575 - Pesticides.

(19) Subchapter 578 - Processed Grains.

(20) Subchapter 580 - Storage.

(21) Subchapter 585 - Vegetables.

(22) Subchapter 587 - Colors.