WSR 25-09-024

PROPOSED RULES

DEPARTMENT OF AGRICULTURE

[Filed April 7, 2025, 2:42 p.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 24-08-030.

Title of Rule and Other Identifying Information: Chapter 16-250 WAC, Commercial rules; the Washington state department of agriculture (WSDA) is proposing the following amendments to this chapter:

Chapter 16-252 WAC, Commercial feed rules—Pet food and specialty pet food; WSDA is proposing the following amendments to this chapter:

Hearing Location(s): On May 27, 2025, at 10:00 a.m., via Microsoft Teams at https://teams.microsoft.com/l/meetup-join/19%3ameeting_MGNiNGMxMjYtY2Y2Ny00NDIzLWFhNzEtYWRlMzM0Y2FmZmNi%40thread.v2/0?context=%7b%22Tid%22%3a%2211d0e217-264e-400a-8ba0-57dcc127d72d%22%2c%22Oid%22%3a%22838c55c7-c187-44ae-8de0-2be684ce5d4a%22%7d, Meeting ID 219 132 939 357, Passcode Sm6Ge6LR; or dial in by phone +1 564-999-2000, Phone conference ID 524 010 224#.

Date of Intended Adoption: June 3, 2025.

Submit Written Comments to: Gloriann Robinson, P.O. Box 42560, Olympia, WA 98504-2560, email WSDARulesComments@agr.wa.gov, fax 360-902-2092, by May 27, 2025.

Assistance for Persons with Disabilities: Contact Leah Cloward, phone 360-902-2070, fax 360-902-2092, TTY 800-833-6388, email leah.cloward@agr.wa.gov, by May 20, 2025.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: WSDA and all states that have animal feed regulatory authority adopt some level of the AAFCO OP which contains a model bill, regulations, and approved ingredients. All updates to the model bill and regulations go through a thorough, multidisciplinary deliberation process and ultimately get approved or denied by AAFCO members which include animal feed regulatory and laboratory officials; but industry, consumer, and academic advisors are involved in the process by providing their perspective, suggestions and voting at the workgroup level. Once approved, it is important for states, including Washington, to stay up-to-date in the adoption of the model bill and regulations to increase consistency of regulations nationwide and better facilitate interstate commerce.

The changes in chapter 16-250 WAC will clarify some guarantees for various types of livestock feeds. Industry has initiated some of these minor changes already. Predominately, it is a low burden to update a livestock feed label, as most print in-house separate tags that they sew onto bags, and a slightly higher burden for smaller packages, since they sometimes have to outsource label printing.

The changes in chapter 16-252 WAC were prompted by the Food and Drug Administration (FDA) and state regulators, industry, and consumers for a need to modernize pet and specialty pet food labels. The nutrition information on the label will be more closely aligned with human food labels. To provide more transparency and consumer understanding of pet and specialty pet food, these regulations will require consistent locations for needed product information on the label.

This project was initiated by AAFCO in 2015. It involved several years of multidisciplinary workgroups, consumer focus groups, periods of public comment and inclusion, and press releases. There will be a healthy enforcement discretion period by policy statement to allow for companies to come into compliance with the new label changes. AAFCO will also be continuing evaluation periods of the enforcement discretion period to ensure practicality and resolve issues such as high demand of label printing companies, etc. Industry will need to invest more time in educating themselves on the changes, planning for changes and implementing the changes. Since some companies have hundreds of pet food products, it can be a lengthy and burdensome process. Again, as a result, the enforcement discretion will be in place and reevaluated regularly.

Reasons Supporting Proposal: If the rules are not amended, Washington regulations would fall behind nationwide adoption of updated regulations and labels would remain inconsistent and easily misunderstood.

Statutory Authority for Adoption: RCW 15.53.9012.

Statute Being Implemented: Chapter 15.53 RCW.

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

Name of Proponent: WSDA, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Ashlee-Rose Ferguson, 1111 Washington Street S.E., Olympia, WA 98504, 360-902-1905.

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. WSDA is not a listed agency under RCW 34.05.328 (5)(a)(i).

The proposed rule does impose more-than-minor costs on businesses.

Chapter 16-250 WAC, Commercial Feed, and

Chapter 16-252 WAC, Commercial Feed—Pet Food and Speciality Pet Food

SECTION 1:Describe the proposed rule, including: A brief history of the issue; an explanation of why the proposed rule is needed; and a brief description of the probable compliance requirements and the kinds of professional services that a small business is likely to need in order to comply with the proposed rule: WSDA is required, under RCW 15.53.9012, to carry out the provisions of this statute and is required to consider AAFCO OP when adopting rules necessary to carry out this purpose. The OP contains, in essence, a model bill, regulations, and a list of ingredients approved for use in animal feed. All updates to the model bill and regulations undergo a thorough, multidisciplinary deliberation process and ultimately get approved or denied by AAFCO members. AAFCO members include animal feed regulators and laboratory officials. However, industry, consumers, and academic advisors are also involved in the process by way of providing perspective, suggestions, and voting at a workgroup level. It is important for all states, including Washington, to stay up-to-date with the model bill's adoption and regulations to both increase regulatory consistency nationwide and promote the facilitation of interstate commerce.

WSDA is proposing to incorporate changes in the most recent version of the AAFCO OP into chapters 16-250 and 16-252 WAC.

Specifically, WSDA is proposing to update chapter 16-250 WAC to clarify some guarantees for various types of livestock feeds, which industry has already begun to initiate. Additionally, WSDA found it to be a lower burden to update a livestock feed label as most industry representatives conveyed that they often print in-house separate tags, which are then sewn onto their bags. Contrarily, WSDA identified a slightly higher burden for smaller packages, as it was shared that these are sometimes outsourced for printing.

Additionally, WSDA is proposing changes in chapter 16-252 WAC that modernize pet and specialty pet food labels. The objective aimed at modernizing the label's nutritional information to more closely align with human food labels. Further, this regulatory effort provides more transparency and consumer understanding of pet and specialty pet food, by requiring consistent product information label locations.

The PFLM project was initiated by AAFCO in 2015, and it involved several years of multidisciplinary workgroups, consumer focus groups, periods of public comment, and press releases. To assist companies in this transitionary period, there will be a healthy enforcement discretionary period until July 1, 2030, to allow for businesses to come into compliance with these new regulations. Further, industry will also need to invest additional time in educating themselves, planning, and implementing the changes. Because some companies have hundreds of pet food products, the transitionary period is anticipated to be both a lengthy and burdensome process including, but not limited to, new lab analysis for each product to comply with "nutrition facts" box regulations; packaging design updates, materials and printing; artwork creation; information systems changes; and advertising and/or educating retailers and consumers.

Should WSDA not adopt AAFCO's model regulations and amend these chapters of rules, Washington state would stand to fall significantly behind the nationwide benchmark. As a result, pet food labels in Washington state would become inconsistent with pet food labels being sold in other states, and continue to be misunderstood by Washington state consumers, creating an even larger burden on industry. These updates not only enhance transparency and consumer trust within the industry, but also better reflect current nutritional science(s) and regulatory practices.

SECTION 3:Analyze the probable cost of compliance. Identify the probable costs to comply with the proposed rule, including: Cost of equipment, supplies, labor, professional services and increased administrative costs; and whether compliance with the proposed rule will cause businesses to lose sales or revenue: WSDA anticipates cost increases for pet food and specialty pet food businesses due to its intended adoption of AAFCO model regulations regarding pet food label modernization in chapter 16-252 WAC. Additionally, in relation to its proposed 16-250 WAC amendments, WSDA determined that there would be minimal, if any, added costs of compliance for commercial feed licensees. This determination was reached as these businesses may elect to add a "sticker" with the guarantor's name and phone number on their current product labels until they reprint their labels at their normal reprint interval, which will be relatively burdenless to the business. The expenses and associated work needed to meet WSDA's regulations will be contingent on a variety of components which include, but are not limited to, the size of the business, its current operational structure, its number of products on the market, and its need to modify nutritional information, ingredient lists, or other specific claims, amongst many other factors.

WSDA employed a multisurvey approach to ensure that stakeholder feedback, along with their perceived economic impact data, was systematically collected and analyzed for both its commercial feed's (chapter 16-250 WAC) and pet food and specialty pet food's (chapter 16-252 WAC) rule proposals. These surveys aimed to capture feedback by requesting nominal data detailing the costs of compliance but also offered opportunities for fill-in/narrative responses.

The first survey, which was sent out to the WSDA's commercial feed licensees, inquired as to whether the proposed rule's requirement to "…include the phone number of the manufacturer or guarantor on your label (whether directly or on a separate printed tag)," would create an added cost. The survey was sent out to a total of 81 commercial feed licensees as part of the animal feed program's newsletter and consisted of an open response period of approximately two weeks. WSDA received one response to this survey relating, in essence, the following:

In order to mitigate costs related to this change in requirement, WSDA will allow commercial feed manufacturers to print out a separate label/sticker with the guarantor's or manufacturer's information and place it onto its products, effectively eliminating the need to update and/or reprint their primary labels immediately. Businesses may instead invest in the purchase of a label maker (if they do not have one already) to print these additional labels/stickers. Adequate label makers can be found at any major retailer and are typically priced as follows:

It is anticipated that businesses will need to assess their specific needs such as print quality, label size, and connectivity options, and then select the lowest cost option.

The second survey, which was sent to pet food and specialty pet food's registrants, inquired as to whether its proposed adoption of AAFCO's PFLM requirements would create added costs to their business. The survey was sent out to a total of 1,200 pet food and specialty pet food registrants as part of the animal feed program's newsletter and consisted of an open response period of approximately three weeks. WSDA received 19 responses to this survey relating, in essence, the following:

The following tables display potential financial considerations, as received from the survey responses.

Table 3.1 - Research & Development (R&D) / Operations

Table 3.1's information was compiled through a variety of survey questions prompting industry to consider the following R&D and operational areas:

(1) Tests and Studies Costs: Conducting tests, studies, and laboratory analysis submissions may be required to ensure new formulations meet new regulatory standards;

(2) Ingredient Sourcing and Testing: If new ingredients need to be sourced or existing ones need to be replaced, costs can include sourcing fees, transportation, and testing for nutritional content and safety;

(3) Additional Analysis: Costs associated with additional analysis for dietary fiber;

(4) Product and Manufacturing: Changes in ingredients may affect production processes, potentially requiring adjustments in equipment or procedures, which may incur additional costs; and

(5) Quality Control and Assurance: Testing and verifying the quality and safety of the reformulated product throughout the manufacturing process is essential, adding to ongoing operational costs.

Due to several businesses responding through narrative rather than nominal amounts, we were unable to calculate and/or approximate the potential price per product as it relates to R&D/operations.

In sum, these costs can vary widely depending on the size of the business, the complexity of its product line, and the extent of changes required to meet AAFCO's updated model regulations.

Table 3.2 - Packaging Design and Materials Updates

Table 3.2's information was compiled through a variety of survey questions prompting industry to consider the following expense areas:

(1) Design Costs: Hiring a graphic designer or using design software to create compliant labels for content, font size, and format may incur costs;

(2) Consulting Fees: If applicable to your business model, you may expect increased consulting fees for regulatory experts/consultants to assist in navigating the new AAFCO guidelines and ensure compliance with nutritional information, ingredient listing(s), and other required elements;

(3) Printing Costs: Costs associated with printing new labels, which may vary depending on the label material, size, and quantity; and

(4) Testing and Verification: Potential costs to ensure that labels accurately reflect the nutritional content and meet new requirements, which may involve testing and verification processes.

As previously noted, these costs can vary widely depending on factors such as the size of the production run and complexity of label design. Because of the different relationships that manufacturers have with either compliance experts or printing companies, discussions will likely need to be had to estimate costs accurately.

In sum, and based on the information provided, WSDA acknowledges that large and multistate businesses will incur some level of costs for packaging design to comply with the new regulatory requirements, but its exact amount(s) will be unknown until they begin to implement the operational changes and incur the associated expenses.

Table 3.3 - Marketing and Consumer Education

Table 3.3's information was compiled through a variety of survey questions prompting industry to consider the following expense areas:

(1) Consumer Education: Costs associated with developing and implementing strategies to educate consumers about changes in pet food labels and product improvements, such as informational materials, FAQs and guides, and online resources;

(2) Marketing Material: Costs associated with creating new marketing materials to highlight product enhancements, transparency, and clarity. These may include in-store signage and product displays;

(3) Digital Marketing Campaigns: Costs such as social media and/or email marketing costs;

(4) Media Relations and Public Relations: Costs such as press releases and media outreach;

(5) Training and Support for Retail Partners: Costs such as retailer training and support materials; and

(6) Monitoring and Feedback: Costs associated with consumer feedback mechanisms and effectiveness monitoring.

These costs can vary widely depending on the size of the business, the complexity of its product line, and the extent of changes required to meet AAFCO's updated model regulations.

Table 3.4 - Information Technology Systems and Data Management

Table 3.4's information was compiled through a variety of survey questions prompting industry to consider the following expense areas:

(1) Software Updates: Updating or integrating IT systems, including enterprise resource planning software, to accommodate changes in labeling requirements and regulatory reporting.

(2) Data Management: Enhancing data collection and management systems to track and report information required by AAFCO, such as ingredient sourcing and nutritional data.

These costs can vary widely depending on the business's size, the complexity of its product line, and the extent of changes required to meet AAFCO's updated model regulations.

Table 3.5 - Regulatory and General Compliance

Table 3.5's information was compiled through a variety of survey questions prompting industry to consider the following expense areas:

(1) Documentation and Recordkeeping: Costs related to preparation/maintenance of documentation demonstrating regulatory compliance, including records of ingredient sourcing, formulation changes, testing results, etc.

(2) Legal Compliance: If applicable, any expenses associated with legal advice to ensure regulatory compliance.

These costs can vary widely depending on the business's size, the complexity of its product line, and the extent of changes required to meet AAFCO's updated model regulations. Based on survey responses, it was conveyed that large and multistate businesses will incur some level of costs for regulatory and general compliance to comply with the rule amendments, but its exact amount(s) will be unknown until they begin to implement the operational changes and incur the associated expenses.

WSDA recognizes that the adoption of AAFCO's model regulations will impose additional costs to pet food and specialty pet food businesses, as well as commercial feed licensees. The overall level of economic impact, however, will be determined by how many products a business sells, its internal operational structure, and its supply chain relationships. Through discussions with industry, it was expressed that most upcoming increases in compliance costs would be passed onto its customers through an increase of product prices. Thus, any business needing to increase its price(s) may potentially be met with loss of sales and/or revenue if:

SECTION 4:Analyze whether the proposed rule may impose more-than-minor costs on businesses in the industry: The proposed rule changes for chapter 16-250 WAC are not anticipated to impose more-than-minor costs on businesses. In relation to chapter 16-250 WAC's rule proposal, WSDA is allowing commercial feed manufacturers to print out a separate label or sticker with the guarantor's or manufacturer's information to place onto its products rather than requiring label updates and reprints immediately and may only need to consider the purchase of a label maker to comply. A basic handheld label maker may range between $10-$50, a more advanced digital label printer may range between $100 to several hundred, and high-end commercial label printers may be purchased for $1,000. It is anticipated that businesses will likely choose the lowest cost option, but even if a higher end model is selected, it is still unlikely that the minor cost threshold would be exceeded.

A review of industry market research and survey response data detailed in Section 3, concluded that chapter 16-252 WAC's rule amendment proposals may likely impose more-than-minor costs on businesses, however the time companies have to implement these changes is up until at least July 1, 2030, and the exact amount of the costs a business is likely to incur is indetermined due to the insufficient nominal data provided by the businesses completing the survey. It is assumed that businesses will choose the least expensive options to maintain product marketability, adequacy, and compliance, but even doing so may create an excess over the minor cost threshold.

The true impact of AAFCO PFLM in Washington state depends on several implementation factors and how they affect production, labeling, and the marketing of pet food. Businesses of all sizes will incur varying levels of costs to come into compliance with the new regulations and that the level of those costs are very dependent upon the number of products the business sells in Washington state. The more products a business has, the higher the costs are for the business. Businesses may exceed the minor cost threshold through one or any combination of the following:

In the 19 survey results, based on their current understanding, the respondents indicated that updates to packaging design or packaging materials alone would potentially cost several hundred dollars per product, and upwards of tens of thousands to nearly $100,000 for an array of products. WSDA has identified these two compliance areas as the most likely to cause an excess over the minor cost threshold for businesses operating under "311111" and "311119" NAICS codes. Similarly, the need to submit additional product laboratory samples for analyses may also range as provided in the survey from several hundreds of dollars per product to tens of thousands of dollars, thus making the research and development/operational consideration an additional compliance area where the minor cost threshold may be exceeded.

SECTION 5:Determine whether the proposed rule may have a disproportionate impact on small businesses as compared to the 10 percent of businesses that are the largest businesses required to comply with the proposed rule: RCW 19.85.040(1) requires WSDA to compare the cost of compliance for small businesses with the cost of compliance for the 10 percent of businesses that are the largest businesses required to comply with the proposed rules using one or more of the following as a basis for comparing costs: (a) Cost per employee; (b) cost per hour of labor; or (c) cost per $100 of sales.

To better understand the potential financial impacts and operational changes that this proposed rule adoption may posit for industry, WSDA sought to obtain survey responses from over 1,200 recipients within its subscriber list, as well as hosted several meetings and webinars. Despite efforts to gather representative economic impact data from both small and large businesses, WSDA found the overall participation skewed heavily toward small businesses. Additionally, for the few large businesses that did participate in the survey, those participants opted to provide narrative responses over nominal amounts. Further, all the large business participants answered in kind and acknowledged the fact that costs would be incurred, but that they were unable to provide any cost estimations at this time.

Without any nominal data provided by large businesses, WSDA is unable to determine whether the rule has a disproportionate impact on small businesses compared to the 10 percent of businesses that are the largest businesses required to comply with the proposed rule.

SECTION 6:If the proposed rule has a disproportionate impact on small businesses, identify the steps taken to reduce the costs of the rule on small businesses. If the costs cannot be reduced provide a clear explanation of why: AAFCO and the National Association of State Departments of Agriculture (NASDA) have recommended a regulatory discretionary period up until at least July 1, 2030, for businesses to fully incorporate the label and packaging changes to their products. Shortly after this recommendation was published, WSDA committed to the recommended transition period for labels to fully comply with PFLM regulation updates. During this period, a business can begin updating their labels with the required changes as they use up their current label inventory for each product and begin submitting PFLM compliant labels to WSDA for registration.

In the AAFCO deliberation process, all impact reductions were considered and discussed as all stakeholders were invited to be involved in the process and provide suggestions to help reduce burden while regulators ensure safety, transparency, and consistency of the proposed requirements.

RCW 19.85.030(2) requires consideration of the following methods of reducing the impact of the proposed amendment on small businesses:

(a) Reducing, modifying, or eliminating substantive regulatory requirements: In relation to its chapter 16-250 WAC rule amendment proposal, WSDA created an allowance for commercial feed manufacturers to print out a separate label/sticker with the guarantor's or manufacturer's information to be placed onto its products and may effectively eliminate the need for businesses to update and/or reprint its labels immediately. This offered interim mitigation allows businesses to:

In relation to its chapter 16-252 WAC rule amendment proposal for pet food and specialty pet food, WSDA will not require registration of both current labels that are still available on the market as well as the new PFLM compliant labels. Currently, if a product with an old version of a label is still in the channels of distribution, the registrant must register both the old and new product labels. For the proposed rule, if a registrant updates their label to the new proposed requirements, WSDA will waive the requirement for registration for the old label granted the registrant will no longer be actively printing and/or distributing the old labeled products, thus reducing a $22-$90 per product financial burden.

(b) Simplifying, reducing, or eliminating recordkeeping and reporting requirements: The proposed rule amendments do not change any recordkeeping or reporting requirements.

(c) Reducing the frequency of inspections: The proposed rules do not change the current frequency of inspections. To become a pet food and specialty pet food registrant or commercial feed licensee in Washington state, businesses must adhere to prescriptive auditing requirements in order to maintain an active and good standing status. As a result, WSDA determined that it is unable to reduce the frequency of inspections as doing so may create adverse consumer safety and trust within the industry, as well as potentially foster the harmful perception of decreased departmental oversight.

(d) Delaying compliance timetables: As noted above, WSDA has committed to AAFCO and NASDA's recommended regulatory discretionary period timeline until at least July 1, 2030, so that businesses are able to fully incorporate their label and packaging changes. This flexibility allows businesses to reduce financial burden by being able to use up their current inventory supply for each product and incorporate the necessary changes throughout their standard label reprint time frame.

(e) Reducing or modifying fine schedules for noncompliance: Any fines related to noncompliance are dictated by statute, and are therefore not able to be reduced or modified by WSDA in either rule or policy outside of the delayed discretionary enforcement process WSDA is utilizing.

(f) Any other mitigation techniques including those suggested by small businesses or small business advocates: WSDA did not receive any additional suggestions regarding mitigation techniques outside what was already suggested by stakeholders during the AAFCO deliberation process. WSDA offered workshops, webinars, and monthly newsletter blurbs/social media campaigns, in conjunction with other state agencies and AAFCO parties, to educate businesses on upcoming compliance requirements in efforts to minimize the learning curve of the upcoming changes.

Additionally, AAFCO will be curating and providing educational materials to consumers, manufacturers, sellers, and veterinarians as various states begin their implementation process. WSDA will remain current and diligent with all this information and be available to explain and/or disperse these at stakeholders' request.

SECTION 7:Describe how small businesses were involved in the development of the proposed rule: WSDA facilitated several opportunities and curated mechanisms for feedback to small businesses so that they could be involved in the rule-making process. The table below details all the industry participation opportunities that WSDA offered while drafting its proposed rule:

Table 7.1 - Stakeholder Engagement Interactions

SECTION 8:Identify the estimated number of jobs that will be created or lost as the result of compliance with the proposed rule: WSDA's adoption of AAFCO PFLM could lead to both job creation and job loss and is dependent on a wide array of factors.

In support of the notion that the proposed regulations may create jobs for currently active businesses, the following professional areas have been identified:

Additionally, the proposed regulations may benefit prospective businesses wishing to enter the industry by way of the following:

In support of the notion that the proposed regulations may cause a loss of jobs, this potential outcome may be evidenced by:

In sum, the net effect on jobs will depend on how companies adapt to the new regulations and the overall economic conditions within the pet food and commercial feed industries.

A copy of the statement may be obtained by contacting Gloriann Robinson, Rules Coordinator, P.O. Box 42560, Olympia, WA 98504-2560, phone 360-902-1802, fax 360-902-2092, TTY 800-833-6388, email WSDARulesComments@agr.wa.gov.

April 4, 2025

Luisa F. Castro

Assistant Director

RDS-5996.2

RDS-6160.3

The following section of the Washington Administrative Code is repealed: