Title of Regulation: 12VAC5-421. Food Regulations (amending 12VAC5-421-3815).

Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: October 2, 2019.

Effective Date: October 17, 2019.

Agency Contact: Julie Henderson, Director of Food and General Environmental Services, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7455, FAX (804) 864-7475, TTY (800) 828-1120, or email julie.henderson@vdh.virginia.gov.

Basis: Section 35.1-3 of the Code of Virginia provides the State Health Commissioner the same regulatory authority as the State Board of Health when the board is not in session. Such authority is subject to rules and regulations as may be prescribed by the board. Sections 35.1-11 and 35.1-14 of the Code of Virginia authorize and require the board to promulgate and enforce regulations governing restaurants in accordance with the provisions of Title 35.1 of the Code of Virginia. The board's authority to regulate is mandatory rather than discretionary.

Purpose: 12VAC5-421-3815 A of the food regulations references the 2014 edition of the "Virginia Department of Health Procedures for Certification and Standardization of Retail Food Protection Staff." The purpose of the standard is to promote uniformity of regulatory food inspections throughout the Commonwealth and outline the process of training (field and classroom) that is required of environmental health staff who perform regulatory inspections of food establishments to protect public health. Updating the standard ensures the standardization process meets industry standards (Conference for Food Protection), guidance from the U.S. Food and Drug Administration (FDA), and conforms with current Virginia Department of Health (VDH) policies. The new edition includes (i) clarification of the prerequisite training required to enroll in the standardization process, (ii) an update of terminology to reflect changes adopted from the 2013 FDA Food Code, (iii) revision of scoring and "level of agreement" regarding evaluation of standardization candidates, (iv) an update to and clarification of provisions to maintain standardization, and (v) an update to and revision of forms used in the standard.

Rationale for Using Fast-Track Rulemaking Process: The proposed amendment updates a document incorporated by reference, which applies only to VDH staff. The new edition of the document provides clarification of expectations of environmental health staff undergoing or maintaining their standardization status and does not have an adverse impact on the regulatory community. Therefore, VDH believes the proposed change will be noncontroversial, allowing use of the fast-track rulemaking process.

Substance: The proposed amendment updates 12VAC5-421-3815 A from "the Virginia Department of Health Procedures for Certification and Standardization of Retail Food Protection Staff, 2014," to "the Virginia Department of Health Procedures for Certification and Standardization of Food Inspection Staff, 2017 edition."

Issues: The primary advantage to the public and the agency or Commonwealth is in providing transparency as to the training standards of environmental health staff who conduct regulatory inspections of food establishments, which is information included in the updated edition of the document. VDH is providing the public, which includes the regulated community and interested stakeholders, detailed information regarding the criteria the department uses to determine if environmental health staff conducting regulatory inspections of food establishments have the knowledge, skills, and ability to adequately perform their duties. The proposed regulatory action poses no disadvantage to the public or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

The State Board of Health (Board) proposes to replace a reference to its internal document for procedures, certification, and standardization of retail food inspections with the updated 2017 version.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The current regulation incorporates by reference an internal document for procedures, certification, and standardization of retail food inspections created for food inspection staff to follow and to be trained. The Board proposes to update the reference from the 2014 version of that document to the 2017 version. According to the Virginia Department of Health (VDH), the 2017 document incorporates changes adopted from the Food and Drug Administration (FDA) Procedures for Standardization of Retail Food Safety Officers (2015 FDA Standard) and the 2013 FDA Food Code. For example, the new document incorporates the procedures for new federal rules about certified food protection manager, clean-up of vomiting and diarrheal events, using a non-continuous cooking process for raw animal foods, etc. These updates in the document are not expected to create any compliance costs as they are already implemented under the federal authority. However, the proposed amendments are beneficial in that the new document incorporates procedures for new federal requirements for training and enforcement of the existing rules. One of the changes in the document establishes a new requirement for one-time training course, "Environmental Assessment of Foodborne Illness Outbreaks," for certificates that expire January 1, 2018, and thereafter. This course addresses the role of environmental assessments within the broader context of outbreak investigations and the food safety system. According to VDH, the skills needed to participate in an outbreak investigation are different from those needed to inspect restaurants and the role of environmental health staff is critical. The course is designed specifically for environmental health professionals and food safety program officials in government agencies, as well as those from scientific, industry, and consumer groups. It focuses on practice of critical skills through simulated exercises, such as interviewing food workers and conducting an environmental assessment of a restaurant implicated in an outbreak; how to investigate foodborne illness outbreaks as a member of a larger outbreak response team; how to identify an outbreak's environmental causes; and what to recommend as appropriate control measures. As of December 14, 2018, 208 staff members have not completed the course. The new training course requirement would require VDH to devote some of its existing resources to offer it online and require inspection staff's time (8-10 hours) to take it. This course would likely improve inspection staff's ability to assess and respond to foodborne illness outbreaks.

Businesses and Entities Affected. This regulation pertains to approximately 230 local health department staff and 37 district standardization officers in Virginia.

Localities Particularly Affected. The proposed amendments would not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments would not affect employment.

Effects on the Use and Value of Private Property. The proposed amendments would not affect the use and value of private property.

Real Estate Development Costs. The proposed amendments would not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments would not have costs or other effects on small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments would not impose adverse impacts on small businesses.

Adverse Impacts:

Businesses. The proposed amendments would not impose adverse impacts on businesses.

Localities. The proposed amendments would not adversely affect localities.

Other Entities. The new training course requirement would require VDH to devote resources to offer it and require inspection staff's time to take it.

Agency Response to Economic Impact Analysis: The Virginia Department of Health concurs with the Department of Planning and Budget's economic impact analysis.

Summary:

The amendment updates a document incorporated by reference.

12VAC5-421-3815. Competency of environmental health specialists.

A. An authorized representative of the commissioner who inspects a food establishment or conducts plan review for compliance with this chapter shall have the knowledge, skills, and ability to adequately perform the required duties. For the purposes of this section, competency shall be demonstrated when an environmental health specialist meets the training and standardization requirements specified in the Virginia Department of Health Procedures for Certification and Standardization of Retail Food Protection Staff, 2014, 2017 edition (VDH, Division of Food and Environmental Services).

B. The regulatory authority shall ensure that authorized representatives who inspect a food establishment or conduct plan review for compliance with this chapter have access to training and continuing education as needed to properly identify violations and apply this chapter.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-421)

Approved Drug Products with Therapeutic Equivalence Evaluations, 34th Edition, 2014, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs at http://www.fda.gov/cder/ob/default.htm

Grade "A" Pasteurized Milk Ordinance, 2013 Revision, U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835

Interstate Certified Shellfish Shippers List (updated monthly), published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Seafood (HFS-417), 5100 Paint Branch Parkway, College Park, MD 20740-3835

National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 2013 Revision, U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Seafood (HFS-417), 5100 Paint Branch Parkway, College Park, MD 20740-3835

NSF/ANSI 18-2012 Manual Food and Beverage Dispensing Equipment, 2012, NSF International, 789 North Dixboro Road, P.O. Box 130140, Ann Arbor, MI 48113-0140, www.nsf.org

Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, Conference for Food Protection, 30 Elliott Court, Martinsville, IN 46151-1331

United States Standards, Grades, and Weight Classes for Shell Eggs, AMS-56, effective July 20, 2000, U.S. Department of Agriculture, Agricultural Marketing Service, Poultry Programs, STOP 0259, Room 3944-South, 1400 Independence Avenue, SW, Washington, DC 20250-0259

VDH Procedures for Certification and Standardization of Retail Food Protection Staff Workbook, 2014, Virginia Department of Health, Division of Food and Environmental Services, 109 Governor Street, 5th Floor, Richmond, VA 23219

VDH Procedures for Certification and Standardization of Food Inspection Staff, 2017, Virginia Department of Health, Division of Food and Environmental Services, 109 Governor Street, 5th Floor, Richmond, VA 23219