Statute Interpreted: s.
97.30, Stats.
DATCP has broad authority, under s.
93.07 (1), Stats., to adopt rules needed to implement laws under its jurisdiction. DATCP licenses retail food establishments under s.
97.30, Stats. DATCP may adopt rules for retail food establishments, pursuant to s.
97.30 (5), Stats. Rules may include standards for the construction and maintenance of facilities; the design, installation, cleaning and maintenance of equipment and utensils; personnel sanitation; food handling, display and storage; and food sources and food labeling.
The format of the Wisconsin Food Code is different from that of most state administrative rules. DATCP and DHFS are authorized, under s.
227.14 (1s), Stats., to use the drafting format of the federal model food code. This rule follows that authorized format.
Background
The United States Food and Drug Administration (“FDA") publishes a federal model food code. The model food code provides practical, science-based food safety standards for grocery stores, restaurants and other retail food establishments. Many states base their retail food regulations on the federal model food code.
Current DATCP and DHFS rules are based on the 1999 version of the model food code. DATCP has adopted the model food code as an Appendix to ch.
ATCP 75, Wis. Adm. Code (the Wisconsin Food Code). DHFS has adopted the model food code as an Appendix to ch.
HFS 196, Wis. Adm. Code.
FDA updated the model food code in 2001. This rule updates the Wisconsin food code based on the 2001 updates to the federal model food code. This rule also makes other minor changes and clarifications to current rules.
Rule Content
This rule makes a large number of updates and technical changes to current DATCP rules. The following are some of the more significant changes:
Food Temperatures
Under current rules, “potentially hazardous foods" must be kept sufficiently hot (or sufficiently cold) to prevent the rapid and progressive growth of infectious or toxigenic microorganisms. This rule changes the required minimum temperature of hot “potentially hazardous" foods from 140o F. to 135o F. This rule also allows cold “potentially hazardous" foods (which are normally refrigerated at 41o F. or lower) to remain unrefrigerated for up to 6 hours if certain procedures are followed.
Definitions
A restaurant is a place that prepares or serves “meals." This rule modifies the definition of “meal" so that it no longer includes individual pastry items served with a beverage. For example, a grocery store will no longer be subject to potential regulation as a “restaurant" merely because it serves doughnuts and coffee. This rule also makes a number of other technical changes to current definitions.
Food Employees
This rule clarifies current standards related to food employee health and sanitation. Among other things, this rule does the following:
-- Allows employees to contact ready-to-eat food with bare hands under certain limited conditions (special requirements apply).
-- Clarifies current provisions limiting food contact by employees affected with certain illnesses or symptoms.
-- Clarifies current requirements related to food employee hand-washing, and requires employees to wash hands before putting on gloves to work with food.
Food Safety and Labeling
This rule clarifies current standards related to the safety and labeling of food offered for sale in a retail food establishment. Among other things, this rule does the following:
-- Clarifies current requirements related to food sources.
-- Clarifies provisions related to the handling and sale of raw eggs and shellfish.
-- Requires hazard control (HACCP) procedures or warning labels for unpasteurized juice.
-- Clarifies date-marking requirements for ready-to-eat “potentially hazardous" foods.
-- Requires warning disclosures related to the sale of certain uncooked ready-to-eat foods, including uncooked meat, fish, eggs and shellfish.
Food Equipment and Utensils
This rule makes minor clarifications related to current standards for food equipment and utensils.
Water, Plumbing and Waste
This rule makes minor technical changes suggested by the Department of Commerce, Wisconsin's plumbing code agency. It also makes minor technical changes related to handwash sinks and temporary food establishments.
Buildings and Facilities
This rule does the following:
-- Prohibits facility configurations that cause the general public to enter or exit a retail food establishment through a food processing area.
-- Requires food establishments to comply with applicable provisions of the Wisconsin commercial building code.
-- Makes other minor technical changes related to standards for retail food buildings and facilities.
License Fee Correction
Current rules incorrectly set an annual license fee of $60 for retail food establishments with annual food sales of less than $25,000. This rule corrects (reduces) the license fee to $40, which is the fee established by s.
97.30(3m)(cm), Stats.
Fiscal Impact
This rule will have no significant fiscal effect on state or local government. The rule will not alter state or local retail food enforcement activities. A fiscal estimate is attached.
Business Impact
This rule affects retail food establishments such as grocery stores, bakeries and convenience stores. Many of these businesses are small businesses. This rule will benefit affected businesses by clarifying existing regulatory requirements. In some cases, this rule gives affected businesses wider latitude to choose a preferred method of compliance. This rule will not have a significant economic impact on small business, and is not subject to the delayed small business effective date provision in s.
227.22 (2) (e), Stats.
The rule adds some minor new requirements for some retail food establishments, but these requirements are not expected to impose any significant burdens. This rule will benefit businesses that have combined grocery and restaurant operations, because it will maintain consistency with DHFS restaurant rules. A small business analysis (“initial regulatory flexibility analysis") is attached.
Under
2003 Wis. Act 145, DATCP and other agencies must adopt rules spelling out their rule enforcement policy for small businesses. DATCP has not incorporated a small business enforcement policy in this rule, but will propose a separate rule on that subject. DATCP will, to the maximum extent feasible, seek voluntary compliance with this rule.
Federal Regulation
Federal law, like state law, generally prohibits the sale of adulterated or misbranded food. There are no federal regulations that specifically address retail food operations. However, FDA publishes a model food code that is based on the best available science and information related to retail food safety.
FDA, the United States Department of Health and Human Services, and the United States Department of Agriculture encourage state and local governments to adopt retail food safety regulations that are consistent with the federal model food code. The current Wisconsin Food Code is based on the 1999 edition of the federal model food code. This rule updates the Wisconsin Food Code to incorporate changes contained in the 2001 (most recent) edition of the federal model food code.
Regulatory Approach and Supporting Information
FDA developed and published the federal model food code based on the best available science and information related to retail food safety. The federal model food code encourages consistent state and local regulation of retail food establishments. Numerous states have adopted state retail food regulations based on the federal model food code. FDA periodically updates the federal model food code. FDA adopted the latest edition in 2001 and added a supplement in 2003.
The current Wisconsin Food Code is based on the 1999 edition of the federal model food code. This rule updates the Wisconsin Food Code based on the 2001 edition of the federal model food code (as supplemented in 2003). DATCP and DHFS made minor adjustments to the model food code in consultation with Wisconsin local health agencies, the Wisconsin Conference on Food Protection, and the National Conference on Food Protection. DATCP and DHFS also drew on 2 years of field experience with the current rule.
DATCP and DHFS also developed this rule in consultation with an advisory committee that included local health agencies (large and small), the Wisconsin Grocers Association, the Wisconsin Restaurant Association, the Tavern League of Wisconsin and the University of Wisconsin Extension-Food Science.
Surrounding State Programs
The states adjacent to Wisconsin have all adopted retail food regulations based on some version of the federal model food code:
Minnesota – Minnesota's current regulations are based on the 1997 edition of the federal model food code.
Iowa - Iowa's current regulations are based on the 1997 edition of the federal model food code.
Illinois – Illinois' current regulations are based on the 1995 edition of the federal model food code. Like Wisconsin, Illinois is proposing to update its regulations based on the 2001 edition of the federal model food code.
Michigan – Michigan's current regulations, like Wisconsin's, are based on the 1999 edition of the federal model food code.
Notice of Hearing
Dentistry Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Dentistry Examining Board in ss.
15.08 (5) (b). 227.11 (2) and 447.02 (2) (b), Stats., and interpreting s.
447.02 (2) (b), Stats., the Dentistry Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal ss.
DE 11.11 and
11.12; to amend s.
DE 11.02 (1) to
(4); to repeal and recreate ss.
DE 11.02 (5) and
11.03 to
11.10; and to create s.
DE 11.02 (1m),
(3m) and
(6) to
(11), relating to the requirements for administering the office facilities and equipment for safe and effective administration and the applicable standards of care, and to provide for reporting of adverse occurrences related to anesthesia.
Hearing Date, Time and Location
Date: November 3, 2004
Time: 9:00 a.m.
Location: 1400 East Washington Avenue
Room 179A
Madison, Wisconsin
Appearances at the Hearing
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Regulation and Licensing, Office of Administrative Rules, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received by November 15, 2004, to be included in the record of rule-making proceedings. Analysis prepared by the Department of Regulation and Licensing.
Analysis
The purpose of this rule is to establish and modify the requirements for administering the office facilities and equipment required for safe and effective administration and the applicable standards of care, in addition to providing for reporting of adverse occurrences related to anesthesia administration.
These requirements are part of a recent attempt by state licensing boards to regulate “oral conscious sedation." Oral conscious sedation drugs are being marketed to dentists for the purpose of managing patient anxiety surrounding dental work in patients that remain conscious throughout the procedure. There are inherent risks to public health and safety that must be managed.
SECTIONS 1, 2, 3, 4, 5, 6 and 7 add new definitions for “anxiolysis," various levels of sedation, types of sedation, routes of sedation and sedation levels; and amends definitions of “local anesthesia," “conscious sedation" and “direct supervision."
SECTION 8 establishes and modifies requirements for administering levels 1 and 2 nitrous oxide or oxygen inhalation analgesia, level 3 enteral conscious sedation, level 3 parenteral sedation, and levels 4 and 5 deep sedation and general anesthesia. It further establishes the requirements for conforming the office facilities and equipment required for safe and effective administration and the applicable standards of care, e.g. emergency preparedness, in addition to providing for reporting of adverse occurrences related to anesthesia administration. In addition to the supervision levels set forth in this section, a permit requirement is added. Finally, the section adds a reporting requirement for dentists for any mortality or other incident resulting in any physical or mental injury that requires hospitalization if that event occurred as a result of anesthesia administration regulated by this chapter.
SECTION 9 repeals ss. DE 11. 11 and 11.12.
A comparison with any existing or proposed federal regulation:
No proposed or existing federal regulation intended to address oral conscious sedation currently exists.
A comparison of similar rules in adjacent states:
Illinois
The Illinois Dental Practice Act contains specific provisions governing anesthesia. Permits are required for the administration of conscious sedation. Dentists are required to have specialized training and office facilities must contain certain equipment Adverse occurrences are also required to be reported. Permits must be renewed biennially. Additional information is available at the Illinois website:
http://www.ildpr.com/WHO/ARpropsd/WEBdentrules.pdf
Indiana
The Indiana State Board of Dentistry requires dentists to obtain a permit prior to administering general anesthesia, deep sedation, or light parenteral conscious sedation. Education and training are required to obtain such permits. Permits must be renewed biennially. Five hours of continuing education are required for permit renewal. Certain emergency equipment is also required. Additional information is available at Indiana's website:
http://www.ai.org/legislative/iac/T08280/A00030.PDF
Iowa
The Iowa Board of Dental Examiners requires a permit for the administration of deep sedation, general anesthesia, and conscious sedation. Dentists are required to have specialized training and office facilities must contain certain equipment. Adverse occurrences are also required to be reported Six hours of continuing education are required for permit renewals. Additional information is available at Iowa's website:
http://www.legis.state.ia.us/Rules/Current/iac/650iac/65029/65029.pdf
Michigan
Minnesota
The Minnesota Board of Dentistry has rules governing general anesthesia and conscious sedation. Education and training are required for both. However, no special permit is issued. Additional information is available at Minnesota's website:
http://www.revisor.leg.state.mn.us/arule/3100/3600.html
