Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
This rule regulates the use of soil fumigant pesticides containing chloropicrin or metam sodium active ingredients. This rule does all of the following:
Creates new rules to regulate the use of chloropicrin soil fumigants.
Modifies current rules regulating the use of metam sodium soil fumigants. Among other things, this rule relaxes current post-application monitoring requirements and current setback requirements for “tarped" applications.
Statutory Authority
The Wisconsin Department of Agriculture, Trade and Consumer Protection (“DATCP") has general authority to adopt rules interpreting statutes under its jurisdiction (
see s.
93.07 (1), Stats.). DATCP is specifically authorized to adopt rules under s.
94.69 (1) (i), Stats., to regulate the use of pesticides.
Background
DATCP administers Wisconsin's pesticide laws. Chloropicrin and metam sodium are soil fumigant pesticides, used mainly by potato growers to control nematodes. Under current DATCP rules, persons using metam sodium soil fumigants must take certain steps to prevent human exposure to volatilized fumigant (there are no equivalent rules for chloropicrin applications). Under current metam sodium rules:
Applicators must be properly certified.
No agricultural application may be made within ¼ mile of a hospital, nursing home, jail or prison, or within ¼ mile of a school that will be in session during the application or within 48 hours after the application.
Agricultural application sites must be covered by a tarp or other impermeable barrier, except when the soil fumigant is injected into the soil or applied by specified chemigation procedures. Application by knife rig injection is prohibited when soil temperatures are too high.
Applicators must pre-notify county public health authorities, and neighbors within ¼ mile, prior to any “chemigation" application. “Chemigation" applications must comply with specific rule standards.
Applicators must monitor application sites after the application, and must take appropriate steps to prevent pesticide drift. Applicators must notify Wisconsin emergency management if it appears that pesticide drift may contact residences or public buildings.
Applicators must keep specified records related to metam sodium applications.
Rule Contents
This rule regulates chloropicrin applications in the same way that current rules regulate metam sodium applications (see above). This rule also modifies current metam sodium regulations as follows (the same regulations will apply to chloropicrin):
For “tarped" agricultural applications, this rule reduces the required minimum setback from schools, hospitals, nursing homes, jails and prisons from 1/4 mile to 1/8 mile. For “untarped" agricultural applications, the required minimum setback remains at 1/4 mile.
The setback requirements applicable to schools are also made applicable to licensed daycare facilities. An exception is provided for an application to a plant nursery that was in existence prior to the first date the daycare facility was licensed if the nursery operator provides at least 24 hours prior notice of the application to the daycare facility operator.
This rule relaxes current follow-up monitoring requirements. Under current rules, a certified applicator must inspect the application site 4-6 hours after the application is completed and again 9-12 hours after the application is completed. Under this rule, a certified applicator must only conduct one follow-up inspection, within one hour of sunset on the day of application.
This rule updates current emergency government references, and makes other minor editorial changes.
Federal Regulations
The U.S. Environmental Protection Agency (EPA) regulates pesticides under the Federal Insecticide, Fungicide and Rodenticide Act. Pesticides must be registered with EPA. EPA registers pesticides and pesticide labels for specific uses. The pesticide manufacturer must provide safety, environmental and other data to support the registration. Pesticide labeling must conform to the EPA registration. Federal and state law prohibit sale or use inconsistent with label directions. Wisconsin and other states work with EPA to assure proper use and handling of pesticides.
States may regulate pesticide applications within their own territory. States may act on their own authority (independent of EPA), and may establish use restrictions that go beyond federal label restrictions. Wisconsin currently has restrictions on the use of metam sodium pesticides that go beyond federal label restrictions.
Surrounding State Regulations
Other states, like Wisconsin, regulate pesticide applications generally. However, none of the states surrounding Wisconsin has adopted specific requirements for metam sodium or chloropicrin applications, beyond requirements specified on the federally-approved pesticide labels.
Business Impact
Businesses Affected
This rule regulates commercial pesticide applicators and agricultural producers that apply or receive applications of metam sodium and chloropicrin soil fumigants. Many of the regulated businesses are small businesses, but others are large. Most of the regulated farmers are potato growers.
This rule protects neighboring farms and businesses from adverse effects of improper soil fumigant applications. Many of the protected businesses are small businesses.
Effects on Business
This rule imposes new regulations on the use of chloropicrin soil fumigants (see above). Approximately 71,000 acres of potatoes were planted in Wisconsin in 2004. Chloropicrin is currently applied on approximately 2,000 acres of potatoes and 25 acres of state-owned seedling nurseries in Wisconsin. Chloropicrin applications are made by commercial pesticide applicators that have the equipment and expertise to handle and apply chloropicrin. Chloropicrin-treated acreage is expected to increase due to pest problems and the efficacy of chloropicrin products.
DATCP estimates that this rule will cost $8,000 to $12,000 per year for the industry as a whole, mainly for increased costs of applying chloropicrin to approximately 2,000 acres of potatoes. Increased pesticide applicator costs will generally be passed on to farmers. Most of the farms that use chloropicrin are small businesses, but the single largest user (accounting for approximately 25% of the treated acreage) is not a small business.
This rule relaxes some current requirements related to metam sodium applications (post-application inspection requirements and setbacks for “tarped" applications). Farmers and pesticide application businesses that apply metam sodium soil fumigants may experience a small decrease in costs as a result of these changes.
By establishing clear application standards and procedures, this rule protects neighboring farms, businesses and individuals from improper applications. It also helps protect complying pesticide users from liability for offsite movement.
This rule applies to large and small businesses alike. An exemption for small business would undermine the effectiveness of the rule in preventing human exposure to metam sodium and chloropicrin. This rule will not have a significant adverse economic impact on small business. Therefore, it is not subject to the delayed small business effective date provision in s.
227.22 (2) (e), Stats.
Fiscal Impact
This rule will not have a significant fiscal impact on Wisconsin state or local government. DATCP will incur some costs for compliance monitoring. However, DATCP expects to absorb those costs. The fiscal estimate is based on the current use of chloropicrin in Wisconsin.
Environmental Impact
This rule regulates chloropicrin soil fumigant applications to prevent potentially hazardous off-site movement of volatilized chloropicrin. This will help prevent harm to human beings and sensitive animal species.
This rule will relax some current regulations related to applications of metam sodium soil fumigant (post-application inspection requirements and setbacks for “tarped" applications). However, this relaxation will not significantly reduce current safety protection, and will not have a significant adverse environmental impact.
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 on emergency rules to amend the effective date of
CR 04-095, 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 administration.
Hearing Date, Time and Location
Date: January 31, 2007
Time: 9:00 a.m.
Location: 1400 East Washington Avenue
Room 121C
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 January 31, 2007, to be included in the record of rule-making proceedings. Analysis prepared by the Department of Regulation and Licensing.
Analysis
Explanation of agency authority: The Dentistry Examining Board has the authority under s.
447.02, Stats., to establish the standards, conditions, and any educational requirements that must be met by a dentist in order to induce anesthesia in connection with the practice of dentistry. Presently, those standards are set forth in Ch.
DE 11. The adopted rules better identify the different levels of anesthesia, including nitrous oxide, anxiolysis, conscious sedation-enteral, conscious sedation-parenteral, deep sedation, and general anesthesia, and the requirements for each level. The rule is intended to ensure that practitioners are adequately trained before they induce anesthesia and that the public is sufficiently protected.
Related statute or rule: There are no related statutes or rules other than those listed above.
Plain language analysis: The purpose of this rule is to delay the effective date of
CR04-095, from January 1, 2007, to July 1, 2007. That rule establishes and modifies the training, certification and staffing requirements for administering sedation and anesthesia at all levels performed in the course of dental practice. A system of permits issued by the Department of Regulation and Licensing, which designates by class the various levels of sedation and anesthesia practice, was established. Office facility and equipment prerequisites for safe and effective administration are delineated, the applicable standards of care are specified, and the procedure necessary for reporting adverse occurrences related to anesthesia administration is described.
These requirements emerged from recent efforts 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.
Summary of, and comparison with, existing or proposed federal regulation:
No proposed or existing federal regulation intended to address oral conscious sedation currently exists.
Comparison with 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
Summary of factual data and analytical methodologies:
The Dentistry Examining Board gathered information from various entities involved in promoting oral conscious sedation and others experienced in regulating the practice. Dr. Joseph Best, Clinical Assistant Professor at Marquette University School of Dentistry, presented information to the board in March, 2003. Dr. Jason Goodchild, representing The Dental Organization for Conscious Sedation, delivered a presentation to the board in May, 2003. Initially, the board decided its focus in regulating oral conscious sedation should be on how it is advertised, how it is titrated so that overdosing is prevented, and how many hours of adequate training and what level of clinical experience should be required to administer it. The subject was further discussed at the American Association of Dental Examiners' 2003 annual meeting in San Francisco. The board held open session discussions as the rules process advanced, and legal counsel reviewed the rules of other states. Eventually the focus of the board broadened, resulting in revision of the board's anesthesia rule with sedation levels identified and a system of permits required for various levels of anesthesia.
Anticipated costs incurred by private sector:
The Department of Regulation and Licensing has determined that this rule has no significant fiscal effect on the private sector.
Fiscal Estimate
See attached.
Effect on small business:
These proposed rules will have no significant economic impact on small businesses, as defined in s.
227.114 (1) (a), Stats. The Department's Regulatory Review Coordinator may be contacted by email at
larry.martin@drl.state.wi.us, or by calling (608) 266-8608.
Agency contact person
Pamela Haack, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708-8935. Telephone: (608) 266-0495. Email:
pamela.haack@drl.state.wi.us.
Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Pamela Haack, Paralegal, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708-8935. Email
pamela.haack@drl.state.wi.us. Comments must be received on or before January 31, 2007, to be included in the record of rule-making proceedings.
TEXT OF RULE
SECTION 1. Rules adopted by the Dentistry Examining Board under
CR04-095 shall be effective July 1, 2007.
This emergency rule shall take effect on December 29, 2006.
Notice of Proposed Rule
