Rule-making notices
Notice of Hearing
Agriculture, Trade and Consumer Protection
The State of Wisconsin Department of Agriculture, Trade, and Consumer Protection (DATCP) announces that it will hold a public hearing on a rule which will repeal and recreate DATCP's current rules related to the manufacture and distribution of fertilizer and soil or plant additives. This rule clarifies standards and procedures related to all of the following:
•
Licensing manufacturers and distributors.
•
License and tonnage fees (this rule does not increase fees).
•
Product labeling and ingredient guarantees.
•
Permits for low-nutrient mixed fertilizers and soil or plant additives.
•
Substantiation of performance claims.
•
Product sampling and analysis.
•
Toxic contaminants.
•
Enforcement and appeals.
DATCP will hold three public hearings at the times and places shown below. DATCP invites the public to attend the hearings and comment on the proposed rule. Following the public hearing, the hearing record will remain open until
Wednesday, March 2, 2005 for additional written comments. Comments may be sent to the Division of Agricultural Resource Management at the address below or by e-mail to
lorett.jellings@datcp.state.wi.us.
WI Department Agriculture, Trade, & Consumer Protection
Division of Agricultural Resource Management
2811 Agriculture Drive
Madison, WI 53708-8911
Telephone: (608) 224-4545
Copies will also be available at the public hearing.
To provide comments or concerns relating to small business, please contact DATCP's small business regulatory coordinator Keeley Moll at the address above, by e-mail at
Keeley.Moll@datcp.state.wi.us or by telephone at (608) 224-5039.
Hearing impaired persons may request an interpreter for these hearings. Please make reservations for a hearing interpreter by Thursday, January 27, 2005 by writing to Kris Gordon, Division of Agricultural Resource Management, 2811 Agriculture Drive, Madison, WI 53708-8911, telephone (608) 224-4509. Alternatively, you may contact the DATCP TDD at (608) 224-5058. Handicap access is available at the hearings.
Hearing Locations:
Tuesday, February 15, 2005, 2:00 p.m. to 9:00 p.m.
Green Bay Regional State Office Building
200 N. Jefferson Street
Green Bay, WI 54301
Thursday, February 17, 2005, 2:00 p.m. to 9:00 p.m.
Prairie Oak State Office Building
2811 Agriculture Drive
Board Room
Madison, WI 53708
Tuesday, February 22, 2005, 2:00 p.m. to 9:00 p.m.
Eau Claire Regional State Office Building
3610 Oakwood Hills Parkway
Eau Claire, WI 54701-7754
Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
The Department of Agriculture, Trade and Consumer Protection (“DATCP") regulates the manufacture and sale of
fertilizer and
soil or plant additives, as required by ss.
94.64 and
94.65, Stats. DATCP regulates to protect farmers, consumers and honest competitors against unfair and deceptive sales practices. Regulation is designed to prevent fraudulent sales of worthless products, deceptive ingredient and performance claims, and latent safety hazards.
Under current law, companies must be licensed to manufacture or distribute fertilizer and soil or plant additives in this state. License holders file annual tonnage reports and pay tonnage fees. Product-specific permits are required for low-nutrient mixed fertilizers, and for soil or plant additives. Permit applicants must submit product labels, and must be able to justify label claims.
This rule repeals and recreates DATCP's current rules related to the manufacture and distribution of fertilizer and soil or plant additives. This rule clarifies standards and procedures related to all of the following:
•
Licensing manufacturers and distributors.
•
License and tonnage fees (this rule does not increase fees).
•
Product labeling and ingredient guarantees.
•
Permits for low-nutrient mixed fertilizers and soil or plant additives.
•
Substantiation of performance claims.
•
Product sampling and analysis.
•
Toxic contaminants.
•
Enforcement and appeals.
This rule does not regulate the application of fertilizer or soil or plant additives. This rule exempts, from regulation, a farmer who sells unpackaged manure produced on his or her farm. This rule also exempts federally listed “organic" products from permit requirements (and from certain labeling and substantiation requirements) under this rule.
DATCP developed this rule in consultation with an advisory committee including agricultural producers, product manufacturers and distributors, “organic" industry representatives, and University of Wisconsin experts.
Statutory Authority
DATCP regulates the manufacture and sale of
fertilizer under s.
94.64, Stats. A
fertilizer is a substance that contains one or more recognized plant nutrients, is used for its plant nutrient content, and is designed for use or claimed to have value in promoting plant growth. The fertilizer law does not apply to “unmanipulated" manure, liming materials or other exempt products. Under the fertilizer law:
•
DATCP licenses fertilizer manufacturers and distributors, regulates fertilizer labeling and sales practices, issues permits for low-nutrient mixed fertilizers, regulates deceptive labeling claims, and tests products for compliance with ingredient guarantees.
•
DATCP collects license, permit and tonnage fees, and allocates fee revenues (according to a statutory formula) for program administration, environmental cleanup and research.
•
DATCP may deny, suspend or revoke licenses or permits, impose license or permit conditions, issue holding orders to prevent the sale of adulterated or misbranded fertilizer, and pursue court action against law violators.
•
DATCP may adopt rules, under s.
94.64 (1) (p),
(3m) (a) 1. and
(9), Stats., related to this regulatory program. DATCP also has general rulemaking authority under s.
93.07 (1), Stats.
DATCP regulates the manufacture and sale of
soil or plant additives under s.
94.65, Stats. A
soil or plant additive is a substance (other than a fertilizer) which is intended for application to seeds, soil or plants, and which is designed for use or claimed to have value in promoting or sustaining plant growth, improving crop yield or quality, promoting or sustaining the fertility of soil, or favorably modifying the structure, physical or biological properties of the soil for agronomic or horticultural purposes. The soil or plant additive law does not apply to “unmanipulated" manure, fertilizer, registered pesticides, liming materials or other exempt products. Under the soil or plant additive law:
•
DATCP licenses product manufacturers and distributors, regulates product labeling and sales practices, issues permits for individual products, regulates deceptive labeling claims, and tests products for compliance with ingredient guarantees.
•
DATCP collects license, permit and tonnage fees, and allocates fees (according to a statutory formula) for program administration, environmental cleanup and research.
•
DATCP may deny, suspend or revoke licenses or permits, impose license or permit conditions, issue holding orders to prevent the sale of adulterated or misbranded products, and pursue court action against law violators.
•
DATCP may adopt rules, under s.
94.65 (1) (a) 2. and
(f),
(5) (g) and
(9), Stats., to implement this regulatory program. DATCP also has general rulemaking authority under s.
93.07 (1), Stats.
DATCP also regulates hazardous substances and consumer product safety under ss.
100.37 and
100.42, Stats. Under these statutes, DATCP may regulate products (including fertilizers or soil or plant additives) that may pose latent safety hazards under foreseeable use conditions.
Rule Contents
License to Manufacture or Distribute
Under current law, a person must have an annual license to manufacture or distribute fertilizers, and a separate license to manufacture or distribute soil or plant additives. This rule clarifies current licensing requirements and procedures.
This rule exempts certain persons from licensing. For example, this rule exempts a farmer who sells unpackaged manure for application to land covered by a nutrient management plan, regardless of whether the manure is “manipulated." This rule also exempts persons who merely sell ingredients to licensed manufacturers, or distribute the packaged and labeled products of license holders.
A person must apply for a license on a form provided by DATCP. The person must include the required license information and fees, and must identify any low-nutrient mixed fertilizers or soil or plant additives for which product-specific permits are required (see below).
DATCP must normally grant or deny a license application within 45 working days after DATCP receives a complete license application. If DATCP denies a license application, or issues a conditional license, it must give its reasons.
License holders are currently required to pay annual license fees (based on number of business locations). License holders must also file confidential annual tonnage reports with DATCP, and pay tonnage fees based on product tonnage distributed in this state. Fee revenues are allocated according to a statutory formula for program administration, environmental cleanup and research. This rule does not change current license or tonnage fees, or the allocation of fee revenues.
Product-Specific Permits
Under current law, a license holder must have a product-specific permit to distribute a low-nutrient mixed fertilizer (in which the sum of the guarantees for primary plant nutrients is less than 24%) or a soil or plant additive. This rule exempts, from these permit requirements, a federally listed “organic" product that is labeled solely for organic crop production (see below).
An application for a product-specific permit must include all of the following:
•
Proposed product labeling. The product label must include recommended uses and use directions to ensure effectiveness.
•
A fee of $25 for a fertilizer and $100 for a soil or plant additive (this rule does not change current fees).
The applicant must certify all of the following in the application:
•
The product is effective and useful for labeled purposes when applied under Wisconsin conditions according to label directions.
•
The applicant has reliable information to substantiate product labeling, including content guarantees. The applicant must specify a lab method for testing the amount of each active ingredient guaranteed on the product label.
•
The applicant has relevant scientific evidence to substantiate product performance claims.
The applicant is not required to submit substantiating information unless DATCP requests that information. DATCP may review a permit application to the extent that it deems appropriate. DATCP may review:
•
Product labeling.
•
Product efficacy, under Wisconsin conditions, when the product is used according to label directions.
•
Product content and performance claims. DATCP may determine whether claims are truthful and properly substantiated. DATCP may also review lab methods used to determine product contents.
•
Possible health, safety and environmental hazards (and hazard labeling).
DATCP has 30 working days to determine whether an application is complete. If an application is incomplete, DATCP must tell the applicant what is needed to complete the application. If the applicant fails to complete the application within 30 days, DATCP may deny the application.
DATCP must grant or deny an application within 60 working days after the applicant submits a complete application, unless DATCP reasonably finds that a supplementary review is necessary (for example, DATCP might request substantiation of performance claims that appear to be false or exaggerated). DATCP must identify the scope of any supplementary review, the reasons for the supplementary review, and any additional information requested of the applicant. DATCP must complete the supplementary review as soon as reasonably possible, but not more than 120 days after DATCP receives the requested information.
When the supplementary review is complete, DATCP must grant or deny the permit. DATCP may impose conditions on a permit as necessary (for example, DATCP may require the applicant to change false label claims).
DATCP currently processes 350 to 400 permits each year. In some cases, where there are serious concerns related to product efficacy or label claims, DATCP consults with university experts and evaluates available scientific evidence.
Fertilizer Labeling
This rule clarifies current fertilizer labeling requirements. Under this rule, all packaged fertilizer must be clearly and conspicuously labeled with the following information:
•
The name and address of the licensed manufacturer or distributor.
•
The fertilizer product name.
•
The fertilizer “grade." This is a shorthand statement of primary plant nutrient contents. Primary plant nutrients are nitrogen (N), available phosphate (P2O5) and soluble potash (K2O), commonly designated as N-P-K.
•
A “guaranteed analysis" of primary nutrients, secondary nutrients, micro-nutrients and enhancing elements, if any. The guaranteed analysis must be presented in a standard format. Guarantees must be expressed as minimum percentages by weight of the fertilizer. Supplementary information is required in some cases.
•
The net weight of the fertilizer contained in the package.
•
Any statements or disclaimers required by this rule.
A manufacturer or distributor of bulk (unpackaged) fertilizer must provide similar information related to each bulk fertilizer delivery, on a written label statement that accompanies the delivery. The label statement must also indicate the delivery date, the name and address of the recipient, and the weight of the delivery.
A manufacturer who “custom-mixes" bulk fertilizer according to the purchaser's specifications may provide the purchaser with a written statement listing the weight and grade of each ingredient, rather than the grade and guarantee of the finished product, unless the purchaser contracts for a specified grade of finished product.
Under current rules, a person who sells bulk agricultural fertilizer to a landowner must record (and keep for 2 years) the name and address of the nutrient management planner who prepared the landowner's nutrient management plan (if any). This rule does not change that requirement.
Soil or Plant Additive Labeling
This rule clarifies current labeling requirements for soil or plant additives. Soil or plant additives must be clearly and conspicuously labeled with the following information:
•
The name and address of the licensed manufacturer or distributor.
•
The product name.
•
The net weight or liquid measure of the package or bulk delivery.
•
The purposes for which the soil or plant additive is recommended.
•
Complete use directions to ensure that the product is effective and useful under Wisconsin conditions. The use directions must include the recommended application sites, methods, rates and frequencies. If effectiveness depends on use with other products or practices, that must be disclosed.
•
A “guaranteed analysis."
•
Supplementary disclosures, if applicable.
The “guaranteed analysis" must list all active and inert ingredients in a standard format. The amount of each active ingredient must be guaranteed as a percentage by weight of the soil or plant additive, unless the active ingredient is a microorganism. If microorganisms are claimed as active ingredients, the label must identify the type of microorganism and must guarantee the number of viable microorganisms per milliliter of liquid product or per gram of non-liquid product.
A federally listed “organic" product need not be labeled with recommended uses or use directions, provided the product is designed and labeled solely for organic crop production (see below). Product labeling must comply with other requirements under this rule. A manufacturer or distributor may not make any untrue, deceptive or misleading claims for the product.
Implied Warranty
A person who distributes a low-nutrient mixed fertilizer or soil or plant additive implicitly warrants that the product is effective for all of the purposes recommended in the product labeling, when applied under Wisconsin conditions according to label directions. This warranty does not apply to federally listed “organic" products that are designed and labeled solely for organic crop production (see below).
Combination Products; Labeling
Combination products (fertilizers or soil or plant additives combined with each other, or with pesticides, seed or liming materials) must be labeled according to this rule and other applicable regulations. For example, fertilizer-pesticide combinations (such as “weed and feed" products) must be labeled according to this rule and applicable pesticide rules.
Substantiating Label Claims
Manufacturers and distributors of fertilizers or soil or plant additives must have:
•
Relevant and reliable information to substantiate product labeling, including product content claims.
•
Relevant scientific evidence to substantiate performance claims made for low-nutrient mixed fertilizers or soil or plant additives. The evidence must substantiate the performance claims under Wisconsin conditions, when the product is applied according to label directions.
Manufacturers and distributors must have substantiation for label claims before they make those claims. DATCP may require a manufacturer or labeler to submit substantiating information. This rule spells out standards for scientific substantiation of performance claims (for example, mere “testimonials" do not qualify).
“Organic" Products
This rule exempts federally listed “organic" products from permit requirements and certain labeling requirements under this rule (see above) if all of the following apply:
•
The product is listed for organic crop production under federal law, or is approved for organic crop production by a federally-accredited certifying agency (and the product label so states).
•
The product label states that “This product is intended for use according to an approved organic system plan."
•
The manufacturer or distributor makes no performance claims for the product.
Although federally listed “organic" products are exempt from some requirements under this rule, they must comply with other requirements. Sellers must be licensed by DATCP, and must label product contents according to this rule. A seller may not make false, deceptive or misleading claims.
Product Sampling and Testing
DATCP may collect and test product samples to determine compliance with content guarantees. For these “official tests," DATCP will use sampling and test methods prescribed in this rule.
Content Deficiencies
A fertilizer is mislabeled if an “official test" shows any of the following:
•
The fertilizer contains less than 90% of the label guarantee for any primary nutrient.
•
The actual percentage amount of any primary nutrient falls at least 2 percentage points short of the percentage amount stated on the label.
•
The economic value of primary nutrients actually present is less than 98% of the “economic value" of the amounts guaranteed (“economic value" is calculated according to this rule).
•
The amount of any secondary nutrient, micronutrient or enhancing element falls short of the label guarantee by an amount specified in this rule.
A soil or plant additive is mislabeled if an “official test" shows that it contains less than 98% of the amount of any active ingredient guaranteed on the label.
Toxic Substances
No product may contain any of the following:
•
Toxic concentrations of metals (toxic concentrations are specified in this rule).
•
A substance that is toxic or injurious to plants, animals or humans when the fertilizer or soil or plant additive is handled or applied under reasonably foreseeable use conditions, unless the substance and its hazards are identified on the product label.
Special Provisions
This rule includes specific regulations or disclosure requirements related to:
•
Fertilizer labeled for foliar application.
•
Phosphite or phosphorus acid.
•
“Humic substances" in soil or plant additives.
Prohibitions
Under this rule:
•
No person may misrepresent or falsify any license or permit application, or any other information filed with DATCP under this rule.
•
No person may do any of the following in connection with the labeling, promotion or distribution of any fertilizer or soil or plant additive:
- Make any statement that is false, deceptive or misleading.
- Make any statement that is inconsistent with the product label.
- Represent that a product contains a plant nutrient or other substance, unless the “guaranteed analysis" includes a guarantee for that substance.
- Make any statement or warranty that is not substantiated, to the extent required under this chapter, at the time the statement or warranty is made.
- State or imply that DATCP endorses or warrants the product.
- Make any performance claim, for a product distributed under permit, that is contrary to the product label contained in the approved permit application.
Enforcement
DATCP may take the following actions against rule violators, as appropriate (per current law):
•
Deny, suspend, revoke, or impose conditions on a license or permit (the affected manufacturer or distributor may demand a formal administrative hearing).
•
Issue holding orders to prevent the sale or movement of illegal products.
•
Prosecute violators in court (seizure actions, injunctions, restitution, civil forfeitures or criminal penalties).
Standards Incorporated by Reference
Pursuant to s.
227.21, Stats., DATCP will request permission from the attorney general and the revisor of statutes to incorporate the following standards by reference in this rule:
•
Fertilizer terms defined in the Official Publication of the Association of American Plant Food Control Officials, No. 57 (2004).
•
Fertilizer sample collection methods specified in the Inspectors Manual of the Association of American Plant Food Control Officials, 6th edition (1999).
•
Fertilizer test methods specified in the “Official Methods of Analysis of AOAC International," volume I, 17th edition as updated by the 2nd revision (2003).
•
Statement of uniform interpretation and policy 25, related to heavy metal concentrations in fertilizer, contained in the Official Publication of the Association of American Plant Food Control Officials, No 57 (2004).
•
Standard chemical names listed in the Merck Index, 12
th edition (1996).
Copies of the standards will be kept on file with DATCP, the secretary of state and the revisor of statutes. Copies may be obtained from the publishing organizations.
Fiscal Impact
This rule will have no fiscal impact on DATCP or local units of government. This rule will clarify current regulations, and improve program administration. DATCP does not anticipate any additional costs or staffing needs. A complete fiscal estimate is attached.
Business Impact
This rule will protect farmers, consumers and honest competitors against unfair and deceptive sales practices. This rule is designed to prevent fraudulent sales of worthless or hazardous products. It is also designed to prevent deceptive labeling claims that may mislead purchasers or give sellers an unfair competitive advantage.
There are approximately 540 persons licensed to manufacture or distribute fertilizers or soil or plant additives in Wisconsin. Up to 30% of these license holders may be small businesses. Affected businesses include farm centers and cooperatives, lawncare businesses, and manufacturers of nonagricultural and specialty fertilizers.
This rule will have few, if any, adverse impacts on business. This rule will not increase fees and, for most honest businesses, will not increase costs. For the most part, this rule merely clarifies current requirements and procedures. However, this rule may require some businesses to modify their labels, or be more diligent in substantiating label claims.
The fertilizer industry serves about 30,000 Wisconsin farmers, many of whom are small businesses. This rule will benefit farmers, by preventing unfair and deceptive sales practices. This rule will facilitate farmer-to-farmer sales of manure, by expanding the current exemption for “unmanipulated" manure and creating an exemption for “manipulated" manure sold for application under a nutrient management plan.
This rule makes special allowance for sellers of federally listed “organic" fertilizers and soil or plant additives. Federally listed “organic" products are exempt from permit requirements, and from certain labeling requirements, if they are designed and labeled solely for use in organic crop production (basic licensing and labeling requirements will still apply). Sellers may not make false, deceptive or misleading claims for “organic" products.
Because this rule will not have a significant adverse impact on small business, it is not subject to the delayed small business effective date provision in s.
227.22 (2) (e), Stats.
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.
Environmental Impact
This rule will have no adverse environmental impact. This rule will clarify the licensing, permitting and labeling requirements for fertilizer and soil or plant additive products. This rule will help prevent environmental and safety hazards associated with some products. A complete environmental assessment is attached.
Federal Regulation
There is no significant federal regulation of fertilizers or soil or plant additives, although there is a long history of regulation by states (see below).
The United States department of agriculture (USDA) has established rules for “organic" crop production. USDA rules list fertilizers and soil or plant additives that are suitable for “organic" crop production, and accredits private organizations that may approve other “organic" products. This rule exempts these federally listed “organic" products from permit requirements and certain labeling requirements under this rule (see above).
Surrounding State Regulation
General
States have historically regulated fertilizer and soil or plant additives to prevent fraudulent sales of worthless products, and to protect farmers, consumers and honest competitors against unfair and deceptive practices.
State fertilizer regulators have organized a national Association of American Plant Food Control Officials (AAPFCO). AAPFCO promotes uniform state laws related to fertilizers, soil or plant additives (also known as soil amendments), and liming materials used to correct soil acidity. Most states, including Wisconsin and surrounding states, follow AAPFCO principles and have similar basic laws. However, there is some variation in laws from state to state.
Fertilizer laws tend to be more standardized than soil or plant additive laws. Wisconsin's soil or plant additive law is similar to laws in Minnesota and Iowa. Illinois has little regulation of soil or plant additives. Michigan's law is similar to those in Wisconsin, Minnesota and Iowa, but is narrower in scope (it exempts various biological and hormone products).
Basic Fertilizer Regulation
Wisconsin and adjoining states have similar basic fertilizer laws, based on AAPFCO models. Wisconsin and adjoining states require similar labeling, and use similar terms and definitions (typically drawn from AAPFCO). There are minor variations between states.
Manure Sales
Fertilizer laws vary in their treatment of manure. All states exempt “unmanipulated" manure from the definition of fertilizer, but there is uncertainty related to the definition of “unmanipulated" manure and the treatment of bulk manure sales sales (including, for example, sales of farm-dried or farm-composted manure). Iowa licenses distributors of “bulk dry animal nutrient products" and has mechanisms to make purchasers aware of nutrient contents. Minnesota licenses commercial animal waste technicians and, effective in 2005, will certify private manure applicators. Illinois and Michigan do not address the issue.
This rule clarifies that manure is “unmanipulated" (and thus exempt from rule coverage) if it is modified solely for purposes of on-farm storage, handling, animal husbandry or odor control, rather than commercial sales. This rule also exempts unpackaged “manipulated" manure sold for use on land covered by a nutrient management plan (this exemption is not available in other states). This exemption does not apply to sales of packaged “manipulated" manure.
Nutrient Content
Wisconsin and all adjoining states, except Minnesota, require minimum percentage guarantees for primary plant nutrients (N-P-K) in mixed fertilizers sold for general agricultural use. The minimum percentage is 24% in Wisconsin, 20% in Illinois and Michigan, and 21% in Iowa (most mixed fertilizers actually have much higher guarantees).
Wisconsin allows sales of low-nutrient mixed fertilizers (below 24%) for specialized agricultural use or nonagricultural use, but only with a permit. Illinois, Michigan and Iowa allow sales only for nonagricultural use (Iowa also allows foliar fertilizers and composts for organic crop production).
The adjoining states require annual permits for nonagricultural fertilizer products (Iowa requires a one-time permit). Wisconsin requires one-time (not annual) permits, and only for low-nutrient products. This rule exempts federally listed “organic" products from the Wisconsin permit requirement. Wisconsin and Iowa spell out procedures for granting and suspending permits (other states are less clear).
Tonnage Reports and Fees
Wisconsin and adjoining states require fertilizer tonnage reports and tonnage fees. Wisconsin requires once-per-year reporting, whereas adjoining states require monthly (IL) or semi-annual (MN, IA, MI) reporting. Wisconsin tonnage fees are higher than surrounding states. Wisconsin is somewhat unique in using tonnage fees to fund environmental cleanup and research, as well as program administration. This rule does not change current tonnage fees.
Use Directions
This rule requires use directions on low-nutrient mixed fertilizers (not other fertilizers) and on soil or plant additives. The AAPFCO model requires use directions for all packaged fertilizers, and Minnesota requires use directions on all nonagricultural fertilizers. Other states do not require use directions, but prohibit agricultural sales of low-nutrient mixed fertilizers (with limited exceptions in Iowa). Minnesota, Iowa and Michigan, like Wisconsin, regulate soil or plant additives to ensure efficacy, and some states require use directions.
Nutrient Guarantees
Wisconsin's label format for fertilizer guarantees is consistent with surrounding states. All states use the AAPFCO model format, and identify the elements or compounds that qualify as recognized plant nutrients.
Labeling Combination Products
This rule clarifies the labeling of products that combine fertilizer and soil or plant additive materials. Although DATCP frequently encounters products of this type, neither AAPFCO nor any adjoining state provides any labeling guidance.
Hazard or Caution Statements
This rule requires hazard or caution statements for certain fertilizers that may be toxic to plants or animals, consistent with the current AAPFCO model rule. Iowa, Illinois and Minnesota follow an earlier draft of the AAPFCO model rule, which specifies precautionary statements for boron or molybdenum.
This rule also prohibits excessive concentrations of heavy metals, consistent with an AAPFCO policy statement. Other states do not specifically address this toxicity concern, except to a very limited extent.
Sample Collection and Analysis
Wisconsin and all adjoining states collect and analyze samples to check for compliance with label guarantees. AAPFCO establishes standard sampling methods and product tolerances that take account of manufacturing variability. This rule follows the AAPFCO model, but allows greater tolerances for individual nutrient guarantees. Other states vary in their approach.
Notice of Hearing
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss.
15.08 (5) (b),
227.11 (2) and
450.02 (3) (b) and
(d), Wis. Stats., and interpreting s.
450.02 (3) (b), Wis. Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to amend s.
Phar 6.08, relating to variance alternatives of alarm systems.
Hearing Date, Time and Location
Date: February 9, 2005
Time: 9:30 A.M.
Location: 1400 East Washington Avenue
Room 180
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 Legal Counsel, P.O. Box 8935, Madison, Wisconsin 53708, or by email to
pamela.haack@drl.state.wi.us. Written comments must be received on or before February 21, 2005 to be included in the record of rule-making proceedings.
Analysis prepared by the Department of Regulation and Licensing.
Explanation of agency authority: Currently, s.
Phar 6.08 requires a pharmacy to have a centrally monitored alarm system in the pharmacy or the immediate physical structure within which the pharmacy is located. Depending upon the physical structure or location of the pharmacy, other means may be available to provide for security of the pharmacy consistent with the public health, safety and welfare. Providing pharmacies a means to seek a variance from the requirements of s.
Phar 6.08 will allow legitimate alternative methods of achieving security to be scrutinized and approved by the board.
Related statute or rule: There are no related statutes or rules other than those listed above.
Plain language analysis: The objective of this proposed rule-making order is to improve security in pharmacies that are located within another structure. Currently such pharmacies may be licensed without requesting a variance from the board if the alarm system is monitored in the pharmacy proper or in the physical structure within which the pharmacy is located. The rule change would require pharmacies without a centrally monitored alarm system in the pharmacy or the immediate physical structure within which the pharmacy is located to seek a variance, and the board would grant the variance request only after the board has reviewed and approved a specific plan.
SECTION 1. Provides greater flexibility to pharmacies in meeting the security requirements of s.
Phar 6.08 consistent with the public health, safety and welfare.
Summary of, and comparison with, existing or proposed federal regulation: Applicable Federal Law: Alarm systems are not required specifically, but may be considered a factor in obtaining substantial compliance with security regulations generally.
21 CFR Section 1301:71: Section 1301.71 Security requirements generally.
(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in Secs. 1301.72-1301.76 as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in Secs. 1301.72, 1301.73 and 1301.75 may be used in lieu of the materials and construction described in those sections.
(b) Substantial compliance with the standards set forth in Secs. 1301.72-1301.76 may be deemed sufficient by the Administrator after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Administrator may consider any of the following factors as he may deem relevant to the need for strict compliance with security requirements:
(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);
(2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or nonusable powders);
(3) The quantity of controlled substances handled;
(4) The location of the premises and the relationship such location bears on security needs;
(5) The type of building construction comprising the facility and the general characteristics of the building or buildings;
(6) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used;
(7) The type of closures on vaults, safes, and secure enclosures;
(8) The adequacy of key control systems and/or combination lock control systems;
(9) The adequacy of electric detection and alarm systems, if any including use of supervised transmittal lines and standby power sources;
(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;
(11) The adequacy of supervision over employees having access to manufacturing and storage areas;
(12) The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel;
(13) The availability of local police protection or of the registrant's or applicant's security personnel, and;
(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations.
(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different schedule, or as a result of a noncontrolled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in Secs. 1301.72-1301.76 when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or as a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.
(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in Secs. 1301.72-1301.76 may submit any plans, blueprints, sketches or other materials regarding the proposed security system either to the Special Agent in Charge in the region in which the system will be used, or to the Division Operations Section, Drug Enforcement Administration, Department of Justice, Washington, DC 20537.
(e) Physical security controls of locations registered under the Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply substantially with the standards set forth in Secs. 1301.72, 1301.73 and 1301.75. Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Administration, shall not necessarily be deemed to comply substantially with the standards set forth in Secs. 1301.72, 1301.73 and
1301.75, notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved by the Administration.
[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, 1982; 51 FR 5319, Feb. 13, 1986]
21 CFR Section 1301.75:
Section 1301.75 Physical security controls for practitioners.
(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.
(b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
(c) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.
(d) Carfentanil etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.
[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997]
Comparison with rules in adjacent states:
Minnesota – none.
Michigan – none.
Illinois
TITLE 68: PROFESSIONS AND OCCUPATIONS
CHAPTER VII: DEPARTMENT OF PROFESSIONAL REGULATION
SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS
PART 1330
PHARMACY PRACTICE ACT OF 1987
Section 1330.75 Security Requirements
a) Whenever the pharmacy (prescription area) is not occupied by a registrant, the pharmacy (prescription area) must be secured and inaccessible to non-licensed persons (employees and public). This may be accomplished by measures such as walling off, locking doors, electronic security equipment, as approved by the Department.
Iowa
657 IAC Chapter
6 GENERAL PHARMACY PRACTICE 657—6.7(124,155A) Security.
While on duty, each pharmacist shall be responsible for the security of the prescription department, including provisions for effective control against theft of, diversion of, or unauthorized access to prescription drugs, records for such drugs, and patient records as provided in 657—Chapter
21.
6.7(1) Department locked. The prescription department shall be locked by key or combination so as to prevent access when a pharmacist is not on site except as provided in subrule 6.7(2).
6.7(2) Temporary absence of pharmacist. In the temporary absence of the pharmacist, only the pharmacist in charge may designate persons who may be present in the prescription department to perform technical and nontechnical functions designated by the pharmacist in charge. Activities identified in subrule 6.7(3) may not be performed during such temporary absence of the pharmacist. A temporary absence is an absence of short duration not to exceed two hours. In the absence of the pharmacist, the pharmacy shall notify the public that the pharmacist is temporarily absent and that no prescriptions will be dispensed until the pharmacist returns.
Indiana
856 IAC 1-13-3 “Prescription department closed" closing hours; electronic monitoring; applicability
Authority: IC 25-26-13-4
Affected: IC 25-26-13-10; IC 25-26-13-19
Sec. 3. (a) This section and section 4 of this rule implement IC 25-26-13-19 concerning board approval for Type I and Type VI pharmacies to be opened to the general public without a pharmacist on duty. This section and section 4 of this rule apply only in situations where the entire area of the business is licensed as a pharmacy. This section, section 4 of this rule, and IC 25-26-13-19 do not apply where the only area of a business licensed as a pharmacy is the prescription department.
(b) The following definitions apply throughout this section:
(1) “Absence of pharmacist" means those periods when the prescription department is closed and secured and the pharmacist is not present in the pharmacy.
(2) “Electronic monitoring system" means a system having the ability by light beam, heat, motion, or other electronically activated method to detect the presence of unauthorized persons or instrumentalities in a given area, and relay or report that detection as described in this section.
(3) “Prescription department" means that area of the pharmacy where the legend drugs, devices, and other merchandise or items which can only be dispensed or delivered by a pharmacist are located and which must be secured in the absence of the pharmacist.
(4) “Reasonable barrier" means an obstruction or barricade that blocks or impedes the entry into the area by an ordinary person, and includes, but is not limited to, a latched or locked gate of sufficient height and construction that an ordinary person cannot breach the barrier and/or violate the space the space being monitored without detection.
(5) “Secured" means either of the following:
(A) An area is completely enclosed as to its perimeter, from floor to ceiling, and locked.
(B) Through installation of reasonable barriers, an area not readily accessible which is monitored by a board approved electronic monitoring system covering all portions of the secured areas.
(c) Before a pharmacy may be open to the general public without a pharmacist on duty, the pharmacy must file an application with the board and have it approved by the board under IC 25-26-13-19. The pharmacy must abide by the closing hours designated in the application. Any change from the hours as stated in the application must be submitted in writing to the board.
(d) Under IC 25-26-13-19, a prescription department may be locked or secured while the remainder of the pharmacy remains open to the public if the following criteria are met:
(1) The prescription department is constructed in such a manner or located in such an area that reasonable barriers are in place which prevent the easy and/or quick access to legend drugs and other articles which are in the prescription department. These barriers may be doors or other obstacles as the occasion requires.
(2) The prescription department, if not secured and locked as described in subsection (b)(5)(A), must be secured and monitored by a board approved electronic monitoring device that provides the following:
(A) On-site audible alarm that is clearly and continuously audible at all points within the pharmacy.
(B) Off-site audible or visual alarm that is continuously monitored at all times that the pharmacy remains open while the prescription department is closed and secured.
(3) Any violation or breach of the secured area shall be duly recorded by the qualifying pharmacist of the pharmacy and by the off-site security monitoring agency and reported to the board within seventy-two (72) hours of the violation or breach. This report shall include the nature of the violation or breach.
(4) Facilities monitored electronically must provide for backup power for the eventuality that there is an electronic power failure for any reason. Such backup power shall be capable of continuing the monitoring for a period of no less than thirty-six (36) hours.
(5) The electronic monitoring system shall be activated and inactivated only by key or combination. Alarms which have been triggered shall only be reset and/or reactivated by a pharmacist. The key or combination shall only be in the possession or knowledge of a pharmacist. Reasonable exceptions shall be made to this for security system operators. However, in no case shall a security system operator have access to the secured area without the presence of a pharmacist. Such exceptions shall be listed in the application under this section and shall be subject to approval by the board.
(e) Under IC 25-26-13-10(b), the board may revoke or limit the privilege to be open to the general public without a pharmacist on duty if the pharmacy violates this section or section 4 of this rule. (Indiana Board of Pharmacy; Reg 13, Sec 3; filed Jun 18, 1962, 10:00 a.m.: Rules and Regs. 1963, p. 124; filed May 15, 1992, 5:00 p.m.: 15 IR 2246; readopted filed Nov 13, 2001, 3:55 p.m.: IR 1330)
Summary of factual data and analytical methodologies: The board reviewed the current alarm rule in view of the security needs of pharmacies that exist in other structures. The draft of the rule was prepared after extensive analysis by both professional and public members of the board, expert advice of pharmacists who operate pharmacies located within another structure, and representatives from the small business community.
Anticipated costs incurred by private sector: The Department of Regulation and Licensing has determined that there will be no anticipated costs that would be incurred by the private sector.
Fiscal estimate:
The proposed rule will have an impact of $120 annually on the department's funds. This represents the salary and fringe benefits for staff to prepare two plans for variance to present to the board per year. The board's legal counsel and bureau director and a professional credentialing supervisor will each need to spend one half hour per variance plan. The department will incur $500 in costs to print and distribute the rule change.
Effect on small business
Pursuant to s.
227.114 (1) (a), Stats., these proposed rules will have no significant economic impact on a substantial number of small businesses.
TEXT OF RULE
SECTION 1. Phar 6.08 is amended to read:
Phar 6.08 Security. Effective January 1, 2000, a A pharmacy shall have a centrally monitored alarm system in the pharmacy or the immediate physical structure within which the pharmacy is located. A security system or plan that does not utilize a centrally monitored alarm system may be used if reviewed and prior approval is obtained from the board.
Notice of Hearing
Transportation
NOTICE IS HEREBY GIVEN that pursuant to s.
343.055 (5), Stats., and interpreting s.
343.055, Stats., the Department of Transportation will hold a public hearing in
Room 132-B, Conference Room B of the Hill Farms State Transportation Building, 4802 Sheboygan Avenue, Madison, Wisconsin on the
27th day of
January, 2005, at
10:00 AM, to consider the creation of s.
Trans 102.23, Wisconsin Administrative Code, relating to military vehicle operator CDL exemption.
An interpreter for the hearing impaired will be available on request for this hearing. Please make reservations for a hearing interpreter at least 10 days prior to the hearing.
Parking for persons with disabilities and an accessible entrance are available on the north and south sides of the Hill Farms State Transportation Building.
Analysis Prepared by the Wisconsin Department of Transportation
Statutes Interpreted: ss.
343.055, Stats.
Plain Language Analysis: Section
343.05 (4) (a) 1., Stats., currently exempts military persons from all state licensing requirements if they are members of the armed services driving a motor vehicle owned by or leased by the federal government.
Section
49 C.F.R. 383.3(c) permits states to exempt drivers operating a commercial motor vehicle for military purposes from CDL requirements. The federal government has requested that Wisconsin exempt all persons operating CMVs for military purposes from CDL requirements without regard to vehicle ownership. This proposed rule making would grant an exemption from CDL requirements for military purposes to the extent permitted by federal law.
Section
343.055 (5) requires WisDOT to issue administrative rules implementing all federal CDL waivers.
Summary of, and Preliminary Comparison with, Existing or Proposed Federal Regulation: Section
49 C.F.R. 383.3(c) permits states to exempt drivers operating a commercial motor vehicle for military purposes from CDL requirements. The federal government has requested that Wisconsin exempt all persons operating CMVs for military purposes from CDL requirements without regard to vehicle ownership. This proposed rule making would implement that exemption as required by s.
343.055 (5), Stats.
Comparison with Rules in Adjacent States: All 50 states have a CDL exemption for military drivers similar to this provision.
Summary of Factual Data and Analytical Methodologies Used and How the Related Findings Support the Regulatory Approach Chosen: No data or analytical methodology was employed in considering this proposed rule making.
Effect on Small Business and, If Applicable, Any Analysis and Supporting Documentation Used to Determine Effect on Small Businesses: This proposed rule making has no effect on small business. This affects only drivers working for the U.S. Military. You may contact the Department's small business regulatory coordinator by phone at (608) 267-3703, or via e-mail at the following website:
Fiscal Effect and Anticipated Costs Incurred by Private Sector: There is no fiscal effect for implementing this rule making, nor will the private sector incur any costs.
Place Where Comments are to be Submitted and Deadline for Submission: The public record on this proposed rule making will be held open until close of business the day of the hearing to permit the submission of comments in lieu of public hearing testimony or comments supplementing testimony offered at the hearing. Any such comments should be submitted to Gary Prideaux-Wentz, Department of Transportation, Division of Motor Vehicles, Room 351, P. O. Box 7995, Madison, WI 53707-7995. You may also contact Mr. Prideaux-Wentz by phone at (608) 264-8714.
