Enforcement
DATCP may take the following actions against rule violators, as appropriate (per current law):
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Deny, suspend, revoke, or impose conditions on a license or permit (the affected manufacturer or distributor may demand a formal administrative hearing).
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Issue holding orders to prevent the sale or movement of illegal products.
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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:
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Fertilizer terms defined in the Official Publication of the Association of American Plant Food Control Officials, No. 57 (2004).
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Fertilizer sample collection methods specified in the Inspectors Manual of the Association of American Plant Food Control Officials, 6th edition (1999).
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Fertilizer test methods specified in the “Official Methods of Analysis of AOAC International," volume I, 17th edition as updated by the 2nd revision (2003).
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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).
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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;
