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.
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License and tonnage fees (this rule does not increase fees).
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Product labeling and ingredient guarantees.
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Permits for low-nutrient mixed fertilizers and soil or plant additives.
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Substantiation of performance claims.
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Product sampling and analysis.
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Toxic contaminants.
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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:
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Proposed product labeling. The product label must include recommended uses and use directions to ensure effectiveness.
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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:
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The product is effective and useful for labeled purposes when applied under Wisconsin conditions according to label directions.
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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.
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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:
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Product labeling.
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Product efficacy, under Wisconsin conditions, when the product is used according to label directions.
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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.
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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:
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The name and address of the licensed manufacturer or distributor.
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The fertilizer product name.
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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.
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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.
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The net weight of the fertilizer contained in the package.
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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:
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The name and address of the licensed manufacturer or distributor.
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The product name.
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The net weight or liquid measure of the package or bulk delivery.
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The purposes for which the soil or plant additive is recommended.
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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.
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A “guaranteed analysis."
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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.
