Chapter II
LABEL ELEMENTS AND REQUIREMENTS
1. State and Federal Authority
2. Placement on the Container
3. Prohibited Containers
4. Legibility and Type Size
5. False or Misleading Statements
1. Product Name
2. Company Name and Address
3. Ingredient Statement4. Human Hazard Signal Word
5. Child Hazard Warning
6. First Aid, Statement of Practical Treatment
7. Precautionary Statements for Human and Domestic Animal Hazards
8. Precautionary Environmental Hazards Statement
9. Precautionary Physical or Chemical Hazards Statement
10. Restricted Use Pesticide Statement
11. U.S. EPA Registration No. or California Registration No.
12. U.S. EPA Establishment No.
13. Directions for Use and Dilution Rate
14. Storage and Disposal Statements
15. Net Weight or Measure of Content
16. Worker Protection Standard (WPS) Statements
17. Warranty or Liability Statement (optional)
1. Home and Garden Use
2. Dual Use Labels
3. Label Refers to Unregistered Product
4. Tank Mixes
5. The Term New
6. Fertilizer Claims
7. Four to Six Gallon Containers
8. Foreign Language Translation
9. Worker Protection Standard (WPS)
10. Resistance Management Statements
11. Supplemental Labeling
12. Sub-Labeling or Split Labeling
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D. CHART OF FEDERAL LABEL REQUIREMENTS IN 40CFR
_______________________________________________________________
Appendix II-1 Type Size Template
Appendix II-2 Sample Label Format
Appendix II-3 deleted
Appendix II-4 deleted
Appendix II-5 2,4-D Letter
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LABEL ELEMENTS AND REQUIREMENTS
1. State and Federal Authority |
FIFRA Sec.3 FAC 12851~12885 CCR 6235~6243 |
| Federal regulation (40 CFR Part 156) outlines the label requirements for pesticides. U.S. EPA's Label Review Manual is available on their home page. | FIFRA 3c9 |
| It is also important that U.S. EPA PR-Notices, LIPs, REDs, and Registration Standard label requirements are followed. | |
| Section 24(b) of FIFRA prohibits states from imposing labeling or packaging requirements different from federal requirements. State requirements for U.S. EPA-registered pesticide products must meet, but not exceed, current U.S. EPA label requirements. | CCR 6243 40CFR 157 |
| California law requires that each separate container of a pesticide offered for sale have a clearly printed label attached. | FAC 12851 |
| For spray adjuvants and other California-only products, DPR uses the label requirements in 40CFR as a guide. |
| 2. Placement on the Container The label must appear on the immediate container. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also appear on the outside wrapper or container if it is part of the retail package. |
40 CFR 156.10(a) CCR 6237 |
| 3. Prohibited containers In no case can a pesticide be placed or kept in any container of a type commonly used for food, drink, or household products. |
CCR 6680 |
| 4. Legibility and Type Size Label information must be all of the following: |
40 CFR 156.10(a) CCR 6240 |
Clearly legible to a person with normal vision.
Use the hard copy template of Appendix II-1 to determine type size.
Use the sample label format in Appendix II-2 for reference.
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| 5. False or misleading label or advertising/literature statements False or misleading label or advertising/literature statements are not allowed. Examples of unacceptable wording: |
FIFRA 3c9 40 CFR 156.10(a) PR Notice 93-6 FAC 12881-12885 12991, 12992 CCR 6300 |
|
memos of 9-29-93, 10-20-93 |
The following lists the minimum items required on a pesticide label. These items are in accordance with 40 CFR, Part 156. Also use U.S. EPA's Label Review Manual available on their home page.
The chart at the end of this chapter outlines the U.S. EPA label requirements and the placement of the label elements.
| 1. Product Name | 40CFR 156.10 |
| The name, brand, or trademark of the pesticide product appearing on the front panel of the label must be the same as that on the license. | FAC 12821 |
| California regulations allow a pesticide to be registered under more than one brand name. However, the same brand name cannot be registered for products (within the same company) of different chemical composition or different physical condition sufficient to affect the pesticidal properties. | CCR 6152 |
A brand name cannot be false or misleading or conflict with other label statements.
| A brand name cannot contain names that are construed as claims in conflict with U.S. EPA's PR Notice 93-6. For example, a brand name cannot contain a claim of heightened efficacy. | FIFRA Sec. 3c9 |
| The name and address given on the label are the name and address of the registrant or the manufacturer. An unqualified name and address are considered the producer. If the registrant is not the producer, or if the name of the person for whom the pesticide was produced appears on the label, it must be qualified by wording such as "Packed for __", "Distributed by __" or "Sold by __". If there are two or more locations, the principal office may be on the label unless DPR requires the exact location for protection of the public. The street address must be included unless shown in a current city or telephone directory. | FIFRA 2q 40CFR 156.10c 152.122 152.50 FAC 12851 CCR 6239 |
The address on the label may differ from the application form and the license.
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| 3. Ingredient Statement | 40CFR 156.10 |
| The ingredient statement on the label must include the identity and percentage of each active ingredient and the
total percentage of the inert ingredients. If the product is Section 25(b) exempt from registration, and the company chose not to register, all active ingredients must be listed along with their percentages and all inert ingredients must be listed although the percentage for each inert does not have to be listed out (as long as the active and the inert ingredients add up to 100%). |
FAC 12821 40CFR 152.25 |
| The ingredient statement must be on the front panel of the label unless the package size or form makes this impractical. The text of the statement must run parallel with, and be distinguishable from, other text on the same panel. If there is an outside container or wrapper and the ingredient statement cannot be clearly read, the ingredient statement must also appear on the outside container or wrapper. | |
| The percentages of ingredients must be stated in terms of percent by weight and must total 100%. All ingredient statements must be expressed as nominal concentration. Nominal concentration is the amount expected to be present in percent by weight. Percentages cannot be expressed by a range on the label such as "22-25 percent". | 40CFR 156.10g USEPA LRM 40CFR 158.153 PR Notice 91-2 |
| Note: If the pesticide contains any form of arsenic, the percentages of total and water-soluble arsenic calculated as elemental arsenic must be on the label. | FIFRA 2n |
ACTIVE INGREDIENTS
Name1 ...................................... XX%
Name2 ..................................... XX%
INERT INGREDIENTS .......................XX%
(or OTHER INGREDIENTS)
| The terms "active ingredients" and "inert ingredients" must be in the same type size, aligned to the same margin, and equally prominent. Percentages are aligned by decimal. The term "inert ingredients" is not required for products containing 100 percent active ingredients. If preferred, registrants may use the term "Other Ingredients" in place of "Inert Ingredients". | PR Notice 97-6 memo of 1-23-98 |
| U.S. EPA requires that the name of each ingredient be the accepted common name, if there is one. If the common name is not well known, it should be followed by the chemical name. If there is no common name, only the chemical name is required. | 40CFR 156.10g PR Notice 97-5 memo of 12-15-97 |
| If the rate of application of the product is expressed as weight of active ingredient per unit area, a statement of the weight of active ingredient per unit volume of the pesticide formulation must appear in the ingredient statement. | 40CFR 156.10g |
| If the product is for internal administration to animals, the ingredient statement may be given in terms of dosage in lieu of percentage by weight. | FAC 12858 |
| The following format, or the above format, may be used for spray adjuvants: | FAC 12883 |
PRINCIPAL FUNCTIONING AGENTS
| Name1 Name2 Name3 |
XX% XX% XX% |
| If more than three functioning agents are present, only the three principal ones need be named. | FAC 12885 |
| c. Microbial products Products containing live organisms must indicate the equivalent number of viable units (spores, cells, colony forming units, etc.) per unit weight of product. Bacillus thuringiensis (B.t.) product active ingredient declaration is based on percent by weight of insecticidal toxin. International units (IU) are used as indicated in U.S. EPA's Label Review Manual, available through their home page. Chapter 6 of U.S. EPA's Label Review Manual more fully outlines the federal label requirements for microbial products. If the product contains Bacillus thuringiensis, the active ingredient percentage on the label may include all dried fermentation products, if approved by U.S. EPA. See P/P 2001-2. |
|
| d. Inerts of Toxicological concern In accordance with U.S. EPA's PR Notice 87-6, the label of a product containing an inert ingredient from U.S. EPA's List 1 Inerts of Toxicological Concern, must state "This product contains the toxic inert ingredient name of inert)." The wording should be placed in close proximity to the ingredient statement in a type size comparable to other front panel text. |
PR Notice 90-1 memos of 6-6-88 6-1-88 3-18-88 3-15-88 EPA Lists List 1 to 4B |
4. Human Hazard Signal Word (DANGER, WARNING, or CAUTION)
The signal word is required on the front panel of the label and is determined by the toxicity category of the product. Refer to 40 CFR Part 156.64 (formerly 156.10) for criteria of the four toxicity categories.
The signal word is preferred in all capital letters:
category I = DANGER
category II = WARNING
category III = CAUTIONcategory IV = not required
If the product is a Category I pesticide because of its oral, inhalation, or dermal toxicity, the word "POISON" must appear in red on a contrasting background and skull and crossbones must appear in immediate proximity to the word "POISON". This is in addition to the required signal word "DANGER."
| The appropriate Spanish language signal word is also required for all category I or II products subject to WPS. | USEPA LRM |
category I = PELIGRO
category II = AVISOUnless the entire label is also in Spanish, the following referral statement is required: "Si Usted no entiende la etiqueta, busque a alguien para que se la explique a Usted en detalle. (If you do not understand the label, find someone to explain it to you in detail.)"
Category IV products no longer require a signal word.
The following table shows the minimum type size requirements for the human hazard signal word and child hazard
warning. Use the hard copy template in Appendix II-1 for comparison.
|
Front Panel |
Minimum Type Size Required |
|
| Size in Square Inches | Signal Words, All Caps | "Keep Out of Reach of Children" |
| 5 and under | 6 point | 6 point |
| above 5-10 | 10 point | 6 point |
| above 10-15 | 12 point | 8 point |
| above 15-30 | 14 point | 10 point |
| over 30 | 18 point | 12 point |
| Overlabeling of the signal word is allowed only if approved by U.S. EPA as stated in 40CFR Part 156.64. The term overlabeling refers to a signal word or a precautionary statement which is more restrictive than that required by 40CFR. This is determined by the Medical Toxicology Branch review. | memos of 6-24-86 1-7-86 |
| 5. Child Hazard Warning (Keep out of Reach of Children); Every label must bear the statement "Keep Out of Reach of Children" on the front panel unless the product's contact with children is extremely remote such as for a manufacturing-use only product as determined by USEPA. The statement is not required if the product is registered for use on infants or small children. See 40CFR Part 156.66. Note also that USEPA PR Notice 2001-3 clarifies acceptable and unacceptable label claims and formulations for insect repellents targeted for use on children and to explain why food fragrances, graphics, statements, and colors associated with food should not be incorporated into insect repellents. |
40CFR 156.10i |
| 6. First Aid (Statement of Practical Treatment, SOPT) A First Aid statement (Statement of Practical Treatment) is required on all pesticide products which are toxicity Category I, II, or III due to oral, inhalation, or dermal toxicity, or are Category I or II for skin or eye irritation. This is required on the front panel for Category I products. The term "First Aid" is now allowed in lieu of "Statement of Practical Treatment" on the label. It is permissible, if approved by USEPA, to have a referral statement such as "See Statement of Practical Treatment on Back Panel." To augment this information for the product when diluted with water, the label can also describe how first aid measures may be modified for the diluted product. See 40CFR Part 156.68. USEPA PR-Notice 2001-1 contains First Aid (SOPT) requirements for product labels. USEPA PR Notice 84-5 contains First Aid (SOPT) requirements for fumigants. |
40CFR 156.10i |
| 7. Precautionary Statements for Human and Domestic Animal Hazard Precautionary statements indicating hazard to human and domestic animals must be stated under the general heading "Precautionary Statements" and under the subheading "Hazards to Humans and Domestic Animals" as outlined in 40CFR Part 156.70. These statements must be immediately preceded by the signal word. Precautionary statements are based on results of the acute toxicity studies. In some cases, additional precautionary statements are allowed for use-dilutions as outlined in 40CFR Part 156.70. For fumigants, see U.S. EPA PR Notice 84-5. |
USEPA LRM |
| 8. Precautionary Environmental Hazards Statement Environmental hazards precautionary statements are required if a hazard to non-target organisms exists. These must be stated under the general heading "Precautionary Statements" and under the subheading "Environmental Hazard" as outlined in 40CFR Part 156.85. As stated in U.S. EPA PR-Notice 93-3 and PR-Notice 93-8, labels which include the statement "Do not apply directly to water, to areas where surface water is present, or to intertidal areas below the mean high water mark" are acceptable. |
memos of 9-9-93 3-10-92 |
All commercially applied products for terrestrial uses are encouraged by U.S. EPA to use the statement:
"For terrestrial uses: Do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate water when cleaning equipment or disposing of equipment washwaters."
If registered only for terrestrial, forestry (except aerial), or domestic outdoor uses, the phrase "For terrestrial uses" may be omitted.
If registered only for outdoor residential use, use the statement "Do not apply directly to water."
Labels need not be submitted for scientific evaluation of this wording.
Note: Effluent discharge label requirements are in U.S.
EPA's PR-Notice 95-1.
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9. Precautionary Physical or Chemical Hazards Statement
| Physical and chemical hazards statements must be stated under the general heading "Precautionary Statements" and under the subheading "Physical or Chemical Hazards" as outlined in 40CFR Part 156.78. | 40CFR 156.10i USEPA LRM |
| These statements include product's flammability, explosiveness, or other hazard features. See also USEPA PR Notice 98-6 for total release foggers. | P/P 99-2 |
Statements should include precautions when handling certain liquid products around electrical equipment.
Nonflammability label statements may appear as a substatement to the ingredient statement, or on a back or side panel. The phrase must not be highlighted or emphasized. Products must meet criteria for declaring non-flammability.
| 10. Restricted Use Pesticide Statement (U.S. EPA-restricted use
products) For federally restricted products, the statement "Restricted Use Pesticide" with a summary statement of the terms of restricted use must be at the top of the label's front panel. It must be the same minimum type size as the human hazard signal word. The term "Restricted Use Pesticide" must also appear directly under the heading of Directions for Use. |
FIFRA 3a PR Notice 93-1 40CFR 156.10j memos of 1-25-93 6-25-93 40CFR 156.10 |
| 11. U.S. EPA Registration Number (EPA Reg. No.) or California Registration Number (Ca. Reg. No.) | 40CFR 156.10e |
For regular products: EPA Reg. No. 00000-00000
For subregistration/distributor registrations: EPA Reg. No. 00000-00000-00000
The first set of digits is the company firm number. The second set of digits is the number assigned to the product. If a third set of digits is shown, this is the firm number assigned to the subregistrant/distributor which has an Application of Supplemental Registration of Distributor on file with U.S. EPA.
For products not registered with U.S. EPA (spray adjuvants, California Only), a State registration number is assigned upon registration and must appear on the label as follows:
CA Reg. No. 00000-00000
The first set of digits is the U.S. EPA-assigned firm number. If no firm number has been assigned by U.S. EPA, a State number is assigned. The second set of digits is the number assigned to the product. See the section on Issuing a Product License in Chapter III for details on assigning numbers.
Products submitted for concurrent review will not yet have an assigned EPA Reg. No.
| 12. U.S. EPA Establishment Number (EPA Est. No.). | FIFRA 2(dd) FIFRA 7 40CFR 156.10f |
The first set of digits is the number assigned by U.S. EPA to the firm. The middle letters indicate the state or, if outside the U.S., the country in which the establishment is located. The last number is the number assigned to the establishment. More than one EPA Est. No. may appear on a label, but only one is indicated as applicable to that specific container.
For example: EPA Est. 0000-WIS-0000.
| 13. Directions for Use. | 40CFR 156.10i |
The directions for use must include:
Labels with agricultural, nursery, golf courses, sodfarms, or greenhouse use must comply with PR Notice 87-1 and include the statment "Do not apply this product through any type of irrigation system." This notice does not apply to adjuvants as they are not considered pesticides under federal law.
It is unacceptable to list only metric units.
Manufacturing-use only labels (for formulation into other pesticides only) do not require directions for use.
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| 14. Storage and Disposal Statements. | FIFRA Sec 19 |
| All labels must comply with U.S. EPA PR Notices 83-3, 84-1 (with errata sheet), 86-2, 94-2, 2001-6, and U.S. EPA-issued Registration Standards and REDs for storage and disposal statements. Prior U.S. EPA acceptance is not required when using the exact wording of the PR-Notices or the mandated changes. Additional information on federal requirements is found in Chapter 13 of U.S. EPA's Label Review Manual | memo of 7-19-94 CCR 6686 |
Storage and disposal instructions must be grouped together in the directions for use portion of the label under the heading "STORAGE AND DISPOSAL". This heading is not required on labels for products intended only for household use.
| a. Storage | CCR 6686 |
b. Pesticide Product Disposal
All product labels must include instructions for pesticide disposal as indicated above and in 40CFR Part 156.10(i).
Residential/household products (except antimicrobials) should include the disposal instructions outlined in USEPA PR Notice 2001-6..
Antimicrobial residential/household label may show the statement "Securely wrap original container in several layers of newspaper and discard in trash".
All other products must have the wording "Do not contaminate water, food or feed by storage or disposal".
c. Container Disposal - All product labels must include container disposal instructions appropriate to the type of container as indicated above.
i. All products (except residential/household use) must bear the following container disposal instructions:
Container Type Disposal Statements
| Metal containers (non-aerosol) | Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, or by other procedures approved by state and local authorities. |
| Plastic containers | Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, or incineration, or, if allowed by state and local authorities, by burning. If burned, stay out of smoke. |
| Glass containers | Triple rinse (or equivalent). Then dispose of in a sanitary landfill or by other approved state and local procedures. |
| Fiber drums with liners | Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles. Empty
residue into application equipment. Then dispose of liner in a sanitary landfill or by incineration if allowed
by State and local authorities. If drum is contaminated and cannot be reused, dispose of in the same manner. The manufacturer may replace this phrase with one indicating whether, and how, fiber drum may be re-used. |
| Paper and plastic bags | Completely empty bag into application equipment. Then dispose of empty bag in a sanitary landfill or by incineration, or, if allowed by State and local authorities, by burning. If burned, stay out of smoke. |
| Compressed gas cylinder | Return empty cylinder for reuse (or similar wording). |
ii. For residential/household products (except antimicrobials), refer to USEPA PR Notice 2001-6. That notice supersedes portions of PR Notices 83-3 and 84-1 regarding disposal statements for these types of products, does not limit container size, and allows for statements about local waste disposal and recycling programs.
Disposal of residential/household (except antimicrobial) products in pressurized containers:
"Do Not Puncture or Incinerate! If empty: Place in trash or offer for recycling if available. If partly filled: Call your local solid waste agency or [toll free number which meets criteria in paragraph II.E of the notice] for disposal instructions."
Disposal of residential/household (except antimicrobial) products in non-pressurized containers. This includes all other types of products including but not limited to liquids, solids such as tablets, dusts, gels, pet products, etc., in all other types of containers including but not limited to bags, boxes, bottles, cans, bait stations, squeeze tubes, etc:
"If empty: Do not reuse this container. Place in trash or offer for recycling if available. If partly filled: Call your local solid waste agency or [toll free number which meets criteria in paragraph II.E of the notice] for disposal instructions. Never place unused product down any indoor or outdoor drain."
iii. For antimicrobial residential/household product labels. USEPA may in future issue guidance for antimicrobial residential/household products. Until then, antimicrobial products may use new recommended statements in PR Notice 2001-6 or the following:
| Container Type |
Statement |
| Nonaerosol Products (bottles, cans, jars). |
Do not reuse container (bottle, can, jar). Rinse thoroughly before discarding in trash. |
| Nonaerosol Products (bags) | Do not reuse bag. Discard bag in trash. |
| Aerosol Products | Replace cap and discard containers in trash. Do not incinerate or puncture. |
Antimicrobial residential/household products may have the statement "Securely wrap original container in several layers of newspaper and discard in trash". The statement "Do not reuse empty container (bottle, can, bucket). Wrap (container) and put in trash" can be used for the following:
| 15. Net Weight or Measure of Contents | 40CFR 156.10d |
The contents must be stated in the largest suitable units. Standard weights and volumes must be used; metric measurements may be added.
Dry formulations are expressed as pounds or ounces, liquids as gallons, and pressurized products as avoirdupois
pounds and ounces.
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| 16. Worker Protection Standard (WPS) | 40CFR 156.200 - .212 40CFR 170 |
For agricultural use products, the Worker Protection Standard (WPS) statements must be on the label. See later
section in this chapter for WPS procedures.
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| 17. Warranty or Liability Statement (optional) | FAC 12853 FAC 12854 |
The label cannot contain limitations of warranty by the seller that exclude or waive the implied warranty that the pesticide corresponds to all claims and descriptions the registrant made in print. No limitations of warranty by the seller shall exclude or waive the implied warranty that the pesticide is reasonably fit for use for any intended purpose according to printed statement by the registrant.
The label, including Section 24c labels, cannot require a signature waiver of liability by the buyer or user.
The label cannot include unacceptable statements. Examples of unacceptable statements, as indicated in Ca Notice 2004-3, October 8, 2004: "A waiver of liability statement must be agreed to in writing as a condition of sale or use." or "This product when used as instructed on the label may result in poor pest control, crop injury, or illegal residues."
Examples of acceptable warranty or liability label statements are given in Ca Notice 2004-3, October 8, 2004.
The following statements are unique to certain products and have special instructions for processing.
| 1. Home and Garden Use Labels | memo of 2-27-86 |
Home and garden use label indicate application of a pesticide to humans or pets associated with a household and include application in, on, or around all structures, vehicles, or areas associated with a household. A householder is a person who uses a pesticide either outside or inside a residential dwelling on property owned or rented by that person.
All words, statements, graphics, designs, and other information required on the label must be clearly legible to a person with normal vision. They must be expressed in terms likely to be read and understood by the householder under customary conditions of purchase and use.
Some labels contain rates of application and dilution rates that are unsuitable for home and garden use. Labels that contain commercial grower's terminology are unfamiliar to the householder and are unsuitable.
a. The following dilution rates, application rates, and use directions are appropriate for home or household use:
b. The following dilution rates, application rates, and use directions are inappropriate for home or household use:
Registration will be denied if the label terms, statements, graphics, designs, etc., are not likely to be understood by the average householder.
Follow storage and disposal statements in item 14 above.
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| 2. Dual Use Labels | Ca Notice 91-2, 91-9 memo of 3-20-91 |
Agricultural use products are not allowed to be sold by retailers not licensed as pesticide dealers. Registrants with products labeled for both home use and agricultural use, or who sell their product through both types of retail stores, should review their dual use label for needed changes.
The following examples of agricultural use statements are in Ca Notice 91-9.
| If the statement "For household use only" is on the label, and the directions for use are appropriate to household use, the product is not considered dual use. | memo of 3-27-92 |
| 3. Label Refers to an Unregistered Product | memo of 12-12-96 |
A registration can be issued even if there is a label reference to an unregistered pesticide. This applies only to statements which are permissive rather than mandatory.
Registration is denied if use of the unregistered product is required by the label, or if the proposed product is not effective without use of the unregistered product. The Registration Specialist should notify the registrant that it is still illegal to sell or use the unregistered product in California.
| 4. Tank Mixes | USEPA PR Notice 82-1 DPR PRB Notice 87-1 |
Tank mix label claims are allowed without supporting compatibility and residue data if the following conditions are met:
"This product can be mixed with (chemical name, including percentage of active ingredient and type of formulation, or specific product name, or both) for use on (crops/sites) in accordance with the more (most) restrictive of label limitations and precautions. No label dosage rates should be exceeded. This product cannot be mixed with any product containing a label prohibition against such mixing. Where a specific product name is recommended for the tank mix, the label statements shall be more explicit, including such information as specific dilution and dosage rates."
| It is acceptable for a label to mention an unregistered product in a tank mix provided: | memo of 12-12-96 |
Note: The Registration Specialist should notify the registrant that it is illegal to sell or use the unregistered product in California.
| 5. The Term "New" | memo of 5-28-93 40CFR 156.10(a)(5), |
Registrants should be encouraged to only use the term "new" on their label for six months after registration. A subregistration/distributor registration should not use the term unless the basic registrant has the term on their label and only for the same duration.
| 6. Fertilizer Claims | P/P 2006-1 |
In the past, DPR worked in conjunction with CDFA to ensure that companies submitted dual-use pesticide/fertilizer product labels to both Departments. This was accomplished by both agencies submitting copies of dual-use labels to one another. This practice has been discontinued. A statement reminding the company to submit their dual-use label to CDFA has been added to our licensing letters where applicable.
| 7. Four to Six Gallon Containers | memos of 9-12-00, 9-30-93, 11-14-94 |
Four to six gallon containers must bear a specific pictogram and labeling which includes the word "warning" and an admonition concerning the hazard to children. This graphic and text can not obscure or interfere with U.S. EPA approved labeling.
| 8. Foreign Language Translation | P/P 2007-2 |
Pesticide labels may contain foreign language statements and translations. Registrants may be required to have limited Spanish translation, such as for Category I and II products or for Worker Protection Standard (WPS) as indicated below. For other products, registrants may choose to translate the label, usually into Spanish. This is allowed by U.S. EPA's PR-Notice 98-10 and 40CFR Part 156. Procedures for acceptance are in Chapter IV.
| 9. Worker Protection Standard (WPS) | 40CFR 156.200, 170 |
| Labels which comply with U.S EPA's Worker Protection Standard (WPS) label requirements, and do not have any other changes, can be accepted without review. If any other changes are made, the label is reviewed and may require scientific evaluation. If additional data are needed, the label is returned or denied. A subregistrant/distributor label must have the same WPS wording as the basic registrant's label. | memos of 1-16-93, 1-20-93, 10-20-93, 9-1-93, 10-1-93, 12-27-93 |
Registrants may "split" a label and separate the non-agricultural uses so that the WPS statements are not required. Instruction for this is in PR-Notice 93-11.
| 2,4-D containing products must comply with the 2,4-D Industry Task Force labeling requirements for WPS in U.S. EPA's October 30, 1992 and 1-14-93 letters found in Appendix II-5. | memos of 11-24-93, 9-14-93, 8-24-93, 8-14-93 |
category I = PELIGRO
category II = AVISO
Unless the entire label is also in Spanish, the following referral statement is required: "Si Usted no entiende la etiqueta, busque a alguien para que se la explique a Usted en detalle. (If you do not understand the label, find someone to explain it to you in detail.)"
10. Resistance Management Statements
USEPA PR Notice 2001-5 encourages companies to include resistance management statements and symbols on the label. If the wording in the notice is used, the submission can be done through the DPR Notification process.
| 11. Supplemental Labeling | U.S. EPA Label Review Manual |
Supplemental labeling is term that describes labeling which includes uses, use directions, or other instructions which differ from those on the end-use label. These are partial labels to be distributed with the product and may be distributed by the registrant or the supplemental distributor. Since these are partial labels, they must bear a statement referring the user to the product label for complete directions and a statement that the labeling must be in the possession of the user. Both the product label and the supplemental labeling are required to safely and effectively apply the product.
Supplemental labeling must be submitted to and be approved by U.S. EPA before it can be approved in California.. At a minimum, U.S. EPA recommends that the following information appear on the label:
- Misuse statement
- The labeling must be in possession of the user at the time of application.
- Read the label affixed to the container for Pesticide X before applying.
- Use of pesticide X according to this labeling is subject to the use precautions
and limitations imposed by the label affixed to the container for pesticide X.
- Product Name
- EPA Registration Number
- Restricted Use Statement (if required)
| 12. Sub-Labeling or Split Labeling | 40CFR 152.130 |
| D. CHART OF USEPA LABEL GUIDELINES in 40CFR | 40CFR |
The following is a summary chart of federal label requirements. Please note that U.S. EPA may sometimes vary from this chart. Also use U.S. EPA's Label Review Manual which is available on their home page.
Federal Label Requirements based on
U.S. EPA's Label Review Manual, FIFRA, and 40CFR
(some of the following will change due to changes in 2002 to 40CFR part 156)
| ITEM | LABEL ELEMENT | APPLICABILITY OF REQUIREMENTS |
PLACEMENT ON LABEL |
COMMENTS |
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1 |
Product name | All products | Front panel | Center front panel |
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2 |
Company name and address |
All products | Front panel | Must be prominent and within type size range required for all label text. | |
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3
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Ingredient statement | All products | Front panel | For residential products, preferred immediately below product name or after hazard stmt. | Text must run parallel with and be distinguishable from other text on the panel. |
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4 |
Human hazard signal word _______________________ Skull and crossbones symbol with the word POISON must also be on label of certain products. |
All products _________________ All Category I oral, dermal, or inhalation. |
Front panel and immediately under precautionary statement heading. _____________ Close proximity to signal word. |
May only appear in three locations - front panel immediately below child hazard warning - immediately under heading for precautionary statements - in the WPS statement, if subject to WPS _______________________________________________ If the word POISON is required, it must be in red on a contrasting background. |
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5 |
Child Hazard Warning- "Keep Out of Reach of Children" | All products except manufacturing-use only products. | Front panel | Preferred on separate line above signal word. | Parallel with other label text. |
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6
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Statement of Practical Treatment (SOPT) or "First Aid" | All products in Categories I, II, III | Front panel for all. Category I oral, dermal, or inhalation products, unless there is a referral statement in close proximity to signal word. |
Front panel preferred for all. Non-required statements may appear on the front, side or back panel. Statements on side or back panel should be grouped near the precautionary statments. |
For Category IV products, registrant may use Category III statements. Certain products specified in U.S. EPA's Label Review Manual chapter 8 must have a Note to Physician which must be in close proximity to the First Aid statement. |
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7 |
Precautionary Statements for Human and Domestsic Animal Hazards. | All products except Category IV. | Any panel. If not on front panel, must have a referral statement. |
Front panel |
Must be preceded by appropriate signal word. All front panel precautionary statements must be grouped togethre, preferrably blocked. The PPE also appears here for products applied by applicators or products subject to WPS. |
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8 |
Environmental Hazards |
All commercially applied products for terrestrial use. Products used outdoors presenting hazards to nontarget organisms other than humans or pets. This includes terrestrial, forestry, aquatic, and domestic sites. |
Products used only indoors or as pet collars may omit statement. | ||
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9
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Physical or Chemical Hazards | Products which are flammable, have explositivity potential, shock potential, or low flash point. | Specific examples are outlined in U.S. EPA's Label Review Manual chapter 10. | ||
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10
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Restricted Use Statement | All federally restricted products | Top center of front panel | Preferably blocked. | The words "RESTRICTED USE PESTICIDE" must be the same type size as the signal word. It
is followed by a statement of the terms of restriction. The phrase Restricted Use Pesticide must also appear under the heading of Directions for Use. |
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11 |
U.S. EPA Registration Number. (EPA Reg. No.) | All products. | Preferred front panel. | Must be in similar type size and run parallel to other print. | |
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12 |
U.S. EPA Establishment Number. (EPA Est. No.) | All products | Front panel, grouped with EPA Reg. No. | May appear on container instead of label. | |
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13 |
Directions for use | All products, except manufacturing use only products. | Conspicuous portion of label. | Use directions must not call for more than the net contents of the package. The misuse statement appears following heading of Directions for Use. Required statement is : "It is a violation of Federal law to use this product in a manner inconsistent with its labeling." Modified statement for Experimental Use Permits: "Use of this product in a manner inconsistent with the terms of the Experimental Use Permit is a violation of Federal Law." |
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14 |
Storage and Disposal | All products. | Blocked with a solid line near end of Directions for Use section. | All products must have container disposal statements specific to the container. Complete information is in U.S. EPA' Label Review Manual chapter 13. |
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15 |
Net contents. | All products | Bottom front panel below company name and address. | State contents in largest suitable units. May be in metric units in addition to standard units. |
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16 |
Worker Protection Standard (WPS) statements 1. General statements 2. REI 3. Notification to Worker 4. Nonagric. Use Reqt's Personal Protective Equipment (PPE) |
Agricultural use products. Greenhouse fumigants. __________________ WPS products |
In the Directions for Use section, must have labeling in four sections (General Statements, REI,
Notification to Worker, and Non-agricultural Use Reqt's) ____________________ For early reentry, PPE must be in the section "Agricultural Use Requirements" immediately after the Restricted-entry statement. PPE must also be in the Precautionary Statements section. |
A Notification to Workers statement: "For greenhouse applications, notify workers of the application by warning orally and by posting warning signs outside all entrances to the greenhouse." If product is Category I, the following statement is required "Notify workers of the application by warning them orally and by posting warning signs at entrances to treated areas." A separate User Safety Recommendation box should be placed at the end of the "Hazards to Humans and Domestic Animals" section. If different REI's exist for certain crops or uses, the REI must appear in the Directions for Use. The REI must be preceded or followed by the word "Restricted Entry Interval" or "REI." PR Notice 93-11 allows non-agricultural uses to be labeled separately to avoid WPS requirements. Non-agricultural uses may be separated in a box called "Non Agricultural Use Requirements" which is after the Agricultural Use box. Non-WPS uses are placed in this box (except PPE requirements.) _____________________________________ Complete PPE wording is in U.S. EPA's Label Review Manual chapters 8 and 11. |
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