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Label Review Manual
Chapter 8: Environmental Hazards

Table of Contents
Chapters:
  1. Purpose of Manual
  2. What is a Pesticide?
  3. General Labeling Requirements
  4. Types of Label Reviews
  5. Ingredient Statement
  6. Use Classification
  7. Precautionary Labeling
  8. Environmental Hazards
  9. Physical or Chemical Hazards
  10. Worker Protection Labeling
  11. Directions for Use
  12. Labeling Claims
  13. Storage and Disposal
  14. Identification Numbers
  15. Company Name and Address
  16. Graphic & Symbols on Labels
  17. Content/Net Weight Statement
  18. Unique Product Labeling
  19. The Consumer Labeling Initiative and Pesticide Labels


On this page

  • I. Introduction
  • II. Reviewing the Statements
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    I. Introduction

    1. The Environmental Hazards statement provides the precautionary language advising of the potential hazards to the environment from transport, use, storage, or spill of the product. The hazards may be to water, soil, air, beneficial insects, plants, and/or wildlife. Generally, the information contained in this section is based upon the results of seven basic acute toxicity studies performed on the technical grade of the active ingredient(s) in the formulation. These seven studies are: (1) avian oral LD (with mallard or bobwhite quail), (2) avian dietary LC50 (mallards), (3) avian dietary LC50 (bobwhite quail), (4) freshwater fish LC50 (rainbow trout), (5) freshwater fish LC50 (bluegill sunfish), (6) acute LC50 freshwater invertebrates (Daphnia magna or water flea) and (7) honeybee contact LD50. For specific data requirements see Part 158.

    2. In addition, data concerning a chemical’s potential to contaminate groundwater or surface water, to drift, to adversely affect non-target plants and bees provide important information. These studies are hydrolysis, batch equilibrium, aerobic soil metabolism, field dissipation, and the prospective groundwater study.

    3. The data generated from all of these studies support the language used for the Environmental Hazards statements. Review of the data is performed by the Environmental Fate and Effects Division (EFED) or other science reviewers who may also evaluate any label text proposed by the registrant to determine what statements are required.

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    II. Reviewing the Statements

    1. Does the Product Require an Environmental Hazards Statement?

      The label reviewer must first determine whether the use patterns on the label require any Environmental Hazards statement. The use pattern of a pesticide helps determine the need for and the specific text of the Environmental Hazards section. The label reviewer may conclude that all pesticides used outdoors must have the statement. However, the reviewer should also look at the proposed statement with a critical eye towards its applicability. Does it makes sense for the product? For example, a granular herbicide would not generally need a statement warning of potential spray drift problems since granular formulations are not "sprayed" and are seldom associated with any "drift."

      1. Products which are intended for use exclusively indoors may omit the Environmental Hazards statement. Products applied to domestic animals, such as flea collars or ear tags may generally omit the statement. However, the statement may be required for a domestic use product such as a dog dip due to the potential for contamination of water by the use of a such a product. Thus it is important for reviewers to carefully evaluate the use of the product to determine whether potential risk from the transport, use, storage or disposal of the product should be mitigated by the Environmental Hazards statement.

      2. Manufacturing use products (MPs), although used indoors to formulate other products, require some Environmental Hazards text because MPs still are generally highly concentrated and could pose a serious hazard if a spill occurred. A discharged statement is also required see section F.1. below for recommended language.

      3. The Agency historically has required products labeled for use outdoors to have Environmental Hazards statements on their labels.

      4. If the reviewer determines that the use pattern triggers the need for Environmental Hazards labeling, the proposed draft labeling must be reviewed according to the requirements outlined in the regulations and the policy described in the remainder of this chapter.

    2. Statement Location.

      The Environmental Hazards section of the label should be located under the general heading "Precautionary Statements." It must have the heading "Environmental Hazards" (not "Environmental Precautions," "Environmental Protections," or anything similar). [40 CFR 156.10(h)(2)]

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    3. Support for Statements.

      The text of the statements is then reviewed according to the type of action:

      1. If the action represents a submission accompanied by data, the environmental science reviewer will evaluate the environmental hazards statements and recommend any necessary label changes as part of the data review. The label reviewer must specify all requested changes in the response to the registrant. The necessary language must be in accordance with mandatory/advisory guidance. See Chapter 3 and PR Notice 2000-5.

      2. The environmental reviewer is responsible for reviewing data on all technical products and may also review data associated with end-use formulations. Data requirements are governed by FIFRA and the implementing regulation set out in Part 158. Generally speaking data are required when an end-use formulation is likely harmful to non-target organisms (for example, micro encapsulated insecticides which are used on crops are potentially harmful to pollinators). If the Reregistration Eligibility Decision (RED) Document has been issued, it may contain appropriate Environmental Hazards statements, but the reviewer should evaluate whether the RED specifically addresses the use at issue and make necessary variations in the label statement. If the reviewer is working on a me-too application for registration (where another identical or substantially similar formulation is already registered), the Environmental Hazards statements of the similar formulation should be compared with those in the RED. If the similar registered product label language is consistent with the RED, the me-too Environment Hazard language should be the same as the currently registered product. If there are no similar products the application should be routed to EFED or the science reviewers. Additionally, if a registrant wishes to amend the Environmental Hazards statements, environmental reviewers may need to see the amendment application.

        1. Since the cited label may have some statements that are outdated and/or missing (required or recommended since the label was accepted), it is important to check the regulations and the statements outlined in the rest of this chapter to make sure that both the cited label and the draft label reflect current Agency requirements and policy.

        2. If an error is discovered in the Environmental Hazards section of the cited me-too label, the reviewer should write a letter informing the registrant of the error(s) and request an application for amendment be submitted within a reasonable time, such as 30 days.

    4. General Statements

      1. Generally, all products with directions for outdoor, terrestrial uses should have the following statements in the Environmental Hazards section:

        “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 disposing of equipment washwater or rinsate."

        1. These statements are preceded by "For terrestrial uses," to make it clear that the statements do not apply to the other general use patterns -- e.g., mosquito adulticides, aquatic uses such as mosquito larvicides, aquatic herbicides, piscicides, etc., greenhouse and indoor uses.

        2. Note that some Bt products do not require the above statements. Based on the fact some Bt products are applied to terrestrial agricultural fields to control mosquitoes in periodic standing water.

        3. If a pesticide product is aerially applied to forests, the above statements should be preceded with the phrase: “Except under the forest canopy” There are many creeks and streams under forest canopies. The statement as written allows spraying the forest canopy, but requires spray valves to be shut off when passing over ponds, streams, etc. not under the forest canopy.

      2. For outdoor residential consumer products (except for lawn care which requires the same statement as outdoor terrestrial uses), the statements generally required by the Agency to meet risk/benefit concerns are as follows:

        "Do not apply directly to water. Do not contaminate water when disposing of equipment washwaters or rinsate."

        1. The reviewer must keep in mind the use pattern of the product undergoing a label review. If the product is actually intended for application to water - to control algal growth, for example, the above two statements would be inappropriate. Or, if the product is a residential aerosol spray in a can for application to wasp or hornet nests, no equipment would be used, and the statement regarding cleaning of equipment may be omitted.

      3. Products with directions for outdoor terrestrial uses requiring a fish or aquatic invertebrate toxicity statement usually contain a statement warning of hazard from drift and or runoff. The word drift should be omitted if the product is a “Granular” or if it is applied “in furrows”or injected into the soil. The Agency has historically required that the following statement appear in the Environmental Hazards section:

        “Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.”

      4. Groundwater Advisories

        1. If the environmental reviewers determine that the chemical (or major degradates) has laboratory-derived mobility (Kd less than 5) and persistence characteristics (e.g., hydrolysis half-life at any pH greater than 30 days or aerobic soil metabolism half-life greater than 2 weeks) similar to other pesticides found in ground water as a result of normal label uses, and no detections are reported in ground water (for example, for a new chemical), the Agency has generally required the following label language:

          Ground Water Advisory
          "This chemical has properties and characteristics associated with chemicals detected in ground water. The use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground-water contamination."

        2. If the environmental reviewers determine that the chemical (or major degradates) has laboratory derived mobility and persistence characteristics similar to other chemicals found in ground water as a result of normal label uses, AND:

          1. Detections are reported in ground water in a prospective ground water study or other monitoring study conducted for registration, or other reliable monitoring data in the publicly available literature, or

          2. Field dissipation results confirm the chemical leaches, then the Agency has historically required the following label language:

            Ground Water Advisory

            "[Name of chemical] [A degradate of (name of chemical)] is known to leach through soil into ground water under certain conditions as a result of label use. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground-water contamination."

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      5. Surface Water Label Advisories

        The Agency has historically required the following statement to be added to all household and agricultural labels modified for the specific pesticide characteristics and targeted audience.

        “This product may contaminate water through runoff. This product has a [insert phrase a.1, a.2, or a.3, according to the pesticide’s “mean” soil partition coefficient (Kd)] for [insert phrase b.1, b.2, or b.3, according to the pesticide’s aerobic soil metabolism half-life] after application. Poorly draining soils and soils with shallow water tables are more prone to produce runoff that contains this product. [insert phrase c.1 or c.2 depending on whether the product is intended for the householder or farmer].”

        1. Soil Partition Coefficient Phrases.

          1. Kd less than 15 - “high potential for runoff”
          2. Kd between 15-300 - “a potential for runoff”
          3. Kd greater than 300 - “a potential for runoff”

        2. Aerobic Soil Metabolism Half-Life Phrases.

          1. T½ less than 8 days - ‘several days after application”
          2. T½ between 8 and 30 days - “several weeks after application”
          3. T½ greater than 30 days - “several months or more after application”

        3. Targeted User Community.

          1. Household Label. Avoid applying this product to ditches, swales, and drainage ways. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours.

          2. Agricultural Label. A level, well maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, streams, and springs will reduce the potential for contamination of water from rainfall-runoff. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours. [For pesticides with a soil partition coefficient of “C” add the following, “ Sound erosion control practices will reduce this product’s contribution to surface water contamination].”

    5. Non-Target Organism Statements

      1. The following statement has historically been required when a pesticide intended for outdoor use contains an active ingredient which has a mammalian acute oral LD50 =100 mg/kg, an avian acute oral LD50 = 100 mg/kg, or a subacute dietary LC50 = 500 ppm:

        "This pesticide is toxic to [birds] [mammals] or [birds and mammals]."

      2. The following statement has historically been required when a pesticide intended for outdoor use contains an active ingredient with a fish acute LC50 or aquatic invertebrate (including estuarine species such as oyster and mysid shrimp) EC50 = 1 ppm:

        "This pesticide is toxic to [fish] [fish and aquatic invertebrates] [oysters/shrimp] or [fish, aquatic invertebrates, oysters and shrimp].”

      3. If field studies or accident history, such as the FIFRA § 6(a)(2) reports, indicate that use of the pesticide may result in fatality to birds, fish or mammals, the following statement has historically been required:

        "This pesticide is extremely toxic to [birds], [mammals], [fish], or [birds and mammals and fish].”

      4. If a pesticide is used outdoors as a foliar application, especially to crops, and is toxic to pollinating insects, a "Bee Hazard" warning must be included in the Environmental Hazards. 40 CFR56.10(h)(2)(ii)(E). The following table sets out the toxicity groupings and required label statements for honey bees:

        Honey Bee Toxicity Groups and Cautions
        Toxicity Group Precautionary Statement if Extended Residual Toxicity is Displayed Precautionary Statement if Extended Residual Toxicity is not Displayed
        I

        Product contains any active ingredient with acute LD50 of 2 micrograms/bee or less         		This product is highly toxic to bees exposed to direct treatment or residues on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds if bees are visiting the treatment area. This product is highly toxic to bees exposed to direct treatment on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds while bees are actively visiting the treatment area.
        II

        Product contains any active ingredient(s) with acute LD50 of greater than 2 micrograms/bee but less than 11 micrograms/bee.         		This product is toxic to bees exposed to direct treatment or residues on blooming crops or weeds. Do not apply this product if bees are visiting the treatment area. This product is toxic to bees exposed to direct treatment. Do not apply this product while bees are actively visiting the treatment area.
        III
        All others.
        		No bee caution required. No bee caution required.

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      5. If a pesticide product is used to control aquatic weeds, the Environmental Hazards section must normally contain the following statement:

        “Treatment of aquatic weeds can result in oxygen loss from decomposition of dead weeds. This loss can cause fish suffocation. Therefore, to minimize this hazard, treat 1/3 to ½ of the water area in a single operation and wait at least 10 to 14 days between treatments. Begin treatment along the shore and proceed outwards in bands to allow fish to move into untreated areas. Consult with the State agency with primary responsibility for regulating pesticides before applying to public waters to determine if a permit is needed.”

      6. Pesticide products that include directions for mosquito control may require one of the following statements in the Environmental Hazards section, although the aquatic toxicity of the specific product may lead to more or less stringent statements. For example, certain bacterial larvicides, such as some Bt products, are considered non-toxic to aquatic organisms and would not require any statement. Some pyrethroids registered as mosquito adulticides are highly toxic to aquatic organisms and may require stronger precautions than those listed below, tailored to the specific products, in order to prevent water contamination. Products with aquatic toxicity concerns between these extremes should have one of the following recommended statements:

        Larvicides--- “Aquatic organisms may be killed in waters where this pesticide is used. Consult with the State agency with primary responsibility for regulating pesticides before applying to public waters to determine if a permit is needed.”

        Adulticides--- “Do not apply over water, except where mosquitoes are emerging or swarming, or to treat vegetation where mosquitoes may rest. Drift and washoff from vegetation may be hazardous to aquatic organisms [and wildlife] in or adjacent to treated areas. Do not contaminate water when disposing of equipment wash waters or rinsate. Before making the first mosquito control application in a season, consult with the State agency with primary responsibility for regulating pesticides to determine if permits are required.”

        NOTE: As this edition of the Label Review Manual is being issued, revisions to label language concerning products for adult mosquito control are being considered by the Agency.

      7. If a pesticide product is applied to irrigation water and contains an ingredient requiring an aquatic organism toxicity statement, the Environmental Hazards section must contain the following statement:

        “Irrigation water treated with this product may be hazardous to aquatic organisms. Treated water must either be held on the irrigated field until absorbed by the soil or not released for (number) days.”

    6. Miscellaneous Statements

      1. For certain registered end-use products, technical grade products and other manufacturing use products (i.e., those used to formulate other products), a "point source discharge" is a possibility because effluent from the manufacturing plant may contain pesticides. This does not include those products used to control roaches or other pests in the facilities, but applies to those chemicals used in the formulation processes.

        1. The Agency recommends that the following National Pollutant Discharge Elimination System (NPDES) statement (as outlined in PR Notice 93-10 ) should appear on such products, in addition to any other required statements.

          "Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA."

        2. PR Notice 95-1 exempts certain end-use products [i.e., products in containers of less than 5 gallons (liquid), less than 50 pounds (solid, dry weight) and in aerosol containers of any size] from bearing effluent discharge statements specified by PR Notice 93-10. PR Notice 93-10 still applies to the following kinds of pesticide products that may result in discharges to the waters of the United States or to municipal sewer systems, including but not limited to: (A) all technical grade and manufacturing use products; and (B) end-use products packaged in containers equal to or greater than 5 gallons (liquid) or 50 pounds (solid, dry weight), and registered for industrial preservative, water treatment, other industrial processing uses (such as cooling tower water systems, pulp and paper mill water systems, secondary oil recovery injection water systems, food processing operations, leather tanning, wood protection and textile treatment), and commercial and institutional uses (including, but not limited to, hospitals, hotels/motels, office buildings, and prisons).

        3. The exemption of certain containers from the labeling requirements of PR Notice 95-1 does not relieve a producer or user of such products from the requirements of the Clean Water Act or state or local requirements, if applicable.

      2. If a pesticide product contains directions for use in treating seed or is formulated as a granule, pellet, or treated bait, the Agency has historically required the following Environmental Hazards statements:

        "Treated _________ [seed], [granules], [pellets], [baits] exposed on soil surface may be hazardous to ___________ [birds], [wildlife], [fish and aquatic invertebrates] or [birds, other wildlife, and fish]. Cover or collect _________ [seeds], [granules], [pellets], [baits] spilled during loading.”

      3. When the label bears a reference to mixing with other products, the Agency recommends that the registrant add a statement such as the following:

        “Observe the most restrictive of the labeling limitations and precautions of all products use in mixtures.”

        NOTE: Chemical specific statements, such as groundwater/surface water, spray drift/runoff, or endangered species statements will be added to the manual as they are identified. The label reviewer should consult with the product manager/team leader and EFED or environmental reviewer.

        4. 1 This information will be found in submitted data, the RED document, or the Registration Standard. It may not necessarily be available to the label reviewer, but helps you to understand the origin of the statements.

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