Jump to main content.


Pilot Criteria for Biodegradability Claims On FIFRA Registered Products On FIFRA Registered Products

You will need Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more.

September 19, 2011

Purpose: EPA’s Antimicrobials Division of the Office of Pesticide Programs (OPP) has undertaken a 2 year Pilot Program to assess the potential benefits of allowing “factual statements” regarding some environmentally preferable characteristics of registered pesticide products. Biodegradability is a critical concern with “down the drain” products which can be aquatically toxic. In order to recognize the value of “biodegradable surfactants” and to incentivize the development of entirely biodegradable products, OPP has developed the following criteria and standards which products must achieve prior to making biodegradability statements under the Pilot Program. EPA will evaluate the results of the Factual Statements Pilot Program prior to making any decision regarding the permissibility of these and other piloted statements going forward.

On This Page


Top of page

  1. “All Ingredients” Claim
  2. Example Claim: “100% Biodegradable. All ingredients in this product are readily biodegradable in water.”

    “All Ingredients” Approval Criteria

    In order for EPA to approve an “all ingredients” claim for a pesticide product, all ingredients in a product’s basic formulation and in all alternate formulations must meet criterion 1 below. In addition, the product as a whole must meet criterion 2. Once EPA approves the claim on the product label, all previously approved Confidential Statements of Formula (CSF) will be superseded by the biodegradable CSF’s.

    1. All surfactants must pass the screen using the DfE Criteria for Surfactants, which considers biodegradability as well as aquatic toxicity. All other ingredients in the candidate product must achieve the pass level in a Ready Biodegradability Test. Per OECD and OCSPP guidelines, the pass level must be reached in a 10-day window for all methods with the exception of OECD Test Guideline 301C, and the MITI method in OCSPP Harmonized Guideline 835.3110. For these two methods, the 10-day window is not applicable. (See list of test methods below.)


    2. The product cannot contain any ingredients considered carcinogens, mutagens, or reproductive toxicants by one of the authorized bodies listed in Tables 1, 2 and 3. Only products classified as FIFRA Toxicity Category II, III or IV are eligible to make this claim.

    Rationale: Biodegradability does not guarantee low toxicity. Chemicals known to be rapidly biodegradable have also been identified as carcinogens, mutagens or reproductive toxicants (CMR). To ensure that these products do not pose an unacceptable risk to human health, or the environment, only products that do not contain ingredients considered to be CMR’s will be eligible to make a biodegradability claim.

    Acceptable Test Methods

    OCSPP (formerly OPPTS) Harmonized Guideline 835.3110 - Ready Biodegradability
    OCSPP (formerly OPPTS) Harmonized Guideline 835.3140 - Ready Biodegradability – CO2 in Sealed Vessels (Headspace Test)
    OECD Test Guideline 301A: DOC Die-Away
    OECD Test Guideline 301B: CO2 Evolution
    OECD Test Guideline 301C: Modified MITI (I)
    OECD Test Guideline 301D: Closed Bottle
    OECD Test Guideline 301E: Modified OECD Screen
    OECD Test Guideline 301F: Manometric Respirometery
    OECD Test Guideline 310: CO2 in sealed vessels

    How to Apply for the “All Ingredients” Claim

    1. PRIA action code is A570 with $3,474 fee. The review period is 9 months, so a 5 month renegotiation request must be included.


    2. All Confidential Statements of Formula (CSF’s) on file for this product (i.e., the basic formula and all alternate formulas) must be submitted for review.


    3. The “All Ingredients” Biodegradability Formulation Disclosure table (PDF) (1 p, 17 K) must be submitted with the first two columns, Ingredient Name and CAS Reg. No., completed.


    4. If a formulation is being modified by the removal or exchange of an inert ingredient;
      1. Confirmatory efficacy data will be required, if applicable.
      2. Primary eye and skin irritation data will be required, if product supports a “Caution” or no signal word.
      3. As an alternative to generating product specific irritation studies, the company may:
        1. Submit a justification outlining why the biodegradable surfactant has either the same level of irritation or is less irritating than the original surfactant; and
        2. Include the acute toxicity data on the new surfactant.

    5. The PRIA Application is “complete” once the following information has been received:
      1. 1 copy of the cover letter indicating the type of action being sought
      2. 1 copy of the transmittal document/bibliography
      3. 1 copy of EPA Form 8570-1, Application of Pesticide Registration (PDF) (2 pp, 1MB)
      4. 2 copies of EPA Form 8570-4, Every Confidential Statements of Formula (PDF) (2 pp, 1.09 MB) (i.e., basic and alternate formulations) on file for the product
      5. 1 copy of the “All Ingredients” Biodegradability Formulation Disclosure table (PDF) (1 p, 17 K)
      6. 1 copy of EPA Form 8573-27, Formulator’s Exemption Statement (PDF) (2 pp, 104.62 k), if applicable
      7. 1 copy of EPA Form 8570-34, Certification with Respect to Citation of Data (PDF) (1 p, 58.08 k), if applicable
      8. 1 copy of EPA Form 8570-35, Data Matrix (PDF) (3 pp, 90.33 k), if applicable
      9. 5 copies of proposed labeling
      10. 3 copies of data for each data requirement (Bounded)


    Top of page

  3. Surfactant Class Claims
  4. Example Claim: “The surfactants contained in this product are biodegradable.”*
    (*Surfactants are cleaning agents.)

    “Surfactant Class” Approval Criteria

    In order for EPA to approve a “surfactant class” claim for a pesticide product, all surfactants/synonyms in a product’s basic formulation and in all alternate formulations must meet criterion 1 below. In addition, the product as a whole must meet criterion 2. Once EPA approves the claim on the product label, all previously approved Confidential Statements of Formula (CSF) will be superseded by the biodegradable surfactant/synonym CSF’s.

    1. Surfactants are substances that lower the surface tension of a liquid, the interfacial tension between two liquids, or that between a liquid and a solid. Surfactants may act as detergents, soaps, wetting agents, degreasers, emulsifiers, foaming agents, and dispersants. All pesticide inert ingredients with these or similar functions will be considered to be surfactants for purposes of this pilot program. Each surfactant ingredient in the product for which the claim is being made must meet the EPA Design for Environment (DfE) Criteria for Surfactants.


    2. The product cannot contain any ingredients considered carcinogens, mutagens, or reproductive toxicants (CMR) by one of the authorized bodies listed in Tables 1, 2 and 3. Only products classified as FIFRA Toxicity Category II, III, or IV are eligible to make this claim.

    Rationale: Some surfactants used in cleaning/disinfecting products pose aquatic toxicity concerns for numerous species and their degradation products may persist; nonylphenol ethoxylates (NPEs) are an example. OPP has decided to recognize the use of surfactants which protect aquatic life by rapid biodegradation to less toxic compounds by allowing the label to contain a claim of “biodegradable surfactants.” EPA’s DfE Criteria for Surfactants examines a surfactant’s rate of biodegradation, degradation products, and level of aquatic toxicity. Only surfactants which meet these criteria will be eligible to make the claim. To ensure that the remaining ingredients in these products do not pose an unacceptable risk to human health or the environment, only OPP registered products which contain no ingredients considered to be CMRs will be eligible to make this claim.

    How to Apply for the “Surfactant Class Based” Claim

    1. PRIA action code is A570 with $3,474 fee. The review period is 4 months.


    2. All Confidential Statements of Formula (CSF’s) on file for this product (i.e., the basic formula and all alternate formulas) must be submitted for review. Column 15, Purpose in Formulation, on the CSF must be revised to indicate that the ingredient is “Biodegradable” surfactant/synonym.


    3. “Surfactant Class” Biodegradability Formulation Disclosure table (PDF) (1 p, 7 K) must be submitted with the first two columns, Ingredient Name and CAS Reg. No., completed.


    4. If a formulation is being modified by the addition or exchange of a surfactant;
      1. Confirmatory efficacy data will be required, if applicable.
      2. Primary eye and skin irritation data will be required, if the product supports a “Caution” or no signal word.
      3. As an alternative to generating product specific irritation studies, the company may:
        1. Submit a justification outlining why the biodegradable surfactant has either the same level of irritation or is less irritating than the original surfactant; and
        2. Include the acute toxicity data on the new surfactant.

    5. PRIA Application is “complete” once the following information has been received:
      1. 1 copy of the cover letter indicating the type of action being sought
      2. 1 copy of the transmittal document/bibliography
      3. 1 copy of EPA Form 8570-1, Application of Pesticide Registration (PDF) (2 pp, 1MB)
      4. 2 copies of EPA Form 8570-4, Every Confidential Statements of Formula (PDF) (2 pp, 1.09 MB) (i.e., basic and alternate formulations) on file for the product
      5. copy of the “Surfactant Class” Biodegradability Formulation Disclosure table (PDF) (1 p, 7 K)
      6. 1 copy of EPA Form 8573-27, Formulator’s Exemption Statement (PDF) (2 pp, 104.62 k), if applicable
      7. 1 copy of EPA Form 8570-34, Certification with Respect to Citation of Data (PDF) (1 p, 58.08 k), if applicable
      8. 1 copy of EPA Form 8570-35, Data Matrix (PDF) (3 pp, 90.33 k), if applicable
      9. 5 copies of proposed labeling
      10. 3 copies of data for each data requirement (Bounded)


    Top of page

  5. Criteria for Review of Listed Carcinogens, Mutagens and Reproductive Toxicants in FIFRA Registered Products Making a Biodegradability Claim April 2011/ August 4, 2011
  6. The following criteria will be used to screen FIFRA registered products seeking to make a biodegradability claim to determine that a candidate products does not contain a carcinogen, mutagen or reproductive toxicant listed by the following recognized authoritative bodies: EPA, NTP, IARC and the EU.

    1. Carcinogenicity
    2. Products containing an ingredient considered to be a carcinogen by one of the authoritative bodies in Table I are not eligible to make the claim.

      Table 1 – Carcinogens
      Authoritative Body Criteria
      National Toxicology Program (NTP) Known to be Human Carcinogen Reasonably Anticipated to be Human Carcinogen
      U.S. Environmental Protection Agency (EPA) (2005/1999) Carcinogenic to humans, Likely to be carcinogenic to humans, or Suggestive evidence of carcinogenic potential (1996) Known/Likely (1986) Group A – Human Carcinogen, Group B – Probable human carcinogen, or Group C – Possible human carcinogen
      International Agency for Research on Cancer (IARC) Group 1 – Carcinogenic to humans
      Group 2A – Probably carcinogenic to humans
      Group 2B – Possibly carcinogenic to humans
      EU CMR List Category 1 – Known to be carcinogenic to humans
      Category 2 – Should be regarded as if carcinogenic to humans
      Category 3 – Cause for concern for humans owing to possible carcinogenic effects
      EU Risk Phrases R45: May cause cancer
      R49: May cause cancer by inhalation
      R40: Limited evidence of a carcinogenic effect
      And all combination risk phrases containing one or more of the above.

    3. Mutagenicity
    4. Products that contain an ingredient considered to be a mutagen or genetic toxicant by one of the authoritative bodies in Table 2 are not eligible to make the claim.

      Table 2 – Mutagenicity and Genetic Toxicity
      Authoritative Body Criteria
      EU CMR List Category 1 – Substances known to be mutagenic to humans
      Category 2 – Substances which should be regarded as if they are mutagenic to humans
      Category 3 – Substances which cause concern for human owing to possible mutagenic effects
      EU Risk Phrases R46: May cause heritable genetic damage
      R68: Possible risk of irreversible effects
      And all combination risk phrases containing one or more of the above.

    5. Reproductive and Developmental Toxicity
    6. Products which contain an ingredient considered to be a reproductive or developmental toxicant by one of the authoritative bodies in Table 3 are not eligible to make the claim.

      Table 3 – Reproductive/Developmental Toxicity
      Authoritative Body Criteria
      EU CMR List Category 1 – Known to impair fertility in humans or known to cause developmental toxicity in humans
      Category 2 – Should be regarded as if they impair fertility in humans or cause developmental toxicity to humans
      Category 3 – Cause concern for human fertility or possible developmental toxic effects
      EU Risk Phrases R60: May impair fertility
      R61: May cause harm to the unborn child
      R62: Possible risk of impaired fertility
      R63: Possible risk of harm to the unborn child
      R64: May cause harm to breastfed babies
      And all combination risk phrases containing one or more of the above.

Top of page

Publications | Glossary | A-Z Index | Jobs


Local Navigation


Jump to main content.