Criteria for Biodegradability Claims on Products Registered under FIFRA

EPA’s Office of Pesticide Programs (OPP) has undertaken a pilot program to assess the potential benefits of allowing label statements regarding some environmentally preferable characteristics of registered pesticide products.

Biodegradability is a critical concern with “down the drain” products, which can be toxic in the aquatic environment. In order to recognize the value of “biodegradable surfactants” and to incentivize the development of entirely biodegradable products, we have developed the following criteria and standards that products must achieve before making biodegradability statements under the pilot program. We will evaluate the results of the Label Statements Pilot Program before making any decision regarding the permissibility of these and other piloted statements in the future.

• “All ingredients” claim
• Surfactant class claims
• Criteria for review of listed carcinogens, mutagens and reproductive toxicants

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"All Ingredients" Claim

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

"All Ingredients" Approval Criteria

If we are 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 we approve the claim on the product label, all previously approved Confidential Statements of Formula (CSF) will be superseded by the biodegradable CSF's.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 Safer Choice 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 (see list below). According to Organization for Economic Cooperation and Development (OECD) and Office of Chemical Safety and Pollution Prevention (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 Respirometry
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 (CSFs) 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 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 we have received the following information:
   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.
   4. 2 copies of EPA Form 8570-4, Every Confidential Statements of Formula (i.e., basic and alternate formulations) on file for the product.
   5. 1 copy of the “All Ingredients” Biodegradability Formulation Disclosure table.
   6. 1 copy of EPA Form 8570-27, Formulator’s Exemption Statement, if applicable.
   7. 1 copy of EPA Form 8570-34, Certification with Respect to Citation of Data, if applicable.
   8. 1 copy of EPA Form 8570-35, Data Matrix, if applicable.
   9. 5 copies of proposed labeling.
   10. 3 copies of data for each data requirement (Bound) 

Surfactant Class Claims

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 interaction at the surface between two liquids (called interfacial tension), 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 Safer Choice 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 that protect aquatic life by rapid biodegradation to less toxic compounds by allowing the label to contain a claim of "biodegradable surfactants." EPA's Safer Choice Criteria for Surfactants examines a surfactant's rate of biodegradation, degradation products and level of aquatic toxicity. Only surfactants that 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, products must be EPA-registered and contain no ingredients considered to be CMRs to 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 (CSFs) 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 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.
   4. 2 copies of EPA Form 8570-4, Every Confidential Statements of Formula (i.e., basic and alternate formulations) on file for the product.
   5. copy of the “Surfactant Class” Biodegradability Formulation Disclosure table.
   6. 1 copy of EPA Form 8570-27, Formulator’s Exemption Statement, if applicable.
   7. 1 copy of EPA Form 8570-34, Certification with Respect to Citation of Data, if applicable.
   8. 1 copy of EPA Form 8570-35, Data Matrix, if applicable.
   9. 5 copies of proposed labeling.
   10. 3 copies of data for each data requirement (Bound).

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Criteria for Review of Listed Carcinogens, Mutagens and Reproductive Toxicants in FIFRA-Registered Products Making a Biodegradability Claim April 2011/ August 4, 2011

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.

Carcinogenicity

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.

Mutagenicity

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.

Reproductive and Developmental Toxicity

Products that 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.