MAY 2 2 2014 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

The Honorable Kamala Harris 

Attorney General of the State of California 

c/o Environment Law Section 

California Department of Justice 

P.O. Box 70550 

1515 Clay St. 

Oakland, CA 94612-0550 

Ms. Kim Leva! 

Northwest Coalition for Alternatives to Pesticides 

P.O. Box I 393 

1216 Lincoln St. 

Eugene, OR 97440 

Mr. Erik Schlenker-Goodrich 

Western Environmental Law Center 

1216 Lincoln St. 

Eugene, OR 97401 

Dear Madam Attorney General, Ms. Leval and Mr. Schlenker-Goodrich: 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

This is an amended response to two petitions you submitted in 2006 identifying 3 71 pesticide inert 

ingredients as hazardous and requesting that the U.S. Environmental Protection Agency require that the 

identities of those inert ingredients appear on the labels of products that include any of the ingredients in 

their formulations. 

On September 30,2009, the EPA partially granted the petitions (Reference 1). The agency stated that 

the EPA agreed with the petitioners that the public should have a means to learn the identities of 

hazardous inert ingredients in pesticide formulations. The agency indicated that it believed that 

increased transparency could lead to better informed decision-making and to better informed pesticide 

use. 

The agency's 2009 response committed to pursuing both voluntary and regulatory actions to address the 

petitions as follows: 

EPA is initiating rulemaking to increase the public availability of hazardous inert ingredient 

identities for specific pesticide formulations. In connection with this rulemaking EPA will also 

be discussing ideas to increase the disclosure of inert ingredient identities to an even greater 

degree than requested by the petitions, for example, by requiring disclosure of all inert 

ingredients, including ingredients not deemed hazardous. 

Internet Address (URL) • http://www.epa gov 

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Therefore the Agency is initiating this rulemaking via an Advance Notice of Proposed 

Rulemaking. 

We continue to support what we believe is our common goal: to ensure that all substances in pesticides -

both inert ingredients and active ingredients - are safe for humans and the environment. While the 

EPA's regulation of pesticides focuses primarily on pesticide active ingredients because of their wellrecognized biological activity, we have been moving ahead with respect to inert ingredients. I would like 

to describe the steps the EPA has taken since the 2009 response to your petitions, what we have learned, 

and why we now think we should pursue a somewhat different approach to address the safety of inert 

ingredients in pesticide products, notwithstanding the value of public knowledge of the identities of the 

ingredients in pesticide formulations. As explained more fully below, the EPA has now decided not to 

pursue finalization of the rulemaking it initiated seeking to mandate the disclosure on the label of a 

pesticide of the presence of a hazardous inert ingredient. 

On December 23,2009, the EPA published an Advance Notice of Proposed Rule Making in the Federal 

Register (74 FR 68215; FRL-8803-3) (Reference 2). The ANPRM initiated rulemaking to increase 

public availability of the. identities of both potentially hazardous inert ingredients and of inert ingredients 

in general. Our intention was to look at various ways to assist consumers and users of pesticides in 

making informed decisions and to reduce the presence of potentially hazardous ingredients in pesticides. 

The EPA sought feedback on whether the rule should mandate disclosure only of potentially hazardous 

ingredients or require disclosure of most or all inert ingredient identities, regardless of hazard. We noted 

that the EPA's ability to mandate disclosure of all inert ingredients regardless ofhazard may be limited 

by laws requiring the EPA to protect the confidentiality of trade secrets and confidential business 

information. The ANPRM also posed a number of specific questions for response. 

In response to the ANPRM, the agency received 405 distinct comments. These comments were very 

general in nature, either advocating for or against mandatory disclosure of inert ingredients of pesticides, 

or offering only broad, general reasons articulating their positions. The EPA did not receive many 

responses to the specific questions asked by the agency in the ANPRM that were intended to assist in 

developing a thorough and comprehensive disclosure rule. For example, there were few suggestions on 

how information should be disclosed, how the information would be used, or what the impact of inert 

disclosure on consumer behavior would be. Some companies did comment, however, that disclosure of 

inert ingredients would be extremely harmful to their businesses because it would reveal valuable trade 

secret information, enabling competitors to copy their products. The comments received also revealed 

considerable disagreement among various sectors of the public regarding the appropriateness and even 

legality of the possible requirements discussed in the ANPRM. For example, some registrants urged the 

EPA to develop risk-based criteria that included both hazard and exposure considerations because they 

did not believe the EPA has authority under the Federal Insecticide, Fungicide and Rodenticide Act to 

require inert ingredients disclosure based on hazard alone. Other registrants said they believed the EPA 

has "no plausible legal argument to support an assertion, that as a class, inert ingredients are not entitled 

to confidential treatment." 

Based in part on the comments, the EPA thinks that further pursuing the rulemaking initiated by the 

ANPRM would be a very complex, lengthy and resource-intensive activity. Despite the EPA's extensive 

list of questions, public comments did not provide some of the basic facts necessary to support the 

rulemaking, such as how effectively disclosure would change consumer behavior and how disclosure 

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might affect businesses' ability to compete. The comments also indicate that there are many contentious 

issues - the scope of any disclosure requirement, what types of information to disclose, the most 

appropriate means of disclosure, the effect of label disclosure on label readability, etc. Moreover, 

because of the process by which the federal government undertakes rulemaking, continuing this 

rulemaking would require a long-term effort. Merely drafting the required portions of a complex rule 

consumes significant staff resources from several parts of the agency. In addition, we must seek and 

consider the comments of other agencies within the federal government, and this rule would likely 

undergo review by the Office of Management and Budget. Publishing the proposal, receiving and 

responding to commen~s, developing a final rule and undergoing the process of publication can easily 

last several years. We must also discuss and document market failure as part of the justification for 

rulemaking, mitigate impact on small businesses, ensure proper legal authority, and adhere strictly to 

processes outlined in several federal laws. At this time, I am reluctant to further commit a significant 

level of resources to this rulemaking effort in the absence of data or information clearly indicating that a 

rule requiring disclosure, but not otherwise affecting the composition or use of a pesticide product, 

would result in a significant reduction in the human health or environmental risks posed by the presence 

of inert ingredients in pesticide products. 

In the 2009 response, the EPA committed to encourage voluntary disclosure. The EPA has long 

encouraged registrants to disclose the inert ingredients in their products. In a 1999 policy statement, 

several examples of disclosure statements were provided for registrants to consider (Reference 3). 

Because we thought more should be done, we began actively working with pesticide stakeholders and 

developed the structure for a voluntary program encouraging registrants of antimicrobial products to 

disclose ingredients. In July 20 I I, the agency issued guidance for antimicrobial pesticide companies that 

wish to voluntarily disclose their ingredients on their website (Reference 4). The guidance suggests full 

disclosure of the product ingredients may be included on the product label or posted on a company's 

website, with the website address added to the product label. The guidance also recommended including 

widely recognized chemical names, bilingual language and Safety Data Sheets. Although we have 

repeatedly reached out through trade associations and other industry contacts to many different pesticide 

registrants, we are aware of only five companies that make antimicrobial pesticides that are participating 

by disclosing the identity of the ingredients in their formulations, either on the label or via their 

company website. While one company has told the EPA it believes there is value in participating in the 

pilot from a public relations standpoint, the company has not been able to provide any information on 

whether, much less how, its disclosure initiatives have affected customers' buying patterns or other 

behavior. While the voluntary disclosure initiative has gained only limited acceptance, we think it is still 

worth encouraging additional companies to participate. With only a modest investment of resources we 

hope that we can gain more experience with different methods of disclosure and a better understanding 

of how disclosure influences customer behavior, and therefore have a stronger basis to evaluate its 

usefulness as a regulatory tool. 

Other information has also shaped our thinking. As part of our efforts to encourage safe pesticide use 

practices, for more than thirty years, we have sponsored a "Read the Label" program for consumer use 

pesticides. Over the past ten years we have collected information through survey and focus groups on 

consumer reading and understanding of labels. Based on this feedback, we believe that most consumers 

quickly read a minimal amount of information on the pesticide label when making a purchase, without 

an in-depth reading of the entire pesticide label. These findings suggest most consumers will not pay 

attention to information on product labels disclosing the identity of inert ingredients. 

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Based on our review of comments to the ANPRM, our experience with the voluntary disclosure 

program, and survey and focus group feedback, the EPA has re-evaluated how to best address 

potentially hazardous inert ingredients in registered pesticide products and now believes that a different 

approach is more appropriate. Instead of further pursuing the rulemaking the EPA initiated that was 

aimed at mandatory disclosure of a large number of specific inert ingredients, we will review inert 

ingredients currently listed for use in pesticides, update ~hat list, establish criteria for prioritization, and 

select top candidate inert ingredients for further analysis and potential action. I believe that, given our 

restricted financial and staff resources, this is the best way to address concerns with inert ingredients in 

pesticides, achieve the human health and environmental benefits that constitute our agency's primary 

mission, and attain my goal in administering FIFRA to minimize the risk of unreasonable adverse 

effects from pesticides. 

The rationale that led the EPA to initiate, via the ANPRM, a rule requiring disclosure of the identity of 

inert ingredients was to provide information to pesticide purchasers and users. The theory behind such 

disclosure is that purchasers would choose those formulations containing less hazardous (but still 

effective) inert ingredients, thereby moving the market in favor of those less hazardous formulations. I 

believe that significant shifts in consumer preferences and purchasing decisions can play an important 

role in the marketplace and could influence manufacturers' decisions about what types of products to 

offer. In fact, that is the premise underlying the reinvigorated Design for the Environment program in 

my Office of Pollution Prevention and Toxics. I question, however, the extent to which a sizeable 

percentage of pesticide users and purchasers would change their behavior based on disclosure of the 

inert ingredients in pesticides. For inert ingredient disclosure to have a significant effect on the 

marketplace, a significant number of consumers would need to read the ingredients statement on the 

label, recognize specific ingredients, understand which ingredients were hazardous, and then act on that 

information. Neither the voluntary program nor any other information supports a conclusion that a large 

percentage of pesticide users' decisions would be significantly influenced by that information. 

I believe that the EPA can achieve greater reduction in the risks from use of pesticides containing 

potentially hazardous inert ingredients through a series of non-rule actions designed to reduce the 

presence of hazardous inert ingredients in specific pesticide products. Moreover, I expect that the agency 

would be able to develop and implement these actions in a timelier manner than rulemaking. I therefore 

intend to pursue a combination of regulatory and focused non-regulatory actions that do not rely on 

rulemaking. 

Steps I am considering include: 

Prioritize pesticide inert ingredients for increased scrutiny: 

1. Revise the list of inert ingredients approved by the EPA for use in pesticide products: The EPA 

maintains a list of chemical substances that have been approved for use as inert ingredients in pesticide 

products. After appropriate evaluation to confirm hazard, the EPA would remove from the approved list 

those inert ingredients listed in your petitions that are no longer being used in pesticide products. Based 

on our initial review of the 371 inerts ingredients, 96 of the inert ingredients identified in your petitions 

could potentially be removed from the approved list. In 1987, the EPA issued its inert ingredients 

strategy to provide guidance (Reference 5) to applicants seeking approval of a new inert ingredient. 

Then, in 2010, the EPA published several guidance documents to provide more up-to-date information 

on the type of data generally needed to approve an inert ingredient (References 6, 7, and 8). The type of 

data generally needed to evaluate a new inert ingredient include, among others, studies to evaluate 

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potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as 

environmental effects associated with any chemical that is persistent or bioaccumulative. Therefore, 

before any of those inert ingredients that are removed from the list could be used in the future, this type 

of data on the ingredient would need to be provided and reviewed by the EPA. Only then would it be 

possible for the inert ingredient to receive approval as part of a new inert ingredient submission request. 

This review process will ensure that the presence of such inert ingredients does not cause unreasonable 

adverse effects on the environment. 

2. Give priority focus to non-food use inert ingredients: By law, the EPA is responsible for regulating 

the pesticides that are used by growers to protect crops and for setting limits on the amount of pesticide 

chemicals - both active ingredients and inert ingredients in pesticide - that may remain in or on foods 

marketed in the United States. These limits on pesticides left on foods are called "tolerances" in the U.S. 

In August 1996, the Federal Food, Drug, and Cosmetic Act was amended to include the Food Quality 

Protection Act. This Act required the EPA to reassess by August 2006 all of the existing pesticide 

tolerances to ensure that they meet current safety standards and are adequately supported by scientific 

data, and to apply the new, stricter standard to all newly established tolerances. The EPA has completed 

the statutorily-mandated tolerance reassessment for food-use inert ingredients. Consequently, given this 

review process, we believe that food-use inert ingredients have been evaluated for their safety for 

humans. Further, we conducted a screening level ecotoxicity risk assessment on th~ food use inert 

ingredients in conjunction with tolerance reassessment and the establishment of new tolerance 

exemptions; these assessments have not identified any significant ecotoxicological risk concerns. 

However, the inert ingredients that are not used on food crops (non-food use inert ingredients) did not 

benefit from these tolerance reassessment activities and therefore these ingredients would be the focus of 

our effort. From your original list of371, 45 were evaluated as food-use inert ingredients and could 

therefore be removed from the list. Giving focus to non-food use inert ingredients as well as potentially 

removing 96 from our approved list, there would remain 230 inert ingredients for further consideration. 

3. Set risk-based priorities: For non-food use inert ingredients, the EPA could employ a methodology to 

identify those inert ingredients that exhibit strong evidence of adverse human health or environmental 

effects. The EPA could consider the practicality of using lists of hazardous chemicals generated by other 

parts of the EPA, other federal agencies, or other governmental or international organizations. 

Understanding the development of these lists could enable the EPA to use these sources of information 

to take a closer look at inert ingredients in pesticide products to prioritize them for further analysis and 

possible actions. With respect to adverse effect on human health, because the EPA's review of an 

application to register a new pesticide product has always considered the acute toxicity and the physical 

and chemical hazards of the pesticide formulation, this step would focus primarily on chronic adverse 

effects. In addition, the priority setting approach would take into account indications of potential for 

significant exposure to humans and non-target organisms. Consideration of both hazard and exposure 

would help us prioritize which inert ingredients potentially posed the greatest risk and thus might need 

further action by the EPA. 

4. Take appropriate action to address risks from pesticide inert ingredients: After using the priorities 

determined by the process discussed in Steps 1 through 3 above, the EPA would then evaluate each 

remaining inert ingredient on a case-by-case basis to determine what combination of voluntary and/or 

regulatory action(s) would be most appropriate. FIFRA provides the agency with the authority to take a 

variety of regulatory actions that offer the potential for reducing risk. 

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Regulatory Programs: 

• Issue Data Call-In Notices requiring registrants to provide data needed by the EPA to 

conduct risk assessments for inert ingredients of concern. 

• For inert ingredients found to pose risks of concern in particular formulations, direct 

registrants to modify their registration, e.g., by reducing the amount of the inert ingredient in 

the formulation, replacing the hazardous inert ingredient in their formulation with an 

alternative, less hazardous chemical, or adding warnings or other labeling requirements. 

• In certain cases, if the EPA identifies risks of concern and a company is not willing to take 

requested actions, consider cancellation of products. 

• For inert ingredients of higher toxicity that supply a needed function in the product and there 

is not a suitable substitute, consider mandatory label disclosure of inert ingredients with a 

more hazardous profile in specific formulations. 

Voluntary Programs: 

• Seek to expand the existing voluntary disclosure program for antimicrobial pesticide 

products to include non-antimicrobial consumer-use pesticide products. 

• Create incentives for pesticide manufacturers to select less hazardous inert ingredient 

choices. 

• Work with retailers who have demonstrated interest in selling products formulated with less 

hazardous ingredients to provide information about the EPA's voluntary programs and 

encourage consistency. 

Some of these points were discussed in a meeting with several of the petitioners on February 25, 2014. 

The agency will look for opportunities to engage the petitioners, registrants, inert ingredient 

manufacturers, and other interested members of the public on how to implement this strategy. Such 

opportunities might include meetings, Federal Register notices soliciting comment, or other avenues. 

In sum, we believe we have identified a more effective and timely way to achieve our common 

objective; but, because this approach would no longer pursue the rulemaking the EPA initiated via the 

ANPRM seeking to mandate the disclosure of potentially hazardous inert ingredients on pesticide labels, 

as requested in the 2006 petitions, this amended response constitutes a denial of the petitions. Other than 

the decision not to pursue this rulemaking, the remainder of the 2009 petition is not amended. 

Thank you for this opportunity to respond to your concerns. I look forward to working with you as our 

organizations all strive to protect human health and the enviro).Ullent. 

Sincerely, 

6 
Copies: 

Ms. Wendy Park, Attorney for Center for Environmental Health, Beyond Pesticides, and 

Physicians for Social Responsibility 

Ms. Claudia Polsky, Deputy Director for Pollution Prevention & Green Technology, California 

Department of Toxic Substances Control 

References: 

1) Response Letter; Deborah Edwards to Petitioners; (September 30, 2009) 

(http://www.epa.gov/opprdOOllinerts/petitionresponse.pdf) (accessed April 30, 2014) 

2) Advance Notice of Proposed Rule Making (ANPRM): Public Availability ofldentities of Inert 

Ingredients in Pesticides; (December 23, 2009; 74 FR 68215; FRL-8803-3) (available at 

regulations.gov using the docket identifier EPA-HQ-OPP-2009-0635) 

3) EPA: Final Report of the Pesticide Program Dialog Committee on the Activities of the Inert 

Disclosure Workgroup, March 2000 through April 2002; Discussion Paper 12; Inert Disclosure 

Stakeholder Workgroup; EPA Response to Labeling Questions Raised by Workgroup Members 

(2001) (http://www.epa.gov/oppfead1/cb/ppdc/inert-finalreport.html) (accessed April 30, 2014) 

4) EPA: Guidelines for Voluntary Disclosure of Antimicrobial Ingredient Information on company 

Websites and/or Labels (http://www.epa.gov/oppadOO 1/voluntarv-disclosure.htrnl) (accessed 

April30, 2014) 

5) EPA: Inert Ingredients in Pesticide Products; Policy Statement 

(http://www.epa.gov/opprd001/inerts/fr52.htm) (accessed April 30, 2014) 

6) General Guidance for Petitioning the Agency for the Establishment of a New/Amended Food 

Use Inert Ingredient Tolerance or Tolerance Exemption under PRIA 3 

(http://www.epa.gov/opprdOO 1 /inerts/inertpetition.pdO (accessed April 30, 20 14) 

7) General Guidance for Requesting the Establishment of a Tolerance Exemption for a Low Risk 

Polymer or Nonfood Use Approval of a low Risk Polymer under PRIA 3 

(http://www.epa.gov/opprd001/inerts/lowriskpolymer.pd0 (accessed April30, 2014) 

8) General Guidance for Requesting the Approval of a New Nonfood Use Inert Ingredient or 

Amending a Currently Approved Nonfood Use Inert Ingredient under PRIA 3 

(http://www.epa.gov/opprd001/inerts/nonfood inert.pdO (accessed April30, 2014) 

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