## MAY 2 2 2014 UNITED STATES ENVIRONMENTAL PROTECTION AGEN CY WASHINGTO N , D

. C

. 20460

The Honorable Kamala Harris Attorney General of t h e State of California c/o Environment Law Section California Department of Ju stice P.O. Box 70550 1515 C lay St. Oakland, CA 94612-05 50 Ms. Kim Leva! Northwest Coalition for Alternati ves to Pe st ic ides P.O. Box I 393 12 16 Lincoln St. Eugene , OR 97440 Mr. Erik Sch le nker-Goodrich Western Environmental Law Center 1216 Lincoln St. Eugene, OR 9740 1 Dear Madam Attorney General , Ms

. Leval and Mr. Schlenker

- Goodrich: OFFICE OF CHEMICAL SAFETY A N D PO L LUT I ON PREVENTION

This is an amended response to two petition s you s ubmitted in 20 06 identifying 371 pest icide inert ingredients as hazardous and requesting that the U

. S. Environmental Protection Agency require that the id entities of those inert ingr e dients appear on the label s of products that include any ofthe ingredients in their formulations. On September 30,2009 , the EPA partially granted the petitions (Reference 1)

. The agency stated that the EPA agreed w ith the petitioners that the public should have a means to learn the identitie s of hazardou s inert ingredients in pestici de formulations. T he agency indicated that it believed t hat increased transparenc y could lead to bett er info rmed decision-making and to better informed pesticide use. The agency ' s 2009 resp onse committed to pursu ing bot h voluntary and regulatory act ions to address the petit ions as follows: EPA is ini tia ting rul emaking to increas e the public availability of haza rdous inert ingredient ident iti es for specific pes ticide formulations. In connection w ith thi s rul emaking EPA will also be discuss ing ideas to increase the di sclosure of inert ingredient identiti es to an even greater degree than requested by the petition s , for examp le , by requiring di sclo s ure ofall inert ingred ients, including ingredients not deemed hazardous.

I n ternet Address (URL) • http ://www

. epa gov Recycled/Rec y cla b le · Printed with Vege t ab l e Oi l Based I nks on 100% Postconsumer

. Process Chlonne Free Recycl ed Paper* * * 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 ingredient s and active ingredients

- are safe for humans and the environment. While the EPA's regulation of pesticides focuses primarily on pesticide act i ve ingredients because of their wellrecognized biological activity, we have been moving ahead with respect to inert ingredients. I would lik e 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 shou ld 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 i t initiated seek in g to mandate the disclosure on the lab el 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 va r ious ways to assist consumers and u sers of pesticides in making informed deci sions and to reduce the presence of potentially hazardous ingredients in pesticides. The EPA sought feedback on whethe r the rule should mandate disclosure only of potentially hazardous in gred ient s or require disclosure of most or all inert ingredient identities, regardless of hazard. We noted th at the EPA's ability to mandate disclosure of all inert ingredients regardless ofhazard may be limi ted by l aws requiring the EPA to protect th e confidentiality of trade secrets and confidential business inf ormation. The ANPRM also posed a numb er of specific questions for response.

In response to the ANPRM, the agency received 405 distinct comme nt s. These comments were very general in nature, eithe r advocating for or against mandatory disclosure of inert ingredients of pesticides, or offe rin g only broad , genera l r easons articulating th ei r positions. The EPA did not receive many responses to the specific qu estions asked by the agency in the ANPRM that were intended to assist i n dev elopi n g a thorough and comprehensive disclosure rule. For example, there were few suggestions on how information s hould 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 ingr edients wou ld be extremely harmful to th eir businesses because it would reveal valuable trade secret inf ormat ion, enabling competitors to copy t heir 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 AN PRM. For example, some registrants urged the EPA to develop risk-based criteria that included both hazard an d exposure considerations because they

did not believe the EPA has authority under the Federal Insecticide, Fungicide an d Rodenticide Act to require inert ingredients disclosure based on hazard alone. Other registrants said they believed the EPA has "no plausible lega l argument to support an assertion , that as a class, inert ingredients are not entitled

to co nfid entia l treatment." Based in part on the comments, th e EPA thinks that further pursuing the rulemaking initiated by the ANPRM would be a very complex, lengthy and resource -int ensive activity. Despite the EPA ' s extensive list of questions, publi c comments did not pro vide some of the ba sic facts necessary to support the rulemaking, such as how effectively disclosure would c han ge consumer be ha vior and how disclosure 2might affect businesses' ability to compete. The comments also indicate that there are many contentious issues

- the scope of any disclo sure 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 thi s rulemaking would require a long-term effort. Merely drafting the required portions of a complex rule consumes significant staff resources from several parts ofthe 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. Publi shing 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 ofresources 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 disclo sure 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 f ull 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. A lthough 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 , e ither 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 provid e any information on whether, much less how, its disclosure initiatives have affected customers' buying patterns or other behavior. While the voluntary disclosure initi ative 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 ofhow disclosure influences customer behavior, and therefore have a stronger basis to evaluate its usefulness as a regulatory tool. Other informa tion 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 label s. Based on thi s feedback, we believe that most consumers quick ly read a minimal amount of information on the pesticide label when making a purchase, without an in

-depth reading ofthe entire pesticide label. These findings suggest most consumers will not pay attention to information on product labels disclosing the identit y of inert ingredients.

3Based 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 se le ct top candidate i nert ingredients for further analysis and pot en tia l action. I believe that, given our restricted financial and staff resources, this is the best way to address concerns with inert ingred i ents in pesticides, achieve the human health and environmental benefits that constitute our agency's primary mission, and attain my goal i n administering FIFRA to minimize the risk of unreasonable adverse

effects from pesticides. The rationale that l ed t he EPA to initia te, v ia the ANPRM , a rule requiring disclosure of the identity of

ine rt 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 ingred i ents, thereby moving the market in favor of those less hazardous formulations. I believe that significant shifts in consumer preferences and purchasing decisions can p la y an important role in the marketplace and could influence manufacturers' decisions about what t ypes 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 i nert in gred ie nts in pesticides. For inert in gred i ent disclosure to have a significant effect on the marketplace, a significant number of consumers wou ld need to read the ingredients statement on the labe l, recognize specific ingredients, understand which ingredients were hazardous, and then act on that information. Neither the voluntary program nor any other information su pports a conclusion that a large

percentage of pesticide users' decisions wou ld be significant l y 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 pes t icide products. Moreover, I expect that the agency would be able to develop and implement these actions in a timelier manner t han 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 E PA maintains a lis t of chemical substances that have been approved for use as inert ingredients in pesticide products. After appropriate evaluation to confirm hazard, th e EPA would remove from the approved list those inert ingredients lis ted in your petitions tha t are no longer being used in pesticide products. Based on our initial review of the 371 inerts ingredients, 96 of the in ert ingredients identified in your petitions could potentially be removed from the approved l ist. In 1987, the EPA i ssued its inert ingredients strategy to provide guidance (Reference 5) to applicants seeking approval of a new inert ingredient. Then, in 2010, the EPA published severa l g uid ance documents to provide more up- t o-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 eval ua te a new inert ingredient include, among others, studies to evaluate 4potential 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 in ert ingredients: By law, the EPA is responsib le for regulating the pesticides that are used by growers to protect crops and for setting limits on the amount ofpesticide chemica l s - 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 ofthe existing pesticide tol erances 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 ecotoxico logical 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 ing r edients that exhibit strong evidence of adverse human health or environmental effects. The EPA could consider the practicality of using lists ofhazardous chemicals generated by other parts ofthe EPA, other federal agencies, or other governmental or international organizations. Understanding the development ofthese lists cou ld 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 ofthe 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 he l p 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 reduc ing risk.

5Regulatory Programs: • I ss ue Data Ca ll-In Notices requirin g registrants to provide data needed by the EPA to conduct risk assessments for inert ingredients of concern. • For inert i ngredients fou nd to pose risks of concern in particular formulations, direct registrants to modify their registration, e.g., by reducing th e amount of the inert ingredient in the formulation, replacing th e hazardous inert ingredient in their formulation with an alternative, les s 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 i ngredie n ts of higher toxicity that s upply a needed function in the product and there is not a s uitabl e substitute, consider mandatory label disclosure of inert i ng redients with a more hazardou s profile in specific formulations. Voluntary Programs: • Seek to expand the existing voluntary disclosure program for antimicrobial pesticide products to include non-antimi crob ial consumer-use pesticide products. • Create incentives for pesticide manufacturers to select le ss 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 we re discussed in a meeting with several of the pe t i t ioners 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 no tices 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 lon ger pursue the rulemaking the EPA initiated via th e ANPRM seeking to mandate the disclosure of potentially hazardous inert ingredients on pesticide labels, as requested in th e 2006 petitions, this amended response constitutes a denia l 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 w ith you as our organizations all strive to protect human health and the enviro).Ullent. Sincerely, 6Copies:Ms. Wendy Park, Attorney for Center for Environmental Health , Beyond Pesticides, and Physicians for Social Re sponsibility 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 Propo sed Rule Making (ANPRM): Public Availability ofldent ities 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 Pest icide Program Dialog Committee on the Activities of the Inert Disclosure Workgroup, March 2000 through April 20 02; Discuss ion Pape r 12; Inert Disclosure Stakeholder Workgroup ; EPA Response to Labeling Questions Raised by Workgroup Members (200 1) (http ://www.epa.gov/oppfead1 /cb / ppdc/ inert-finalreport. html) (accessed April 30, 2014) 4) EPA: Guidelines for Voluntary Di sclosure ofAntimicrobial Ingredient Information on company Websites and /or Labels (http: //www.epa.gov /oppadOO 1/voluntarv-disclosure.htrnl) (accessed Apr il30 , 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 Establi s hment of a New/Amended Food Use Inert Ingredient Tolera nce or Tolerance Exemption under PRIA 3 (http: //www .epa.gov /opprdOO 1 /inerts/inertpetition.pdO (acc essed April 30, 20 14) 7) General Guidance for Requesting the Establi shment of a Tol erance Exemption for a Low Risk Polymer or Nonfood Use Approval of a low Ri sk Polymer under PRIA 3 ( http: //www.epa.gov /opprd001 /i nerts/ lowriskpolymer.pd0 (accessed April30 , 2014) 8) General Guidance for Requesting the Approval of a New Nonfood Use Inert Ingredient or Amending a C urrently Approved Nonfood Use Inert Ingredi ent under PRIA 3 (http: //www.epa.gov/opprd001 /inerts/ nonfood inert.pdO (accessed April30 , 2014)

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