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Docket ID No. EPA

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Response to Public Comments
on the Proposed Rule:

“ Pesticides; Revisions to Minimum Risk Exemption ”

[ 77 FR 76979 ]

August 4 , 2015

Table of Contents

I. Introduction Page 2

II. Commenters Page 2

III. Comments and Responses Page 3 A: Comments on Specific Aspects of the Rulemaking Page 3 B: Comments Outside of the Scope of this Rulemaking Page 19Page 2 of 22

I. Introduction

On Monday, December 31, 2012, EPA published in the Federal Register a proposed

ru le , entitled “Pesticides; Revisions to Minimum Risk Exemption (77 FR 76976) ,” to revise 40 CFR 152.25(f) to more clearly describe the active and inert ingredients that are permitted in products that are eligible for the minimum risk pesticide exemption. EP A proposed to improve the clarity and transparency of the minimum risk exemption by codifying the inert ingredients list and by adding specific chemical identifiers, where available, for all eligible active and inert ingredients. EPA also proposed to modif y the labeling requirements in the exemption to require products to list ingredients on the label with a designated label display name and to provide producer contact information on the product’s label.

This “Response to Comments” document addresses com ments that EPA has received on the proposed rule. These comments are available at www.regulations.gov using the docket identifier EPA

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- 0305. Comments were received between December 31, 2012 and April 1, 2013. This “Response to Comments” document provides a summary of the comments received during the entire comment period and EPA’s responses to those

comments.

II. Commenters:

EPA received 27 comments on the “Pesticides; Revisions to Minimum Risk Exemption ” proposed rule

. The following 13 companies or trade associations, 6 private citizens, 6 S tate pesticide agencies

, 1 S tate professional association

, and 1 environmental advocacy organization submitted comments on the proposed rule :

Docket Commenter No. Affiliate

EPA

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- 0018 Private Citizen

EPA

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- 0019 Private Citizen

EPA

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- 0020 Private Citizen

EPA

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- 0021 TyraTech, Inc.

EPA

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- 0022 Neudorff

EPA

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- 0023 Spargo Enterprises, Inc.

EPA

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- 0024 National Candle Association

EPA

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- 0025 Bonide Products, Inc.

EPA

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- 2010

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- 0026 Private Citizen

EPA

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- 0027 Private Citizen

EPA

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- 0028 The Scotts Company, LLC

EPA

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- 0029 Washington State Department of Agriculture

EPA

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- 0030 Pennsylvania Department of Agriculture

EPA

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- 0031 New Mexico Department of AgriculturePage 3 of 22 Docket Commenter No. Affiliate

EPA

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- 0032 Bayer CropScience

EPA

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- 0033 National Pest Management Association

EPA

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- 0034 Private Citizen

EPA

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- 0035 Messina Wildlife

EPA

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- 0036 Beyond Pesticides

EPA

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- 0037 Council of Producers & Distributors of Agrotechnology

EPA

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- 0038 Colorado Department of Agriculture

EPA

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- 0040 Consumer Specialty Products Association

EPA

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- 0041 Responsible Industry for a Sound Environment

EPA

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- 0042 Association of Structural Pest Control Regulatory Officials

EPA

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- 0043 The Liquid Fence Company, Inc.

EPA

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- 0044 Arizona Department of Agriculture

EPA

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- 0045 Oregon Department of Agriculture

III. Comments and Responses:

A. Comments on Specific Aspects of the Rulemaking

1

. Comments on the Format of the Active and Inert Ingredients Lists:

Comm enters were generally in support of the revised format of the active and inert ingredients lists.

2. Comments on the Information Provided in the Active and Inert Ingredients Tables.

Comments on United States Pharmacopeia (USP) Specifications for Active Ingredients

.

Several commenters expressed concerns about the proposed requirement that approximately 19 active ingredients must meet the USP standard to be eligible for use in minimum risk pesticide products. Many of these commenters state d that requiring USP standards for these in gredients go es beyond the stated purpose of the proposal , wh ich was

t o clarify the act ive and inert ingredient lists. Commenters also stated that this would i mpose a new burden on producers that EPA has failed to acknowledge in its proposal and cost analysis. These commenters said that USP standards might ultimately result in the need to reformulat e many products since technical grade active ingredients currently eligible would be removed from the exemption because they would be unlikely to meet the USP standards . The se commenter said this change would crea t e a new additional burden on minimum risk pesticide product manufacturers. Some commenters alsoPage 4 of 22

suggested that EPA has not provided enough information about why the Agency proposed USP standards for the active ingre dients

.

Response: While EPA believes that there is value in having a USP standard

a ssociated with the active ingredients identified in the proposed rule since it provides more certainty that the ingredients are minimum risk to human health and the environment

, for the final regul ation, EPA has removed the USP specification for all of the active ingredients except for castor oil

. As discussed in the proposed rule, t he primary objective of EPA’s rulemaking i s to clarify t he active and inert ingredients ; no ingredients were to be a dded to or removed from the lists

. Based on the comments received, EPA recognizes that the addition of USP specification s for the active ingredients identified would result in the removal of technical grade active ingredients that are currently eligible f or the minimum risk exemption

. Since this was not the original intent of this rulemaking , EPA is not i ncluding the USP specifications for 18 of the 19 active ingredients in the final regulatory text

. EPA, however, has retained t he specification for castor oil to say “United States Pharmacopeia ( USP ) standard or equivalent ” since this specification was a part of the original active ingredients list.

3

. Comments on Label Display Names

3.1 Several c ommenter s support ed EPA’s proposal to specify a “ label display

name ” for each of the ingredients

. They stated the label display name will help

consumers , as well as manufacturers and regulators , to determine product ingredients and minimize uncertainty

. One commenter suggested that the requirement to use a “Label Display Name” could potentially reduce the amount of time it takes to review and register

new minimum risk products at the s tate level and prevent unnecessary enforcement actions.

3 .2 One c ommenter agree d that the use of a standard label display name will provide clarity and uniformity for s tate inspectors and consumers. However, the

commenter stated that requiring certain label display names to contain bracketed text fails to add any additional clarity to consumers and inspectors and could create confusion

. The commenter cited several inert ingredients with bracketed information in the label display

name , such as v inegar (maximum 8% acetic acid in solution). The commenter recommended that the Agency remove the bracke ted text included in the “Label Display Name” column, but continue to leave the bracketed information solely in the “ Chemical
Name ” column because the bracketed text best serves as clarification for manufacturers to meet the requirements of the minimum ris k exemption. The commenter suggested that k eeping bracketed text in the “C hemical N ame ” column and providing such information

at s tate registration or upon request enables efficient monitoring of the exempted ingredients in a minimum risk pesticide , and a llows for a more consumer

- friendly label.

Response : EPA believes that the bracketed information provide s within the parentheses is important clarifying and safety information for manufacturers toPage 5 of 22 meet the requirements of the exemption and for those states who review and register minimum risk pesticide products

. This information ranges from safety limitations on certain inert ingredients such as vinegar (maximum 8% acetic acid in solution)

, to chemical formulas for inert ingredients suc h as c alcite (Ca(CO 3 ) )

. However, after examin ing the inert ingredients with bracketed information in the label display name, EPA agrees with the commenter that this information is not necessary to include on the label . The information provided within the brackets is more for manufacturers to correctly identify the specific inert ingredients and understand limitations on inert ingredients than it is to improve the clarity of the label for consumers . EPA agrees that this information could potentially create confusion for consumer s and adds more information than what consumer s would want or need about an inert ingredient

. Therefore, EPA has remove d the bracketed information from the “L abel D isplay N ame ” column in the final regulatory text

. EPA , however, will continue to provide the bracketed information to manufacturers within the “ C hemical N ame ” column to help manufacturers comply with the minimum risk exemption’s requirements.

4. Comments on specific ingredients in the active i ngredients l ist :

4 .1 Two c ommenters noted that common salt (sodium chloride) was missing from the proposed active ingredients list , while o ne of the c ommenter s also noted that ground sesame plant was not list ed in the active ingredients list

.

Response : The d eletion of sodium chloride and ground sesame plant from the list of active ingredients were inadvertent omissions in the proposed regulatory text

. EPA did not intend for these ingredients to be removed from the exemption. EPA is restoring sodium chloride ( Chemical Ab stract Services Registry Number (CAS No.) 7647

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- 5) into the table of active ingredients , and is placing “including ground sesame plant” into the specifications column for sesame in the final regulatory text

.

4 .2 Several commenters suggested that spearmint oil (CAS No. 8008

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- 5) should be included under the definition of “mint oil” in the active ingredients l ist. The commenters stated that “mint oil” could include several varietals under the genus Mentha , and that spearmint oil has traditionally been accepted as an eligible active ingredient by the Agency. One commenter suggest ed that EPA needs to address the other oils that are broadly categorized as mint ( Mentha ), while another commenter recommended that EPA should include a specific notation or include all individual CAS numbers whenever multiple CAS numbers may be applicable.

Response: During the development of the proposal, EPA considered the historical us e of the terms “mint” and “mint oil.” “Mint” is a broad term for the

genus Mentha , and could represent a number of different mints or mint oils

. H owever, in promulgating the minimum risk exemption, EPA did not intend the term “mint and mint oil” to include all oils from the genus Mentha . P eppermint and peppermint oil (derived from Mentha piperita ), for example, was listedPage 6 of 22 separately from “ mint and mint oil” in the 1996 active ingredient list. When the minimum risk exemption was promulgated in 199 6, “mint and mint oil” was technically meant to refer only to cornmint and cornmint oil ( Mentha arvensis )

, since spearmint oil ( Mentha spicata ) at that time was a registered active ingredient

. However, “mint and mint oil” was written broadly so that spearmint and spearmint oil could also be included under this term 1

.

EPA agrees with the commenters that spearmint oil has traditionally been accepted under the definition of “mint oil” and has been regarded as a minimum risk pesticide ingredient by the Agency . Therefore, in addition to cornmint oil,
EPA is including the CAS No. for spearmint oil (CAS N o. 8008

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- 5) in the active ingredients list. Additionally, since n o other ingredients were intended to be included under “mint and mint oil ” whe n the minimum risk exemption was written , EPA is also revising how cornmint, cornmint oil, spearmint, and spearmint oil are listed in the table

. Instead of being identified under the general terms “mint” and “mint oil,” which has caused confusion in the pa st, these terms are being removed from the active ingredients lists and are being replaced with separate listing s for “cornmint,” “cornmint oil,” “spearmint,” and “spearmint oil.” EPA believes that this change will improve the clarity and transparency of t he listing for these mints and mint oils , while also being more consistent with how the Agency lists these specific substances in other databases

.
Since the purpose of this rulemaking is to clarify those ingredients t hat were intended to be exempt under the original exemption and not to add or

remove ingredients , EPA is not reassess ing the appropriateness of whether or not the other mints or mint oils s hould be included under this rulemaking

. If stakeholders have information that they believe suppo rt s the inclusion of other mints or mint oil s , the stakeholder can provide such information to EPA in a petition for evaluation

. EPA will consider and respond to all such petitions

.

5. Comments on the u se of C hemical Abstract Services (CAS) Registry Numbers to identify eligible ingredients :

5. 1 Several commenters expressed support for using CAS Nos. to identify eligible ingredients when available

. These commenters ag ree d that the use of CAS Nos. would clearly establish and minimize the current uncertainty about what ingredients qualify for the exemption. One c ommenter stated that the use of CAS Nos. in the tables will more clearly define what substances are allowed. Another c ommenter said that the purchaser should easily be able to identify minimum ri sk pesticides using CAS Nos

.

5 .2 One commenter stated that EPA’s assumption that the CAS No. is a “unique chemical identifier” that would “assure manufacturers that they are purchasing and using the chemicals that can be used in minimum risk pe sticide products” is not

1 EPA. OPP. Decision Memorandum: Mint Oil. (2008). Docket ID: EPA

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accurate for every ingredient. The commenter noted, for example, that m any [active] ingredients have multiple CAS Nos. that could apply, some have none, and many CAS
Nos. are defined as broad general categories.

The commenter recom mend ed that EPA add the Consumer Specialty Product s Association’s ( CSPA ) Consumer Product Ingredients Dictionary (CSPA Dictionary) to the list of reference sources because the CSPA Dictionary Nomenclature Committee addresses the issues identified above

. The commenter state d that the CSPA Dictionary contains monographs was developed by its Nomenclature Committee to establish consistent nomenclature for consumer product ingredients (including those in antimicrobial an d pest management products) submitted for inclusion, and carefully defines each ingredient, including all CAS numbers and other names that the Committee finds for the ingredient, in addition to recommending a CSPA Name that is judged to be best for consume r ingredient communication. The commenter suggested that including the CSPA Dictionary as a nomenclature option would further the stated goals of identifying the active ingredients by universally accepted names, since it includes all of the CAS Registry N umbers and names where they are available and considered applicable.

Response : EPA has traditionally provided the chemical name s, as determined by the Chemical Abstract Services, and CAS R egistry N umber (CAS No.) , when available, for each of the eligib le inert ingredients in the list of minimum risk inert ingredients that is available on the Agency’s website 2

. EPA’s experience with providing this information on the publicly

- available inert ingredient list has not shown to be problematic in the past

. CAS Index N ames and CAS N o s

. are generally recognized as universal identifiers for chemicals, which helps to reduce confusion and improves clarity for the permitted ingredients. In fact, the use of these chemical names and CAS N o s

. have benefitted S tate r eviewers and formulators by providing the specific chemical identifier s needed to determine whether a n inert ingredient is or is not permitted in minimum risk pesticide products

. CAS Nos. are also required on Material Safety Data Sheets, which makes the C AS No. a useful tool for enforcement purposes

. EPA believes that continuing this practice for the inert ingredient list and providing similar information in the active ingredients list will provide the specificity needed to help with compliance and enforcement of the exemption while maintaining consistency with Agency practice s

.
Regarding the use of the CSPA Dictionary as a reference option, the CSPA Dictionary is not a publically

- available information source, and individuals would have to purchase the dictionary in order to reference the information provided in it. Therefore, EPA believes that referencing the CSPA Dictionary would reduce transparency. While a webpage does offer access to publicly

available indices associated with the CSPA Dictionary , EPA does not believe that these indices alone offer improved transparency and clarity. EPA’s intent in proposing the use of a label display name was to provide a chemical name more

2 http://www2.epa.gov/minimum

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, thus increas ing transparency and consistency.
A dditionally, a standardized label display name provides the opportunity for S tate inspectors to become familiar with the name, thus decreasing label review timeframes. EPA believes that the CAS approach prov ides the most consistent and transparent way to provide information since this information is universally recognized and consistent with how the Agency has been identifying chemicals in the past

.

5.3 The previous commenter also suggested that it was possible that the CSPA Dictionary could serve to assist EPA in designating additional 25(b) active and inert ingredients for use. The commenter stated that i f EPA recognized the CSPA Dictionary as a nomenclature source, perhaps it would provide a mechanism for identifying new ingredients that have been approved for use in minimum risk pesticide products between rulemaking updates to the codified list.

The commenter state d that CAS Nos. are not unique identifiers for inert ingredients. They cite d six chemic als approved as minimum risk inert ingredients that are already listed in the CSPA Dictionary to illustrate their point:

Amorphous Silica has two CAS Nos. , only one of which is shown on the proposed minimum risk list.

Kaolin Clay has two CAS Nos. , with o nly one listed under the exemption for Kaolin.

Magnesium Sulfate has two CAS Nos. , with only one listed under the exemption

.

Oleic Acid has two CAS Nos. , with only one listed under the exemption

. Sodium Carboxymethyl Cellulose has two CAS Nos. , with onl y one listed under the exemption

.

Sodium Citrate has four CAS Nos. , with only one listed under the exemption . In this case, commenter states that the CAS No. used by EPA designates the anhydrous state, while there also are two CAS Nos. for the dehydrate a nd pentahydrate states of the compound. T he commenter thought that it was unlikely that EPA mean t to designate only the anhydrous compound for use, since the chemical would readily hydrate in products that are formulated aqueous solutions.

The commenter stated that the examples provide d clear evidence of the CSPA Dictionary’s utility to ingredient communication. They state d that i f EPA move d forward with the proposed ingredient communication for minimum risk pesticide products, the CSPA Dictionary should be utilized, since its approach to nomenclature would provide the clarity and consistency EPA sought while appropriately safeguarding proprietary information.

Response : As stated in the previous comment, EPA has not experienced any issues regarding the u se of CAS chemical names and CAS Nos. when identifyingPage 9 of 22 minimum risk inert ingredients, and plans to continue using its existing practice as noted in the response to comment 5.2. EPA’s intention for this rulemaking is not to add or remove ingredients
from the lists or reassess the appropriateness of specific ingredients , but rather to clarify the existing lists

. Since t he additional CAS Nos. for the six inert ingredients referenced by the commenter were not originally a part of the eligible inert ingredients list prior to this rulemaking , those CAS Nos. will not be added to the list for this rulemaking

. The commenter , however, may petition the Agency to add those additional ingredients and CAS Nos. to 40 CFR 152.25(f) using information from the CSP A Dictionary monographs, if appropriate, but a ny changes to the lists would need to be done in a separate rulemaking.

6

. Comments on other criteria considered for the exemption:

6 .1 Comments on requiring company name and contact info Several commenters support ed requiring company name and contact information to be placed on product labels

, stat ing that this would assist with s tate inspection issues when attempting to document the product information and to follow up with a company. The commenters agreed that all products should have contact information included on their labels.

6.2 In additi on to company contact information

, one commenter also support ed a batch code so that any adverse reactions or formulation problems can be properly traced.

Re sponse : EPA believes that requiring a batch code has potential merit, as it could be beneficial for making information available and transparent for

consumers and inspectors should an inciden t occur while using a minimum risk pesticide product . However, since the proposed rule did not contemplate having a batch code on the label, such a new requirement cannot be included in the final rule without revising the proposal

. EPA plans to develop labeling guidance that

may recommend that companies use a batch c ode because of the benefits one would provide to consumers and inspectors, and may provide examples of how a batch code could be implemented on a label if a company chose to use one. EPA may revisit whether a batch code should be included in a future rule making effort.

6.3 Comments on r evising the exemption to require a label statement that signals exempt status

One c ommenter suggested that a statement such as “This product is exempt from EPA registration at 40 CFR 152 and the safety and efficacy have not been reviewed by the Agency” and other statements indicating exempt status c ould make it clear to s tate reviewers and inspectors that the product is claiming minimum risk exemption status. Another c ommenter said that such statements should not be required and are likely to be confusing to the public.Page 10 of 22 Response : EPA believes that requiring a label sta tement that signals exempt status is unlikely to provide any significant benefit to consumers. As described in the proposal, a n analysis from open literature and survey results 3 indicated that in general, most people do not read, understand, or believe di sclaimers, and is therefore unlikely to change consumer behavior or influence a purchasing decision. Because of this, EPA believes that a label statement signaling exempt

status would provide minimal benefit to consumers and could potentially be confusing to the public. If EPA were to require a label statement signaling exempt status, EPA would need to con duct additional research to ensure that the statement would be clearly understood by the public to prevent any potential confusion

. As a result, EPA wi ll not be including this as a requirement under this rulemaking.

While EPA believes that there could be a benefit from such a statement for enforcement purposes, EPA did not receive any comments from the s ta tes indicating whether label statement s signaling exempt status would be beneficial for enforcement purposes. Ultimately, a labeling statement would indicate to inspectors that they would need to review the product to ensure that it meets the exemption’s requirements , which they would need to do even if this statement was not included on the label , and would add a potential misbranding violation in the case that it is false or misleading

. EPA may consider some type of exemption

statement in a future rulemaking based on feedback from the states indicat ing that such a statement would be beneficial for enforcement purposes and provid ed that an appropriate statement for the public can be developed

.

6.4 Comments on revising the exemption to require directions for use on minimum risk pesticide products

6.4.1 One c ommenter said that requiring directions for use should be included on all labels. T he commenter stated that at a minimum, first aid statements for eye and skin contact should be required, and in addition to direction s for use, exempt products should contain other appropriate first aid statements, storage and disposal, and precautionary label statements to protect consumers, applicators, children, and pets.

A second c ommenter said that basic minimum use directions wou ld be beneficial to ensure that the product is used effectively

. The commenter suggested that s imple use directions would be ap propriate for most products, while in some cases, more elaborate information may be required.

A third c ommenter stated that a l ack of directions for use has the potential to lead to the misuse of a pesticide as pest management professionals and

3 Review of Literature on Consumer Use of Label Statements and Findings Relevant to Planned Action on Minimum Risk Insect Repellents , EPA Docket ID EPA

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- 0011Page 11 of 22 consumers are left to make decisions regarding proper use of a given product to control pests. The commenter support ed efforts to ensure every person using a pesticide, including minimum risk pesticides, fully understands the label and proper use of a pesticide, including necessary protections for themselves, public, and environment.

Response : EPA agrees with the commenters that including directions for use on minimum risk pesticide product labels provides much needed information to ensure that minimum risk pesticide products are used safely and correctly , and encourages all minimum risk pesticide manufacturers to provide this information on their labels . However, a s stated in the proposed rule 4 , EPA did not pursue making this a requirement of the exemption under this rulemaking since the purpose, or scope, of the rulemaking was to clarify the terms of the original exemption, not to

create new conditions for the exemption. A “directions for use” requirement would require assessing the risk s of certain uses of minimum risk pesticides already determined to be minimum risk to adequately address it, which was not EPA’s intent with this action. EPA therefore did not propose this as a requirement in the rulemaking since it went beyond clarifying the existing conditions of the exemption.

EPA will continue to explore ways to create a requirement for directions for use that is both broad enough to apply to all minimum risk products, yet specific enough to be enforced fairly and effectively. In the meantime, EPA will look into developing guidance describing the kinds of information that may be useful to provide in a “directions for use” section on a label, and will continue to seek input on how to improve this information while meeting the needs for all minimum risk products.

6.4.2 One c ommenter recommended that EPA consider adopting the labeling exemption guidance from the Worker Hea lth and Safety Branch of the California Department of Pesticide Regulations pertaining to exempt pesticide products for active ingredients that may cause skin and eye irritation. The commenter stated that t h e i nformation provides guidance on when cautiona ry statements should be included on the product’s label.

Response : EPA has reviewed the California regulations provided by the

commenter , and understands that the regulations are intended to ensur e that minimum risk pesticides are used safely. Even t hough EPA believes that regulation of these minimum risk substances are not necessary to prevent unreasonable adverse effects on human health and the environment, EPA acknowledges that there is a small potential for injury or environmental hazard from mini mum risk pesticide products when used improperly. Requiring cautionary statements for ingredients would help to

4 77 FR 76979, December 31, 2012Page 12 of 22 ensure that these products are used correctly and do not cause harm to individuals

.
However, reassessing the risks and requiring cautionary statem ents as a result of those assessments was not part of EPA’s proposed rule. This means that the use of cautionary statements cannot be incorporated as part of th is final rulemaking

. EPA does, however, see value in specifying when cautionary statement s should be incorporated. In a future rulemaking, EPA may consider s etting threshold s for when cautionary

statements are required

. EPA will also evaluate and consider this information during the development of the labeling guidance

.

7

. Comments on the c odification of the i nert i ngredients l ist

7 .1 Several commenters expressed support for the codification of the inert ingredient list , stating that the codification of the inert ingredient list will improve the clarity and understanding of eligible ingre dients for all stakeholders , and will help to ensure compliance with the exemption.

7 .2 Several commenters expressed concerns about the codification of the inert ingredient list . Since the 1996 promulgation of the minimum risk exemption, the list has been reference d in 40 CFR 152.25(f)(2), updated periodically, and maintained on EPA’s public website. The commenters questioned what it would mean for getting ingredients added or removed from the list

. The commenters understood that notice and comment rulemaking would be needed to make changes to the inert ingredi ents list once codified in 40 CFR 152.25(f). Accordingly, t he commenters suggested that the rulemaking process would in advertently create a barrier to adding new ingredients, as well as potentially slowing the agency’s ability to remove an ingredient should the need arise. The

c ommenters questioned if an efficient mechanism could be developed so that additions or deletion s from the list could be easily accomplished

.

One commenter recommend ed that EPA should first solicit recommendations for adding ingredients to the lists that conform to the minimum risk screening criteria to the proposed list, and then promulgate a fin al rule to codify the revised list to ensure that the inert ingredients are both minimum risk and chemically suitable for the development of high

- quality, marketable minimum risk products. Another commenter recommend ed that codifying the list is not the b est option, and that EPA should continue to maintain a decisive list on a website that could be updated quickly as necessary

.

Response: For the final regulations, EPA believes that c odifying the inert ingredient list in 40 CFR 152.25(f)(2) provides immediate benefits to all parties

. A n inert ingredient list directly in the regulations offers much needed clarity to federal, s tate , and tribal inspectors, and manufacturers

. Having all of the ingredients codified also improves the efficiency of inspecti ons becausePage 13 of 22 inspectors will not have to look through multiple sources to find the information they need.

EPA understands that stakeholders may want to add or remove ingredients from the ingredient lists for various reasons. Regardless of this final rule

, notice and comment rulemaking is required under the Administrative Procedure Act (APA) to make changes to the lists of active and inert ingredients. EPA has been examining ways to make the process of adding or removing an ingredient from the exemption as streamlined as possible while meeting the requirements of notice and comment rulemaking. For example

, EPA is considering developing guidance that would de scribe the process and types of information EPA may need for a stakeholder to request the addition or removal of an ingredient from the lists. Any guidance that EPA may develop in the future for minimum risk pesticides would be available on EPA’s website a t http://www2.epa.gov/minimum

- risk

- pesticides

.

EPA believes that codifying and revising the active and inert ingredient lists as soon as possible via this final rule, even if the guidance is n ot yet available, is appropriate to provide the immediate benefits previously described

. C ompanies may at any time petition the Agency to add or remove an ingredient from the active or inert ingredient lists under the APA , even in the absence of guidance . EPA cannot predict in advance what the response will be to any particular petition to amend the list of ingredients eligible for the exemption. If the Agency were to grant such a petition, the changes to the ingredient lists would be subject to notice an d comment rulemaking.

8

. Comments on the proposed timeframe ( two years from the effective date of the final rule) to comply with label changes:

Most commenters indicated that the proposed 2

- year compliance period was reasonable, although a few commente rs supported a 3

- year implementation period that would allow the smallest companies more time to complete the changes and sell existing stock at minimal cost

. Response : EPA has decided to use a 3

- year compliance period instead of the proposed 2

- year compliance p eriod

. EPA’s C ost A nalysis document indicated that th e costs to change labels over a 2

- year compliance period would cost the average small business $14,634, or 0.5% of their gross revenue. However, a 3

- year comp liance period would be the most sensitive to the smallest firms, costing the average small business $3,857, or 0.1% of their gross revenue. Based on estimates described in the Cost Analysis, c ompanies typically change labels every 3 years, so costs to com ply with the changes made in this rule making would be reduced by almost 75% when using a 3

- year compliance period instead of a 2

- year time frame

.

9

. EPA’s Estimation of Costs Associated with the Proposed Changes

Four commenters felt that EPA did not account for all costs associated with the proposals, specifically the costs associated with a possible reformulation if USP standardsPage 14 of 22

were required for the 19 active ingredients identified in the proposed rule. These

comm enters indicated that if USP standards were required, costs would increase substantially, and any additional restrictions or limitation on minimum risk producers may result in significant cost impacts. One commenter stated that w hile the label changes hav e minimal cost impact on small companies, EPA must be aware in the rule finalization process that clarifications representing additional restrictions or limitations may result in significant cost impacts.

Response : Since EPA is removing the USP specification for 18 of the 19 active ingredients in the final rule, EPA i s not aware of any other costs that producers may encounter outside of changing the label

. T he commenters did not provide cost information related to any other aspect of the proposa l besides the USP requirement , and did not provide alternative analyses regarding the costs of changing the labels due to this rulemaking effort. As a result, EPA believes that all costs have been accounted for in this rule making and has not made any chan ges to the cost estimates in the Cost Analysis for the final rule

.

10

. How will these changes impact s tate and local agencies?

10 .1 One s tate commenter said the rule would have a beneficial and positive impact, allowing s tates the ability to make better and timelier registration and enforcement decisions.

A second s tate commenter stated that many of the changes proposed will be of benefit to their pesticide registration program. The commenter state d that it is an impro vement to list both allowable active and inert ingredients in the rule, including CAS numbers to more clearly define what substances are allowed, specifying a “label display name” for each ingredient, and requiring that name to be used on the label. The

c ommenter also stated that requiring company name and contact information on the label was also needed.

10 .2 One s tate commenter indicated that any change to labeling will have some impact on the workload of s tate registration programs that register minimum risk products

. For example, the commenter state d that t here are 427 products registered in their s tate , and these changes could increase their workload for reviewing labels by 8

- 10% during the year of implementation. If the USP gra de requirement is pursued, manufacturers may need to reformulate certain products. They would therefore need to revise their Confidential Statement of Formula s (CSFs) , which could increase the one time extra burden on the s tate to review these changes

.

Response : Since EPA is not requiring the USP specifications for the 18 active ingredients as described previously in this document, s tates who register minimum risk pesticides should not see an increase in burden as a result of having to review revised CS Fs due to registrants reformulating their products

. B y making the implementation period 3 years, EPA does not believe that the workload for the S tates will increase by 8

- 10% during the years of implementation since mostPage 15 of 22 label ing revisions will occur within manufacturers’ routine label revision activities , thereby reducing the potential for a high volume of label reviews in any given year

.

1 1

. Publishing updated labeling guidance on the minimum risk exemption

Several c ommenter s stated that updated guidance online would be helpful. They indicated that labeling guidance would be helpful for smaller manufacturers, and would help s tate reviewers ensure that exempt pesticide labels are complete , while also providing s tates with a reference to provide t o manufacturers

. One commenter suggest ed that more examples of appropriate and inappropriate label claims for exempt products be provided, especially safety claims. A second c ommenter stated that they would welcome general guidance on appropriate placemen t and size of information in designing a label for a minimum risk pesticide , saying that this information should be easily accessible on
an EPA web page and be clearly defined as guidanc e rather than as a requirement.

One commenter noted that EPA did not p rovide any examples/details of what will be included in the label guidance. The commenter did not believe that s ignificant changes/requirements to minimal risk product labels are justified, and suggest ed that

g uidance may result in labels for minimum risk products being so similar to synthetic product labels that they become indistinguishable to the consumer. The commenter also

state d that statements such as "SAFE" must continue to be allowed on labels and in advertising. The commenter stated that thi s is an important differ entiator for certain
consumers, as t he categorization of these products is based upon the fact that "both actives and inert ingredients are demonstrably safe for the intended use. ”

Response : EPA has been in the process of updating the minimum risk guidance that is available via the EPA website . EPA will make additional updates once the final rule is effective to reflect the changes related to this rulemaking. This information will be made available on EPA’s webpage dedicated to the minimum risk exemption, which is currently found at http://www2.epa.gov/minimum

- risk

- pesticides . EPA will aim to ensure that any information that is provided as guidance is labeled as such , and that recommendations within the guidance are not binding on stakeholders or EPA.

It is not possible for guidance to change the codified requirements of the exemption

. The purpose of guidance is to provide more detailed information

, including exampl es, to producers and s tates , which will also reduce the number of questions that both EPA and the s tate s receive . Such guidance would assist manufacturers in comply ing with the codified requirements of the exemption.

For the labeling guidance

, EPA may provide example s of labeling formats

or directions for use, and ways to display ingredient lists. EPA may also provide some examples of appropriate and inappropriate labeling statements, but these examples would not be exhaustive. EPA notes that the ter m “safe” would
continue to be allowed on minimum risk pesticide product labels. EPA will makePage 16 of 22 it clear that the recommendations made in these guidances are not required, and that any clarifications communicated through this kind of guidance would not be

c onsidered new requirements for compliance with the exemption.

EPA does not intend to mak e the labels of minimum risk products appear similar to registered products with this guidance , but rather to help producers ensure that their product s meet the requirements of the exemption. The guidance would provide example s of how to display key information that will help improve the clarity and transparency of labels for consumers and inspectors while complying with the exemption

. There is, howeve r, the potential for minimum risk labels to look like registered products not because of the guidance, but because of the flexibility that manufacturers have with labeling their products. S ince the inception of the exemption

, companies have had flexibilit y in how they label their products as long as the labeling conditions set forth in 40 CFR 152.25(f) are met

. For example, s everal minimum risk pesticide manufacturers also produce registered products and commonly, although not always, use similar labeling formats on their minimum risk products as they do for their registered products for consistency in their labeling practices . As a result, their minimum risk pesticide labels already have a look that is similar to registered products. Unless EPA were to change the requirements of the exemption to make minimum risk products look different from registered products, companies will continue to have flexibility in its label ing provided that the label is not false or misleading and meets the conditions at 40 CFR 152.25(f)

. EPA believes that l imiting labeling flexibility is not desirable.

12 . Comments Related to Tolerances/Tolerance Exemption for Minimum Risk Pesticide Ingredients

12.1 Two commenters believe that the website reference for information on tolerance exemptions would provide clarity when maintained and updated as needed. One of those

commenters would like to see the tolerance or tolerance exemptions clearly listed (or noted) in the active and in ert ingredients tables in the exemption to assist state authorities during inspections, as well as helping manufacturers from mistakenly assuming that t he ingredients have tolerance s or tolerance exemptions

.

12.2 One state c ommenter indicated that the most challenging issue for their s tate has been the lack of understanding about when residue tolerances or tolerance exemptions are required for products intended for use on food or feed sites. The commenter state d that they regularly encounter m inimum risk products labeled for food/feed uses that do not comply with the tolerance/tolerance exemption requirements in 40 CFR 180, and have been challenged over this issue by several registrants. The commenter stated that this problem is exacerbated by poor guidance, conflicting messages received by registrants from direct contacts within EPA, and inconsistent regulation am ong s tates regarding the issue. The commenter stated that the proposed revisions will do little to alleviate the problems associated with meeting the requirements for residue tolerances or exemptions from the tolerance requirement.Page 17 of 22 Response : This rule does not attempt to address when a tolerance or tolerance exemption may be required or to list existing tolerances and exemptions applicable to minimum risk pesticides. The latter is addressed in the tolerance regulations in 40 CFR part 180. Nonetheless, EPA understands that there can be confusion regarding whether a minimum risk pesticide ingredient is included in a pesticide tolerance or tolerance exemption and regarding when a tolerance or exemption is necessary for use of a minimum risk pesticide product on food or feed

. As noted in the propos al of this rulemaking , EPA intends to address some of th e se issues by directing manufacturers to 40 CFR part 180 to find information about tolerance requirements

. EPA is finalizing this change as propos ed

.

On its website, at http://www2.epa.gov/minimum

- risk

- pesticides

, EPA recently provid ed additional guidance with clearer descriptions of where tolerance information can be found for those ingredients that are eligible for use on food or food

- use sites. EPA believes the additi onal guidance will help manufacturers find the information they need to comply with pesticide tolerance requirements while alleviating some of the problems experienced by the commenter

.

12.3 Another s tate commenter stated that better clarification is needed regarding allowed ingredients that do not have tolerance exemptions for residues t hat may end up in food or feed. T he commenter states that the current minimum risk exemption language makes no mention that exemption of a product is conditional on li mitations on food use sites for products containing active and/or inert ingredients without tolerance exemptions. With the language provided in the proposed rule, the commenter stated that if EPA’s intent is that minimum risk products must restrict labele d use sites based on the status of tolerance or tolerance exemptions of the ingredients, then the Agency should clearly state that as a requirement of the exemption. The commenter did not believe that r eferring minimum risk pesticide manufacturers to guid ance with the suggestion that they consult tolerance information would be sufficient.

The commenter also state d that even if EPA amends the exemption to add label restrictions for food crop use sites as a condition of the exemption, this still would not be enough. The commenter argues that since these products are exempt from FIFRA, the prohibition in FIFRA on use of pesticides inconsistent with label directions would not apply. The commenter states that w hile some States such as theirs are able to enforce minimum risk pesticide labels since t hey require state registration , EPA and the s tates

cannot require the user to adhere to directions on labels for exempted products. The commenter also states that the general reference to section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA ) in the proposal is not sufficient authority for their s tate to deny regis tration applications or to stop the distribution of a minimum risk exempt product that has food use sites but no tolerance or tolerance exemption for one or more ingredients. The y also state that the same is true for the guidance referenced in the proposed regulatory text. Their s tate ’s laws and rules incorporate by reference 40 CFR 152.25(f) in their label requirements. The commenter indicated that they do not have any authority to enforce FFDCA. As a result, the commenter encourage d EPA to not include ingredients as allowable active ingredients in minimum risk pesticides exempted fromPage 18 of 22

FIFRA if they do not have enough information to issue a broad tolerance exemption for use on food crops

.

Response : EPA is not attempting to enforce adherence to the labels of minimum risk pesticides , which as noted cannot be done for pesticides subject to 40 CFR 152.25(f) . Rather, the Agency is assisting minimum risk pesticide producers in ensuring that the use directions on the product do not cause the label to be false or misleading. An exemption from FIFRA requirements under section 25(b) of the statute, including t he minimum risk exemption at 40 CFR 152.25(f) , cannot exempt pesticides from the requirements of a tolerance or tolerance exemption

un der FFDCA. Under FFDCA

, a ny pesticide chemical residue to be used in or on food s in commerce in the United States must have either an established tolerance or a tolerance exemption

. When a minimum risk product explicitly states on its label that it can be used in or on food or food

- use sites in commerce , but one or more of the ingredients does not have a n established tolerance or tolerance exemption, the label is indicating that the product may be used in a way that would violate Federal law. Such a label is therefore false or misleading . One of the requirements for the exemption, contained in § 152.25(f)(3)(iii), is that the product must not include any false or misleading labeling statements. A product bearing a label that is false or misleading w ould therefore no t be eligible for the minimum risk exempt ion, and the sale and distribution of that product would require FIFRA registration , including any needed label changes

. If s tate law requires a pesticide to be compliant with FIFRA, the s tate can i nsist that the label not allow a food use without the necessary tolerance or exemption. This will help ensure that products label ed for food

- use s are properly labeled , thus helping to reduce the potential for improper use of the product.

In the regulatory text of the proposal, EPA stated in § 152.25(f)(1) that “ all active ingredients may be used in non

- food use products, ” but products intended to be used “ on food and animal feed can only include active ingredients with applicable tolerance s or tol erance exemption s in p art 180 ” to comply with FFDCA. During development of the proposal, EPA considered adding tolerance information into the reformatted ingredients tables in 40 CFR 152.25(f) for reference purposes . However, EPA did not include this information because tolerances or tolerance exemptions can change frequently, meaning that any tolerance information in 152.25(f) would also have to be revised via rulemaking

, possibly leading to errors in the regulation.

To improve the clarity of the i nformation about tolerances in the regulatory text

, EPA is revising the explanatory text about tolerances in 152.25(f)(1) for active ingredients

, and is add ing similar text for inert ingredients in 152.25(f) (2)

. As s pecified in the final regulatory text, E PA is using its website to provide additional guidance on where tolerance information can be found

. As needed, i nformation on the website can be easily changed and can direct people where to find the tolerance information they need to comply with FFDCA . EPA believes that these approaches will make it clear that manufacturers should reviewPage 19 of 22 the tolerance information in 40 CFR part 180 before labeling their product for food uses to prevent their labels from potentially being false or misleading

.

B. Comments Outside of the Scope of this Rulemaking

All of the following comments are considered to be outside the scope of the rulemaking that EPA proposed on December 31, 2012. Some of the comments may be relevant to future activities (either rulemaking or developing guidance) concerning the minimum risk exemption.

1. Comments to add to or remove ingredients from the active or inert ingredients lists:

One commenter re quested that EPA remove “carrageenan” from the inert ingredient list. Other commenters generally requested that we add more ingredients to both the active and inert ingredient lists.

Response : EPA is not adding or removing ingredients from the lists as part of this rulemaking effort at this time

.
EPA understands that producers will eventually want other chemicals to be approved for use in minimum risk pesticide products or that some may wish to have chemicals removed from the scope of the exemption

. Any addition or removal of ingredients from the lists would have to be done through separate, future rulemakings. As stated earlier, EPA is considering developing guidance that would describe how ingredients can be added or removed from the exemption, but this guidance would be completed independent of this rulemaking. Companies may at any time petition the Agency to add or remove an ingredient from the active or inert ingredient lists under the APA, even in the absence of guidance.

2

. Comments requesting EPA to require full registration for minimum risk products

Several commenters indicated that they prefer that EPA require full registration of minimum risk products. They said that full registration of these products is the only acceptable fix to the exemption since they believe that there will always be issues with enf or cement unless it is repealed. One c ommenter argue d that s tates lack the resources to pursue issues related to products that do not comply with the exemption, especially in respect to the claims on the label and on labeling for efficacy in controlling ce rtain public health pests. Another c ommenter state d that the only acceptable “fix” to the exemption is to require registration for all pesticide products, and suggest ed that a rule should be developed that establishes a separate review process under FIFRA section 3.

Response : EPA remains open to working with the s tates and industry in the future to address any other issues that may exist that were not addressed by thisPage 20 of 22 rulemaking , and will continue to explore options for improving the exemption, either through additional rulemaking or improved guidance

.

3. Comments asking EPA to require products with public health pest claims to provide efficacy data or become registered with EPA

Five commenters have state d that the Agency should amend the exemption t o require minimum risk pesticide products that claim to control or mitigate public health pests (e.g., mosquitoes, ticks, bed bugs, etc.) to submit efficacy data to the Agency to support their efficacy claims against those pests

. T he se commenters acknowledge d that this is not what the aim of the rulemaking was about, but stated that this is an important issue that the Agency should address. They expressed concerns that there are some products that have unsubstantiated claims that are m isinforming the public and putting consumers at risk.

Response: EPA acknowledges that this concern was previously raised to the Agency. EPA received a petition on this issue from the Consumer Specialty Products Association, dated March 15, 2006, request ing the Agency to exclude public health pest claims from the exemption. On September 13, 2006, EPA published in the Federal Register a Notice of Availability and Request for Comments on the petition, which can be found at www.regulations.gov using the Docket ID number EPA

- HQ

- OPP

- 2006

- 0687 . EPA analyzed the comments received, and concluded that public health products must be supported by evidence that they are e ffective against the target public health pests

. CSPA’s letter of June 11, 2007 5 suggested that EPA engage in expedited rulemaking, including promulgating an interim final rule without notice and comment. In a letter dated July 18, 2007 6 , EPA responded to the CSPA letter as well as the initial petition.

To that end, EPA has explored rulemaking regarding personal insect repellents and is considering a proposal to remove personal mosquito and tick repellents from the minimum risk pesticides exemption currently in 40 CFR 152.25(f). This means that once removed from the exemption, personal mosquito and tick repellents would need to be registered as a pesticide product with EPA before sale or distribution in the United States. Since the current rulemaking is only intended to clarify the specific ingredients that are eligible for the exemption and improve the clarity and transparency of products’ labels, the issue discussed by the commenters would need to be addressed through a separate, future rulemaking effort.

4

. Comment on establishing a m aximum concentration for specific inert ingredients
allowed in minimum risk pesticides :

5 http://www2.epa.gov/minimum

- risk

- pesticides/consumer

- specialty

- products

- association

- letter

- and

- epa

- response

re

- minimum

6 Ibid.Page 21 of 22 One commenter suggested that EPA determine what the maximum concentration of specific inert ingredients should be allowed in minimum risk products

, and consider codifying the maximum percentages of these chemicals

. The c ommenter state d that certain eligible inert ingredients can act as an active above a certain concentration level. The commenter state d that i f an ingredient can act as either an acti ve or an inert ingredient, then EPA should specify the maximum concentration allowed as an inert in minimum risk products. The commenter provided wintergreen oil as an example, citing that FDA requires certain labeling requirements for wintergreen oil whe n the percentage in drugs is significant (more than 5%).

Response : Since this rulemaking is meant to clarify the current eligible ingredients and not to reassess or impose new requirements on those ingredients,

s etting limitations on the percentage (by weight) of ingredients that can be used in a minimum risk pesticide product would need to be done through a separate rulemaking.

5

. Comments about the safety of minimum risk ingredients:

One commenter stated that they do not want any product to be exempt from FIFRA registration, and that they want to know about the risks with all pesticides, including minimum risk pesticides. Another c ommenter asked several questions about the safety of mi nimum risk pesticides. These questions were, as follows :

 “ Why does EPA have to have two separate lists ? There’s a list for actives and a list for inerts. Seems that if the ingredient is safe, then it shouldn’t matter how the producer chooses to use the chemical in an exempted product. ”

 “ Is EPA sure that these chemicals are safe to use? Has EPA conducted an analysis of the chemical’s safety? Where are those risk assessments posted? ”

 “ Why isn’t there a limitation for the essential oils? If someone produces an exempted product that is 100% essential oil, is that safe? Do the risk assessments assume that 100% of an essential oil could be used in an exempted product? ”

Response : The commenter makes an important point that some chemicals can be either an inert or an active ingredient, depending on the pesticidal intent of the ingredient

. FIFRA distinguishes betwee n active and inert ingredients, which is why the exemption was established with separate lists for active and inert ingredients

.
This rulemaking is not intended to reassess the current active and inert ingredient lists, which were assessed as part of the original rulemaking that established the exemption (61 FR 8876, March 6, 1996) and the subsequent change s to the inert ingredients list as described in the proposal for this rulemaking (77 FR 76981, December 31, 2012) , but to clari fy those ingredients that have already been listed under the exemption

.Page 22 of 22 If there are any concerns about the safety of specific ingredient s that are currently listed in the exemption, individuals with concerns about an ingredient

can provide information to the agency to have those ingredients removed through further rulemaking after the promulgation of th is final rule.

6

. General comments about pesticides:

One c ommenter favored clear, co mprehensive pesticide labeling, and u rged the government to eliminate and heavily restrict chemicals that harm human health and the environment. Another c omme nter suggested that if EPA wanted to better inform the public with respect to what they are buying, then EPA should require that all registered pesticide s disclose their inert ingredients on their labels like minimum risk products are required to do.

Response : The Agency recognizes that some individuals want pesticides that harm human health and the environment to be eliminated or restricted, and want all information, including inert ingredients , to be included on all pesticide labels. These comments are mo re about pesticides in general than minimum risk pesticides, and do not specifically address the changes th at were in the proposed rule, which were to clarify the ingredients that are permitted in minimum risk pesticide products and to improve the clarity and transparency of minimum risk pesticide labels.