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Docket ID No. EPA-HQ-OPP-2010-0305

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 19
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I. Introduction

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

rule, 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. EPA 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 modify 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 comments that EPA has received 

on the proposed rule. These comments are available at www.regulations.gov using the 

docket identifier EPA-HQ-OPP-2010-0305. 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 State pesticide agencies, 1 State professional association, and 1 environmental 

advocacy organization submitted comments on the proposed rule:

Docket Commenter No. Affiliate

EPA-HQ-OPP-2010-0305-0018 Private Citizen

EPA-HQ-OPP-2010-0305-0019 Private Citizen

EPA-HQ-OPP-2010-0305-0020 Private Citizen

EPA-HQ-OPP-2010-0305-0021 TyraTech, Inc. 

EPA-HQ-OPP-2010-0305-0022 Neudorff

EPA-HQ-OPP-2010-0305-0023 Spargo Enterprises, Inc.

EPA-HQ-OPP-2010-0305-0024 National Candle Association

EPA-HQ-OPP-2010-0305-0025 Bonide Products, Inc.

EPA-HQ-OPP-2010-0305-0026 Private Citizen

EPA-HQ-OPP-2010-0305-0027 Private Citizen

EPA-HQ-OPP-2010-0305-0028 The Scotts Company, LLC

EPA-HQ-OPP-2010-0305-0029 Washington State Department of Agriculture

EPA-HQ-OPP-2010-0305-0030 Pennsylvania Department of Agriculture

EPA-HQ-OPP-2010-0305-0031 New Mexico Department of Agriculture
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Docket Commenter No. Affiliate

EPA-HQ-OPP-2010-0305-0032 Bayer CropScience

EPA-HQ-OPP-2010-0305-0033 National Pest Management Association

EPA-HQ-OPP-2010-0305-0034 Private Citizen

EPA-HQ-OPP-2010-0305-0035 Messina Wildlife

EPA-HQ-OPP-2010-0305-0036 Beyond Pesticides

EPA-HQ-OPP-2010-0305-0037 Council of Producers & Distributors of Agrotechnology

EPA-HQ-OPP-2010-0305-0038 Colorado Department of Agriculture

EPA-HQ-OPP-2010-0305-0040 Consumer Specialty Products Association

EPA-HQ-OPP-2010-0305-0041 Responsible Industry for a Sound Environment

EPA-HQ-OPP-2010-0305-0042 Association of Structural Pest Control Regulatory Officials

EPA-HQ-OPP-2010-0305-0043 The Liquid Fence Company, Inc. 

EPA-HQ-OPP-2010-0305-0044 Arizona Department of Agriculture

EPA-HQ-OPP-2010-0305-0045 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:

Commenters 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 stated that requiring USP 

standards for these ingredients goes beyond the stated purpose of the proposal, which was 

to clarify the active and inert ingredient lists. Commenters also stated that this would

impose 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 reformulate 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. These commenter said this change would create a new additional 

burden on minimum risk pesticide product manufacturers. Some commenters also 
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suggested that EPA has not provided enough information about why the Agency 

proposed USP standards for the active ingredients.

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

associated 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 regulation, EPA has removed the USP 

specification for all of the active ingredients except for castor oil. As discussed 

in the proposed rule, the primary objective of EPA’s rulemaking is to clarify the 

active and inert ingredients; no ingredients were to be added to or removed from 

the lists. Based on the comments received, EPA recognizes that the addition of

USP specifications for the active ingredients identified would result in the 

removal of technical grade active ingredients that are currently eligible for the 

minimum risk exemption. Since this was not the original intent of this 

rulemaking, EPA is not including the USP specifications for 18 of the 19 active 

ingredients in the final regulatory text. EPA, however, has retained the 

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 commenters supported 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 state level and prevent unnecessary enforcement 

actions.

3.2 One commenter agreed that the use of a standard label display name will 

provide clarity and uniformity for state 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 vinegar (maximum 8% acetic acid in solution). The commenter 

recommended that the Agency remove the bracketed 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 risk exemption. The commenter suggested that 

keeping bracketed text in the “Chemical Name” column and providing such information 

at state registration or upon request enables efficient monitoring of the exempted 

ingredients in a minimum risk pesticide, and allows for a more consumer-friendly label. 

Response: EPA believes that the bracketed information provides within the 

parentheses is important clarifying and safety information for manufacturers to 
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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 such as calcite (Ca(CO3)). 

However, after examining 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 consumers and adds more information than what consumers would 

want or need about an inert ingredient. Therefore, EPA has removed the 

bracketed information from the “Label Display Name” column in the final 

regulatory text. EPA, however, will continue to provide the bracketed

information to manufacturers within the “Chemical Name” column to help 

manufacturers comply with the minimum risk exemption’s requirements.

4. Comments on specific ingredients in the active ingredients list:

4.1 Two commenters noted that common salt (sodium chloride) was missing 

from the proposed active ingredients list, while one of the commenters also noted that 

ground sesame plant was not listed in the active ingredients list. 

Response: The deletion 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 Abstract Services Registry Number (CAS 

No.) 7647-14-5) 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. 8008-79-5) 

should be included under the definition of “mint oil” in the active ingredients list. 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 suggested 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 use 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. 

However, in promulgating the minimum risk exemption, EPA did not intend the 

term “mint and mint oil” to include all oils from the genus Mentha. Peppermint 

and peppermint oil (derived from Mentha piperita), for example, was listed 
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separately from “mint and mint oil” in the 1996 active ingredient list. When the 

minimum risk exemption was promulgated in 1996, “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 term1. 

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 No. 8008-79-5) in the 

active ingredients list. Additionally, since no other ingredients were intended to 

be included under “mint and mint oil” when 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 past, these terms 

are being removed from the active ingredients lists and are being replaced with 

separate listings for “cornmint,” “cornmint oil,” “spearmint,” and “spearmint oil.” 

EPA believes that this change will improve the clarity and transparency of the 

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 that 

were intended to be exempt under the original exemption and not to add or 

remove ingredients, EPA is not reassessing the appropriateness of whether or not 

the other mints or mint oils should be included under this rulemaking. If 

stakeholders have information that they believe supports the inclusion of other 

mints or mint oils, 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 use of Chemical 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 agreed that the use of CAS Nos.

would clearly establish and minimize the current uncertainty about what ingredients 

qualify for the exemption. One commenter stated that the use of CAS Nos. in the tables 

will more clearly define what substances are allowed. Another commenter said that the 

purchaser should easily be able to identify minimum risk 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 pesticide products” is not 

 

1 EPA. OPP. Decision Memorandum: Mint Oil. (2008). Docket ID: EPA-HQ-OPP-2010-0305 (accessible at 

www.regulations.gov. 
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accurate for every ingredient. The commenter noted, for example, that many [active] 

ingredients have multiple CAS Nos. that could apply, some have none, and many CAS 

Nos. are defined as broad general categories. 

The commenter recommended that EPA add the Consumer Specialty Products

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 stated that the CSPA Dictionary 

contains monographs was developed by its Nomenclature Committee to establish 

consistent nomenclature for consumer product ingredients (including those in 

antimicrobial and 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 consumer 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 Numbers and names where they are available and considered 

applicable. 

Response: EPA has traditionally provided the chemical names, as determined by 

the Chemical Abstract Services, and CAS Registry Number (CAS No.), when 

available, for each of the eligible inert ingredients in the list of minimum risk inert 

ingredients that is available on the Agency’s website2. 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 Names and CAS Nos. 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 Nos. have benefitted State reviewers and 

formulators by providing the specific chemical identifiers needed to determine 

whether an 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 CAS 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 practices. 

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 publiclyavailable 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-risk-pesticides
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understandable to many consumers, thus increasing transparency and consistency. 

Additionally, a standardized label display name provides the opportunity for State 

inspectors to become familiar with the name, thus decreasing label review 

timeframes. EPA believes that the CAS approach provides 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 if 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 stated that CAS Nos. are not unique identifiers for inert 

ingredients. They cited six chemicals 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 only 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 only 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 and 

pentahydrate states of the compound. The commenter thought that it was unlikely 

that EPA meant 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 provided clear evidence of the CSPA 

Dictionary’s utility to ingredient communication. They stated that if EPA moved 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 use of CAS chemical names and CAS Nos. when identifying 
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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 the 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 CSPA Dictionary monographs, if appropriate, but any 

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 supported requiring company name and contact information 

to be placed on product labels, stating that this would assist with state 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 addition to company contact information, one commenter also supported a 

batch code so that any adverse reactions or formulation problems can be properly traced. 

Response: 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 incident 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 code 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 rulemaking effort. 

6.3 Comments on revising the exemption to require a label statement that signals 

exempt status

One commenter 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 could make it clear to state 

reviewers and inspectors that the product is claiming minimum risk exemption status. 

Another commenter said that such statements should not be required and are likely to be 

confusing to the public. 
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Response: EPA believes that requiring a label statement that signals exempt 

status is unlikely to provide any significant benefit to consumers. As described in 

the proposal, an analysis from open literature and survey results3indicated that in 

general, most people do not read, understand, or believe disclaimers, 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 conduct additional research to ensure that the 

statement would be clearly understood by the public to prevent any potential 

confusion. As a result, EPA will 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 states 

indicating whether label statements 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 indicating that 

such a statement would be beneficial for enforcement purposes and provided 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 commenter said that requiring directions for use should be included 

on all labels. The commenter stated that at a minimum, first aid statements for 

eye and skin contact should be required, and in addition to directions 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 commenter said that basic minimum use directions would be 

beneficial to ensure that the product is used effectively. The commenter 

suggested that simple use directions would be appropriate for most products, 

while in some cases, more elaborate information may be required.

A third commenter stated that a lack 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-HQ-OPP-2010-0305-0011

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2010-0305-0011
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consumers are left to make decisions regarding proper use of a given product to 

control pests. The commenter supported 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, as stated in the 

proposed rule4, 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 risks 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 commenter recommended that EPA consider adopting the labeling 

exemption guidance from the Worker Health 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 the information provides guidance on when cautionary 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 ensure

that minimum risk pesticides are used safely. Even though 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 minimum risk pesticide products when used 

improperly. Requiring cautionary statements for ingredients would help to 

 

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

individuals. 

However, reassessing the risks and requiring cautionary statements 

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 this final rulemaking. EPA does, however, see value in specifying 

when cautionary statements should be incorporated. In a future 

rulemaking, EPA may consider setting thresholds 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 codification of the inert ingredients list

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 ingredients 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 referenced 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 ingredients list once codified in 

40 CFR 152.25(f). Accordingly, the commenters suggested that the rulemaking process 

would inadvertently 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 

commenters questioned if an efficient mechanism could be developed so that additions or 

deletions from the list could be easily accomplished. 

One commenter recommended 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 final 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 recommended that 

codifying the list is not the best 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 codifying the inert 

ingredient list in 40 CFR 152.25(f)(2) provides immediate benefits to all parties. 

An inert ingredient list directly in the regulations offers much needed clarity to 

federal, state, and tribal inspectors, and manufacturers. Having all of the 

ingredients codified also improves the efficiency of inspections because 
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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 describe 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 at 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 not yet 

available, is appropriate to provide the immediate benefits previously described.

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. 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 and 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 commenters 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 period. EPA’s Cost Analysis document indicated 

that the 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 compliance 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, companies typically change labels every 

3 years, so costs to comply with the changes made in this rulemaking would be 

reduced by almost 75% when using a 3-year compliance period instead of a 2-

year timeframe.

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

commenters 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 while the label 

changes have 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 is not aware of any other costs that 

producers may encounter outside of changing the label. The commenters did not 

provide cost information related to any other aspect of the proposal 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 rulemaking and has not made any 

changes to the cost estimates in the Cost Analysis for the final rule. 

10. How will these changes impact state and local agencies?

10.1 One state commenter said the rule would have a beneficial and positive impact, 

allowing states the ability to make better and timelier registration and enforcement 

decisions. 

A second state commenter stated that many of the changes proposed will be of 

benefit to their pesticide registration program. The commenter stated that it is an 

improvement 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 

commenter also stated that requiring company name and contact information on the label 

was also needed.

10.2 One state commenter indicated that any change to labeling will have some impact 

on the workload of state registration programs that register minimum risk products. For 

example, the commenter stated that there are 427 products registered in their state, and 

these changes could increase their workload for reviewing labels by 8-10% during the 

year of implementation. If the USP grade requirement is pursued, manufacturers may 

need to reformulate certain products. They would therefore need to revise their 

Confidential Statement of Formulas (CSFs), which could increase the one time extra 

burden on the state to review these changes. 

Response: Since EPA is not requiring the USP specifications for the 18 active 

ingredients as described previously in this document, states who register 

minimum risk pesticides should not see an increase in burden as a result of having 

to review revised CSFs due to registrants reformulating their products. By making 

the implementation period 3 years, EPA does not believe that the workload for the 

States will increase by 8-10% during the years of implementation since most 
Page 15 of 22

labeling revisions will occur within manufacturers’ routine label revision 

activities, thereby reducing the potential for a high volume of label reviews in any 

given year.

11. Publishing updated labeling guidance on the minimum risk exemption

Several commenters stated that updated guidance online would be helpful. They 

indicated that labeling guidance would be helpful for smaller manufacturers, and would 

help state reviewers ensure that exempt pesticide labels are complete, while also 

providing states with a reference to provide to manufacturers. One commenter suggested

that more examples of appropriate and inappropriate label claims for exempt products be 

provided, especially safety claims. A second commenter stated that they would welcome 

general guidance on appropriate placement and size of information in designing a label 

for a minimum risk pesticide, saying that this information should be easily accessible on 

an EPA webpage and be clearly defined as guidance rather than as a requirement.

One commenter noted that EPA did not provide any examples/details of what will

be included in the label guidance. The commenter did not believe that significant 

changes/requirements to minimal risk product labels are justified, and suggested that 

guidance 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 

stated that statements such as "SAFE" must continue to be allowed on labels and in 

advertising. The commenter stated that this is an important differentiator for certain 

consumers, as the 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 examples, to producers and states, which will also reduce the number of 

questions that both EPA and the states receive. Such guidance would assist 

manufacturers in complying with the codified requirements of the exemption. 

For the labeling guidance, EPA may provide examples 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 term “safe” would 

continue to be allowed on minimum risk pesticide product labels. EPA will make 
Page 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 

considered new requirements for compliance with the exemption.

EPA does not intend to make the labels of minimum risk products appear 

similar to registered products with this guidance, but rather to help producers 

ensure that their products meet the requirements of the exemption. The guidance 

would provide examples 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, however, 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. Since the 

inception of the exemption, companies have had flexibility in how they label their 

products as long as the labeling conditions set forth in 40 CFR 152.25(f) are met. 

For example, several 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 labeling provided that the label is not false or misleading and 

meets the conditions at 40 CFR 152.25(f). EPA believes that limiting 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 inert ingredients tables in the exemption to assist state authorities 

during inspections, as well as helping manufacturers from mistakenly assuming that the 

ingredients have tolerances or tolerance exemptions. 

12.2 One state commenter indicated that the most challenging issue for their state 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 stated that 

they regularly encounter minimum 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 among states 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 proposal of this rulemaking, EPA intends to address some 

of these issues by directing manufacturers to 40 CFR part 180 to find information

about tolerance requirements. EPA is finalizing this change as proposed.

On its website, at http://www2.epa.gov/minimum-risk-pesticides, EPA 

recently provided 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 additional 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 state commenter stated that better clarification is needed regarding 

allowed ingredients that do not have tolerance exemptions for residues that may end up in 

food or feed. The commenter states that the current minimum risk exemption language 

makes no mention that exemption of a product is conditional on limitations 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 labeled 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 referring 

minimum risk pesticide manufacturers to guidance with the suggestion that they consult 

tolerance information would be sufficient. 

The commenter also stated 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 while some States such as theirs are able to enforce 

minimum risk pesticide labels since they require state registration, EPA and the states 

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 state to 

deny registration 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. They also state that the same is true for the guidance referenced in the 

proposed regulatory text. Their state’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 encouraged EPA to not include 

ingredients as allowable active ingredients in minimum risk pesticides exempted from 
Page 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 the minimum risk exemption at 40 CFR 152.25(f), cannot

exempt pesticides from the requirements of a tolerance or tolerance exemption 

under FFDCA. Under FFDCA, any pesticide chemical residue to be used in or on 

foods 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 an 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 would therefore not be eligible for the 

minimum risk exemption, and the sale and distribution of that product would 

require FIFRA registration, including any needed label changes. If state law 

requires a pesticide to be compliant with FIFRA, the state can insist that the label 

not allow a food use without the necessary tolerance or exemption. This will help 

ensure that products labeled for food-uses 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 tolerances or tolerance exemptions in part 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 information about tolerances in the 

regulatory text, EPA is revising the explanatory text about tolerances in 

152.25(f)(1) for active ingredients, and is adding similar text for inert ingredients 

in 152.25(f)(2). As specified in the final regulatory text, EPA is using its website 

to provide additional guidance on where tolerance information can be found. As 

needed, information 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 review
Page 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 requested 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 

enforcement unless it is repealed. One commenter argued that states 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 certain public 

health pests. Another commenter stated that the only acceptable “fix” to the exemption is 

to require registration for all pesticide products, and suggested that a rule should be 

developed that establishes a separate review process under FIFRA section 3. 

Response: EPA remains open to working with the states and industry in the

future to address any other issues that may exist that were not addressed by this 
Page 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 stated that the Agency should amend the exemption to 

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. These commenters acknowledged 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 misinforming 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, requesting 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 effective against the target public health pests. CSPA’s 

letter of June 11, 20075suggested that EPA engage in expedited rulemaking, 

including promulgating an interim final rule without notice and comment. In a 

letter dated July 18, 20076, 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 maximum 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-responsere-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 commenter stated that 

certain eligible inert ingredients can act as an active above a certain concentration level. 

The commenter stated that if an ingredient can act as either an active 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 when 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, 

setting 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 commenter asked several questions about the safety of 

minimum 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 between 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

changes to the inert ingredients list as described in the proposal for this 

rulemaking (77 FR 76981, December 31, 2012), but to clarify those ingredients 

that have already been listed under the exemption. 
Page 22 of 22

If there are any concerns about the safety of specific ingredients 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 this final rule. 

6. General comments about pesticides:

One commenter favored clear, comprehensive pesticide labeling, and urged the 

government to eliminate and heavily restrict chemicals that harm human health and the 

environment. Another commenter suggested that if EPA wanted to better inform the 

public with respect to what they are buying, then EPA should require that all registered 

pesticides 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 more about pesticides in general than minimum risk 

pesticides, and do not specifically address the changes that 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.