Pesticides; Revisions to Minimum Risk Exemption, 80653-80665 [2015-32325]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Rules and Regulations]
[Pages 80653-80665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32325]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[EPA-HQ-OPP-2010-0305; FRL-9934-44]
RIN 2070-AJ79


Pesticides; Revisions to Minimum Risk Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revising its regulations to more clearly describe the 
active and inert ingredients that are permitted in products eligible 
for the minimum risk pesticide exemption. EPA is improving 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. These 
specific identifiers will make it easier for manufacturers, the public, 
and Federal, state, and tribal inspectors to determine the specific 
chemical substances that are permitted in minimum risk pesticide 
products. EPA is also modifying the labeling requirements in the 
exemption to require products to list ingredients on the label with a 
designated label display name and to provide the producer's contact 
information on the product's label. These changes will provide more 
consistent information for consumers and clearer regulations for 
producers, and will simplify compliance determination by states, 
tribes, and EPA.

DATES: This final rule is effective February 26, 2016. The compliance 
date for the requirements to label ingredients with a label display 
name and to provide company contact information on the label is 
February 26, 2019.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2010-0305, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Ryne Yarger, Field and External 
Affairs Divisions (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 605-1193; fax number: (703) 305-5884; 
email address: yarger.ryne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you manufacture, distribute, 
sell, or use minimum risk pesticide products. Minimum risk pesticide 
products are exempt from registration and other requirements under the 
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and are 
described in 40 CFR 152.25(f). The following list of North American 
Industrial Classification System (NAICS) codes is not intended to be 
exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
may include:
     Manufacturers of these products, which includes pesticide 
and other agricultural chemical manufacturers (NAICS codes 325320 and 
325311), as well as other manufacturers in similar industries such as 
animal feed (NAICS

[[Page 80654]]

code 311119), cosmetics (NAICS code 325620), and soap and detergents 
(NAICS code 325611).
     Manufacturers who may also be distributors of these 
products, which includes farm supplies merchant wholesalers (NAICS code 
424910), drug and druggists merchant wholesalers (NAICS code 424210), 
and motor vehicle supplies and new parts merchant wholesalers (NAICS 
code 423120).
     Retailers of minimum risk pesticide products (some of 
which may also be manufacturers), which includes nursery, garden 
center, and farm supply stores (NAICS code 444220), outdoor power 
equipment stores (NAICS code 444210), and supermarkets (NAICS code 
445110).
     Users of minimum risk pesticide products, including the 
public in general, as well as exterminating and pest control services 
(NAICS code 561710), landscaping services (NAICS code 561730), sports 
and recreation institutions (NAICS code 611620), and child daycare 
services (NAICS code 624410). Many of these companies also manufacture 
minimum risk pesticide products.

B. What action is the agency taking?

    EPA is revising its regulations to more clearly describe the active 
and inert ingredients permitted in products eligible for the minimum 
risk pesticide exemption (40 CFR 152.25(f)). EPA is doing this by 
codifying the inert ingredients list and reformatting the active and 
inert ingredients lists, adding specific chemical identifiers, where 
available, for each eligible active and inert ingredient. These 
identifiers, through the use of Chemical Abstracts Service Registry 
Numbers (CAS Nos.), will make it easier for manufacturers, the public, 
and Federal, state, and tribal inspectors to determine the specific 
chemical substances that are permitted in minimum risk pesticide 
products. EPA is also modifying the labeling requirements in the 
exemption to require the use of a designated label display name for 
each ingredient in the lists of ingredients on minimum risk pesticide 
product labels, and to require producers to provide contact information 
on their products' labels. EPA is finalizing most of the regulatory 
text that was proposed in the Federal Register of December 31, 2012 
(Ref. 1), with changes based on the comments submitted to the Agency.

C. What is the agency's authority for taking this action?

    This action is issued under the authority of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq., particularly sections 3 and 25.

D. What are the incremental costs and benefits of the action?

    EPA has determined that the total cost for industry to comply with 
the labeling requirements of this rulemaking is approximately $800,000 
under a 3-year implementation period as described in the Cost Analysis 
for this rulemaking (Ref. 2). EPA proposed a 2-year implementation 
period, but instead determined to use a 3-year implementation period 
based on public comments since 3 years would be the most sensitive to 
the smallest firms. The costs for industry to comply with this 
rulemaking are a result of meeting the new labeling requirements to 
list ingredients using a designated label display name and to list the 
company's contact information on the product's label. Since most 
companies update their labels every 3 years, EPA has determined that a 
rule implementation period of 3 years will allow most companies to meet 
the labeling requirements of the rule as part of their normal labeling 
practices and will therefore keep industry costs to a minimum.
    Benefits of the rule include the improved clarity of the ingredient 
lists and the improved clarity and transparency of how minimum risk 
products are labeled. By providing specific chemical identifiers, such 
as the CAS Nos. for active and inert ingredients, manufacturers and 
Federal, state, and tribal inspectors will be able to easily determine 
whether a chemical substance can be used in a minimum risk product, 
i.e., is eligible for the exemption. These regulatory changes improve 
compliance and enforcement of the exemption. Requiring ingredients to 
be listed on the label with common label display names will help 
inspectors to efficiently determine whether a product is in compliance 
with the exemption, and will also provide improved clarity and 
transparency for consumers who want more information about the 
ingredients used in a product. Additionally, requiring company contact 
information on labels will provide further transparency and 
accountability should an adverse event occur while using a product.

II. Background

A. Summary of the Proposed Rule

    EPA published a notice of proposed rulemaking (NPRM) in the Federal 
Register of December 31, 2012 (77 FR 76979) (FRL-9339-1) (Ref. 1) 
proposing to revise the regulations in 40 CFR 152.25(f) that created an 
exemption from FIFRA requirements for minimum risk pesticide products. 
The primary goal of the proposed revisions was to clarify the 
conditions of exemption for minimum risk pesticides by clearly 
specifying the chemical substances permitted in minimum risk pesticide 
products. EPA's proposed revisions clarified the specific active and 
inert ingredients permitted in minimum risk pesticide products, 
specified how the ingredients should be presented on the label, and 
provided consumers with the manufacturer's contact information on the 
product's label. EPA's intent with the proposed revisions was to 
clarify the terms of the original exemption and to provide additional 
clarity and transparency concerning the ingredients that are currently 
used in exempted products. As described in the proposal, no ingredients 
were intended to be added or removed from the lists.

B. Public Comment on the Proposed Rule

    EPA evaluated all comments received and developed a Response to 
Comments document, which is available in the docket at https://www.regulations.gov using Docket ID No. EPA-HQ-OPP-2010-0305 (Ref. 3). 
Only the key comments within the scope of the proposed rule and the 
Agency's responses to those comments are summarized here. For detailed 
responses, please see the Response to Comment document (Ref. 3).
    1. United States Pharmacopeia (USP) Specifications for 19 active 
ingredients. Several commenters expressed concern that adding a USP 
specification for 19 active ingredients in the active ingredients table 
would go beyond the stated purpose of the proposal, which was to 
clarify the original active and inert ingredient lists. 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 the 
ingredients would be unlikely to meet the USP standards. These 
commenters said this change would create a new additional burden on 
minimum risk pesticide product manufacturers.
    In response, for the final regulation, EPA has removed the USP 
specification for all of the active ingredients except for castor oil. 
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 rulemaking is to

[[Page 80655]]

clarify the currently eligible active and inert ingredients and not to 
add or remove substances from the ingredients lists, EPA is not 
including the USP specification 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 part of the original active 
ingredients list.
    2. Brackets in the label display name. One commenter stated that 
requiring certain label display names to contain bracketed text fails 
to add 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 since the bracketed text best serves as 
clarification for manufacturers to meet the requirements of the minimum 
risk exemption. The commenter suggested that keeping the information 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.
    In response, EPA believes that the bracketed information provides 
important clarifying and safety information for manufacturers to 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 labels for 
consumers. EPA agrees that this information could potentially create 
confusion for consumers and may add 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 for those inert ingredients in the 
``Chemical Name'' column to help manufacturers comply with the minimum 
risk exemption's requirements.
    3. Missing active ingredients. Two commenters noted that common 
salt (sodium chloride) was missing from the proposed active ingredients 
table, while one of the commenters also noted that ground sesame plant 
was not listed in the active ingredients list.
    In response, the deletion of sodium chloride and ground sesame 
plant from the exemption 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 (CAS No. 7647-14-
5) into the table of active ingredients, and is placing ``includes 
ground sesame plant'' into the specifications column for ``sesame'' in 
the final regulatory text.
    4. Inclusion of ``spearmint oil'' under the term ``mint oil.'' 
Several commenters suggested that spearmint oil (CAS No. 8008-79-5) 
should be included under the definition of ``mint oil'' in the active 
ingredients table. 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, while another commenter 
suggested that EPA should include specific notation or include all CAS 
numbers whenever multiple CAS numbers may be applicable.
    In 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 mint 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 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 
intended 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 oil could also be included under this term (Ref. 3).
    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 active 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 list 
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 
listings 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 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, 
they can provide such information to EPA in a petition for evaluation. 
EPA will consider and respond to all such petitions.
    5. Use of CAS Nos. to identify eligible ingredients. While several 
commenters expressed support for using CAS Nos. to identify eligible 
ingredients when available, one commenter stated that EPA's assumption 
that CAS Nos. are unique chemical identifiers is not accurate for every 
ingredient. The commenter noted, for example, that many ingredients 
have multiple CAS Nos. that could apply, other ingredients have none, 
and many CAS Nos. are defined as broad general categories.
    The commenter recommended that EPA add the Consumer Specialty 
Products Association's 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

[[Page 80656]]

contains monographs developed by the 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 Nos. and other 
names 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 Nos. and names where they are 
available and considered applicable.
    In response, EPA has consistently provided the chemical names, as 
determined by the Chemical Abstracts Service, and CAS Nos., when 
available, for each of the eligible ingredients on the minimum risk 
inert ingredients list that has been provided on the Agency's Web site. 
EPA's experience with providing this information on the publicly-
available inerts 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 publicly-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 Web 
page 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 
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.
    6. Codification of the inert ingredient list and the need for an 
efficient mechanism for adding or remove ingredients from the lists. 
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 held as a reference within 40 CFR 
152.25(f)(2), updated periodically, and maintained on EPA's public Web 
site. The commenters questioned what codification would mean for 
getting ingredients added or removed from the list. These 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.
    In response, for the final regulation, 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 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. 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 Web site at https://www2.epa.gov/minimum-risk-pesticides.
    EPA believes that codifying the inert ingredient list and revising 
both 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 Administrative Procedure 
Act, 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.
    7. Proposed timeframe for implementation. 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.
    In response, EPA has decided to use a 3-year compliance period 
instead of the proposed 2-year compliance period. EPA's Cost Analysis 
document (Ref. 2) 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.
    8. Tolerance/tolerance exemptions for minimum risk pesticide 
ingredients. 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 requirements in 40 CFR part 180, 
and have been challenged over this issue by

[[Page 80657]]

several registrants. The commenter stated 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.
    Another state commenter stated that better clarification is needed 
regarding allowed ingredients that do not have tolerance exemptions for 
residues that may end up on food or feed. The commenter stated 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 amended 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 argued 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 stated that while some states such as theirs are able to 
enforce minimum risk pesticide labels, EPA and the states cannot 
require the user to adhere to directions on labels for exempted 
products. The commenter also stated 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 stop the distribution of a minimum risk 
exempt product that has food use sites but no tolerance exemption for 
one or more ingredients, and that the same is true for the guidance 
referenced in the proposed regulatory text. The commenter indicated 
that their state does not have the 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 
FIFRA if EPA does not have enough information to issue a broad 
tolerance exemption for use on food crops.
    In response, this rule does not attempt to address when a tolerance 
or tolerance exemption may be required or to list existing tolerances 
or exemptions applicable to minimum risk pesticides. 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 tolerance exemption is necessary for 
use of a minimum risk pesticide product on food or feed. As noted in 
the NPRM, EPA proposed 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 Web site, at https://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.
    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 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 Sec.  152.25(f)(3)(iii), 
is that the product must not include any false and misleading labeling 
statements. A product bearing a label that is false and misleading 
would therefore not be eligible for the minimum risk exemption, and 
sale or 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 tolerance 
exemption. This will help ensure that products labeled for food-uses 
are properly labeled, thus reducing the potential for improper use of 
the product.
    In the regulatory text of the proposal, EPA stated in Sec.  
152.25(f)(1) that ``all listed 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 Sec.  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 Sec.  152.25(f)(1) for active ingredients, and is adding similar 
explanatory text for inert ingredients in Sec.  152.25(f)(2). As 
specified in the final regulatory text, EPA is using its Web site to 
provide additional guidance on where tolerance information can be 
found. As needed, information on the Web site 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 
clearer that manufacturers should review 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.

C. Other Modifications to the Regulatory Text

    While responding to the comments regarding mint oil, EPA realized 
that additional clarity would be helpful for the descriptions of cedar 
oil in the active ingredients table. ``Cedar oil'' is a non-specific 
term, and the proposal

[[Page 80658]]

listed three separate CAS Nos. for it. While each CAS No. is associated 
with a specific type of cedar oil, the type of cedar oil was not 
indicated in the label display name or the chemical name. EPA is 
revising the label display names from ``Cedar oil'' to ``Cedarwood 
oil'' to improve clarity and the chemical names to more clearly reflect 
the differences among the three CAS Nos. for cedarwood oil. These 
revisions will also improve the clarity and transparency of the 
eligible ingredients for manufacturers and inspectors. This does not 
change the list of ingredients eligible for the exemption or impose any 
additional requirements on producers of minimum risk pesticides 
containing one of these ingredients. The chemical name changes for the 
three cedarwood oil ingredients are, as follows:
     CAS No. 85085-29-6 will have the chemical name, 
``Cedarwood oil (China).''
     CAS No. 68990-83-0 will have the chemical name, 
``Cedarwood oil (Texas).''
     CAS No. 8000-27-9 will have the chemical name, ``Cedarwood 
oil (Virginia).''
    Additionally, EPA determined to finalize only the first sentence of 
proposed Sec.  152.25(f)(3)(v). EPA believes that a description of the 
information available on EPA's Web site is not needed in regulatory 
text. Since this is not a condition of the exemption, EPA is finalizing 
the first sentence of proposed Sec.  152.25(f)(3)(v) in a new Sec.  
152.25(f)(4) to be entitled ``Providing guidance.''
    Because these changes do not modify the list of eligible 
ingredients for the exemption or otherwise affect the scope of the 
exemption, EPA has determined that notice and comment are unnecessary 
in accordance with the good cause exemption contained in 5 U.S.C. 
553(b)(B) of the Administrative Procedure Act.

III. The Final Rule

    With the exception of the modifications discussed in Unit II.B. and 
II.C., EPA is finalizing the rule in essentially the same form as the 
proposed rule. The final rule continues to do the following:
     Redesign the format of the active ingredients list,
     Codify the list of permitted inert ingredients,
     Provide specific chemical identifiers, through the use of 
CAS Nos., for each eligible active and inert ingredient when available,
     Require that a common ``label display name'' for each 
ingredient be used when listing ingredients on a product's label, and
     Require company name and contact information on product 
labels.
    EPA recently updated its guidance on minimum risk pesticides online 
at https://www2.epa.gov/minimum-risk-pesticides. This Web site now 
includes guidance on pesticide tolerances for minimum risk ingredients 
and provides alternative formats of the active and inert ingredient 
lists that may be more suitable for some users. Shortly after the 
effective date of this final rule, EPA intends to include additional 
guidance, as needed, such as labeling guidance for minimum risk 
pesticides and how to request additional ingredients to be added or 
removed from the minimum risk exemption.

IV. References

    As indicated under ADDRESSES, a docket has been established for 
this final rule under docket ID number EPA-HQ-OPP-2010-0305. The 
following is a listing of the documents that are specifically 
referenced in this action. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

    1. U.S. EPA. Pesticides; Revisions to Minimum Risk Exemption; 
Proposed Rule. Federal Register December 31, 2012 (77 FR 76979) 
(FRL-9339-1).
    2. U.S. EPA. Office of Pesticide Programs (OPP). Cost and Small 
Business Analysis of Revisions to Minimum Risk Exemption (2014).
    3. U.S. EPA, (OPP). Response to Public Comments on the Proposed 
Rule: ``Pesticides; Revisions to Minimum Risk Exemption.'' (2014).
    4. U.S. EPA, (OPP). Decision Memorandum: Mint Oil (2008).
    5. U.S. EPA, (OPP). Supporting Statement for an Information 
Collection Request (ICR): Labeling Change for Certain Minimum Risk 
Pesticides under FIFRA Section 25(b). EPA ICR No. 2475.02; OMB 
Control No. 2070-0187 (2015).

V. FIFRA Review Requirements

    In accordance with FIFRA sections 21 and 25(a), the Agency 
submitted a draft of this final rule to the appropriate Congressional 
Committees, the Secretary of the Department of Agriculture (USDA), and 
the Secretary of the Department of Health and Human Services (HHS). HHS 
waived its review of this rule on June 19, 2015. On June 18, 2015, USDA 
reviewed this rule, and did not have any comments related to policy. 
USDA provided a technical comment, which EPA has reviewed and accepted.
    Under FIFRA section 25(d), EPA also submitted a draft of this final 
rule to the FIFRA Scientific Advisory Panel (SAP). The SAP waived its 
scientific review of the final rule on June 24, 2015, because the final 
rule does not contain scientific issues that warrant review by the 
Panel.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was 
therefore not submitted to the Office of Management and Budget (OMB) 
for review under Executive Orders 12866, October 4, 1993 (58 FR 51735) 
and 13563, January 21, 2011 (76 FR 3821).

B. Paperwork Reduction Act (PRA)

    The information collection activities in this rule have been 
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The 
Information Collection Request (ICR), identified by EPA ICR No. 2475.02 
(Ref. 5), is available in the docket for this rule, and it is briefly 
summarized here.
    The information collection activities in this rule consist of 
changes to existing requirements that involve the one-time relabeling 
of products currently exempt under 40 CFR 152.25(f) in order to list 
chemical names in the format required by EPA and to include the 
producer's contact information. The ICR accounts for the burden for a 
one time label change which provides important regulatory information 
for the Federal, state, and tribal authorities that regulate minimum 
risk pesticide products.
    Respondent's obligation to respond: Required to obtain or retain a 
benefit (40 CFR 152.25(f)).
    Estimated number of respondents: 216.
    Frequency of response: One-time for each product needing a label 
change.
    Total estimated burden: 2,123 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $198,811.23 (per year). There are no capital 
or operation and maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA 
regulations in 40 CFR

[[Page 80659]]

are listed in 40 CFR part 9. When OMB approves this ICR, the Agency 
will announce that approval in the Federal Register and publish a 
technical amendment to 40 CFR part 9 to display the OMB control number 
for the approved information collection activities contained in this 
final rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. The small entities subject to the requirements of 
this action are small businesses who manufacture minimum risk pesticide 
products. No small governmental jurisdictions or not-for-profit 
enterprises are known to produce minimum risk pesticide products. The 
Agency has determined that there are approximately 97 small firms (out 
of a total of 192), accounting for approximately 51% of the industry. 
These small firms may experience an impact of 0.1% of gross revenue 
given a 3-year compliance period. To account for the impacts on very 
small firms, i.e., those with sales less than $500K, EPA performed a 
refined analysis that divided each individual firm's relabeling cost by 
that firm's sales revenue. With a 3-year compliance period, 7 small 
firms (or approximately 7% of all small firms) are likely to experience 
an economic impact of 1% or more of gross sales, while no small firms 
will incur impacts greater than or equal to 3% of gross sales. Details 
of this analysis are presented in the analysis for this rule (Ref. 2).
    The selection of the 3-year compliance period was based on 
information obtained in 2009 from a group of small manufacturers of 
minimum risk insect repellent products, as well as comments received 
during the public comment period for the proposed rule. EPA initially 
proposed a 2-year compliance period for companies to relabel their 
products since the companies indicated they needed at least 2 years in 
order to avoid significant costs (Ref. 2). This would allow most 
companies to incorporate the changes into their regularly planned label 
updates, and sell any products with older labels, thus reducing the 
cost and burden of the changes to the exemption. During the public 
comment period for the proposed rule, EPA received comments that 
expressed support for both the proposed 2-year compliance period and 
the longer 3-year compliance period. While several commenters felt that 
the 2-year period would provide sufficient time to comply with the new 
labeling requirements, some commenters felt that a 3-year compliance 
period would benefit the smallest companies to incorporate the changes 
into regularly planned updates and to sell their existing stock, thus 
minimizing their costs and burden to comply with the new requirements. 
EPA is aware that most companies make regularly planned label updates 
every 3 years (Ref. 2). By going with a 3-year compliance period 
instead of the originally proposed 2-year timeframe, costs on industry 
would be reduced by almost 75% from the 2-year implementation period, 
thereby being more sensitive to the smallest of small firms.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. EPA has determined 
that this action imposes no enforceable duty on any state, local, or 
tribal governments because there are no known instances where such 
governments currently produce any pesticides such that they would be 
subject to this rulemaking. In addition, the potential costs for the 
private sector do not qualify as an unfunded mandate under UMRA.

E. Executive Order 13132: Federalism

    This action does not have federalism implications, as specified in 
Executive Order 13132, August 10, 1999 (64 FR 43255). It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175, November 9, 2000 (65 FR 67249). There are no 
known instances where a tribal government is the producer of a minimum 
risk pesticide currently exempt from regulation. Thus, Executive Order 
13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045, April 23, 1997 (62 FR 
19885) as applying only to those regulatory actions that concern 
environmental health or safety risks that the EPA has reason to believe 
may disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order. This 
action is not subject to Executive Order 13045 because it does not 
concern an environmental health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, May 22, 2001 
(66 FR 28355) because it is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards that would 
require the consideration of voluntary consensus standards pursuant to 
NTTAA section 12(d), 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not involve special consideration of environmental 
justice related issues as specified in Executive Order 12898, February 
16, 1994 (59 FR 7629). EPA believes the human health or environmental 
risk addressed by this action will not have potential 
disproportionately high and adverse human health or environmental 
effects on minority, low-income, or indigenous populations because it 
does not affect the level of protection provided to human health or the 
environment. To the contrary, this action will increase the level of 
environmental protection for all affected populations without having 
disproportionately high and adverse human health or environmental 
effects on any population, including any minority or low-income 
population. This action only involves minimum risk pesticide products, 
and may have positive impacts for all communities, since the rule 
provides increased information for consumers considering the use of 
pesticides. This action, which will improve clarity on product labels, 
will enable all users regardless of economic status to become more 
informed about the pesticide substances they may be interested in 
using.

VII. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and the 
EPA will submit a rule report to each House of Congress and the 
Comptroller of the

[[Page 80660]]

United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 152

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 16, 2015.
Gina McCarthy,
Administrator.

    Therefore, 40 CFR chapter I is amended as follows:

PART 152--[AMENDED]

0
1. The authority citation for part 152 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; subpart U is also issued under 31 
U.S.C. 9701.
0
2. Amend Sec.  152.25 by revising paragraph (f) to read as follows:


Sec.  152.25  Exemptions for pesticides of a character not requiring 
FIFRA regulation.

* * * * *
    (f) Minimum risk pesticides--(1) Exempted products. Products 
containing the following active ingredients, alone or in combination 
with other substances listed in table 1 of this paragraph, are exempt 
from the requirements of FIFRA provided that all of the criteria of 
this section are met. All listed active ingredients may be used in non-
food use products. Under section 408 of the Federal Food, Drug, and 
Cosmetic Act and EPA (FFDCA) implementing regulations at part 180 of 
this chapter, food and animal feed in commerce can bear pesticide 
residues only for those ingredients that have tolerances or tolerance 
exemptions in part 180 of this chapter. Such tolerances or exemptions 
may be found, for example, in Sec. Sec.  180.950, 180.1071, 180.1087, 
180.1233, and 180.1251 of this chapter.

                Table 1--Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products
----------------------------------------------------------------------------------------------------------------
         Label display name               Chemical name          Specifications                CAS No.
----------------------------------------------------------------------------------------------------------------
Castor oil.........................  Castor oil............  United States           8001-79-4
                                                              Pharmacopeia (U.S.P.)
                                                              or equivalent.
Cedarwood oil......................  Cedarwood oil (China).  ......................  85085-29-6
Cedarwood oil......................  Cedarwood oil (Texas).  ......................  68990-83-0
Cedarwood oil......................  Cedarwood oil           ......................  8000-27-9
                                      (Virginia).
Cinnamon...........................  Cinnamon..............  ......................  N/A
Cinnamon oil.......................  Cinnamon oil..........  ......................  8015-91-6
Citric acid........................  2-Hydroxypropane-1,2,3- ......................  77-92-9
                                      tricarboxylic acid.
Citronella.........................  Citronella............  ......................  N/A
Citronella oil.....................  Citronella oil........  ......................  8000-29-1
Cloves.............................  Cloves................  ......................  N/A
Clove oil..........................  Clove oil.............  ......................  8000-34-8
Corn gluten meal...................  Corn gluten meal......  ......................  66071-96-3
Corn oil...........................  Corn oil..............  ......................  8001-30-7
Cornmint...........................  Cornmint..............  ......................  N/A
Cornmint oil.......................  Cornmint oil..........  ......................  68917-18-0
Cottonseed oil.....................  Cottonseed oil........  ......................  8001-29-4
Dried blood........................  Dried blood...........  ......................  68991-49-9
Eugenol............................  4-Allyl-2-              ......................  97-53-0
                                      methoxyphenol.
Garlic.............................  Garlic................  ......................  N/A
Garlic oil.........................  Garlic oil............  ......................  8000-78-0
Geraniol...........................  (2E)-3,7-Dimethylocta-  ......................  106-24-1
                                      2,6-dien-1-ol.
Geranium oil.......................  Geranium oil..........  ......................  8000-46-2
Lauryl sulfate.....................  Lauryl sulfate........  ......................  151-41-7
Lemongrass oil.....................  Lemongrass oil........  ......................  8007-02-1
Linseed oil........................  Linseed oil...........  ......................  8001-26-1
Malic acid.........................  2-Hydroxybutanedioic    ......................  6915-15-7
                                      acid.
Peppermint.........................  Peppermint............  ......................  N/A
Peppermint oil.....................  Peppermint oil........  ......................  8006-90-4
2-Phenylethyl propionate...........  2-Phenylethyl           ......................  122-70-3
                                      propionate.
Potassium sorbate..................  Potassium (2E,4E)-hexa- ......................  24634-61-5
                                      2,4-dienoate.
Putrescent whole egg solids........  Putrescent whole egg    ......................  51609-52-0
                                      solids.
Rosemary...........................  Rosemary..............  ......................  N/A
Rosemary oil.......................  Rosemary oil..........  ......................  8000-25-7
Sesame.............................  Sesame................  Includes ground sesame  N/A
                                                              plant.
Sesame oil.........................  Sesame oil............  ......................  8008-74-0
Sodium chloride....................  Sodium chloride.......  ......................  7647-14-5
Sodium lauryl sulfate..............  Sulfuric acid           ......................  151-21-3
                                      monododecyl ester,
                                      sodium salt.
Soybean oil........................  Soybean oil...........  ......................  8001-22-7
Spearmint..........................  Spearmint.............  ......................  N/A
Spearmint oil......................  Spearmint oil.........  ......................  8008-79-5
Thyme..............................  Thyme.................  ......................  N/A
Thyme oil..........................  Thyme oil.............  ......................  8007-46-3
White pepper.......................  White pepper..........  ......................  N/A
Zinc...............................  Zinc..................  Zinc metal strips       7440-66-6
                                                              (consisting solely of
                                                              zinc metal and
                                                              impurities).
----------------------------------------------------------------------------------------------------------------

    (2) Permitted inert ingredients. A pesticide product exempt under 
paragraph (f)(1) of this section may only include the inert ingredients 
listed in paragraphs (f)(2)(i) through (iv) of this section. All listed 
inert ingredients may

[[Page 80661]]

be used in non-food use products. Under FFDCA section 408 and EPA 
implementing regulations at part 180 of this chapter, food and animal 
feed in commerce can bear pesticide residues only for those ingredients 
that have tolerances or tolerance exemptions in part 180 of this 
chapter. Such tolerances or exemptions may be found, for example, in 
Sec. Sec.  180.910, 180.920. 180.930, 180.940, 180.950, and 180.1071 of 
this chapter.
    (i) Commonly consumed food commodities, as described in Sec.  
180.950(a) of this chapter.
    (ii) Animal feed items, as described in Sec.  180.950(b) of this 
chapter.
    (iii) Edible fats and oils, as described in Sec.  180.950(c) of 
this chapter.
    (iv) Specific chemical substances, as listed in the following 
table.

 Table 2--Inert Ingredients Permitted in Minimum Risk Pesticide Products
------------------------------------------------------------------------
     Label display name           Chemical name            CAS No.
------------------------------------------------------------------------
Acetyl tributyl citrate.....  Citric acid, 2-       77-90-7
                               (acetyloxy)-,
                               tributyl ester.
Agar........................  Agar................  9002-18-0
Almond hulls................  Almond hulls........  N/A
Almond oil..................  Oils, almond........  8007-69-0
Almond shells...............  Almond shells.......  N/A
alpha-Cyclodextrin..........  alpha-Cyclodextrin..  10016-20-3
Aluminatesilicate...........  Aluminatesilicate...  1327-36-2
Aluminum magnesium silicate.  Silicic acid,         1327-43-1
                               aluminum magnesium
                               salt.
Aluminum potassium sodium     Silicic acid,         12736-96-8
 silicate.                     aluminum potassium
                               sodium salt.
Aluminum silicate...........  Aluminum silicate...  1335-30-4
Aluminum sodium silicate....  Silicic acid,         1344-00-9
                               aluminum sodium
                               salt.
Aluminum sodium silicate....  Silicic acid (H4      12003-51-9
                               SiO4), aluminum
                               sodium salt (1:1:1).
Ammonium benzoate...........  Benzoic acid,         1863-63-4
                               ammonium salt.
Ammonium stearate...........  Octadecanoic acid,    1002-89-7
                               ammonium salt.
Amylopectin, acid-            Amylopectin, acid-    113894-85-2
 hydrolyzed, 1-                hydrolyzed, 1-
 octenylbutanedioate.          octenylbutanedioate.
Amylopectin, hydrogen 1-      Amylopectin,          125109-81-1
 octadecenylbutanedioate.      hydrogen 1-
                               octadecenylbutanedi
                               oate.
Animal glue.................  Animal glue.........  N/A
Ascorbyl palmitate..........  Ascorbyl palmitate..  137-66-6
Attapulgite-type clay.......  Attapulgite-type      12174-11-7
                               clay.
Beeswax.....................  Beeswax.............  8012-89-3
Bentonite...................  Bentonite...........  1302-78-9
Bentonite, sodian...........  Bentonite, sodian...  85049-30-5
beta-Cyclodextrin...........  beta-Cyclodextrin...  7585-39-9
Bone meal...................  Bone meal...........  68409-75-6
Bran........................  Bran................  N/A
Bread crumbs................  Bread crumbs........  N/A
(+)-Butyl lactate...........  Lactic acid, n-butyl  34451-19-9
                               ester, (S).
Butyl lactate...............  Lactic acid, n-butyl  138-22-7
                               ester.
Butyl stearate..............  Octadecanoic acid,    123-95-5
                               butyl ester.
Calcareous shale............  Calcareous shale....  N/A
Calcite.....................  Calcite (Ca(CO3))...  13397-26-7
Calcium acetate.............  Calcium acetate.....  62-54-4
Calcium acetate monohydrate.  Acetic acid, calcium  5743-26-0
                               salt, monohydrate.
Calcium benzoate............  Benzoic acid,         2090-05-3
                               calcium salt.
Calcium carbonate...........  Calcium carbonate...  471-34-1
Calcium citrate.............  Citric acid, calcium  7693-13-2
                               salt.
Calcium octanoate...........  Calcium octanoate...  6107-56-8
Calcium oxide silicate......  Calcium oxide         12168-85-3
                               silicate (Ca3
                               O(SiO4)).
Calcium silicate............  Silicic acid,         1344-95-2
                               calcium salt.
Calcium stearate............  Octadecanoic acid,    1592-23-0
                               calcium salt.
Calcium sulfate.............  Calcium sulfate.....  7778-18-9
Calcium sulfate dihydrate...  Calcium sulfate       10101-41-4
                               dihydrate.
Calcium sulfate hemihydrate.  Calcium sulfate       10034-76-1
                               hemihydrate.
Canary seed.................  Canary seed.........  N/A
Carbon......................  Carbon..............  7440-44-0
Carbon dioxide..............  Carbon dioxide......  124-38-9
Carboxymethyl cellulose.....  Cellulose,            9000-11-7
                               carboxymethyl ether.
Cardboard...................  Cardboard...........  N/A
Carnauba wax................  Carnauba wax........  8015-86-9
Carob gum...................  Locust bean gum.....  9000-40-2
Carrageenan.................  Carrageenan.........  9000-07-1
Caseins.....................  Caseins.............  9000-71-9
Castor oil..................  Castor oil..........  8001-79-4
Castor oil, hydrogenated....  Castor oil,           8001-78-3
                               hydrogenated.
Cat food....................  Cat food............  N/A
Cellulose...................  Cellulose...........  9004-34-6
Cellulose acetate...........  Cellulose acetate...  9004-35-7
Cellulose, mixture with       Cellulose, mixture    51395-75-6
 cellulose carboxymethyl       with cellulose
 ether, sodium salt.           carboxymethyl
                               ether, sodium salt.
Cellulose, pulp.............  Cellulose, pulp.....  65996-61-4

[[Page 80662]]

 
Cellulose, regenerated......  Cellulose,            68442-85-3
                               regenerated.
Cheese......................  Cheese..............  N/A
Chlorophyll a...............  Chlorophyll a.......  479-61-8
Chlorophyll b...............  Chlorophyll b.......  519-62-0
Citric acid.................  Citric acid.........  77-92-9
Citric acid, monohydrate....  Citric acid,          5949-29-1
                               monohydrate.
Citrus meal.................  Citrus meal.........  N/A
Citrus pectin...............  Citrus pectin.......  9000-69-5
Citrus pulp.................  Citrus pulp.........  68514-76-1
Clam shells.................  Clam shells.........  N/A
Cocoa.......................  Cocoa...............  8002-31-1
Cocoa shell flour...........  Cocoa shell flour...  N/A
Cocoa shells................  Cocoa shells........  N/A
Cod-liver oil...............  Cod-liver oil.......  8001-69-2
Coffee grounds..............  Coffee grounds......  68916-18-7
Cookies.....................  Cookies.............  N/A
Cork........................  Cork................  61789-98-8
Corn cobs...................  Corn cobs...........  N/A
Cotton......................  Cotton..............  N/A
Cottonseed meal.............  Cottonseed meal.....  68424-10-2
Cracked wheat...............  Cracked wheat.......  N/A
Decanoic acid, monoester      Decanoic acid,        26402-22-2
 with 1,2,3-propanetriol.      monoester with
                               1,2,3-propanetriol.
Dextrins....................  Dextrins............  9004-53-9
Diglyceryl monooleate.......  9-Octadecenoic acid,  49553-76-6
                               ester with 1,2,3-
                               propanetriol.
Diglyceryl monostearate.....  9-Octadecanoic acid,  12694-22-3
                               monoester with
                               oxybis(propanediol).
Dilaurin....................  Dodecanoic acid,      27638-00-2
                               diester with 1,2,3-
                               propanetriol.
Dipalmitin..................  Hexadecanoic acid,    26657-95-4
                               diester with 1,2,3-
                               propanetriol.
Dipotassium citrate.........  Citric acid,          3609-96-9
                               dipotassium salt.
Disodium citrate............  Citric acid,          144-33-2
                               disodium salt.
Disodium sulfate decahydrate  Disodium sulfate      7727-73-3
                               decahydrate.
Diatomaceous earth..........  Kieselguhr;           61790-53-2
                               Diatomite (less
                               than 1% crystalline
                               silica).
Dodecanoic acid, monoester    Dodecanoic acid,      27215-38-9
 with 1,2,3-propanetriol.      monoester with
                               1,2,3-propanetriol.
Dolomite....................  Dolomite............  16389-88-1
Douglas fir bark............  Douglas fir bark....  N/A
Egg shells..................  Egg shells..........  N/A
Eggs........................  Eggs................  N/A
(+)-Ethyl lactate...........  Lactic acid, ethyl    687-47-8
                               ester, (S).
Ethyl lactate...............  Lactic acid, ethyl    97-64-3
                               ester.
Feldspar....................  Feldspar............  68476-25-5
Ferric oxide................  Iron oxide (Fe2O3)..  1309-37-1
Ferrous oxide...............  Iron oxide (FeO)....  1345-25-1
Fish meal...................  Fish meal...........  N/A
Fish oil....................  Fish oil............  8016-13-5
Fuller's earth..............  Fuller's earth......  8031-18-3
Fumaric acid................  Fumaric acid........  110-17-8
gamma-Cyclodextrin..........  gamma-Cyclodextrin..  17465-86-0
Gelatins....................  Gelatins............  9000-70-8
Gellan gum..................  Gellan gum..........  71010-52-1
Glue........................  Glue (as depolymd.    68476-37-9
                               animal collagen).
Glycerin....................  1,2,3-Propanetriol..  56-81-5
Glycerol monooleate.........  9-Octadecenoic acid   111-03-5
                               (Z)-, 2,3-
                               dihydroxypropyl
                               ester.
Glyceryl dicaprylate........  Octanoic acid,        36354-80-0
                               diester with 1,2,3-
                               propanetriol.
Glyceryl dimyristate........  Tetradecanoic acid,   53563-63-6
                               diester with 1,2,3-
                               propanetriol.
Glyceryl dioleate...........  9-Octadecenoic acid   25637-84-7
                               (9Z)-, diester with
                               1,2,3-propanetriol.
Glyceryl distearate.........  Octadecanoic acid,    1323-83-7
                               diester with 1,2,3-
                               propanetriol.
Glyceryl monomyristate......  Tetradecanoic acid,   27214-38-6
                               monoester with
                               1,2,3-propanetriol.
Glyceryl monooctanoate......  Octanoic acid,        26402-26-6
                               monoester with
                               1,2,3-propanetriol.
Glyceryl monooleate.........  9-Octadecenoic acid   25496-72-4
                               (9Z)-, monoester
                               with 1,2,3-
                               propanetriol.
Glyceryl monostearate.......  Octadecanoic acid,    31566-31-1
                               monoester with
                               1,2,3-propanetriol.
Glyceryl stearate...........  Octadecanoic acid,    11099-07-3
                               ester with 1,2,3-
                               propanetriol.
Granite.....................  Granite.............  N/A
Graphite....................  Graphite............  7782-42-5
Guar gum....................  Guar gum............  9000-30-0
Gum Arabic..................  Gum arabic..........  9000-01-5
Gum tragacanth..............  Gum tragacanth......  9000-65-1
Gypsum......................  Gypsum..............  13397-24-5
Hematite....................  Hematite (Fe2O3)....  1317-60-8
Humic acid..................  Humic acid..........  1415-93-6
Hydrogenated cottonseed oil.  Hydrogenated          68334-00-9
                               cottonseed oil.
Hydrogenated rapeseed oil...  Hydrogenated          84681-71-0
                               rapeseed oil.

[[Page 80663]]

 
Hydrogenated soybean oil....  Hydrogenated soybean  8016-70-4
                               oil.
Hydroxyethyl cellulose......  Cellulose, 2-         9004-62-0
                               hydroxyethyl ether.
Hydroxypropyl cellulose.....  Cellulose, 2-         9004-64-2
                               hydroxypropyl ether.
Hydroxypropyl methyl          Cellulose, 2-         9004-65-3
 cellulose.                    hydroxypropyl
                               methyl ether.
Iron magnesium oxide........  Iron magnesium oxide  12068-86-9
                               (Fe2MgO4).
Iron oxide, hydrate.........  Iron oxide (Fe2O3),   12259-21-1
                               hydrate.
Iron oxide..................  Iron oxide (Fe3O4)..  1317-61-9
Isopropyl alcohol...........  2-Propanol..........  67-63-0
Isopropyl myristate.........  Isopropyl myristate.  110-27-0
Kaolin......................  Kaolin..............  1332-58-7
Lactose.....................  Lactose.............  63-42-3
Lactose monohydrate.........  Lactose monohydrate.  64044-51-5
Lanolin.....................  Lanolin.............  8006-54-0
Latex rubber................  Latex rubber........  N/A
Lauric acid.................  Lauric acid.........  143-07-7
Lecithins...................  Lecithins...........  8002-43-5
Licorice extract............  Licorice extract....  68916-91-6
Lime dolomitic..............  Lime (chemical)       12001-27-3
                               dolomitic.
Limestone...................  Limestone...........  1317-65-3
Linseed oil.................  Linseed oil.........  8001-26-1
Magnesium carbonate.........  Carbonic acid,        546-93-0
                               magnesium salt
                               (1:1).
Magnesium benzoate..........  Magnesium benzoate..  553-70-8
Magnesium oxide.............  Magnesium oxide.....  1309-48-4
Magnesium oxide silicate....  Magnesium oxide       12207-97-5
                               silicate
                               (Mg3O(Si2O5)2),
                               monohydrate.
Magnesium silicate..........  Magnesium silicate..  1343-88-0
Magnesium silicate hydrate..  Magnesium silicate    1343-90-4
                               hydrate.
Magnesium silicon oxide.....  Magnesium silicon     14987-04-3
                               oxide (Mg2Si3O8).
Magnesium stearate..........  Octadecanoic acid,    557-04-0
                               magnesium salt.
Magnesium sulfate...........  Magnesium sulfate...  7487-88-9
Magnesium sulfate             Magnesium sulfate     10034-99-8
 heptahydrate.                 heptahydrate.
Malic acid..................  Malic acid..........  6915-15-7
Malt extract................  Malt extract........  8002-48-0
Malt flavor.................  Malt flavor.........  N/A
Maltodextrin................  Maltodextrin........  9050-36-6
Methylcellulose.............  Cellulose, methyl     9004-67-5
                               ether.
Mica........................  Mica................  12003-38-2
Mica-group minerals.........  Mica-group minerals.  12001-26-2
Milk........................  Milk................  8049-98-7
Millet seed.................  Millet seed.........  N/A
Mineral oil.................  Mineral oil (U.S.P.)  8012-95-1
1-Monolaurin................  Dodecanoic acid, 2,3- 142-18-7
                               dihydroxypropyl
                               ester.
1-Monomyristin..............  Tetradecanoic acid,   589-68-4
                               2,3-dihydroxypropyl
                               ester.
Monomyristin................  Decanoic acid,        53998-07-1
                               diester with 1,2,3-
                               propanetriol.
Monopalmitin................  Hexadecanoic acid,    26657-96-5
                               monoester with
                               1,2,3-propanetriol.
Monopotassium citrate.......  Citric acid,          866-83-1
                               monopotassium salt.
Monosodium citrate..........  Citric acid,          18996-35-5
                               monosodium salt.
Montmorillonite.............  Montmorillonite.....  1318-93-0
Myristic acid...............  Myristic acid.......  544-63-8
Nepheline syenite...........  Nepheline syenite...  37244-96-5
Nitrogen....................  Nitrogen............  7727-37-9
Nutria meat.................  Nutria meat.........  N/A
Nylon.......................  Nylon...............  N/A
Octanoic acid, potassium      Octanoic acid,        764-71-6
 salt.                         potassium salt.
Octanoic acid, sodium salt..  Octanoic acid,        1984-06-1
                               sodium salt.
Oleic acid..................  Oleic acid..........  112-80-1
Oyster shells...............  Oyster shells.......  N/A
Palm oil....................  Palm oil............  8002-75-3
Palm oil, hydrogenated......  Palm oil,             68514-74-9
                               hydrogenated.
Palmitic acid...............  Hexadecanoic acid...  57-10-3
Paper.......................  Paper...............  N/A
Paraffin wax................  Paraffin wax........  8002-74-2
Peanut butter...............  Peanut butter.......  N/A
Peanut shells...............  Peanut shells.......  N/A
Peanuts.....................  Peanuts.............  N/A
Peat moss...................  Peat moss...........  N/A
Pectin......................  Pectin..............  9000-69-5
Perlite.....................  Perlite.............  130885-09-5
Perlite, expanded...........  Perlite, expanded...  93763-70-3
Plaster of paris............  Plaster of paris....  26499-65-0
Polyethylene................  Polyethylene........  9002-88-4
Polyglyceryl oleate.........  Polyglyceryl oleate.  9007-48-1
Polyglyceryl stearate.......  Polyglyceryl          9009-32-9
                               stearate.

[[Page 80664]]

 
Potassium acetate...........  Acetic acid,          127-08-2
                               potassium salt.
Potassium aluminum silicate,  Potassium aluminum    1327-44-2
 anhydrous.                    silicate, anhydrous.
Potassium benzoate..........  Benzoic acid,         582-25-2
                               potassium salt.
Potassium bicarbonate.......  Carbonic acid,        298-14-6
                               monopotassium salt.
Potassium chloride..........  Potassium chloride..  7447-40-7
Potassium citrate...........  Citric acid,          7778-49-6
                               potassium salt.
Potassium humate............  Humic acids,          68514-28-3
                               potassium salts.
Potassium myristate.........  Tetradecanoic acid,   13429-27-1
                               potassium salt.
Potassium oleate............  9-Octadecenoic acid   143-18-0
                               (9Z)-, potassium
                               salt.
Potassium ricinoleate.......  9-Octadecenoic acid,  7492-30-0
                               12-hydroxy-,
                               monopotassium salt,
                               (9Z, 12R)-.
Potassium sorbate...........  Sorbic acid,          24634-61-5
                               potassium salt.
Potassium stearate..........  Octadecanoic acid,    593-29-3
                               potassium salt.
Potassium sulfate...........  Potassium sulfate...  7778-80-5
Potassium sulfate...........  Sulfuric acid,        7646-93-7
                               monopotassium salt.
1,2-Propylene carbonate.....  1,3-Dioxolan-2-one,   108-32-7
                               4-methyl-.
Pumice......................  Pumice..............  1332-09-8
Red cabbage color...........  Red cabbage color     N/A
                               (expressed from
                               edible red cabbage
                               heads via a
                               pressing process
                               using only
                               acidified water).
Red cedar chips.............  Red cedar chips.....  N/A
Red dog flour...............  Red dog flour.......  N/A
Rubber......................  Rubber..............  9006-04-6
Sawdust.....................  Sawdust.............  N/A
Shale.......................  Shale...............  N/A
Silica, amorphous, fumed....  Silica, amorphous,    112945-52-5
                               fumed (crystalline
                               free).
Silica, amorphous,            Silica, amorphous,    7699-41-4
 precipitate and gel.          precipitate and gel.
Silica......................  Silica (crystalline   7631-86-9
                               free).
Silica gel..................  Silica gel..........  63231-67-4
Silica gel, precipitated,     Silica gel,           112926-00-8
 crystalline-free.             precipitated,
                               crystalline-free.
Silica, hydrate.............  Silica, hydrate.....  10279-57-9
Silica, vitreous............  Silica, vitreous....  60676-86-0
Silicic acid, magnesium salt  Silicic acid          13776-74-4
                               (H2SiO3), magnesium
                               salt (1:1).
Soap........................  Soap (The water       N/A
                               soluble sodium or
                               potassium salts of
                               fatty acids
                               produced by either
                               the saponification
                               of fats and oils,
                               or the
                               neutralization of
                               fatty acid).
Soapbark....................  Quillaja saponin....  1393-03-9
Soapstone...................  Soapstone...........  308076-02-0
Sodium acetate..............  Acetic acid, sodium   127-09-3
                               salt.
Sodium alginate.............  Sodium alginate.....  9005-38-3
Sodium benzoate.............  Benzoic acid, sodium  532-32-1
                               salt.
Sodium bicarbonate..........  Sodium bicarbonate..  144-55-8
Sodium carboxymethyl          Cellulose,            9004-32-4
 cellulose.                    carboxymethyl
                               ether, sodium salt.
Sodium chloride.............  Sodium chloride.....  7647-14-5
Sodium citrate..............  Sodium citrate......  994-36-5
Sodium humate...............  Humic acids, sodium   68131-04-4
                               salts.
Sodium oleate...............  Sodium oleate.......  143-19-1
Sodium ricinoleate..........  9-Octadecenoic acid,  5323-95-5
                               12-hydroxy-,
                               monosodium salt,
                               (9Z,12R)-.
Sodium stearate.............  Octadecanoic acid,    822-16-2
                               sodium salt.
Sodium sulfate..............  Sodium sulfate......  7757-82-6
Sorbitol....................  D-glucitol..........  50-70-4
Soy protein.................  Soy protein.........  N/A
Soya lecithins..............  Lecithins, soya.....  8030-76-0
Soybean hulls...............  Soybean hulls.......  N/A
Soybean meal................  Soybean meal........  68308-36-1
Soybean, flour..............  Soybean, flour......  68513-95-1
Stearic acid................  Octadecanoic acid...  57-11-4
Sulfur......................  Sulfur..............  7704-34-9
Syrups, hydrolyzed starch,    Syrups, hydrolyzed    68425-17-2
 hydrogenated.                 starch,
                               hydrogenated.
Tetraglyceryl monooleate....  9-Octadecenoic acid   71012-10-7
                               (9Z)-, monoester
                               with tetraglycerol.
Tricalcium citrate..........  Citric acid, calcium  813-94-5
                               salt (2:3).
Triethyl citrate............  Citric acid,          77-93-0
                               triethyl ester.
Tripotassium citrate........  Citric acid,          866-84-2
                               tripotassium salt.
Tripotassium citrate          Citric acid,          6100-05-6
 monohydrate.                  tripotassium salt,
                               monohydrate.
Trisodium citrate...........  Citric acid,          68-04-2
                               trisodium salt.
Trisodium citrate dehydrate.  Citric acid,          6132-04-3
                               trisodium salt,
                               dehydrate.
Trisodium citrate             Citric acid,          6858-44-2
 pentahydrate.                 trisodium salt,
                               pentahydrate.
Ultramarine blue............  C.I. Pigment Blue 29  57455-37-5
Urea........................  Urea................  57-13-6
Vanillin....................  Benzaldehyde, 4-      121-33-5
                               hydroxy-3-methoxy-.
Vermiculite.................  Vermiculite.........  1318-00-9
Vinegar.....................  Vinegar (maximum 8%   8028-52-2
                               acetic acid in
                               solution).
Vitamin C...................  L-Ascorbic acid.....  50-81-7
Vitamin E...................  Vitamin E...........  1406-18-4
Walnut flour................  Walnut flour........  N/A

[[Page 80665]]

 
Walnut shells...............  Walnut shells.......  N/A
Wheat.......................  Wheat...............  N/A
Wheat flour.................  Wheat flour.........  N/A
Wheat germ oil..............  Wheat germ oil......  8006-95-9
Wheat oil...................  Oils, wheat.........  68917-73-7
Whey........................  Whey................  92129-90-3
White mineral oil...........  White mineral oil     8042-47-5
                               (petroleum).
Wintergreen oil.............  Wintergreen oil.....  68917-75-9
Wollastonite................  Wollastonite          13983-17-0
                               (Ca(SiO3)).
Wool........................  Wool................  N/A
Xanthan gum.................  Xanthan gum.........  11138-66-2
Yeast.......................  Yeast...............  68876-77-7
Zeolites....................  Zeolites (excluding   1318-02-1
                               erionite (CAS Reg.
                               No. 66733-21-9)).
Zeolites, NaA...............  Zeolites, NaA.......  68989-22-0
Zinc iron oxide.............  Zinc iron oxide.....  12063-19-3
Zinc oxide..................  Zinc oxide (ZnO)....  1314-13-2
Zinc stearate...............  Octadecanoic acid,    557-05-1
                               zinc salt.
------------------------------------------------------------------------

    (3) Other conditions of exemption. All of the following conditions 
must be met for products to be exempted under this section:
    (i) Each product containing the substance must bear a label 
identifying the label display name and percentage (by weight) of each 
active ingredient as listed in table 1 in paragraph (f)(1) of this 
section. Each product must also list all inert ingredients by the label 
display name listed in table 2 in paragraph (f)(2)(iv) of this section.
    (ii) The product must not bear claims either to control or mitigate 
microorganisms that pose a threat to human health, including but not 
limited to disease transmitting bacteria or viruses, or claims to 
control insects or rodents carrying specific diseases, including, but 
not limited to ticks that carry Lyme disease.
    (iii) Company name and contact information.
    (A) The name of the producer or the company for whom the product 
was produced must appear on the product label. If the company whose 
name appears on the label in accordance with this paragraph is not the 
producer, the company name must be qualified by appropriate wording 
such as ``Packed for [insert name],'' ``Distributed by [insert name], 
or ``Sold by [insert name]'' to show that the name is not that of the 
producer.
    (B) Contact information for the company specified in accordance 
with paragraph (f)(3)(iii)(A) of this section must appear on the 
product label including the street address plus ZIP code and the 
telephone phone number of the location at which the company may be 
reached.
    (C) The company name and contact information must be displayed 
prominently on the product label.
    (iv) The product must not include any false and misleading labeling 
statements, including those listed in 40 CFR 156.10(a)(5)(i) through 
(viii).
    (4) Providing guidance. Guidance on minimum risk pesticides is 
available at https://www2.epa.gov/minimum-risk-pesticides or successor 
Web pages.
[FR Doc. 2015-32325 Filed 12-24-15; 8:45 am]
 BILLING CODE 6560-50-P