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[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Proposed Rules]
[Pages 76979-76996]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31188]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[EPA-HQ-OPP-2010-0305; FRL-9339-1]
RIN 2070-AJ79

Pesticides; Revisions to Minimum Risk Exemption

AGENCY: Environmental Protection Agency (EPA).

[[Page 76980]]

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to more clearly describe the active and inert 
ingredients permitted in products eligible for the exemption from 
regulation for minimum risk pesticides. EPA is proposing to reorganize 
these lists with a focus on clarity and transparency by adding specific 
chemical identifiers. The identifiers would make it clearer to 
manufacturers; the public; and Federal, state, and tribal inspectors 
which ingredients are permitted in minimum risk pesticide products. EPA 
is also proposing to modify the label requirements in the exemption to 
require the use of specific common chemical names in lists of 
ingredients on minimum risk pesticide product labels, and to require 
producer contact information on the label. Once final, these proposed 
changes would maintain the availability of minimum risk pesticide 
products while providing more consistent information for consumers, 
clearer regulations for producers, and easier identification by states, 
tribes and EPA as to whether a product is in compliance with the 
exemption.

DATES: Comments must be received on or before April 1, 2013.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number 12P-0200 EPA-HQ-OPP-2010-0305, by one of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC) (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001. In addition, please mail a copy of your comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, Office of Management and Budget, ATTN: Desk Officer 
for EPA, 725 17th St. NW., Washington, DC 20503.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Ryne Yarger, Field and External 
Affairs Division (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. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
distribute, sell, or use minimum risk pesticide products. Minimum risk 
pesticide products are exempt from Federal regulation, 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 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 44220); outdoor power 
equipment stores (NAICS code 444210); and supermarkets (NAICS code 
445110).
     Users of minimum risk pesticides, 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 day care 
services (NAICS code 624410). Many of these companies also manufacture 
minimum risk pesticide products.

B. 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., sections 3 and 25.

C. What action is the agency taking?

    EPA is proposing to more clearly describe the active and inert 
ingredients permitted in products eligible for the exemption from 
regulation for minimum risk pesticides (40 CFR 152.25(f)). EPA is 
proposing to reorganize these lists by adding specific chemical 
identifiers. The identifiers would make it clearer to manufacturers; 
the public; and Federal, state, and tribal inspectors the specific 
ingredients that are permitted in minimum risk pesticide products. EPA 
is also proposing to modify the label requirements in the exemption to 
require the use of specific common chemical names in lists of 
ingredients on minimum risk pesticide product labels, and to require 
producer contact information on the label.

D. Why is EPA taking this action?

    The primary goal of this proposal is to clarify the conditions of 
exemption for minimum risk pesticides by making clearer the specific 
ingredients that are permitted in minimum risk pesticide products. EPA 
has exempted from the requirement of registration certain pesticide 
products if they are composed of specified ingredients and labeled 
according to EPA's regulations in 40 CFR 152.25(f). EPA created the 
exemption for minimum risk pesticides to eliminate the need to expend 
significant resources to regulate products that were deemed to be of 
minimum risk to human health and the environment. In addition, 
exempting such products freed Agency resources to focus on evaluating 
formulations whose toxicity was less well characterized or of higher 
toxicity. The existing regulatory structure, however, leads to 
confusion as to which ingredients are exempt under 40 CFR 152.25(f), 
and how they should be labeled on products.
    The proposed revisions to the exemption would clarify the specific 
ingredients that are permitted, specify how they should be presented on 
a label, and provide consumers with contact information for the 
manufacturer of the products. EPA's intention is to restructure the 
exemption with a focus on clarity and transparency for the ingredient 
lists. Once final, these proposed changes would provide more consistent 
information for consumers, clearer regulations for producers, and 
easier identification by states, tribes and EPA as to whether a product 
is in compliance with the exemption.

[[Page 76981]]

II. Background

A. The Minimum Risk Pesticide Exemption

    Under FIFRA section 25(b)(2), EPA may exempt from the requirements 
of FIFRA any pesticide that is ``of a character unnecessary to be 
subject to [FIFRA].'' Pursuant to this authority, in March 1996, EPA 
promulgated 40 CFR 152.25(g), which exempted from FIFRA any pesticide 
product consisting solely of specified ingredients that EPA judged to 
pose minimum risk to humans and the environment (61 FR 8876, March 6, 
1996) (FRL-4984-8). This provision was later redesignated as 40 CFR 
152.25(f) (66 FR 64759, December 14, 2001) (FRL-6752-1).
    Unlike registered pesticides, sale and distribution of products 
exempted under 40 CFR 152.25(f) do not require that the products be 
registered with EPA, payment of registration fees, or reporting of 
production to EPA. To meet the criteria for the minimum risk exemption, 
a pesticide must:
     Contain only specified active and inert ingredients.
     List active ingredients on the label by name and percent 
weight in the formula.
     List inert ingredients on the label by name.
     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.
     Not include false or misleading labeling statements, 
specified in 40 CFR 156.10(a)(5)(i) through (viii). These include false 
or misleading statements about product composition, effectiveness, 
comparison to other products, endorsement by the Federal Government, or 
label disclaimers.
    Restrictions on which ingredients may be used in minimum risk 
pesticide products are key aspects of the exemption, since the 
properties of these specific ingredients are the reason EPA exempted 
minimum risk pesticide products from FIFRA regulatory requirements. As 
stated in the notice of proposed rulemaking for the minimum risk 
exemption, ``EPA believes regulation of these substances is not 
necessary to prevent unreasonable adverse effects on man or the 
environment, and these substances are not of a character necessary to 
be subject to FIFRA in order to carry out its purposes'' (Ref. 1).
    1. Active ingredients. Active ingredients for minimum risk 
pesticide products are listed in 40 CFR 152.25(f)(1); no new active 
ingredients have been added since 1996.
    2. Inert ingredients. Inert ingredients for minimum risk pesticide 
products were originally listed in List 4A, referenced at 40 CFR 
152.25(f)(2). The 4A Inert Ingredient List was created on November 22, 
1989 (54 FR 48314) (FRL-3667-6). List 4A ingredients were described as 
minimal risk, or ``substances for which there is no information to 
indicate that there is a basis for concern'' (Ref. 2). On September 28, 
1994, EPA added new chemicals to List 4A by publishing an updated list 
in the Federal Register (Ref. 3). The exemption for minimum risk 
pesticides referred to this list, as it appeared in the Federal 
Register in September 1994.
    Since 1994, EPA has updated the list of inert ingredients permitted 
in minimum risk pesticide products. In 2002, EPA proposed (in January) 
and finalized (in May) a consolidated set of tolerance exemptions for 
minimum risk chemicals under section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a. These changes primarily allowed a 
set of commonly consumed foods to be included in minimum risk 
pesticides with food uses (Ref. 4). Some commonly consumed foods (such 
as peanuts, tree nuts, milk, soybeans, eggs, fish, crustacean, and 
wheat) were excluded due to their known allergenic properties. EPA 
proposed and finalized these changes as part of the tolerance 
reassessment requirements of the Food Quality Protection Act of 1996, 
which amended FFDCA. In the 2002 proposal, EPA explained that commonly 
consumed foods could be considered minimum risk, since ``it is unlikely 
that a commonly consumed food commodity could be used to control a pest 
via a toxic mode of action'' and that foods are generally recognized as 
safe (Ref. 2). The 2002 final rule explained that, with some 
exceptions, all commonly consumed food items and all animal feed items 
would be considered minimum risk pesticide chemicals and would be 
located in the newly established 40 CFR 180.950. The 2002 final rule 
did not amend the FIFRA minimum risk exemption in 40 CFR 152.25(f). In 
2004, EPA updated List 4A to specifically list the substances in the 
2002 rulemaking (Ref. 5).
    In 2006, EPA classified additional substances as minimum risk for 
purposes of tolerance exemptions under 40 CFR 180.950(e). The proposed 
rule also clarified that EPA was shifting existing tolerance exemptions 
for the inert ingredients that appear on List 4A from that list to 40 
CFR 180.950(e) (Ref. 6).
    Since 2006, EPA has been responding to stakeholder input and 
revising the Web page that lists inert ingredients eligible for use in 
minimum risk pesticide products. Among these updates, this Web page was 
revised on March 3, 2009, to include a common chemical name for many of 
the chemicals and to clearly delineate the food and non-food use status 
of the chemical substances.
    The list was most recently re-formatted on December 20, 2010, to 
provide a more easily understood format for the chemicals listed. The 
list is available on the Agency's Web site at http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf (Ref. 7).
    3. Labeling requirements. Labeling requirements are also a key 
component of the exemption. While EPA does not review these products, 
and therefore a label review is not conducted, in order to maintain 
exempt status, an exempt product's label must meet certain criteria. 
The methods for displaying active and inert ingredient information are 
detailed in the exemption: Labels must include percentage (by weight) 
of active ingredients and list all inert ingredients.
    The regulations for displaying ingredients on minimum risk 
pesticide product labels differ from the regulations for registered 
products. Since exempt products are not registered with EPA and 
manufacturers submit no information to the Agency, listing product 
ingredients provides important information to the public, and to 
enforcement officials who must determine whether or not a product 
complies with the exemption.

B. EPA's Initial Expectations for the Exemption

    EPA had several expectations regarding this exemption:
     Reduction of burden on the Agency and manufacturers of 
minimum risk pesticides.
     Facilitate the development of more low-risk methods of 
pest control.
     No significant environmental use of these substances as 
pesticides.
     Uncomplicated enforcement.
    Though some of these expectations were met, the lack of clarity 
regarding ingredients has produced significant enforcement 
difficulties. For example, the way active ingredients are currently 
listed in the exemption is vague, and inspectors are confronted with 
the need to determine whether certain product ingredients as they are 
listed on product labels, such as cedar leaf oil or cedar wood oil, are 
exempt under the more

[[Page 76982]]

general terminology used in 40 CFR 152.25(f), which lists only ``cedar 
oil.'' EPA has attempted to provide clarity by updating its Web site 
explaining minimum risk pesticide products; however, feedback from 
stakeholders indicated this was not sufficient to address the problems 
described in the next unit.

C. Reactions From and Challenges for States

    1. State registration practices. Though minimum risk pesticide 
products are exempt from Federal regulation, most states regulate these 
products in some manner. In 2010, approximately 37 states and the 
District of Columbia required products that are exempt from Federal 
regulation under 40 CFR 152.25(f) to have a state-registration. In some 
ways, this is similar to many states' registration processes for 
federally registered pesticides, which also must be approved in each 
state in which they are sold or used.
    However, a state's registration of a federally registered pesticide 
usually relies heavily on the previous Federal review of the product's 
toxicity, use patterns, and label. In contrast, given that minimum risk 
pesticides are largely exempt from Federal regulation under FIFRA, the 
numerous states that do regulate these products review and examine the 
products using criteria that vary from state to state. In some states, 
manufacturers of minimum risk pesticide products are only required to 
pay a registration fee; in others, there is a label review, which can 
include a review of the ingredients used in the product; and a few 
require Material Safety Data Sheets and data on product efficacy.
    Though some states have more detailed registration processes for 
minimum risk pesticide products, and some states do not register these 
products at all, the exemption created significant enforcement concerns 
for all states since it created a category of legal but federally 
unregistered products. Instead of being able to rely on a Federal 
determination of whether a pesticide product was complying with 
relevant regulations, each state's enforcement authority had to make 
those decisions. To do this, each state had to become familiar with all 
active and inert ingredients permitted under the Federal exemption in 
order to determine whether a pesticide product lacking an EPA 
registration number was lawfully exempt from Federal regulation.
    Inspectors have found it difficult to determine whether seemingly 
exempt products were complying with the exemption. One of the most 
common minimum risk pesticide product issues encountered by inspectors 
and enforcement case developers are products that claim the 40 CFR 
152.25(f) exemption, but contain active or inert ingredients whose 
status as an ingredient that may be used in minimum risk pesticide 
products is not readily apparent from the name of the ingredient as 
listed on the label. Since ingredients may be listed on the label with 
one of numerous chemical, common, or Latin names, determining whether 
an ingredient on a pesticide product label is the same substance 
referred to by the active or inert ingredient lists is a time consuming 
task.
    The lack of clarity in which ingredients are permitted in minimum 
risk pesticide products makes it difficult for companies to determine 
whether a specific formulation is within the exemption. The lack of 
consistency in how those ingredients are displayed on the product 
labels by the various manufacturers has led to inefficiencies in 
enforcement of the exemption. As discussed in Unit IV., by creating a 
situation in which enforcement officials cannot swiftly examine an 
unregistered pesticide product label and then determine if the 
ingredients listed on the label are eligible for use in minimum risk 
pesticide products creates slowdowns in developing enforcement cases.
    2. Early negative response. States' frustration with the exemption 
developed quickly. In 1998, less than 2 years after the exemption took 
effect, the Association of American Pesticide Control Officials (AAPCO) 
surveyed its members regarding 40 CFR 152.25(f) (Ref. 8). Overall, 
respondents indicated that the 1996 exemption has had a negative effect 
on their agencies or their states, and that ingredient or labeling 
issues are a major concern. Responses to selected questions from the 
survey are shown in Table 1.

                        Table 1--Responses to Selected Questions in the 1998 AAPCO Survey
----------------------------------------------------------------------------------------------------------------
                                                                                                    Percent of
                                                                  Percent of all                  states at that
                                                                     states +      No. of states       time
                    Response                       Total Number   territories in      exempt        registering
                                                     of states      AAPCO  (53)     products in       exempt
                                                                     (percent)         1998        products (36)
                                                                                                     (percent)
----------------------------------------------------------------------------------------------------------------
Have problems with companies submitting labels                11              21               9              25
 for 25(b) products that contain active
 ingredients not on the list....................
Have a system for determining changes in List 4A               7              13               5              14
 (inert ingredients)............................
Have seen exempt products that fail to list                   21              40              18              50
 inert ingredients on the label as required.....
----------------------------------------------------------------------------------------------------------------

    3. Continuing enforcement challenges. States' experience with 40 
CFR 152.25(f) indicate that the exemption from regulation is not 
working as intended and, instead, has resulted in numerous 
inefficiencies. Under the exemption as it is currently written, 
inspectors have difficulty determining on-site whether a product is 
legally exempt from regulation or if it is an illegal product. If the 
pesticide's exemption status is not clear, the inspector collects 
evidence documenting sale/distribution (photos, sales records, etc.) 
and follows-up with EPA. This creates a noticeable resource burden for 
the states and EPA.
    In 2006, in response to a petition from the Consumer Specialty 
Products Association, several states submitted comments that described 
their difficulties enforcing the terms of the exemption for minimum 
risk pesticide products. For example, the comment from Colorado stated:

    In Colorado this results in numerous cases of enforcement 
actions requiring Colorado retailers to remove unregistered products 
from their shelves. We issue about 90 Cease and Desist Orders per 
year to retailers selling unregistered pesticides that claim to be 
25(b) exempt. (Ref. 9)
    A similar comment was received from California:
    Although well intended, rather than relieving the States of ever 
increasing regulatory workload, the proliferation of minimum risk 
pesticides now available in

[[Page 76983]]

the marketplace has resulted in the opposite effect. In California, 
recent data indicates that approximately 20% of the routine 
marketplace inspections include some type of additional follow up 
having to be performed to determine compliance status for 25(b) 
minimum risk pesticides. (Ref. 10)

    Many of these burdens and inefficiencies resulted from confusion 
created by ambiguities in the list of ingredients permitted for use in 
pesticide products exempt from Federal regulation. Several lists must 
be consulted to determine if a product's ingredients are permitted, 
and, often, ingredients on product labels may--legitimately--use 
chemical names different from those that appear on the ingredient 
lists. Chemicals often have multiple names. However, inspectors and 
consumers may be unfamiliar with alternative chemical names, resulting 
in confusion over whether the product complies with the exemption. For 
example, as Colorado stated in its comment on the 2006 petition:

    There is also continuing confusion among applicants, extension 
educators, state regulators and even regional EPA staff on which 
ingredients are or are not allowed, and what statements can or 
cannot be on labels for 25(B) products. Even after 10 years, we 
frequently see applications for products with ingredients that are 
not allowed. (Ref. 9).

    As currently written, it is difficult and time-consuming for state 
regulators and producers to determine which ingredients are allowed in 
products claiming the exemption. As a result, marketplace inspections 
are hobbled, and discovery of non-compliant products is delayed. As 
California stated in its comment on the 2006 petition:

    The increased workload generated by unregulated 25(b) pesticides 
impacts other vital regulatory duties, such as worker protection 
inspections, and product registration (Ref. 10).

    This encourages a proliferation of illegal products, or products 
that do not meet the Federal exemption criteria for ingredients, 
labeling, or other conditions.
    The burden on the states is clear: Identifying which minimum risk 
pesticide products are compliant with the exemption requires 
significant state resources for inspection, yet when products are found 
to be violating the Federal exemption, states in many cases cannot 
precisely identify the problem or take action without significant 
guidance and assistance from EPA, which must interpret the ingredient 
lists and other criteria in the exemption to determine whether a 
product is compliant.

III. Need for This Rulemaking

    More than a decade of experience with 40 CFR 152.25(f) on the 
Federal and state levels has indicated that there is confusion over 
permitted ingredients. This lack of clarity has created a significant 
burden for enforcement of the exemption. Confusion over permitted 
ingredients may also result in public hazards due to the proliferation 
of unregistered pesticide products that do not comply with the 
ingredient restrictions in the exemption. As part of a survey of 
compliance with the exemption, EPA conducted an analysis of labels of 
products sold as minimum risk personal insect repellents (also referred 
to as skin-applied repellents), relying in part on information provided 
by the Nielsen Company. Personal insect repellent products are 
estimated to make up approximately 14% of products registered by states 
that make their registration databases publicly available. EPA found 
that nearly half (47%) of the minimum risk personal insect repellent 
products contained ingredients not permitted under 152.25(f) (Ref. 11). 
This finding is based on:
     Identification of 135 personal insect repellent products 
claiming to be exempt, or that were not registered with EPA. These 
products were identified through state registration lists, nationwide 
sales data compiled by the Nielsen Company, and Internet searches.
     Examination of publicly available labels of these personal 
insect repellent products. Labels were not available for 26 products 
(or 19% of all identified).
     Comparison of any stated ingredients with those on the 
active and inert ingredient lists specified in or referenced by the 
exemption. Forty-five products, or 33% of all identified, seemed to 
list only permitted ingredients; 64 products, or 47%, listed 
ingredients not permitted under the exemption.
    The data are likely an underestimate of the non-compliance rate 
with the ingredient criteria of the exemption. These underestimations 
result from a lack of information available on these products, and the 
sources used to identify these products are not comprehensive of the 
entire universe of minimum risk personal insect repellents, which are 
not registered in all states and which may not be sold in the major 
retailers tracked by the Nielsen Company nor sold online. Furthermore, 
the compliance rate for skin-applied insect repellents may not be 
representative of all minimum risk pesticide products. EPA has not 
examined the other products with respect to compliance, since labels 
from other minimum risk pesticide products representative of the 
national marketplace could not be located.
    Lack of compliance with the requirements of the exemption may 
result from producers' uncertainty about which ingredients are 
permitted, or inspectors' inability to develop enforcement cases to 
remove non-compliant products from the marketplace in a timely manner. 
Currently, it may not be clear to companies which specific ingredients 
are permitted for minimum risk pesticides exempt from regulation, since 
the terminology describing the ingredients is difficult to understand. 
Additionally, product labels often use unfamiliar terms for permitted 
ingredients, which creates confusion for state and Federal inspectors 
who are not familiar with all possible names for these chemicals. For 
example, some products use Latin names for some ingredients, such as a 
product that listed some of its inert ingredients as Glycine Soja Oil, 
Cymbopogon Nardus Oil, and Pimenta Acris Leaf Oil, which most 
inspectors and members of the public would not recognize as soybean 
oil, citronella oil, and bay leaf oil, respectively. Inspectors have 
reported the difficulty of determining the legality of some minimum 
risk pesticide products during field inspections.
    The actions proposed today will provide greater specificity and 
clarity concerning the inert and active ingredients that can be used in 
exempted products, and specify the exact chemical terms that must be 
displayed on product labels. This will aid in resolving many of the 
issues surrounding non-compliance, as well as providing clearer 
information to consumers of these products without adversely affecting 
the availability of minimum risk pesticide products. Providing accurate 
and clear information to the public will assist users in making good 
choices regarding their use of pesticides. EPA believes that these 
beneficial label changes cannot be achieved through non-regulatory 
means.

IV. What EPA Considered

    EPA considered the following options for addressing the issues 
described previously related to the minimum risk exemption:
    Item 1: Revising the exemption to redesign the format of the active 
ingredient list.
    Item 2: Revising the exemption to codify the inert ingredient list 
into the CFR.

[[Page 76984]]

    Item 3: Revising the exemption to require the use of a common 
chemical name on the label.
    Item 4: Revising the exemption to require a label statement that 
signals exempt status.
    Item 5: Publishing guidance on how an exempt label should look.
    Items 1 and 2 would provide clarity regarding the ingredients and, 
to some extent, promote states' abilities to enforce the exemption 
while continuing the availability of minimum risk pesticide products.
    Item 3 would not only significantly increase the clarity of the 
ingredients in a product claiming to be a minimum risk pesticide, but 
also augment visibility of that product's compliance with the 
exemption. Though companies would need to modify product labels to 
comply with the changes, the costs expended would be minimal and this 
would not impede the continued availability of minimum risk pesticides.
    When considering Item 4, EPA believes that Item 4 is unlikely to 
provide any significant benefit to consumers from having a statement, a 
disclaimer, which signals exempt status on the product label. EPA's 
analysis of information from open literature and survey results 
indicates that in general most people do not read, understand, or 
believe a disclaimer. This means that a label disclaimer is unlikely to 
change consumer behavior or influence a purchasing decision. For a 
label statement to be effective, the purchaser must first read the 
label and notice the disclaimer, and then read the disclaimer, 
understand the disclaimer, believe the disclaimer, and choose to act on 
the disclaimer (Ref. 12). Potentially, there could be a slight benefit 
from such a statement for enforcement, as state inspectors could use 
this statement as part of their determination of a product's status 
under the exemption. However, as other pieces of label information may 
provide more useful information to consumers and enforcement, EPA chose 
to focus on making those modifications to the exemption.
    Item 5 would assist manufacturers with complying with the minimum 
risk exemption. EPA plans to update its Web site on minimum risk 
pesticides (Ref. 13) to provide this guidance, including label formats, 
directions for use, and ways to display ingredient lists. Any 
clarifications communicated through this kind of guidance, however, 
would not be considered requirements for compliance with the exemption, 
and would not aid in efficient enforcement of the exemption. For this 
reason, merely providing guidance to manufacturers is not sufficient to 
address the exemption's issues related to enforcement difficulties and 
current lack of clarity. EPA intends to provide guidance by updating 
the sections of its Web site explaining the minimum risk exemption, but 
this would be independent of rulemaking.
    Additional issues regarding the minimum risk exemption have been 
raised by states, with states expressing interest in:
    Item 6: Revising the exemption to require directions for use on 
minimum risk pesticide products.
    Item 7: Revising the exemption to require company name and contact 
information.
    Item 6 would provide consumers with directions for safe use of the 
product. Though many products already include directions on how to 
apply the product, some do not, and even for minimum risk pesticides 
there is a theoretical potential for injury or environmental hazard 
from improper use of the products. However, assessing the risk of 
certain uses of minimum risk pesticides already determined to be 
minimum risk is outside the scope of this rulemaking, which only 
proposes to clarify the terms of the original exemption. Additionally, 
EPA was not able to create a requirement for directions for use that 
would be both broad enough to apply to all potential categories of 
products, yet specific enough to be enforced fairly and effectively. 
For these reasons, EPA chose to focus on other aspects of minimum risk 
pesticide product labeling and on the ingredient lists. EPA will 
continue to seek ways to provide guidance on improving directions for 
use on minimum risk pesticide products.
    Item 7 would provide a significant benefit to consumers, who may be 
unable to determine which company manufactured or distributed a minimum 
risk pesticide product. Although the labels of many products already 
provide this information, it does not appear on all minimum risk 
pesticide products. These changes would provide useful information 
without burdening manufacturers beyond the cost of changing their 
labels. Unlike directions for use, the requirements for company name 
and contact information (such as address and phone number) can be 
specified clearly in the proposed amendments to the exemption. Though 
this does not deal with ingredient clarity, EPA feels that in the 
interest of efficiency it is appropriate to propose this change at the 
same time, since it would provide a strong benefit to consumers with 
little added cost.
    EPA determined that a combination of revisions and guidance would 
provide the best approach to the issues discussed previously. This 
combination is:
    Item 1: Redesign the format of the active ingredient list.
    Item 2: Codify the list of permitted inert ingredients.
    Item 3: Require that common chemical names be used to describe 
active and inert ingredients on product labels.
    Item 5: Provide guidance on how an exempt label should look.
    Item 6: Require company name and address on product labels.
    Items 1, 2, 3, and 6 are proposed in this rulemaking and are 
discussed in greater detail in Unit VII. Item 5 includes Web site 
changes that are in addition to the rulemaking proposed here, and is 
also outlined later in this document.
    By clarifying the way ingredients are defined in the exemption and 
the way they should be displayed on product labels, EPA will be able to 
protect public health while relieving product manufacturers of the 
burdens associated with regulation. Similarly, requiring contact 
information on product labels would provide important consumer 
information and greater producer accountability with minimal cost.

V. Proposal To Modify the Minimum Risk Exemption To Improve Clarity

A. Clarify the List of Active Ingredients

    EPA proposes to replace the text in 40 CFR 152.25(f) specifying the 
active ingredients and their variations with a table that would show, 
for each permitted active ingredient:
     Label Display Name. This is the common chemical name that 
would be required to be used on labels of products that contain these 
ingredients.
     Chemical Name, as determined by Chemical Abstract Services 
(CAS).
     Specifications. Though this column would generally be 
empty, some substances listed in the exemption had specifications 
associated with them in the text of the exemption as published in 1996.
     CAS Registry Number (CAS No.). The Agency listed the CAS 
No. for each of the chemical substances listed in 40 CFR 152.25(f) 
where a CAS No., was available. A CAS No. is a unique numerical 
identifier that provides one of the most distinct, readily available, 
and universally accepted means of identifying chemical substances. 
Identifying chemicals permitted in minimum risk pesticides by CAS No. 
would assure manufacturers that they

[[Page 76985]]

are purchasing and using the chemicals that can be used in minimum risk 
pesticide products. Only substances identified by the CAS No. listed 
would be permitted for use as active ingredients in minimum risk 
pesticide products. EPA is only providing additional clarity concerning 
the ingredients that are currently used in exempted products: No 
ingredients are being added or removed from the list.
    An example of this table is provided here, as Table 2.

                              Table 2--Example of New Format for Active Ingredients
----------------------------------------------------------------------------------------------------------------
           Label display name                   Chemical name              Specifications            CAS No.
----------------------------------------------------------------------------------------------------------------
Citric Acid............................  2-Hydroxypropane-1,2,3-     USP......................           77-92-9
                                          tricarboxylic acid.
Citronella Oil.........................  Citronella Oil............  .........................         8000-29-1
----------------------------------------------------------------------------------------------------------------

    In this document, EPA is not proposing to remove or add any active 
ingredients to the list. The current list is being clarified by using 
more precise chemical identifiers and nomenclature. For approximately 
20 of the active ingredients in the proposed table, EPA is proposing to 
include the specification of USP (United States Pharmacopeia) standard 
in the Specifications column. USP standards are set for quality, 
purity, and identity, and usually provide information on chemical 
formula, chemical weight, CAS numbers, function, definition, packaging, 
storage, and labeling requirements. Information on the USP standards is 
included in the docket for this proposal.
    State and Federal inspectors and interested members of the public 
would be able to easily match the name of the active ingredient on the 
label to the column in the table in 40 CFR 152.25(f)(1) that contains 
label display names. Linking the CAS No., the label display name, and 
the chemical name maintains the chemical identity specificity needed 
for enforcement, would provide the public and inspectors with 
understandable information, and would provide guidance for product 
manufacturers who may be unsure of the specific ingredients that their 
products can and cannot contain in order to comply with the minimum 
risk exemption.

B. Codify the Existing List of Inert Ingredients

    As previously discussed, in Unit III.A.2., the minimum risk 
exemption in 40 CFR 152.25(f)(2) references a list of chemicals 
permitted to be used as inert ingredients that has been updated and 
currently is maintained on EPA's public Web site. To clarify which 
inert ingredients may be used in these products, EPA proposes to codify 
in the CFR a reference to sections detailing which chemicals may be 
used in addition to a reformatted version of the table that currently 
appears online.
    The proposed changes to the section of the exemption dealing with 
inert ingredients would include references to 40 CFR 180.950(a), (b), 
and (c), which describe chemical substances exempt from the 
requirements of a tolerance and that may also be used as inert 
ingredients in minimum risk pesticides. The regulatory reference will 
provide the clarity needed for understanding which commonly consumed 
food commodities, animal feed items, and edible fats and oils can be 
used in exempted products. Additionally, EPA proposes to add a table 
that would contain the chemicals currently listed in 40 CFR 180.950(e) 
as well as those that appeared originally on List 4A. A version of this 
table currently appears online. Any duplicate listings would be 
removed.
    EPA believes that adding these references and reformatting the 
table and placing it into the CFR will provide needed clarity, in as 
much as State inspectors, members of the public, or manufacturers of 
minimum risk pesticide products would be able to more quickly determine 
whether a given ingredient is a permitted inert ingredient for minimum 
risk pesticide products.
    The columns of the table that would be codified would be:
     Label Display Name.
     Chemical Name, as determined by CAS.
     CAS No. (described previously).
    An example of this table is listed, as Table 3.

     Table 3--Example of New Format for Permitted Inert Ingredients
------------------------------------------------------------------------
        Label display name            Chemical name          CAS No.
------------------------------------------------------------------------
Aluminum potassium sodium          Silicic acid,              12736-96-8
 silicate.                          aluminum potassium
                                    sodium salt.
Aluminum silicate................  Silicic acid,               1335-30-4
                                    aluminum salt.
Aluminum sodium silicate.........  Silicic acid,               1344-00-9
                                    aluminum sodium
                                    salt.
------------------------------------------------------------------------

    Unlike the proposed table listing the active ingredients, the 
proposed table for the inert ingredients does not include a column 
outlining specifications, since none were outlined in the exemption. 
However, some of the substances have no tolerances or tolerance 
exemptions under FFDCA section 408 and thus have not been permitted for 
use in pesticides that may come in contact with foods, which are also 
known as food-use pesticides. For this reason, EPA is proposing that in 
addition to the proposed table listing inert ingredients, the text of 
the exemption be amended to indicate the address of an EPA Web site at 
which information can be found on which chemicals listed could be used 
in food-use pesticide products.
    The FFDCA requires all active and inert ingredients that come into 
contact with food have an applicable tolerance or exemption from the 
tolerance requirement. EPA currently indicates on the minimum risk 
inert ingredient table that appears online (at http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf) those chemicals that are exempt 
from the requirement of a tolerance, and thus could be used in 
pesticides that come in contact with food. EPA proposes to maintain as 
guidance the online list that includes a column indicating which 
chemicals may be allowed as active or inert ingredients in pesticides 
that come in contact with food; there would also be a note indicating 
where the exemptions from the requirements of a tolerance are detailed 
in the CFR. This table could thus continue to serve as a quick guide

[[Page 76986]]

to manufacturers, enforcement officials, and members of the public.
    There are benefits to having all information about the minimum risk 
exemption consolidated in one location, and the CFR is a useful 
reference for many people interested in the exemption. Therefore, EPA 
proposes to add a reference to the address of the Web site that would 
contain the reformatted active and inert ingredient tables that include 
a ``food use'' and ``non-food use'' column. EPA would make clear that 
the information on the Web site is advisory and serves as guidance, and 
that the specific regulations should be consulted when seeking to learn 
about a chemical's exemption from the requirements of a tolerance. 
However, EPA believes that highlighting in the CFR where this guidance 
is available online would be helpful in explaining some of the more 
complicated aspects of the minimum risk exemption.

C. Require That Ingredient Lists Use a Label Display Name

    Currently, the chemical names on exempted labels are derived from a 
variety of sources, which include CAS nomenclature, informal or lay 
terminology, and Latin plant name derivatives. This causes confusion 
for inspectors and the public, who may not be aware of the multiple 
names a single chemical may have. All stakeholders would benefit from 
the use of a common chemical name for ingredients listed on the product 
label. EPA proposes to revise 40 CFR 152.25(f)(3) to include the 
requirement that labels of exempt products use the ``label display 
name'' in the ingredient listing, when a label display name is 
specified in the exemption.

D. Require Company Name and Contact Information

    An additional revision to the exemption would require that 
producers of minimum risk pesticide products include their company's 
name and contact information (address and telephone number) on the 
product label. In separate guidance, to be posted on EPA's Web site on 
minimum risk pesticides, companies would be encouraged to also provide 
a phone number, mailing address, Web site, or email address on their 
minimum risk pesticide product labels.
    Requiring a company name and contact information would provide 
valuable information to consumers with minimal cost. It would also 
provide state and Federal inspectors with important information that 
currently can be difficult to find. To provide additional clarity, if a 
company name appears on the label and that company is not the producer, 
EPA proposes that the text indicate that the product was ``packed for'' 
``distributed by'' or ``sold by'' to show that the company selling the 
product is not the producer.

E. Estimated Costs Associated With These Proposed Changes

    The potential costs incurred by manufacturers of minimum risk 
pesticide products to comply with these proposed changes are estimated 
to be minimal. The analysis summarized in this unit estimates the cost 
of label changes required by the proposed rule, as separate and 
distinct from (i.e., incremental to) routine label changes that 
producers already undertake. For greater detail, including the 
assumptions used for the cost analysis, see the ``Cost and Small 
Business Analysis of Proposed Revisions to Minimum Risk Exemption'' 
(Ref. 14).
    For Items 1 and 2 (Revising the exemption to redesign the format of 
the active ingredient list and revising the exemption to codify the 
inert ingredient list into the CFR), there are no costs to producers of 
exempt products. Since no ingredients are being added or removed from 
the list, manufacturers of currently exempted products should not need 
to change their product formulations.
    For Items 3 and 7 (Revising the exemption to require the use of a 
common chemical name, and company name and contact information on the 
label), the cost is the cost of changing the label. To comply with the 
proposed changes for labeling requirements for minimum risk pesticide 
products, EPA expects that all products may need to be re-labeled in 
order to list ingredients by common chemical name. Some companies may 
also need to add their company name and contact information to product 
labels. The estimated costs associated with changing a label are 
summarized here.
    Currently, EPA is aware of 216 companies producing 757 minimum risk 
pesticide products. EPA derived this information from publicly 
available lists of state registrations for minimum risk pesticides 
(Ref. 15), and AC Nielsen retail store scanner data (Ref. 16). As 
explained in the cost analysis, 192 parent companies were identified. 
Together, the 192 parent companies account for 541 minimum risk 
pesticide products, or about 79% percent of those identified by EPA.
    Table 4 shows the distribution of firms by NAICS code. Most firms 
in the minimum risk pesticide industry belong to Chemical Manufacturing 
(NAICS code 325) and Merchant Wholesalers, Nondurable Goods (NAICS code 
424). Forty-two firms are divided among 31 NAICS codes.

              Table 4--Producers of Minimum Risk Pesticides
------------------------------------------------------------------------
                                                       Number of  parent
    3-Digit NAICS code        NAICS code description         firms
------------------------------------------------------------------------
325.......................  Chemical Manufacturing...                 72
339.......................  Miscellaneous                              8
                             Manufacturing.
423.......................  Merchant Wholesalers,                     11
                             Durable Goods.
424.......................  Merchant Wholesalers,                     32
                             Nondurable Goods.
444.......................  Building Material and                      7
                             Garden Equipment and
                             Supplies Dealers.
541.......................  Professional, Scientific,                  7
                             and Technical Services.
561.......................  Administrative and                        13
                             Support Services.
Others....................  .........................                 42
                           ---------------------------------------------
    Total with              .........................                192
     classification.
------------------------------------------------------------------------

    The estimated cost of the proposed rule consists of a one-time 
change in the design of the label to comply with the proposed 
requirements. The estimated incremental cost of the proposed rule 
depends on the extent to which the

[[Page 76987]]

change is separate and distinct from the routine label changes firms 
undertake on a regular basis. Firms routinely change their labels to 
update or ``refresh'' their product labels. This is an important factor 
that determines the magnitude of the cost of the rule since the 
expected cost of the label change will depend on the duration of the 
implementation period. A longer implementation period means that the 
new requirements could be incorporated into a routine or planned re-
label.
    Many products have more than one size or type of package. Each is 
referred to as a stock keeping unit (SKU). Each SKU would have to be 
relabeled to comply with the new requirements. Using an estimate of 
1.53 SKUs per product, there are 1,158 products to be relabeled.
    In its analysis, EPA has assumed that firms will routinely re-label 
every 3 years, although some firms may re-label more or less 
frequently. EPA also assumed that if the changes occurred during a 
routine label update, then one-third of the label's artwork cost would 
be due to the new requirements. If the firm's routine relabeling cycle 
falls outside the rule compliance period (that is, if the rule 
requirements cannot be incorporated into the firm's routine labeling 
change), then the full cost of label change is due to the change in 
regulations.
    The estimated costs of the rule under different rule compliance 
periods are shown in Table 5.

     Table 5--Relabeling Cost per SKU (Stock Keeping Unit) for Three
                         Implementation Periods
------------------------------------------------------------------------
                                                           Average  cost
                  Implementation period                      estimate
------------------------------------------------------------------------
Immediate relabeling....................................          $6,306
2-year implementation...................................           2,550
3-year implementation...................................             672
------------------------------------------------------------------------

    Using the average cost estimates from Table 5, EPA estimates the 
total potential industry cost in Table 6.

                          Table 6--Industry Cost for Three Rule Implementation Periods
----------------------------------------------------------------------------------------------------------------
                         Industry costs                              Immediate        2 Years         3 Years
----------------------------------------------------------------------------------------------------------------
Total number of SKUs............................................           1,158           1,158           1,158
Average cost per SKU label change (from Table 5)................          $6,306          $2,550            $672
                                                                 -----------------------------------------------
    Total cost to industry......................................      $7,300,282      $2,952,097        $778,005
----------------------------------------------------------------------------------------------------------------

    Under an implementation period of 2 years, the estimated industry 
cost is about $3 million.

VI. Request for Comments

    The Agency invites the public to provide its views and suggestions 
for changes on all the various proposals in this document. Specifically 
included within the Agency's request for comments are the following:
     The format of the ingredient lists (active and inert 
ingredients).
     The information in the new format of the ingredient lists 
(active and inert ingredients).
     The proposed reference to a Web site that contains a table 
formatted to include more information on exemptions from the 
requirement of a tolerance (which would indicate whether or not a 
substance can be in a pesticide used on or near food). Would this Web 
site provide the clarity some stakeholders seek?
     EPA's methodology for estimating the costs associated with 
the proposed label changes.
     The proposed timeframe (2 years from the effective date of 
the final rule) for complying with label changes.
     How will these changes impact state and local agencies?
     What are effective methods and venues for communicating 
these proposed changes to affected entities, and receiving their 
feedback?
     Because EPA's analysis was conducted with a subset of 
products, EPA was unable to determine if most minimum risk pesticide 
products for sale today comply with the requirements of the exemption, 
and it is unclear how specifying active and inert ingredients would 
affect the composition of products on the market. EPA expects that the 
only costs to industry will be re-labeling; however, the Agency is 
especially interested in learning of any products that would need to be 
reformulated as a result of these proposed changes.
    Commenters are encouraged to present any data or information that 
should be considered by EPA during the development of the final rule. 
Please describe any assumptions and provide any technical information 
used in preparing your comments. You should explain estimates in 
sufficient detail to allow for them to be reproduced for validation. 
EPA's underlying principle in developing the proposed revisions has 
been to strike an appropriate balance among:
     Clarifying the ingredients permitted for use in minimum 
risk pesticide products.
     Having revised labels with better information on the 
labels quickly.
     Minimizing the impacts on the affected industry.

VII. Reference List

    The following is a listing of the documents that are specifically 
referenced in this proposed rule. The docket for this rulemaking, 
identified by docket ID number EPA-HQ-OPP-2010-0305, includes these 
documents and other information considered by EPA in developing this 
proposed rule. In some cases this may include 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 documents, please consult the person listed 
under FOR FURTHER INFORMATION CONTACT.
    1. U.S. Environmental Protection Agency (EPA). Pesticides; 
Exemption of Certain Substances from Federal Insecticide, Fungicide, 
and Rodenticide Act Requirements; Proposed Rule. Federal Register (59 
FR 47289, September 15, 1994) (FRL-4872-4). https://federalregister.gov/a/94-22855.
    2. EPA. Pesticides; Tolerance Exemptions for Minimal Risk Active 
and Inert Ingredients; Proposed Rule. Federal Register (67 FR 1925, 
January 15, 2002) (FRL-6807-8). https://federalregister.gov/a/02-699.
    3. EPA. Inert Ingredients in Pesticide Products; List of Minimal 
Risk Inerts; Notice. Federal Register (September 28, 1994; FRL-4872-5). 
http://www.gpo.gov/fdsys/pkg/FR-1994-06-23/html/94-15013.htm.
    4. EPA. Pesticides; Tolerance Exemptions for Minimal Risk Active 
and Inert Ingredients; Final Rule. Federal Register (67 FR 36534, May 
24, 2002) (FRL-6834-8); http://federalregister.gov/a/02-12973.
    5. EPA. Office of Pesticide Programs (OPP). List 4A--Minimal Risk 
Inert Ingredients--By CAS Number. (August

[[Page 76988]]

2004). http://www.epa.gov/opprd001/inerts/inerts_list4Acas.pdf.
    6. EPA. Pesticides: Minimal Risk Tolerance Exemptions; Proposed 
Rule. Federal Register (71 FR 4087, January 25, 2006) (FR-7754-8). 
http://federalregister.gov/a/06-574.
    7. EPA. OPP. Inert Ingredients Eligible for FIFRA 25(b) Pesticide 
Products. (December 20, 2010). http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf.
    8. AAPCO. 25(b) Exempt Pesticides Survey. (1998). Accessible at: 
http://aapco.ceris.purdue.edu/doc/surveys/25b_1srvy.html. Survey 
results accessible at: http://aapco.ceris.purdue.edu/doc/surveys/25b_1.html.
    9. Comment attachment by L. Quakenbush, Colorado Department of 
Agriculture. Docket ID No.: EPA-HQ-OPP-2006-0687. Document ID No.: EPA-
HQ-OPP-2006 0687-0026.
    10. Comment submitted by G. Farnsworth, Department of Pesticides 
Regulation (DPR). Docket ID No.: EPA-HQ-OPP-2006-0687. Document ID No.: 
EPA-HQ-OPP- 2006-0687-0064.
    11. EPA. OPP. EPA Analysis of Labeled Ingredients on Minimum Risk 
Insect Repellent Products. (2009). Docket ID No.: EPA-HQ-OPP-2010-0305. 
Document ID No.: EPA-HQ-OPP-2010-0305-0010.
    12. EPA. OPP. Review of Literature on Consumer Use of Label 
Statements and Findings Relevant to Planned Action on Minimum Risk 
Insect Repellents. (2009). Docket ID No.: EPA-HQ-OPP-2010-0305. 
Document ID No.: EPA-HQ-OPP-2010- 0305-0011.
    13. EPA. OPP. Minimum Risk Pesticides. http://www.epa.gov/oppbppd1/biopesticides/regtools/25b_list.htm.
    14. EPA. OPP. Cost and Small Business Analysis of Proposed 
Revisions to Minimum Risk Exemption. (2012). Docket ID No.: EPA-HQ-OPP-
2010-0305. Document ID No.: EPA-HQ-OPP-2010-0305-0012.
    15. EPA. OPP. Minimum Risk Products Registered with States with 
Publicly Searchable Databases (AL, AK, AZ, CO, IA, LA, MS, NH, NC, OK, 
RI, SC, SD, and WA). (2010). Docket ID No.: EPA-HQ-OPP-2010-0305. 
Document ID No.: EPA-HQ-OPP-2010-0305-0013.
    16. EPA. OPP. Products Located Through EPA Query of Nielson Company 
Scanner Data + Walmart Customer Panel Surveys. (2008). Docket ID No.: 
EPA-HQ-OPP-2010-0305. Document ID No.: EPA-HQ-OPP-2010-0305-0014.
    17. EPA. OPP. Supporting Statement for an Information Collection 
Request (ICR): Labeling Change for Certain Minimum Risk Pesticides 
under FIFRA Section 25(b). (2012). Docket ID No.: EPA-HQ-OPP-2010-0305. 
Document ID No.: EPA-HQ-OPP-2010-0305-0015.
    18. Small Entity Representative (SER) comments from 2009 SBREFA 
Panel, for minimum risk insect repellents proposed rule. Docket ID No.: 
EPA-HQ-OPP-2010-0305. Document ID No.: EPA-HQ-OPP-2010-0305-0016.

VIII. FIFRA Review Requirements

    Under FIFRA section 25(a), EPA submitted a draft of the proposed 
rule to the Secretary of the Department of Agriculture (USDA) and the 
appropriate Congressional Committees. Additionally, under FIFRA section 
21(b), EPA submitted a draft of the proposed rule to the Secretary of 
the Department of Health and Human Services (HHS). No comments were 
received regarding this proposed rule. USDA waived its review of the 
draft proposed rule on December 19, 2011, and HHS waived its review of 
the draft proposed rule on February 2, 2012. Both USDA and HHS have 
retained the right to review a draft of the final rule.
    Under FIFRA section 25(d), EPA submitted a draft of the proposed 
rule to the Scientific Advisory Panel (SAP). The SAP waived its 
scientific review of the proposed rule on January 4, 2012, because the 
proposed rule does not contain scientific issues that warrant review by 
the Panel.

IX. 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'') under the 
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and was 
not therefore submitted to the Office of Management and Budget (OMB) 
for review under Executive Orders 12866 and 13563 (76 FR 3821, January 
21, 2011).

B. Paperwork Reduction Act (PRA)

    The information collection requirements in this proposed rule have 
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et 
seq. The Information Collection Request (ICR) document prepared by EPA 
has been assigned EPA ICR No. 2475.01; and OMB Control No. 2070-tbd, 
entitled ``Labeling Change for Certain Minimum Risk Pesticides under 
FIFRA Section 25(b)''.
    The information collection requirements in this proposed rule 
consist of proposed changes to existing requirements that would involve 
the relabeling of products currently exempt under 40 CFR 152.25(f) in 
order to list chemical names in the format EPA proposes to require. The 
proposed change would be a one-time burden increase for existing 
products. The estimated annual respondent burden for this rule-related 
collection is estimated to be 5.5 hours per response, for a total one-
time burden of 6,369 hours. Burden is defined at 5 CFR 1320.3(b).
    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's 
regulations in 40 CFR are listed in 40 CFR part 9.
    To comment on the Agency's need for this information, the accuracy 
of the provided burden estimates, and any suggested methods for 
minimizing respondent burden, EPA asks that you use the public docket 
established for this rule, i.e., Docket ID No. EPA-HQ-OPP-2010-0305. 
Submit any comments related to the ICR to EPA and OMB. For EPA, follow 
the instructions in the ADDRESSES section at the beginning of this 
document. For OMB, send comments to the following address: Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
725 17th Street NW., Washington, DC 20503, Attention: Desk Office for 
EPA. Since OMB is required to make a decision concerning the ICR 
between 30 and 60 days after December 31, 2012, a comment to OMB is 
best assured of having its full effect if OMB receives it by January 
30, 2013. EPA will consider comments on the ICR as it develops the 
final rule, and will respond in the final rule to any OMB or public 
comments on the information collection requirements contained in this 
proposal.

C. Regulatory Flexibility Act (RFA)

    The RFA, 5 U.S.C. 601 et seq., generally requires an agency to 
prepare a regulatory flexibility analysis of any rule subject to notice 
and comment rulemaking requirements under the Administrative Procedure 
Act, 5 U.S.C. 551-553, or any other statute unless the agency certifies 
that the rule will not have a significant economic impact on a 
substantial number of small entities. Small entities include small 
businesses, small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this proposed rule on 
small entities, small entity is defined as:
    1. A small business as defined by the Small Business 
Administration's (SBA)

[[Page 76989]]

regulations at 13 CFR 121.201. As indicated in the Cost Analysis 
prepared for this proposed rule (Ref. 14), which is summarized in Unit 
V.E., most firms in the minimum risk pesticide industry are identified 
under NAICS code 325. A small business that manufactures pesticides and 
other agricultural chemicals as defined by NAICS code 325 has 500 or 
fewer employees based on the SBA standards.
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district, or special district with a 
population of less than 50,000. This proposed rule is not expected to 
impact any governmental jurisdictions.
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field. 
This proposed rule is not expected to impact any not-for-profit 
entities.
    After considering the economic impacts of this final rule on small 
entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The factual 
basis for the Agency's determination is presented in the small entity 
impact analysis prepared as part of the Cost Analysis for this proposed 
rule (Ref. 14) that is summarized in Unit V.E., and a copy of which is 
available in the docket at http://www.regulations.gov. The following is 
a brief summary of the factual basis for this certification.
    EPA has determined that this rulemaking does not impact any small 
governmental jurisdictions or any small not-for-profit enterprise 
because these entities are rarely producers of pesticide products. As 
such, EPA assessed the impacts on small businesses.
    EPA determined that for the minimum risk pesticide industry, there 
are 97 small firms (out of the total 192), accounting for approximately 
51% of the industry. EPA estimated the impacts on small firms in two 
ways. The first analysis estimated the impacts of the proposed rule on 
small firms by measuring the cost of the rule as a percent of the 
average small business annual revenue. These average small business 
impacts are presented in Table 6.

                            Table 6--Small Business Impacts Based on Average Revenues
----------------------------------------------------------------------------------------------------------------
                                                                   Average cost    Average cost    Impact (% of
                   Rule implementation period                         per SKU        per firm     gross revenue)
----------------------------------------------------------------------------------------------------------------
Immediate.......................................................          $6,306         $36,189             1.3
With 2 years to change labels...................................           2,550          14,634             0.5
With 3 years to change labels...................................             672           3,857             0.1
----------------------------------------------------------------------------------------------------------------

    However, this average revenues analysis may not account for the 
realities of very small firms. To account for the impacts on very small 
firms, i.e., those with sales of less than $500K, EPA performed a 
refined analysis that divided each individual firm's relabeling cost by 
that firm's sales revenue. Additionally, a lower labeling cost was 
assumed for very small firms. These impacts are presented in Table 7.

            Table 7--Small Business Impacts--Refined Analysis
------------------------------------------------------------------------
                                                   Impact (% of annual
                                                     gross revenue)
          Rule implementation period           -------------------------
                                                   >= 1%        >= 3%
------------------------------------------------------------------------
Immediate.....................................      64 (62)      21 (21)
With 2 years to change labels.................      27 (26)        9 (9)
With 3 years to change labels.................        7 (7)        0 (0)
------------------------------------------------------------------------

    With a 2-year compliance period, 26 small firms (or 27% of all 
small firms) are likely to experience an economic impact of 1% or more 
of gross sales, and nine small firms (9% of all small firms) may incur 
impacts greater than or equal to 3% of gross sales. The selection of 
the 2-year compliance period was also based on information obtained in 
2009, from a group of small manufacturers of minimum risk insect 
repellents. These small manufacturers, in comments submitted to EPA, 
indicated that they would need 2 years to re-label their products to 
avoid significant costs (Ref. 18). By providing a 2-year transition 
period (2 years from the effective date of the final rule), most 
companies would be able to incorporate the changes proposed in this 
document into their regularly planned label updates, and sell any 
products with older labels, thus reducing the cost and burden of the 
proposed changes to the exemption.
    EPA is particularly interested in receiving comment from small 
businesses as to the benefits, costs and impacts of this proposed rule. 
Any comments should be submitted to the Agency in the manner specified 
under ADDRESSES.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for 
Federal agencies, unless otherwise prohibited by law, to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. This proposed rule does not contain 
a Federal mandate that may result in expenditures of $100 million or 
more for state, local and tribal governments, in the aggregate, or for 
the private sector in any 1 year. This proposed rule is unlikely to 
affect state, local, and tribal governments at all, because no minimum 
risk pesticide products have been found to be produced by any state, 
local, or tribal governments. As summarized previously, under an 
implementation period of 2 years, the estimated industry total costs 
for the one-time relabeling proposed in this rule is about $3 million.
    Thus, this proposed rule is not subject to the requirements of UMRA 
sections 202 or 205. This rule is also not subject to the requirements 
of UMRA section 203, because it contains no regulatory requirements 
that might significantly or uniquely affect small governments.

E. Executive Order 13132: Federalism

    This rule does not have federalism implications because 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, 
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). 
As indicated previously, there are no known instances where a state or 
local government is currently the producer of a minimum risk pesticide 
currently exempt from regulation. Thus, Executive Order 13132 does not 
apply to this action.
    In the spirit of Executive Order 13132 and consistent with EPA 
policy to promote communication between EPA, and state and local 
governments, EPA did consult with representatives of state and local 
governments in developing

[[Page 76990]]

this action. These consultations were conducted during the September 
2010 meeting of the State-FIFRA Issues Research and Evaluation Group 
(SFIREG), two meetings of the Pesticide Regulatory Education Program 
(PREP) (July 2010 and April 2011) and a separate telephone conference 
with state pesticide regulators held on February 16, 2010.
    Although these proposed changes would not have substantial direct 
effects on the states, they may indirectly affect states in two ways. 
First, the states that register minimum risk pesticide products may 
determine that they need to re-evaluate those registrations, since 
companies selling products claiming to be exempt from EPA registration 
would have to adopt the new label requirements, and demonstrate that 
compliance to any states in which they register. However, since most 
states that register minimum risk products require a new registration 
every year, little or no extra burden on state pesticide registration 
services is anticipated as a result of the changes at the Federal 
level. Second, there may be an improvement in the efficiency of state 
pesticide inspections, since the proposed changes would make it easier 
and faster for inspectors to identify which unregistered pesticide 
products contain ingredients that comply with the minimum risk 
exemption. This would positively affect all states, including those 
that do not register minimum risk pesticide products.
    EPA specifically solicits comment on this proposed rule from state 
and local officials.

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

    This proposed rule does not have tribal implications because it 
will not have substantial direct effects on Indian Tribes, will not 
significantly or uniquely affect the communities of Indian Tribal 
governments, and does not involve or impose any requirements that 
affect Indian Tribes, as specified in Executive Order 13175 (65 FR 
67249, November 9, 2000). As indicated previously, there are no known 
instances where a tribal government is currently the producer of a 
minimum risk pesticide currently exempt from regulation. Thus, 
Executive Order 13175 does not apply to this proposed rule. EPA 
specifically solicits comment on this proposed rule from tribal 
officials.

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), 
as applying only to those regulatory actions that concern health or 
safety risks, such that the analysis required under section 5-501 of 
the Executive Order has the potential to influence the regulation. This 
action is not subject to Executive Order 13045, because it is not an 
``economically significant regulatory action'' as defined in Executive 
Order 12866, and because the Agency does not have reason to believe the 
environmental health or safety risks addressed by this action present a 
disproportionate risk to children. This proposed rule does not involve 
an environmental standard that is intended to have a negatively 
disproportionate effect on children. To the contrary, this proposed 
rule is intended to provide added protection to children by requiring 
clearer and more transparent information on the labels of exempted 
pesticide products.

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use 
voluntary consensus standards in its regulatory activities unless to do 
so would be inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. NTTAA directs EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards. This action does not involve 
any technical standards. Therefore, EPA did not consider the use of any 
voluntary consensus standards. EPA invites comment on its conclusion 
regarding the applicability of voluntary consensus standards to this 
rulemaking.

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

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes 
the Federal executive policy on environmental justice. Its main 
provision directs Federal agencies, to the greatest extent practicable 
and permitted by law, to make environmental justice part of their 
mission by identifying and addressing, as appropriate, 
disproportionately high and adverse human health or environmental 
effects of their programs, policies, and activities on minority 
populations and low-income populations in the United States.
    EPA has determined that this proposed rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations, because it is expected 
to increase the level of environmental protection for all affected 
populations without having any disproportionately high and adverse 
human health or environmental effects on any population, including any 
minority or low-income population. This proposed rule only impacts 
minimum risk pesticide products, and, once final, may have positive 
impacts for all communities, since the rule provides increased 
information for consumers considering the use of pesticides. This 
proposed action, which would improve clarity on product labels, will 
enable all users, regardless of economic status, to become more 
informed about the substances they may be interested in using as 
pesticides.

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 13, 2012.
 Lisa Jackson,
Administrator.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 152--[AMENDED]

    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.

    2. Section 152.25 is amended by revising paragraph (f) to read as 
follows:

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

* * * * *

[[Page 76991]]

    (f) Minimum risk pesticides. (1) Products containing the following 
active ingredients are exempt from the requirements of FIFRA, alone or 
in combination with other substances listed in this paragraph, 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 implementing 
regulations at part 180 of this chapter, products intended for use on 
food or animal feed can only include active ingredients with applicable 
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, 180.1233, and 180.1251 of this chapter.

----------------------------------------------------------------------------------------------------------------
         Label display name               Chemical name          Specifications              CAS Reg. No.
----------------------------------------------------------------------------------------------------------------
Castor oil.........................  Castor oil............  United States           8001-79-4
                                                              Pharmacopeia (USP)
                                                              standard.
Cedar oil..........................  Cedar oil.............  ......................  8000-27-9
Cedar oil..........................  Cedar oil.............  ......................  68990-83-0
Cedar oil..........................  Cedar oil.............  ......................  85085-29-6
Cinnamon...........................  Food: N/A.............  ......................  Food: N/A
Cinnamon oil.......................  Cinnamon oil..........  USP...................  8015-91-6
Citric acid........................  2-Hydroxypropane-1,2,3- USP...................  77-92-9
                                      tricarboxylic acid.
Citronella.........................  N/A...................  ......................  N/A
Citronella oil.....................  Citronella oil........  ......................  8000-29-1
Cloves.............................  Food: N/A.............  ......................  Food: N/A
Clove oil..........................  Clove oil.............  USP...................  8000-34-8
Corn gluten meal...................  Corn gluten...........  ......................  66071-96-3
Corn oil...........................  Corn oil..............  USP...................  8001-30-7
Cottonseed oil.....................  Cottonseed oil........  USP...................  8001-29-4
Dried blood........................  N/A...................  ......................  68991-49-9
Eugenol............................  4-Allyl-2-              USP...................  97-53-0
                                      methoxyphenol.
Garlic.............................  Food: N/A.............  ......................  Food: N/A
Garlic oil.........................  Garlic oil............  USP...................  8000-78-0
Geraniol...........................  (2E)-3,7-Dimethylocta-  USP...................  106-24-1
                                      2,6-dien-1-Ol.
Geranium oil.......................  Geranium oil..........  USP...................  8000-46-2
Lauryl sulfate.....................  Lauryl sulfate........  ......................  151-41-7
Lemongrass oil.....................  Lemongrass oil........  USP...................  8007-02-1
Linseed oil........................  Linseed oil...........  ......................  8001-26-1
Malic acid.........................  2-Hydroxybutanedioic    USP...................  6915-15-7
                                      acid.
Mint...............................  Food: N/A.............  ......................  Food: N/A
Mint oil...........................  Mint oil..............  USP...................  68917-18-0
Peppermint.........................  Food: N/A.............  ......................  Food: N/A
Peppermint oil.....................  Peppermint oil........  USP...................  8006-90-4
2-Phenylethyl propionate...........  2-Phenylethyl           ......................  122-70-3
                                      propionate.
Potassium sorbate..................  Potassium (2E,4E)-hexa- USP...................  24634-61-5
                                      2,4-Dienoate.
Putrescent whole egg solids........  Putrescent whole egg    ......................  51609-52-0
                                      solids.
Rosemary...........................  Food: N/A.............  ......................  Food: N/A
Rosemary oil.......................  Rosemary oil..........  USP...................  8000-25-7
Sesame.............................  Food: N/A.............  ......................  Food: N/A
Sesame oil.........................  Sesame oil............  ......................  8008-74-0
Sodium lauryl sulfate..............  Sulfuric acid           USP...................  151-21-3
                                      monododecyl ester,
                                      sodium salt.
Soybean oil........................  Soybean oil...........  USP...................  8001-22-7
Thyme..............................  Food: N/A.............  ......................  Food: N/A
Thyme oil..........................  Thyme oil.............  USP...................  8007-46-3
White pepper.......................  Food: N/A.............  ......................  Food: 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.
    (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.

------------------------------------------------------------------------
     Label display name           Chemical name         CAS Reg. 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 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.

[[Page 76992]]

 
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
 (1:1:1).                      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 (Ca(CO3 ))..........  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
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.

[[Page 76993]]

 
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............  Disodium sulfate      7727-73-3
                               decahydrate.
Diatomaceous earth..........  Kieselguhr;           61790-53-2
                               Diatomite.
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
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 (as depolymd. animal     Glue (as depolymd.    68476-37-9
 collagen).                    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.........  Glyceryl distearate.  1323-83-7
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 (Fe2O3)............  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.
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
                               (Fe2 MgO4 ).
Ferric oxide................  Iron oxide (Fe2 O3 )  1309-37-1
Iron oxide (Fe2 O3 ),         Iron oxide (Fe2 O3    12259-21-1
 hydrate.                      ), hydrate.
Iron oxide (Fe3 O4 )........  Iron oxide (Fe3 O4 )  1317-61-9
Ferric oxide................  Iron oxide (FeO)....  1345-25-1
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 (chemical) 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 (Mg3 O(Si2
                               O5 )2 ),
                               monohydrate.
Magnesium silicate..........  Magnesium silicate..  1343-88-0
Magnesium silicate hydrate..  Magnesium silicate    1343-90-4
                               hydrate.

[[Page 76994]]

 
Magnesium silicon oxide.....  Magnesium silicon     14987-04-3
                               oxide (Mg2 Si3 O8 ).
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 (U.S.P.)........  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.
Oils, almond................  Oils, almond........  8007-69-0
Oils, wheat.................  Oils, wheat.........  68917-73-7
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.
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
 (crystalline free).           fumed (crystalline
                               free).
Silica, amorphous,            Silica, amorphous,    7699-41-4
 precipitate and gel.          precipitate and gel.

[[Page 76995]]

 
Silica (crystalline free)...  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 (H2 SiO3 ),      Silicic acid (H2      13776-74-4
 magnesium salt (1:1).         SiO3 ), 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.
Tetragylceryl 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 (maximum 8% acetic    Vinegar (maximum 8%   8028-52-2
 acid in solution).            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
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
Whey........................  Whey................  92129-90-3
White mineral oil             White mineral oil     8042-47-5
 (petroleum).                  (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. It must also list all inert ingredients by the label 
display name listed in the table 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

[[Page 76996]]

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 * * *,'' ``Distributed by * * *,'' or ``Sold by * 
* *'' 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 Sec.  156.10(a)(5)(i) through 
(viii).
    (v) Guidance on minimum risk pesticides is available at http://www.epa.gov/oppbppd1/biopesticides/regtools/25b_list.htm (or successor 
web pages at http://www.epa.gov). This advisory information includes 
guidance on label formats, explanation of when exemptions from the 
requirements of a tolerance should be consulted, and tables in 
alternative formats that may be suitable for some users.
[FR Doc. 2012-31188 Filed 12-28-12; 8:45 am]
BILLING CODE 6560-50-P
```