Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 76979 

installed on airplanes of U.S. registry. 

We also estimate that one hour would 

be required per engine to accomplish 

the actions required by this AD. The 

average labor rate is $85 per hour. We 

also estimate that the required parts will 

cost about $370 per engine. We estimate 

that the cost of the idle leak check is 

$1,000 per engine. Based on these 

figures, we estimate the total cost of the 

proposed AD to U.S. operators is 

$3,275,231. 

Authority for this Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in Subtitle VII, 

Part A, Subpart III, Section 44701: 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect 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. 

For the reasons discussed above, I 

certify this proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Is not a ‘‘significant rule’’ under 

the DOT Regulatory Policies and 

Procedures (44 FR 11034, February 26, 

1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2012–XX–XX General Electric Company: 

Docket No. FAA–2012–0817; Directorate 

Identifier 99–NE–24–AD. 

(a) Comments Due Date 

We must receive comments by March 1, 

2013. 

(b) Affected ADs 

This AD supersedes AD 2000–04–14, 

Amendment 39–11597 (65 FR 10698, 

February 29, 2000). 

(c) Applicability 

This AD applies to all General Electric 

Company (GE) CF6–80C2 A1/A2/A3/A5/A8/ 

A5F/B1/B2/B4/B5F/B6/B1F/B2F/B4F/B6F/ 

B7F/D1F turbofan engines with fuel tubes, 

part number (P/N) 1321M42G01, 

1334M88G01, 1374M30G01, 1383M12G01, 

1606M57G03, 1606M57G01, or 1775M61G01, 

or supporting bracket, P/N 1321M88P001A, 

installed. 

(d) Unsafe Condition 

This AD was prompted by several reports 

of fuel leaks, and two reports of engine fire, 

due to mis-assembled supporting brackets on 

the fuel tube connecting the flowmeter to the 

Integrated Drive Generator (IDG) fuel-oil 

cooler. We are proposing this AD to prevent 

high-pressure fuel leaks caused by improper 

seating of fuel tube flanges, which could 

result in an engine fire and damage to the 

airplane. 

(e) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(f) Replacement 

After the effective date of this AD, if the 

fuel tubes are disconnected for any reason, or 

at the next engine shop visit, whichever 

occurs first, replace the fuel tubes and 

brackets with improved tubes and brackets 

eligible for installation. For on-wing 

maintenance, replace only tubes and brackets 

that have been disconnected. Do the 

following: 

(1) Replace the fuel flowmeter to IDG fueloil cooler fuel tube, P/N 1321M42G01, with 

a part eligible for installation. 

(2) For engines with Power Management 

Controls, replace the Main Engine Control to 

fuel flowmeter fuel tube, P/N 1334M88G01, 

with a part eligible for installation. 

(3) For engines with Full Authority Digital 

Electronic Controls, replace the 

Hydromechanical Unit to fuel flowmeter fuel 

tubes, P/Ns 1383M12G01 and 1374M30G01, 

with a part eligible for installation. 

(4) Replace supporting bracket, P/N 

1321M88P001A, and spray shields, P/Ns 

1606M57G01, 1606M57G03, and 

1775M61G01 with one-piece supporting 

bracket, P/N 2021M83G01. 

(5) Perform an idle leak check after 

accomplishing paragraphs (f)(1), (f)(2), (f)(3), 

or (f)(4), or any combination thereof. 

(g) Prohibition 

After the effective date of this AD, do not 

install any of the following parts into any GE 

CF6–80C2 series turbofan engines: P/Ns 

1321M42G01, 1321M88P001A, 1334M88G01, 

1374M30G01, 1383M12G01, 1606M57G01, 

1606M57G03, and 1775M61G01. 

(h) Alternative Methods of Compliance 

(AMOCs) 

The Manager, Engine Certification Office, 

FAA, may approve AMOCs for this AD. Use 

the procedures found in 14 CFR 39.19 to 

make your request. 

(i) Related Information 

(1) For more information about this AD, 

contact Kasra Sharifi, Aerospace Engineer, 

Engine Certification Office, FAA, Engine & 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

phone: 781–238–7773; fax: 781–238–7199; 

email: kasra.sharifi@faa.gov. 

(2) For guidance on the replacements, refer 

to GE Alert Service Bulletins CF6–80C2 SB 

73–A0224, CF6–80C2 SB 73–A0231, CF6– 

80C2 SB 73–A0401, and CF6–80C2 SB 73– 

0242. 

(3) For service information identified in 

this AD, contact General Electric Company, 

GE-Aviation, Room 285, 1 Neumann Way, 

Cincinnati, OH 45215, phone: (513) 552– 

3272; email: geae.aoc@ge.com. You may view 

this service information at the FAA, Engine 

& Propeller Directorate, 12 New England 

Executive Park, Burlington, MA. For 

information on the availability of this 

material at the FAA, call 781–238–7125. 

Issued in Burlington, Massachusetts on 

December 20, 2012. 

Robert J. Ganley, 

Acting Manager, Engine & Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. 2012–31362 Filed 12–28–12; 8:45 am] 

BILLING CODE 4910–13–P 

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). 


srobinson on DSK4SPTVN1PROD with 
76980 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 

ACTION: Proposed rule. 

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. 


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Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 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 reformatted 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 


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76982 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 

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

Response Total Number 

of states 

Percent of all 

states + territories in 

AAPCO 

(53) 

(percent) 

No. of states 

exempt products in 1998 

Percent of 

states at that 

time registering exempt products 

(36) 

(percent) 

Have problems with companies submitting labels for 25(b) products that 

contain active ingredients not on the list ..................................................... 11 21 9 25 

Have a system for determining changes in List 4A (inert ingredients) ........... 7 13 5 14 

Have seen exempt products that fail to list inert ingredients on the label as 

required ........................................................................................................ 21 40 18 50 

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 


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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 noncompliant 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. 


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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 


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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-tricarboxylic acid ............. USP ....................... 77–92–9 

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 silicate ....................................... Silicic acid, aluminum potassium sodium salt ......................... 12736–96–8 

Aluminum silicate ...................................................................... Silicic acid, aluminum salt ........................................................ 1335–30–4 

Aluminum sodium silicate ......................................................... Silicic acid, aluminum sodium salt ........................................... 1344–00–9 

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 fooduse 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 


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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

3-Digit NAICS 

code NAICS code description Number of parent firms 

325 .................... Chemical Manufacturing ................................................................................................................................. 72 

339 .................... Miscellaneous Manufacturing ......................................................................................................................... 8 

423 .................... Merchant Wholesalers, Durable Goods ......................................................................................................... 11 

424 .................... Merchant Wholesalers, Nondurable Goods ................................................................................................... 32 

444 .................... Building Material and Garden Equipment and Supplies Dealers .................................................................. 7 

541 .................... Professional, Scientific, and Technical Services ........................................................................................... 7 

561 .................... Administrative and Support Services ............................................................................................................. 13 

Others ............... ......................................................................................................................................................................... 42 

Total with 

classification.

......................................................................................................................................................................... 192 

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 


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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 onethird 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

Implementation period 

Average 

cost 

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 


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76988 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 

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) 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 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

Rule implementation period Average cost 

per SKU 

Average cost 

per firm 

Impact (% of 

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

Rule implementation period 

Impact (% of annual 

gross revenue) 

≥ 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 


srobinson on DSK4SPTVN1PROD with 
76990 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 

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: 

§ 152.25 Exemptions for pesticides of a 

character not requiring FIFRA regulation. 

* * * * * 


srobinson on DSK4SPTVN1PROD with 
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(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 §§ 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 Pharmacopeia (USP) 

standard.

8001–79–4 

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-tricarboxylic 

acid.

USP ........................................................ 77–92–9 

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-methoxyphenol ......................... USP ........................................................ 97–53–0 

Garlic ....................................................... Food: N/A ............................................... ................................................................ Food: N/A 

Garlic oil .................................................. Garlic oil ................................................. USP ........................................................ 8000–78–0 

Geraniol ................................................... (2E)-3,7-Dimethylocta-2,6-dien-1-Ol ...... USP ........................................................ 106–24–1 

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 acid ..................... USP ........................................................ 6915–15–7 

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 propionate ....................... ................................................................ 122–70–3 

Potassium sorbate ................................... Potassium (2E,4E)-hexa-2,4-Dienoate .. USP ........................................................ 24634–61–5 

Putrescent whole egg solids ................... Putrescent whole egg solids .................. ................................................................ 51609–52–0 

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 monododecyl ester, sodium salt.USP ........................................................ 151–21–3 

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 (consisting solely of 

zinc metal and impurities).

7440–66–6 

(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 

§ 180.950(a) of this chapter. 

(ii) Animal feed items as described in 

§ 180.950(b) of this chapter. 

(iii) Edible fats and oils as described 

in § 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-(acetyloxy)-, tributyl ester ................................... 77–90–7 

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, aluminum magnesium salt .................................... 1327–43–1 


srobinson on DSK4SPTVN1PROD with 
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Label display name Chemical name CAS Reg. No. 

Aluminum potassium sodium silicate ........................................ Silicic acid, aluminum potassium sodium salt ......................... 12736–96–8 

Aluminum silicate ....................................................................... Aluminum silicate ..................................................................... 1335–30–4 

Aluminum sodium silicate .......................................................... Silicic acid, aluminum sodium salt ........................................... 1344–00–9 

Aluminum sodium silicate (1:1:1) .............................................. Silicic acid (H4 SiO4 ), aluminum sodium salt (1:1:1) ............. 12003–51–9 

Ammonium benzoate ................................................................. Benzoic acid, ammonium salt .................................................. 1863–63–4 

Ammonium stearate ................................................................... Octadecanoic acid, ammonium salt ......................................... 1002–89–7 

Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate .............. Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate ............. 113894–85–2 

Amylopectin, hydrogen 1-octadecenylbutanedioate .................. Amylopectin, hydrogen 1-octadecenylbutanedioate ................ 125109–81–1 

Animal glue ................................................................................ Animal glue .............................................................................. N/A 

Ascorbyl palmitate ..................................................................... Ascorbyl palmitate .................................................................... 137–66–6 

Attapulgite-type clay .................................................................. Attapulgite-type clay ................................................................. 12174–11–7 

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 ester, (S) ................................................... 34451–19–9 

Butyl lactate ............................................................................... Lactic acid, n-butyl ester .......................................................... 138–22–7 

Butyl stearate ............................................................................. Octadecanoic acid, butyl ester ................................................. 123–95–5 

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 salt, monohydrate ................................... 5743–26–0 

Calcium benzoate ...................................................................... Benzoic acid, calcium salt ........................................................ 2090–05–3 

Calcium carbonate ..................................................................... Calcium carbonate ................................................................... 471–34–1 

Calcium citrate ........................................................................... Citric acid, calcium salt ............................................................ 7693–13–2 

Calcium octanoate ..................................................................... Calcium octanoate ................................................................... 6107–56–8 

Calcium oxide silicate ................................................................ Calcium oxide silicate (Ca3 O(SiO4)) ...................................... 12168–85–3 

Calcium silicate .......................................................................... Silicic acid, calcium salt ........................................................... 1344–95–2 

Calcium stearate ........................................................................ Octadecanoic acid, calcium salt .............................................. 1592–23–0 

Calcium sulfate .......................................................................... Calcium sulfate ......................................................................... 7778–18–9 

Calcium sulfate dihydrate .......................................................... Calcium sulfate dihydrate ......................................................... 10101–41–4 

Calcium sulfate hemihydrate ..................................................... Calcium sulfate hemihydrate .................................................... 10034–76–1 

Canary seed .............................................................................. Canary seed ............................................................................. N/A 

Carbon ....................................................................................... Carbon ...................................................................................... 7440–44–0 

Carbon dioxide ........................................................................... Carbon dioxide ......................................................................... 124–38–9 

Carboxymethyl cellulose ............................................................ Cellulose, carboxymethyl ether ................................................ 9000–11–7 

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, hydrogenated .......................................................... 8001–78–3 

Cat food ..................................................................................... Cat food .................................................................................... N/A 

Cellulose .................................................................................... Cellulose ................................................................................... 9004–34–6 

Cellulose acetate ....................................................................... Cellulose acetate ...................................................................... 9004–35–7 

Cellulose, mixture with cellulose carboxymethyl ether, sodium 

salt.

Cellulose, mixture with cellulose carboxymethyl ether, sodium 

salt.

51395–75–6 

Cellulose, pulp ........................................................................... Cellulose, pulp .......................................................................... 65996–61–4 

Cellulose, regenerated ............................................................... Cellulose, regenerated ............................................................. 68442–85–3 

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, monohydrate .......................................................... 5949–29–1 

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 with 1,2,3- propanetriol ................... Decanoic acid, monoester with 1,2,3- propanetriol ................. 26402–22–2 


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Label display name Chemical name CAS Reg. No. 

Dextrins ...................................................................................... Dextrins .................................................................................... 9004–53–9 

Diglyceryl monooleate ............................................................... 9-Octadecenoic acid, ester with 1,2,3- propanetriol ................ 49553–76–6 

Diglyceryl monostearate ............................................................ 9-Octadecanoic acid, monoester with oxybis(propanediol) ..... 12694–22–3 

Dilaurin ....................................................................................... Dodecanoic acid, diester with 1,2,3- propanetriol ................... 27638–00–2 

Dipalmitin ................................................................................... Hexadecanoic acid, diester with 1,2,3- propanetriol ................ 26657–95–4 

Dipotassium citrate .................................................................... Citric acid, dipotassium salt ..................................................... 3609–96–9 

Disodium citrate ......................................................................... Citric acid, disodium salt .......................................................... 144–33–2 

Disodium sulfate ........................................................................ Disodium sulfate decahydrate .................................................. 7727–73–3 

Diatomaceous earth ................................................................... Kieselguhr; Diatomite ............................................................... 61790–53–2 

Dodecanoic acid, monoester with 1,2,3- propanetriol ............... Dodecanoic acid, monoester with 1,2,3- propanetriol ............. 27215–38–9 

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 ester, (S) ...................................................... 687–47–8 

Ethyl lactate ............................................................................... Lactic acid, ethyl ester ............................................................. 97–64–3 

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 collagen) ........................................ Glue (as depolymd. animal collagen) ...................................... 68476–37–9 

Glycerin ...................................................................................... 1,2,3-Propanetriol ..................................................................... 56–81–5 

Glycerol monooleate .................................................................. 9-Octadecenoic acid (Z)-, 2,3-dihydroxypropyl ester ............... 111–03–5 

Glyceryl dicaprylate ................................................................... Octanoic acid, diester with 1,2,3-propanetriol ......................... 36354–80–0 

Glyceryl dimyristate ................................................................... Tetradecanoic acid, diester with 1,2,3-propanetriol ................. 53563–63–6 

Glyceryl dioleate ........................................................................ 9-Octadecenoic acid (9Z)-, diester with 1,2,3-propanetriol ..... 25637–84–7 

Glyceryl distearate ..................................................................... Glyceryl distearate ................................................................... 1323–83–7 

Glyceryl monomyristate ............................................................. Tetradecanoic acid, monoester with 1,2,3-propanetriol ........... 27214–38–6 

Glyceryl monooctanoate ............................................................ Octanoic acid, monoester with 1,2,3-propanetriol ................... 26402–26–6 

Glyceryl monooleate .................................................................. 9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol 25496–72–4 

Glyceryl monostearate ............................................................... Octadecanoic acid, monoester with 1,2,3-propanetriol ........... 31566–31–1 

Glyceryl stearate ........................................................................ Octadecanoic acid, ester with 1,2,3-propanetriol .................... 11099–07–3 

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 cottonseed oil ................................................... 68334–00–9 

Hydrogenated rapeseed oil ....................................................... Hydrogenated rapeseed oil ...................................................... 84681–71–0 

Hydrogenated soybean oil ......................................................... Hydrogenated soybean oil ....................................................... 8016–70–4 

Hydroxyethyl cellulose ............................................................... Cellulose, 2-hydroxyethyl ether ................................................ 9004–62–0 

Hydroxypropyl cellulose ............................................................. Cellulose, 2-hydroxypropyl ether ............................................. 9004–64–2 

Hydroxypropyl methyl cellulose ................................................. Cellulose, 2-hydroxypropyl methyl ether .................................. 9004–65–3 

Iron magnesium oxide ............................................................... Iron magnesium oxide (Fe2 MgO4 ) ........................................ 12068–86–9 

Ferric oxide ................................................................................ Iron oxide (Fe2 O3 ) ................................................................ 1309–37–1 

Iron oxide (Fe2 O3 ), hydrate .................................................... Iron oxide (Fe2 O3 ), hydrate .................................................. 12259–21–1 

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) dolomitic ........................................................ 12001–27–3 

Limestone .................................................................................. Limestone ................................................................................. 1317–65–3 

Linseed oil .................................................................................. Linseed oil ................................................................................ 8001–26–1 

Magnesium carbonate ............................................................... Carbonic acid, magnesium salt (1:1) ....................................... 546–93–0 

Magnesium benzoate ................................................................ Magnesium benzoate ............................................................... 553–70–8 

Magnesium oxide ....................................................................... Magnesium oxide ..................................................................... 1309–48–4 

Magnesium oxide silicate .......................................................... Magnesium oxide silicate (Mg3 O(Si2 O5 )2 ), monohydrate 12207–97–5 

Magnesium silicate .................................................................... Magnesium silicate ................................................................... 1343–88–0 

Magnesium silicate hydrate ....................................................... Magnesium silicate hydrate ..................................................... 1343–90–4 


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Label display name Chemical name CAS Reg. No. 

Magnesium silicon oxide ........................................................... Magnesium silicon oxide (Mg2 Si3 O8 ) .................................. 14987–04–3 

Magnesium stearate .................................................................. Octadecanoic acid, magnesium salt ........................................ 557–04–0 

Magnesium sulfate ..................................................................... Magnesium sulfate ................................................................... 7487–88–9 

Magnesium sulfate heptahydrate .............................................. Magnesium sulfate heptahydrate ............................................. 10034–99–8 

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 ether ............................................................ 9004–67–5 

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-dihydroxypropyl ester ............................ 142–18–7 

1-Monomyristin .......................................................................... Tetradecanoic acid, 2,3-dihydroxypropyl ester ........................ 589–68–4 

Monomyristin .............................................................................. Decanoic acid, diester with 1,2,3-propanetriol ......................... 53998–07–1 

Monopalmitin .............................................................................. Hexadecanoic acid, monoester with 1,2,3-propanetriol ........... 26657–96–5 

Monopotassium citrate ............................................................... Citric acid, monopotassium salt ............................................... 866–83–1 

Monosodium citrate ................................................................... Citric acid, monosodium salt .................................................... 18996–35–5 

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 salt .................................................... Octanoic acid, potassium salt .................................................. 764–71–6 

Octanoic acid, sodium salt ........................................................ Octanoic acid, sodium salt ....................................................... 1984–06–1 

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, hydrogenated ............................................................ 68514–74–9 

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 stearate ................................................................ 9009–32–9 

Potassium acetate ..................................................................... Acetic acid, potassium salt ...................................................... 127–08–2 

Potassium aluminum silicate, anhydrous .................................. Potassium aluminum silicate, anhydrous ................................. 1327–44–2 

Potassium benzoate .................................................................. Benzoic acid, potassium salt ................................................... 582–25–2 

Potassium bicarbonate .............................................................. Carbonic acid, monopotassium salt ......................................... 298–14–6 

Potassium chloride .................................................................... Potassium chloride ................................................................... 7447–40–7 

Potassium citrate ....................................................................... Citric acid, potassium salt ........................................................ 7778–49–6 

Potassium humate ..................................................................... Humic acids, potassium salts .................................................. 68514–28–3 

Potassium myristate .................................................................. Tetradecanoic acid, potassium salt ......................................... 13429–27–1 

Potassium oleate ....................................................................... 9-Octadecenoic acid (9Z)-, potassium salt .............................. 143–18–0 

Potassium ricinoleate ................................................................. 9-Octadecenoic acid, 12-hydroxy-, monopotassium salt, (9Z, 

12R)-.

7492–30–0 

Potassium sorbate ..................................................................... Sorbic acid, potassium salt ...................................................... 24634–61–5 

Potassium stearate .................................................................... Octadecanoic acid, potassium salt .......................................... 593–29–3 

Potassium sulfate ...................................................................... Potassium sulfate ..................................................................... 7778–80–5 

Potassium sulfate ...................................................................... Sulfuric acid, monopotassium salt ........................................... 7646–93–7 

1,2-Propylene carbonate ........................................................... 1,3-Dioxolan-2-one, 4-methyl- .................................................. 108–32–7 

Pumice ....................................................................................... Pumice ..................................................................................... 1332–09–8 

Red cabbage color .................................................................... Red cabbage color (expressed from edible red cabbage 

heads via a pressing process using only acidified water).

N/A 

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 (crystalline free) ............................... Silica, amorphous, fumed (crystalline free) ............................. 112945–52–5 

Silica, amorphous, precipitate and gel ...................................... Silica, amorphous, precipitate and gel ..................................... 7699–41–4 


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Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 76995 

Label display name Chemical name CAS Reg. No. 

Silica (crystalline free) ............................................................... Silica (crystalline free) .............................................................. 7631–86–9 

Silica gel .................................................................................... Silica gel ................................................................................... 63231–67–4 

Silica gel, precipitated, crystalline-free ...................................... Silica gel, precipitated, crystalline-free .................................... 112926–00–8 

Silica, hydrate ............................................................................ Silica, hydrate ........................................................................... 10279–57–9 

Silica, vitreous ............................................................................ Silica, vitreous .......................................................................... 60676–86–0 

Silicic acid (H2 SiO3 ), magnesium salt (1:1) ........................... Silicic acid (H2 SiO3 ), magnesium salt (1:1) .......................... 13776–74–4 

Soap ........................................................................................... Soap (The water soluble sodium or potassium salts of fatty 

acids produced by either the saponification of fats and oils, 

or the neutralization of fatty acid).

N/A 

Soapbark .................................................................................... Quillaja saponin ........................................................................ 1393–03–9 

Soapstone .................................................................................. Soapstone ................................................................................ 308076–02–0 

Sodium acetate .......................................................................... Acetic acid, sodium salt ........................................................... 127–09–3 

Sodium alginate ......................................................................... Sodium alginate ....................................................................... 9005–38–3 

Sodium benzoate ....................................................................... Benzoic acid, sodium salt ........................................................ 532–32–1 

Sodium bicarbonate ................................................................... Sodium bicarbonate ................................................................. 144–55–8 

Sodium carboxymethyl cellulose ............................................... Cellulose, carboxymethyl ether, sodium salt ........................... 9004–32–4 

Sodium chloride ......................................................................... Sodium chloride ....................................................................... 7647–14–5 

Sodium citrate ............................................................................ Sodium citrate .......................................................................... 994–36–5 

Sodium humate .......................................................................... Humic acids, sodium salts ....................................................... 68131–04–4 

Sodium oleate ............................................................................ Sodium oleate .......................................................................... 143–19–1 

Sodium ricinoleate ..................................................................... 9-Octadecenoic acid, 12-hydroxy-, monosodium salt, 

(9Z,12R)-.

5323–95–5 

Sodium stearate ......................................................................... Octadecanoic acid, sodium salt ............................................... 822–16–2 

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, hydrogenated ................................. Syrups, hydrolyzed starch, hydrogenated ............................... 68425–17–2 

Tetragylceryl monooleate .......................................................... 9-Octadecenoic acid (9Z)-, monoester with tetraglycerol ........ 71012–10–7 

Tricalcium citrate ........................................................................ Citric acid, calcium salt (2:3) .................................................... 813–94–5 

Triethyl citrate ............................................................................ Citric acid, triethyl ester ........................................................... 77–93–0 

Tripotassium citrate ................................................................... Citric acid, tripotassium salt ..................................................... 866–84–2 

Tripotassium citrate monohydrate ............................................. Citric acid, tripotassium salt, monohydrate .............................. 6100–05–6 

Trisodium citrate ........................................................................ Citric acid, trisodium salt .......................................................... 68–04–2 

Trisodium citrate dehydrate ....................................................... Citric acid, trisodium salt, dehydrate ........................................ 6132–04–3 

Trisodium citrate pentahydrate .................................................. Citric acid, trisodium salt, pentahydrate ................................... 6858–44–2 

Ultramarine blue ........................................................................ C.I. Pigment Blue 29 ................................................................ 57455–37–5 

Urea ........................................................................................... Urea .......................................................................................... 57–13–6 

Vanillin ....................................................................................... Benzaldehyde, 4-hydroxy-3-methoxy- ..................................... 121–33–5 

Vermiculite ................................................................................. Vermiculite ................................................................................ 1318–00–9 

Vinegar (maximum 8% acetic acid in solution) ......................... Vinegar (maximum 8% acetic acid in solution) ....................... 8028–52–2 

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 (petroleum) .................................................... White mineral oil (petroleum) ................................................... 8042–47–5 

Wintergreen oil ........................................................................... Wintergreen oil ......................................................................... 68917–75–9 

Wollastonite ............................................................................... Wollastonite (Ca(SiO3 )) .......................................................... 13983–17–0 

Wool ........................................................................................... Wool ......................................................................................... N/A 

Xanthan gum ............................................................................. Xanthan gum ............................................................................ 11138–66–2 

Yeast .......................................................................................... Yeast ........................................................................................ 68876–77–7 

Zeolites ...................................................................................... Zeolites (excluding erionite (CAS Reg. No. 66733–21–9)) ..... 1318–02–1 

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, zinc salt .................................................... 557–05–1 

(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 


srobinson on DSK4SPTVN1PROD with 
76996 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Proposed Rules 

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 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 745 

[EPA–HQ–OPPT–2010–0173; FRL–9373–7] 

RIN 2070–AJ56 

Lead; Renovation, Repair, and Painting 

Program for Public and Commercial 

Buildings; Request for Information and 

Advance Notice of Public Meeting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Request for information and 

advance notice of public meeting. 

SUMMARY: In 2010, EPA issued an 

advance notice of proposed rulemaking 

(2010 ANPRM) concerning renovation, 

repair, and painting activities on and in 

public and commercial buildings. EPA 

is in the process of determining whether 

these activities create lead-based paint 

hazards, and, for those that do, 

developing certification, training, and 

work practice requirements as directed 

by the Toxic Substances Control Act 

(TSCA). This document opens a 

comment period to allow for additional 

data and other information to be 

submitted by the public and interested 

stakeholders. This document also 

provides advance notice of EPA’s plan 

to hold a public meeting on June 26, 

2013. 

DATES: Comments must be received on 

or before April 1, 2013. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2010–0173, 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: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• 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: For 

technical information contact: Hans 

Scheifele, National Program Chemicals 

Division (7404T), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (202) 564–3122; 

email address: scheifele.hans@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

This document is directed to the 

public in general. However, you may be 

potentially affected by this action if you 

perform renovations, repairs, or painting 

activities on the exterior or interior of 

public buildings or commercial 

buildings. 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. Other 

types of entities not listed may also be 

affected. Potentially affected entities 

may include: 

• Building construction (NAICS code 

236), e.g., commercial building 

construction, industrial building 

construction, commercial and 

institutional building construction, 

building finishing contractors, drywall 

and insulation contractors, painting and 

wall covering contractors, finish 

carpentry contractors, other building 

finishing contractors. 

• Specialty trade contractors (NAICS 

code 238), e.g., plumbing, heating, and 

air-conditioning contractors; painting 

and wall covering contractors; electrical 

contractors; finish carpentry contractors; 

drywall and insulation contractors; 

siding contractors; tile and terrazzo 

contractors; glass and glazing 

contractors. 

• Real estate (NAICS code 531), e.g., 

lessors of non-residential buildings and 

dwellings, non-residential property 

managers. 

• Other general government support 

(NAICS code 921), e.g., general services 

departments, government, public 

property management services, 

government. 

If you have any questions regarding 

the applicability of this action to a 

particular entity, consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 


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