Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules 35383 

13Attachment A to the December 3, 2010, 

submittal includes revisions to 326 IAC 2–7 to add 

GHG provisions to Indiana’s Title V regulations. 

However, these regulations are not part of the SIP 

and IDEM has not included 326 IAC 2–7 in the 

December 3, 2010, request for SIP approval. IDEM 

intends to make a separate submittal requesting 

approval of the 326 IAC 2–7 regulatory revisions. 

regulations at 326 Indiana 

Administrative Code (IAC) 2–2–1 and 

326 IAC 2–2–4.13

Indiana is currently a SIP-approved 

state for the PSD program, and has 

incorporated EPA’s 2002 NSR reform 

revisions (67 FR 80186) for PSD into its 

SIP (72 FR 33395). In a letter provided 

to EPA on July 23, 2010, Indiana 

notified EPA of its interpretation that 

the state currently has the authority to 

regulate GHGs under its 326 IAC 2–2 

PSD regulations. The current Indiana 

program (adopted prior to the 

promulgation of EPA’s Tailoring Rule) 

applies to major stationary sources 

(having the potential to emit at least 100 

tpy or 250 tpy or more of a regulated 

NSR pollutant, depending on the type of 

source) or modifications undertaken in 

areas designated attainment or 

unclassifiable with respect to the 

NAAQS. 

Indiana has revised 326 IAC 2–2–1 to 

add GHG-related language to the 

definitions of ‘‘regulated NSR pollutant’’ 

and ‘‘significant’’ and to add a new 

definition for ‘‘subject to regulation.’’ 

We find these revisions to be consistent 

with the Tailoring Rule. 

In 326 IAC 2–2–4, Indiana has added 

language that says the air quality 

analysis requirements of this section 

shall not apply with respect to GHGs. 

This does not affect the air qualityrelated requirements elsewhere in the 

PSD rule, including requirements for 

source information (326 IAC 2–2–10), 

additional impact analysis (326 IAC 2– 

2–7), or additional requirements for 

sources impacting Federal Class I areas 

(326 IAC 2–2–14). We find this revision 

to be approvable. 

V. What action is EPA taking? 

EPA is proposing to approve Indiana’s 

December 3, 2010, SIP submittal, 

relating to PSD requirements for GHGemitting sources in 326 IAC 2–2–1 and 

326 IAC 2–2–4. Specifically, Indiana’s 

December 3, 2010, proposed SIP 

revision establishes appropriate 

emissions thresholds for determining 

PSD applicability to new and modified 

GHG-emitting sources in accordance 

with EPA’s Tailoring Rule. EPA has 

made the preliminary determination 

that this SIP submittal is approvable 

because it is in accordance with the 

CAA and EPA regulations regarding 

PSD permitting for GHGs. 

If EPA does approve Indiana’s 

changes to its air quality regulations to 

incorporate the appropriate thresholds 

for GHG permitting applicability into 

Indiana’s SIP, then 40 CFR 52.773(k), as 

included in EPA’s SIP Narrowing Rule, 

which codifies EPA’s limiting its 

approval of Indiana’s PSD SIP to not 

cover the applicability of PSD to GHGemitting sources below the Tailoring 

Rule thresholds, is no longer necessary. 

In this proposed action, EPA is also 

proposing to amend 40 CFR 52.773 to 

remove this unnecessary regulatory 

language. 

VI. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely approves state law as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by state law. For that 

reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act 

(5 U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

Tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on Tribal governments or preempt 

Tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

and Reporting and recordkeeping 

requirements. 

Dated: June 9, 2011. 

Susan Hedman, 

Regional Administrator, Region 5. 

[FR Doc. 2011–15102 Filed 6–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Chapter I 

[EPA–HQ–OPP–2010–0197; FRL–8877–9] 

RIN 2070–ZA11 

Pesticides; Policies Concerning 

Products Containing Nanoscale 

Materials; Opportunity for Public 

Comment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed policy statement. 

SUMMARY: EPA seeks comment on 

several possible approaches for 

obtaining information about what 

nanoscale materials are present in 

registered pesticide products. Under one 

approach, EPA would use section 6(a)(2) 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) to obtain 

information regarding what nanoscale 

material is present in a registered 

pesticide product and its potential 

effects on humans or the environment. 

If EPA adopts this approach, 40 CFR 

152.50(f)(3) would also require the 

inclusion of such information with any 

application for registration of a pesticide 

product that contains a nanoscale 

material. Under an alternative approach, 

EPA would obtain such information 

using Data Call-In notices (DCIs) under 

FIFRA section 3(c)(2)(B). If EPA adopts 

this alternate approach, EPA would also 

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35384 Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules 

need to require the inclusion of this 

information with any application for 

registration of a pesticide product that 

contains a nanoscale material. It is 

EPA’s view that FIFRA section 6(a)(2) is 

the most efficient and expedient 

administrative approach to obtaining 

information about nanoscale materials 

in pesticides and EPA would prefer to 

use this approach. EPA is also 

proposing a new approach for how EPA 

will determine on a case-by-case basis 

whether a nanoscale active or inert 

ingredient is a ‘‘new’’ active or inert 

ingredient for purposes of FIFRA and 

the Pesticide Registration Improvement 

Act (PRIA), even when an identical, 

non-nanoscale form of the nanoscale 

ingredient is already registered. 

DATES: Comments must be received on 

or before July 18, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0197, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPP–2010– 

0197. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either in the 

electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

hours of operation of this Docket 

Facility are from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Jed 

Costanza, Antimicrobials Division 

(7510P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0204; fax number: (703) 308– 

8005; e-mail address: 

costanza.jed@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. What is this document about? 

This document describes several 

possible approaches for obtaining 

certain additional information on the 

composition of pesticide products. The 

notice focuses particularly on 

information about what nanoscale 

materials are present in registered 

pesticide products. In connection with 

this document, EPA describes 

‘‘nanoscale material’’ as an active or 

inert ingredient and any component 

parts thereof intentionally produced to 

have at least one dimension that 

measures between approximately 1 and 

100 nanometers (nm). 

Under one approach, EPA would use 

section 6(a)(2) of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

to obtain information regarding what 

nanoscale material is present in a 

registered pesticide product and its 

potential effects on humans or the 

environment. If EPA adopts this 

approach, 40 CFR 152.50(f)(3) would 

also require the inclusion of such 

information with any application for 

registration of a pesticide product that 

contains a nanoscale material. 

Under an alternative approach, EPA 

would obtain such information using 

Data Call-In notices (DCIs) under FIFRA 

section 3(c)(2)(B). If EPA adopts this 

alternate approach, EPA would also 

need to require the inclusion of this 

information with any application for 

registration of a pesticide product that 

contains a nanoscale material. EPA is 

reviewing whether this could be done 

under existing regulations or whether 

EPA would need to amend existing 

regulations to clarify that the 

information is required with any 

application for registration. 

It is EPA’s view that FIFRA section 

6(a)(2) is the most efficient and 

expedient administrative approach to 

obtaining information about nanoscale 

materials in pesticides and EPA would 

prefer to use this approach. 

This document also proposes a new 

approach for how EPA will determine 

on a case-by-case basis whether a 

nanoscale active or inert ingredient is a 

‘‘new’’ active or inert ingredient for 

purposes of FIFRA and the Pesticide 

Registration Improvement Act (PRIA), 

even when an identical, non-nanoscale 

form of the nanoscale ingredient is 

already registered. 

After considering any public 

comments on the use of FIFRA section 

6(a)(2) or DCIs under FIFRA section 

3(c)(2)(B), as well as public comments 

submitted in response to other questions 

posed in this document, EPA plans to 

issue a subsequent document in the 

Federal Register announcing its 

approach to gather this information. 

EPA is also asking for specific input on 

the proposed approach for determining 

whether a nanoscale material is ‘‘new’’ 

under FIFRA and PRIA. 

B. Does this action apply to me? 

This action is directed to those 

persons who manufacture, distribute, 

sell, apply, or regulate pesticide 

products, including agricultural, 

commercial, and residential products 

(NAICS codes 32532 and 32561). This 

listing is not intended to be exhaustive, 

but rather provides a guide for readers 

regarding entities likely to be affected by 

this action. Other types of entities not 

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Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules 35385 

listed in this unit could also be affected. 

The North American Industrial 

Classification System (NAICS) codes 

have been provided to assist you and 

others in determining whether this 

action might apply to certain entities. If 

you have any questions regarding the 

applicability of this action to a 

particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

C. 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 e-mail. 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. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Applicable Statutory and Regulatory 

Requirements 

As a general matter, pesticides may 

not be sold or distributed in the United 

States unless they are registered with 

EPA. FIFRA section 3(a) (7 U.S.C. 

136a(a)). In order to obtain a pesticide 

registration, an applicant must provide 

EPA with data (or cite existing data) 

demonstrating that the proposed 

registration complies with the 

requirement for registration. FIFRA 

section 3(c)(1)(F) (7 U.S.C. 

136a(c)(1)(F)). FIFRA contains two 

provisions under which EPA may 

register pesticides: Section 3(c)(5) for 

‘‘unconditional’’ registration and section 

3(c)(7) for ‘‘conditional’’ registration (7 

U.S.C. 136a(c)(5) and 7 U.S.C. 

136a(c)(7)). Importantly, EPA must 

make statutorily required findings for 

each and every pesticide product for 

which registration is sought, regardless 

of whether another pesticide product 

with the same or similar composition 

and use patterns is already registered. 

The standard for determining whether 

an application should be granted 

unconditionally is found in FIFRA 

section 3(c)(5). This section provides 

that, in order to grant a registration, EPA 

must find that a product’s composition 

warrants the proposed claims for it; that 

the product’s labeling and other 

material required to be submitted 

comply with FIFRA; that the product 

will perform its intended function 

without causing unreasonable adverse 

effects on the environment; and that, 

when used in accordance with 

widespread and commonly recognized 

practice, the product will not cause 

unreasonable adverse effects on the 

environment. 

FIFRA defines ‘‘unreasonable adverse 

effects on the environment’’ as 

including ‘‘any unreasonable risk to 

man or the environment, taking into 

account the economic, social, and 

environmental costs and benefits of the 

use of any pesticide.’’ FIFRA section 

2(bb) (7 U.S.C. 136(bb)). Thus, a critical 

aspect of determining whether or not a 

pesticide product should be granted a 

registration is an evaluation of whether 

the benefits associated with the use of 

a pesticide outweigh the risks associated 

with such use. The burden of 

demonstrating that a product meets the 

standards for registration rests at all 

times on the registrant or applicant for 

registration. See, e.g., Industrial Union 

Dept. v. American Petroleum Institute, 

448 U.S. 607, 653 n. 61 (1980); 

Environmental Defense Fund v. EPA, 

510 F.2d 1292, 1297, 1302 (DC Cir. 

1975). 

The Agency has promulgated 

regulations in 40 CFR parts 158 and 161 

which identify the types of data EPA 

expects an applicant to provide to 

support an application for registration of 

a pesticide product. The Agency 

requires a wide variety of studies in 

order to evaluate whether a pesticide 

will cause unreasonable adverse effects 

on the environment. These required 

studies include both toxicity tests and 

data to characterize exposure to a 

pesticide, including extensive 

information on a product’s composition, 

and its fate in the environment and 

within the human body. For certain 

pesticides EPA also requires data on 

product efficacy. 

If an applicant cannot provide 

necessary data for EPA to make the 

determinations required to register a 

product unconditionally under FIFRA 

section 3(c)(5), EPA may still be able to 

register the product ‘‘conditionally’’ 

under FIFRA section 3(c)(7). FIFRA 

section 3(c)(7) authorizes EPA to register 

a pesticide product on the condition 

that the applicant provides additional 

data necessary to support a finding that 

the product meets the statutory 

standards in FIFRA section 3(c)(5). 

FIFRA section 3(c)(7) authorizes 

conditional registration in three 

circumstances. First, the Agency may 

conditionally register a product if EPA 

determines, among other things, that the 

product is identical or substantially 

similar to a currently registered 

pesticide or differs only in ways that 

would not significantly increase the risk 

of unreasonable adverse effects on the 

environment, and that approving the 

registration in the manner proposed 

would not significantly increase the risk 

of any unreasonable adverse effect on 

the environment. FIFRA section 

3(c)(7)(A) (7 U.S.C. 136a(c)(7)(A)). 

Products approved under this authority 

are commonly called ‘‘me-too 

registrations.’’ Second, EPA may register 

a pesticide for an additional use, if the 

applicant provides data to evaluate the 

safety of the new use, and use of the 

product would not significantly increase 

the risk of unreasonable adverse effects 

on the environment compared to 

products already registered. FIFRA 

section 3(c)(7)(B) (7 U.S.C. 

136a(c)(7)(B)). These product approvals 

are referred to as ‘‘new use’’ 

registrations. Finally, EPA may 

conditionally register a pesticide 

product that contains an active 

ingredient not present in any currently 

registered pesticide product, if the 

Administrator determines that: 

1. The applicant has provided all data 

necessary to evaluate the safety of the 

pesticide, with the exception of any data 

which are lacking because the applicant has 

not had enough time to generate the data 

since learning of the requirement; 

2. Use of the pesticide during the time 

period needed to develop the additional data 

will not cause unreasonable adverse effects 

on the environment; and 

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3. Use of the pesticide is in the public 

interest. 

FIFRA section 3(c)(7)(C) (7 U.S.C. 

136a(c)(7)(C)). 

As with applications for 

unconditional registrations, applicants 

for conditional registration bear the 

burden at all times of demonstrating 

that the statutory standards are met. 

The Agency’s interest in data to 

evaluate the risks and benefits of a 

pesticide does not necessarily end once 

EPA has registered a pesticide product. 

Accordingly, other provisions of FIFRA 

allow the Agency to require pesticide 

registrants to develop and submit 

information the Agency believes it 

needs in order to maintain the 

registration of pesticide products. 

A. DCI 

Under FIFRA section 3(c)(2)(B), EPA 

may send a DCI notice to a registrant 

requiring the registrant to provide 

additional data or other information, 

which the registrant may need to 

generate or compile. Specifically, ‘‘if the 

Administrator determines that 

additional data are required to maintain 

in effect an existing registration of a 

pesticide, the Administrator shall notify 

all existing registrants of the pesticide to 

which the determination relates and 

provide a list of such registrants to any 

interested person.’’ Failure to respond to 

the DCI can serve as the basis for 

suspending the registration of the 

product, thereby making it unlawful for 

the registrant to sell or distribute the 

pesticide. 

Generally, EPA’s determination that 

additional data are needed is 

contemplated to occur for one of the 

following five reasons: 

1. The Re-registration Program. 

Section 4 of FIFRA requires EPA to reassess the health and safety data for all 

pesticide active ingredients registered 

before November 1, 1984, to determine 

whether these ‘‘older’’ pesticides meet 

the criteria for registration that would be 

expected of a pesticide being registered 

today for the first time. Section 4 of 

FIFRA directs EPA to use section 

3(c)(2)(B) authority to obtain the 

required data. 

2. The Registration Review Program. 

Section 3(g) of FIFRA contains 

provisions to help achieve the goal of 

reviewing each pesticide every 15 years 

to assure that the pesticide continues to 

pose no risk of unreasonable adverse 

effects on human health or the 

environment. Section 3(g) instructs EPA 

to use the section 3(c)(2)(B) authority to 

obtain the required data. 

3. Anticipated Residue/Percent Crop 

Treated Information. Under section 408 

of the Federal Food, Drug, and Cosmetic 

Act (FFDCA), before a pesticide may be 

used on food or feed crops, the Agency 

must establish a tolerance for the 

pesticide residues on that crop or 

establish an exemption from the 

requirement to have a tolerance. Section 

408(b)(2)(E) and (F) of FFDCA authorize 

the use of anticipated or actual residue 

(AR) data and percent crop treated 

(PCT) data to establish, modify, 

maintain, or revoke a tolerance for a 

pesticide. FFDCA requires that if AR 

data are used, data must be reviewed 5 

years after a tolerance is initially 

established. 

4. The Special Review Program. EPA 

may conduct a Special Review if EPA 

believes that a pesticide poses risks of 

unreasonable adverse effects on human 

health or the environment. In the 

Special Review Program, EPA focuses 

on specific hazards or uses of a 

pesticide. Special Reviews are not 

intended to be comprehensive 

evaluations of the pesticide; instead the 

Special Review DCIs are to address the 

specific hazard or exposure concerns 

that are at issue. 

5. Enforcement and Unanticipated 

Circumstances. The need for a DCI may 

arise from the discovery of deficiencies 

in previously submitted data, or from 

the discovery of specific attributes of the 

pesticide or its ingredients. This may 

lead the Agency to determine that 

additional information is necessary to 

reassess whether the pesticide will 

cause unreasonable adverse effects on 

the environment. This type of DCI is 

needed because the concern and 

therefore the need for data arise not 

from a mandated review program like 

Re-registration or Registration Review 

described above, but from unanticipated 

circumstances. Section 3(c)(2)(B) of 

FIFRA provides a means of obtaining 

any needed data. 

B. FIFRA Section 6(a)(2) 

FIFRA section 6(a)(2) provides that 

registrants must inform the Agency of 

relevant information relating to their 

products, even though it was not 

specifically requested by EPA. 

Specifically, FIFRA section 6(a)(2) 

requires that, ‘‘[i]f at any time after the 

registration of a pesticide the registrant 

has additional factual information 

regarding unreasonable adverse effects 

on the environment of the pesticide, the 

registrant shall submit such information 

to the Administrator.’’ (7 U.S.C. 

136d(a)(2)). For over 30 years, EPA has 

interpreted this provision expansively 

to include not only information relating 

directly to adverse effects caused by 

pesticides, but also to other types of 

information and studies that EPA would 

typically use in assessing whether a 

pesticide meets the statutory standard 

for registration (i.e., the ‘‘unreasonable 

adverse effects on the environment’’ 

risk/benefit standard). See 43 FR 37611 

(August 23, 1978). 

In 1997, EPA promulgated a final rule 

at 40 CFR part 159, subpart D in the 

Federal Register issue of September 19, 

1997 (62 FR 49370) (FRL–5739–1), 

setting forth EPA’s interpretation and 

enforcement policy regarding FIFRA 

section 6(a)(2). The rule explains, 

among other things, what information 

EPA regards as ‘‘additional’’ and 

‘‘factual,’’ as well as how quickly and to 

whom such information must be 

reported. The regulation specifies many 

kinds of information, from varied 

scientific disciplines, that EPA requires 

registrants to submit pursuant to FIFRA 

section 6(a)(2). The types of information 

reflect the variety of scientific data used 

by EPA in making the statutorily 

required determinations—whether 

pesticides cause unreasonable adverse 

effects on the environment. Thus, for 

example, the regulations generally 

require registrants to report studies 

indicating that a pesticide causes new or 

a higher incidence of toxic effects than 

previously identified (see 40 CFR 

159.165) and to report incidents 

involving injury to humans, pets, or 

wildlife resulting from exposure to a 

pesticide (40 CFR 159.184). But, EPA 

uses other types of information that do 

not directly demonstrate adverse effects 

in its risk assessments, and new factual 

information of this kind is also 

reportable under the regulation. For 

example, registrants must report studies 

that identify new metabolites, 

degradates, impurities, or contaminants 

of pesticides (40 CFR 159.179); certain 

information on the detection of 

pesticide residues in water, food, and 

feed (40 CFR 159.178); and new studies 

of human exposure (40 CFR 159.170). In 

sum, EPA’s regulation requires reporting 

of many types of information relevant to 

EPA’s assessment of the safety of a 

pesticide product—in the words of 

section 6(a)(2) ‘‘information regarding 

unreasonable adverse effects on the 

environment of the pesticide’’—not 

merely information that directly 

concerns adverse effects. 

In promulgating that regulation, 

however, EPA also recognized it was 

impossible to establish rules addressing 

every type of factual information that 

might become relevant in the future to 

judging whether a registered pesticide 

product continued to meet the FIFRA 

statutory standards. Accordingly, 40 

CFR 159.195(a) provides: 

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The registrant shall submit to the 

Administrator information other than that 

described in §§ 159.165 through 159.188 if 

the registrant knows, or reasonably should 

know, that if the information should prove to 

be correct, EPA might regard the information 

alone or in conjunction with other 

information about the pesticide as raising 

concerns about the continued registration of 

a product or about the appropriate terms and 

conditions of registration of a product. 

In addition, 40 CFR 159.195(c) provides 

that: 

[t]he registrant shall submit * * * 

information other than that described in 

§§ 159.165 through 159.188 if the registrant 

has been informed by EPA that such 

additional information has the potential to 

raise questions about the continued 

registration of a product or about the 

appropriate terms and conditions of 

registration of a product. 

Thus, once the Agency has informed 

registrants that EPA considers a 

particular type of information relevant 

to determining whether a pesticide has 

the potential to cause unreasonable 

adverse effects on the environment, that 

type of information becomes reportable 

under FIFRA section 6(a)(2). 

Finally, EPA promulgated a regulation 

at 40 CFR part 152 addressing the 

submission of applications for 

registration (53 FR 15952, May 4, 1988) 

(FRL–3266–9b). That rule specifies, 

among other things, certain types of 

information that an application for 

registration of a pesticide product must 

contain. The rule provides that the 

applicant must ‘‘furnish with his 

application any factual information of 

which he is aware regarding 

unreasonable adverse effects of the 

pesticide on man or the environment, 

which would be required to be reported 

under FIFRA section 6(a)(2), if the 

product were registered.’’ 40 CFR 

152.50(f)(3). 

Registrants’ compliance with FIFRA 

section 6(a)(2) and EPA’s implementing 

regulations in 40 CFR parts 152 and 159 

ensures that EPA has access to any 

additional factual information that 

could be important for determining 

whether a previous Agency decision to 

register a pesticide remains a correct 

one, and whether a registered pesticide 

can in fact be used without posing 

unreasonable adverse effects to human 

health and the environment. This 

provision of FIFRA recognizes that 

registrants may come into the 

possession of important new 

information that was not anticipated by 

the Agency or of information the 

importance of which was not previously 

known, and that in the absence of 

registrants submitting such information, 

EPA might well remain unaware of the 

information. Failures to report required 

information, or delays in reporting, are 

regarded by EPA as violations of FIFRA 

section 6(a)(2), which in turn makes 

them actionable under FIFRA sections 

12(a)(2)(B)(ii) and 12(a)(2)(N) (7 U.S.C. 

136j(a)(2)(B)(ii) and 7 U.S.C. 

136j(a)(2)(N)). 

III. EPA’s Interest in Nanoscale 

Materials as Pesticide Ingredients 

EPA believes that certain information 

concerning pesticide ingredients, which 

applicants and registrants have not 

routinely provided previously, is 

relevant to the Agency’s statutory 

obligation to determine whether the 

registration of a pesticide may cause 

unreasonable adverse effects on the 

environment. For the reasons discussed 

below, EPA is particularly interested in 

nanoscale materials in this context. 

Accordingly, EPA is considering how to 

collect information about what 

nanoscale materials are in pesticide 

products and is therefore soliciting 

public comment on two possible 

approaches. It is important to first 

clarify how the term ‘‘nanoscale 

material’’ is being used for purposes of 

this document. 

A. Nanoscale Material 

To date, EPA has not developed 

formal definitions for the terms 

‘‘nanotechnology’’ or ‘‘nanoscale 

materials’’ or any similar terms for 

regulatory purposes under any statute 

administered by the Agency. Broad 

definitions for the terms 

‘‘nanotechnology’’ or ‘‘nanoscale 

materials’’ and discussions of 

nanotechnology generally reflect the 

same common elements, namely: 

1. The material’s particle size 

measures typically between 

approximately 1 and 100 nm in at least 

one dimension; 

2. The material exhibits unique or 

novel properties compared to larger 

particles of the same material; and 

3. Rather than occurring naturally, the 

material has been manufactured or 

engineered at the nanoscale to take 

advantage of these unique properties. 

See, for example, the definition from the 

National Nanotechnology Initiative at: 

http://www.nano.gov/html/facts/ 

whatIsNano.html. 

These elements do not readily work in 

a regulatory context because of the high 

degree of subjectivity involved with 

interpreting such phrases as ‘‘unique or 

novel properties’’ or ‘‘manufactured or 

engineered to take advantage of these 

properties.’’ Moreover, the contribution 

of these subjective elements to risk has 

not been established. 

Instead, OPP will focus on more 

objective criteria in describing when 

information about a ‘‘nanoscale 

material’’ in a pesticide product may be 

relevant to determining whether the 

product has an unreasonable adverse 

environmental effect. Specifically, such 

information may be relevant in this 

context when the active or inert 

ingredient and any component parts 

thereof is intentionally produced to 

have at least one dimension that 

measures between approximately 1 and 

100 nanometers, regardless of the 

aggregation or agglomeration state of the 

final material. 

In determining whether an ingredient 

meets this description, EPA may review 

particle size data and, among other 

things, the manufacturing process to 

determine whether it employs processes 

specifically to create or enhance the 

proportion of nanoscale materials in the 

product, as compared with other 

processes used to produce similar 

products. The Agency generally expects 

that these ingredients may comprise, but 

are not limited to, metal-based (e.g., 

silver) and carbon-based (e.g., carbon 

nanotubes) nanoscale materials. The 

Agency does not, however, intend this 

description to cover biological materials 

(e.g., DNA, RNA, proteins) or materials 

in their natural state (e.g., clays). To the 

extent that the application of this 

description to a particular product or 

ingredient is unclear, EPA would review 

information provided by a registrant or 

applicant concerning the composition of 

the pesticide product and to provide an 

Agency view on whether the product 

did (or did not) contain a nanoscale 

material for purposes of this policy. 

B. Potential of Nanoscale Materials To 

Affect Human Health and the 

Environment 

There is a growing body of scientific 

evidence showing that differences can 

exist between nanoscale material(s) and 

their non-nanoscale counterpart(s) (Ref. 

1). Nanoscale materials may have 

different or enhanced properties—for 

example, electrical, chemical, magnetic, 

mechanical, thermal, or optical 

properties—or features, such as 

improved hardness or strength, that are 

highly desirable for applications in 

commercial, medical, military, and 

environmental sectors (Ref. 2). These 

properties are a direct consequence of 

small size, which results in a larger 

surface area per unit of volume and/or 

quantum effects that occur at the 

nanometer scale (i.e., 1 x 0¥9 meters). 

Small size itself is also a desirable 

property of nanoscale materials that is 

exploited for miniaturization of 

applications/processes and/or 

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stabilization or delivery of payloads to 

diverse environments or incorporation 

into diverse products. 

Nanoscale materials have a range of 

potentially beneficial public and 

commercial applications, including 

medicine and public health, clean 

energy through more efficient solar 

panels, pollution reduction and 

environmental cleanup, and improved 

products such as stronger, lighter, and 

more durable or conductive materials. 

These benefits arise from the distinctive 

properties of nanoscale materials, in 

that they are potentially more 

interactive or durable than other 

chemicals as a result of their size and 

composition. EPA sees the emergence of 

nanoscale materials as offering potential 

benefits for society in many different 

fields, including pest control products. 

The use of nanoscale materials in 

pesticide products and treated articles 

may allow for more effective targeting of 

pests, use of smaller quantities of a 

pesticide, and minimizing the frequency 

of spray-applied surface disinfection. 

These could contribute to improved 

human and environmental safety and 

could lower pest control costs. For 

example, as a materials preservative, 

nanosilver should maintain its efficacy 

longer and require smaller quantities 

than other silver preservatives due to an 

expected gradual and controlled release 

of silver as opposed to the rapid release 

of for example, silver from a zeolite 

structure or the immediate dissolution 

of a silver salt. Therefore EPA seeks to 

encourage innovative work in 

developing nanoscale materials to 

realize these benefits. 

However, a number of organizations 

have considered whether the small size 

of nanoscale materials or the unique or 

enhanced properties of nanoscale 

materials may, under specific 

conditions, pose new or increased 

hazards to humans and the 

environment. Government, academic, 

and private sector scientists in multiple 

countries are performing research into 

the human health effects of diverse 

nanoscale materials, resulting in a 

substantial and rapidly growing body of 

scientific evidence. Recently, 

governmental and expert peer review 

organizations have reviewed and 

summarized this evidence and offered 

views about the implications of this 

evidence for environmental and human 

health and safety. 

For instance, in 2009, the National 

Institute of Occupational Safety and 

Health (NIOSH) issued a report, 

‘‘Approaches to Safe Nanotechnology: 

Managing the Health and Safety 

Concerns Associated with Engineered 

Nanomaterials,’’ which summarized the 

available scientific information about 

nanoscale materials and identified the 

following potential health and safety 

properties: 

• Nanomaterials have the greatest potential 

to enter the body through the respiratory 

system if they are airborne and in the form 

of respirable-sized particles (nanoparticles). 

They may also come into contact with the 

skin or be ingested. 

• Based on results from human and animal 

studies, airborne nanoparticles can be 

inhaled and deposit in the respiratory tract; 

and based on animal studies, nanoparticles 

can enter the bloodstream, and translocate to 

other organs. 

• Experimental studies in rats have shown 

that equivalent mass doses of insoluble 

incidental nanoparticles are more potent than 

large particles of similar composition in 

causing pulmonary inflammation and lung 

tumors. Results from in vitro cell culture 

studies with similar materials are generally 

supportive of the biological responses 

observed in animals. 

• Experimental studies in animals, cell 

cultures, and cell-free systems have shown 

that changes in the chemical composition, 

crystal structure, and size of particles can 

influence their oxidant generation properties 

and cytotoxicity. 

• Studies in workers exposed to aerosols of 

some manufactured or incidental 

microscopic (fine) and nanoscale (ultrafine) 

particles have reported adverse lung effects 

including lung function decrements and 

obstructive and fibrotic lung diseases. The 

implications of these studies to engineered 

nanoparticles, which may have different 

particle properties, are uncertain. 

• Some nanomaterials may initiate 

catalytic reactions depending on their 

composition and structure that would not 

otherwise be anticipated based on their 

chemical composition. (Ref. 3). 

Earlier the same year, the Scientific 

Committee on Emerging and Newly 

Identified Health Risks (SCENIHR), an 

independent scientific committee 

advising the European Commission’s 

Health and Consumer Directorate, 

issued a report, ‘‘Risk assessment of 

products of nanotechnologies.’’ The 

SCENIHR report identified properties 

similar to those identified in the NIOSH 

report: 

Some specific hazards, discussed in the 

context of risk for human health, have been 

identified. These include the possibility of 

some nanoparticles to induce protein 

fibrillation, the possible pathological effects 

caused by specific types of carbon nanotubes, 

the induction of genotoxicity, and size effects 

in terms of biodistribution. 

and: 

For some nanomaterials, toxic effects on 

environmental organisms have been 

demonstrated, as well as the potential to 

transfer across environmental species, 

indicating a potential for bioaccumulation in 

species at the end of that part of the food 

chain. 

(Ref. 4). 

In another recent survey of scientific 

research on nanoscale materials, the 

authors reported: 

Many studies have examined the proinflammatory effects of manufactured NPs 

[nanoparticles], on the basis that their ability 

to cause inflammation is a major predictor of 

potential hazard in such particles. The first 

important finding was that NPs have a more 

pronounced effect on inflammation, cell 

damage and cell stimulation than an equal 

mass of particles of the same material of 

greater size [* * *]. This appears to hold true 

for materials as varied as carbon black, 

titanium dioxide, various metals and 

polystyrene [* * *]. Surface area is the 

metric driving the pro-inflammatory effects 

and this is evident both in vitro [* * *] and 

in vivo [* * *], particles of various sizes 

producing inflammatory effects that are 

directly related to the surface area dose. 

(Ref. 5 [reference numbers in the 

original were omitted]). 

Other reports in the scientific 

literature have indicated that some 

nanoscale materials may cross the 

placental barrier (Ref. 6) or translocate 

to diverse organs following oral 

exposure (Ref. 7). Once in these diverse 

sites and organs, the large surface area 

of nanoscale materials may facilitate 

increased reactivity and/or an 

inflammatory response, resulting in 

toxic effects. 

Two recent literature surveys describe 

a broad range of effects in nonmammalian species following exposure 

to nanoscale materials (Refs. 8 and 9). 

These include, for example, increased 

ventilation rates, mucus production, 

and pathologies, and related alteration 

of enzyme activities and indicators of 

oxidative stress in rainbow trout, 

Oncorhyncus mykiss (Refs. 10 and 11), 

and ingestion and accumulation of 

nanoscale material in the digestive tract, 

as well as mortality, increased heart 

rates, and reduced fecundity in Daphnia 

magna (Refs. 12, 13, and 14). 

Translocation of nano-scale materials 

from gill and gut surface to blood and 

other organs in exposed Medaka, 

Oryzius latipes, has also been reported 

(Ref. 15) and carbon nanotubes, 

although unable to cross the egg surface, 

have been shown to delay hatching in 

zebrafish, Danio rerio (Ref. 16). A recent 

review of lethal effects and 

concentrations determined for a wide 

variety of species showed that some 

nanoscale materials, including nanotitanium, nano-zinc oxide, nano-silver, 

nano-copper oxide, C60, and single- and 

multi-walled carbon nanotubes, would 

be classified as harmful to extremely 

toxic to non-mammalian species (Ref. 

17). 

While the reports and articles cited 

previously have focused primarily on 

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differences between nanoscale material 

and conventionally sized material of the 

same substances, EPA has also 

consulted with the FIFRA Scientific 

Advisory Panel (SAP) on the extent to 

which different types of nanoscale 

materials may display different 

properties. (The SAP is a Federal 

advisory committee consisting of 

external, independent, expert, scientific 

peer reviewers who provide advice to 

EPA on scientific issues involved in the 

regulation of pesticides.) In response to 

EPA questions on how size and other 

properties of nanoscale materials 

potentially affect risk and how to assess 

such risks, the SAP said: ‘‘Existing data 

clearly indicate that many properties of 

particles change with size, including 

rate of release of ionic forms of metal, 

reactivity or catalytic efficiency, 

Plasmon resonance, and quantum 

effects. * * * The effect of particle size 

on biological responses to particle 

exposure is less well defined.’’ (Ref. 18). 

The SAP also noted that ‘‘[o]ther 

physicochemical properties, such as 

shape, charge and surface coating, are 

also likely to impact biological response 

and environmental fate [of nanoscale 

materials]. * * * The lack of a clear 

understanding of how particle size and 

other physical properties affect hazard 

profiles led most Panel members to be 

unsupportive of bridging among silverbased materials with different 

properties.’’ (Ref. 18). 

It is important to emphasize that, 

while the conclusions described 

previously apply to the specific 

material(s) and or context in which the 

study was conducted, any individual 

type of nanoscale material may not 

display all or even any of the 

characteristics observed and reported 

for other nanoscale materials. In other 

words, some nanoscale materials may 

have properties which, for purposes of 

assessing the risk of a pesticide, are 

essentially identical to larger sized 

materials (or particles) of the same 

substance. Furthermore, nanoscale 

materials may also have properties that 

make them less risky, or more beneficial 

in some other way, than larger sized 

materials (or particles) of the same 

substance. So, it appears increasingly 

likely that there are few, if any, 

universal ‘‘nanoscale’’ effects, and the 

distinctive effects seen at nanoscale are 

specific to the properties of each 

material type under specific exposure 

scenarios. Thus, EPA does not regard 

the fact that an ingredient meets our 

description of a nanoscale material as 

evidence that a pesticide containing the 

ingredient would cause unreasonable 

adverse effects on the environment and 

thus would no longer meet the statutory 

standards for registration. Rather, the 

presence of a nanoscale material in a 

pesticide is grounds for EPA to consider 

the possible need for data to 

characterize the potential of the 

ingredient to pose risks. However, the 

registration status of a product would 

not change merely as a result of 

providing information to EPA about the 

presence of a previously-unreported 

nanoscale material. If, based on a 

science based assessment of the risks of 

the specific pesticide ingredients 

involved, EPA were to determine that 

the pesticide no longer met the criteria 

for registration, or that some change was 

needed in the conditions of use, EPA 

would conduct a separate action to 

notify the manufacturer of that 

determination, consistent with current 

FIFRA regulations. 

Finally, scientifically speaking, there 

currently is no bright line with respect 

to a size below (or above) which 

nanoscale materials do (or do not) 

exhibit properties that might be of 

interest in assessing whether a pesticide 

product has the potential to cause 

unreasonable adverse effects on the 

environment. Therefore, the precise size 

range in nanometers addressed by the 

policies proposed in this document 

might be revised in the future as new 

information becomes available. 

C. Nanoscale Materials and Pesticides 

The Agency has information 

indicating that the use of 

nanotechnology has started to expand 

into pesticide products, as it already has 

in many other fields. For instance, a 

number of companies have contacted 

EPA expressing an interest in obtaining 

registrations for pesticide products 

containing ingredients identified as 

nanosilver or nanosilver composite 

structures (jointly referred to as 

‘‘nanosilver’’), and several companies 

have submitted applications to register 

pesticides containing nanosilver. In 

addition, EPA now has information 

suggesting that there are other pesticide 

products currently registered and in the 

marketplace that contain nanosilver as 

an active ingredient. 

In order for EPA to fulfill its 

responsibilities to regulate pesticides 

under FIFRA, it needs to determine 

whether pesticidal products meet the 

statutory standards for registration. As 

summarized previously, EPA believes 

that what intentionally produced 

nanoscale materials are in a pesticide 

product, whether as an active or inert 

ingredient, is relevant to that 

determination. Accordingly, EPA is 

considering how to collect information 

not only about what nanoscale materials 

are in pesticide products, but also other 

information that may be relevant to the 

assessment of the potential of such 

pesticide products to cause 

unreasonable adverse effects on the 

environment. Such information may be 

important for EPA to determine whether 

EPA should continue the registration of 

a product, or amend, as appropriate, the 

terms and conditions of registration of a 

product. EPA is therefore soliciting 

public comment on two possible 

approaches for obtaining this 

information, as discussed in this 

document. 

IV. Information Relevant To Assessing 

the Presence of Nanoscale Materials in 

a Pesticide 

In light of the foregoing and in 

consideration of the potential for 

nanoscale material to cause different 

effects and to behave differently in the 

environment and within organisms from 

larger particles of the same substance, as 

well as from nanoscale materials with 

different characteristics (see Unit III.B.), 

EPA believes that any of the following 

types of information are relevant to 

assessing the potential of a pesticide to 

cause unreasonable adverse effects on 

the environment: 

• Any information concerning what 

nanoscale materials are present in 

pesticides, whether as an active 

ingredient or as an inert ingredient; 

• For any pesticide product that 

contains nanoscale material, whether 

active or inert, any existing information 

that characterizes the size and size 

distribution of the nanoscale material as 

measured in nanometers; 

• For any pesticide product that 

contains nanoscale materials, whether 

active or inert, any existing information 

that describes the manufacturing 

process used to produce the nanoscale 

material in whatever size range it is 

produced; 

• For any pesticide product that 

contains nanoscale materials, whether 

active or inert, and that also is or will 

be used for an end-use formulation that 

contain(s) a composite (e.g., the active 

ingredient is a matrix complex 

comprised of the nanoscale material(s) 

in combination with a carrier, such as 

silica or sulfur), any existing 

information that characterizes the size 

and size distribution of the composite; 

and 

• For any pesticide product that 

contains nanoscale materials, whether 

active or inert, any existing information 

that shows adverse effects at any level 

of exposure to the nanoscale material on 

humans or nontarget species, and/or 

that shows the levels or nature (e.g. 

routes, frequency, or life stage) of 

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potential human and environmental 

exposure. 

Importantly, the foregoing is not 

intended to be an exclusive list. To the 

extent that a registrant has a pesticide 

product that contains a nanoscale 

material, and in addition has any other 

existing information not captured in the 

previous list that pertains to, concerns, 

or otherwise relates to the nanoscale 

material and has the potential to raise 

questions about the continued 

registration of a product or the 

appropriate terms and conditions of a 

product registration, EPA is also 

considering whether this too should be 

submitted to the Agency. 

EPA will review information 

submitted concerning what nanoscale 

materials are present, including any 

existing information not previously 

provided to the Agency on size and size 

distribution, manufacturing process, 

and adverse effects. EPA will use this 

and product use information to 

determine if it raises any issues, not 

previously considered, regarding the 

product’s potential to cause 

unreasonable adverse effects on the 

environment. In some cases, EPA may 

determine that additional information is 

needed to assess such potential; in this 

case, additional data may be required 

including data on physical and 

chemical properties, rate of nanoscale 

material release, and acute, subchronic, 

and chronic toxicity to human and 

ecological receptors. 

V. Reporting the Presence of Nanoscale 

Materials in Pesticide Products 

As discussed in Units III. and IV. of 

this document, EPA believes that 

information about what nanoscale 

materials are in pesticide products is 

important to its assessment of whether 

pesticides meet the statutory standard 

for registration. EPA may require such 

information under either FIFRA section 

6(a)(2) or section 3(c)(2)(B). The Agency 

believes that announcing the 

applicability of FIFRA section 6(a)(2) to 

this type of information would be the 

most efficient and expedient 

administrative approach to obtaining 

existing information about nanoscale 

materials in pesticides, in which case 

any registrants with this type of 

information would be required to report 

it to EPA. The Agency is considering, 

however, an alternative approach under 

which it would issue DCIs under FIFRA 

section 3(c)(2)(B) to obtain this 

information, in which case registrants 

that received the DCI would be required 

to respond. This unit of the document 

discusses the two possible approaches 

and related procedures for obtaining 

information concerning nanoscale 

materials in pesticides. 

A. FIFRA Section 6(a)(2) 

As mentioned previously, FIFRA 

section 6(a)(2) and implementing 

regulations in 40 CFR part 159 require 

pesticide registrants to report certain 

information if that information: 

1. Is additional; 

2. Is factual; and 

3. Regards unreasonable adverse 

effects on the environment of the 

pesticide. 

Per 40 CFR 159.195, this includes 

information that, if correct, a registrant 

knows, or reasonably should know, 

would be regarded by EPA, either alone 

or in conjunction with other 

information about the pesticide, as 

raising concerns about the continued 

registration of a product or about the 

appropriate terms and conditions of 

registration of a product. 

Announcing the applicability of 

FIFRA section 6(a)(2) to information 

about nanoscale materials in pesticides 

would not mean that EPA is expanding 

its interpretation of FIFRA section 

6(a)(2) or changing its regulations. 

Rather, consistent with EPA’s section 

6(a)(2) regulations, EPA would be 

merely identifying a set of information 

that adds to the subset of reportable 

section 6(a)(2) data explicitly identified 

at present under the section 6(a)(2) 

regulations. 

Further, the Agency notes that the 

identification of information as 

reportable under FIFRA section 6(a)(2) 

does not mean that any particular 

pesticide or group of pesticides, to 

which such information pertains, poses 

a risk. Rather, the requirement merely 

indicates that EPA has determined that 

a particular type of information is 

relevant to, and may improve the 

Agency’s ability to assess, whether the 

pesticide would cause an unreasonable 

adverse environmental effect. 

As part of this approach, EPA would 

also require that any such information 

be reported in connection with any 

application to register a pesticide 

product containing any nanoscale 

material (40 CFR 152.50(f)(3)). As with 

the reporting obligation under FIFRA 

section 6(a)(2), EPA would consider the 

failure to provide these types of 

information with an application for a 

product containing nanoscale material 

to be a violation of FIFRA sections 

12(a)(2)(B)(ii) and 12(a)(2)(N). 

Agency regulations implementing 

FIFRA section 6(a)(2) provide that a 

registrant must submit information to 

EPA that is reportable under section 

6(a)(2) no later than the 30th calendar 

day after the registrant first possesses or 

becomes aware of the information (40 

CFR 159.155). In addition, a registrant is 

required to submit to EPA any section 

6(a)(2) information not explicitly 

covered under the section 6(a)(2) 

regulations if EPA has informed the 

registrant that such additional 

information has the potential to raise 

questions about the continued 

registration of a product or the 

appropriate terms and conditions of 

registration of a product (40 CFR 

159.195). 

After learning that EPA was 

considering relying on FIFRA 6(a)(2) to 

require reporting, some stakeholders 

raised questions about the use of FIFRA 

section 6(a)(2) to obtain this 

information. Even though, as stated 

above, EPA is not making a judgment 

that the presence of any particular 

nanoscale material poses a risk, it has 

been argued that use of the ‘‘adverse 

effects’’ reporting authority in FIFRA 

section 6(a)(2) could create a ‘‘stigma’’ 

for the nanotechnology industry. 

EPA does not believe that using 

FIFRA section 6(a)(2) to gather 

information on the presence of 

nanoscale materials in pesticide 

products would create a stigma for the 

nanotechnology industry. EPA’s 

longstanding interpretation of section 

6(a)(2) is that it is not limited to 

requiring reporting only of actual 

‘‘adverse effects’’ of pesticides, and its 

use does not imply that ‘‘adverse 

effects’’ actually have occurred, or even 

could occur, in connection with the 

pesticide or pesticide ingredient on 

which the information is being 

obtained. FIFRA section 6(a)(2) requires 

reporting of ‘‘additional factual 

information regarding unreasonable 

adverse effects on the environment,’’ 

where ‘‘unreasonable adverse effects on 

the environment’’ is specifically defined 

as a risk/benefit standard. EPA’s 

implementing regulations require 

reporting of a wide range of data, 

which—like information on nanoscale 

materials—are relevant to EPA’s risk/ 

benefit evaluations, but which do not 

indicate the pesticide causes any 

adverse effects. Any suggestion that this 

information gathering proposal implied 

an EPA position on the adverse effects 

of pesticides containing nanoscale 

materials would be a misinterpretation 

of EPA’s intent. 

It is further EPA’s position that 

merely filing an additional report under 

FIFRA section 6(a)(2) does not 

stigmatize pesticides and would not 

stigmatize any nanomaterials in 

pesticides, since filing such reports is 

quite common. On average, EPA 

receives 200 studies and 56,000 incident 

reports per year under this authority. In 

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fact, over the last 10 years, pesticide 

registrants have filed section 6(a)(2) 

reports on more than two-thirds of all 

pesticide active ingredients. 

Use of FIFRA section 6(a)(2) also 

would have only a minimal overall 

administrative burden for both EPA and 

industry. Under section 6(a)(2), only 

registrants who know that their 

products contain nanoscale materials 

would be required to report to EPA. 

Further, they would be required to 

report only the information they know 

about. Section 6(a)(2) does not require a 

registrant to generate new data or to 

seek out additional information. 

Further, registrants and applicants 

whose products do not contain 

nanoscale materials (or who do not 

know that their products contain 

nanoscale materials) would have no 

reporting obligation under FIFRA 

section 6(a)(2). Under this approach, 

EPA would be required to keep track of 

each response received under 6(a)(2), 

but would not otherwise need to 

prepare or track individual requests for 

the information. 

B. DCIs Under FIFRA Section 3(c)(2)(B) 

As an alternative to relying on FIFRA 

section 6(a)(2) to obtain information 

concerning nanoscale materials in 

pesticides, EPA is also considering 

issuing DCIs under FIFRA section 

3(c)(2)(B). The Agency has authority 

under FIFRA section 3(c)(2)(B) to issue 

a DCI notice to a pesticide registrant 

directing them to provide data ‘‘required 

to maintain in effect an existing 

registration of a pesticide * * *’’ The 

DCI notice is addressed to an individual 

registrant, specifically identifies the 

information or data that the registrant 

must provide, prescribes an initial 

response deadline of 90 days, and, if 

data are to be generated, it may 

prescribe a timeframe for generating and 

providing that data. Under FIFRA, EPA 

can suspend the registration of a 

pesticide if the registrant fails to 

respond to a DCI. 

As part of this alternate approach, 

EPA would also need to require the 

inclusion of this information with any 

application for registration of a pesticide 

product that contains a nanoscale 

material. EPA is reviewing whether this 

could be done under existing 

regulations or whether EPA would need 

to amend existing regulations to clarify 

that this information is required with 

any application for registration. As with 

the reporting obligation under FIFRA 

section 6(a)(2), EPA would consider the 

failure to provide these types of 

information with an application for a 

product containing nanoscale material 

to be a violation of FIFRA sections 

12(a)(2)(B)(ii) and 12(a)(2)(N). 

Since EPA’s goal is to identify what 

nanoscale materials are contained in 

products (and the products that contain 

them) and to gather existing information 

not previously provided to assess their 

safety, the DCI would need to require 

the kinds of information specified in 

Unit IV. of this document. Because such 

a request is not consistent with the Reregistration or Registration Review 

programs, the Agency would use the 

Enforcement and Unanticipated 

Circumstances category available in the 

currently approved Information 

Collection Request (73 FR 55072, 

September 24, 2008) (FRL–8719–3). 

Unless a registrant has already 

disclosed the presence of nanoscale 

material in all of its products, there 

currently is no way to identify with 

certainty what nanoscale materials are 

in products (and the products that 

contain them). Therefore, in order to 

identify what nanoscale materials are in 

products, EPA could initially send an 

individual Enforcement and 

Unanticipated Circumstances DCI order 

to each of the 1,716 currently registered 

pesticide producers. Under this 

approach each of these pesticide 

registrants would then be required to 

respond within 90 days by either 

providing the requested information 

about the nanoscale materials in their 

product(s) or certifying that their 

product(s) do not contain nanoscale 

materials. In addition to keeping track of 

each response like under FIFRA section 

6(a)(2), the approach under FIFRA 

section 3(c)(2)(B) could require EPA to 

also prepare and track the issuance of 

individual DCIs for each pesticide 

registrant, as well as determine and take 

any necessary enforcement actions for 

non-responders. EPA notes that only 

pesticide registrants receive DCIs; EPA 

would need to employ additional 

administrative procedures to ensure that 

applicants also provided such 

information. 

A variation on this approach would 

be for EPA to craft a DCI that would be 

more targeted and place less burden on 

industry and the Agency, possibly by 

not requiring a response from recipients 

of the DCI who do not have (or who do 

not know that they have) nanoscale 

material in their registered pesticide 

products. The Agency has not used such 

an approach with any DCI in the past; 

however, and a number of issues, 

including enforcement, would need to 

be addressed if it were to seek to do so 

here. EPA could also focus its initial 

data gathering on certain classes of 

pesticides that might be most likely to 

contain a nanoscale material that EPA 

would be interested in knowing about. 

EPA is interested in receiving comments 

on these variations. 

It is useful to note that while FIFRA 

section 6(a)(2) can be used to obtain 

existing information, the DCI approach 

under FIFRA section 3(c)(2)(B) allows 

the Agency to request that data be 

generated. If EPA uses FIFRA section 

6(a)(2) authority and the Agency learns, 

for instance, the identity of a nanoscale 

material present in a product, and 

subsequently determines that sufficient 

data are not available to support the 

continued registration of the pesticide, 

EPA could then use the DCI approach 

under FIFRA section 3(c)(2)(B) to gather 

such information. EPA must use the DCI 

approach if EPA intends to require a 

registrant to provide information which 

the registrant does not already possess. 

It is anticipated that some registrants 

will request that EPA review 

information to determine if their 

product contains nanoscale materials. 

To the extent that the description of 

nanoscale material to a particular 

product or ingredient is unclear, EPA 

will review information concerning the 

composition and manufacturing process 

of the pesticide product and, based on 

that information, the Agency will 

determine whether the product does (or 

does not) contain nanoscale material. 

It has been suggested that the use of 

a 3(c)(2)(B) approach would result in 

submission of information that only 

reflected the composition of registrants’ 

products at the time of their responses, 

but that EPA would need periodically to 

issue DCIs to ensure that registrants did 

not alter the composition of the 

products to add nanoscale materials 

after submitting their responses. EPA is 

interested in receiving comments on 

options whereby it can ensure 

registrants report what nanoscale 

materials are in products, regardless of 

when they are added to the pesticide. 

Under either the 6(a)(2) or the 

3(c)(2)(B) approach, DCIs targeted to 

individual pesticide products that 

contain specific nanoscale materials 

would likely be used in the future to 

collect more specific information or data 

about particular products. EPA would 

consider doing so on a case-by-case 

basis and would tailor any request for 

information accordingly. 

C. Amending the Pesticide Data 

Requirement Regulations 

Some stakeholders have suggested, as 

an alternative to relying on either FIFRA 

section 6(a)(2) or 3(c)(2)(B) DCIs to 

obtain information concerning 

nanoscale materials in pesticides, that 

EPA instead promulgate a regulation 

amending the data requirements in 40 

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CFR parts 158 and 161. The Agency 

could amend the data requirements to 

include disclosure of what nanoscale 

materials are present as part of the 

pesticide registration process. However, 

completing this action would not 

provide information on currently 

registered pesticide products. 

The Agency sees such proposed 

rulemaking with a broader scope in that 

it would address not only the basic 

information such as identifying what 

nanoscale materials are in products, but 

also many other types of data required 

for making safety evaluations. The 

Agency is currently making data need 

decisions on a case-by-case basis, and 

EPA is trying to tailor data requirements 

to the particular characteristics of each 

product. The Agency does not yet have 

the knowledge base typically gained 

through the registration process to 

support the development of specific 

data requirements that would be 

imposed broadly for the registration of 

pesticides containing nanoscale 

materials across all the application and 

use scenarios, as required for such a 

rulemaking. 

Although it could take considerable 

time to finalize and implement a rule 

establishing standard data requirements 

for pesticides containing nanoscale 

materials, and the Agency thus believes 

that this approach by itself would not 

generate information on nanoscale 

ingredients in pesticides in a timely 

manner, EPA also seeks comment on 

this approach. 

VI. Proposed Policy Regarding 

Classification of Applications Under 

FIFRA and PRIA for Products 

Containing Nanoscale Active and Inert 

Ingredients 

As discussed in more detail earlier in 

this document, under FIFRA, all 

pesticides must meet stringent statutory 

and regulatory standards before they are 

registered by the Agency and allowed to 

be marketed and sold. Pesticides 

containing nanoscale materials, whether 

as active or inert ingredients, must meet 

the same safety standards as other 

pesticides. Because of the large and 

increasing body of data described in 

Unit III.B. of this document 

demonstrating that size can alter the 

manner in which materials behave and, 

in turn, the potential risk to human 

health and the environment associated 

with such materials, EPA proposes to 

apply an initial presumption that active 

and inert ingredients, which are the 

nanoscale versions of non-nanoscale 

active and inert ingredients already 

present in registered pesticide products, 

are potentially different from those 

conventionally sized counterparts. 

Because the size, shape, and other 

characteristics of nanoscale ingredients 

are likely to vary widely, EPA also 

proposes to apply an initial 

presumption that nanoscale active and 

inert ingredients are potentially 

different even from other, alreadyregistered nanoscale versions of the 

same ingredients. As explained later in 

this document, however, applicants can 

overcome this presumption on a caseby-case basis. 

Historically, EPA has evaluated an 

application for registration of a pesticide 

product that claims to have the same 

composition and uses as a currently 

registered pesticide—a so-called ‘‘metoo application’’—under either the 

‘‘conditional’’ registration or 

‘‘unconditional’’ registration authorities 

in FIFRA section 3(c)(7) and section 

3(c)(5), respectively. In making the 

statutory determinations under section 

3(c)(7)(A)—whether the applicant’s 

product is identical or substantially 

similar to a currently registered 

pesticide or differs only in ways that 

would not significantly increase the risk 

of unreasonable adverse effects on the 

environment, and that approving the 

registration in the manner proposed 

would not significantly increase the risk 

of any unreasonable adverse effect on 

the environment—EPA has focused on 

whether the use patterns of the products 

are identical or similar and whether the 

ingredients present in the products have 

the same chemical structure and are 

present in about the same percentages. 

Until recently, EPA generally has not 

focused on the size of an ingredient as 

an attribute relevant to making the 

determinations under section 3(c)(7)(A). 

As noted previously, however, once 

the size of an ingredient is reduced 

below approximately 100 nm, a 

substance can exhibit different 

properties, and therefore it may also 

have different potential environmental 

health and safety properties. 

Accordingly, for a product containing 

an ingredient that is a nanoscale version 

of a conventionally sized active or inert 

ingredient contained in an alreadyregistered product, EPA may require 

additional data in order to determine 

that the nanoscale material differs only 

in ways that do not significantly 

increase the risk of unreasonable 

adverse effects on the environment and 

that approving the registration in the 

manner proposed would not 

significantly increase the risk of any 

unreasonable adverse effect on the 

environment, and/or require different 

terms and conditions for the 

registration. EPA is thus proposing that 

it not make the requisite findings absent 

specific information on the nanoscale 

material included in a pesticide product 

when the application relies on a 

comparison to a currently registered 

pesticide product containing either a 

non-nanoscale version of the same 

ingredient or another nanoscale version 

of the ingredient that has different 

characteristics. Under this approach, the 

Agency would follow the same thinking 

in making the statutorily required 

determinations under FIFRA section 

3(c)(7)(B) and 3(c)(7)(C), as well as 

FIFRA section 3(c)(5). 

For purposes of registration under 

FIFRA section 3(c)(5) or 3(c)(7), 

therefore, EPA would initially classify 

any application for registration of a 

pesticide product containing an active 

or inert ingredient that is a nanoscale 

material as an application for a ‘‘new’’ 

active or inert ingredient, even when 

another registered pesticide product 

contains a non-nanoscale form of the 

ingredient or a nanoscale form of the 

ingredient with different size 

dimensions or other properties. This 

initial presumption, however, could be 

rebutted on a case-by-case basis through 

the submission of, among other 

possibilities, bridging data or other 

information demonstrating to EPA’s 

satisfaction that the nanoscale material’s 

properties, which are relevant to 

assessing the potential risks to human 

health and the environment, are 

substantially similar to the properties of 

the already-registered non-nanoscale or 

already-registered nanoscale form of the 

material, or that the nanoscale material 

differs only in ways that do not 

significantly increase the risk of 

unreasonable adverse effects on the 

environment, and that approving the 

registration in the manner proposed 

would not significantly increase the risk 

of any unreasonable adverse effect on 

the environment. 

If an applicant could make this 

showing to EPA’s satisfaction, then the 

application would be processed as a 

‘‘me-too’’ application within the 

timeframes prescribed for such 

applications. However, if an applicant 

could not make this showing to EPA’s 

satisfaction, then EPA would process 

such products as new active ingredients 

or new inert ingredients and would 

complete its review within the 

timeframes prescribed for such 

applications. In those circumstances, 

the Agency would likely require the 

applicant to provide the types of data 

typically required for an assessment of 

the potential hazards and exposure to a 

new active or inert ingredient. Under 

this proposed policy, it would also 

follow that if a registrant wished to 

change the composition of its product to 

include a nanoscale version of a 

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material that EPA had previously 

approved in non-nanoscale form, the 

registrant would need to notify EPA and 

obtain EPA approval before making 

such a change in the composition of its 

product. However, as noted earlier, the 

registration status of a product would 

not change merely as a result of 

providing information to EPA about the 

presence of a previously-unreported 

nanoscale material. If EPA made an 

affirmative finding that a change in 

status or conditions of use was 

necessary, EPA would notify the 

registrant in accordance with applicable 

regulations and procedures. 

VII. Does this document contain 

binding requirements? 

This document seeks comments on 

how the Agency could use FIFRA 

section 6(a)(2) or FIFRA section 

3(c)(2)(B) to gain information on what 

nanoscale materials are in pesticides. 

Given that the Agency is seeking 

comment before determining its 

approach to obtaining information on 

what nanoscale materials are in 

pesticides, there are no binding 

requirements in this document. 

Once this document is finalized, the 

Agency’s policy for determining 

whether a nanoscale material is a new 

active or inert ingredient for purposes of 

both FIFRA and PRIA would be 

intended only as guidance to EPA 

personnel and decision-makers and to 

pesticide applicants. While the 

requirements in the statute and Agency 

regulations are binding on EPA and the 

applicants, the proposed policy 

described in this document would not 

be binding on EPA personnel, pesticide 

applicants, or the public. Accordingly, 

EPA may depart from the policy 

proposed herein if and when 

circumstances warrant. Likewise, 

pesticide applicants may assert that the 

proposed policy is not applicable to a 

specific pesticide or situation in which 

EPA may be expected to apply it. 

VIII. Questions for Comment 

The Agency is seeking public 

comment on several questions, 

including whether it should use the 

FIFRA section 6(a)(2) reporting 

obligation to obtain information on what 

nanoscale materials are in pesticide 

products or use FIFRA section 3(c)(2)(B) 

as described in this document to obtain 

such information. 

With respect to the scope of 

reportable information, EPA specifically 

invites comments on the following 

issues: 

1. In view of the Agency’s goal of 

identifying what nanoscale materials are 

in products so that EPA can determine 

whether it needs additional data to 

evaluate the products’ safety under 

FIFRA, should EPA change the 

description of a ‘‘nanoscale material’’? 

For example, should the size range 

remain ‘‘between approximately 1 and 

100 nm in one dimension’’? Are there 

other characteristics that EPA should 

consider, e.g., morphology, including 

shape and crystal structure; surface 

chemistry and reactivity; specific 

surface area, charge; solubility; 

conductive, magnetic, and optical 

properties? 

2. Should the reporting requirement 

apply only to nanoscale material that is 

‘‘intentionally produced to have at least 

one dimension that measures between 

approximately 1 and 100 nanometers,’’ 

or should it also apply to naturally 

occurring materials? Why? 

3. Is the meaning of ‘‘intentionally 

produced’’ sufficiently clear? If not, in 

what circumstances would the term be 

unclear and how might it be clarified? 

Would offering a consultation 

procedure—by which a registrant or 

applicant describes to EPA the 

production process that results in the 

presence of a material in the nanoscale 

size range, and EPA responds with a 

determination regarding whether 

reporting is required—be an acceptable 

approach to providing clarity? 

4. Should the reporting requirement 

apply to ingredients in pesticides that 

contain any amount of a nanoscale 

material, or should the requirement 

apply only if an ingredient contains 

more than a specified percentage (e.g., 

10%) of nanoscale material? If the latter, 

what should the specified percentage be 

and why? 

5. How should the reporting 

requirement apply to a pesticide 

manufacturer who purchases 

ingredients that may contain nanoscale 

material? 

6. Are there ways in which the 

description of ‘‘nanoscale materials’’ 

can be refined and clarified, including 

ways in which agglomeration and 

aggregation could be considered as well 

as suggestions for ways in which more 

subjective criteria, such as ‘‘unique or 

novel properties’’ can be incorporated 

into the screening criteria? 

7. Is EPA’s description of ‘‘nanoscale 

material’’ inconsistent with other 

definitions of nanoscale material or 

similar terms? If so, please comment on 

whether such differences create any 

regulatory issues. In particular, does the 

focus on ‘‘intentionally produced’’ 

materials create any such inconsistency 

with other definitions of nanoscale 

materials or similar terms? 

8. If a pesticide is identified as 

containing a particular nanoscale 

material, what would be the most useful 

next steps to inform EPA’s 

understanding of potential risks 

associated with the pesticide? Are there 

tests that could provide useful 

information toward an understanding of 

risk that would be common to all 

nanoscale materials, or should the data 

requirements necessarily be compoundand situation-specific? How should 

bioavailability be considered in 

determining testing requirements (e.g., 

are nano-particles respirable or bound to 

other components)? 

With respect to the proposed 

approaches, EPA is seeking comment on 

how to implement them to ensure 

efficient, effective, and timely review of 

applications. EPA specifically invites 

comments on the following issues: 

1. Is there a way to determine, in 

advance of receiving an application for 

registration of a product containing a 

nanoscale material, whether a particular 

kind of nanoscale material has 

properties that, for purposes of risk 

assessment, are essentially the same as 

larger sized materials of the same 

substance? If so, how would such 

determinations be made and on what 

would they be based? 

2. What kinds of information should 

EPA accept as demonstrating that a 

pesticide product containing a 

nanoscale ingredient is identical or 

substantially similar to a currently 

registered pesticide or differs only in 

ways that would not significantly 

increase the risk of unreasonable 

adverse effects on the environment, and 

that approving the registration in the 

manner proposed would not 

significantly increase the risk of any 

unreasonable adverse effect on the 

environment? 

3. Can you suggest any alternative(s) 

to the proposed approaches that would 

be equally or even more effective in 

addressing the status of nanoscale 

materials as new active or inert 

ingredients for purposes of both FIFRA 

and PRIA, keeping in mind the data 

showing that size, especially when 

reduced below approximately 100 nm, 

may alter the manner in which materials 

behave and, in turn, the potential risk to 

human health and the environment 

associated with such materials? 

With respect to the potential 

alternative ways of obtaining the needed 

information on what nanoscale 

materials are in pesticide products, EPA 

specifically invites comments on the 

following issues: 

1. Has EPA appropriately 

characterized in this document the 

current scientific understanding of the 

potential risks of nanoscale materials? If 

not, please comment on how to 

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35394 Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Proposed Rules 

characterize the potential risks of 

nanoscale materials. How would the 

perception of the risks of nanoscale 

materials differ depending on the 

approach used by EPA to require 

needed data on nanoscale materials in 

pesticides? How could EPA lessen the 

possibility that issuance of a final 

requirement to report what nanoscale 

materials are in pesticides will result in 

a public misunderstanding of the 

potential risks of nanotechnology more 

generally? 

2. Do commenters believe that 

identification of the nanoscale materials 

in pesticide products is relevant to 

EPA’s statutory determination regarding 

the potential for unreasonable adverse 

effects on the environment? Please 

provide the scientific or legal basis for 

your view. 

3. Has EPA characterized the 

alternative approaches with respect to 

which they would: (a) result in a 

misunderstanding of the potential risks 

posed by nanoscale materials; (b) result 

in the timely submission of needed 

information; and (c) impose burdens on 

pesticide companies, those whose 

products do, and do not, contain 

nanoscale materials? If not, please 

comment on those issues. 

4. If EPA uses FIFRA section 6(a)(2) 

to obtain the needed information on 

nanoscale materials in pesticides, how 

could the Agency ensure that its action 

is not mischaracterized or 

misunderstood as a determination that 

the mere fact that a pesticide contains 

nanoscale materials causes 

unreasonable adverse environmental 

effects? 

5. If EPA were to use DCIs to obtain 

the needed information on nanoscale 

materials in pesticides, how could EPA 

reduce both the burdens on registrants 

and on EPA, as well as the time required 

to complete such a process? For 

example, is it possible to reduce the 

burdens on registrants by targeting only 

certain types of products? If so, how 

would EPA determine which products 

should receive DCIs? 

6. What are the advantages and 

disadvantages of requesting information 

on nanoscale materials specifically 

versus requesting information on size 

distribution generally? (Note that either 

type of information could be collected 

under either the 6(a)(2) or the 3(c)(2)(B) 

approach, except that 6(a)(2) cannot be 

used to require the production of new 

information that does not already exist, 

while a collection under 3(c)(2)(B) must 

be directed to an individual registrant 

and requires a response.) Is identifying 

what nanoscale materials are in 

products a useful first step, or should 

EPA move towards immediate 

collection of more specific information, 

such as particle size distribution, on 

products that might contain nanoscale 

materials? Are there other physical and/ 

or chemical properties that might be 

equally or more important for assessing 

the potential of a pesticide to cause 

unreasonable adverse effects on the 

environment (e.g., morphology, 

including shape and crystal structure; 

surface chemistry and reactivity; 

specific surface area, charge; solubility; 

conductive, magnetic, and optical 

properties)? Should information on 

these properties be separately 

requested? What would be the value and 

burden of obtaining such information? 

1. If EPA were to use rulemaking to 

establish data requirements for 

pesticides containing nanoscale 

materials, what types of information 

should EPA use to determine 

appropriate data requirements? What 

types of studies should EPA require to 

evaluate a nanoscale material? 

2. When choosing an approach for 

obtaining needed data, how should EPA 

weigh considerations relating to the 

need to update its safety evaluations of 

currently marketed pesticides in a 

timely manner, the goal of ensuring 

marketplace equity, and the interest in 

minimizing the burdens on regulated 

entities? 

IX. References 

As indicated under ADDRESSES, a 

docket has been established for this 

document under docket ID number 

EPA–HQ–OPP–2010–0197. The 

following is a listing of the documents 

that are specifically referenced in this 

document. The docket includes these 

documents and other information 

considered by EPA, including 

documents that are referenced within 

the documents that are included in the 

docket, even if the referenced document 

is not physically located in the docket. 

For assistance in locating these other 

documents, please consult the technical 

contact person listed under FOR FURTHER

INFORMATION CONTACT. 

1. Oberdo ̈rster, G. et al. 2005. 

Nanotoxicology: an emerging discipline 

evolving from studies of ultrafine 

particles. Environmental Health 

Perspectives. (113):823–839. 

2. National Nanotechnology Initiative. 2011. 

Strategic Plan. http://www.nano.gov/ 

nnistrategicplan211.pdf. 

3. Department of Health and Human 

Services. Centers for Disease Control and 

Prevention. National Institute for 

Occupational Safety and Health. 

Approaches to Safe Nanotechnology: 

Managing the Health and Safety 

Concerns Associated with Engineered 

Nanomaterials. November 2009. http:// 

www.cdc.gov/niosh/docs/2009-125/pdfs/ 

2009-125.pdf. 

4. SCENIHR. 2009. Risk Assessment of 

Products of Nanotechnologies. European 

Commission. Directorate-General for 

Health and Consumers. Scientific 

Committee on Emerging and Newly 

Identified Risks, Brussels: 28th Plenary 

Meeting. January 19, 2009. http:// 

ec.europa.eu/health/ph_risk/ 

committees/04_scenihr/docs/ 

scenihr_s_01.pdf. 

5. Seaton, A. et al. 2010. Nanoparticles, 

human health hazard and regulation. J.R. 

Soc. Interface 7:S119–S129. http:// 

rsif.royalsocietypublishing.org/content/ 

early/2009/08/31/ 

rsif.2009.0252.focus.full#ref-14. 

6. Wick, P. et al. 2009. Barrier Capacity of 

Human Placenta for Nanosized 

Materials. Environ. Health Perspect. 

118:432–436.http://ehp.niehs.nih.gov/ 

members/2009/0901200/0901200.pdf. 

7. Kim, Y.S. et al. 2008. Twenty-Eight Day 

Oral Toxicity, Genotoxicity, and GenderRelated Tissue Distribution of Silver 

Nanoparticles in Sprague-Dawley Rats. 

Inhalation Toxicology. 20 (6):575–583. 

8. Handy et al. 2008. The ecotoxicology and 

chemistry of manufactured 

nanoparticles. Ecotoxicology 17:287– 

314. 

9. Klaine et al. 2008. Nanomaterials in the 

Environment: Behavior, Fate, 

Bioavailability, and Effects. Environ. 

Toxicol. Chem. 27: 1825–1851. 

10. Federici et al. 2007. Toxicity of titanium 

dioxide to rainbow trout (Oncorhynchus 

mykiss): Gill injury, oxidative stress, and 

other physiological effects. Aquat. 

Toxicol. 84:415–430. 

11. Smith et al. 2007. Toxicity of single 

walled carbon nanotubes on rainbow 

trout (Oncorhyncos mykiss): Respiratory 

toxicity, organ pathologies, and other 

physiological effects. Aquat. Toxicol. 

82:94–109. 

12. Lovern and Klaper. 2006. Daphnia magna 

mortality when exposed to titanium 

nanoparticles and fullerene (C60) 

nanoparticles. Environ. Toxicol. Chem. 

25:1132–1137. 

13. Oberdorster et al. 2006. Ecotoxicology of 

carbon-based engineered nanoparticles: 

effects of fullerene (C–60) on aquatic 

organisms. Carbon 44:1112–1120. 

14. Roberts et al. 2007. In vivo 

biomodification of lipidcoated carbon 

nanotubes by Daphnia magna. Environ. 

Sci. Technol. 41:3025–3029 

15. Kashiwada et al. 2006. Distribution of 

nanoparticles in the see-through Medaka 

(Oryzias latipes). Environ. Health 

Perspect. 114:1697–1702. 

16. Cheng et al. 2007. Effect of carbon 

nanotubes on developing zebrafish 

(Danio rerio) embryos. Environ. Toxicol. 

Chem. 26:708–716. 

17. Kahru and Dubourguier. 2010. Review: 

From ecotoxicology to 

nanoecotoxicology. Toxicology 269:105– 

119. 

18. FIFRA Science Advisory Panel (SAP). 

2010. ‘‘Evaluation of Hazard and 

Exposure Associated with Nanosilver 

and Other Nanometal Pesticide 

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Products.’’ Report from the FIFRA 

Scientific Advisory Panel Meeting of 

November 2009. http://www.epa.gov/ 

scipoly/sap/meetings/2009/november/ 

110309ameetingminutes.pdf. 

X. Applicable Statutory and Executive 

Order Reviews 

EPA submitted this document to the 

Office of Management and Budget 

(OMB) for review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Any changes made in 

response to OMB recommendations 

have been documented in the docket for 

this action as required by section 

6(a)(3)(E) of the Executive Order. 

The information collection 

requirements associated with reporting 

under FIFRA section 6(a)(2) as 

prescribed in 40 CFR part 159, subpart 

D are approved under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq. The approval is identified under 

OMB Control No. 2070–0039 and EPA 

ICR No. 1204. The information 

collection requirements associated with 

DCIs is approved under OMB Control 

No. 2070–0174 and identified by EPA 

ICR No. 2288. If EPA were to finalize a 

policy that required additional reporting 

of information not currently collected, 

or that substantively changed the 

burden for such reporting (for example 

if it resulted in a larger number of such 

reports than covered in current burden 

estimates), EPA would submit a request 

for revised PRA approval to OMB. 

The various other statutory and 

Executive Order review requirements 

that apply to a regulatory action do not 

apply to this action because this 

document is not a regulatory action and 

does not otherwise impose new 

requirements. As indicated previously, 

this document requests comment on 

several approaches for applying existing 

requirements in order to obtain 

information on nanoscale materials in 

pesticide products and presents the 

Agency’s proposed policy for 

determining whether a nanoscale 

material is a new active or inert 

ingredient for purposes of both FIFRA 

and PRIA. 

List of Subjects 

Environmental protection, 

Administrative practice and procedure, 

Nanotechnology, Pesticides and pests. 

Dated: June 8, 2011. 

Stephen A. Owens, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

[FR Doc. 2011–14943 Filed 6–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

mstockstill on DSK4VPTVN1PROD with PROPOSALS