Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 18995 

considered a decision in the review 

reversing an adverse determination of 

patentability as that phrase is used in 35 

U.S.C. 154(b)(2) as amended by section 

532(a) of the Uruguay Round 

Agreements Act, Public Law 103–465, 

108 Stat. 4809, 4983–85 (1994), and a 

final decision in favor of the applicant 

under paragraph (c)(3) of this section. A 

remand by a panel of the Board of 

Patent Appeals and Interferences shall 

not be considered a decision in the 

review reversing an adverse 

determination of patentability as 

provided in this paragraph if there is 

filed a request for continued 

examination under 35 U.S.C. 132(b) that 

was not first preceded by the mailing, 

after such remand, of at least one of an 

action under 35 U.S.C. 132 or a notice 

of allowance under 35 U.S.C. 151. A 

reopening of prosecution after a notice 

of appeal has been filed shall not be 

considered a decision in the review 

reversing an adverse determination as 

provided in this paragraph if appellant 

files a request to withdraw the appeal, 

an amendment pursuant to § 41.33 of 

this chapter canceling all of the claims 

on appeal, or a request for continued 

examination under 35 U.S.C. 132(b). 

* * * * * 

3. Section 1.702 is proposed to be 

amended by revising paragraph (e) to 

read as follows: 

§ 1.702 Grounds for adjustment of patent 

term due to examination delay under the 

Patent Term Guarantee Act of 1999 (original 

applications, other than designs, filed on or 

after May 29, 2000). 

* * * * * 

(e) Delays caused by successful 

appellate review. Subject to the 

provisions of 35 U.S.C. 154(b) and this 

subpart, the term of an original patent 

shall be adjusted if the issuance of the 

patent was delayed due to review by the 

Board of Patent Appeals and 

Interferences under 35 U.S.C. 134 or by 

a Federal court under 35 U.S.C. 141 or 

145, if the patent was issued under a 

decision in the review reversing an 

adverse determination of patentability. 

If an application is remanded by a panel 

of the Board of Patent Appeals and 

Interferences and the remand is the last 

action by a panel of the Board of Patent 

Appeals and Interferences prior to the 

mailing of a notice of allowance under 

35 U.S.C. 151 in the application or if the 

Office reopens prosecution after a notice 

of appeal has been filed but before any 

decision by the Board of Patent Appeals 

and Interferences and issues an Office 

action under 35 U.S.C. 132 or notice of 

allowance under 35 U.S.C. 151, the 

remand or issuance of an Office action 

under 35 U.S.C. 132 or notice of 

allowance under 35 U.S.C. 151 shall be 

considered a decision in the review 

reversing an adverse determination of 

patentability as that phrase is used in 35 

U.S.C. 154(b)(1)(C)(iii), and a final 

decision in favor of the applicant under 

§ 1.703(e). A remand by a panel of the 

Board of Patent Appeals and 

Interferences shall not be considered a 

decision in the review reversing an 

adverse determination of patentability 

as provided in this paragraph if there is 

filed a request for continued 

examination under 35 U.S.C. 132(b) that 

was not first preceded by the mailing, 

after such remand, of at least one of an 

action under 35 U.S.C. 132 or a notice 

of allowance under 35 U.S.C. 151. A 

reopening of prosecution after a notice 

of appeal has been filed shall not be 

considered a decision in the review 

reversing an adverse determination as 

provided in this paragraph if appellant 

files a request to withdraw the appeal, 

an amendment pursuant to § 41.33 of 

this title canceling all of the claims on 

appeal, or a request for continued 

examination under 35 U.S.C. 132(b). 

* * * * * 

4. Section 1.704 is amended by 

revising paragraph (d) to read as 

follows: 

§ 1.704 Reduction of period of adjustment 

of patent term. 

* * * * * 

(d)(1) A paper containing only an 

information disclosure statement in 

compliance with §§ 1.97 and 1.98 will 

not be considered a failure to engage in 

reasonable efforts to conclude 

prosecution (processing or examination) 

of the application under paragraphs 

(c)(6), (c)(8), (c)(9), or (c)(10) of this 

section if it is accompanied by a 

statement that each item of information 

contained in the information disclosure 

statement: 

(i) Was first cited in any 

communication from a patent office in 

a counterpart foreign or international 

application or from the Office and this 

communication was not received by any 

individual designated in § 1.56(c) more 

than thirty days prior to the filing of the 

information disclosure statement; or 

(ii) Is a communication that was 

issued by a patent office in a 

counterpart foreign or international 

application or by the Office and this 

communication was not received by any 

individual designated in § 1.56(c) more 

than thirty days prior to the filing of the 

information disclosure statement. 

(2) The thirty-day period set forth in 

paragraph (d)(1) of this section is not 

extendable. 

* * * * * 

Teresa Stanek Rea, 

Deputy Under Secretary of Commerce for 

Intellectual Property and Deputy Director of 

the United States Patent and Trademark 

Office. 

[FR Doc. 2011–8275 Filed 4–5–11; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 168 

[EPA–HQ–OPP–2009–0607; FRL–8862–2] 

RIN 2070–AJ53 

Pesticides; Regulation to Clarify 

Labeling of Pesticides for Export 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to revise the 

regulations on labeling of pesticides and 

devices intended for export. Internal 

review of the regulations revealed that 

the current regulations needed 

clarification and restructuring to 

increase understandability and ease of 

use. 

DATES: Comments must be received on 

or before June 6, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ—OPP–2009–0607, 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–2009– 

0607. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 


erowe on DSK5CLS3C1PROD with PROPOSALS-1
18996 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

available on-line at hitp:// 

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: Vera 

Au, Field and External Affairs Division 

(7506P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9069; fax number: (703) 305– 

5884; e-mail address: au.vera@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you export a pesticide 

product, a pesticide device, or an active 

ingredient used in producing a 

pesticide. Potentially affected entities 

may include, but are not limited to: 

Pesticide and other agricultural 

chemical manufacturing (NAICS code 

325320), e.g., Pesticides manufacturing, 

Insecticides manufacturing, Herbicides 

manufacturing, Fungicides 

manufacturing, etc. 

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 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. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or 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, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the agency taking? 

Section 17(a)(1) of the Federal 

Insecticide, Fungicide and Rodenticide 

Act (FIFRA) requires that unregistered 

pesticides and devices intended for 

export be subject to several provisions 

that include labeling, production 

reports, inspection of establishments, 

and reporting and recordkeeping. These 

provisions are contained in 40 CFR 

168.65 and 168.85. FIFRA section 17(a) 

further requires that exporters obtain a 

purchaser acknowledgement statement 

(PAS) before exporting an unregistered 

pesticide (but not a device). The 

requirements related to PAS are 

contained in 40 CFR 168.75. 

On February 18, 1993, regulations 

interpreting the FIFRA requirements 

about the export of unregistered 

pesticides and devices were published 

in the Federal Register (58 FR 9085) as 

subpart D of 40 CFR part 168. Subpart 

D implements FIFRA sections 17(a) and 

17(b). 

The current regulations in subpart D 

have not been changed since 1993. 

Recently, an EPA internal review 

determined that the 1993 regulations are 

not as clear as EPA intended and that 

the resulting ambiguity might have led 

to uncertainty in compliance. To clarify 

the regulations in order to aid 

compliance, EPA decided to propose 

adding a more specific labeling 

requirement. In addition, EPA is 

restructuring the regulations to increase 

ease of use. Clarification and 

restructuring of the current regulations 

are administrative actions with no 

significant policy issues. 

This proposed rule will supplement 

the requirements of 40 CFR 168.65 

Pesticide export label and labeling 

requirements. 

B. What is the agency’s authority for 

taking this action? 

EPA is authorized under FIFRA to 

regulate the sale, distribution, and use 


erowe on DSK5CLS3C1PROD with PROPOSALS-1
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 18997 

of pesticide products and devices 

through a licensing (registration) 

scheme. This action is issued under the 

authority of section 17 of FIFRA (7 

U.S.C. 136–136y). 

Executive Order 12988, entitled Civil 

Justice Reform (61 FR 4729, February 7, 

1996), requires agencies that are 

reviewing existing regulations take the 

necessary steps to eliminate drafting 

errors and ambiguity, minimize 

potential litigation, and provide a clear 

legal standard for affected conduct. 

III. Purpose and Scope of Proposal 

EPA is proposing to clarify, 

restructure, and add specificity to 

labeling regulations for the export of 

unregistered pesticide products and 

devices according to Executive Order 

12988 to eliminate ambiguity and 

simplify EPA regulations. This action is 

discretionary and is not subject to a 

statutory, judicial, or administrative 

deadline. Clarification, restructuring, 

and adding specificity will not change 

the substance of the current 

requirements. 

EPA is also proposing to include a 

specific indication that these 

requirements also pertain to 

unregistered export pesticide products 

and devices shipped between registered 

establishments operated by the same 

producer pursuant to 40 CFR 152.30(a). 

Section 152.30(a) states that an 

unregistered pesticide product 

transferred between registered 

establishments operated by the same 

producer must be labeled according to 

40 CFR part 156. However, there are 

additional label requirements at 

§ 168.65 that also apply to a subset of 

the products covered by § 152.30(a), 

specifically, unregistered export 

pesticide products. For example, part 

156 does not require that the label 

indicate that the pesticide product or 

device is not registered for use in the 

United States, while § 168.65 requires 

the statement ‘‘Not Registered for Use in 

the United States’’ to appear on the label 

of any unregistered export pesticide 

product or device. This statement may 

be further amplified by adding the 

reason for the unregistered status. For 

example: 

1. Not Registered for Use in the 

United States of America because the 

product is exempt from registration; 

2. Not Registered for Use in the 

United States of America because 

pesticide devices are not required to be 

registered; 

3. Not Registered for Use in the 

United States of America because [insert 

crop name] is not grown in the United 

States. 

EPA believes that including the 

information required by § 168.65 on the 

label while an export product moves 

within the United States prior to its 

actual export further protects public 

health and the environment by 

contributing to safer and more 

appropriate handling and distribution of 

unregistered pesticide products and 

devices. EPA also believes that 

unregistered pesticide products and 

devices intended for export must be 

clearly marked with the labeling 

according to § 168.65 to prevent them 

from inadvertently entering the U.S. 

market. EPA requests comment on the 

amplifications of the phrase ‘‘Not 

Registered for Use in the United States.’’ 

IV. Overview of Proposed Changes 

A. Clarification and Restructuring of 

Current Regulations 

The clarifications and added 

specificity are consistent with section 

1(b)(12) of Executive Order 12866; this 

section requires each agency to draft its 

regulations to be simple and easy to 

understand, with the goal of minimizing 

the potential for uncertainty and 

litigation arising from such uncertainty. 

Certainty can also contribute to 

increased compliance with the 

requirements. 

B. Definitions 

In order to clarify and distinguish 

between the labeling requirements for 

pesticide products from the 

requirements for pesticide devices, two 

definitions are proposed for 40 CFR part 

168, subpart D: Export pesticide 

product, and export pesticide device. 

Export pesticide products include 

registered export pesticide products and 

unregistered export pesticide products. 

The requirements for registered export 

pesticide products, unregistered export 

pesticide products, and export pesticide 

devices are presented in separate 

categories. This way the producer and/ 

or exporter can more easily determine 

the status of the product and follow the 

specific directions for its category. 

C. Labeling Export Shipments of 

Unregistered Pesticides and Devices 

Between Establishments Operated by 

Same Producer 

EPA believes the minimal identity 

and safety information required for 

export labeling in FIFRA section 

17(a)(1) is important in ensuring 

unregistered pesticide products and 

devices are properly identified during 

transportation both within the United 

States and upon arrival in the importing 

country. The current regulations in 40 

CFR 152.30(a) allow the transfer of 

unregistered pesticide products between 

registered establishments operated by 

the same producer. The notification of 

identity and safety measures of products 

intended for export is not only 

important between the time the 

unregistered pesticide product or device 

leaves a U.S. port and the time it arrives 

in the importing country; this labeling is 

equally important while the 

unregistered pesticide product or device 

is shipped between registered 

establishments operated by the same 

producer within the United States. 

EPA intended that the labeling 

requirements in § 168.65 be followed for 

each unregistered export pesticide 

product as it makes its way towards the 

importing country. However, the 

regulations promulgated in 1993 

inadvertently failed to explicitly state 

that the § 168.65 labeling requirements 

applied to unregistered pesticide 

products and devices intended for 

export as they move between registered 

establishments operated by the same 

producer in the United States, including 

transfers authorized by § 152.30(a). 

If the producer exports an 

unregistered pesticide product or device 

directly, then it is clear that the label 

that must accompany the unregistered 

pesticide product or device when it 

leaves the production facility must 

comply with § 168.65. 

The requirement to label the 

unregistered pesticide product and 

pesticide device as it begins to move 

between registered establishments 

operated by the same producer may 

transfer the responsibility for the label 

to the producer from the exporter/ 

reformulator/repackager if the latter was 

primarily responsible for the label 

before export. 

Therefore, EPA is proposing to 

explicitly require labeling as prescribed 

by § 168.65 to accompany the 

unregistered export pesticide product or 

device at all times, even when they are 

being shipped between registered 

establishments operated by the same 

producer. Section 168.65 has been 

replaced by a proposed new numbering 

of sections to accommodate the new 

categories of products and 

accompanying regulations. EPA invites 

public comment on the requirement for 

labeling unregistered pesticide products 

and devices being shipped between 

establishments operated by the same 

producer. 

V. Implementation 

This proposal addresses the future 

labeling of unregistered pesticide 

products and devices shipped between 

establishments operated by the same 

producer. The proposed labeling 


erowe on DSK5CLS3C1PROD with PROPOSALS-1
18998 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

requirements, once final, would apply 

to all pesticide products and devices 

intended for export that are produced 

after the effective date of the rule. The 

Agency believes that producers do not 

frequently redesign the labels they use 

on unregistered pesticide products and 

devices, so producers will have time to 

plan and implement any changes to 

their current products or practices. 

Therefore, the Agency is proposing an 

effective date of 1 year after the date of 

publication of the final rule. The 

Agency requests comment on the 

proposed effective date. 

VI. FIFRA Review Requirements 

In accordance with FIFRA section 

25(a), EPA submitted a draft of the 

proposed rule to the FIFRA Scientific 

Advisory Panel (SAP), the Secretary of 

Agriculture (USDA), and appropriate 

Congressional Committees. The FIFRA 

SAP waived its review of this proposal 

on December 8, 2010, because this 

proposal does not raise scientific issues. 

USDA waived the opportunity to review 

the draft proposal on November 29, 

2010, because clarification and 

restructuring of the current regulations 

are administrative actions with no 

scientific or policy issues. 

VII. Statutory and Executive Order 

Reviews 

A. Regulatory Planning and Review 

This action is not a ‘‘significant 

regulatory action’’ subject to review by 

the Office of Management and Budget 

(OMB) under the terms of Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). 

EPA has determined that the cost is 

minimal to comply with the new 

requirement that the unregistered 

pesticide product or device shipped 

between registered establishments 

operated by the same producer be 

labeled with the statement ‘‘Not 

Registered for Use in the United States.’’ 

This determination was made given that 

labeling is already in place under 

existing requirements and the burden of 

adding the additional statement to 

unregistered products or devices 

shipped between establishments would 

be negligible. EPA believes that this 

labeling change may be easily 

accomplished using commonly 

available word processing software; in 

addition, this label change does not 

require label submission to or approval 

by EPA, and shall be phased in as part 

of normal business operations. EPA 

concludes that the per firm and industry 

level impact of the rule is not 

significant. 

B. Information Collection Burdens 

This action does not impose any new 

information collection burden that 

would require additional review or 

approval by OMB under the Paperwork 

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

seq. OMB previously approved the 

information collection requirements 

contained in the existing regulations, 40 

CFR 168.65, and has assigned OMB 

control number 2070–0027 (EPA ICR 

No. 0161). Burden is defined at 5 CFR 

1320.3(b). An agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations in 40 CFR are displayed in 

the Federal Register and are listed in 40 

CFR part 9. 

C. Small Entity Impacts 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., the Agency hereby 

certifies that this action will not have a 

significant adverse economic impact on 

a substantial number of small entities. 

Under the RFA, small entities include 

small businesses, small organizations, 

and small governmental jurisdictions. 

For purposes of assessing the impacts of 

this proposed rule on small entities, 

small entity is defined in accordance 

with section 601 of the RFA as: 

1. A small business as defined by the 

Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201. A small 

business that manufactures pesticides 

and other agricultural chemicals as 

defined by NAICS code 325320, has 500 

or fewer employees based on the SBA 

standards. 

2. A small governmental jurisdiction 

that is a government of a city, county, 

town, school district or special district 

with a population of less than 50,000. 

3. A small organization that is any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field. 

The small entities directly regulated 

by this proposed rule are small 

manufacturers of pesticides which 

export unregistered pesticide products 

or devices. 

EPA has determined that the cost is 

minimal to comply with the new 

requirements that the unregistered 

pesticide product or device be labeled 

with ‘‘Not Registered for Use in the 

United States.’’ This is because the 

labeling is already in place under 

existing requirements and the burden of 

adding the additional statement to 

unregistered pesticide products or 

devices shipped between establishments 

operated by the same producer would 

be negligible. EPA believes this labeling 

change may be easily accomplished 

using commonly available word 

processing software; in addition, this 

label change does not require label 

submission to or approval by EPA, and 

shall be phased in as part of normal 

business operations. EPA concludes that 

the per firm and industry level impact 

of the proposed rule is insignificant. 

Although this proposed rule will not 

have a significant economic impact on 

a substantial number of small entities, 

EPA believes that increasing the 

specificity of the current regulations 

will minimally affect all manufacturers 

of export pesticide products and 

devices, not just small entities. The 

more specific indication that ‘‘Not 

Registered for Use in the United States’’ 

will be required while unregistered 

pesticides products and devices are 

shipped between establishments 

operated by the same manufacturer; this 

is the identical information that is 

required before the unregistered 

pesticide product or device is exported 

to another country. 

The Agency continues to be interested 

in the potential impacts of the proposed 

rule on small entities and welcome 

comments on issues related to such 

impacts. 

D. Unfunded Mandates 

This rule does not contain a Federal 

mandate as described in the Unfunded 

Mandates Reform Act (UMRA), 2 U.S.C. 

1531–1538, that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or the private sector in 

any one year. This action is expected to 

only affect producers, transporters, 

formulators, packagers, and exporters of 

unregistered pesticide products and 

devices but not resulting in 

expenditures of $100 million or more. 

Since no State, local, or tribal 

government is known to produce, 

transport, formulate, package, or export 

unregistered pesticide products or 

devices, this rule is not expected to 

affect State, local, and tribal 

governments individually, much less in 

the aggregate. Thus, this rule is not 

subject to the requirements of sections 

202 or 205 of UMRA. 

This rule is also not subject to the 

requirements of section 203 of UMRA 

because it contains no regulatory 

requirements that might significantly or 

uniquely affect small governments. 

Since no small government is known to 

produce, transport, formulate, package, 

or export unregistered pesticide 

products or devices, this rule is not 


erowe on DSK5CLS3C1PROD with PROPOSALS-1
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 18999 

subject to the requirements of section 

203 of UMRA. 

E. Federalism 

This action does not have federalism 

implications because it is not expected 

to have substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). This action is expected to only 

affect producers, transporters, 

formulators, packagers, and exporters of 

unregistered pesticide products and 

devices. Since no State or local 

government is known to produce, 

transport, formulate, package, or export 

unregistered pesticide products or 

devices, there is no effect on a State, the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Thus, Executive 

Order 13132 does not apply to this 

action. 

In the spirit of Executive Order 13132, 

and consistent with EPA policy to 

promote communications between EPA 

and State and local governments, EPA 

specifically solicits comment on this 

proposed action from State and local 

officials. 

F. Indian Tribal Implications 

This action does not have tribal 

implications, as specified in Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000). This action is expected to only 

affect producers, transporters, 

formulators, packagers, and exporters of 

unregistered pesticide products and 

devices. Since no Indian tribal 

government is known to produce, 

transport, formulate, package, or export 

unregistered pesticide products or 

devices, this action has no tribal 

implications. Thus, Executive Order 

13175 does not apply to this action. 

EPA specifically solicits additional 

comment on this proposed action from 

tribal officials. 

G. Children’s Health Protection 

EPA interprets Executive Order 

13045, entitled Protection of Children 

from Environmental Health Risks and 

Safety Risks (62 FR 19885, April 23, 

1997), as applying only to those 

regulatory actions that concern health or 

safety risks, such that the analysis 

required under section 5–501 of the 

Executive Order has the potential to 

influence the regulation. This action is 

not subject to Executive Order 13045 

because it does not establish an 

environmental standard intended to 

mitigate health or safety risks, nor is it 

an ‘‘economically significant regulatory 

action’’ as defined in Executive Order 

12866. The clarification and 

restructuring of current regulations for 

the export of unregistered pesticide 

products and devices do not present a 

disproportionate risk to children. 

Requiring that such unregistered 

pesticide products and devices shipped 

between establishments operated by the 

same producer be labeled according to 

the current regulations in § 168.65 

prevents them from inadvertently 

entering the U.S. market and provides 

compliance assistance. This 

requirement further protects public 

health and the environment by ensuring 

safe and appropriate handling and 

distribution without presenting a 

disproportionate risk to children. 

H. Effect on Energy Supply, Distribution 

or Use 

This action is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211, entitled Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001), because this 

action is not likely to have any effect on 

the supply, distribution, or use of 

energy. 

I. Technical Standards 

Because this action does not involve 

any technical standards, section 12(d) of 

The National Technology Transfer and 

Advancement Act of 1995 (NTTAA) (15 

U.S.C. 272 note), does not apply to this 

action. 

J. Environmental Justice 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). EPA has determined 

that this proposed rule will not have 

disproportionately high and adverse 

human health or environmental effects 

on minority or low-income populations 

because it increases the level of 

environmental protection for all affected 

populations without having any 

disproportionately high and adverse 

human health or environmental effects 

on any population, including any 

minority or low-income population. 

This rule is proposing to clarify, 

restructure, and add specificity to the 

current regulations and thus add an 

extra margin of safety for all affected 

populations as shipments of 

unregistered pesticides and devices 

move between establishments operated 

by the same producer. Labeling 

regulations at 40 CFR 152.30(a) 

currently require that an unregistered 

pesticide transferred between 

establishments operated by the same 

producer must follow labeling 

requirements in 40 CFR part 156. EPA 

believes that requiring the registration 

status information from 40 CFR168.65 

on the label further protects public 

health and the environment by 

contributing to safer and more 

appropriate handling and distribution of 

unregistered pesticide products and 

devices. EPA believes that unregistered 

pesticide products and devices intended 

for export must be clearly marked with 

the labeling according to § 168.65 to 

prevent them from inadvertently 

entering the U.S. market. 

List of Subjects in 40 CFR Part 168 

Environmental protection, Exports, 

Labeling, Pesticides and pests. 

Dated: March 25, 2011. 

Lisa P. Jackson, 

Administrator. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 168—STATEMENTS OF 

ENFORCEMENT POLICIES AND 

INTERPRETATION 

1. The authority citation for part 168 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y. 

§ 168.65 [Removed and Reserved]. 

2. Remove and reserve § 168.65. 

3. Add §§ 168.66 through 168.71 to 

read as follows: 

* * * * * 

Sec. 

168.66 Labeling of pesticide products and 

devices for export. 

168.67 Definitions. 

168.68 Applicability. 

168.69 Registered export pesticide 

products. 

168.70 Unregistered export pesticide 

products. 

168.71 Export pesticide devices. 

* * * * * 

§ 168.66 Labeling of pesticide products 

and devices for export. 

(a) This subpart describes the labeling 

requirements applicable to pesticide 

products and devices that are intended 

solely for export from the United States 

under the provisions of FIFRA sec. 

17(a). The requirements for pesticide 

production reporting, recordkeeping 

and inspection and purchaser 


erowe on DSK5CLS3C1PROD with PROPOSALS-1
19000 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

acknowledgement provisions can be 

found in the following parts: 

(1) Pesticide production reporting 

requirements under FIFRA sec. 7 are 

located in part 167 of this chapter (or 

§ 168.85(b)); 

(2) Recordkeeping and inspection 

requirements under FIFRA sec. 8 are 

located in part 169 of this chapter (or 

§ 168.85(a)); 

(3) Purchaser acknowledgement 

statement provisions under FIFRA sec. 

17(a) are located in § 168.75. 

(b) The required label information 

may be fully met by: 

(1) The product label attached to the 

immediate product; 

(2) The product label and 

supplemental labeling; or 

(3) Supplemental labeling that must 

be: 

(i) Attached at all times during 

shipping or while being held for 

shipping; or 

(ii) Attached to the immediate 

product container or to the shipping 

container. 

§ 168.67 Definitions. 

Terms used in this subpart have the 

same meaning as in the Act. The 

definitions of terms in § 152.3 of this 

chapter apply to this subpart unless 

defined in this section, 

Export pesticide device means a 

device, as defined in FIFRA sec. 2(h), 

that is intended solely for export from 

the United States to another country. 

Export pesticide product means a 

pesticide product, as defined in § 152.3 

of this chapter, that is intended solely 

for export from the United States to 

another country. 

§ 168.68 Applicability. 

This subpart applies to all export 

pesticide products and export pesticide 

devices regardless of the purpose of the 

export. 

§ 168.69 Registered export pesticide 

products. 

(a) Each export pesticide product that 

is registered under FIFRA sec. 3 or 

FIFRA sec. 24(c) must bear a label or be 

accompanied by labeling approved by 

EPA for its registration. 

(b) For the purposes of this subpart, 

a registered export pesticide product is 

considered to be any of the following: 

(1) A pesticide product of 

composition, packaging and labeling as 

described in its registration under 

FIFRA sec. 3; 

(2) A pesticide product that has been 

modified in compliance with the 

notification or non-notification 

provisions of § 152.46 of this chapter, 

and any associated procedures issued 

under § 156.10(e) of this chapter, 

regardless of whether such modification 

has been made for the pesticide 

product’s registration under FIFRA sec. 

3; 

(3) A pesticide product initially 

registered by a State under FIFRA sec. 

24(c), and whose Federal registration 

has not been disapproved by EPA under 

§ 162.164 of this chapter. 

(c) The text of the label or 

supplemental labeling of the registered 

pesticide product must be provided in 

one of the following languages besides 

English: 

(1) The language of the country of 

final destination, if known; 

(2) The language predominantly used 

in the importing country; or 

(3) The language in which official 

government business is conducted in 

the importing country. 

§ 168.70 Unregistered export pesticide 

products. 

(a) Any export pesticide product that 

does not meet the terms of § 168.69 is 

an unregistered export pesticide for 

purposes of this subpart. 

(b) Each unregistered export pesticide 

product must bear a label or be 

accompanied by supplemental labeling 

that complies with all requirements of 

this section and § 168.66(b). 

(1) The label or supplemental labeling 

must comply with all of the prominence 

and legibility requirements of 

§ 156.10(a)(2) of this chapter. 

(2) The label or supplemental labeling 

must comply with all the language 

requirements in § 168.69(c) and 

§ 156.10(a)(3) of this chapter. 

(3) The label or supplemental labeling 

must bear the following information: 

(i) The name and address of the 

producer, in accordance with the 

requirements of § 156.10(c) of this 

chapter; 

(ii) The net weight or measure of 

contents, in accordance with the 

requirements of § 156.10(d) of this 

chapter; 

(iii) The pesticide producing 

establishment number, in accordance 

with the requirements of § 156.10(f) of 

this chapter; 

(iv) An ingredients statement, in 

accordance with the requirements of 

§ 156.10(g) of this chapter, except that: 

(A) The ingredients statement need 

not appear in a second language besides 

English if the English language version 

is likely to be understood by the 

ordinary individual in the importing 

country; and 

(B) An export pesticide product 

intended solely for research and 

development purposes, (and which 

bears the statement ‘‘For research and 

development purposes only. Not for 

distribution, sale or use,’’ or similar 

language) may bear coded ingredient 

information to protect confidentiality. 

(v) Human health and precautionary 

statements in accordance with the 

requirements of subpart D of part 156 of 

this chapter. If a translated U.S. 

precautionary statement is 

inappropriate in the importing country, 

an equivalent statement appropriate to 

the importing country must be 

substituted; 

(vi) The statement ‘‘Not Registered for 

Use in the United States of America,’’ 

which may be amplified by additional 

statements describing the reason(s) why 

the export pesticide product is not 

registered in the United States, or is not 

registered for particular uses. 

(c) This section also applies to all 

unregistered pesticide products and 

devices that are transferred, distributed, 

or sold between registered 

establishments operated by the same 

producer under the exemptions 

provided by § 152.30(a) of this chapter 

if: 

(1) The transfer, distribution or sale 

occurs between a point in the United 

States and a point outside the United 

States, or 

(2) The transfer occurs within the 

United States solely for the purpose of 

export from the United States. 

§ 168.71 Export pesticide devices. 

(a) Each export pesticide device sold 

or distributed anywhere in the United 

States must bear a label or be 

accompanied by supplemental labeling 

that complies with all requirements of 

this section and § 168.66(b). 

(b) The label or supplemental labeling 

of each export pesticide device must 

meet all of the prominence and 

legibility requirements of § 156.10(a)(2) 

of this chapter. 

(c) The label or supplemental labeling 

must also comply with all the language 

requirements in § 168.69(c) and 

§ 156.10(a)(3) of this chapter. 

(d) The label or supplemental labeling 

must bear the following information: 

(1) The name and address of the 

producer, meeting the requirements of 

§ 156.10(c) of this chapter; 

(2) The producing establishment 

number, meeting the requirements of 

§ 156.10(f) of this chapter; 

(3) The statement ‘‘Not Registered for 

Use in the United States of America,’’ 

which may be amplified by additional 

statements describing the reason why 

the export pesticide device is not 

registered in the United States. 


erowe on DSK5CLS3C1PROD with PROPOSALS-1
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 19001 

(e) An export pesticide device is not 

required to bear an ingredients 

statement. 

[FR Doc. 2011–7900 Filed 4–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0174; FRL–8867–9] 

Sulfuryl Fluoride; Addendum to 

Proposed Order Granting Objections 

to Tolerances and Denying Request for 

a Stay; Extension of Comment Period 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed order and extension of 

comment period. 

SUMMARY: In this document, EPA is 

supplementing its proposed order 

published January 19, 2011, regarding 

sulfuryl fluoride and fluoride tolerances 

promulgated under the Federal Food, 

Drug, and Cosmetic Act (FFDCA) to 

include proposed effective dates for the 

termination of tolerances for rice 

commodities. In order to provide a 90- 

day comment period on the proposed 

effective date for terminating the rice 

tolerances, while also maintaining a 

consistent closing date for all comments 

on the proposed sulfuryl fluoride 

actions and accommodating several 

comment period extension requests, the 

Agency will accept comment on both 

the proposed order and this addendum 

for 90 days following publication of this 

notice in the Federal Register. In 

addition, EPA is clarifying that all 

tolerances for sulfuryl fluoride and the 

associated fluoride tolerances were 

intended to be covered by the proposed 

order despite discrepancies in the way 

those tolerances are described in EPA’s 

regulations. 

DATES: Comments must be received on 

or before July 5, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2005–0174, 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–2005– 

0174. 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: 

Meredith Laws, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–7038; e-mail address: 

laws.meredith@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, pesticide 

manufacturer, or consumer. Potentially 

affected entities may include, but are 

not limited to: 

• Food manufacturing (NAICS code 

311), e.g., grain and oilseed milling; 

animal food manufacturing; flour 

milling; bread and bakery product 

manufacturing; cookie, cracker, and 

pasta manufacturing; snack food 

manufacturing. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., pesticide 

manufacturers; commercial applicators. 

• Community Food Services (NAICS 

code 624210), e.g., food banks. 

• Farm Product Warehousing and 

Storage (NAICS 493130), e.g., grain 

elevators, private and public food 

warehousing and storage. 

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 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. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or 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 


erowe on DSK5CLS3C1PROD with PROPOSALS-1