Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29475 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0327; FRL–8826–2] 

Maneb; Proposed Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to revoke all 

the tolerances for the fungicide maneb 

because the Agency has approved 

requests for voluntary cancellation by 

registrants of the last registrations for 

the food uses of maneb in the United 

States. 

DATES: Comments must be received on 

or before July 26, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0327, 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– 

0327. 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 website 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: 

Joseph Nevola, Pesticide Re-evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8037; e-mail address: 

nevola.joseph@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, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit II.A. 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. 


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viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

C. What Can I do if I Wish the Agency 

to Maintain a Tolerance that the Agency 

Proposes to Revoke? 

This proposed rule provides a 

comment period of 60 days for any 

person to state an interest in retaining 

a tolerance proposed for revocation. If 

EPA receives a comment within the 60– 

day period to that effect, EPA will not 

proceed to revoke the tolerance 

immediately. However, EPA will take 

steps to ensure the submission of any 

needed supporting data and will issue 

an order in the Federal Register under 

section 408(f) of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), if needed. 

The order would specify data needed 

and the timeframes for its submission, 

and would require that within 90 days 

some person or persons notify EPA that 

they will submit the data. If the data are 

not submitted as required in the order, 

EPA will take appropriate action under 

FFDCA. 

EPA issues a final rule after 

considering comments that are 

submitted in response to this proposed 

rule. In addition to submitting 

comments in response to this proposal, 

you may also submit an objection at the 

time of the final rule. If you fail to file 

an objection to the final rule within the 

time period specified, you will have 

waived the right to raise any issues 

resolved in the final rule. After the 

specified time, issues resolved in the 

final rule cannot be raised again in any 

subsequent proceedings. 

II. Background 

A. What Action is the Agency Taking? 

EPA is proposing to revoke all the 

tolerances for residues of the fungicide 

maneb, manganous 

ethylenebisdithiocarbamate, because the 

Agency has approved requests for 

voluntary cancellation by registrants of 

the last registrations for food uses of 

maneb in the United States. These 

tolerances are associated with food uses 

that are no longer registered under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), and therefore 

are no longer needed. It is EPA’s general 

practice to propose revocation of those 

tolerances/tolerance exemptions for 

residues of pesticide active ingredients 

on crop uses for which there are no 

active registrations under FIFRA, unless 

any person submits comments on the 

proposal that indicate a need for the 

tolerance to cover residues in or on 

imported commodities or legally treated 

domestic commodities. 

EPA completed a Reregistration 

Eligibility Decision (RED) for maneb in 

2005, which included a tolerance 

reassessment summary for maneb. As 

part of the tolerance reassessment, the 

Agency recommended specific changes 

to the tolerance definition for maneb, 

changes to tolerance values, tolerances 

to be revoked, and new tolerances to be 

proposed to be established. EPA also 

reviewed any Codex Alimentarius 

maximum residue limits (MRLs) for 

maneb. Because Codex has no 

established MRLs for maneb per se, but 

groups MRLs for maneb with MRLs for 

dithiocarbamate pesticides expressed in 

terms of parts per million (ppm) carbon 

disulfide, EPA recommended 

harmonizing with Codex by changing 

the tolerance definition for maneb, so 

that it is expressed in terms of carbon 

disulfide. 

In the maneb RED, the Agency 

recommended revocation of certain 

maneb tolerances which still exist in 40 

CFR 180.110(a). Maneb use on certain 

crops was disallowed by EPA, as 

announced in a notice published in the 

Federal Register of March 2, 1992 (57 

FR 7484) (FRL–4045–8). In that notice, 

the Agency announced its conclusion of 

Special Review (PD4) regarding 

ethylene bisdithiocarbamate (EBDC) 

fungicides, including maneb, and its 

intent to cancel any EBDC product 

registrations bearing food uses that 

included, among others, apricots, 

succulent beans, carrots, celery, 

nectarines, and peaches. There have 

been no U.S. registrations for maneb use 

on apricots, succulent beans, nectarines, 

and peaches since 1992, and no U.S. 

registrations for maneb use on carrots 

and celery since 1994. Therefore, the 

maneb tolerances on these commodities 

are no longer needed and should be 

revoked. Consequently, EPA is 

proposing to revoke the tolerances in 40 

CFR 180.110(a) for maneb residues of 

concern in or on apricot; bean, 

succulent; carrot, roots; celery; 

nectarine; and peach. 

Subsequent to the RED, all maneb 

technical and end-use registrants chose 

to request voluntary cancellation of all 

U.S. registrations for maneb technical 

grade active ingredient and end-use 

maneb products. Registrants submitted 

their voluntary requests for cancellation 

of their maneb technical and product 

registrations to EPA in accordance with 

section 6(f) of FIFRA, and the Agency 

published notices of their receipt and 

subsequent cancellation orders in the 

Federal Register, which are summarized 

herein. 

In a Federal Register notice of 

September 12, 2008 (73 FR 53007) 

(FRL–8380–7), EPA announced receipt 

of a request from United Phosphorous 

Inc. to voluntarily cancel all of its 

maneb registrations. EPA accepted this 

request and published a cancellation 

order, for all United Phosphorous 

maneb products, in a Federal Register 

notice of August 26, 2009 (74 FR 

43124)(FRL–8429–6), effective on 

August 26, 2009. Under conditions of 

the cancellation order, United 

Phosphorous Inc. was permitted to sell 

and distribute existing stocks of the 

canceled maneb products until 

December 31, 2009. Also, this order 

permitted persons other than the 

registrant to sell and distribute existing 

stocks of the canceled maneb products 

until supplies were exhausted and 

formulate end use products until March 

2010. 

In a Federal Register notice of January 

6, 2010 (75 FR 860) (FRL–8806–3), EPA 

announced the Agency’s receipt of a 

request from Drexel Chemical Company 

to voluntarily cancel its technical 

registration for maneb and thereby 

terminate the last maneb technical 

product registered in the United States 

(EPA Reg. No. 19713–377). After the 

close of the 30–day comment period, 

EPA approved cancellation of this last 

maneb technical product, and issued a 

cancellation order in the Federal 

Register notice of February 24, 2010 (75 

FR 8340) (FRL–8813–9), effective on 

February 24, 2010. Under conditions of 

the cancellation order, Drexel Chemical 

Company was permitted to sell and 

distribute existing stocks of the canceled 

maneb technical product until February 

26, 2010 and formulate end-use 

products until March 10, 2010. Also, 

this order permitted persons other than 

the registrants to use the maneb end-use 

products until supplies are exhausted. 

In another Federal Register notice of 

January 6, 2010 (75 FR 869) (FRL–8806– 

2), EPA announced the Agency’s receipt 

of request from Drexel Chemical 

Company to voluntarily cancel its last 

maneb registrations. After the close of 

the 30–day comment period, EPA 

approved cancellation of the 

registrations, and issued a cancellation 

order in a Federal Register notice of 

February 26, 2010 (75 FR 8942) (FRL– 

8813–6), effective February 26, 2010. 

Under conditions of the cancellation 

order, Drexel Chemical Company was 

permitted to sell and distribute existing 

stocks of the canceled maneb products 

until supplies are exhausted. Also, this 

order permitted persons other than the 

registrants to sell, distribute, and use 

existing stocks of the canceled maneb 

products until supplies are exhausted. 

Also, in a Federal Register notice of 

March 4, 2010 (75 FR 9896) (FRL–8813– 

5), EPA announced the Agency’s receipt 


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of requests from DuPont Crop Protection 

to voluntarily cancel their maneb 

product registration (EPA Reg. No. 352– 

655), the last maneb product registered 

for use in the United States, thereby 

terminating the last maneb food uses in 

the United States. After the close of the 

30–day comment period, EPA approved 

cancellation of this product registration 

and issued a cancellation order in the 

Federal Register of April 16, 2010 (75 

FR 19967) (FRL–8822–2), effective on 

April 16, 2010. Under conditions of the 

cancellation order, DuPont Crop 

Protection was permitted to sell and 

distribute existing stocks of the canceled 

maneb product until supplies are 

exhausted. Also, this order permitted 

persons other than the registrants to sell, 

distribute, and use existing stocks of the 

canceled maneb product until supplies 

are exhausted. 

In the time since the last cancellation 

order, the Agency has received 

information from the registrants that 

significant levels of existing stocks of 

the canceled maneb products are 

unlikely. Therefore, the Agency believes 

that end users have had sufficient time 

to exhaust those existing stocks and for 

maneb treated commodities to have 

cleared the channels of trade. The 

termination of the last food uses means 

that the tolerances will no longer be 

needed and should be revoked. 

Consequently, EPA is proposing to 

revoke the tolerances in 40 CFR 

180.110(a) on almond; apple; banana 

(not more than 0.5 part per million shall 

be in the pulp after peel is removed and 

discarded (preharvest application 

only)); bean, dry, seed; beet, sugar, tops; 

broccoli; Brussels sprouts; cabbage; 

cabbage, Chinese, bok choy; cabbage, 

Chinese, napa; cauliflower; collards; 

corn, sweet, kernel plus cob with husks 

removed; cranberry; cucumber; 

eggplant; endive; fig; grape; kale; 

kohlrabi; lettuce; melon; mustard 

greens; onion; papaya; pepper; potato; 

pumpkin; squash, summer; squash, 

winter; tomato; turnip, greens; and 

turnip, roots. EPA is proposing that 

these revocations become effective on 

the date of publication of the final rule 

for maneb in the Federal Register. 

Because the time-limited tolerance 

associated with the use of maneb under 

a FIFRA section 18 emergency 

exemption for combined maneb 

residues of concern in or on walnut 

expired on December 31, 2009, it should 

be removed. Therefore, EPA is 

proposing to remove the expired 

tolerance in 40 CFR 180.110(b) on 

walnut. 

B. What is the Agency’s Authority for 

Taking this Action? 

A ‘‘tolerance’’ represents the 

maximum level for residues of pesticide 

chemicals legally allowed in or on raw 

agricultural commodities and processed 

foods. Section 408 of FFDCA, 21 U.S.C. 

346a, as amended by Food Quality 

Protection Act (FQPA) of 1996, Public 

Law 104–170, authorizes the 

establishment of tolerances, exemptions 

from tolerance requirements, 

modifications in tolerances, and 

revocation of tolerances for residues of 

pesticide chemicals in or on raw 

agricultural commodities and processed 

foods. Without a tolerance or 

exemption, food containing pesticide 

residues is considered to be unsafe and 

therefore ‘‘adulterated’’ under section 

402(a) of FFDCA, 21 U.S.C. 342(a). Such 

food may not be distributed in interstate 

commerce (21 U.S.C. 331(a)). For a fooduse pesticide to be sold and distributed, 

the pesticide must not only have 

appropriate tolerances under the 

FFDCA, but also must be registered 

under FIFRA (7 U.S.C. 136 et seq.). 

Food-use pesticides not registered in the 

United States must have tolerances in 

order for commodities treated with 

those pesticides to be imported into the 

United States. 

EPA’s general practice is to propose 

revocation of tolerances/tolerance 

exemptions for residues of pesticide 

active ingredients on crops for which 

FIFRA registrations no longer exist and 

on which the pesticide may therefore no 

longer be used in the United States. EPA 

has historically been concerned that 

retention of tolerances that are not 

necessary to cover residues in or on 

legally treated foods may encourage 

misuse of pesticides within the United 

States. Nonetheless, EPA will establish 

and maintain tolerances even when 

corresponding domestic uses are 

canceled if the tolerances, which EPA 

refers to as ‘‘import tolerances,’’ are 

necessary to allow importation into the 

United States of food containing such 

pesticide residues. However, where 

there are no imported commodities that 

require these import tolerances, the 

Agency believes it is appropriate to 

revoke tolerances for unregistered 

pesticides in order to prevent potential 

misuse. 

Furthermore, as a general matter, the 

Agency believes that retention of import 

tolerances not needed to cover any 

imported food may result in 

unnecessary restriction on trade of 

pesticides and foods. Under section 408 

of FFDCA, a tolerance/tolerance 

exemption may only be established or 

maintained if EPA determines that the 

tolerance is safe based on a number of 

factors, including an assessment of the 

aggregate exposure to the pesticide and 

an assessment of the cumulative effects 

of such pesticide and other substances 

that have a common mechanism of 

toxicity. In doing so, EPA must consider 

potential contributions to such exposure 

from all tolerances. If the cumulative 

risk is such that the tolerances in 

aggregate are not safe, then every one of 

these tolerances is potentially 

vulnerable to revocation. Furthermore, 

if unneeded tolerances are included in 

the aggregate and cumulative risk 

assessments, the estimated exposure to 

the pesticide would be inflated. 

Consequently, it may be more difficult 

for others to obtain needed tolerances or 

to register needed new uses. To avoid 

potential trade restrictions, the Agency 

is proposing to revoke tolerances/ 

tolerance exemptions for residues on 

crops uses for which FIFRA 

registrations no longer exist, unless 

someone expresses a need for such 

tolerances/tolerance exemptions. 

Through this proposed rule, the Agency 

is inviting individuals who need these 

import tolerances to identify themselves 

and the tolerances that are needed to 

cover imported commodities. 

Parties interested in retention of the 

tolerances/tolerance exemptions should 

be aware that additional data may be 

needed to support retention. These 

parties should be aware that, under 

section 408(f) of FFDCA, if the Agency 

determines that additional information 

is reasonably required to support the 

continuation of a tolerance, EPA may 

require that parties interested in 

maintaining the tolerances provide the 

necessary information. If the requisite 

information is not submitted, EPA may 

issue an order revoking the tolerance/ 

tolerance exemption at issue. 

C. When Do These Actions Become 

Effective? 

EPA is proposing that revocation of 

these maneb tolerances and removal of 

the expired maneb tolerance become 

effective on the date of publication of 

the final rule in the Federal Register. 

Most of the maneb tolerances proposed 

for revocation in this document are 

associated with uses that have been 

canceled in 2010. However, the 

available information on recently 

canceled maneb products indicates that 

significant levels of existing stocks are 

unlikely. Therefore, the Agency believes 

that existing stocks of maneb products 

labeled for uses associated with 

tolerances proposed for revocation have 

been completely exhausted and that 

maneb treated commodities have had 

sufficient time for passage through the 


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channels of trade. However, if EPA is 

presented with information that existing 

stocks would still be available and that 

information is verified, the Agency will 

consider that information prior to 

moving forward with tolerance 

revocation. If you have comments 

regarding existing stocks and whether 

the effective date allows sufficient time 

for treated commodities to clear the 

channels of trade, please submit 

comments as described under 

SUPPLEMENTARY INFORMATION. 

Any commodities listed in this 

proposal treated with the pesticides 

subject to this proposal, and in the 

channels of trade following the 

tolerance revocations, shall be subject to 

section 408(l)(5) of FFDCA, as 

established by FQPA. Under this unit, 

any residues of these pesticides in or on 

such food shall not render the food 

adulterated so long as it is shown to the 

satisfaction of the Food and Drug 

Administration that: 

1. The residue is present as the result 

of an application or use of the pesticide 

at a time and in a manner that was 

lawful under FIFRA, and 

2. The residue does not exceed the 

level that was authorized at the time of 

the application or use to be present on 

the food under a tolerance or exemption 

from tolerance. Evidence to show that 

food was lawfully treated may include 

records that verify the dates when the 

pesticide was applied to such food. 

III. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by section 408(b)(4) of FFDCA. 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, section 408(b)(4) of FFDCA 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for maneb per se. 

IV. Statutory and Executive Order 

Reviews 

In this proposed rule, EPA is 

proposing to revoke specific tolerances 

established under section 408 of 

FFDCA. The Office of Management and 

Budget (OMB) has exempted this type of 

action (e.g., tolerance revocation for 

which extraordinary circumstances do 

not exist) from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this proposed 

rule has been exempted from review 

under Executive Order 12866 due to its 

lack of significance, this proposed rule 

is not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This proposed rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations as required by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994); or OMB review or 

any other Agency action under 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Pursuant to 

the Regulatory Flexibility Act (RFA) (5 

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

previously assessed whether revocations 

of tolerances might significantly impact 

a substantial number of small entities 

and concluded that, as a general matter, 

these actions do not impose a significant 

economic impact on a substantial 

number of small entities. This analysis 

was published on December 17, 1997 

(62 FR 66020) (FRL–5753–1), and was 

provided to the Chief Counsel for 

Advocacy of the Small Business 

Administration. Taking into account 

this analysis, and available information 

concerning the pesticides listed in this 

proposed rule, the Agency hereby 

certifies that this proposed rule will not 

have a significant negative economic 

impact on a substantial number of small 

entities. In a memorandum dated May 

25, 2001, EPA determined that eight 

conditions must all be satisfied in order 

for an import tolerance or tolerance 

exemption revocation to adversely affect 

a significant number of small entity 

importers, and that there is a negligible 

joint probability of all eight conditions 

holding simultaneously with respect to 

any particular revocation. (This Agency 

document is available in the docket of 

this proposed rule). Furthermore, for the 

pesticide named in this proposed rule, 

the Agency knows of no extraordinary 

circumstances that exist as to the 

present proposal that would change the 

EPA’s previous analysis. Any comments 

about the Agency’s determination 

should be submitted to the EPA along 

with comments on the proposal, and 

will be addressed prior to issuing a final 

rule. In addition, the Agency has 

determined that this action will not 

have a substantial direct effect on 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). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that 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.’’ This proposed 

rule directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this 

proposed rule does not have any ‘‘tribal 

implications’’ as described in Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000). Executive Order 13175, 

requires EPA to develop an accountable 

process to ensure ‘‘meaningful and 

timely input by tribal officials in the 

development of regulatory policies that 

have tribal implications.’’ ‘‘Policies that 

have tribal implications’’ is defined in 

the Executive order to include 

regulations that have ‘‘substantial direct 

effects on one or more Indian tribes, on 

the relationship between the Federal 

Government and the Indian tribes, or on 


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the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

proposed rule will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this proposed rule. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 14, 2010. 

Steven Bradbury, 

Acting Director, Office of Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 180—[AMENDED] 

1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

§ 180.110 [Removed] 

2. Section 180.110 is removed. 

[FR Doc. 2010–12376 Filed 5–25–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 482 and 485 

[CMS–3227–P] 

RIN 0938–AQ05 

Medicare and Medicaid Programs: 

Proposed Changes Affecting Hospital 

and Critical Access Hospital (CAH) 

Conditions of Participation (CoPs): 

Credentialing and Privileging of 

Telemedicine Physicians and 

Practitioners 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise the conditions of participation 

(CoPs) for both hospitals and critical 

access hospitals (CAHs). These revisions 

would allow for a new credentialing and 

privileging process for physicians and 

practitioners providing telemedicine 

services. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 26, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–3227–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3227– 

P, P.O. Box 8010, Baltimore, MD 21244– 

1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3227–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. (Because 

access to the interior of the Hubert H. 

Humphrey Building is not readily 

available to persons without Federal 

government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is 

available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the 

comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

‘‘Collection of Information 

Requirements’’ section in this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: CDR 

Scott Cooper, USPHS (410) 786–9465. 

Marcia Newton, (410) 786–5265. Jeannie 

Miller, (410) 786–3164. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244, on Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. EST. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

Electronic Access 

This Federal Register document is 

also available from the Federal Register 

online database through GPO Access, a 

service of the U.S. Government Printing 

Office. Free public access is available on 

a Wide Area Information Server (WAIS) 

through the Internet and via 

asynchronous dial-in. Internet users can 

access the database by using the World 

Wide Web (the Superintendent of 

Documents’ home page address is 

http://www.gpoaccess.gov/index.html), 

by using local WAIS client software, or 

by telnet to swais.access.gpo.gov, then 

login as guest (no password required). 

Dial-in users should use 

communications software and modem 

to call (202) 512–1661; type swais, then 

login as a guest (no password required). 


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