21294 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Proposed Rules 

266. San Miguel. 

267. South San Juan Adjacent. 

268. Storm Peak. 

269. Treasure Mountain. 

270. Turkey Creek. 

271. Weminuche Adjacent. 

272. West Needles. 

273. Winter Hills/Serviceberry Mountain. 

White River National Forest 

274. Adam Mountain. 

275. Ashcroft. 

276. Assignation Ridge. 

277. Baldy Mountain. 

278. Basalt Mountain A. 

279. Basalt Mountain B. 

280. Berry Creek. 

281. Big Ridge to South Fork A. 

282. Big Ridge to South Fork B. 

283. Black Lake East. 

284. Black Lake West. 

285. Blair Mountain. 

286. Boulder. 

287. Budges. 

288. Buffer Mountain. 

289. Burnt Mountain. 

290. Chicago Ridge. 

291. Corral Creek. 

292. Crystal River. 

293. Deep Creek. 

294. Dome Peak. 

295. East Divide-Four Mile Park. 

296. East Vail. 

297. East Willow. 

298. Elk Creek B. 

299. Elliot Ridge. 

300. Fawn Creek-Little Lost Park. 

301. Freeman Creek. 

302. Gallo Hill. 

303. Game Creek. 

304. Grizzly Creek. 

305. Gypsum Creek. 

306. Hardscrabble. 

307. Hay Park. 

308. Holy Cross City. 

309. Homestake. 

310. Hoosier Ridge. 

311. Housetop Mountain. 

312. Hunter. 

313. Little Grand Mesa. 

314. Lower Piney. 

315. Mamm Peak. 

316. Maroon East. 

317. Maryland Creek. 

318. McClure Pass. 

319. McFarlane. 

320. Meadow Mountain A. 

321. Meadow Mountain B. 

322. Morapos A. 

323. Morapos B. 

324. Mormon Creek. 

325. No Name. 

326. North Elk. 

327. North Independent A. 

328. North Independent B. 

329. North Woody. 

330. Pagoda Peak. 

331. Piney Lake. 

332. Porcupine Peak. 

333. Ptarmigan A. 

334. Ptarmigan B. 

335. Ptarmigan C. 

336. Ptarmigan Hill A. 

337. Ptarmigan Hill B. 

338. Red Dirt A. 

339. Red Dirt B. 

340. Red Mountain. 

341. Red Table. 

342. Reno Mountain. 

343. Ripple Creek Pass-Trappers Lake. 

344. Ryan Gulch. 

345. Salt Creek. 

346. Sloan Peak. 

347. Spraddle Creek A. 

348. Spraddle Creek B. 

349. Sweetwater A. 

350. Sweetwater B. 

351. Tenderfoot Mountain. 

352. Tenmile. 

353. Thompson Creek. 

354. Tigiwon. 

355. Treasure Mountain. 

356. West Brush Creek. 

357. West Lake Creek. 

358. Wildcat Mountain. 

359. Wildcat Mountain B. 

360. Wildcat Mountain C. 

361. Williams Fork. 

362. Willow. 

363. Woods Lake. 

Dated: April 11, 2011. 

Jay J. Jensen, 

Deputy Under Secretary, NRE. 

[FR Doc. 2011–9119 Filed 4–14–11; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 158 

[EPA–HQ–OPP–2010–0670; FRL–8857–7] 

RIN 2070–AJ80 

Pesticides; Microbial Pesticide 

Definitions and Applicability; 

Clarification and Availability of Draft 

Test Guideline for Comment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: As promulgated, EPA’s 

regulations distinguish ‘‘isolates’’ and 

‘‘strains’’ in a confusing and non-obvious 

manner. This has resulted in significant 

uncertainty within the regulated 

industry. This proposed rule addresses 

this problem by proposing new 

regulatory language that clarifies the 

requirements applicable to new strains 

that are considered to be new active 

ingredients under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). EPA is also soliciting 

comment on a draft microbial pesticide 

test guideline, explaining the deposition 

of a sample in a nationally recognized 

culture collection data requirement, for 

comment. The revisions proposed in 

this rule also include several other 

minor corrections to words and 

references. The changes should enhance 

the ability of industry to efficiently 

manage their microbial pesticide 

registration submissions. 

DATES: Comments must be received on 

or before July 14, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0670, 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– 

0670. 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 

e-mail. 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 


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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: Rose 

Kyprianou, Field and External Affairs 

Division (7506P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–5354; fax number: 

(703) 305–5884; e-mail address: 

kyprianou.rose@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 a producer or 

registrant of a microbial pesticide 

product. This proposal also may affect 

any person or company who might 

petition the Agency for a tolerance or an 

exemption from the requirement of a 

tolerance for the residues of a microbial 

pesticide, holds a pesticide registration 

with an existing tolerance or tolerance 

exemption for a microbial pesticide, or 

is interested in obtaining or retaining a 

tolerance or tolerance exemption in the 

absence of a registration (i.e., an import 

tolerance or tolerance exemption for a 

microbial pesticide). Potentially affected 

entities may include, but are not limited 

to: 

• Pesticide and Other Agricultural 

Chemical Manufacturing (NAICS code 

325320), e.g., pesticide manufacturers or 

formulators of pesticide products, 

importers, or any person or company 

who seeks to register a pesticide or to 

obtain a tolerance or tolerance 

exemption for a pesticide. 

• Crop Production (NAICS code 111). 

• Animal Production (NAICS code 

112). 

• Food Manufacturing and Processing 

(NAICS 311). 

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. What is EPA’s authority for taking 

this action? 

This action is issued under the 

authority of sections 3, 5, 10, 12, and 25 

of the Federal, Insecticide, Fungicide, 

and Rodenticide Act (FIFRA), as 

amended, and section 408 of the Federal 

Food, Drug, and Cosmetic Act (FFDCA). 

III. What action is EPA taking? 

EPA is proposing several changes and 

corrections to the Microbial Pesticides 

data requirements (40 CFR part 158, 

subpart V). Two revisions are proposed 

to be made to text found in the 

Microbial Pesticides Definition and 

Applicability section (40 CFR 158.2100). 

The first is a correction, replacing ‘‘part’’ 

with ‘‘subpart’’ in 40 CFR 158.2100(c)(1). 

The other is a clarification, involving 

revisions to 40 CFR 158.2100(c)(2), and 

is in response to recent confusion over 

the distinction between isolates and 

strains and exactly how EPA is 

considering both of these terms. The 

clarification to 40 CFR 158.2100(c)(2) 

also proposes to include a requirement 

for the use of a unique identifier, as part 

of the microbial pesticide active 

ingredient taxonomic name, to allow for 

improved identification of companyspecific registered isolates. 

In conjunction with the change 

detailed for 40 CFR 158.2100(c)(2), EPA 

is also developing a draft microbial 

pesticide test guideline (OCSPP 

Guideline 885.1250) to explain the data 

requirement for the deposition of a 

sample in a nationally recognized 

culture collection, which is found in the 

tables in 40 CFR 158.2120(c) and 40 

CFR 158.2171(c); presently, there is no 

test guideline referenced in the tables 

for this requirement. A copy of this draft 

test guideline is in the docket for this 

action to solicit public comment. 

Additionally, to clarify this microbial 

deposition data requirement, EPA is 

proposing to add a test note to the 

aforementioned tables, emphasizing the 

need for the continuing maintenance of 

a culture deposit to ensure it remains 

available in case EPA requests a sample. 

Finally, EPA is proposing to remove 

incorrect references, in 40 CFR 158.2120 

and 40 CFR 158.2171, to a paragraph (e) 

that does not exist. 

The improved clarity and 

transparency of the information 

proposed as changes to 40 CFR part 158, 

subpart V should enhance the ability of 

industry to efficiently manage their 

microbial pesticide registration 

submissions. Applicants may save time 

and money by understanding the 


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standards and interpretations of the 

definitions for the data that are needed. 

Having all required studies and 

information available to EPA at the time 

of application may reduce potential 

delays in the registration process, 

thereby enabling registration of 

microbial pesticides sooner and 

allowing microbial pesticide products to 

enter the market faster. 

IV. Today’s Proposed Revisions 

A. Correcting the Statement in 40 CFR 

158.2100(c)(1) 

The Agency believes that 40 CFR 

158.2100(c)(1), after replacing ‘‘part’’ 

with ‘‘subpart,’’ should read as follows: 

‘‘This subpart applies to microbial 

pesticides as specified in paragraphs 

(c)(2), (3), and (4) of this section.’’ This 

section, as currently presented, could be 

misconstrued or interpreted to mean 

that all of 40 CFR part 158 applies to 

microbial pesticides and conflicts with 

the information presented in 40 CFR 

158.1(c)(3). 

B. Clarifying the Statement in 40 CFR 

158.2100(c)(2) 

The preamble of the final rule (71 FR 

60988, October 26, 2007), codifying the 

provision found at 40 CFR 

158.2100(c)(2), explained that 

registering a new isolate of an already 

registered microbial strain did not 

necessarily increase the amount of data 

needed to obtain such a registration. 

The following language is from that 

preamble: 

EPA carefully considered the comment 

raising the issue of whether an isolate 

occasionally could be evaluated to satisfy a 

subset of data requirements at a higher 

taxonomic level than strain level and 

whether an isolate might sometimes be 

included as part of a very similar strain. EPA 

believes the proposed microbial pesticide 

definition applicability provision is 

sufficiently flexible to ensure adequate 

consideration and data on new isolates, 

while allowing use of existing data to support 

registration if similar to an existing strain 

that is already registered. The wording of the 

provision relating to applicability of the 

microbial data requirements reads, ‘‘each new 

isolate of a microbial pesticide is treated as 

a new strain and must be registered 

independently of any similar registered 

microbial pesticide strain and supported by 

data required in this subpart.’’ This wording 

does not preclude the possibility of using 

data from another isolate to support the 

assessment if it can be shown that the two 

isolates are sufficiently closely related. In 

this way, it ensures that each isolate will be 

independently considered for registration 

purposes. The differences in taxonomy 

between different microorganism 

classifications, particularly for baculoviruses, 

would make any attempt to further clarify 

this provision very complex and potentially 

confusing as the systematic nomenclature of 

these organisms change over time. The 

Agency intends to use its best scientific 

judgment in each instance to determine if 

one isolate is sufficiently closely related to 

another isolate to allow sharing of data or 

waiving of data requirements. 

In this action, EPA is proposing new 

language for 40 CFR 158.2100(c)(2) to 

clarify that the use of the phrase ‘‘is 

treated as a new strain’’ was intended to 

illustrate that a new strain is considered 

to be a new active ingredient. EPA 

believes that this interpretation is 

consistent with its discussion in the 

2007 final rule preamble and with how 

EPA has been implementing this 

regulation. Moreover, in order to allow 

for improved identification of companyspecific registered isolates, these 

modifications will include a provision 

requiring use of a unique identifier as 

part of the microbial pesticide active 

ingredient taxonomic name (e.g., a 

culture collection deposit identification 

number or another unique identifier, 

such as company initials followed by a 

number). Currently registered microbial 

pesticide active ingredients would not 

have to conform to this identification 

provision until they go through the 

registration review process. 

C. Clarifying Particular Information 

Found in 40 CFR 158.2120 and 

158.2171 Through Development of a 

Draft Test Guideline 

In conjunction with the proposed 

change detailed for 40 CFR 

158.2100(c)(2) (see Unit IV.B.), EPA is 

also developing a draft microbial 

pesticide test guideline (OCSPP 

Guideline 885.1250) to explain the 

deposition of a sample in a nationally 

recognized culture collection data 

requirement, which is currently found 

in the tables in 40 CFR 158.2120(c) and 

40 CFR 158.2171(c). Presently, there is 

no test guideline referenced in the tables 

for this requirement. Instead, 

information on this data requirement is 

briefly mentioned at the end of the 

Microbial Pesticide Test Guideline for 

Manufacturing Process (OPPTS 

Guideline 885.1200): ‘‘A sample of 

registered [Microbial Pest Control 

Agents] MPCAs is to be maintained on 

deposit in a nationally recognized 

culture collection.’’ In 1996, this 

particular statement was transferred 

from the 1989 revision of Subdivision M 

of the Pesticide Assessment Guidelines 

(specifically 151A–11) to the Microbial 

Pesticide Test Guideline for 

Manufacturing Process (OPPTS 

Guideline 885.1200). The term 

‘‘maintained’’ was used because some 

culture collections will discard deposits 

after a certain time if they do not get 

subsequent requests to purchase 

samples from that deposit. In creating a 

distinct test guideline for the microbial 

deposition data requirement, EPA will 

provide a more easily found reference 

that can be added to the data 

requirement table. Furthermore, the 

draft test guideline will make clear that 

the deposition requirement is analogous 

to the submittal of samples data 

requirement (OPPTS Guideline 

830.1900), which established that 

chemical pesticides must be deposited 

in the EPA National Pesticide Standard 

Repository. Some of this background 

information was explained in the 

preamble to the proposed rule for Data 

Requirements for Microbial and 

Biochemical Pesticides (71 FR 12072, 

March 8, 2006): 

f. Submittal of samples. This provision is 

typically intended to enable EPA to identify 

the active ingredient and provide standards 

to governmental agencies needing to monitor 

chemical pesticide residues and is 

conditionally required (CR). The Agency 

proposes to require (R) these data as a 

product analysis requirement to be deposited 

in a nationally recognized culture collection 

to allow EPA to validate strain identity if 

issues arise (guideline 885.1200). 

Since the Agency does not have capacity 

to store the variety of microbial pesticides 

that may be submitted, EPA did not set up 

a nationally recognized culture collection. 

There are several nationally recognized 

culture collections in this country (and 

abroad) such as the American Type Culture 

Collection and a microbial collection 

maintained in Peoria, Ill., by the USDA. 

These facilities have a vast number of 

microbial and cell cultures that [the facilities] 

are dedicated to transferring, maintaining 

and identifying. Rather than duplicate this 

effort, EPA chose to refer microbial pesticide 

producers to these facilities who have the 

routine expertise to keep and distribute (or 

protect) microbial cultures. There is a certain 

element of required expertise but really the 

cost and small number of our microbial 

pesticides would make it prohibitively 

expensive for the Agency to do this 

collection rather than direct the companies to 

these specialized facilities. 

To clarify this microbial deposition 

data requirement, the Agency is 

proposing to add a test note to the tables 

in 40 CFR 158.2120 and 40 CFR 

158.2171, emphasizing the need for the 

continuing maintenance of a culture 

deposit to ensure it remains available in 

case the Agency requests a sample. 

D. Correcting Statements in 40 CFR 

158.2120 and 158.2171 

The current paragraphs (a) and (b) of 

both 40 CFR 158.2120 and 158.2171 

incorrectly reference a paragraph (e) that 

does not exist. EPA proposes to remove 

these incorrect references. Specifically, 

EPA proposes to do the following in 40 


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CFR 158.2120 and 158.2171: (1) Revise 

the last sentence of paragraph (a) for 

each of these sections to read as ‘‘Notes 

that apply to an individual test and 

include specific conditions, 

qualifications, or exceptions to the 

designated test are identified in 

paragraph (d) of this section’’ and (2) 

remove the last sentence in paragraph 

(b) for each of these sections. 

V. FIFRA Review Requirements 

Pursuant to FIFRA sections 25(a) and 

(d), EPA has submitted a draft of this 

proposed rule to the Committee on 

Agriculture in the House of 

Representatives, the Committee on 

Agriculture, Nutrition, and Forestry in 

the United States Senate, and the U.S. 

Department of Agriculture (USDA). 

The FIFRA Scientific Advisory Panel 

(SAP) and the USDA waived review of 

this proposed rule. The FIFRA SAP 

waived its review of this proposed rule 

because the significant scientific issues 

involved have already been reviewed by 

the SAP and additional review is not 

necessary. The SAP waived its review of 

this proposed rule on August 17, 2010. 

VI. Statutory and Executive Order 

Reviews 

This action only proposes to clarify 

the existing regulatory text to allow EPA 

and stakeholders a clearer 

understanding of 40 CFR part 158, 

subpart V. It does not otherwise propose 

to amend or impose any other 

requirements. The proposed rule will 

not otherwise involve any significant 

policy or legal issues and will not 

increase existing costs. As such, this 

action is not subject to review by the 

Office of Management and Budget 

(OMB) as a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Nor does it impose or change any 

information collection burden that 

requires additional review by OMB 

under the provisions of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

The information collection activities 

contained in the regulation are already 

approved under Information Collection 

Request (ICR) instruments related to the 

submission of data to EPA in order to 

establish a tolerance or an exemption 

from the requirement of a tolerance 

currently approved under OMB Control 

No. 2070–0024 (EPA ICR No. 0597), the 

activities associated with the 

application for a new or amended 

registration of a pesticide currently 

approved under OMB Control No. 2070– 

0060 (EPA ICR No. 0277), the activities 

associated with the application for an 

experimental use permit currently 

approved under OMB Control No. 2070– 

0040 (EPA ICR No. 0276), and the 

activities associated with the generation 

of data for regulatory review programs 

currently approved under OMB Control 

No. 2070–0174 (EPA ICR No. 2288). An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. The OMB control numbers for 

EPA’s regulations in 40 CFR are listed 

in 40 CFR part 9. 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), EPA hereby certifies 

that this proposed rule does not have a 

significant adverse economic impact on 

a substantial number of small entities. 

This action only proposes to clarify the 

existing regulatory text to allow EPA 

and stakeholders a clearer 

understanding of 40 CFR part 158, 

subpart V. It does not otherwise propose 

to amend or impose any other 

requirements. In general, EPA strives to 

minimize potential adverse impacts on 

small entities when developing 

regulations to achieve the 

environmental and human health 

protection goals of the statute and the 

Agency. EPA solicits comments 

specifically about potential small 

business impacts. 

State, local, and Tribal governments 

are rarely pesticide applicants or 

registrants, so this proposed rule is not 

expected to affect these governments. 

Accordingly, pursuant to Title II of the 

Unfunded Mandates Reform Act 

(UMRA) (2 U.S.C. 1531–1538), EPA has 

determined that this action is not 

subject to the requirements in sections 

202 and 205 because it does not contain 

a Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and Tribal governments, 

in the aggregate, or for the private sector 

in any one year. In addition, this action 

does not significantly or uniquely affect 

small governments or impose a 

significant intergovernmental mandate, 

as described in sections 203 and 204 of 

UMRA. For the same reasons, EPA has 

determined that this proposed rule does 

not have ‘‘federalism implications’’ as 

specified in Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), because it would not 

have substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in the 

Order. Thus, Executive Order 13132 

does not apply to this proposed rule. 

Nor does it have ‘‘Tribal implications’’ as 

specified in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

22951, November 9, 2000). EPA is not 

aware of any Tribal governments that 

are pesticide registrants. Thus, 

Executive Order 13175 does not apply 

to this action. 

Since this action is not economically 

significant under Executive Order 

12866, it is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), and Executive Order 

13211, entitled Actions Concerning 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). In addition, 

EPA interprets Executive Order 13045 

as applying only to those regulatory 

actions that concern health or safety 

risks, which is not the case in this 

proposed rule. 

This action does not involve technical 

standards that would require the 

consideration of voluntary consensus 

standards pursuant to section 12(d) of 

the National Technology Transfer and 

Advancement Act (NTTAA) (15 U.S.C. 

272). 

This action does not have an adverse 

impact on the environmental and health 

conditions in low-income and minority 

communities. Therefore, this action 

does not involve special consideration 

of environmental justice related issues 

as specified in Executive Order 12898, 

entitled Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

List of Subjects in 40 CFR Part 158 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 7, 2011. 

Lisa P. Jackson, 

Administrator. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 158—[AMENDED] 

1. The authority citation for part 158 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y; 21 U.S.C. 

346a. 

2. Amend § 158.2100 as follows: 

a. Revise paragraph (c)(1). 

b. Revise paragraph (c)(2). 

The revised text reads as follows: 


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§ 158.2100 Microbial pesticides definition 

and applicability. 

* * * * * 

(c) Applicability. (1) This subpart 

applies to microbial pesticides as 

specified in paragraphs (c)(2), (3) and (4) 

of this section. 

(2) Because of the potential for 

variation in microorganisms, each new 

isolate of a microbial pesticide is treated 

as a new active ingredient and must be 

registered independently of any 

similarly designated and already 

registered microbial pesticide active 

ingredient. Each new isolate for which 

registration is sought must have a 

unique identifier following the 

taxonomic name of the microorganism, 

and the registration application must be 

supported by data required in this 

subpart. This does not preclude the 

possibility of using data from another 

isolate, provided sufficient similarity is 

established, to support registration. 

* * * * * 

3. Amend § 158.2120 as follows: 

a. Revise paragraph (a). 

b. Revise paragraph (b). 

c. Revise paragraph (c). 

d. In paragraph (d), redesignate test 

notes 1 through 4 as 2 through 5, 

respectively, and add new test note 1. 

The revised and added text reads as 

follows: 

§ 158.2120 Microbial pesticides product 

analysis data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table 

to determine the product analysis data 

requirements and the substance to be 

tested for a particular microbial 

pesticide. Notes that apply to an 

individual test and include specific 

conditions, qualifications, or exceptions 

to the designated test are identified in 

paragraph (d) of this section. 

(b) Key. R = Required; CR = 

Conditionally required; NR = Not 

required; MP = Manufacturing-use 

product; EP = End-use product; TEP = 

Typical end-use product; TGAI = 

Technical grade of the active ingredient; 

All = All of the above. 

(c) Table. The following table shows 

the data requirements for microbial 

pesticides product analysis. The test 

notes are shown in paragraph (d) of this 

section. 

TABLE—MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS

Guideline No. Data requirement All use 

patterns 

Test substance 

Test notes 

MP EP 

Product Chemistry and Composition 

885.1100 ....... Product identity ............................................................................ R MP EP ..........................

885.1200 ....... Manufacturing process ................................................................. R TGAI and MP TGAI and EP ..........................

885.1250 ....... Deposition of a sample in a nationally recognized culture collection.R TGAI TGAI 1 

885.1300 ....... Discussion of formation of unintentional ingredients ................... R TGAI and MP TGAI and EP ..........................

Analysis and Certified Limits 

885.1400 ....... Analysis of samples ..................................................................... R TGAI and MP TGAI and EP 2 

885.1500 ....... Certification of limits ..................................................................... R MP EP ..........................

Physical and Chemical Characteristics 

830.6302 ....... Color ............................................................................................. R TGAI TGAI ..........................

830.6303 ....... Physical state ............................................................................... R TGAI TGAI ..........................

830.6304 ....... Odor ............................................................................................. R TGAI TGAI ..........................

830.6313 ....... Stability to normal and elevated temperatures, metals and 

metal ions.

R TGAI TGAI ..........................

830.6317 ....... Storage stability ............................................................................ R TGAI and MP TGAI and EP ..........................

830.6319 ....... Miscibility ...................................................................................... R MP EP 3 

830.6320 ....... Corrosion Characteristics ............................................................. R MP EP 4 

830.7000 ....... pH ................................................................................................. R TGAI TGAI ..........................

830.7100 ....... Viscosity ....................................................................................... R MP EP 5 

830.7300 ....... Density/relative density/bulk density (specific gravity) ................. R TGAI TGAI ..........................

(d) * * * 

1. Required for each isolate of a 

microbial pesticide. New isolates must 

be deposited with an agreement to 

ensure that the sample will be 

maintained and will not be discarded 

for the duration of the associated 

registration(s). 

* * * * * 

4. Amend § 158.2171 as follows: 

a. Revise paragraph (a). 

b. Revise paragraph (b). 

c. Revise paragraph (c). 

d. In paragraph (d), redesignate test 

notes 3 through 6 as 4 through 7, 

respectively and add a new test note 3. 

The revised and added text reads as 

follows: 

§ 158.2171 Experimental use permit 

microbial pesticides product analysis data 

requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table 

to determine the product analysis data 

requirements and the substance to be 

tested for a particular microbial 

pesticide. Notes that apply to an 

individual test and include specific 

conditions, qualifications, or exceptions 

to the designated test are identified in 

paragraph (d) of this section. 

(b) Key. R = Required; CR = 

Conditionally required; NR = Not 

required; MP = Manufacturing-use 

product; EP = End-use product; TEP = 

Typical end-use product; TGAI = 

Technical grade of the active ingredient; 

All = All of the above. 

(c) Table. The following table shows 

the data requirements for experimental 

use permit microbial pesticides product 

analysis. The test notes are shown in 

paragraph (d) of this section. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Proposed Rules 21299 

TABLE—EUP MICROBIAL PRODUCT ANALYSIS DATA REQUIREMENTS

Guideline No. Data requirement All use 

patterns 

Test substance 

Test notes 

MP EP 

Product Chemistry and Composition 

885.1100 ........ Product identity ............................................................................ R MP EP ..........................

885.1200 ........ Manufacturing process ................................................................ R TGAI and MP TGAI and EP 1, 2 

885.1250 ........ Deposition of a sample in a nationally recognized culture collection.R TGAI TGAI 3 

885.1300 ........ Discussion of formation of unintentional ingredients ................... R TGAI and MP TGAI and EP 2 

Analysis and Certified Limits 

885.1400 ........ Analysis of samples ..................................................................... R TGAI and MP TGAI and EP 2, 4 

885.1500 ........ Certification of limits .................................................................... R MP EP ..........................

Physical and Chemical Characteristics 

830.6302 ........ Color ............................................................................................ R TGAI TGAI ..........................

830.6303 ........ Physical state ............................................................................... R TGAI TGAI ..........................

830.6304 ........ Odor ............................................................................................. R TGAI TGAI ..........................

830.6313 ........ Stability to normal and elevated temperatures, metals and 

metal ions.

R TGAI TGAI ..........................

830.6317 ........ Storage stability ........................................................................... R TGAI and MP TGAI and EP ..........................

830.6319 ........ Miscibility ...................................................................................... R MP EP 5 

830.6320 ........ Corrosion characteristics ............................................................. R MP EP 6 

830.7000 ........ pH ................................................................................................ R TGAI TGAI ..........................

830.7100 ........ Viscosity ....................................................................................... R MP EP 7 

830.7300 ........ Density/relative density/bulk density (specific gravity) ................ R TGAI TGAI ..........................

(d) * * * 

3. Required for each isolate of a 

microbial pesticide. New isolates must 

be deposited with an agreement to 

ensure that the sample will be 

maintained and will not be discarded 

for the duration of the associated 

experimental use permit(s). 

* * * * * 

[FR Doc. 2011–9191 Filed 4–14–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 281 

[EPA–R10–UST–2011–0097; FRL–9296–1] 

Oregon: Tentative Approval of State 

Underground Storage Tank Program: 

Public Hearing Cancellation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule; cancellation of 

notice of public hearing. 

SUMMARY: This document cancels a 

public hearing on a proposed 

rulemaking relating to the State of 

Oregon’s application for final approval 

of its Underground Storage Tank (UST) 

Program under Subtitle I of the Resource 

Conservation and Recovery Act (RCRA). 

The Environmental Protection Agency 

did not receive any comments or a 

request for a public hearing. 

DATES: The public hearing originally 

scheduled for April 13, 2011 at 9 a.m. 

has been cancelled. 

FOR FURTHER INFORMATION CONTACT: 

Katherine Griffith, U. S. Environmental 

Protection Agency, Region 10, 1200 

Sixth Avenue, Suite 900, Mail Stop: 

OCE–082, Seattle, WA 98101, phone 

number: (206) 553–2901, e-mail: 

griffith.katherine@epa.gov. 

SUPPLEMENTARY INFORMATION: A notice 

of proposed rulemaking and a notice of 

public hearing that appeared in the 

Federal Register on Wednesday, March 

2, 2011 (76 FR 11404) announced that 

a public hearing was scheduled for 

April 13, 2011, at 9 a.m. at the United 

States Environmental Protection 

Agency, 805 SW. Broadway, Suite 500, 

Portland, Oregon 97205. 

The public comment period for the 

proposed rulemaking expired on April 

1, 2011. The notice of proposed 

rulemaking and notice of public hearing 

instructed those interested in testifying 

at the public hearing to submit a 

request. As of Monday, April 4, 2011, no 

one has requested to speak. Therefore, 

the public hearing scheduled for April 

13, 2011, is cancelled. 

Dated: April 8, 2011. 

Dennis J. McLerran, 

Regional Administrator, Region 10. 

[FR Doc. 2011–9184 Filed 4–14–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 355 

[EPA–HQ–SFUND–2010–0586; FRL–9295–6] 

RIN 2050–AF08 

Emergency Planning and Notification; 

Emergency Planning and List of 

Extremely Hazardous Substances and 

Threshold Planning Quantities 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to revise the 

manner by which the regulated 

community would apply the threshold 

planning quantities (TPQs) for those 

extremely hazardous substances (EHSs) 

that are non-reactive solid chemicals in 

solution form. Specifically, facilities 

with a solid EHS in solution would be 

subject to the Emergency Planning 

requirements if the amount of the solid 

chemical on-site, when multiplied by 

0.2, equaled or exceeded the lower 

published TPQ, based on data that 

shows less potential for the solid 

chemical in solution to remain airborne 

in the event of an accidental release. 

Previously, EPA assumed that 100% of 

the chemical could become airborne in 

the event of an accidental release. 

DATES: Comments must be submitted on 

or before June 14, 2011. 


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