52610 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 158 

[EPA–HQ–OPP–2010–0670; FRL–9338–9] 

RIN 2070–AJ80 

Pesticides; Microbial Pesticide 

Definitions and Applicability; 

Clarification and Availability of Test 

Guideline 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This final rule clarifies the 

distinction between ‘‘isolates’’ and 

‘‘strains,’’ and clarifies the requirements 

applicable to new isolates, which are 

considered to be new active ingredients 

under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA). Additional revisions to 

regulatory text include several minor 

corrections to words and references. 

Finally, EPA is announcing the 

availability of a final microbial pesticide 

test guideline that further explains the 

existing data requirement to deposit a 

sample in a nationally recognized 

culture collection. Collectively, the final 

rule clarifications and revisions, as well 

as the final microbial pesticide test 

guideline, are expected to enhance the 

ability of industry to efficiently manage 

its microbial pesticide registration 

submissions. 

DATES: This final rule is effective 

October 29, 2012. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0670, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

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; email address: 

kyprianou.rose@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. 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 action also may affect any 

person or company who might petition 

EPA for a tolerance or an exemption 

from the requirement of a tolerance for 

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., a tolerance or tolerance 

exemption for an imported microbial 

pesticide). 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. 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 code 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. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

II. Background 

In the Federal Register of October 26, 

2007 (72 FR 60988) (FRL–8109–8), a 

final rule, entitled ‘‘Pesticides; Data 

Requirements for Biochemical and 

Microbial Pesticides,’’ revised the data 

requirements for biochemical and 

microbial pesticides—regulations that 

had originally been promulgated in and 

had remained largely unchanged since 

1984. In doing so, EPA established a 

distinct subpart for microbial pesticides 

(i.e., 40 CFR part 158, subpart V) that 

provided a definition for these 

particular pesticides and clearly 

identified the data required to support 

their registration. Since 2007, however, 

EPA has consistently encountered 

questions from industry stakeholders on 

certain portions of 40 CFR part 158, 

subpart V, particularly with regard to 

the language set forth in 40 CFR 

158.2100(c)(2). 

To address these questions, in the 

Federal Register of April 15, 2011 (76 

FR 21294) (FRL–8857–7), EPA proposed 

specific revisions to the regulatory text 

in 40 CFR 158.2100(c)(2) for purposes of 

enhanced clarity. In addition, EPA also 

recognized that an existing data 

requirement under 40 CFR 158.2120(c) 

and 40 CFR 158.2171(c), deposition of a 

sample in a nationally recognized 

culture collection, did not have an 

accompanying test guideline and that 

there were several minor errors in the 

regulatory text of 40 CFR part 158, 

subpart V. Therefore, with the proposed 

rule, EPA also made available for public 

comment a draft test guideline, entitled 

‘‘Deposition of a Sample in a Nationally 

Recognized Culture Collection’’ and 

identified as OCSPP Test Guideline 

885.1250, addressing the deposition of a 

sample in a nationally recognized 

culture collection data requirement, and 

proposed to make other minor 

corrections to the regulations. The 

public comment period for the proposed 

rule closed on July 14, 2011, and EPA 

received no comments on the proposed 

rule or the draft test guideline. 

III. Final Changes 

A. What action is EPA taking? 

EPA is finalizing most of the changes 

and corrections proposed. Although no 

comments were received, EPA has 

revised a few of the originally proposed 

changes and corrections to further 

clarify the regulatory text being 

modified. These changes are not 

substantive in nature. The specific 

changes being promulgated with this 

action and the anticipated benefits of 

such changes are described in this final 

rule and the rationale supporting the 

revisions can be found in the proposed 

rule (see Unit IV. of the April 15, 2011 

proposed rule). 

Specifically, EPA is making several 

changes and corrections to the Microbial 

Pesticides data requirements (40 CFR 

part 158, subpart V). First, EPA is 

revising 40 CFR 158.2100(c)(2) to reduce 

confusion over the distinction between 

‘‘isolates’’ and ‘‘strains’’ and exactly 

how EPA views both of these terms. To 

this end, EPA substitutes ‘‘active 

ingredient’’ for ‘‘strain.’’ The 


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Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 52611 

clarification to 40 CFR 158.2100(c)(2) 

also includes 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 company-specific 

registered isolates. The clarification also 

mentions the possibility for data 

citation, in lieu of data generation, 

should sufficient similarity be 

established between isolates. Moreover, 

after further consideration, EPA has 

decided against including the proposed 

explanatory text (i.e., ‘‘Because of the 

potential for variation in 

microorganisms’’) at the beginning of 

the first sentence in 40 CFR 

158.2100(c)(2). This phrase is not 

necessary or appropriate as regulatory 

text because it does not add anything to 

the regulatory provision. 

Second, in conjunction with the 

changes detailed for 40 CFR 

158.2100(c)(2), EPA is announcing the 

availability of a final microbial pesticide 

test guideline under Series 885, entitled 

‘‘Deposition of a Sample in a Nationally 

Recognized Culture Collection’’ and 

identified as OCSPP Test Guideline 

885.1250. This OCSPP test guideline is 

intended to explain the existing data 

requirement to deposit a sample in a 

nationally recognized culture collection 

found in the tables in 40 CFR 

158.2120(c) and 40 CFR 158.2171(c). 

Additionally, to clarify this microbial 

deposition data requirement, EPA is 

adding a test note to 40 CFR 158.2120(d) 

and 40 CFR 158.2171(d), emphasizing 

the need for the continuing maintenance 

of a culture deposit to ensure that it 

remains available for the duration of an 

associated registration or experimental 

use permit in case EPA requests a 

sample. This requirement already 

applies to all isolates; thus, the 

reference to ‘‘new isolates’’ in the 

proposed rulemaking was an oversight 

and is just ‘‘isolates’’ in this final rule. 

Finally, to correct several minor 

errors, EPA is replacing ‘‘part’’ with 

‘‘subpart’’ in 40 CFR 158.2100(c)(1) and 

removing references to a non-existing 

paragraph (e) that appears in 40 CFR 

158.2120 and 40 CFR 158.2171. 

The improved clarity and 

transparency resulting from the 

insertion of this information in 40 CFR 

part 158, subpart V, are expected to 

enhance the ability of industry to 

efficiently manage its microbial 

pesticide registration submissions. 

Applicants may save time and money 

from an improved understanding of the 

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 also reduce potential 

delays in the registration process, 

thereby enabling registration of 

microbial pesticides sooner and 

allowing microbial pesticide products to 

enter the market sooner. 

B. What is EPA’s authority for taking 

this action? 

This final rule is issued under the 

authority of FIFRA sections 3, 5, 10, 12, 

and 25 (7 U.S.C. 136 et seq.), and 

section 408 of the Federal Food, Drug, 

and Cosmetic Act (FFDCA) (21 U.S.C. 

346a). 

C. Electronic Access to the OCSPP Test 

Guidelines 

To access the OSCPP test guidelines 

referenced in this final rule 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ You may also 

access the test guidelines in http:// 

www.regulations.gov grouped by Series 

under Docket ID numbers: EPA–HQ– 

OPPT–2009–0150 through EPA–HQ– 

OPPT–2009–0159 and EPA–HQ–OPPT– 

2009–0576. 

IV. FIFRA Review Requirements 

Pursuant to FIFRA sections 25(a) and 

(d), EPA has submitted a draft of this 

final rule to the Committee on 

Agriculture in the House of 

Representatives; the Committee on 

Agriculture, Nutrition, and Forestry in 

the United States Senate; the United 

States Department of Agriculture 

(USDA); and the FIFRA Scientific 

Advisory Panel (SAP). FIFRA SAP and 

USDA waived review of this final rule. 

V. Statutory and Executive Order 

Reviews 

This action only clarifies existing 

regulatory text to allow EPA and 

stakeholders a clearer understanding of 

40 CFR part 158, subpart V. It does not 

otherwise impose any other 

requirements, involve any significant 

policy or legal issues, or increase 

existing costs. As such, EPA is not 

required to make special considerations 

or evaluations under the following 

statutory and Executive Order review 

requirements. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This is not a ‘‘significant regulatory 

action’’ under Executive Order 12866 

(58 FR 51735, October 4, 1993) and was 

therefore not reviewed by the Office of 

Management and Budget (OMB) under 

Executive Orders 12866 and 13563 (76 

FR 3821, January 21, 2011). 

B. Paperwork Reduction Act (PRA) 

This action does not impose or change 

any information collection burden that 

requires additional review by OMB 

under the provisions of PRA (44 U.S.C. 

3501 et seq.). 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 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument, or form, if 

applicable. 

The revisions in this final rule involve 

existing information collection activities 

that are already approved by OMB 

under PRA. Specifically, the submission 

of data to EPA in order to establish a 

tolerance or an exemption from the 

requirement of a tolerance are 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 are currently approved under 

OMB Control No. 2070–0060 (EPA ICR 

No. 0277); the activities associated with 

the application for an experimental use 

permit are 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 are 

currently approved under OMB Control 

No. 2070–0174 (EPA ICR No. 2288). 

C. Regulatory Flexibility Act (RFA) 

Pursuant to RFA section 605(b) (5 

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

that this final rule does not have a 

significant adverse economic impact on 

a substantial number of small entities. 

Under RFA, small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. In 

making this determination, the impact 

of concern is any significant adverse 

economic impact on small entities 

because the primary purpose of 

regulatory flexibility analysis is to 

identify and address regulatory 

alternatives ‘‘which minimize any 

significant economic impact of the rule 

on small entities.’’ 5 U.S.C. 603 and 604. 

Thus, an agency may certify under RFA 

when the rule relieves regulatory 

burden, or otherwise has no expected 

economic impact on small entities 

subject to the rule. 

This action only clarifies existing 

regulatory text to allow EPA and 

stakeholders a clearer understanding of 


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52612 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 

40 CFR part 158, subpart V. It does not 

otherwise amend or impose any other 

requirements. As such, this final rule 

will not have any adverse economic 

impact on any entities, large or small. 

D. Unfunded Mandates Reform Act 

(UMRA) 

State, local, and Tribal governments 

are rarely pesticide applicants or 

registrants, so this final rule is not 

expected to affect these governments 

and is not expected to adversely affect 

the private sector. Accordingly, 

pursuant to Title II of UMRA (2 U.S.C. 

1531–1538), EPA has determined that 

this action is not subject to the 

requirements in UMRA 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 1 year. In addition, this action 

does not significantly or uniquely affect 

small governments or impose a 

significant intergovernmental mandate, 

as described in UMRA sections 203 and 

204. 

E. Executive Order 13132: Federalism 

This action will not have federalism 

implications because it is not expected 

to 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 (64 FR 43255, 

August 10, 1999). Thus, Executive Order 

13132 does not apply to this action. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

EPA is not aware of any Tribal 

governments that are pesticide 

registrants. This action will not, 

therefore, have Tribal implications 

because it is not expected to have 

substantial direct effects on Indian 

Tribes, will not significantly or uniquely 

affect the communities of Indian Tribal 

governments, and does not involve or 

impose any requirements that affect 

Indian Tribes, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). Accordingly, the requirements of 

Executive Order 13175 do not apply to 

this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

(62 FR 19885, April 23, 1997) as 

applying only to those regulatory 

actions that concern health or safety 

risks, such that the analysis required 

under section 5–501 of the Executive 

Order has the potential to influence the 

regulation. This action is not subject to 

Executive Order 13045 because it does 

not establish an environmental standard 

intended to mitigate health or safety 

risks, nor is it an ‘‘economically 

significant regulatory action’’ as defined 

by Executive Order 12866. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001) because it is not a significant 

regulatory action under Executive Order 

12866, nor will it affect energy supply, 

distribution, or use. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This action does not involve technical 

standards that would require the 

consideration of voluntary consensus 

standards pursuant to NTTAA section 

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

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

This action does not have 

disproportionately high and adverse 

human health or environmental effects 

on minority or low-income populations 

because it does not affect the level of 

protection provided to human health or 

the environment. Therefore, this action 

does not involve special consideration 

of environmental justice-related issues 

as specified in Executive Order 12898 

(59 FR 7629, February 16, 1994). 

VI. Congressional Review Act (CRA) 

Pursuant to CRA (5 U.S.C. 801 et 

seq.), EPA will submit a report 

containing this rule and other required 

information to the U.S. Senate, the U.S. 

House of Representatives, and the 

Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This action is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 158 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 24, 2012. 

James Jones, 

Acting Assistant Administrator, Office of 

Chemical Safety and Pollution Prevention. 

Therefore, 40 CFR chapter I is 

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. In § 158.2100, revise paragraphs 

(c)(1) and (2) to read as follows: 

§ 158.2100 Microbial pesticides definition 

and applicability. 

* * * * * 

(c) * * * 

(1) This subpart applies to microbial 

pesticides as specified in paragraphs 

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

(2) Each new isolate of a microbial 

pesticide is 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. In § 158.2120: 

■ a. Revise paragraphs (a), (b), and (c). 

■ b. Redesignate in paragraph (d), test 

notes 1 through 4 as test notes 2 through 

5 and add new test note 1. 

The amendments read 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 table in this paragraph 

shows the data requirements for 

microbial pesticides product analysis. 


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Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 52613 

The test notes are shown in paragraph 

(d) of this section. 

TABLE—MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS

Test 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. 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. In § 158.2171: 

■ a. Revise paragraphs (a), (b), and (c). 

■ b. Redesignate in paragraph (d), test 

notes 3 through 6 as test notes 4 through 

7 and add new test note 3. 

The amendments read 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 table in this paragraph 

shows the data requirements for 

experimental use permit microbial 

pesticides product analysis. The test 

notes are shown in paragraph (d) of this 

section. 

TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS

Test 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 .................................. ............


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52614 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 

TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS—Continued 

Test guideline 

No. Data requirement All use patterns 

Test substance Test 

notes 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. 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. 2012–21430 Filed 8–29–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 152 

[CMS–9995–IFC2] 

RIN 0938–AQ70 

Pre-Existing Condition Insurance Plan 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Amendment to interim final 

rule with request for comments. 

SUMMARY: This document contains an 

amendment regarding program 

eligibility to the interim final regulation 

implementing the Pre-Existing 

Condition Plan program under 

provisions of the Patient Protection and 

Affordable Care Act. In light of a new 

process recently announced by the 

Department of Homeland Security, 

eligibility for the program is being 

amended so that the program does not 

inadvertently expand the scope of that 

process. 

DATES: Effective date. These interim 

final regulations are effective on August 

30, 2012. 

Comment date. Comments are due on 

or before October 29, 2012. 

Applicability date. This amendment 

to the interim final regulation generally 

applies to individuals on August 30, 

2012. 

ADDRESSES: Written comments may be 

submitted to any of the addresses 

specified below. Please do not submit 

duplicates. 

All comments will be made available 

to the public. Warning: Do not include 

any personally identifiable information 

(such as name, address, or other contact 

information) or confidential business 

information that you do not want 

publicly disclosed. All comments are 

posted on the Internet exactly as 

received, and can be retrieved by most 

Internet search engines. No deletions, 

modifications, or redactions will be 

made to the comments received, as they 

are public records. Comments may be 

submitted anonymously. 

In commenting, please refer to file 

code CMS–9995–IFC2. 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 ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–9995–IFC2, P.O. Box 8016, 

Baltimore, MD 21244–8016. 

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–9995–IFC2, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments only to the 

following addresses prior to the close of 

the comment period: 

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, call 

telephone number (410) 786–4492 in 

advance to schedule your arrival with 

one of our staff members. 

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 


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