60208 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Proposed Rules 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); and 

3. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this proposed AD and placed it in the 

AD docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The FAA amends § 39.13 by adding 

the following new AD: 

Bombardier, Inc. (Formerly de Havilland, 

Inc.): Docket No. FAA–2008–1083; 

Directorate Identifier 2008–NM–130–AD. 

Comments Due Date 

(a) We must receive comments by 

November 10, 2008. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Bombardier Model 

DHC–8–400, DHC–8–401, and DHC–8–402 

airplanes, certificated in any category, Serial 

numbers 4003, 4004, 4006, and 4008 through 

4184 inclusive. 

Subject 

(d) Air Transport Association (ATA) of 

America Code 32: Landing Gear. 

Reason 

(e) The mandatory continuing 

airworthiness information (MCAI) states: 

‘‘There have been several cases reported 

where the landing gear did not retract after 

take-off. Subsequent investigation revealed 

this was caused by fatigue failure of the nose 

landing gear electrical harness. In 

conjunction with one engine being 

inoperable, this could, in certain operating 

conditions, affect continued safe flight and 

landing.’’ 

‘‘This directive mandates incorporation of 

new weight-on-wheels (WOW) and steering 

harnesses that have a new conduit 

construction.’’ 

Actions and Compliance 

(f) Unless already done, do the following 

actions. 

(1) Within 2,500 flight hours after the 

effective date of this AD, replace the WOW 

and steering harnesses by incorporating 

Modsum 4–126401, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 84–32–51, Revision ‘B,’ 

dated December 17, 2007. 

(2) Actions done before the effective date 

of this AD in accordance with Bombardier 

Service Bulletin 84–32–51, dated August 16, 

2007, or Revision ‘A,’ dated August 22, 2007, 

are acceptable for compliance with the 

corresponding requirements of this AD. 

FAA AD Differences 

Note: This AD differs from the MCAI and/ 

or service information as follows: No 

differences. 

Other FAA AD Provisions 

(g) The following provisions also apply to 

this AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Systems and Flight 

Test Branch, ANE–172, FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. Send information to ATTN: Wing 

Chan, Aerospace Engineer, Systems and 

Flight Test Branch, ANE–172, FAA, New 

York Aircraft Certification Office, 1600 

Stewart Avenue, Suite 410, Westbury, New 

York 11590; telephone (516) 228–7311; fax 

(516) 794–5531. Before using any approved 

AMOC on any airplane to which the AMOC 

applies, notify your appropriate principal 

inspector (PI) in the FAA Flight Standards 

District Office (FSDO), or lacking a PI, your 

local FSDO. 

(2) Airworthy Product: For any 

requirement in this AD to obtain corrective 

actions from a manufacturer or other source, 

use these actions if they are FAA-approved. 

Corrective actions are considered FAAapproved if they are approved by the State 

of Design Authority (or their delegated 

agent). You are required to assure the product 

is airworthy before it is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, under the 

provisions of the Paperwork Reduction Act, 

the Office of Management and Budget (OMB) 

has approved the information collection 

requirements and has assigned OMB Control 

Number 2120–0056. 

Related Information 

(h) Refer to MCAI Canadian Airworthiness 

Directive CF–2008–22, dated June 24, 2008, 

and Bombardier Service Bulletin 84–32–51, 

Revision ‘B,’ dated December 17, 2007, for 

related information. 

Issued in Renton, Washington, on October 

2, 2008. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E8–24161 Filed 10–9–08; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[REG–123829–08] 

RIN 1545–BI02 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AB27 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[CMS–4137–NC] 

45 CFR Parts 144, 146, and 148 

RIN 0938–AP37 

Request for Information Regarding 

Sections 101 Through 104 of the 

Genetic Information Nondiscrimination 

Act of 2008 

AGENCIES: Internal Revenue Service, 

Department of the Treasury; Employee 

Benefits Security Administration, 

Department of Labor; Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services. 

ACTION: Request for Information. 

SUMMARY: This document is a request for 

comments regarding issues under 

sections 101 through 104 of the Genetic 

Information Nondiscrimination Act of 

2008 (GINA). The Departments of Labor, 

Health and Human Services (HHS), and 

the Treasury (collectively, the 

Departments) have received inquiries 

from the public on a number of issues 

under these provisions and are 

welcoming public comments in advance 

of future rulemaking. 

DATES: Comments must be submitted on 

or before December 9, 2008. 

ADDRESSES: Written comments may be 

submitted to any of the addresses 

specified below. Any comment that is 

submitted to any Department will be 

shared with the other Departments. 

Please do not submit duplicates. 

Department of Labor. Comments to 

the Department of Labor by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: E–OHPSCA.EBSA@dol.gov. 

• Mail or Hand Delivery: Office of 

Health Plan Standards and Compliance 

Assistance, Employee Benefits Security 


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Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Proposed Rules 60209 

Administration, Room N–5653, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Washington, DC 20210, 

Attention: GINA Comments. 

Comments received by the 

Department of Labor will be posted 

without change to http:// 

www.regulations.gov and http:// 

www.dol.gov/ebsa, and available for 

public inspection at the Public 

Disclosure Room, N–1513, Employee 

Benefits Security Administration, 200 

Constitution Avenue, NW., Washington, 

DC 20210, including any personal 

information provided. 

Department of HHS. Comments to the 

Department of HHS, identified by CMS– 

4137–NC, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–4137–NC, P.O. Box 8017, 

Baltimore, MD 21244–8010. 

• Hand or courier delivery. 

Comments may be delivered to either 

7500 Security Boulevard, Baltimore, MD 

21244–1850 or Room 445–G, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201. 

For delivery to Baltimore, please call 

telephone number (410) 786–7195 in 

advance to schedule your arrival with 

one of our staff members. For delivery 

to Washington, because access to the 

interior of the HHH 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 proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed. 

All submissions submitted to HHS 

will be available for public inspection as 

they are received, generally beginning 

approximately three weeks after 

publication of a document, at the 

headquarters for the Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Baltimore, MD 

21244, Monday through Friday of each 

week from 8:30 a.m. to 4 p.m. To 

schedule an appointment to view public 

comments, phone (410) 786–7195. 

Internal Revenue Service. Comments 

to the IRS, identified by REG–123829– 

08, by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: CC:PA:LPD:PR (REG–123829– 

08), Room 5205, Internal Revenue 

Service, P.O. Box 7604, Ben Franklin 

Station, Washington, DC 20044. 

• Hand or courier delivery: Monday 

through Friday between the hours of 8 

a.m. and 4 p.m. to: CC:PA:LPD:PR 

(REG–123829–08), Courier’s Desk, 

Internal Revenue Service, 1111 

Constitution Avenue, NW., Washington, 

DC 20224. 

All submissions to the IRS will be 

open to public inspection and copying 

in room 1621, 1111 Constitution 

Avenue, NW., Washington, DC from 9 

a.m. to 4 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Amy Turner, Employee Benefits 

Security Administration, Department of 

Labor, at (202) 693–8335; Russ 

Weinheimer, Internal Revenue Service, 

Department of the Treasury, at (202) 

622–6080; Adam Shaw, Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, at (877) 267–2323 extension 

61091. 

Customer Service Information: 

Individuals interested in obtaining 

information from the Department of 

Labor concerning employment-based 

health coverage laws, including the 

nondiscrimination protections, may call 

the EBSA Toll-Free Hotline at 1–866– 

444–EBSA (3272) or visit the 

Department of Labor’s Web site (http:// 

www.dol.gov/ebsa). In addition, 

individuals may request a copy of 

CMS’s publication entitled ‘‘Protecting 

Your Health Insurance Coverage’’ by 

calling 1–800–633–4227. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Genetic Information 

Nondiscrimination Act of 2008 (GINA) 

was enacted on May 21, 2008 (Pub. L. 

110–233). Title I of GINA amends the 

Employee Retirement Income Security 

Act of 1974 (ERISA), the Public Health 

Service Act (PHS Act), the Internal 

Revenue Code of 1986 (Code), and the 

Social Security Act (SSA) to prohibit 

discrimination in health coverage based 

on genetic information. Sections 101 

through 104 of GINA apply to 

employment-based health coverage, 

individual market health insurance, and 

Medicare supplemental (MedSupp or 

Medigap) coverage. The new 

requirements were added to Part 7 of 

Subtitle B of Title I of ERISA, Title 

XXVII of the PHS Act, Subtitle K of the 

Code, and section 1882 of the SSA. 

GINA prohibits group health plans 

and health insurance issuers (that is, 

insurance companies or health 

maintenance organizations (HMOs)) in 

the group market from using genetic 

information to adjust premium or 

contribution amounts for the group 

covered under the plan. Plans and 

issuers in the group market are still 

allowed to increase the premium rate for 

an employer based on the manifestation 

of a disease or disorder of an individual 

enrolled in the plan, but they are 

prohibited from using the manifested 

disease or disorder of one individual as 

genetic information about other group 

members to further increase the 

premium. 

In the individual market, health 

insurance issuers are prohibited from 

using genetic information to determine 

individual eligibility or premium rates, 

although they are allowed (to the extent 

consistent with other provisions of law) 

to use information about a manifestation 

of a disease or disorder to determine 

eligibility or premium rates for an 

individual who is covered or would be 

covered by a policy. Individual market 

health insurance issuers are also 

prohibited from using genetic 

information in imposing a preexisting 

condition exclusion, although a 

manifestation of a disease or disorder in 

an individual can be the basis for an 

exclusion. In the MedSupp market, 

GINA prohibits issuers from denying or 

conditioning the issuance or 

effectiveness of a policy (including the 

imposition of any exclusion of benefits 

based on a preexisting condition) or 

discriminating in the pricing of the 

policy based on an individual’s genetic 

condition. However, if otherwise 

permitted under section 1882 of the 

Social Security Act, the issuer can still 

impose such limitations based on a 

manifested disease of an individual who 

is covered or would be covered under 

the policy. 

GINA also prohibits group health 

plans and health insurance issuers in 

the group, individual, and MedSupp 

markets from requesting or requiring an 

individual or family member of an 

individual to undergo a genetic test. 

Plans and issuers are not precluded 

from obtaining and using the results of 

a genetic test to make a determination 

regarding payment, but they may only 

use the minimum amount of 

information necessary. 

GINA includes a research exception 

under which a group health plan or a 

health insurance issuer in the group, 

individual, or MedSupp market may 

request (but not require) a participant or 

beneficiary to undergo a genetic test if 

the following five conditions are met: 

• The request is made in writing 

pursuant to research that complies with 

45 CFR Part 46, or equivalent Federal 

regulations, and any applicable State or 

local law or regulations for the 


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60210 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Proposed Rules 

protection of human subjects in 

research. 

• The plan or issuer clearly indicates 

to each participant or beneficiary to 

whom the request is made that 

compliance is voluntary and noncompliance will have no effect on 

enrollment status or premium 

contribution amounts. 

• None of the genetic information 

collected can be used for underwriting 

purposes. 

• The plan or issuer notifies the 

appropriate Secretary in writing that it 

is conducting such research activities, 

including a description of the activities 

conducted. 

• The plan or issuer complies with 

such other conditions as may be 

required by regulations for such 

activities. 

Group health plans and health 

insurance issuers in the group, 

individual, and MedSupp markets are 

prohibited from requesting, requiring, or 

purchasing genetic information for 

underwriting purposes or prior to an 

individual’s enrollment under a plan or 

policy. Plans and issuers are still 

allowed to collect (that is, to request, 

require, or purchase) health information 

that relates to the manifestation of a 

disease or disorder of an individual 

enrolled in a plan or who is covered by 

or would be covered by a policy issued 

in the individual or MedSupp market, 

and use it for permitted underwriting 

purposes with respect to that 

individual. Furthermore, an exception 

to the prohibition on requesting, 

requiring, or purchasing genetic 

information is included for collection of 

genetic information which is incidental 

to the request, requirement, or purchase 

of other information concerning an 

individual, provided it is not used for 

underwriting purposes. 

GINA defines genetic information 

with respect to any individual as 

information about that individual’s 

genetic tests, the genetic tests of family 

members of the individual, and the 

manifestation of a disease or disorder in 

family members of the individual. The 

term genetic information also includes 

an individual’s request for, or receipt of, 

genetic services, but does not include 

information about the sex or age of any 

individual. Genetic services are further 

defined as a genetic test, genetic 

counseling (which includes obtaining, 

interpreting, or assessing genetic 

information), or genetic education. A 

genetic test is defined for purposes of 

Title I of GINA as an analysis of human 

DNA, RNA, chromosomes, proteins, or 

metabolites that detects genotypes, 

mutations, or chromosomal changes. 

The term is not meant to include an 

analysis of proteins or metabolites that 

does not detect genotypes, mutations, or 

chromosomal changes, or an analysis of 

proteins or metabolites that is directly 

related to a manifested disease, 

disorder, or pathological condition that 

a health care professional with 

appropriate training and expertise could 

reasonably detect. Definitions of family 

member and underwriting purposes are 

also included, as well as provisions 

clarifying that references to genetic 

information concerning an individual 

include the genetic information of a 

fetus carried by a pregnant woman and 

of an embryo legally held by an 

individual utilizing an assisted 

reproductive technology. 

The provisions of GINA are effective 

with respect to group health plans and 

health insurance issuers in the group 

market for plan years beginning after 

May 21, 2009. For health insurance 

issuers in the individual market, the 

provisions are effective with respect to 

health insurance coverage sold, issued, 

renewed, in effect, or operated in the 

individual market after May 21, 2009. 

For MedSupp coverage, States must 

incorporate the GINA provisions into 

their regulatory programs no later than 

July 1, 2009. 

II. Solicitation of Comments 

A. Comments Regarding Economic 

Analysis, Paperwork Reduction Act, and 

Regulatory Flexibility Act 

Executive Order 12866 requires an 

assessment of the costs and benefits of 

a significant rulemaking action and the 

alternatives considered, using the 

guidance provided by the Office of 

Management and Budget. These costs 

and benefits are not limited to the 

Federal government, but pertain to the 

affected public as a whole. Under 

Executive Order 12866, a determination 

must be made whether implementation 

of GINA sections 101 through 104 will 

be economically significant. A rule that 

has an annual effect on the economy of 

$100 million or more is considered 

economically significant. 

In addition, the Regulatory Flexibility 

Act may require the preparation of an 

analysis of the economic impact on 

small entities of proposed rules and 

regulatory alternatives. An analysis 

under the Regulatory Flexibility Act 

must generally include, among other 

things, an estimate of the number of 

small entities subject to the regulations 

(for this purpose, plans, employers, and 

issuers and, in some contexts small 

governmental entities), the expense of 

the reporting and other compliance 

requirements (including the expense of 

using professional expertise), and a 

description of any significant regulatory 

alternatives considered that would 

accomplish the stated objectives of the 

statute and minimize the impact on 

small entities. The Departments seek 

additional information from small 

entities regarding any special problems 

they might encounter in implementing 

the requirements of sections 101 

through 104 of GINA and any regulatory 

guidance that might minimize those 

problems. 

The Paperwork Reduction Act 

requires an estimate of how many 

‘‘respondents’’ will be required to 

comply with any ‘‘collection of 

information’’ aspects of the regulations 

and how much time and cost will be 

incurred as a result. A collection of 

information includes record-keeping, 

reporting to governmental agencies, and 

third-party disclosures. 

The Departments are requesting 

comments that may contribute to the 

analyses that will be performed under 

these requirements, both generally and 

with respect to the following specific 

areas: 

(i) What policies, procedures, or 

practices of group health plans and 

health insurance issuers may be 

impacted by regulations under GINA? 

What direct or indirect costs would 

result? What direct or indirect benefits 

would result? Which stakeholders will 

be impacted by such benefits and costs? 

(ii) Are there unique costs and 

benefits for small employers or small 

plans? What special consideration, if 

any, is needed for small employers or 

small plans? 

B. Comments Regarding Regulatory 

Guidance 

The Departments are seeking 

comments to aid in the development of 

regulations regarding sections 101 

through 104 of GINA. To assist 

interested parties in responding, this 

request for information describes 

specific areas in which the Departments 

are particularly interested; however, the 

Departments also request comments and 

suggestions concerning any area or issue 

pertinent to the development of 

regulations. 

Specific Areas in Which the 

Departments Are Interested Include the 

Following 

1. To what extent do group health 

plans and health insurance issuers 

currently use genetic information, such 

as family medical history, and for what 

purposes? For example, is genetic 

information currently used for group 

rating purposes, or for purposes of a 

wellness program that otherwise 


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Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Proposed Rules 60211 

complies with HIPAA’s 

nondiscrimination requirements? 

2. How do plans and issuers currently 

obtain genetic information (for example, 

through health risk assessments, the 

Medical Information Bureau, or other 

entities under common control)? 

3. Under what circumstances do plans 

or issuers currently request or require an 

individual to take a genetic test? 

4. Under what circumstances do plans 

or issuers currently ask for the results of 

a genetic test in order to make a 

determination regarding payment of 

benefits? What is the minimum amount 

of information necessary for a plan or 

issuer to make a determination under 

such circumstances? 

5. What types of research do plans or 

issuers currently conduct or support 

using genetic tests? 

6. Would a model notice be helpful to 

facilitate disclosure to plan participants 

and beneficiaries regarding a plan’s or 

issuer’s use of the research exception? 

In this regard, what information would 

be most helpful to participants and 

beneficiaries? 

7. Similarly, would a model form be 

helpful for reporting to the Departments 

by a plan or issuer claiming the research 

exception? In this regard, what 

information should plans and issuers 

report? 

8. When might genetic information be 

collected incidentally? 

9. What terms or provisions (such as 

genetic information, genetic test, genetic 

services, or underwriting) would require 

additional clarification to facilitate 

compliance? What specific clarifications 

would be helpful? 

Signed at Washington, DC this 4th day of 

June, 2008. 

Alan Tawshunsky, 

Deputy Division Counsel/Deputy Associate 

Chief Counsel, Tax Exempt and Government 

Entities, Internal Revenue Service, 

Department of the Treasury. 

Signed at Washington, DC this 5th day of 

June, 2008. 

W. Thomas Reeder, 

Benefits Tax Counsel, Department of the 

Treasury. 

Signed at Washington, DC this 2nd day of 

October, 2008. 

Bradford P. Campbell, 

Assistant Secretary, Employee Benefits 

Security Administration, U.S. Department of 

Labor. 

Dated: June 30, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E8–24194 Filed 10–9–08; 8:45 am] 

BILLING CODES 4830–01–P; 4510–29–P; 4120–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 158 and 161 

[EPA–HQ–OPP–2008–0110; FRL–8383–6] 

Data Requirements for Antimicrobial 

Pesticides; Notice of Public Workshop 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule; notice of public 

workshop. 

SUMMARY: EPA is convening a public 

workshop to explain the provisions of 

its recently proposed rule to update and 

revise the data requirements for 

registration of antimicrobial pesticides. 

The workshop is intended to provide an 

opportunity for members of the public 

to ask questions about the proposed rule 

and seek any clarification they believe 

may assist them in submitting 

comments to the docket for the 

proposed rule. Any person wishing to 

comment on the proposed rule must 

submit any comments to the docket 

within the timeframe set forth in the 

Notice of Proposed Rulemaking. 

DATES: The meeting will be held on 

November 6, 2008, from 8:30 a.m. to 

4:00 p.m. 

To request accommodation of a 

disability, please contact the person 

listed under FOR FURTHER INFORMATON

CONTACT, preferably at least 10 days 

prior to the meeting, to give EPA as 

much time as possible to process your 

request. 

ADDRESSES: The meeting will be held at 

the Office of Pesticide Programs (OPP), 

First Floor Conference Center, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA 22202. 

To facilitate the Agency’s planning, 

your intention to participate in the 

Antimicrobials Workshop, may be 

submitted to the person listed under FOR

FURTHER INFORMATION CONTACT. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn Boyle, Field and External 

Affairs Division (7506P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: 703.305.6304; 

fax number: 703.305.5884; e-mail 

address: boyle.kathryn@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be affected by this action if 

you are a producer of pesticide products 

(NAICS code 32532), antifoulants 

(NAICS code 32551), antimicrobial 

pesticides (NAICS code 32561) or wood 

preservatives (NAICS code 32519), 

importers of such products, or any 

person or company who seeks to register 

an antimicrobial, antifoulant coating, 

ballast water treatment, or wood 

preservative pesticide or to obtain a 

tolerance for such a pesticide. 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 above 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, please contact Norm 

Cook, Chief of the Risk Assessment and 

Science Support Branch in the 

Antimicrobials Division of the Office of 

Pesticide Programs at 703–308–8253 or 

via email, cook.norm@epa.gov. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established a 

docket for this action under docket ID 

number EPA–HQ–OPP–2008–0110. 

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 Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA 22202. 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. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. 

II. Background 

EPA is convening a public workshop 

to explain the proposed revisions to the 

data requirements for the registration of 

antimicrobial pesticides. Under the 

Federal Insecticide, Fungicide and 

Rodenticide Act (FIFRA) and the 

Federal Food, Drug and Cosmetic Act 

(FFDCA), anyone seeking to register a 

pesticide product is required to provide 

information to EPA to demonstrate that 

their products can be used without 

posing ‘‘unreasonable adverse effects on 

the environment’’ as defined by FIFRA 

section 2(bb). 

The public workshop will include 

presentations by staff from the 

Antimicrobial, and the Field and 


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