9056 Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Proposed Rules 

concerning consumer perception of fuel 

rating labels. Does this new information 

indicate that the Rule should be 

modified? If so, why, and how? If not, 

why not? 

(8) Please provide any evidence that 

has become available since 1993 

concerning consumer interest in 

particular fuel rating issues. Does this 

new information indicate that the Rule 

should be modified? If so, why, and 

how? If not, why not? 

(9) What benefits, if any, has the Rule 

provided to businesses, and in 

particular to small businesses? What 

evidence supports the asserted benefits? 

(10) What modifications, if any, 

should be made to the Rule to increase 

its benefits to businesses, and 

particularly to small businesses? 

(a) What evidence supports your 

proposed modifications? 

(b) How would these modifications 

affect the costs and benefits of the Rule 

for consumers? 

(c) How would these modifications 

affect the costs and benefits of the Rule 

for businesses? 

(11) What significant costs, including 

costs of compliance, has the Rule 

imposed on businesses, particularly 

small businesses? What evidence 

supports the asserted costs? 

(12) What modifications, if any, 

should be made to the Rule to reduce 

the costs imposed on businesses, and 

particularly on small businesses? 

(a) What evidence supports your 

proposed modifications? 

(b) How would these modifications 

affect the costs and benefits of the Rule 

for consumers? 

(c) How would these modifications 

affect the costs and benefits of the Rule 

for businesses? 

(13) What evidence is available 

concerning the degree of industry 

compliance with the Rule? Does this 

evidence indicate that the Rule should 

be modified? If so, why, and how? If 

not, why not? 

(14) Are any of the Rule’s 

requirements no longer needed? If so, 

explain. Please provide supporting 

evidence. 

(15) What potentially unfair or 

deceptive practices concerning the 

rating, certifying, and posting of the 

rating of automotive fuels, if any, are not 

covered by the Rule? 

(a) What evidence demonstrates the 

existence of such practices? 

(b) With reference to such practices, 

should the Rule be modified? If so, why, 

and how? If not, why not? 

(16) What modifications, if any, 

should be made to the Rule to account 

for changes in relevant technology, 

including development of new liquid 

alternative fuels, or economic 

conditions? 

(a) What evidence supports the 

proposed modifications? 

(b) How would these modifications 

affect the costs and benefits of the Rule 

for consumers and businesses, 

particularly small businesses? 

(17) Does the Rule overlap or conflict 

with other federal, state, or local laws or 

regulations? If so, how? 

(a) What evidence supports the 

asserted conflicts? 

(b) With reference to the asserted 

conflicts, should the Rule be modified? 

If so, why, and how? If not, why not? 

(c) Is there evidence concerning 

whether the Rule has assisted in 

promoting national consistency with 

respect to the rating, certifying, and 

posting the rating of automotive fuels? 

If so, please provide that evidence. 

(18) Are there foreign or international 

laws, regulations, or standards with 

respect to the rating, certifying, and 

posting the rating of automotive fuels 

that the Commission should consider as 

it reviews the Rule? If so, what are they? 

(a) Should the Rule be modified in 

order to harmonize with these foreign or 

international laws, regulations, or 

standards? If so, why, and how? If not, 

why not? 

(b) How would such harmonization 

affect the costs and benefits of the Rule 

for consumers and businesses, 

particularly small businesses? 

List of Subjects in 16 CFR Part 306 

Fuel ratings, Trade practices. 

Authority: 15 U.S.C. 2801 et seq; 42 U.S.C. 

17021 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E9–4282 Filed 2–27–09: 8:45 am] 

BILLING CODE 6750–01–S 

EQUAL EMPLOYMENT OPPORTUNITY 

COMMISSION 

29 CFR Part 1635 

RIN 3046–AA84 

Regulations Under the Genetic 

Information Nondiscrimination Act of 

2008 

AGENCY: Equal Employment 

Opportunity Commission. 

ACTION: Proposed rule. 

SUMMARY: The Equal Employment 

Opportunity Commission (‘‘EEOC’’ or 

‘‘Commission’’) is issuing a proposed 

rule that would implement Title II of the 

Genetic Information Nondiscrimination 

Act of 2008 (‘‘GINA’’). Congress enacted 

Title II of GINA to protect job 

applicants, current and former 

employees, labor union members, and 

apprentices and trainees from 

discrimination based on their genetic 

information. Title II of GINA requires 

the EEOC to issue implementing 

regulations. The Commission is 

proposing these rules under that 

authority to provide all persons subject 

to Title II of GINA additional guidance 

with regard to the law’s requirements. 

The Commission invites written 

comments from members of the public 

on these proposed rules and on any 

specific issues related to this proposal. 

DATES: Comments regarding this 

proposal must be received by the 

Commission on or before May 1, 2009. 

Please see the section below entitled 

ADDRESSES and SUPPLEMENTARY

INFORMATION for additional information 

on submitting comments. 

ADDRESSES: You may submit comments 

by any of the following methods: 

By mail to Stephen Llewellyn, 

Executive Officer, Executive Secretariat, 

Equal Employment Opportunity 

Commission, 131 M Street, NE., Suite 

6NE03F, 20507. 

By facsimile (‘‘FAX’’) machine to 

(202) 663–4114. (There is no toll free 

FAX number.) Only comments of six or 

fewer pages will be accepted via FAX 

transmittal, in order to assure access to 

the equipment. Receipt of FAX 

transmittals will not be acknowledged, 

except that the sender may request 

confirmation of receipt by calling the 

Executive Secretariat staff at (202) 663– 

4070 (voice) or (202) 663–4074 (TTY). 

(These are not toll free numbers.) 

By the Federal eRulemaking Portal: 

http://www.regulations.gov. After 

accessing this Web site, follow its 

instructions for submitting comments. 

Instructions: All comment 

submissions must include the agency 

name and docket number or the 

Regulatory Information Number (RIN) 

for this rulemaking. Comments need be 

submitted in only one of the abovelisted formats, not all three. All 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information you provide. 

Copies of the received comments also 

will be available for inspection in the 

EEOC Library, FOIA Reading Room, by 

advanced appointment only, from 9 a.m. 

to 5 p.m., Monday through Friday 

except legal holidays, from March 2, 

2009 until the Commission publishes 

the rule in final form. Persons who 

schedule an appointment in the EEOC 

Library, FOIA Reading Room, and need 


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1These regulations do not interpret the 

requirements of GINA Title I relating to genetic 

nondiscrimination in health coverage. Those 

requirements are administered by the Departments 

of Health and Human Services, Labor, and the 

Treasury. 

2Currently, Executive Order 13145 prohibits 

federal executive branch agencies from 

discriminating against applicants and employees on 

the basis of genetic information and limits access 

to and use of genetic information. Upon its effective 

date in November 2009, GINA will protect federal 

employees from genetic discrimination. 

3Unless otherwise noted, use of the term ‘‘GINA’’ 

means ‘‘Title II of GINA.’’ When needed for clarity, 

the preamble will refer to Title I of GINA or Title 

II of GINA. 

assistance to view the comments will be 

provided with appropriate aids upon 

request, such as readers or print 

magnifiers. To schedule an appointment 

to inspect the comments at the EEOC 

Library, FOIA Reading Room, contact 

the EEOC Library by calling (202) 663– 

4630 (voice) or (202) 663–4641 (TTY). 

(These are not toll free numbers.) 

FOR FURTHER INFORMATION CONTACT: 

Christopher J. Kuczynski, Assistant 

Legal Counsel, or Kerry E. Leibig, Senior 

Attorney Advisor, at (202) 663–4638 

(voice) or (202) 663–7026 (TTY). (These 

are not toll free numbers.) This notice 

also is available in the following 

formats: large print, Braille, audio tape, 

and electronic file on computer disk. 

Requests for this notice in an alternative 

format should be made to the 

Publications Information Center at 1– 

800–669–3362 (voice) or 1–800–800– 

3302 (TTY). 

SUPPLEMENTARY INFORMATION: 

Introduction 

On May 21, 2008, President Bush 

signed the Genetic Information 

Nondiscrimination Act of 2008 

(‘‘GINA’’), Pub. L. 110–233, 122 Stat. 

881, codified at 42 U.S.C. 2000ff et seq. 

into law. Congress enacted GINA in 

recognition of, among many 

achievements in the field of genetics, 

the decoding of the human genome and 

the creation and increased use of 

genomic medicine. As Congress noted, 

‘‘New knowledge about genetics may 

allow for the development of better 

therapies that are more effective against 

disease or have fewer side effects than 

current treatments. These advances give 

rise to the potential misuse of genetic 

information to discriminate in health 

insurance and employment.’’ GINA 

Section 2(1), 42 U.S.C. 2000ff, note. 

Experts predict that the twenty-first 

century will see tremendous strides in 

the new field of genomic medicine, 

bringing it into mainstream medical 

practice. The National Human Genome 

Research Institute, the institute within 

the National Institutes of Health 

responsible for the mapping of the 

human genome, notes that ‘‘by 

identifying the genetic factors associated 

with disease, researchers may be able to 

design more effective drugs; to prescribe 

the best treatment for each patient; to 

identify and monitor individuals at high 

risk from disease; and to avoid adverse 

drug reactions.’’ NHGRI, The Future of 

Genomic Medicine: Policy Implications 

for Research and Medicine (Bethesda, 

Md., Nov. 16, 2005), available at 

http://www.genome.gov/17516574 (last 

visited July 16, 2008). 

Many genetic tests now exist that can 

inform individuals whether they may be 

at risk for developing a specific disease 

or disorder. But just as the number of 

genetic tests increase, so do the 

concerns of the general public about 

whether they may be at risk of losing 

access to health coverage or 

employment if insurers or employers 

have their genetic information. Congress 

enacted GINA to address these 

concerns, by prohibiting discrimination 

based on genetic information and 

restricting acquisition and disclosure of 

such information, so that the general 

public would not fear adverse 

employment- or health coverage-related 

consequences for having a genetic test 

or participating in research studies that 

examine genetic information. Scientific 

advances require significant cooperation 

and participation from among members 

of the general public. In the absence of 

such participation, geneticists and other 

scientists would be hampered in their 

research, and efforts to develop new 

medicines and treatments for genetic 

diseases and disorders would be slowed 

or stymied. 

GINA Title I applies to group health 

plans sponsored by private employers, 

unions, and state and local government 

employers; issuers in the group and 

individual health insurance markets; 

and issuers of Medicare supplemental 

(Medigap) insurance.1 Title I generally 

prohibits discrimination in group 

premiums based on genetic information 

and the use of genetic information as a 

basis for determining eligibility or 

setting premiums in the individual and 

Medigap insurance markets, and places 

limitations on genetic testing and the 

collection of genetic information in 

group health plan coverage, the 

individual insurance market, and the 

Medigap insurance market. Title I also 

provides a clarification with respect to 

the treatment of genetic information 

under privacy regulations promulgated 

pursuant to the Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA). 

Title II of GINA prohibits use of 

genetic information in the employment 

context, restricts the deliberate 

acquisition of genetic information by 

employers and other entities covered by 

Title II, and strictly limits such entities 

from disclosing genetic information. 

The law incorporates by reference many 

of the familiar definitions, remedies, 

and procedures from Title VII of the 

Civil Rights Act of 1964, as amended, 

and other statutes protecting federal, 

state, and Congressional employees 

from discrimination.2

Summary of the Proposed Regulation 

GINA section 211, 42 U.S.C. 2000ff– 

10, requires the EEOC to issue 

regulations implementing Title II of the 

Act within one year of its enactment. 

The Commission is issuing this 

proposed rule in compliance with this 

requirement and pursuant to the 

Administrative Procedures Act, 5 U.S.C. 

553. The Commission seeks public 

comment on the proposed rule, the 

discussion in this preamble, and other 

Title II issues not addressed in either 

document. 

The report for the bill introduced into 

the Senate in 2007 noted that ‘‘[a]s a 

guiding principle, [GINA] is designed to 

extend to individuals in the area of 

genetic discrimination the same 

procedures and remedies as are 

provided under Title VII of the Civil 

Rights Act of 1964, as amended [(‘‘Title 

VII’’)].’’ S. Rep. No. 110–48 at 27. 

Although the Senate and House 

modified the bill between its initial 

introduction and final passage, the idea 

of extending Title VII protections to 

applicants and employees in the area of 

genetic information did not change. 

In developing this proposed 

regulation, the Commission closely 

followed the terms of the statute. The 

Commission’s goal is to implement the 

various provisions of Title II consistent 

with Congress’s intent, to provide some 

additional clarification of those 

provisions, and to explain more fully 

those sections where Congress 

incorporated by reference provisions 

from other statutes. For example, where 

GINA section 201(2)(A)(i) defines 

employee by reference to Title VII of the 

Civil Rights Act of 1964 and other 

statutes, this proposed regulation 

expands on that reference by importing 

language from these statutes so that 

those using the proposed regulation 

need not refer to other sources when 

determining the scope of GINA’s 

coverage.3

The Commission also recognizes that 

Title II of GINA includes terms that are 

outside the areas of its expertise. In 

particular, the definition of ‘‘genetic 


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4The Commission’s definition of ‘‘dependent’’ is 

solely for purposes of interpreting Title II of GINA, 

and is not relevant to interpreting the term 

‘‘dependent’’ under Title I of GINA or under section 

701(f)(2) of ERISA and the parallel provisions of the 

Public Health Service Act and the Internal Revenue 

Code. The Commission believes its interpretation of 

the term ‘‘family member,’’ particularly the way in 

which GINA’s reference to section 701(f)(2) of 

ERISA relates to that term, is consistent with the 

plain language of both section 701(f)(2) and Title II 

of GINA, furthers Congress’s intent to prohibit 

genetic discrimination in the employment context, 

and provides covered entities with clear standards 

governing compliance with the law. 

test’’ refers to ‘‘analysis of human DNA, 

RNA, chromosomes, proteins, or 

metabolites that detects genotypes, 

mutations, or chromosomal changes.’’ 

None of these terms are common to 

employment discrimination law. For 

this reason, Commission staff sought 

and obtained technical assistance from 

the National Human Genome Research 

Institute, the institute within the 

National Institutes of Health responsible 

for decoding the human genome and for 

developing technologies applicable to 

the study of the genetic components of 

complex disorders. 

The Commission also coordinated 

with the Departments of Labor (DOL), 

Health and Human Services (HHS), and 

the Treasury, which have responsibility 

for issuing regulations applicable to 

GINA Title I. In particular, DOL, HHS 

(the Centers for Medicare & Medicaid 

Services) and the Treasury (the Internal 

Revenue Service) are responsible for 

issuing regulations applicable to GINA 

sections 101–103. The HHS Office for 

Civil Rights is responsible for issuing 

the regulations applicable to GINA 

section 105. The National Association of 

Insurance Commissioners has issued 

conforming model regulations relating 

to section 104. Among the various Title 

II provisions are several that address the 

relationship between Title I and Title II, 

and the relationship between Title II 

and several statutes that the 

Departments enforce, including the 

Employee Retirement Income Security 

Act of 1974 (ERISA), the Public Health 

Service Act, the Internal Revenue Code, 

and HIPAA. 

Section-by-Section Analysis of the 

Regulation 

Section 1635.1 Purpose 

In this section, the Commission sets 

forth the general purposes of GINA. 

Title II of GINA restricts the deliberate 

acquisition of genetic information by 

covered entities, prohibits use of genetic 

information in employment decisionmaking, requires that genetic 

information be kept confidential (which 

includes maintaining written genetic 

information that exists in paper or 

electronic form as a confidential 

medical record), and places strict limits 

on disclosure of genetic information. 

Section 1635.2 Definitions—General 

The Commission reiterates the 

definitions set forth in GINA section 

201, many of which come from Title VII 

of the Civil Rights Act of 1964. 

However, where the statute merely 

incorporates by reference different 

categories of covered employees, the 

proposed regulation describes more 

fully the employees GINA protects. 

Moreover, GINA specifically provides 

that the term ‘‘employee’’ includes 

applicants, see 42 U.S.C. 2000ff–1(a)(1), 

and the Supreme Court has held that the 

term ‘‘employee’’ under Title VII 

includes former employees. See 

Robinson v. Shell Oil Co., 519 U.S. 337, 

346 (1997). Accordingly, the proposed 

regulation makes clear that the term 

‘‘employee’’ includes an applicant and a 

former employee. Similarly, the 

proposed regulation provides a concise 

explanation of the employers covered by 

GINA, rather than following the statute’s 

example of providing citations to 

definitions of ‘‘employer’’ provided by 

other laws. For example, the proposed 

regulation explains that Indian tribes, as 

well as bona fide private clubs (other 

than labor organizations) that are 

exempt from taxation under section 

501(c) of the Internal Revenue Code of 

1986, are not employers, rather than 

merely referring to Title VII’s exclusion 

of these groups from the definition of 

‘‘employer.’’ See 42 U.S.C. 2000e(b)(1) 

and (2). 

The proposed regulation includes a 

definition of ‘‘covered entity.’’ This 

proposed regulation uses the term to 

refer to all entities subject to Title II of 

GINA: The different categories of GINAcovered employers (private sector, state 

and local government, Congressional 

employers, executive branch, federal/ 

civil service), as well as employment 

agencies, labor organizations, and joint 

labor-management training and 

apprenticeship programs. The proposed 

regulation uses the term ‘‘covered 

entity’’ when describing the 

requirements or prohibited practices 

applicable to all entities subject to Title 

II of GINA, thus avoiding some of the 

repetition found in sections 202–205 of 

the statute. This use of the term 

‘‘covered entity’’ as a simplifying 

shorthand to aid in the readability of the 

proposed regulation is similar to EEOC’s 

use of ‘‘covered entity’’ in the regulation 

implementing Title I of the Americans 

with Disabilities Act, 42 U.S.C. 12111 

(ADA). The term ‘‘covered entity’’ in 

this proposed regulation is not intended 

to be synonymous with use of the same 

term in Title I of GINA, in regulations 

implementing Title I of GINA or HIPAA, 

or in section 206(c) of GINA (which 

specifically refers to HIPAA covered 

entities). 

The proposed regulation says that the 

term ‘‘covered entity’’ includes an 

‘‘employing office.’’ The term 

‘‘employing office,’’ referenced in 

sections 201 and 207 of GINA, is used 

in the Congressional Accountability Act, 

which protects employees in the 

legislative branch. See 2 U.S.C. 1301(9). 

Although the EEOC has no enforcement 

authority under the Congressional 

Accountability Act, as the only agency 

with authority to issue regulations 

under Title II of GINA, we believe that 

referencing that law in this proposed 

regulation is appropriate to put 

employees in the legislative branch and 

covered employing offices on notice of 

their rights and responsibilities under 

GINA. 

Section 1635.3 Definitions Specific to 

GINA 

GINA includes six terms not found in 

any of the other employment 

discrimination statutes that the 

Commission enforces. This proposed 

regulation provides some additional 

guidance regarding these terms, and 

EEOC seeks comment both as to what is, 

and is not, included in this preamble or 

in the text of the proposed regulation. 

The Commission notes that DOL, HHS, 

and the Treasury have published a 

Request for Information (RFI) under 

GINA Title I. See 73 FR 60208 (October 

10, 2008). All comments submitted 

under this proposed rule and the RFI are 

being shared among the Federal 

Agencies. 

Section 1635.3(a) Family Member 

The statute defines an individual’s 

‘‘family member’’ both by reference to 

ERISA section 701(f)(2) and as 

extending to the individual’s fourth 

degree relatives. First, section 201(3)(a) 

of GINA states that family member is 

defined as ‘‘a dependent (as that term is 

used for purposes of section [701(f)(2) of 

ERISA]’’ of the individual. For purposes 

of Title II, the Commission has 

determined that the dependents covered 

by Title II are limited to persons who 

are or become related to an individual 

through marriage, birth, adoption, or 

placement for adoption.4

Second, GINA includes as family 

members persons related from the first 

to the fourth degree of an individual. 

The degree of relationship, which 

reflects the average proportion of genes 

in common between two individuals, is 

determined by counting generational 

levels separating them. The GINA 


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5Since 2004 the U.S. Surgeon General’s Family 

History Initiative has actively promoted the 

collection and use of family history information in 

clinical settings, including featuring a bilingual 

Web-based tool through which the user creates and 

organizes his/her family health history (http:// 

www.hhs.gov/familyhistory/). GINA is not intended 

to limit the collection of family medical history by 

health care professionals for diagnostic or treatment 

purposes. 

provisions thus include the individual’s 

children, siblings, and parents (first 

degree) and extend to great-great 

grandparents and first cousins once 

removed (the children of a first cousin), 

as well as family members who are in 

between the individual and these 

persons (including parents, siblings, 

half-siblings, nieces, nephews, 

grandparents, great grandparents, aunts, 

uncles, great aunts and uncles, and first 

cousins). 

Section 1635.3(b) Family Medical 

History 

The proposed regulation includes a 

definition of ‘‘family medical history’’ 

because it is a term used in the statute’s 

discussion of prohibited employment 

practices, but it is not specifically 

defined by the statute. In the legislative 

history of GINA, Congress stated that 

the term ‘‘family medical history 

[should] be understood as it is used by 

medical professionals when treating or 

examining patients.’’ S. Rep. No. 110– 

48, at 16. In particular, the Senate 

Report notes as follows: 

[T]he American Medical Association (AMA) 

has developed an adult family history form 

as a tool to aid the physician and patient to 

rule out a condition that may have developed 

later in life, which may or may not have been 

inherited. This form requests information 

about the patient’s brothers, sisters, and their 

children, biological mother, the mother’s 

brothers, sisters, and their children, maternal 

grandfather, maternal grandmother, 

biological father, the father’s brothers, sisters, 

and their children, paternal grandfather and 

paternal grandmother. The committee 

expects that the use of ‘‘family history’’ in 

this bill will evolve with the medical 

profession and the tools it develops in this 

area. 

Id. The Report further notes that ‘‘a 

family medical history could be used as 

a surrogate for a genetic trait,’’ id., and 

that the definition of ‘‘genetic 

information’’ had to include ‘‘family 

medical history’’ to prevent a covered 

entity from making decisions about an 

individual’s health based on the 

existence of an inheritable disease of a 

family member. See also id. at 28 

(reiterating the Title I discussion of 

family medical history in the Report 

section addressing Title II).5

Section 1635.3(c) Genetic Information 

GINA section 201(4) and the proposed 

regulation define genetic information to 

include information from genetic tests, 

the genetic tests of family members, 

family medical history, and genetic 

information of a fetus carried by an 

individual or an individual’s family 

member or an embryo lawfully held by 

an individual or family member 

receiving assistive reproductive 

services. Genetic information also 

includes information about an 

individual’s or family member’s request 

for or receipt of genetic services. The 

statute and proposed regulation exclude 

from coverage information about an 

individual’s or family member’s age or 

gender. 

Section 1635.3(d) Genetic Monitoring 

Genetic monitoring is defined in 

GINA section 201(5) as the ‘‘periodic 

examination of employees to evaluate 

acquired modifications to their genetic 

material * * * caused by the toxic 

substances they use or are exposed to in 

performing their jobs.’’ The proposed 

regulation uses language similar to that 

found in the statute in defining the 

term. As more fully described in 

1635.8(b)(5) and its accompanying 

Preamble discussion, a covered entity 

may acquire genetic information as part 

of genetic monitoring that is either 

required by law or voluntarily 

undertaken, provided the entity 

complies strictly with certain 

conditions. 

Section 1635.3(e) Genetic Services 

The term ‘‘genetic services’’ is defined 

in GINA section 201(6). It includes 

genetic tests, genetic counseling, and 

genetic education. Making an 

employment decision based on 

knowledge that an individual has 

received genetic services violates GINA, 

even if the covered entity is unaware of 

the specific nature of the genetic 

services received or the specific 

information exchanged in the course of 

providing them. 

Section 1635.3(f) Genetic Test 

GINA section 201(7) defines ‘‘genetic 

test’’ to mean the ‘‘analysis of human 

DNA, RNA, chromosomes, proteins, or 

metabolites, that detects genotypes, 

mutations, or chromosomal changes.’’ 

Genetic tests are used to detect gene 

variants associated with a specific 

disease or condition. For example, tests 

to determine whether an individual 

carries the genetic variant evidencing a 

predisposition to breast cancer— 

whether the individual has the BRCA1 

or BRCA2 variant—or to determine 

whether an individual has a genetic 

variant associated with hereditary 

nonpolyposis colorectal cancer are 

genetic tests. It is important to note, 

however, that the presence of a genetic 

variant relating to a predisposition to 

disease is not evidence of, and does not 

equate to, disease. Similarly, a positive 

test for a genetic variant as strongly 

penetrant as Huntington’s Disease does 

not equate to the presence of the 

disease, even though development of 

the disease is almost inevitable. 

The Commission invites comments on 

the scope of the term ‘‘genetic test.’’ The 

proposed regulation includes two 

examples of tests that are not genetic: a 

test for the presence of a virus that is not 

composed of human DNA, RNA, 

chromosomes, proteins, or metabolites 

and a test for drug or alcohol use. 

Another example of what is not a 

genetic test and might be mentioned, 

either in the text of the regulation or in 

the final preamble, is a test for 

infectious and communicable diseases 

that may be transmitted through food 

handling, which, the Commission 

believes, is not covered by the definition 

of ‘‘genetic test.’’ Similarly, routine tests 

such as complete blood counts, 

cholesterol tests, and liver-function tests 

would not be protected under GINA. We 

seek comment as to how the term 

should be applied, whether the 

proposed regulation should be more or 

less expansive, and whether it or the 

preamble should provide examples of 

what should be included or excluded. 

The Commission further notes that 

the Title II definition of ‘‘genetic test’’ 

differs from the definition of this term 

in Title I. Specifically, the Title II 

definition of ‘‘genetic test’’ does not 

have the express exclusion that Title I 

does for ‘‘an analysis of proteins or 

metabolites that is directly related to a 

manifested disease, disorder, or 

pathological condition that could 

reasonably be detected by a health care 

professional with appropriate training 

and expertise in the field of medicine 

involved.’’ GINA 101(d), 29 U.S.C. 

1191b–(d)(7)(B). Title II does not require 

this language of exclusion because 

Congress determined that these uses 

‘‘are not applicable in the employment 

context.’’ S. Rep. No. 110–48 at 28. 

However, as explained below, the 

Commission borrowed from Title I’s use 

of the term ‘‘manifest’’ in the definition 

of ‘‘genetic test’’ in formulating a 

definition of ‘‘manifested or 

manifestation.’’ 

Section 1635.3(g) Manifestation or 

Manifested 

We have added a definition of 

‘‘manifestation or manifested’’ to the 

proposed regulation, because sections 


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201(4)(A)(iii) and 210 use the terms. 

Specifically, GINA section 

201(4)(A)(iii), defining ‘‘genetic 

information,’’ refers to the 

‘‘manifestation of a disease or disorder 

in family members’’ of an individual, 

and section 210, entitled ‘‘Medical 

information that is not genetic 

information,’’ refers to a ‘‘manifested 

disease, disorder, or pathological 

condition.’’ The definition of 

‘‘manifestation or manifested’’ was 

developed with the assistance of the 

National Human Genome Research 

Institute, an Institute within the 

National Institutes of Health. The 

proposed regulation defines 

‘‘manifestation or manifested’’ to mean, 

with respect to a disease, disorder, or 

pathological condition: 

That an individual has been or could 

reasonably be diagnosed with the disease, 

disorder, or pathological condition by a 

health care professional with appropriate 

training and expertise in the field of 

medicine involved. For purposes of this part, 

a disease, disorder, or pathological condition 

is not manifested if the diagnosis is based 

principally on genetic information or on the 

results of one or more genetic tests. 

This understanding of the term 

‘‘manifested’’ is consistent both with the 

definition of genetic test found in Title 

I, which permits use of certain 

diagnostic tests in order to determine 

whether an individual has a current—or 

manifest—disease, disorder, or 

condition, see id. at 16, and with the 

notion, discussed above in conjunction 

with the definition of genetic test 

(section 1635.3(f)), that the mere 

presence of a genetic variant does not 

mean that an individual has an 

associated condition, disease, or 

disorder. The presence of a genetic 

variant alone does not constitute a 

diagnosis; other signs or symptoms must 

be present. This interpretation is 

consistent with current ERISA 

regulations which prohibit a group 

health plan, and a health insurance 

issuer offering group health insurance 

coverage, from imposing a preexisting 

condition exclusion relating to a 

condition based solely on genetic 

information. However, if an individual 

is diagnosed with a condition, even if 

the condition relates to genetic 

information, the plan may impose a 

preexisting condition exclusion with 

respect to the condition, subject to other 

HIPAA portability requirements. See 29 

CFR 2590.701–3(b)(6)(i). Thus, for 

example, a woman who has group 

health plan coverage and has the BRCA1 

gene variant may not be subject to a 

preexisting condition exclusion merely 

because she has the variant. Id. Example 

at 2590.703(b)(6)(ii). 

Similarly, Huntington’s disease (HD) 

is an example of a genetic disease that 

is not diagnosed solely through use of 

a genetic test; other signs and symptoms 

must be present. The presence of the 

genetic variant virtually guarantees the 

later development of disease, but the 

disease does not usually manifest until 

adulthood. Therefore, even when a 

genetic variant is 100 percent predictive 

for development of disease, the presence 

of the variant does not by itself equal 

diagnosis of the disease. 

Section 1635.4 Prohibited Practices— 

In General 

In describing the prohibited practices 

under GINA Title II, Congress adopted 

language similar to that used in Title VII 

and other equal employment statutes, 

evincing its intent to prohibit 

discrimination with respect to a wide 

range of covered entity practices, 

including hiring, promotion and 

demotion, seniority, discipline, 

termination, compensation, and the 

terms, conditions, and privileges of 

employment. In separate GINA sections 

203–205, the statute notes additional 

covered actions of employment agencies 

(failing or refusing to refer for 

employment), labor unions (excluding 

or expelling from membership), and 

training, retraining, and apprenticeship 

programs (denying admission to or 

employment in such programs). 

Section 1635.5 Limiting, Segregating, 

and Classifying 

The proposed regulation reiterates the 

statutory language barring actions by 

covered entities that may limit, 

segregate, or classify employees because 

of genetic information. For example, an 

employer could not reassign someone 

whom it learned had a family medical 

history of heart disease from a job it 

believed would be too stressful and 

might eventually lead to heart-related 

problems for the employee. This section 

also makes clear that although the 

language of the statute specifically 

prohibits actions that have the ‘‘purpose 

or effect’’ of limiting, segregating, or 

classifying individuals on the basis of 

genetic information, neither the statute 

nor the proposed regulation creates a 

cause of action for disparate impact. 

Section 208 of GINA specifically 

prohibits such actions, and establishes 

the Genetic Non-Discrimination Study 

Commission, to examine ‘‘the 

developing science of genetics’’ and 

recommend to Congress ‘‘whether to 

provide a disparate impact cause of 

action under this Act.’’ The proposed 

regulation does not address the 

establishment of this Commission, 

which is scheduled to begin its work on 

May 21, 2014. 

Section 1635.6 Causing an Employer 

To Discriminate 

GINA sections 203(c), 204(c), and 

205(d) expressly bar employment 

agencies, labor organizations, and 

apprenticeship or other training 

programs from causing an employer to 

discriminate on the basis of genetic 

information. These sections recognize 

that employers engage in most of the 

employment-related activities that the 

Act reaches. Other covered entities, 

however, might engage in conduct that 

could cause an employer to 

discriminate. For example, an 

employment agency or union might 

share or attempt to share genetic 

information it obtained (whether legally 

or not) about a client or member with 

an employer in an effort to affect the 

individual’s employment prospects. 

Such conduct would violate sections 

203(c) and 204(c). 

Although section 202 does not 

include a similar provision explicitly 

prohibiting an employer from causing 

another covered entity to discriminate, 

it is well settled under Title VII that the 

definition of employer includes 

employers’ agents under common law 

agency principles. See Vinson v. Meritor 

Savings Bank, 477 U.S. 57, 72 (1986). 

Because GINA incorporates Title VII’s 

definition of employer, including the 

application of common law agency 

principles, GINA would bar an 

employer from engaging in actions that 

would cause another covered entity 

acting as its agent to discriminate. For 

example, an employer that directed an 

employment agency to ask applicants 

for genetic information or told the 

employment agency not to send it 

candidates with a family medical 

history for certain conditions would 

violate GINA. An employment agency 

that acted pursuant to the employer’s 

direction would be liable for violating 

GINA either directly, because the law 

applies to employment agencies, or as 

an agent of the employer. Similarly, an 

employer would violate GINA if it used 

a labor organization’s hiring hall to 

obtain genetic information in making 

job referrals, and the labor union would 

be liable under GINA either directly or 

as the employer’s agent. 

Section 1635.7 Retaliation 

The proposed regulation reiterates the 

statutory prohibition against retaliation 

where an individual opposes any act 

made unlawful by GINA, files a charge 

of discrimination or assists another in 

doing so, or gives testimony in 

connection with a charge. Because 


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Congress adopted in GINA the language 

of the anti-retaliation provision in Title 

VII of the Civil Rights Act of 1964, the 

Commission believes that Congress 

intended the standard for determining 

what constitutes retaliatory conduct 

under GINA to be the same as the 

standard under Title VII, as announced 

by the Supreme Court in Burlington 

Northern & Santa Fe Ry. v. White, 548 

U.S. 53 (2006). In that case, the Court 

held that Title VII’s anti-retaliation 

provision protects an individual from 

conduct, whether related to 

employment or not, that a reasonable 

person would have found ‘‘materially 

adverse,’’ meaning that the action ‘‘well 

might have ‘dissuaded a reasonable 

worker from making or supporting a 

charge of discrimination.’ ’’ Id. at 57–58 

(citations omitted). 

Section 1635.8 Acquisition of Genetic 

Information 

Each of the discrete GINA sections 

addressing the conduct of employers, 

employment agencies, labor 

organizations, and apprenticeship or 

other training programs includes a 

section prohibiting covered entities 

from requesting genetic information 

from applicants, employees or other 

individuals; from requiring that 

applicants or employees provide genetic 

information; or from purchasing genetic 

information about an applicant or 

employee. Each section also includes 

the same five exceptions. Sections 202, 

covering employers, and 205 covering 

joint labor-management training and 

apprenticeship programs, include a 

sixth exception. The proposed 

regulation addresses each of the 

exceptions. Covered entities are 

cautioned, however, that the use of 

genetic information to discriminate, no 

matter how that information may have 

been acquired, is prohibited. 

Inadvertently Requesting or Requiring 

Genetic Information: First, a covered 

entity that ‘‘inadvertently requests or 

requires family medical history’’ from 

an individual does not violate GINA. 

Congress intended this exception to 

address what it called the ‘‘ ‘water 

cooler problem’ in which an employer 

unwittingly receives otherwise 

prohibited genetic information in the 

form of family medical history through 

casual conversations with an employee 

or by overhearing conversations among 

co-workers.’’ S. Rep. No. 110–48, at 29; 

see also H.R. Comm. on Education and 

Labor, Genetic Information 

Nondiscrimination Act of 2007, H.R. 

Rep. No. 110–28 part I, 37–38 (2008) 

(H.R. Rep. No. 110–28, part I). Congress 

did not want casual conversation among 

co-workers regarding health to trigger 

federal litigation whenever someone 

mentioned something that might 

constitute protected family medical 

history. The Commission’s proposed 

regulation thus notes that a covered 

entity inadvertently acquires family 

medical history where a manager or 

supervisor overhears a conversation 

among co-workers that includes 

information about family medical 

history (e.g., a conversation in which 

one employee tells another that her 

father has Alzheimer’s Disease), or 

receives an unsolicited e-mail message 

from a co-worker that includes genetic 

information. 

Although the language of this 

exception in GINA specifically refers to 

family medical history, the Commission 

believes that it is consistent with 

Congress’s intent to extend the 

exception to any genetic information 

that an employer inadvertently acquires. 

The Commission does not believe, for 

example, that Congress intended that an 

employer would be liable for the 

acquisition of genetic information 

because it overhears a conversation in 

which one employee tells another that 

her mother had a genetic test to 

determine whether she was at increased 

risk of getting breast cancer. If the 

exception were read to cover only 

family medical history, this type of 

acquisition of genetic information 

would violate GINA, even though it 

occurred inadvertently, because 

information that a family member has 

had a genetic test, while genetic 

information, is not information about 

the occurrence of a disease or disorder 

in a family member. 

The Commission also understands 

this exception to apply in any situation 

in which an employer might 

inadvertently acquire genetic 

information, not just situations 

involving conversations between coworkers that are overheard. The 

proposed regulation provides an 

illustrative list of situations where we 

believe the acquisition comes within 

Congress’s intent. Thus, for example, 

the exception applies when the covered 

entity, acting through a supervisor or 

other official, receives family medical 

history directly from an individual 

following a general health inquiry (e.g., 

‘‘How are you?’’) or a question as to 

whether the individual has a manifested 

condition. Similarly, a casual question 

between colleagues, or between a 

supervisor and supervisee, concerning 

the health of a parent or child would not 

violate GINA (e.g., ‘‘How’s your son 

feeling today?’’). 

A covered entity that asks for family 

medical history or other genetic 

information as part of an inquiry or 

medical examination related to an 

applicant’s or employee’s manifested 

disease, disorder, or pathological 

condition will not be considered to have 

acquired such information 

inadvertently. Thus, even though the 

ADA allows an employer to require a 

medical examination of all employees to 

whom it has offered a particular job, for 

example, to determine whether they 

have heart disease that would affect 

their ability to perform a physically 

demanding job, GINA would prohibit 

inquiries about family medical history 

of heart disease as part of such an 

examination. Such a limitation will not 

affect an employer’s ability to use a 

post-offer medical examination for the 

limited purpose of determining an 

applicant’s current ability to perform a 

job. 

Covered entities should ensure that 

any medical inquiries they make or any 

medical examinations they require are 

modified so as to comply with the 

requirements of GINA. In particular, we 

note that at present, the ADA permits 

employers to obtain medical 

information, including genetic 

information, from post-offer job 

applicants. As we interpret GINA, this 

will change on the November 21, 2009 

effective date of Title II of GINA: 

Employers no longer will be permitted 

to obtain any genetic information, 

including family medical history, from 

post-offer applicants. Employers will 

likewise be prohibited from obtaining 

this type of information through any 

type of medical examination required of 

employees for the purpose of 

determining continuing fitness for duty. 

However, Title II of GINA will not 

apply to information obtained by a 

health care professional in the course of 

a medical examination, diagnosis, or 

treatment unrelated to a determination 

of fitness for duty, except to the extent 

the information is obtained as part of an 

employer-provided voluntary wellness 

program subject to 1635.8(b)(2) of this 

proposed rule. For example, a doctor 

working at a hospital may ask for family 

medical history from a hospital 

employee who requests a medical 

examination. See 29 CFR 1635.8(b)(2) 

(allowing collection of genetic 

information, under certain specified 

conditions, when an employer offers 

health or genetic services as part of a 

voluntary wellness program). 

The proposed regulation notes that 

when a covered entity seeks information 

from an individual who requests a 

reasonable accommodation under the 

ADA or other state or local law, the 

acquisition of genetic information as 

part of the documentation that the 

individual provides in support of the 


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request is considered inadvertent, as 

long as the request for documentation 

was lawful (e.g., was not overly broad). 

For information on the type of medical 

information an employer may lawfully 

request in connection with a request for 

reasonable accommodation see EEOC’s 

Enforcement Guidance on Reasonable 

Accommodation and Undue Hardship 

Under the Americans with Disabilities 

Act, EEOC Notice No. 915.002 (Oct. 17, 

2002), available at http://www.eeoc.gov/ 

policy/docs/accommodation.html. We 

note that GINA’s prohibition on 

requesting, requiring, or purchasing 

genetic information would control 

during the interactive process used to 

determine an appropriate reasonable 

accommodation. The Commission 

knows of no reason why a covered 

entity would need to request genetic 

information to determine an 

individual’s current physical or mental 

limitations and whether those 

limitations can be accommodated. 

The Commission further recognizes 

that other federal, state, or local laws 

may allow covered entities to obtain 

medical information about employees 

(other than genetic information). The 

proposed regulation makes it clear that 

a covered entity that inadvertently 

receives genetic information in response 

to a lawful request for medical 

information under such a law would not 

violate GINA, including, for example, 

where a covered entity received genetic 

information in connection with the 

FMLA’s employee return to work 

certification requirements. 

The Commission believes that the first 

exception to the general prohibition of 

requesting, requiring, or purchasing 

genetic information should also apply 

when an individual requests leave 

pursuant to a leave policy independent 

of a federal, state, or local leave or 

disability law, unless the covered 

entity’s request was overbroad. For 

example, a request for an employee’s 

entire medical record or the entire 

medical record related to a particular 

impairment is likely to include family 

medical history. An employer who 

receives family medical history or other 

genetic information in response to such 

a broad request would violate GINA. For 

information on the appropriate scope of 

inquiries in response to requests for 

leave (other than as a reasonable 

accommodation), see EEOC’s 

Enforcement Guidance on DisabilityRelated Inquiries and Medical 

Examinations of Employees Under the 

Americans with Disabilities Act, 8 Fair 

Empl. Prac. Man. (BNA) 405:7701, 

Questions 15–17 (July 27, 2000) 

(‘‘Enforcement Guidance’’), available at 

http://www.eeoc.gov/policy/docs/ 

guidance-inquiries.html. 

In addition to complying with 

relevant EEOC guidance, covered 

entities may wish to take proactive 

measures to avoid even the inadvertent 

acquisition of genetic information. For 

example, as a best practice, an employer 

that asks an employee to have a health 

care professional provide 

documentation about a disability in 

support of a request for accommodation 

could specifically indicate on a 

questionnaire provided for this purpose 

that family medical history or other 

genetic information about the employee 

should not be provided. 

Health or Genetic Services: Second, 

GINA permits covered entities to offer 

health or genetic services, and notes that 

a covered entity that meets specific 

requirements may offer such services as 

a part of a wellness program. The 

proposed regulation reiterates the 

statutory provision, but further notes 

that a wellness program seeking medical 

information must be voluntary, which is 

a requirement set forth in the ADA. The 

Commission notes that according to the 

Enforcement Guidance, a wellness 

program is voluntary ‘‘as long as an 

employer neither requires participation 

nor penalizes employees who do not 

participate. Id., Question 22. The 

Commission has not further addressed 

how the term ‘‘voluntary’’ should be 

defined for purposes of the ADA’s 

application to wellness programs. We 

invite comments regarding the scope of 

this term. 

The proposed regulation lists the 

specific requirements in the statute as 

prerequisites to the acquisition of 

genetic information when providing 

genetic services: A request in writing 

and in language reasonably likely to be 

understood by the individual from 

whom the information is sought; a 

description of the information being 

requested; and a description of the 

safeguards in place to protect against 

unlawful disclosure. The proposed 

regulation states that individually 

identifiable information may be 

provided only to the individual from 

whom it was obtained and that covered 

entities are entitled only to receive 

information in aggregate terms that do 

not disclose the identity of specific 

individuals. Although not stated in the 

proposed regulation, a covered entity 

that receives ‘‘aggregate’’ information 

may still violate GINA where the small 

number of participants, alone or in 

conjunction with other factors, makes 

an individual’s genetic information 

readily identifiable. 

The Commission notes that although 

this provision permits covered entities 

to implement wellness programs that 

seek family medical history voluntarily, 

other provisions in GINA Title I place 

strict limits on the genetic information 

that group health plans may request or 

require from covered individuals. In this 

regard, the Commission further notes 

that DOL, HHS and the Treasury are 

responsible for addressing the 

limitations on group health plans and 

insurance issuers under Title I. Covered 

entities that sponsor, establish, or 

maintain group health plans that 

implement wellness programs or other 

health-related services are cautioned to 

consider carefully whatever limitations 

these Departments place on group 

health plans with respect to the 

acquisition of genetic information. 

The Commission also notes that 

Congress made clear at section 206(c) 

that GINA’s Title II provisions are not to 

be construed to interfere with or 

otherwise apply to uses and disclosures 

of health information that are governed 

by the privacy regulations promulgated 

pursuant to HIPAA (‘‘the HIPAA 

Privacy Rule’’). As discussed below, the 

proposed rule implements this general 

statutory provision at proposed 

1635.11(d) by excluding from coverage 

genetic information that is health 

information otherwise protected by the 

HIPAA Privacy Rule. Consistent with 

proposed 1635.11(d), the Commission 

further notes that nothing in section 

1635.8 should be read as applying to or 

otherwise restricting the use or 

disclosure of genetic information that is 

protected health information subject to 

the HIPAA Privacy Rule. Thus, where a 

health care provider covered by the 

HIPAA Privacy Rule is providing health 

or genetic services, that provider is 

subject to the requirements of the 

HIPAA Privacy Rule with regard to uses 

and disclosures of protected health 

information, including HIPAA’s 

conditions on disclosures to employers, 

and not this proposed regulation’s 

provisions. 

Family and Medical Leave Act: Third, 

GINA recognizes that individuals 

requesting leave under the Family and 

Medical Leave Act (FMLA) or similar 

state or local law might provide family 

medical history. For example, an 

individual requesting FMLA leave to 

care for a seriously ill relative may 

disclose family medical history when 

completing the certification required by 

section 103 of the FMLA. A covered 

entity that receives family medical 

history under these circumstances 

would not violate GINA. Because this 

information is still subject to GINA’s 

confidentiality requirements, however, 

the information must be placed in a 

separate medical file and must be 


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6 Genetic information that a covered entity 

receives verbally and does not reduce to writing 

must still be kept confidential, except to the extent 

that GINA permits disclosure. 

treated as a confidential medical record, 

as more fully described below. 

Commercially and Publicly Available 

Information: Fourth, GINA provides an 

exception for the purchase of 

commercially and publicly available 

materials that may include family 

medical history. As with the exception 

applicable to the inadvertent acquisition 

of family medical history, the 

Commission reads this exception as 

applying to all genetic information, not 

just to family medical history. For 

example, an employer would not violate 

GINA if it learned that an employee had 

the breast cancer gene by reading a 

newspaper article profiling several 

women living with the knowledge that 

they have the gene. 

The statute identifies newspapers, 

magazines, periodicals, and books as 

potential sources of genetic information. 

The proposed regulation adds to that list 

information obtained through electronic 

media, such as the Internet, television, 

and movies. The exception does not 

include family medical history 

contained in medical databases or court 

records. Research databases available to 

scientists on a restricted basis, such as 

databases that NIH maintains for the 

scientific community, would not be 

considered ‘‘commercially and publicly 

available.’’ The Commission invites 

public comment on whether there are 

sources similar in kind to those 

identified in the statute that may 

contain family medical history and 

should be included either in the group 

of excepted sources or the group of 

prohibited sources, such as personal 

Web sites, or social networking sites. 

Further, we would appreciate comment 

regarding whether the additional 

sources that are noted in the proposed 

regulation should be deemed similar in 

nature to those contained in the statute 

so as to remain a part of the regulation. 

Genetic Monitoring: Fifth, the statute 

permits a covered entity to engage in the 

genetic monitoring of the biological 

effects of toxic substances in the 

workplace. The statute and proposed 

regulation note that monitoring must 

meet certain requirements. First, a 

covered entity must provide written 

notice of the monitoring and, where the 

monitoring is not specifically required 

by federal or state law, must obtain an 

individual’s prior knowing, written, and 

voluntary authorization. Second, the 

proposed regulation describes the type 

of authorization the employer must 

provide in order to ensure that it is 

knowing and voluntary. The 

authorization must be written in a way 

that is reasonably likely to be 

understood by the person from whom 

the information is being sought, must 

describe the type of genetic information 

that will be obtained and the general 

purposes for which it will be used, and 

must describe the limitations on 

disclosure of the genetic information. 

Third, all monitoring must comply with 

all applicable provisions of the law and 

implementing regulations, including 

regulations promulgated pursuant to the 

Occupational Safety and Health Act of 

1970 (29 U.S.C. 651 et seq.), the Federal 

Mine Safety and Health Act of 1977 (30 

U.S.C. 801 et seq.) , and the Atomic 

Energy Act of 1954 (42 U.S.C. 2011 et 

seq.). 

Whether or not the monitoring is 

undertaken pursuant to federal or state 

law, GINA requires that the individual 

receive results of the monitoring and 

that the covered entity receive 

information only in aggregate terms that 

do not disclose the identity of specific 

individuals. As noted above in the 

paragraph addressing genetic services, 

covered entities that engage in genetic 

monitoring, particularly when done on 

a voluntary basis, are cautioned where 

the monitoring encompasses only a few 

individuals: Information obtained in the 

aggregate may make a particular 

individual’s genetic information 

identifiable. 

DNA Testing for Law Enforcement or 

Human Remains Identification 

Purposes: Finally, sections 202(b), 

covering employers, and 205(b), 

covering apprenticeship or other 

training programs, include a sixth 

exception for employers that engage in 

DNA testing for law enforcement 

purposes as a forensic lab or for 

purposes of human remains 

identification. GINA provides that these 

entities may request or require ‘‘genetic 

information of such employer’s 

employees, apprentices, or trainees, but 

only to the extent that such genetic 

information is used for analysis of DNA 

identification markers for quality 

control to detect sample contamination 

and maintained in a manner consistent 

with such use.’’ This is a very limited 

exception and, if properly conducted, 

an employer or training program would 

not obtain health-related genetic 

information. The EEOC invites 

comments on the impact of this 

exception on law enforcement. 

Section 1635.9 Confidentiality 

GINA section 206 addresses 

confidentiality of genetic information 

generally, establishes permitted 

disclosures, and describes the 

relationship between GINA and HIPAA. 

Each of these items is discussed below. 

Section 1635.9(a) Treatment of Genetic 

Information 

Under GINA, covered entities are 

required to treat genetic information the 

same way they treat medical 

information generally. That is, covered 

entities in possession of genetic 

information must keep the information 

confidential and, if the information is in 

writing, must keep it apart from other 

personnel information in separate 

medical files.6 Congress made express 

the requirement that covered entities 

keep genetic information confidential by 

using the confidentiality regime 

required by the ADA generally for 

medical records. H.R. Rep. 110–28, part 

I, at 39. GINA does not require that 

covered entities maintain a separate 

medical file for genetic information. 

Genetic information may be kept in the 

same file as medical information subject 

to the ADA. 

As noted above, a covered entity does 

not violate GINA when it acquires 

genetic information available through 

publicly available sources. For example, 

an employer that purchased a 

newspaper with an obituary about a 

family member of an employee 

indicating that the employee’s relative 

died of a disease or disorder that has a 

genetic component would not violate 

GINA. Similarly, a labor organization 

may lawfully acquire a magazine or 

periodical with an article about a 

member that includes family medical 

history information about the member’s 

parent, sibling, or child. In neither 

instance, nor in any similar instance 

where a covered entity acquires family 

medical history through publicly 

available sources, must the covered 

entity place the information into a 

confidential medical file. Moreover, 

inasmuch as one of GINA’s purposes is 

the protection from disclosure of 

otherwise private genetic information, 

disclosure of publicly available 

information does not violate the Act. 

However, a covered entity may not use 

family medical history to make 

employment decisions, even if the 

information was acquired through 

commercially and publicly available 

sources. 

Section 1635.9(b) Limitations on 

disclosure 

GINA permits disclosure of genetic 

information in limited circumstances. 

First, a covered entity may disclose 

genetic information to the individual to 

whom it relates, if the individual 


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requests disclosure in writing. Second, 

the section states that genetic 

information may be provided to an 

occupational health researcher ‘‘if the 

research is being conducted in 

compliance with the regulations under’’ 

45 CFR part 46. 

The third exception permits 

disclosure in compliance with a court 

order. It provides that the disclosure of 

genetic information must be carefully 

tailored to the terms of the order and the 

covered entity must inform the 

individual about the order and what 

information it disclosed. This exception 

does not allow disclosures in other 

circumstances during litigation, such as 

in response to discovery requests that 

are not governed by an order specifying 

the genetic information that must be 

disclosed. 

The fourth exception permits 

disclosure of relevant genetic 

information to government officials 

investigating compliance with the 

statute. The fifth exception permits 

disclosure consistent with the 

requirements of the FMLA or similar 

state or local leave law. For example, an 

employee’s supervisor who receives a 

request for FMLA leave from an 

employee who wants to care for a child 

with a serious health condition may 

forward this request to persons with a 

need to know the information because 

of responsibilities relating to the 

handling of FMLA requests. Finally, the 

sixth exception permits disclosure of 

family medical history to federal, state, 

or local public health officials in 

connection with a contagious disease 

that presents an imminent hazard of 

death or life-threatening illness. The 

statute requires the covered entity to 

notify the employee of any release of a 

family member’s medical history 

information when undertaken for this 

purpose. 

Section 1635.9(c) Relationship to 

HIPAA Privacy Regulations 

GINA section 206(c) provides that the 

provisions of Title II of GINA are not 

intended to apply to uses and 

disclosures of health information 

governed by the HIPAA Privacy Rule. 

Accordingly, and consistent with the 

general rule of construction 

implementing this statutory provision at 

1635.11(d), this proposed rule provides 

at 1635.9(c) that nothing in 1635.9 

should be construed as applying to the 

use or disclosure of genetic information 

that is protected health information 

subject to the HIPAA Privacy Rule. See 

discussion of Section 1635.11(d), infra, 

for an example of the interaction under 

GINA between the HIPAA Privacy Rule 

and this proposed regulation. 

Section 1635.10 Enforcement and 

Remedies 

In crafting GINA’s enforcement and 

remedies section, Congress recognized 

the advisability of using the existing 

mechanisms in place for redress of other 

forms of employment discrimination. In 

particular, the Senate noted that this 

section intends to take ‘‘advantage of the 

expertise and process of the EEOC.’’ S. 

Rep. No. 110–48, at 31 & n.17. In this 

regard, GINA and the proposed 

regulation provide the following: 

• The enforcement mechanism 

applicable and remedies available to 

employees and others covered by Title 

VII apply to GINA as well. The statute 

references sections 705–707, 709–711, 

and 717 of Title VII, 42 U.S.C. 2000e– 

4, et seq. The Commission notes that its 

implementing regulations found at 29 

CFR parts 1601 (procedural regulations), 

1602 (recordkeeping and reporting 

requirements under Title VII and the 

ADA), and 1614 (federal sector 

employees) apply here as well. 

• The procedures applicable and 

remedies available to employees 

covered by sections 302 and 304 of the 

Government Employee Rights Act of 

1991, 42 U.S.C. 2000e–16(b) & (c) 

(GERA) apply under GINA. EEOC 

regulations applicable to GERA are 

found at 29 CFR part 1603. 

• The procedures applicable and 

remedies available to employees 

covered by 3 U.S.C. 401 et seq. are set 

forth in 3 U.S.C. 451–454. These 

sections provide for counseling and 

mediation of employment 

discrimination allegations and the 

formal process of complaints before the 

Commission using the same 

administrative process generally 

applicable to employees in the 

Executive Branch of the Federal 

government; that is, the process set forth 

in 29 CFR part 1614. 

Employees covered through the 

Congressional Accountability Act of 

1995 must use the procedures set forth 

in that statute. The Commission has no 

authority with respect to the 

enforcement of GINA as to employees 

covered through this provision. 

The proposed regulation includes a 

separate reference to the remedies 

provisions applicable to GINA. Similar 

to other federal anti-discrimination 

laws, GINA provides for recovery of 

pecuniary and non-pecuniary damages, 

including compensatory and punitive 

damages. The statute’s incorporation by 

reference of section 1977A of the 

Revised Statutes of the United States (42 

U.S.C. 1981a) also imports the 

limitations on the recovery of 

compensatory damages for future 

pecuniary losses, emotional pain, 

suffering, etc., and punitive damages 

applicable generally in employment 

discrimination cases, depending on the 

size of the employer. Punitive damages 

are not available in actions against the 

federal government, or against state or 

local government employers. 

Finally, the proposed regulation notes 

that covered entities are required to post 

notices in conspicuous places 

describing GINA’s applicable 

provisions. The Commission, prior to 

GINA’s effective date, will publish in 

the Federal Register appropriate 

language for use in such notices. 

Section 1635.11 Construction 

GINA section 209 and this section of 

the proposed regulation set forth rules 

of construction applicable to GINA’s 

coverage and prohibitions. They address 

principally GINA’s relationship to other 

federal laws covering discrimination, 

health insurance, and other areas of 

potential conflict. 

Section 1635.11(a) Relationship to 

Other Laws Generally 

The subsection first addresses the 

relationship of Title II of GINA to other 

federal, state, local, and tribal laws 

governing genetic discrimination, the 

privacy of genetic information, and 

discrimination based on disability. Over 

40 states have laws addressing genetic 

discrimination in employment. Some 

may be more stringent than GINA; 

others less so. GINA makes clear that it 

does not preempt any other state or 

local law that provides equal or greater 

protections than GINA from 

discrimination on the basis of genetic 

information or improper access or 

disclosure of genetic information. 

Additionally, Title II of GINA does not 

limit the rights or protections under 

federal, state, local or Tribal laws that 

provide greater privacy protection to 

genetic information. 

Similarly, GINA does not affect an 

individual’s rights under the ADA, the 

Rehabilitation Act, or state or local laws 

that prohibit discrimination against 

individuals based on disability. So, for 

example, an individual could challenge 

the disclosure of genetic information 

under the ADA where the information is 

also considered medical information 

subject to that law. Additionally, even 

though information that an employee 

currently has a disease, such as cancer, 

is not subject to GINA’s confidentiality 

provisions, such information would be 

protected under the ADA, and an 

employer would be liable under that 

law for disclosing the information, 

unless a specific ADA exception 

applied. 


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GINA does limit, however, an 

employer’s ability to obtain genetic 

information as a part of a disabilityrelated inquiry or medical examination. 

For example, upon the effective date of 

GINA, an employer will no longer be 

able to obtain family medical history or 

conduct genetic tests of post-offer job 

applicants, as it currently may do under 

the ADA. 

Other provisions in this section 

clarify that GINA does not (1) Limit or 

expand rights or obligations under 

workers’ compensation laws; (2) limit or 

expand the rights of federal agencies to 

conduct or support occupational or 

other health research conducted in 

accordance with the rules found in 45 

CFR part 46; or (3) limit the statutory or 

regulatory authority of the Occupational 

Safety and Health Administration or the 

Mine Safety and Health Administration 

or other workplace health and safety 

laws and regulations. Another provision 

addresses the exemption from GINA of 

the Armed Forces Repository of 

Specimen Samples for the Identification 

of Remains. 

The final provision in this subsection 

makes clear that GINA does not require 

that a covered entity provide 

individuals with any specific benefits or 

specialized health coverage. A covered 

entity does not have to offer health 

benefits that relate to any specific 

genetic disease or disorder. GINA 

merely requires that the covered entity 

not discriminate against those covered 

by the Act on the basis of genetic 

information. 

Section 1635.11(b) Relationship to 

Other Federal Laws Governing Health 

Coverage 

GINA section 209(a)(2)(B) includes 

four subsections that address the 

relationship between Title II and 

requirements or prohibitions that are 

subject to enforcement under other 

federal statutes addressing health 

coverage. Section 209(a)(2)(B)(i) states 

that nothing in Title II provides for 

enforcement of or penalties for 

violations of requirements or 

prohibitions subject to enforcement for 

a violation of GINA Title I. The three 

following subsections, sections 

209(a)(2)(B)(ii)–(iv), state that nothing in 

Title II provides for enforcement of or 

penalties for any requirement or 

prohibition subject to enforcement for a 

violation or violations of various 

sections of ERISA, the Public Health 

Service Act, and the Internal Revenue 

Code, which generally prohibit a group 

health plan or health insurance issuer in 

the group market from: 

• Imposing a preexisting condition 

exclusion based solely on genetic 

information, in the absence of a 

diagnosis of a condition; 

• Discriminating against individuals 

in eligibility and continued eligibility 

for benefits based on genetic 

information; and 

• Discriminating against individuals 

in premium or contribution rates under 

the plan or coverage based on genetic 

information, although such a plan or 

issuer may adjust premium rates for an 

employer based on the manifestation of 

a disease or disorder of an individual 

enrolled in the plan. 

The intent of this section is to create 

a clear ‘‘firewall’’ between GINA Titles 

I and II. Section 209(a)(1)(B) eliminates 

‘‘double liability’’ by preventing Title II 

causes of action from being asserted 

regarding matters subject to enforcement 

under Title I or the other genetics 

provisions for group coverage in ERISA, 

the Public Health Service Act, and the 

Internal Revenue Code. The firewall 

seeks to ensure that health plan or 

issuer requirements or prohibitions are 

addressed and remedied through ERISA, 

the Public Health Service Act, or the 

Internal Revenue Code and not through 

Title II and other employment 

discrimination procedures. The 

proposed regulation reiterates the 

language of the section, noting the 

specific sections from ERISA, the Public 

Health Service Act, and the Internal 

Revenue Code that the section covers. 

The Commission notes that the 

firewall does not immunize covered 

entities from liability for decisions and 

actions taken that violate Title II, 

including employment decisions based 

on health benefits, because such 

benefits are within the definition of 

compensation, terms, conditions, or 

privileges of employment. For example, 

an employer that fires an employee 

because of anticipated high health 

claims based on genetic information 

remains subject to liability under Title 

II. On the other hand, acts or omissions 

relating to health plan eligibility, 

benefits, or premiums, or a health plan’s 

request for or collection of genetic 

information remain subject to 

enforcement under Title I exclusively. 

Section 1635.11(c) Relationship to 

Authorities Under GINA Title I 

The final subsection in GINA section 

209 provides that nothing in GINA Title 

II prohibits a group health plan or group 

health insurance issuer from engaging in 

any activity that is authorized under 

GINA Title I or the provisions identified 

in GINA section 209(a)(2)(B)(i)–(iv), 

including any implementing regulations 

thereunder. The section and the 

proposed implementing regulation 

reiterate the limitations imposed on 

Title II in the area of group health 

coverage. 

Section 1635.11(d) Relationship to 

HIPAA Privacy Regulations 

Proposed section 1635.11(d) 

implements section 206(c) of GINA Title 

II by providing, as a general rule of 

construction, that this proposed 

regulation does not apply to health 

information subject to the HIPAA 

Privacy Rule. Thus, entities subject to 

the HIPAA Privacy Rule must continue 

to apply the requirements of the HIPAA 

Privacy Rule, and not the requirements 

of GINA Title II and these implementing 

regulations, to genetic information that 

is protected health information. For 

example, if a hospital subject to the 

HIPAA Privacy Rule treats a patient 

who is also an employee of the hospital, 

any genetic information that is obtained 

or created by the hospital in its role as 

a health care provider is protected 

health information and is subject to the 

requirements of the HIPAA Privacy Rule 

and not those of GINA. In contrast, 

however, any genetic information 

obtained by the hospital in its role as 

employer, for example, as part of a 

request for leave by the employee, 

would be subject to GINA Title II and 

this rule. 

Section 1635.12 Medical Information 

That Is Not Genetic Information 

The proposed regulation states that a 

covered entity does not violate GINA by 

acquiring, using, or disclosing medical 

information about a manifested disease 

or disorder that is not genetic 

information, even if the disease or 

disorder may have a genetic basis or 

component. It further notes, however, 

that the Americans with Disabilities 

Act, and the applicable regulations 

issued in support of the Act, would 

limit the disclosure of genetic 

information that also is medical 

information and covered by the ADA. 

Regulatory Procedures 

Executive Order 12866 

Pursuant to Executive Order 12866, 

EEOC has coordinated this proposed 

rule with the Office of Management and 

Budget. Under section 3(f)(1) of 

Executive Order 12866, EEOC has 

determined that the proposed regulation 

will not have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

state, local or tribal governments or 

communities. Therefore, a detailed costVerDate Nov<24>2008 12:24 Feb 27, 2009 Jkt 217001 PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 E:\FR\FM\02MRP1.SGM 02MRP1

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benefit assessment of the proposed 

regulation is not required. 

Paperwork Reduction Act 

This proposal contains no new 

information collection requirements 

subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). 

Regulatory Flexibility Act 

Title II of GINA applies to all 

employers with fifteen or more 

employees, approximately 822,000 of 

which are small firms (entities with 15– 

500 employees) according to data 

provided by the Small Business 

Administration Office of Advocacy. See 

Firm Size Data at http://sba.gov/advo/ 

research/data.html#us. 

The Commission certifies under 5 

U.S.C. 605(b) that this proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities because it imposes no reporting 

burdens and only minimal costs on such 

firms. GINA is intended to prevent 

discrimination based on concerns that 

genetic information about an individual 

suggests an increased risk of, or 

predisposition to, acquiring a condition 

in the future. Because individuals 

protected under GINA do not have 

currently manifested conditions that 

would result in any workplace barriers, 

the law imposes no costs related to 

making workplace modifications. To the 

extent GINA requires businesses that 

obtain genetic information about 

applicants or employees to maintain it 

in confidential files, GINA permits them 

to do so using the same confidential 

files they are already required to 

maintain under Title I of the Americans 

with Disabilities Act. 

The Act may require some 

modification to the post offer/preemployment medical examination 

process of some employers, to remove 

from the process questions pertaining to 

family medical history. We do not have 

data on the number and size of 

businesses that obtain family medical 

history as part of a post-offer medical 

examination. However, our experience 

with enforcing the ADA, which required 

all employers with fifteen or more 

employees to remove medical inquiries 

from their application forms, suggests 

that the cost of revising post-offer 

medical questionnaires to eliminate 

questions about family medical history 

would not impose significant costs. 

GINA will require that covered 

entities obtain and post revised notices 

informing covered individuals of their 

rights under the law. Employers will not 

incur any costs related to obtaining or 

posting these notices, because the 

Commission provides employers, at no 

cost, a poster explaining the EEO laws 

that will be updated to include 

information about GINA. 

To the extent that employers will 

need to expend resources to train 

human resources staff and others on the 

requirements of GINA, we note that the 

EEOC conducts extensive outreach and 

technical assistance programs, many of 

them at no cost to employers, to assist 

in the training of relevant personnel on 

EEO-related issues. In FY 2008, for 

example, EEOC’s outreach efforts 

included 5,360 education, training, and 

outreach events reaching over 270,000 

people. EEOC conducted over 700 

outreach events directed specifically 

toward small businesses, reaching 

35,515 small business representatives. 

In FY 2009, we expect to include 

information about GINA in our outreach 

programs in general and to offer 

numerous GINA-specific outreach 

programs, once the regulations 

implementing Title II of GINA become 

final. We will also post technical 

assistance documents on our Web site 

explaining the basics of the new 

regulation, as we do with all of our new 

regulations and policy documents. We 

estimate that the typical human 

resources professional will need to 

dedicate, at most, three hours to gain a 

satisfactory understanding of the new 

requirements, either by attending an 

EEOC-sponsored event or reviewing the 

relevant materials on their own. We 

further estimate that the median hourly 

pay rate of an HR professional is 

approximately $45.00. See Bureau of 

Labor Statistics, Occupational 

Employment and Wages, May 2007 at 

http://www.bls.gov/oes/current/ 

oes113049.htm#5#5. Assuming that 

small entities have between one and five 

HR professionals/managers, we estimate 

that the cost per entity of providing 

appropriate training will be between 

approximately $135.00 and $675.00, at 

the high end. EEOC does not believe 

that this cost will be significant for the 

impacted small entities. 

We urge small entities to submit 

comments concerning EEOC’s estimates 

of the number of small entities 

impacted, as well as the cost to those 

entities. 

Unfunded Mandates Reform Act of 1995 

This proposed rule will not result in 

the expenditure by state, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

in any one year, and it will not 

significantly or uniquely affect small 

governments. Therefore, no actions were 

deemed necessary under the provisions 

of the Unfunded Mandates Reform Act 

of 1995. 

Dated: February 23, 2009. 

For the Commission. 

Stuart J. Ishimaru, 

Acting Chairman. 

List of Subjects in 29 CFR Part 1635 

Administrative practice and 

procedure, Equal employment 

opportunity. 

For the reasons set forth in the 

preamble, the EEOC proposes to amend 

29 CFR chapter XIV by adding part 1635 

to read as follows: 

PART 1635—GENETIC INFORMATION 

NONDISCRIMINATION ACT OF 2008 

Sec. 

1635.1 Purpose. 

1635.2 Definitions—general. 

1635.3 Definitions specific to GINA. 

1635.4 Prohibited Practices—in general. 

1635.5 Limiting, segregating, and 

classifying. 

1635.6 Causing an employer to 

discriminate. 

1635.7 Retaliation. 

1635.8 Acquisition of genetic information. 

1635.9 Confidentiality. 

1635.10 Enforcement and remedies. 

1635.11 Construction. 

1635.12 Medical information that is not 

genetic information. 

Authority: 110 Stat. 233; 42 U.S.C. 2000ff. 

§ 1635.1 Purpose. 

The purpose of this part is to 

implement Title II of the Genetic 

Information Non-Discrimination Act of 

2008, 42 U.S.C. 2000ff, et seq. Title II of 

GINA prohibits use of genetic 

information in employment decisionmaking, restricts deliberate acquisition 

of genetic information, requires that 

genetic information be maintained as a 

confidential medical record, and places 

strict limits on disclosure of genetic 

information. The law provides remedies 

for individuals whose genetic 

information is acquired, used, or 

disclosed in violation of its protections. 

§ 1635.2 Definitions—general. 

(a) Commission means the Equal 

Employment Opportunity Commission, 

as established by section 705 of the Civil 

Rights Act of 1964, 42 U.S.C. 2000e–4. 

(b) Covered Entity means an 

employer, employing office, 

employment agency, labor organization, 

or joint labor-management committee. 

(c) Employee means an individual 

employed by a covered entity, as well as 

an applicant for employment and a 

former employee. An employee, 

including an applicant for employment 

and a former employee, is 


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(1) As defined by section 701 of the 

Civil Rights Act of 1964, 42 U.S.C. 

2000e, an individual employed by a 

person engaged in an industry affecting 

commerce who has fifteen or more 

employees for each working day in each 

of twenty or more calendar weeks in the 

current or preceding calendar year and 

any agent of such a person; 

(2) As defined by section 304(a) of the 

Government Employee Rights Act, 42 

U.S.C. 2000e-16c(a), a person chosen or 

appointed by an individual elected to 

public office by a State or political 

subdivision of a State to serve as part of 

the personal staff of the elected official, 

to serve the elected official on a policymaking level, or to serve the elected 

official as the immediate advisor on the 

exercise of the elected official’s 

constitutional or legal powers. 

(3) As defined by section 101 of the 

Congressional Accountability Act, 2 

U.S.C. 1301, any employee of the House 

of Representatives, the Senate, the 

Capitol Guide Service, the Capitol 

Police, the Congressional Budget Office, 

the Office of the Architect of the 

Capitol, the Office of the Attending 

Physician, the Office of Compliance, or 

the Office of Technology Assessment; 

(4) As defined by, and subject to the 

limitations in, section 2(a) of the 

Presidential and Executive Office 

Accountability Act, 3 U.S.C. 411(c), any 

employee of the executive branch not 

otherwise covered by section 717 of the 

Civil Rights Act of 1964, 42 U.S.C. 

2000e–16, section 15 of the Age 

Discrimination in Employment Act of 

1967, 29 U.S.C. 633a, or section 501 of 

the Rehabilitation Act of 1973, 29 U.S.C. 

791, whether appointed by the President 

or any other appointing authority in the 

executive branch, including an 

employee of the Executive Office of the 

President; 

(5) As defined by, and subject to the 

limitations in, section 717 of the Civil 

Rights Act of 1964, 42 U.S.C. 2000e–16, 

and regulations of the Equal 

Employment Opportunity Commission 

at 29 CFR 1614.103, an employee of a 

federal executive agency, the United 

States Postal Service and the Postal Rate 

Commission, the Tennessee Valley 

Authority, the National Oceanic and 

Atmospheric Administration 

Commissioned Corps, the Government 

Printing Office, and the Smithsonian 

Institution; an employee of the federal 

judicial branch having a position in the 

competitive service; and an employee of 

the Library of Congress. 

(d) Employer means any person that 

employs an employee defined in 

§ 1635.2(c) of this part, and any agent of 

such person, except that, as limited by 

section 701(b)(1) and (2) of the Civil 

Rights Act of 1964, 42 U.S.C. 

2000e(b)(1) and (2), an employer does 

not include an Indian tribe or a bona 

fide private club (other than a labor 

organization) that is exempt from 

taxation under section 501(c) of the 

Internal Revenue Code of 1986. 

(e) Employing office is defined in the 

Congressional Accountability Act, 2 

U.S.C. 1301(9), to mean the personal 

office of a Member of the House of 

Representatives or of a Senator; a 

committee of the House of 

Representatives or the Senate or a joint 

committee; any other office headed by a 

person with the final authority to 

appoint, hire, discharge, and set the 

terms, conditions, or privileges of the 

employment of an employee of the 

House of Representatives or the Senate; 

or the Capitol Guide Board, the Capitol 

Police Board, the Congressional Budget 

Office, the Office of the Architect of the 

Capitol, the Office of the Attending 

Physician, the Office of Compliance, 

and the Office of Technology 

Assessment. 

(f) Employment agency is defined in 

42 U.S.C. 2000e(c) to mean any person 

regularly undertaking with or without 

compensation to procure employees for 

an employer or to procure for employees 

opportunities to work for an employer 

and includes an agent of such a person. 

(g) Joint labor-management committee 

is defined as an entity that controls 

apprenticeship or other training or 

retraining programs, including on-thejob training programs. 

(h) Labor organization is defined at 42 

U.S.C. 2000e(d) to mean an organization 

with fifteen or more members engaged 

in an industry affecting commerce, and 

any agent of such an organization in 

which employees participate and which 

exists for the purpose, in whole or in 

part, of dealing with employers 

concerning grievances, labor disputes, 

wages, rates of pay, hours, or other 

terms or conditions of employment. 

(i) Member includes, with respect to 

a labor organization, an applicant for 

membership. 

(j) Person is defined at 42 U.S.C. 

2000e(a) to mean one or more 

individuals, governments, governmental 

agencies, political subdivisions, labor 

unions, partnerships, associations, 

corporations, legal representatives, 

mutual companies, joint-stock 

companies, trusts, unincorporated 

organizations, trustees, trustees in cases 

under title 11, or receivers. 

(k) State is defined at 42 U.S.C. 

2000e(i) and includes a State of the 

United States, the District of Columbia, 

Puerto Rico, the Virgin Islands, 

American Samoa, Guam, Wake Island, 

the Canal Zone, and Outer Continental 

Shelf lands defined in the Outer 

Continental Shelf Lands Act (43 U.S.C. 

1331 et seq.). 

§ 1635.3 Definitions specific to GINA. 

(a) Family member means with 

respect to any individual 

(1) A person who is a dependent of 

that individual as the result of marriage, 

birth, adoption, or placement for 

adoption; or 

(2) A first-degree, second-degree, 

third-degree, or fourth-degree relative of 

the individual, or of a dependent of the 

individual as defined in § 1635.3(a)(1). 

(i) First-degree relatives include an 

individual’s parents, siblings, children, 

and half-siblings. 

(ii) Second-degree relatives include an 

individual’s grandparents, 

grandchildren, uncles, aunts, nephews, 

and nieces. 

(iii) Third-degree relatives include an 

individual’s great-grandparents, great 

grandchildren, great uncles/aunts, and 

first cousins. 

(iv) Fourth-degree relatives include an 

individual’s great-great grandparents, 

great-great grandchildren, and first 

cousins once-removed (i.e., the children 

of the individual’s first cousins). 

(b) Family medical history. Family 

medical history means information 

about the manifestation of disease or 

disorder in family members of the 

individual. 

(c) Genetic information. (1) Genetic 

information means information about: 

(i) An individual’s genetic tests; 

(ii) The genetic tests of that 

individual’s family members; 

(iii) The manifestation of disease or 

disorder in family members of the 

individual (family medical history); 

(iv) An individual’s request for, or 

receipt of, genetic services, or the 

participation in clinical research that 

includes genetic services by the 

individual or a family member of the 

individual; or 

(v) The genetic information of a fetus 

carried by an individual or by a 

pregnant woman who is a family 

member of the individual and the 

genetic information of any embryo 

legally held by the individual or family 

member using an assisted reproductive 

technology. 

(2) Genetic information does not 

include information about the sex or age 

of the individual or the sex or age of 

family members. 

(d) Genetic monitoring means the 

periodic examination of employees to 

evaluate acquired modifications to their 

genetic material, such as chromosomal 

damage or evidence of increased 

occurrence of mutations, caused by the 

toxic substances they use or are exposed 


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to in performing their jobs, in order to 

identify, evaluate, and respond to the 

effects of or control adverse 

environmental exposures in the 

workplace. 

(e) Genetic services means a genetic 

test; genetic counseling (including 

obtaining, interpreting, or assessing 

genetic information); or genetic 

education. 

(f) Genetic test—(1) In general. 

‘‘Genetic test’’ means an analysis of 

human DNA, RNA, chromosomes, 

proteins, or metabolites that detects 

genotypes, mutations, or chromosomal 

changes. 

(i) An analysis of proteins or 

metabolites that does not detect 

genotypes, mutations, or chromosomal 

changes is not a genetic test. 

(ii) A medical examination that tests 

for the presence of a virus that is not 

composed of human DNA, RNA, 

chromosomes, proteins, or metabolites 

is not a genetic test. 

(2) Alcohol and drug testing. (i) A test 

for the presence of alcohol or drugs is 

not a genetic test. 

(ii) A test to determine whether an 

individual has a genetic predisposition 

for alcoholism or drug use is a genetic 

test. 

(g) Manifestation or manifested 

means, with respect to a disease, 

disorder, or pathological condition, that 

an individual has been or could 

reasonably be diagnosed with the 

disease, disorder, or pathological 

condition by a health care professional 

with appropriate training and expertise 

in the field of medicine involved. For 

purposes of this part, a disease, 

disorder, or pathological condition is 

not manifested if the diagnosis is based 

principally on genetic information or on 

the results of one or more genetic tests. 

§ 1635.4 Prohibited practices—in general. 

(a) It is unlawful for an employer to 

discriminate against an individual on 

the basis of the genetic information of 

the individual in regard to hiring, 

discharge, compensation, terms, 

conditions, or privileges of employment. 

(b) It is unlawful for an employment 

agency to fail or refuse to refer any 

individual for employment or otherwise 

discriminate against any individual 

because of genetic information of the 

individual. 

(c) It is unlawful for a labor 

organization to exclude or to expel from 

the membership of the organization, or 

otherwise to discriminate against, any 

member because of genetic information 

with respect to the member. 

(d) It is an unlawful employment 

practice for any employer, labor 

organization, or joint labor-management 

committee controlling apprenticeship or 

other training or retraining programs, 

including on-the-job training programs 

to discriminate against any individual 

because of the individual’s genetic 

information in admission to, or 

employment in, any program 

established to provide apprenticeship or 

other training or retraining. 

§ 1635.5 Limiting, segregating, and 

classifying. 

(a) A covered entity may not limit, 

segregate, or classify an individual, or 

fail or refuse to refer for employment 

any individual, in any way that would 

deprive or tend to deprive the 

individual of employment opportunities 

or otherwise affect the status of the 

individual as an employee, because of 

genetic information with respect to the 

individual. 

(b) Notwithstanding any language in 

this part, a cause of action for disparate 

impact within the meaning of section 

703(k) of the Civil Rights Act of 1964, 

42 U.S.C. 2000e–2(k), is not available 

under this part. 

§ 1635.6 Causing an employer to 

discriminate. 

An employment agency, labor 

organization, or joint labor-management 

training or apprenticeship program may 

not cause or attempt to cause an 

employer, or its agent, to discriminate 

against an individual in violation of this 

part, including with respect to the 

individual’s participation in an 

apprenticeship or other training or 

retraining program, or with respect to a 

member’s participation in a labor 

organization. 

§ 1635.7 Retaliation. 

A covered entity may not discriminate 

against any individual because such 

individual has opposed any act or 

practice made unlawful by this title or 

because such individual made a charge, 

testified, assisted, or participated in any 

manner in an investigation, proceeding, 

or hearing under this title. 

§ 1635.8 Acquisition of genetic 

information. 

(a) General prohibition. A covered 

entity may not request, require, or 

purchase genetic information of an 

individual, except as specifically 

provided in paragraph (b) of this 

section. 

(b) Exceptions. The general 

prohibition against requesting, 

requiring, or purchasing genetic 

information does not apply: 

(1) Where a covered entity 

inadvertently requests or requires 

genetic information of the individual or 

family member of the individual. This 

exception to the acquisition of genetic 

information applies in, but is not 

necessarily limited to, situations 

where— 

(i) A manager, supervisor, union 

representative, or employment agency 

personnel learns genetic information 

about an individual by overhearing a 

conversation between the individual 

and others; 

(ii) A manager, supervisor, union 

representative, or employment agency 

personnel learns genetic information 

about an individual by receiving it from 

the individual or third-parties without 

having solicited or sought the 

information; 

(iii) An individual provides genetic 

information as part of documentation to 

support a request for reasonable 

accommodation under Federal, State, or 

local law, as long as the covered entity’s 

request for such documentation is 

lawful; 

(iv) An employer requests medical 

information (other than genetic 

information) as permitted by Federal, 

State, or local law from an individual, 

who responds by providing, among 

other information, genetic information; 

(v) An individual provides genetic 

information to support a request for 

leave that is not governed by Federal, 

State, or local laws requiring leave, as 

long as the documentation required to 

support the request otherwise complies 

with the requirements of the Americans 

with Disabilities Act and other laws 

limiting a covered entity’s access to 

medical information; or 

(vi) A covered entity learns genetic 

information about an individual in 

response to an inquiry about the 

individual’s general health, an inquiry 

about whether the individual has any 

current disease, disorder, or 

pathological condition, or an inquiry 

about the general health of an 

individual’s family member; 

(2) Where a covered entity offers 

health or genetic services, including 

such services offered as part of a 

voluntary wellness program. This 

exception applies only where— 

(i) The individual provides prior 

knowing, voluntary, and written 

authorization that 

(A) Is written so that the individual 

from whom the genetic information is 

being obtained is reasonably likely to 

understand the form; 

(B) Describes the type of genetic 

information that will be obtained and 

the general purposes for which it will be 

used; and 

(C) Describes the restrictions on 

disclosure of genetic information. 

(ii) Individually identifiable genetic 

information is provided only to the 


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individual (or family member if the 

family member is receiving genetic 

services) and the licensed health care 

professional or board certified genetic 

counselor involved in providing such 

services; and 

(iii) Any individually identifiable 

genetic information provided under 

paragraph (b)(2) of this section is only 

available for purposes of such services 

and is not disclosed to the covered 

entity except in aggregate terms that do 

not disclose the identity of specific 

individuals. 

(3) Where the employer requests 

family medical history to comply with 

the certification provisions of the 

Family and Medical Leave Act of 1993 

(29 U.S.C. 2601 et seq.) or State or local 

family and medical leave laws. 

(4) Where the covered entity acquires 

genetic information from documents 

that are commercially and publicly 

available for review or purchase, 

including newspapers, magazines, 

periodicals, or books, or through 

electronic media, such as information 

communicated through television, 

movies, or the Internet, except that a 

covered entity may not research medical 

databases or court records, even where 

such databases may be publicly and 

commercially available, for the purpose 

of obtaining genetic information about 

an individual. 

(5) Where the covered entity acquires 

genetic information for use in the 

genetic monitoring of the biological 

effects of toxic substances in the 

workplace. In order for this exception to 

apply, the covered entity must provide 

written notice of the monitoring to the 

individual. This exception further 

provides that such monitoring: 

(i) Either is required by federal or 

state law, or conducted only where an 

individual gives prior knowing, 

voluntary and written authorization to 

the monitoring that— 

(A) Is written so that the individual 

from whom the genetic information is 

being obtained is reasonably likely to 

understand the form.; 

(B) Describes the genetic information 

that will be obtained; 

(C) Describes the restrictions on 

disclosure of genetic information; 

(ii) Ensures that the individual is 

informed of individual monitoring 

results; 

(iii) Is conducted in compliance with 

any Federal genetic monitoring 

regulations, including any regulations 

that may be promulgated by the 

Secretary of Labor pursuant to the 

Occupational Safety and Health Act of 

1970 (29 U.S.C. 651 et seq.), the Federal 

Mine Safety and Health Act of 1977 (30 

U.S.C. 801 et seq.), or the Atomic Energy 

Act of 1954 (42 U.S.C. 2011 et seq.); or 

State genetic monitoring regulations, in 

the case of a State that is implementing 

genetic monitoring regulations under 

the authority of the Occupational Safety 

and Health Act of 1970 (29 U.S.C. 651 

et seq.); and 

(iv) Provides for reporting of the 

results of the monitoring to the covered 

entity, excluding any licensed health 

care professional or board certified 

genetic counselor involved in the 

genetic monitoring program, only in 

aggregate terms that do not disclose the 

identity of specific individuals. 

(6) Where an employer that conducts 

DNA analysis for law enforcement 

purposes as a forensic laboratory or for 

purposes of human remains 

identification requests or requires 

genetic information of its employees, 

apprentices, or trainees, but only to the 

extent that the genetic information is 

used for analysis of DNA identification 

markers for quality control to detect 

sample contamination and maintained 

in a manner consistent with such use. 

(c) A covered entity may not use 

genetic information obtained pursuant 

to the exceptions in § 1635.8(b) of this 

part to discriminate, as defined by 

§§ 1635.4, 1635.5, or 1635.6, and must 

keep such information confidential as 

required by § 1635.9. 

§ 1635.9 Confidentiality. 

(a) Treatment of genetic information. 

(1) A covered entity that possesses 

genetic information in writing about an 

employee or member must maintain 

such information on forms and in 

medical files (including where the 

information exists in electronic forms 

and files) that are separate from 

personnel files and treat such 

information as a confidential medical 

record. 

(2) A covered entity may maintain 

genetic information about an employee 

or member in the same file in which it 

maintains confidential medical 

information subject to section 

102(d)(3)(B) of the Americans with 

Disabilities Act, 42 U.S.C. 

12112(d)(3)(B). 

(3) Genetic information that a covered 

entity receives orally need not be 

reduced to writing, but may not be 

disclosed, except as permitted by this 

part. 

(4) Genetic information that a covered 

entity acquires through publicly 

available sources, as provided by 

§ 1635.8(b)(4) of this part, is not 

considered confidential genetic 

information, but may not be used to 

discriminate against an individual as 

described in §§ 1635.4, 1635.5, or 

1635.6 of this part. 

(b) Limitations on disclosure. A 

covered entity that possesses any 

genetic information, regardless of how 

the entity obtained the information 

(except for genetic information acquired 

through publicly available sources), may 

not disclose it except: 

(1) To the employee or member (or 

family member if the family member is 

receiving the genetic services) about 

whom the information pertains upon 

receipt of the employee’s or member’s 

written request; 

(2) To an occupational or other health 

researcher if the research is conducted 

in compliance with the regulations and 

protections provided for under 45 CFR 

part 46; 

(3) In response to an order of a court, 

except that the covered entity may 

disclose only the genetic information 

expressly authorized by such order; and 

if the court order was secured without 

the knowledge of the individual to 

whom the information refers, the 

covered entity shall inform the 

individual of the court order and any 

genetic information that was disclosed 

pursuant to such order; 

(4) To government officials 

investigating compliance with this title 

if the information is relevant to the 

investigation; 

(5) To the extent that such disclosure 

is made in support of an employee’s 

compliance with the certification 

provisions of section 103 of the Family 

and Medical Leave Act of 1993 (29 

U.S.C. 2613) or such requirements 

under State family and medical leave 

laws; or 

(6) To a Federal, State, or local public 

health agency only with regard to 

information about the manifestation of a 

disease or disorder that concerns a 

contagious disease that presents an 

imminent hazard of death or lifethreatening illness, provided that the 

individual whose family member is the 

subject of the disclosure is notified of 

such disclosure. 

(c) Relationship to HIPAA Privacy 

Regulations. Pursuant to § 1635.11(d) of 

this part, nothing in this section shall be 

construed as applying to the use or 

disclosure of genetic information that is 

protected health information subject to 

the regulations issued pursuant to 

section 264(c) of the Health Insurance 

Portability and Accountability Act of 

1996. 

§ 1635.10 Enforcement and Remedies. 

(a) Powers and procedures: The 

following powers and procedures shall 

apply to allegations that Title II of GINA 

has been violated: 

(1) The powers and procedures 

provided to the Commission, the 


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9070 Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Proposed Rules 

Attorney General, or any person by 

sections 705 through 707 and 709 

through 711 of the Civil Rights Act of 

1964, 42 U.S.C. 2000e–4 through 2000e– 

6 and 2000e–8 through 2000e–10, where 

the alleged discrimination is against an 

employee defined in 1635.2(c)(1) of this 

part or against a member of a labor 

organization; 

(2) The powers and procedures 

provided to the Commission and any 

person by sections 302 and 304 of the 

Government Employees Rights Act, 42 

U.S.C. 2000e–16b and 2000e–16c, and 

in regulations at 29 CFR part 1603, 

where the alleged discrimination is 

against an employee as defined in 

§ 1635.2(c)(2) of this part; 

(3) The powers and procedures 

provided to the Board of Directors of the 

Office of Compliance and to any person 

under the Congressional Accountability 

Act, 2 U.S.C. 1301 et seq. (including the 

provisions of Title 3 of that act, 2 U.S.C. 

1381 et seq.), where the alleged 

discrimination is against an employee 

defined in § 1635.2(c)(3) of this part; 

(4) The powers and procedures 

provided in 3 U.S.C. 451 et seq., to the 

President, the Commission, or any 

person in connection with an alleged 

violation of section 3 U.S.C. 411(a)(1), 

where the alleged discrimination is 

against an employee defined in 

§ 1635.2(c)(4) of this part; 

(5) The powers and procedures 

provided to the Commission, the 

Librarian of Congress, and any person 

by section 717 of the Civil Rights Act, 

42 U.S.C. 2000e–16, where the alleged 

discrimination is against an employee 

defined in § 1635.2(c)(5) of this part. 

(b) Remedies. The following remedies 

are available for violations of GINA 

sections 202, 203, 204, 205, 206, and 

207(f): 

(1) Compensatory and punitive 

damages as provided for, and limited 

by, 42 U.S.C. 1981a(a)(1) and (b); 

(2) Reasonable attorney’s fees, 

including expert fees, as provided for, 

and limited by, 42 U.S.C. 1988(b) and 

(c); and 

(3) Injunctive relief, including 

reinstatement and hiring, back pay, and 

other equitable remedies as provided 

for, and limited by, 42 U.S.C. 2000e– 

5(g). 

§ 1635.11 Construction. 

(a) Relationship to other laws, 

generally. This part does not— 

(1) Limit the rights or protections of 

an individual under any other Federal, 

State, or local law that provides equal or 

greater protection to an individual than 

the rights or protections provided for 

under this part, including the 

Americans with Disabilities Act of 1990 

(42 U.S.C. 12101 et seq.), the 

Rehabilitation Act of 1973 (29 U.S.C. 

701 et seq.), and State and local laws 

prohibiting genetic discrimination or 

discrimination on the basis of disability; 

(2) Apply to the Armed Forces 

Repository of Specimen Samples for the 

Identification of Remains; 

(3) Limit or expand the protections, 

rights, or obligations of employees or 

employers under applicable workers’ 

compensation laws; 

(4) Limit the authority of a Federal 

department or agency to conduct or 

sponsor occupational or other health 

research in compliance with the 

regulations and protections provided for 

under 45 CFR part 46; 

(5) Limit the statutory or regulatory 

authority of the Occupational Safety and 

Health Administration or the Mine 

Safety and Health Administration to 

promulgate or enforce workplace safety 

and health laws and regulations; or 

(6) Require any specific benefit for an 

employee or member or a family 

member of an employee or member 

(such as additional coverage for a 

particular health condition that may 

have a genetic basis) under any group 

health plan or health insurance issuer 

offering group health insurance 

coverage in connection with a group 

health plan. 

(b) Relation to certain Federal laws 

governing health coverage. Nothing in 

GINA Title II provides for enforcement 

of, or penalties for, violation of any 

requirement or prohibition of a covered 

entity subject to enforcement for a 

violation of: 

(1) Amendments made by Title I of 

GINA. 

(2) Section 701(a) of the Employee 

Retirement Income Security Act (29 

U.S.C. 1181) (ERISA), section 2701(a) of 

the Public Health Service Act (42 U.S.C. 

300gg(a)), and section 9801(a) of the 

Internal Revenue Code (26 U.S.C. 

9801(a)), as such sections apply with 

respect to genetic information pursuant 

to 29 U.S.C. 1181(b)(1)(B), 42 U.S.C. 

300gg(b)(1)(B), and 26 U.S.C. 

9801(b)(1)(B), respectively, of such 

sections, which prohibit a group health 

plan or a health insurance issuer in the 

group market from imposing a 

preexisting condition exclusion based 

solely on genetic information, in the 

absence of a diagnosis of a condition; 

(3) Section 702(a)(1)(F) of ERISA (29 

U.S.C. 1182(a)(1)(F)), section 

2702(a)(1)(F) of the Public Health 

Service Act (42 U.S.C. 300gg–1(a)(1)(F)), 

and section 9802(a)(1)(F) of the Internal 

Revenue Code (26 U.S.C. 9802(a)(1)(F)), 

which prohibit a group health plan or a 

health insurance issuer in the group 

market from discriminating against 

individuals in eligibility and continued 

eligibility for benefits based on genetic 

information; or 

(4) Section 702(b)(1) of ERISA (29 

U.S.C. 1182(b)(1)), section 2702(b)(1) of 

the Public Health Service Act (42 U.S.C. 

300gg–1(b)(1), and section 9802(b)(1) of 

the Internal Revenue Code (26 U.S.C. 

9802(b)(1)), as such sections apply with 

respect to genetic information as a 

health status-related factor, which 

prohibit a group health plan or a health 

insurance issuer in the group market 

from discriminating against individuals 

in premium or contribution rates under 

the plan or coverage based on genetic 

information. 

(c) Relationship to authorities under 

GINA Title I. GINA Title II does not 

prohibit any group health plan or health 

insurance issuer offering group health 

insurance coverage in connection with a 

group health plan from engaging in any 

action that is authorized under any 

provision of law noted in § 1635.11(b) of 

this part, including any implementing 

regulations noted in § 1635.11(b). 

(d) Relationship to HIPAA Privacy 

Regulations. This part does not apply to 

genetic information that is protected 

health information subject to the 

regulations issued by the Secretary of 

Health and Human Services pursuant to 

section 264(c) of the Health Insurance 

Portability and Accountability Act of 

1996. 

§ 1635.12 Medical information that is not 

genetic information. 

(a) Medical information about a 

manifested disease, disorder, or 

pathological condition. (1) A covered 

entity shall not be considered to be in 

violation of this part based on the use, 

acquisition, or disclosure of medical 

information that is not genetic 

information about a manifested disease, 

disorder, or pathological condition of an 

employee or member, even if the 

disease, disorder, or pathological 

condition has or may have a genetic 

basis or component. 

(2) Notwithstanding paragraph (a)(1) 

of this section, the acquisition, use, and 

disclosure of medical information that is 

not genetic information about a 

manifested disease, disorder, or 

pathological condition is subject to 

applicable limitations under sections 

103(d)(1)–(4) of the Americans with 

Disabilities Act (42 U.S.C. 12112(d)(1)– 

(4)), and regulations at 29 CFR 1630.13, 

1630.14, and 1630.16. 

(b) Genetic information related to a 

manifested disease, disorder, or 

pathological condition. 

Notwithstanding paragraph (a) of this 

section, genetic information about a 

manifested disease, disorder, or 


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pathological condition is subject to the 

requirements and prohibitions in 

sections 202 through 206 of GINA and 

§§ 1635.4 through 1635.7 and 1635.9 of 

this part. 

[FR Doc. E9–4221 Filed 2–27–09; 8:45 am] 

BILLING CODE 6570–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 160, 161, 164, and 165 

[USCG–2005–21869] 

RIN 1625–AA99 

Vessel Requirements for Notices of 

Arrival and Departure, and Automatic 

Identification System 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of second public 

meeting; request for comments. 

SUMMARY: In response to requests 

received, the Coast Guard announces a 

second public meeting, to be held 

March 25, 2009, in Seattle, WA, to 

receive comments on a notice of 

proposed rulemaking to amend Coast 

Guard regulations governing Notice of 

Arrival and Departure (NOAD) and 

Automatic Identification System (AIS) 

requirements. This is an additional 

meeting to the one previously 

announced for March 5, 2009, in 

Washington, DC. 

DATES: A public meeting will be held in 

Seattle, WA, on March 25, 2009, from 1 

p.m. to 3:30 p.m. The comment period 

for the proposed rule closes April 15, 

2009. All written comments and related 

material must be received by the Coast 

Guard on or before April 15, 2009. 

ADDRESSES: The March 25, 2009, public 

meeting will be held at the following 

location: 

• Seattle, WA—Henry M. Jackson 

Federal Building, 915 Second Ave., 

Fourth Floor North Auditorium, Seattle, 

WA 98174–1067. 

A government-issued photo 

identification will be required for 

entrance to the building. 

Written comments and related 

material may also be submitted to Coast 

Guard personnel specified at that 

meeting. All comments and related 

material submitted after the meeting 

must be submitted using any one of the 

following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov under 

docket number USCG–2005–21869. 

(2) Fax: 202–493–2251. 

(3) Mail: Docket Management Facility 

(M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590– 

0001. 

(4) Hand delivery: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

To avoid duplication, please use only 

one of these four methods. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions concerning the 

NOAD portion of this proposed 

rulemaking or concerning the public 

meeting, please contact Lieutenant 

Sharmine Jones, Office of Vessel 

Activities (CG–543), Coast Guard, 

Sharmine.N.Jones@uscg.mil, telephone 

202–372–1234. If you have questions on 

the AIS portion of this proposed 

rulemaking, contact Mr. Jorge Arroyo, 

Office of Navigation Systems (CG–5413), 

Coast Guard, Jorge.Arroyo@uscg.mil, 

telephone 202–372–1563. If you have 

questions on viewing or submitting 

material to the docket, call Ms. Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

We published a notice of proposed 

rulemaking (NPRM) in the Federal 

Register on December 16, 2008 (73 FR 

76295), entitled ‘‘Vessel Requirements 

for Notices of Arrival and Departure, 

and Automatic Identification System.’’ 

In it we stated our intention to hold a 

public meeting, and to publish a notice 

to announce the location and date of the 

public meeting. 73 FR 76296. In this 

notice, we announce an additional 

public meeting, to the one previously 

announced for March 5, 2009, in 

Washington, DC (74 FR 7534), to receive 

comments on this proposed rule. 

In the NPRM, we proposed to expand 

the applicability of Notice of Arrival 

and Departure (NOAD) and Automatic 

Identification System (AIS) 

requirements to more commercial 

vessels, modify NOAD reporting 

requirements, establish a mandatory 

method for electronic data submission 

and establish a separate requirement for 

certain vessels to submit notices of 

departure. The proposed rulemaking 

would also clarify existing AIS 

requirements and extend the 

applicability of AIS requirements to 

additional vessels and beyond Vessel 

Traffic Service areas to all U.S. 

navigable waters. 

You may view the NPRM in our 

online docket, in addition to supporting 

documents prepared by the Coast Guard 

(Regulatory Analysis & Initial 

Regulatory Flexibility Analysis, Valuing 

Mortality Risk Reductions in Homeland 

Security Regulatory Analyses—Final 

Report June 2008, and an Environmental 

Checklist), and comments submitted 

thus far by going to http:// 

www.regulations.gov. Once there, select 

the Advanced Docket Search option on 

the right side of the screen, insert 

USCG–2005–21869 in the Docket ID 

box, press Enter, and then click on the 

item in the Docket ID column. If you do 

not have access to the Internet, you may 

view the docket by visiting the Docket 

Management Facility in Room W12–140 

on the ground floor of the Department 

of Transportation West Building, 1200 

New Jersey Avenue, SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. We have an agreement with 

the Department of Transportation to use 

the Docket Management Facility. 

We encourage you to participate in 

this rulemaking by submitting 

comments either orally at the meeting or 

in writing. If you bring written 

comments to the meeting, you may 

submit them to Coast Guard personnel 

specified at the meeting to receive 

written comments. These comments 

will be submitted to our online public 

docket. All comments received will be 

posted without change to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. 

Anyone can search the electronic 

form of comments received into any of 

our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review a Privacy 

Act notice regarding our public dockets 

in the January 17, 2008, issue of the 

Federal Register (73 FR 3316). 

Information on Service for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

public meeting, contact Lieutenant 

Sharmine Jones at the telephone number 

indicated under the FOR FURTHER

INFORMATION CONTACT section of this 

notice. 

Public Meeting 

The Coast Guard will hold a public 

meeting regarding this proposed 

rulemaking on March 25, 2009, from 

1 p.m. to 3:30 p.m., in Seattle, WA, at 

the Henry M. Jackson Federal Building, 

915 Second Ave., Fourth Floor North 

Auditorium, Seattle, WA 98174–1067. 


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