51252 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 

exports and reexports to India by about 

150 to 200 annually. 

Send comments regarding these 

burden estimates or any other aspect of 

this collection of information, including 

suggestions for reducing the burden, to 

David Rostker, OMB Desk Officer, by email at david_rostker@omb.eop.gov or 

by fax to (202) 395–7285; and to the 

Regulatory Policy Division, Bureau of 

Industry and Security, Department of 

Commerce, P.O. Box 273, Washington, 

DC 20044. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined in Executive Order 

13132. 

4. The provisions of the 

Administrative Procedure Act (5 U.S.C. 

553) requiring notice of proposed 

rulemaking, the opportunity for public 

participation, and a delay in effective 

date, are inapplicable because this 

regulation involves a military or foreign 

affairs function of the United States (see 

5 U.S.C. 553(a)(1)). Further, no other 

law requires that a notice of proposed 

rulemaking and an opportunity for 

public comment be given for this rule. 

Because a notice of proposed 

rulemaking and an opportunity for 

public comment are not required to be 

given for this rule by 5 U.S.C. 553, or 

by any other law, the analytical 

requirements of the Regulatory 

Flexibility Act, 5 U.S.C. 601 et seq., are 

not applicable. 

List of Subjects 

15 CFR Part 738 

Exports, Foreign Trade. 

15 CFR Part 742 

Exports, Terrorism. 

15 CFR Part 744 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

■ Accordingly, parts 738, 742 and 744 

of the Export Administration 

Regulations (15 CFR Parts 730–799) are 

amended as follows: 

PART 738—[AMENDED] 

■ 1. The authority citation for 15 CFR 

part 738 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 

7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C. 

287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 

30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 

U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 

466c; 50 U.S.C. app. 5; Sec. 901–911, Pub. L. 

106–387; Sec. 221, Pub. L. 107–56; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 2, 2005, 70 

FR 45273 (August 5, 2005). 

Supplement No. 1 to Part 738 

[Amended] 

■ 2. Supplement No. 1 to part 738—

(Commerce Country Chart) is amended 

by removing the ‘‘X’’ from the column 

heading NP 2 in the row for India. 

PART 742—[AMENDED] 

■ 3. The authority citation for part 742 

is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 18 U.S.C. 2510 et seq.; 

22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; Sec. 

901–911, Pub. L. 106–387; Sec. 221, Pub. L. 

107–56; Sec. 1503, Pub. L. 108–11,117 Stat. 

559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 

Comp., p. 179; E.O. 12851, 58 FR 33181, 3 

CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 

59099, 3 CFR, 1994 Comp., p. 950; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Presidential Determination 

2003–23 of May 7, 2003, 68 FR 26459, May 

16, 2003; Notice of November 4, 2004, 69 FR 

64637 (November 8, 2004); Notice of August 

2, 2005, 70 FR 45273 (August 5, 2005). 

■ 4. Section 742.3 is amended by 

revising paragraph (a)(2) to read as 

follows: 

§ 742.3 Nuclear Nonproliferation. 

(a) * * * 

(2) If NP Column 2 of the Country 

Chart (Supplement No. 1 to part 738 of 

the EAR) is indicated in the applicable 

ECCN, a license is required to Country 

Group D:2 (see Supplement No. 1 to part 

740 of the EAR) except India. 

* * * * * 

PART 744—[AMENDED] 

■ 5. The authority citation for 15 CFR 

part 744 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 

42 U.S.C. 2139a; Sec. 901–911, Pub. L. 106–

387; Sec. 221, Pub. L. 107–56; E.O. 12058, 43 

FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 

12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 

608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 

Comp., p. 950; E.O. 12947, 60 FR 5079, 3 

CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 

58767, 3 CFR, 1996 Comp., p. 228; E.O. 

13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 

208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; E.O. 13224, 66 FR 49079, 3 

CFR, 2001 Comp., p. 786; Notice of 

November 4, 2004, 69 FR 64637 (November 

8, 2004); Notice of August 2, 2005, 70 FR 

45273 (August 5, 2005). 

Supplement No. 4 to Part 744 

[Amended] 

■ 6. Supplement No. 4 to part 744, 

under the country of India is amended 

by: 

■ a. Removing the following 

subordinate entities from the entry for 

the Indian Space Research Organization 

(ISRO): ISRO Telemetry, Tracking and 

Command Network (ISTRAC), ISRO 

Inertial Systems Unit (IISU), 

Thiruvananthapuram, and Space 

Applications Center (SAC), Ahmadabad; 

■ b. Adding to the entry for ‘‘Nuclear 

reactors (including power plants) not 

under International Atomic Energy 

Agency (IAEA) safeguards, fuel 

processing and enrichment facilities, 

heavy water production facilities and 

their collocated ammonia plants,’’

immediately following the word 

‘‘safeguards,’’ the phrase ‘‘(excluding 

Kundankulam 1 and 2)’; and 

■ c. Removing, in its entirety, the 

second entry for the Department of 

Atomic Energy which reads: ‘‘The 

following Department of Atomic Energy 

entities: Nuclear reactors (including 

power plants) subject to International 

Atomic Energy Agency (IAEA) 

safeguards: Tarapur (TAPS 1 & 2), and 

‘‘Rajasthan (RAPS 1 & 2).’’

* * * * * 

Dated: August 24, 2005. 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 05–17241 Filed 8–29–05; 8:45 am] 

BILLING CODE 3510–33–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 404 

[Regulation No. 4] 

RIN 0960–AF32 

Revised Medical Criteria for Evaluating 

Impairments That Affect Multiple Body 

Systems 

AGENCY: Social Security Administration. 

ACTION: Final rules. 

SUMMARY: We are revising the criteria in 

the Listing of Impairments (the listings) 

that we use to evaluate claims involving 

impairments that affect multiple body 

systems. We apply these criteria when 

you claim benefits based on disability 

under title II and title XVI of the Social 

Security Act (the Act). The revisions 

reflect current medical knowledge, 

methods of evaluating impairments that 

affect multiple body systems, treatment, 

and our adjudicative experience. 

DATES: These regulations are effective 

October 31, 2005. 

ADDRESSES: Electronic Version: The 

electronic file of this document is 

available on the date of publication in 

the Federal Register at 

http://www.gpoaccess.gov/fr/ 

index.html. It is also available on the 

Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 51253 

Internet site for SSA (i.e., Social 

Security Online): 

http://www.socialsecurity.gov/ 

regulations/final-rules.htm. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne DiMarino, Social Insurance 

Specialist, Office of Regulations, Social 

Security Administration, 107 Altmeyer 

Building, 6401 Security Boulevard, 

Baltimore, Maryland 21235–6401, (410) 

965–1769 or TTY (410) 966–5609. For 

information on eligibility or filing for 

benefits, call our national toll-free 

number, 1–800–772–1213 or TTY 1–

800–325–0778, or visit our Internet Web 

site, Social Security Online, at http:// 

www.socialsecurity.gov. 

SUPPLEMENTARY INFORMATION: We are 

revising and making final the rules we 

proposed in the Notice of Proposed 

Rulemaking (NPRM) published in the 

Federal Register on December 23, 2002 

(67 FR 78196). We provide a summary 

of the provisions of the final rules 

below, with an explanation of the 

changes we have made from the 

proposed rules. We then provide a 

summary of the public comments and 

our reasons for adopting or not adopting 

the recommendations in the summaries 

of the comments in the section, ‘‘Public 

Comments.’’ The text of the final rules 

follows the preamble. 

What Programs Do These Final Rules 

Affect? 

These final rules affect disability 

determinations and decisions that we 

make under title II and title XVI of the 

Act. In addition, to the extent that 

Medicare entitlement and Medicaid 

eligibility are based on whether you 

qualify for disability benefits under title 

II or title XVI, these final rules also 

affect the Medicare and Medicaid 

programs. 

Who Can Get Disability Benefits? 

Under title II of the Act, we provide 

for the payment of disability benefits if 

you are disabled and belong to one of 

the following three groups: 

• Workers insured under the Act, 

• Children of insured workers, and 

• Widows, widowers, and surviving 

divorced spouses (see § 404.336) of 

insured workers. 

Under title XVI of the Act, we provide 

for Supplemental Security Income (SSI) 

payments on the basis of disability if 

you are disabled and have limited 

income and resources. 

How Do We Define Disability? 

Under both the title II and title XVI 

programs, disability must be the result 

of any medically determinable physical 

or mental impairment or combination of 

impairments that is expected to result in 

death or which has lasted or can be 

expected to last for a continuous period 

of at least 12 months. Our definitions of 

disability are shown in the following 

table: 

If you file a claim under . . . And you are . . . Disability means you have a medically determinable impairment(s) as 

described above that results in . . . 

Title II .............................................. an adult or a child .......................... the inability to do any substantial gainful activity (SGA). 

Title XVI ........................................... an individual age 18 or older ......... the inability to do any SGA. 

TitleXVI ............................................ an individual under age 18 ............ marked and severe functional limitations. 

How Do We Decide Whether You Are 

Disabled? 

If you are seeking benefits under title 

II of the Act, or if you are an adult 

seeking benefits under title XVI of the 

Act, we use a five-step ‘‘sequential 

evaluation process’’ to decide whether 

you are disabled. We describe this fivestep process in our regulations at 

§§ 404.1520 and 416.920. We follow the 

five steps in order and stop as soon as 

we can make a determination or 

decision. The steps are: 

1. Are you working, and is the work 

you are doing substantial gainful 

activity? If you are working and the 

work you are doing is substantial 

gainful activity, we will find that you 

are not disabled, regardless of your 

medical condition or your age, 

education, and work experience. If you 

are not, we will go on to step 2. 

2. Do you have a ‘‘severe’’

impairment? If you do not have an 

impairment or combination of 

impairments that significantly limits 

your physical or mental ability to do 

basic work activities, we will find that 

you are not disabled. If you do, we will 

go on to step 3. 

3. Do you have an impairment(s) that 

meets or medically equals the severity 

of an impairment in the listings? If you 

do, and the impairment(s) meets the 

duration requirement, we will find that 

you are disabled. If you do not, we will 

go on to step 4. 

4. Do you have the residual functional 

capacity to do your past relevant work? 

If you do, we will find that you are not 

disabled. If you do not, we will go on 

to step 5. 

5. Does your impairment(s) prevent 

you from doing any other work that 

exists in significant numbers in the 

national economy, considering your 

residual functional capacity, age, 

education, and work experience? If it 

does, and it meets the duration 

requirement, we will find that you are 

disabled. If it does not, we will find that 

you are not disabled. 

We use a different sequential 

evaluation process for children who 

apply for payments based on disability 

under SSI. If you are already receiving 

benefits, we also use a different 

sequential evaluation process when we 

decide whether your disability 

continues. See §§ 404.1594, 416.424, 

416.994, and 416.994a of our 

regulations. However, all of these 

processes include steps at which we 

consider whether your impairment(s) 

meets or medically equals one of our 

listings. 

What Are the Listings? 

The listings are examples of 

impairments that we consider severe 

enough to prevent you as an adult from 

doing any gainful activity. If you are a 

child seeking SSI benefits based on 

disability, the listings describe 

impairments that we consider severe 

enough to result in marked and severe 

functional limitations. Although the 

listings are contained only in appendix 

1 to subpart P of part 404 of our 

regulations, we incorporate them by 

reference in the SSI program in 

§ 416.925 of our regulations and apply 

them to claims under both title II and 

title XVI of the Act. 

How Do We Use the Listings? 

The listings are in two parts. There 

are listings for adults (part A) and for 

children (part B). If you are an 

individual age 18 or over, we apply the 

listings in part A when we assess your 

claim, and we never use the listings in 

part B. 

If you are an individual under age 18, 

we first use the criteria in part B of the 

listings. If the listings in part B do not 

apply, and the specific disease 

process(es) has a similar effect on adults 

and children, we then use the criteria in 

part A. (See §§ 404.1525 and 416.925.) 

51254 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 

If your impairment(s) does not meet 

any listing, we will also consider 

whether it medically equals any listing; 

that is, whether it is as medically severe 

as an impairment in the listings. (See 

§§ 404.1526 and 416.926.) 

What If You Do Not Have an 

Impairment(s) That Meets or Medically 

Equals a Listing? 

We use the listings only to decide that 

individuals are disabled or that they are 

still disabled. We will not deny your 

claim or decide that you no longer 

qualify for benefits because your 

impairment(s) does not meet or 

medically equal a listing. If you are not 

working and you have a severe 

impairment(s) that does not meet or 

medically equal any listing, we may still 

find you disabled based on other rules 

in the ‘‘sequential evaluation process.’’

Likewise, we will not decide that your 

disability has ended only because your 

impairment(s) does not meet or 

medically equal a listing. 

Also, when we conduct reviews to 

determine whether your disability 

continues, we will not find that your 

disability has ended because we have 

changed a listing. Our regulations 

explain that, when we change our 

listings, we continue to use our prior 

listings when we review your case, if 

you qualified for disability benefits or 

SSI payments based on our 

determination or decision that your 

impairment(s) met or medically equaled 

a listing. In these cases, we determine 

whether you have experienced medical 

improvement, and if so, whether the 

medical improvement is related to the 

ability to work. If your condition(s) has 

medically improved so that you no 

longer meet or medically equal the prior 

listing, we evaluate your case further to 

determine whether you are currently 

disabled. We may find that you are 

currently disabled, depending on the 

full circumstances of your case. See 

§§ 404.1594(c)(3)(i) and 

416.994(b)(2)(iv)(A). If you are a child 

who is eligible for SSI payments, we 

follow a similar rule when we decide 

that you have experienced medical 

improvement in your condition(s). (See 

§ 416.994a(b)(2).) 

Why Are We Revising the Listings for 

Impairments That Affect Multiple Body 

Systems? 

We are updating the listings for 

impairments that affect multiple body 

systems to update the medical criteria in 

the listings, to provide more information 

about how we evaluate impairments 

that affect multiple body systems, and to 

reflect our adjudicative experience. We 

last published final rules revising the 

adult listings for impairments that affect 

multiple body systems in the Federal 

Register on May 19, 2000 (65 FR 31800); 

the rules were effective on June 19, 

2000. We last published final rules 

revising the childhood listings for 

impairments that affect multiple body 

systems in the Federal Register on 

December 12, 1990 (55 FR 51204). 

What Do We Mean by ‘‘Final Rules’’

and ‘‘Prior Rules’’? 

Even though these rules will not go 

into effect until 60 days after 

publication of this notice, for clarity we 

refer to the changes we are making here 

as the ‘‘final rules’’ and to the rules that 

will be changed by these final rules as 

the ‘‘prior rules.’’

When Will We Start To Use These Final 

Rules? 

We will start to use these final rules 

on their effective date. We will continue 

to use our prior rules until the effective 

date of these final rules. When these 

final rules become effective, we will 

apply them to new applications filed on 

or after the effective date of these rules 

and to claims pending before us, as we 

describe below. 

As is our usual practice when we 

make changes to our regulations, we 

will apply these final rules on or after 

their effective date when we make a 

determination or decision, including 

those claims in which we make a 

determination or decision after remand 

to us from a Federal court. With respect 

to claims in which we have made a final 

decision, and that are pending judicial 

review in Federal court, we expect that 

the court’s review of the 

Commissioner’s final decision would be 

made in accordance with the rules in 

effect at the time of the administrative 

law judge’s (ALJ’s) decision if the ALJ’s 

decision is the final decision of the 

Commissioner. If the court determines 

that the Commissioner’s final decision 

is not supported by substantial 

evidence, or contains an error of law, we 

would expect that the court would 

reverse the final decision and remand 

the case for further administrative 

proceedings pursuant to the fourth 

sentence of section 205(g) of the Act, 

except in those few instances in which 

the court determines that it is 

appropriate to reverse the final decision 

and award benefits without remanding 

the case for further administrative 

proceedings. In those cases decided by 

a court after the effective date of the 

rules, where the court reverses the 

Commissioner’s final decision and 

remands the case for further 

administrative proceedings, on remand, 

we will apply the provisions of these 

final rules to the entire period at issue 

in the claim. 

How Long Will These Final Rules Be 

Effective? 

These final rules will no longer be 

effective 8 years after the date on which 

they become effective, unless we extend 

them, or revise and issue them again. 

What Revisions Are We Making With 

These Final Rules? 

We are: 

• Changing the name of this body 

system from ‘‘Multiple Body Systems’’

to ‘‘Impairments That Affect Multiple 

Body Systems’’; 

• Expanding, updating, and 

reorganizing the guidance in the 

introductory text to the listings; 

• Removing prior listing 110.07; 

• Making conforming changes in 

related regulations; and 

• Making nonsubstantive editorial 

changes. 

Why Are We Changing the Name of 

This Body System? 

We are changing the name of this 

body system from ‘‘Multiple Body 

Systems’’ to ‘‘Impairments That Affect 

Multiple Body Systems’’ to more 

accurately indicate that we use the 

listings in this body system to evaluate 

single impairments that affect two or 

more body systems. 

How Are We Changing the Introductory 

Text to the Adult Multiple Body 

Systems Listings? 

10.00—Impairments That Affect 

Multiple Body Systems 

We are expanding, updating, and 

reorganizing the introductory text to 

provide additional guidance for 

evaluating impairments under this body 

system. A detailed description of the 

revised introductory text follows. 

Final 10.00A—What Impairment Do We 

Evaluate Under This Body System? 

In this section, we are expanding and 

clarifying prior 10.00A, ‘‘Down 

syndrome (except for mosaic Down 

syndrome),’’ and provide a description 

of Down syndrome. There are four 

subsections: 

• In final 10.00A1, we explain that 

we evaluate non-mosaic Down 

syndrome under this body system. 

• Final 10.00A2 is a new paragraph 

that describes Down syndrome and 

explains that it exists in ‘‘non-mosaic’’

and ‘‘mosaic’’ forms. We are revising the 

language we proposed in the NPRM for 

medical accuracy, clarity, and 

consistency with final 10.00A3. 

However, there are no substantive 

changes from the NPRM. 

Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 51255 

• In final 10.00A3a, we describe nonmosaic Down syndrome. Similar to the 

changes in final 10.00A2, we are making 

minor editorial revisions from the 

NPRM for medical accuracy and clarity. 

In final 10.00A3b, we explain that we 

evaluate non-mosaic Down syndrome 

under final listing 10.06. We also 

explain that, if you have confirmed nonmosaic Down syndrome, we consider 

you disabled from birth. This provision 

was part of prior listing 10.06, but we 

are moving it to the introductory text 

because it is not a criterion for meeting 

the listing. It explains only when your 

disability began. We are also moving the 

examples of common impairments 

associated with Down syndrome from 

proposed 10.00A2 to this section and 

revising them slightly for clarity. 

• We describe mosaic Down 

syndrome in final 10.00A4a. In final 

10.00A4b, we explain that we evaluate 

adults with confirmed mosaic Down 

syndrome under the listing criteria in 

any affected body system(s) on an 

individual case basis, and we refer to 

10.00C for an explanation of how we 

adjudicate claims involving mosaic 

Down syndrome. We are making minor 

editorial revisions from the NPRM 

consistent with the changes we are 

making in final 10.00A2 and A3. 

Final 10.00B—What Documentation Do 

We Need To Establish That You Have 

Non-Mosaic Down Syndrome? 

In this section, we are expanding and 

modifying prior 10.00B. We explain the 

documentation we need to establish that 

you have non-mosaic Down syndrome. 

We are also revising this section as we 

proposed it in the NPRM to reflect our 

adjudicative experience, to eliminate an 

unnecessary requirement in the prior 

rules, and to reflect modern medical 

practices. We are also making minor 

revisions for clarity. 

We proposed two paragraphs in 

10.00B in the NPRM; there are three 

paragraphs in these final rules. In final 

10.00B1, we explain the basic 

requirement in our disability programs 

that the documentation we need to 

establish the existence of a medically 

determinable impairment must come 

from an acceptable medical source, as 

defined in §§ 404.1513(a) and 416.913(a) 

of our regulations. 

In final 10.00B2, we provide that we 

will find that you have non-mosaic 

Down syndrome based only on a report 

from an acceptable medical source 

indicating that you have the impairment 

when that report includes the actual 

laboratory report of definitive 

chromosomal analysis showing that you 

have non-mosaic Down syndrome. We 

define the phrase ‘‘definitive 

chromosomal analysis’’ as meaning 

karyotype analysis. Karyotype analysis 

is currently the most accurate and 

reliable indicator of the existence of 

non-mosaic Down syndrome. It is also 

the kind of analysis that is used most 

often and the test we refer to in our 

internal operating instructions. 

Based on our adjudicative experience, 

we have determined that a report from 

an acceptable medical source indicating 

that you have non-mosaic Down 

syndrome that is supported by 

definitive chromosomal karyotype 

analysis is sufficient to establish the 

existence of non-mosaic Down 

syndrome. We do not additionally 

require a clinical description of the 

diagnostic physical features of the 

impairment when we have this 

evidence, as we required under the prior 

rules and in the NPRM, because 

karyotype analysis shows definitively 

whether you have non-mosaic Down 

syndrome. Chromosomal analysis has 

become much more common in recent 

years and is often in the medical 

evidence we obtain. This was not the 

case in 1990 when we published the 

original rules for children, the rules we 

used as a basis for the adult listing we 

first published on May 19, 2000. See 65 

FR 31800. Moreover, physicians 

generally order chromosomal testing for 

Down syndrome when their clinical 

findings suggest that an individual 

might have Down syndrome, so we 

believe that we can reasonably presume 

that the diagnostic physical features are 

present. 

In these final rules, we require the 

laboratory report to be submitted by an 

acceptable medical source because in 

this situation it will be the objective 

medical evidence we rely on to establish 

the existence of the medically 

determinable impairment. This does not 

mean that an acceptable medical source 

must conduct the actual karyotype 

analysis, only that an acceptable 

medical source must submit the 

evidence together with an opinion that 

you have non-mosaic Down syndrome. 

In final 10.00B3, we explain that, 

when we do not have the actual 

laboratory report of definitive 

chromosomal analysis, we need 

evidence from an acceptable medical 

source that includes a clinical 

description of the diagnostic physical 

features of Down syndrome, and that is 

persuasive that a positive diagnosis has 

been confirmed by definitive 

chromosomal analysis at some time 

prior to our evaluation. This is 

essentially the same alternative 

provision that we included in prior 

10.00B and in proposed 10.00B2 of the 

NPRM. The section includes the 

guidance in prior 10.00B about what we 

mean by medical evidence that is 

‘‘persuasive.’’

We are also making other changes 

from proposed 10.00B2 in final 10.00B3. 

As in the NPRM, we include examples 

of other evidence that may help to 

establish that you have the impairment, 

such as your educational history or the 

results of psychological testing. In 

response to a comment, we are adding 

references to limitations in adaptive 

functioning and to mental disorders that 

may be associated with non-mosaic 

Down syndrome in these final rules 

because these findings are frequently in 

the evidence we obtain and are useful 

for establishing the diagnosis. We are 

also revising the proposed examples to 

remove the reference to ‘‘the description 

of abnormal physical findings’’ we 

included in the NPRM because it might 

be confused with the requirement for ‘‘a 

clinical description of the diagnostic 

physical features of Down syndrome’’

we included earlier in the same 

paragraph. Finally, we are making a 

number of editorial changes for clarity 

and for consistency with other changes 

that we are making in these final rules. 

We are also making other 

nonsubstantive editorial changes 

throughout final 10.00B. For example, 

we are changing the heading of the 

section to refer specifically to nonmosaic Down syndrome because that is 

the only impairment we list in this body 

system. (We are not making the same 

change to the heading in 110.00B 

because the childhood listings include 

other multiple body system 

impairments.) In final 10.00B3 

(proposed 10.00B2), we are also 

removing the phrase ‘‘if available,’’

referring to the example of 

psychological testing, because it is 

unnecessary. It is self-evident that the 

results of psychological testing would 

have to be available or we would not be 

able to use them. 

Final 10.00C—How Do We Evaluate 

Other Impairments That Affect Multiple 

Body Systems? 

In this section, we expand and clarify 

prior 10.00C, ‘‘Other chromosomal 

abnormalities; e.g., mosaic Down 

syndrome.’’ We explain how we 

evaluate impairments that affect 

multiple body systems other than nonmosaic Down syndrome. There are three 

subsections: 

• In final 10.00C1, we explain that, if 

you have a severe impairment(s) other 

than non-mosaic Down syndrome that 

affects multiple body systems, we must 

consider whether your impairment(s) 

meets the criteria of a listing in another 

body system. In these final rules, we are 

51256 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 

making minor editorial changes from 

the NPRM for clarity. For example, 

instead of referring to non-mosaic Down 

syndrome as a ‘‘common impairment’’

that affects multiple body systems, we 

are clarifying that it is an impairment 

that ‘‘commonly affects’’ multiple body 

systems. Although Down syndrome 

occurs more commonly than other 

genetic disorders, it still occurs 

relatively rarely, in only one out of 

every 750–800 live births in the United 

States. We are also changing the word 

‘‘severe’’ in the first sentence to 

‘‘significant’’ because the word ‘‘severe’’

has a special meaning in our rules and 

this will remove any confusion about 

our intent. 

• In final 10.00C2, we give some 

examples of the many other 

impairments that can affect multiple 

body systems, such as triple X 

syndrome (XXX syndrome), fragile X 

syndrome, phenylketonuria (PKU), 

caudal regression syndrome, and fetal 

alcohol syndrome. (In an editorial 

change from the NPRM, we revised the 

reference to ‘‘trisomy X syndrome’’ from 

the NPRM to refer to two of the more 

commonly used names of the syndrome: 

‘‘triple X syndrome’’ and ‘‘XXX 

syndrome.’’) We also explain that, 

because these impairments can affect 

various body systems, and the effects on 

each person can vary widely, we 

evaluate these impairments under the 

listing criteria in any affected body 

system on an individual case basis. 

Final 10.00C2 generally corresponds to 

prior 10.00C. 

• In final 10.00C3, we explain that, if 

you have a severe medically 

determinable impairment(s) that does 

not meet a listing, we will consider 

whether your impairment(s) medically 

equals a listing. If it does not, we will 

proceed to the fourth and, if necessary, 

fifth steps of the sequential evaluation 

process in §§ 404.1520 and 416.920. We 

also explain that we follow the rules in 

§§ 404.1594 and 416.994, as 

appropriate, when we decide whether 

you continue to be disabled. 

As in final 10.00B, we are also making 

nonsubstantive editorial changes from 

the NPRM throughout final 10.00C. 

How Are We Changing the Criteria in 

the Listing for Non-Mosaic Down 

Syndrome in Adults? 

Final 10.06—Non-Mosaic Down 

Syndrome 

We are simplifying the heading to 

make it clear that we evaluate only nonmosaic Down syndrome under this 

listing. As already noted, we are also 

moving the last sentence of prior listing 

10.06 to final 10.00A3b. Because of the 

changes we are making in final 10.00B2, 

we are revising the proposed rule 

toremove the requirement for ‘‘clinical 

and laboratory’’ findings in every case. 

Instead, we are requiring that you show 

that you have non-mosaic Down 

syndrome ‘‘established as described in 

10.00B.’’

What Changes Are We Making for 

Children? 

The following is an explanation of the 

changes we are making in part B, the 

listings for individuals who are under 

age 18. Except as described below, if we 

use the same criteria in both the adult 

and childhood rules, we are making 

these changes in the childhood rules for 

the same reasons we made the changes 

in the adult rules. 

We describe below only the changes 

in the final rules in part B that are 

substantively different from the changes 

in part A. We do not describe minor, 

nonsubstantive differences in the 

language of the final rules specifically to 

address children. 

How Are We Changing the Introductory 

Text to the Child Multiple Body 

Systems Listing? 

Final 110.00A—What Kinds of 

Impairments Do We Evaluate Under 

This Body System? 

In final 110.00A1, we provide a 

general description of the kinds of 

impairments we evaluate under this 

body system. We also provide a brief 

description of the effects that these 

impairments generally have on a child’s 

ability to perform age-appropriate 

activities. We also explain that, when 

we use the term ‘‘very seriously’’ in 

these listings, we mean an ‘‘extreme’’

limitation as we define it in 

§ 416.926a(e)(3) of our regulation for 

functional equivalence. To correct an 

error in the NPRM, we deleted the 

reference to mosaic Down syndrome as 

one of the impairments we evaluate 

under these listings. There is no listing 

for mosaic Down syndrome in these 

final rules. 

In final 110.00A5a, we describe what 

we mean by ‘‘catastrophic congenital 

abnormalities or diseases.’’ We explain 

that they are present at birth and that it 

is reasonably certain that they will 

result in early death or interfere very 

seriously with development. In final 

110.00A5b, we explain that we evaluate 

catastrophic congenital abnormalities or 

diseases under final listing 110.08. 

Final 110.00B—What Documentation 

Do We Need To Establish That You 

Have an Impairment That Affects 

Multiple Body Systems? 

We are making the same change in 

final 110.00B2 that we made in final 

10.00B2, which provides that we will 

find that you have non-mosaic Down 

syndrome based on definitive 

chromosomal analysis (that is, 

karyotype analysis) if we have a copy of 

the laboratory report and it is submitted 

by an acceptable medical source who 

tells us that you have non-mosaic Down 

syndrome. In such cases, as in the final 

adult rules, we do not additionally 

require a clinical description of the 

diagnostic physical features of Down 

syndrome. As in final 10.00B3, we are 

also expanding the list of examples in 

final 110.00B3 to include examples of 

limitations in adaptive functioning or 

signs of a mental disorder. 

Final 110.00B differs from final 10.00 

because the listings in final 110.00 

include other kinds of multiple body 

system impairments besides non-mosaic 

Down syndrome. Final 110.00B2a and 

110.00B2b correspond to final 10.00B2 

and 10.00B3. They explain we need to 

establish the existence of non-mosaic 

Down syndrome under final listing 

110.06. Final 110.00B3 explains the 

evidence we need to establish the 

existence of the catastrophic congenital 

abnormalities and diseases we evaluate 

under final listing 110.08. Final 

110.00B3a, explains how we document 

genetic disorders (such as Trisomy 13 or 

18, chromosomal deletion syndromes, 

and genetic metabolic disorders) under 

final listing 110.08. Final 110.00B3b 

explains how we document other kinds 

of catastrophic congenital abnormalities 

(such as anencephaly and cyclopia) 

under final listing 110.08. In both cases, 

we need a clinical description of the 

physical abnormalities that are 

diagnostic for the impairments. In the 

case of genetic disorders under final 

listing 110.08, we also need the report 

of the definitive laboratory testing (for 

example, genetic analysis or evidence of 

biochemical abnormalities) appropriate 

to the impairment. However, as in the 

case of non-mosaic Down syndrome, we 

can also use a report from an acceptable 

medical source that is persuasive that 

appropriate testing was done in the past 

and that is consistent with the other 

information in the case record. In 

response to a comment, we are also 

including in final 110.00B3a examples 

of genetic disorders that we evaluate 

under final listing 110.08. 

Final 110.00B is also different from 

final 10.00B in other ways. For example, 

we are not changing the heading of final 

Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 51257 

110.00B even though we changed the 

heading in 10.00B because we list a 

number of different impairments in 

110.00 in addition to non-mosaic Down 

syndrome. 

Final 110.00C—How Do We Evaluate 

Impairments That Affect Multiple Body 

Systems and That Do Not Meet the 

Criteria of the Listings in This Body 

System? 

In final 110.00C2, as in the final adult 

rules and the NPRM, we explain that 

there are many other impairments that 

affect multiple body systems apart from 

the ones we include in these listings. 

However, because these impairments 

can vary widely in their effects on 

children, we need to evaluate their 

particular effects under the body system 

or body systems appropriate to those 

effects. In response to a comment about 

our proposed deletion of listing 110.07, 

we are also expanding final 110.00C2 to 

refer to specific categories of 

impairments involving multiple body 

systems, such as congenital anomalies, 

chromosomal disorders, and 

dysmorphic syndromes. As in the 

NPRM, we are also including some 

examples of specific impairments that 

can affect multiple body systems, such 

as triple X syndrome (XXX syndrome), 

fragile X syndrome, PKU, caudal 

regression syndrome, and fetal alcohol 

syndrome. 

In final 110.00C3, we explain that, if 

you have a severe medically 

determinable impairment(s) that does 

not meet a listing, we will consider 

whether your impairment(s) medically 

equals a listing. If your impairment(s) 

does not meet or medically equal a 

listing, we will consider whether it 

functionally equals the listings. In the 

last sentence of final 110.00C3, we 

explain that we use the rules in 

§ 416.994a when we consider whether 

you continue to be disabled. In a change 

from the NPRM, we are deleting the 

phrase ‘‘If you are receiving SSI 

payments,’’ which we proposed for the 

beginning of the last sentence. This will 

clarify that we use the rules in 

§ 416.994a whenever we consider 

whether you continue to be disabled. 

This may occur, for example, when we 

make a ‘‘closed period’’ determination 

or decision; that is, a determination or 

decision that you were disabled and 

eligible for payments at the time you 

filed your application for SSI but, at the 

same time, that you are now no longer 

disabled. In such a situation you will 

not yet have received any SSI payments. 

How Are We Changing the Criteria in 

the Listings for Evaluating Impairments 

That Affect Multiple Body Systems in 

Children? 

If the same criteria exist in both the 

adult and childhood rules, we are 

making the same changes in the 

childhood rules that we made for the 

adult rules for the same reasons we 

made the changes in the adult rules. The 

following is an explanation of the 

changes where they differ substantively 

from the final adult rules. 

Final 110.01—Category of Impairments, 

Impairments That Affect Multiple Body 

Systems 

Prior Listing 110.07—Multiple Body 

Dysfunction 

We are removing prior listing 110.07 

for two reasons. 

• First, we established listing 

110.07A in 1990 to help us evaluate 

physical impairments in infants and 

young children. However, we wrote this 

listing before we had the policy of 

functional equivalence in § 416.926a, 

which we first published in 1991 and 

have updated several times, and before 

we updated several listings to better 

evaluate impairments in such children. 

All children who could qualify under 

any of the provisions of prior listing 

110.07 will continue to qualify under 

other listings or the rules for functional 

equivalence. Therefore, prior listing 

110.07A has become outdated and 

unnecessary. 

• Second, the remaining criteria, 

prior listings 110.07B through F, were 

solely reference listings that referred 

adjudicators to other listings in other 

body systems. As we update the listings 

in each of the body systems in the 

Listing of Impairments, we are removing 

reference listings because they are 

redundant. 

Final Listing 110.08—A Catastrophic 

Congenital Abnormality or Disease 

In the final rules, we provide listings 

for two kinds of catastrophic congenital 

abnormalities or diseases: 

• Ones in which death usually is 

expected within the first months of life, 

and the rare individuals who survive 

longer are profoundly impaired (final 

listing 110.08A); and 

• Ones that interfere very seriously 

with development (final listing 

110.08B). 

In the final listing, we are changing 

the references to incompatibility with 

‘‘extrauterine life’’ in prior listing 

110.08A and ‘‘life outside of the uterus’’

in the proposed listing to recognize that 

some children with the kinds of 

abnormalities listed may live for months 

or even a few years. The final language, 

‘‘Death usually is expected within the 

first months of life, and the rare 

individuals who survive longer are 

profoundly impaired,’’ explains our 

intent more clearly. 

In final listing 110.08B, we are 

changing the phrase ‘‘attainment of the 

growth and development of 2 years is 

not expected to occur’’ from the prior 

listing to ‘‘interferes very seriously with 

development.’’ This language in the 

final listing takes into consideration 

advances in the evaluation and 

management of these abnormalities and 

diseases, and will include under the 

listing some children with very serious 

limitations in development who were 

not included under the prior listing. 

This revised language is also consistent 

with our definition of ‘‘extreme’’

limitation in § 416.926a(e)(3). We are 

also clarifying in response to a comment 

that, for those diseases that have both 

infantile-onset and later-onset forms (for 

example, Tay-Sachs disease), only the 

earlier onset forms, which tend to be 

associated with more serious outcomes, 

are included under this listing. 

Finally, we are making final listing 

110.08 clearer and easier to understand 

by: 

• Changing the word ‘‘abnormalities’’

from prior listing 110.08 to 

‘‘abnormality’’ to emphasize that there 

need be only a single abnormality or 

disease involved. 

• Removing the requirement for ‘‘a 

positive diagnosis’’ from prior listings 

110.08A and B and instead crossreferring to 110.00B in the opening 

statement of final listing 110.08. This is 

a nonsubstantive change from the 

provision we proposed in the NPRM, 

which continued to use the phrase ‘‘a 

positive diagnosis.’’ We believe the 

phrase is unnecessary because 110.00B 

describes the evidence we need to 

establish whether a child has an 

impairment listed under 110.08. 

• Updating, in response to a 

comment, the examples of ‘‘trisomy D 

and trisomy E’’ in final listing 110.08A 

to their more modern and medically 

accurate names, ‘‘trisomy 13’’ and 

‘‘trisomy 18,’’ and updating and 

clarifying the examples in final listing 

110.08B. 

What Other Rules Are We Changing? 

We are revising sections 8.00E3 and 

108.00E3 in our skin body system 

listings for consistency with the changes 

we are making in final sections 10.00B 

and 110.00B. We recently published 

these final rules in the Federal Register. 

See 69 FR 32260 (June 9, 2004). In the 

final skin listings, we established new 

listings 8.07A and 108.07A for 

51258 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 

xeroderma pigmentosum (XP), and 

listings 8.07B and 108.07B for other 

genetic photosensitivity disorders. In 

8.00E3 and 108.00E3 in the introductory 

text to those listings, we provided rules 

for establishing the existence of XP and 

other genetic photosensitivity disorders 

that we based on the prior rules for 

establishing the existence of non-mosaic 

Down syndrome. Under those rules, we 

required both a clinical description of 

the impairment and evidence of 

definitive genetic laboratory studies 

establishing the impairment. See 69 FR 

32263. Our reasons for the changes in 

these final rules for establishing the 

existence of non-mosaic Down 

syndrome apply equally to our rules for 

establishing the existence of XP and 

other genetic photosensitivity disorders. 

Therefore, we are revising 8.00E3 and 

108.00E3 for consistency with final 

10.00B and 110.00B. As in the final 

multiple body system listings, the 

changes will simplify our rules for 

establishing the existence of the 

impairments. 

We are also replacing the last 

sentence of 101.00B2c(2), ‘‘How we 

assess inability to perform fine and 

gross movements in very young 

children,’’ in the introductory text of the 

childhood musculoskeletal body system 

listings, because it refers adjudicators to 

prior 110.07A, which we are removing 

from the multiple body system listings. 

The final provision is based on the 

language of 101.00B2b(2), which 

addresses the assessment of the ability 

to ambulate effectively in very young 

children, but in terms relevant to the 

inability to perform fine and gross 

movements in such children. 

What Other Changes Are We Making? 

We are making a number of editorial 

changes from the NPRM in these final 

rules. The changes simplify and clarify 

language, change some sentences to 

active voice, and improve consistency 

between the provisions of part A and 

part B. These are not substantive 

changes, and we do not intend for them 

to change the meaning of the language 

we proposed in the NPRM. 

What Rules Are We Not Changing? 

In the NPRM, we proposed to change 

prior § 416.934(g), which was a 

provision in one of our regulations 

about presumptive disability and 

presumptive blindness payments under 

SSI. The prior provision used language 

that was out-of-date. However, on 

August 28, 2003, we published final 

rules that made this change. (See 

‘‘Revised Medical Criteria for Evaluating 

Amyotrophic Lateral Sclerosis,’’ 68 FR 

51689, 51692.) Therefore, we are not 

including the change in these final rules 

because we have already made it. We 

did not receive any public comments 

about the proposed change. 

Public Comments 

In the NPRM we published on 

December 23, 2002 (67 FR 78196), we 

provided the public with a 60-day 

period in which to comment. The 

period ended on February 21, 2003. We 

mailed electronic copies to national 

medical organizations and professionals 

who have expertise in the evaluation of 

impairments that affect multiple body 

systems. As a part of our outreach 

efforts, we invited comments from 

advocacy groups and legal services 

organizations. 

We received comments from six 

commenters. We carefully considered 

all of the comments. Because some of 

the comments were long, we have 

condensed, summarized, and 

paraphrased them. We have tried to 

summarize the commenters’ views 

accurately, and to respond to all of the 

significant issues raised by the 

commenters that were within the scope 

of these rules. 

Final Section 10.00B—What 

Documentation Do We Need To 

Establish That You Have Non-Mosaic 

Down Syndrome? 

Final Section 110.00B—What 

Documentation Do We Need To 

Establish That You Have an Impairment 

That Affects Multiple Body Systems? 

Comment: One commenter stated that 

the provisions of prior 10.00B and 

110.00B did not permit the use of 

mental and adaptive behaviors to be 

used in conjunction with laboratory 

tests to confirm a probable positive 

diagnosis of Down syndrome. The 

commenter said that the wording 

appeared to require the description of 

abnormal physical findings to confirm 

the diagnosis in all cases. The 

commenter suggested that when we 

consider the full range of signs, 

symptoms, and laboratory findings we 

include, in addition to physical 

findings, mental and adaptive clinical 

evidence. 

Response: We adopted the comment 

in final 10.00B3 and 110.00B2b. 

Final Listings 10.06 and 110.06—NonMosaic Down Syndrome 

Comment: A commenter said that the 

proposed listings were silent on the 

issues of how many biopsies and 

chromosome evaluations, and of how 

many different body tissues, would be 

necessary to absolutely and definitively 

rule out the presence of mosaicism. The 

commenter believed that we should 

specify how non-mosaicism must be 

established. The commenter asked 

whether a treating physician’s assertion 

would be sufficient or a chromosomal 

analysis of only one body tissue and, if 

so, of which tissue. 

Response: The standard diagnostic 

test for Down syndrome in both the nonmosaic and mosaic forms is a blood 

chromosomal (karyotype) analysis, and 

the great majority of people with Down 

syndrome have the non-mosaic form. 

Mosaic Down syndrome is rare: only 

about 1 to 2 percent of people who have 

Down syndrome have the mosaic form. 

In these final rules, we are making 

clear in response to this comment that 

a treating physician’s statement alone is 

not sufficient to establish whether Down 

syndrome is mosaic or non-mosaic, 

although a treating physician’s 

statement, supported by karyotype 

analysis, as outlined in 10.00B2 and 

110.00B2a, will be sufficient to establish 

that you have non-mosaic Down 

syndrome. Under final listings 10.06 

and 110.06, either a report of definitive 

chromosomal analysis alone or a 

physician’s statement that there was 

chromosomal testing together with the 

physician’s description of the diagnostic 

physical findings will support a finding 

of disability. 

Final Listing 110.07—Multiple Body 

Dysfunction 

Comment: One commenter said that, 

although prior listing 110.07 was 

basically a reference listing, it served to 

reinforce the need to assess multiple 

body dysfunction regardless of the 

underlying condition. The commenter 

believed that the listing served as a 

valuable reminder of this basic concept, 

and that we should retain it, especially 

for adjudicators who are less 

experienced. 

Response: We did not adopt the 

comment. We do not agree that the prior 

reference listing would be especially 

helpful to adjudicators, even newer 

ones. All children who could qualify 

under any of the provisions of prior 

listing 110.07 will continue to qualify 

under other listings or the rules for 

functional equivalence. Also, as we 

have already noted, because reference 

listings are redundant, we are removing 

them from all the body systems as we 

revise them; therefore, retaining one 

reference listing in this body system 

would be anomalous. 

We did include information about the 

SSI childhood disability regulations in 

the introductory text to these final 

listings as a reminder about our other 

rules. Additionally, because the last 

sentence of 101.00B2c(2) in the 

introductory text of the childhood 

Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 51259 

musculoskeletal listings referred 

adjudicators to prior 110.07A, we are 

replacing that sentence with clearer 

guidance for assessing extreme 

limitation of fine and gross movements 

in very young children, similar to the 

guidance in 101.00B2b(2). 

Final Listing 110.08—Catastrophic 

Congenital Abnormality or Disease 

Comment: One commenter asked 

whether proposed listings 110.08A and 

B would include trisomies 8, 9, 13, and 

18, as well as 21. The commenter also 

asked if the deletions listed under 

proposed listing 110.08B included the 

deletions for chromosomes 5, 8, 11, 13, 

18, 21, and 22. Finally, the commenter 

asked whether our example of TaySachs disease was meant to suggest that 

other conditions, such as medium- and 

long-chain dehydrogenase deficiencies, 

Zellweger syndrome, Niemann-Pick 

disease, Krabbe disease and 

mucolipidosis, should also be included 

in this category. 

Response: We clarified the listing in 

response to this comment. We also 

included similar clarifications in final 

110.00B3a of the introductory text. 

In 110.08A, we changed the examples 

of trisomy D and E to their more 

currently accepted names, trisomy 13 

and 18, respectively. Most children born 

with trisomy 13 or 18 die relatively 

shortly after birth. Trisomy 21 is Down 

syndrome, so it is covered under final 

listing 110.06. 

Most of the other non-mosaic trisomy 

syndromes in which a lifespan beyond 

age 1 is generally expected are 

associated with profound 

developmental retardation, and so 

would be included under final listing 

110.08B. However, when the clinical 

course of a trisomy syndrome is 

variable, we will evaluate the 

impairment under the affected body 

system(s). 

With regard to deletion syndromes, 

we clarified in final 110.08B that the 

example of ‘‘5p-syndrome’’ (cri du chat 

syndrome) was an example of a deletion 

syndrome: ‘‘deletion 5p syndrome.’’

Any of the other chromosomal deletion 

syndromes that are associated with 

profound developmental retardation 

will also meet the requirements of final 

listing 110.08B. When the clinical 

course of a deletion syndrome is more 

variable, we will evaluate the 

impairment under the affected body 

system(s). 

In response to this comment, we are 

also clarifying our intent in final listing 

110.08B. We are clarifying that the 

example of Tay-Sachs disease—which is 

a metabolic disease (betahexosaminidase deficiency)—refers to 

the infantile onset form; we will 

evaluate the later onset forms of TaySachs disease under the affected body 

systems. This policy principle will also 

apply to other deficiency/storage 

diseases, such as medium-chain 

dehydrogenase deficiency, NiemannPick disease, and Krabbe disease. The 

infantile onset forms, which are 

associated with the most serious 

outcomes, will meet listing 110.08B, 

and we will evaluate the effects of other 

forms under the appropriate body 

systems. 

Other Comments 

Comment: Two commenters wrote to 

us about impairments that they wanted 

us to add to the multiple body systems 

listings. The first commenter wanted us 

to include chronic granulomatous 

disease (CGD), which he described as an 

impairment that, with proper treatment, 

does not cause any visible 

manifestations but that, without 

treatment, can be fatal in just a few 

years. Because of the characteristics of 

the disease, the commenter believed we 

should make determinations of 

disability based on how serious a 

person’s condition is, regardless of 

whether he or she receives treatment. 

Similarly, the second commenter 

asked us to include BeckwithWiedemann syndrome in our listings for 

children. He expressed a concern that, 

without a listing to go by, we would 

have a harder time finding out the 

severity of the disorder. 

Response: Although we agree that 

these impairments can be disabling, we 

did not adopt the comments asking us 

to add them to the listings. CGD exists 

in multiple forms with variable effects 

and prognoses. Beckwith-Wiedemann 

syndrome also varies in its clinical 

course and its effects on different 

individuals. 

Regulatory Procedures 

Executive Order (E.O.) 12866 

We have consulted with the Office of 

Management and Budget (OMB) and 

determined that these final rules meet 

the criteria for a significant regulatory 

action under E.O. 12866, as amended by 

E.O. 13258. Thus, they were subject to 

Office of Management and Budget 

review. 

Regulatory Flexibility Act 

We certify that these final rules will 

not have a significant economic impact 

on a substantial number of small entities 

because they affect only individuals. 

Thus, a regulatory flexibility analysis as 

provided in the Regulatory Flexibility 

Act, as amended, is not required. 

Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

says that no persons are required to 

respond to a collection of information 

unless it displays a valid Office of 

Management and Budget control 

number. In accordance with the 

Paperwork Reduction Act, SSA is 

providing notice that the Office of 

Management and Budget has approved 

the information collection requirements 

contained in sections 10.00B, 10.00C, 

110.00B, and 110.00C. The Office of 

Management and Budget Control 

Number for this (these) collection(s) is 

0960–0642, expiring March 31, 2008. 

(Catalog of Federal Domestic Program Nos. 

96–001, Social Security-Disability Insurance; 

96.002, Social Security-Retirement Insurance; 

96–004, Social Security-Survivors Insurance; 

and 96–006, Supplemental Security Income) 

List of Subjects in 20 CFR Part 404 

Administrative practice and 

procedure, Blind, Disability benefits, 

Old-Age, Survivors, and Disability 

Insurance, Reporting and recordkeeping 

requirements, Social Security. 

Dated: May 20, 2005. 

Jo Anne B. Barnhart, 

Commissioner of Social Security. 

■ For the reasons set forth in the 

preamble, subpart P of part 404 of 

chapter III of title 20 of the Code of 

Federal Regulations is amended as 

follows: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950–) 

Subpart P—[Amended] 

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows: 

Authority: Secs. 202, 205(a), (b), and (d)–

(h), 216(i), 221(a) and (i), 222(c), 223, 225, 

and 702(a)(5) of the Social Security Act (42 

U.S.C. 402, 405(a), (b), and (d)–(h), 416(i), 

421(a) and (i), 422(c), 423, 425, and 

902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 

Stat. 2105, 2189. 

Appendix 1 to Subpart P of Part 404—

[Amended] 

■ 2. Item 11 in the introductory text 

before part A of appendix 1 to subpart 

P of part 404 is amended to read as 

follows: 

Appendix 1 to Subpart P of Part 404—Listing 

of Impairments 

* * * * * 

11. Impairments That Affect Multiple Body 

Systems (10.00 and 110.00): (Insert date 8 

years after effective date of final regulations.) 

* * * * * 

51260 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 

■ 3. The list of sections for part A is 

amended by revising the heading of 

section 10.00 to read as follows: 

Part A 

* * * * * 

10.00 Impairments That Affect Multiple 

Body Systems 

* * * * * 

■ 4. In listing 8.00, Skin Disorders, 

section 8.00E3 and the introductory text 

of listing 8.07 are revised to read as 

follows: 

* * * * * 

E. How Do We Evaluate Genetic 

Photosensitivity Disorders? 

* * * * * 

3. Clinical and laboratory findings. 

a. General. We need documentation from 

an acceptable medical source, as defined in 

§§ 404.1513(a) and 416.913(a), to establish 

that you have a medically determinable 

impairment. In general, we must have 

evidence of appropriate laboratory testing 

showing that you have XP or another genetic 

photosensitivity disorder. We will find that 

you have XP or another genetic 

photosensitivity disorder based on a report 

from an acceptable medical source indicating 

that you have the impairment, supported by 

definitive genetic laboratory studies 

documenting appropriate chromosomal 

changes, including abnormal DNA repair or 

another DNA or genetic abnormality specific 

to your type of photosensitivity disorder. 

b. What we will accept as medical evidence 

instead of the actual laboratory report. When 

we do not have the actual laboratory report, 

we need evidence from an acceptable 

medical source that includes appropriate 

clinical findings for your impairment and 

that is persuasive that a positive diagnosis 

has been confirmed by appropriate laboratory 

testing at some time prior to our evaluation. 

To be persuasive, the report must state that 

the appropriate definitive genetic laboratory 

study was conducted and that the results 

confirmed the diagnosis. The report must be 

consistent with other evidence in your case 

record. 

* * * * * 

8.01 Category of Impairments, Skin 

Disorders 

* * * * * 

8.07 Genetic photosensitivity disorders, 

established as described in 8.00E. 

* * * * * 

■ 5. Listing 10.00, Multiple Body 

Systems, is revised to read as follows: 

* * * * * 

10.00 Impairments That Affect Multiple 

Body Systems 

A. What Impairment Do We Evaluate Under 

This Body System? 

1. General. We evaluate non-mosaic Down 

syndrome under this body system. 

2. What is Down syndrome? Down 

syndrome is a condition in which there are 

three copies of chromosome 21 within the 

cells of the body instead of the normal two 

copies per cell. The three copies may be 

separate (trisomy), or one chromosome 21 

copy may be attached to a different 

chromosome (translocation). This extra 

chromosomal material changes the orderly 

development of the body and brain. Down 

syndrome is characterized by a complex of 

physical characteristics, delayed physical 

development, and mental retardation. Down 

syndrome exists in non-mosaic and mosaic 

forms. 

3. What is non-mosaic Down syndrome? 

a. Non-mosaic Down syndrome occurs 

when you have an extra copy of chromosome 

21 in every cell of your body. At least 98 

percent of people with Down syndrome have 

this form (which includes either trisomy or 

translocation type chromosomal 

abnormalities). Virtually all cases of nonmosaic Down syndrome affect the mental, 

neurological, and skeletal systems, and they 

are often accompanied by heart disease, 

impaired vision, hearing problems, and other 

conditions. 

b. We evaluate adults with confirmed nonmosaic Down syndrome under 10.06. If you 

have confirmed non-mosaic Down syndrome, 

we consider you disabled from birth. 

4. What is mosaic Down syndrome? 

a. Mosaic Down syndrome occurs when 

you have some cells with the normal two 

copies of chromosome 21 and some cells 

with an extra copy of chromosome 21. When 

this occurs, there is a mixture of two types 

of cells. Mosaic Down syndrome occurs in 

only 1–2 percent of people with Down 

syndrome, and there is a wide range in the 

level of severity of the impairment. Mosaic 

Down syndrome can be profound and 

disabling, but it can also be so slight as to be 

undetected clinically. 

b. We evaluate adults with confirmed 

mosaic Down syndrome under the listing 

criteria in any affected body system(s) on an 

individual case basis, as described in 10.00C. 

B. What Documentation Do We Need To 

Establish That You Have Non-Mosaic Down 

Syndrome? 

1. General. We need documentation from 

an acceptable medical source, as defined in 

§§ 404.1513(a) and 416.913(a), to establish 

that you have a medically determinable 

impairment. 

2. Definitive chromosomal analysis. We 

will find that you have non-mosaic Down 

syndrome based on a report from an 

acceptable medical source that indicates that 

you have the impairment and that includes 

the actual laboratory report of definitive 

chromosomal analysis showing that you have 

the impairment. Definitive chromosomal 

analysis means karyotype analysis. In this 

case, we do not additionally require a clinical 

description of the diagnostic physical 

features of your impairment. 

3. What if we do not have the results of 

definitive chromosomal analysis? When we 

do not have the actual laboratory report of 

definitive chromosomal analysis, we need 

evidence from an acceptable medical source 

that includes a clinical description of the 

diagnostic physical features of Down 

syndrome, and that is persuasive that a 

positive diagnosis has been confirmed by 

definitive chromosomal analysis at some 

time prior to our evaluation. To be 

persuasive, the report must state that 

definitive chromosomal analysis was 

conducted and that the results confirmed the 

diagnosis. The report must be consistent with 

other evidence in your case record; for 

example, evidence showing your limitations 

in adaptive functioning or signs of a mental 

disorder that can be associated with nonmosaic Down syndrome, your educational 

history, or the results of psychological 

testing. 

C. How Do We Evaluate Other Impairments 

That Affect Multiple Body Systems? 

1. Non-mosaic Down syndrome (10.06) is 

an example of an impairment that commonly 

affects multiple body systems and that we 

consider significant enough to prevent you 

from doing any gainful activity. If you have 

a different severe impairment(s) that affects 

multiple body systems, we must also 

consider whether your impairment(s) meets 

the criteria of a listing in another body 

system. 

2. There are many other impairments that 

can cause deviation from, or interruption of, 

the normal function of the body or interfere 

with development; for example, congenital 

anomalies, chromosomal disorders, 

dysmorphic syndromes, metabolic disorders, 

and perinatal infectious diseases. In these 

impairments, the degree of deviation or 

interruption may vary widely from 

individual to individual. Therefore, the 

resulting functional limitations and the 

progression of those limitations also vary 

widely. For this reason, we evaluate the 

specific effects of these impairments on you 

under the listing criteria in any affected body 

system(s) on an individual case basis. 

Examples of such impairments include triple 

X syndrome (XXX syndrome), fragile X 

syndrome, phenylketonuria (PKU), caudal 

regression syndrome, and fetal alcohol 

syndrome. 

3. If you have a severe medically 

determinable impairment(s) that does not 

meet a listing, we will consider whether your 

impairment(s) medically equals a listing. (See 

§§ 404.1526 and 416.926.) If your 

impairment(s) does not meet or medically 

equal a listing, you may or may not have the 

residual functional capacity to engage in 

substantial gainful activity. In that situation, 

we proceed to the fourth and, if necessary, 

the fifth step of the sequential evaluation 

process in §§ 404.1520 and 416.920. We use 

the rules in §§ 404.1594 and 416.994, as 

appropriate, when we decide whether you 

continue to be disabled. 

10.01 Category of Impairments, 

Impairments That Affect Multiple Body 

Systems 

10.06 Non-mosaic Down syndrome, 

established as described in 10.00B. 

* * * * * 

■ 6. The list of sections for part B is 

amended by revising the heading of 

section 110.00 to read as follows: 

Part B 

* * * * * 

Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 51261 

110.00 Impairments That Affect Multiple 

Body Systems 

* * * * * 

■ 7. Paragraph B2c(2) of the 

introductory text of section 101.00, 

Musculoskeletal System, of part B of 

appendix 1 of subpart P of part 404 is 

revised to read as follows: 

* * * * * 

B. * * * 

2. * * * 

* * * * * 

c. * * * 

* * * * * 

(2) How we assess inability to perform fine 

and gross movements in very young children. 

For very young children, we consider 

limitations in the ability to perform 

comparable age-appropriate activities 

involving the upper extremities compared to 

the ability of children the same age who do 

not have impairments. For such children, an 

extreme level of limitation means skills or 

performance at no greater than one-half of 

age-appropriate expectations based on an 

overall developmental assessment. 

■ 8. In listing 108.00, Skin Disorders, 

section 108.00E3 and the introductory 

text of listing 108.07 are revised to read 

as follows: 

* * * * * 

E. How Do We Evaluate Genetic 

Photosensitivity Disorders? 

* * * * * 

3. Clinical and laboratory findings. 

a. General. We need documentation from 

an acceptable medical source, as defined in 

§§ 404.1513(a) and 416.913(a), to establish 

that you have a medically determinable 

impairment. In general, we must have 

evidence of appropriate laboratory testing 

showing that you have XP or another genetic 

photosensitivity disorder. We will find that 

you have XP or another genetic 

photosensitivity disorder based on a report 

from an acceptable medical source indicating 

that you have the impairment, supported by 

definitive genetic laboratory studies 

documenting appropriate chromosomal 

changes, including abnormal DNA repair or 

another DNA or genetic abnormality specific 

to your type of photosensitivity disorder. 

b. What we will accept as medical evidence 

instead of the actual laboratory report. When 

we do not have the actual laboratory report, 

we need evidence from an acceptable 

medical source that includes appropriate 

clinical findings for your impairment and 

that is persuasive that a positive diagnosis 

has been confirmed by appropriate laboratory 

testing at some time prior to our evaluation. 

To be persuasive, the report must state that 

the appropriate definitive genetic laboratory 

study was conducted and that the results 

confirmed the diagnosis. The report must be 

consistent with other evidence in your case 

record. 

* * * * * 

108.01 Category of Impairments, Skin 

Disorders 

* * * * * 

108.07 Genetic photosensitivity disorders, 

established as described in 108.00E. 

* * * * * 

■ 9. Listing 110.00, Multiple Body 

Systems, of part B of appendix 1 of 

subpart P of part 404 is revised to read 

as follows: 

* * * * * 

110.00 Impairments That Affect Multiple 

Body Systems 

A. What Kinds of Impairments Do We 

Evaluate Under This Body System? 

1. General. We use these listings when you 

have a single impairment that affects two or 

more body systems. Under these listings, we 

evaluate impairments that affect multiple 

body systems due to non-mosaic Down 

syndrome or a catastrophic congenital 

abnormality or disease. These kinds of 

impairments generally produce long-term, if 

not lifelong, interference with ageappropriate activities. Some of them result in 

early death or interfere very seriously with 

development. We use the term ‘‘very 

seriously’’ in these listings to describe an 

‘‘extreme’’ limitation of functioning as 

defined in § 416.926a(e)(3). 

2. What is Down syndrome? Down 

syndrome is a condition in which there are 

three copies of chromosome 21 within the 

cells of the body instead of the normal two 

copies per cell. The three copies may be 

separate (trisomy), or one chromosome 21 

copy may be attached to a different 

chromosome (translocation). This extra 

chromosomal material changes the orderly 

development of the body and brain. Down 

syndrome is characterized by a complex of 

physical characteristics, delayed physical 

development, and mental retardation. Down 

syndrome exists in non-mosaic and mosaic 

forms. 

3. What is non-mosaic Down syndrome? 

a. Non-mosaic Down syndrome occurs 

when you have an extra copy of chromosome 

21 in every cell of your body. At least 98 

percent of people with Down syndrome have 

this form (which includes either trisomy or 

translocation type chromosomal 

abnormalities). Virtually all cases of nonmosaic Down syndrome affect the mental, 

neurological, and skeletal systems, and they 

are often accompanied by heart disease, 

impaired vision, hearing problems, and other 

conditions. 

b. We evaluate children with confirmed 

non-mosaic Down syndrome under 110.06. If 

you have confirmed non-mosaic Down 

syndrome, we consider you disabled from 

birth. 

4. What is mosaic Down syndrome? 

a. Mosaic Down syndrome occurs when 

you have some cells with the normal two 

copies of chromosome 21 and some cells 

with an extra copy of chromosome 21. When 

this occurs, there is a mixture of two types 

of cells. Mosaic Down syndrome occurs in 

only 1–2 percent of people with Down 

syndrome, and there is a wide range in the 

level of severity of the impairment. Mosaic 

Down syndrome can be profound and 

disabling, but it can also be so slight as to be 

undetected clinically. 

b. We evaluate children with confirmed 

mosaic Down syndrome under the listing 

criteria in any affected body system(s) on an 

individual case basis, as described in 

110.00C. 

5. What are catastrophic congenital 

abnormalities or diseases? 

a. Catastrophic congenital abnormalities or 

diseases are present at birth, although they 

may not be apparent immediately. They 

cause deviation from, or interruption of, the 

normal function of the body and are 

reasonably certain to result in early death or 

to interfere very seriously with development. 

b. We evaluate catastrophic congenital 

abnormalities or diseases under 110.08. 

B. What Documentation Do We Need To 

Establish That You Have an Impairment That 

Affects Multiple Body Systems? 

1. General. We need documentation from 

an acceptable medical source, as defined in 

§§ 404.1513(a) and 416.913(a), to establish 

that you have a medically determinable 

impairment. In general, the documentation 

should include a clinical description of the 

diagnostic physical features associated with 

your multiple body system impairment, and 

any appropriate laboratory tests. 

2. Non-mosaic Down syndrome (110.06). 

a. Definitive chromosomal analysis. We 

will find that you have non-mosaic Down 

syndrome based on a report from an 

acceptable medical source that indicates that 

you have the impairment and that includes 

the actual laboratory report of definitive 

chromosomal analysis showing that you have 

the impairment. Definitive chromosomal 

analysis for Down syndrome means 

karyotype analysis. When we have the 

laboratory report of the actual karyotype 

analysis, we do not additionally require a 

clinical description of the physical features 

of Down syndrome. 

b. What if you have Down syndrome and 

we do not have the results of definitive 

chromosomal analysis? When you have 

Down syndrome and we do not have the 

actual laboratory report of definitive 

chromosomal analysis, we need evidence 

from an acceptable medical source that 

includes a clinical description of the 

diagnostic physical features of your 

impairment, and that is persuasive that a 

positive diagnosis has been confirmed by 

definitive chromosomal analysis at some 

time prior to our evaluation. To be 

persuasive, the report must state that 

definitive chromosomal analysis was 

conducted and that the results confirmed the 

diagnosis. The report must be consistent with 

other evidence in your case record; for 

example, evidence showing your limitations 

in adaptive functioning or signs of a mental 

disorder that can be associated with nonmosaic Down syndrome, your educational 

history, or the results of psychological 

testing. 

3. Catastrophic congenital abnormalities or 

diseases (110.08). 

a. Genetic disorders. For genetic multiple 

body system impairments (other than nonmosaic Down syndrome), such as Trisomy 13 

(Patau Syndrome or Trisomy D), Trisomy 18 

(Edwards’ Syndrome or Trisomy E), 

chromosomal deletion syndromes (for 

51262 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Rules and Regulations 

example, deletion 5p syndrome, also called 

cri du chat syndrome), or inborn metabolic 

disorders (for example, Tay-Sachs disease), 

we need evidence from an acceptable 

medical source that includes a clinical 

description of the diagnostic physical 

features of your impairment, and the report 

of the definitive laboratory study (for 

example, genetic analysis or evidence of 

biochemical abnormalities) that is diagnostic 

of your impairment. When we do not have 

the actual laboratory report, we need 

evidence from an acceptable medical source 

that is persuasive that a positive diagnosis 

was confirmed by appropriate laboratory 

analysis at some time prior to our evaluation. 

To be persuasive, the report must state that 

the appropriate definitive laboratory study 

was conducted and that the results confirmed 

the diagnosis. The report must be consistent 

with other evidence in your case record. 

b. Other disorders. For infants born with 

other kinds of catastrophic congenital 

abnormalities (for example, anencephaly, 

cyclopia), we need evidence from an 

acceptable medical source that includes a 

clinical description of the diagnostic physical 

features of the impairment. 

C. How Do We Evaluate Impairments That 

Affect Multiple Body Systems and That Do 

Not Meet the Criteria of the Listings in This 

Body System? 

1. These listings are examples of 

impairments that commonly affect multiple 

body systems and that we consider 

significant enough to result in marked and 

severe functional limitations. If your severe 

impairment(s) does not meet the criteria of 

any of these listings, we must also consider 

whether your impairment(s) meets the 

criteria of a listing in another body system. 

2. There are many other impairments that 

can cause deviation from, or interruption of, 

the normal function of the body or interfere 

with development; for example, congenital 

anomalies, chromosomal disorders, 

dysmorphic syndromes, metabolic disorders, 

and perinatal infectious diseases. In these 

impairments, the degree of deviation or 

interruption may vary widely from child to 

child. Therefore, the resulting functional 

limitations and the progression of those 

limitations are more variable than with the 

catastrophic congenital abnormalities and 

diseases we include in these listings. For this 

reason, we evaluate the specific effects of 

these impairments on you under the listing 

criteria in any affected body system(s) on an 

individual case basis. Examples of such 

impairments include, but are not limited to, 

triple X syndrome (XXX syndrome), fragile X 

syndrome, phenylketonuria (PKU), caudal 

regression syndrome, and fetal alcohol 

syndrome. 

3. If you have a severe medically 

determinable impairment(s) that does not 

meet a listing, we will consider whether your 

impairment(s) medically equals a listing. If 

your impairment(s) does not meet or 

medically equal a listing, we will consider 

whether it functionally equals the listings. 

(See §§ 404.1526, 416.926, and 416.926a.) 

When we decide whether you continue to be 

disabled, we use the rules in § 416.994a. 

110.01 Category of Impairments, 

Impairments That Affect Multiple Body 

Systems 

110.06 Non-mosaic Down syndrome, 

established as described in 110.00B. 

110.08 A catastrophic congenital 

abnormality or disease, established as 

described in 110.00B, and: 

A. Death usually is expected within the 

first months of life, and the rare individuals 

who survive longer are profoundly impaired 

(for example, anencephaly, trisomy 13 or 18, 

cyclopia); 

or 

B. That interferes very seriously with 

development; for example, cri du chat 

syndrome (deletion 5p syndrome) or TaySachs disease (acute infantile form). 

* * * * * 

[FR Doc. 05–17114 Filed 8–29–05; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[CGD09–05–118] 

RIN 1625–AA00 

Safety Zone; Northerly Island, Chicago, 

IL 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

the Stormwater Conveyance System 

Construction Project located off of 

Northerly Island, Lake Michigan, 

Chicago, IL. The safety zone is necessary 

to protect vessels and persons from 

potential hazards during the initial 

tunneling phase of the project. This 

phase will involve extensive blasting 

operations. This safety zone is intended 

to restrict vessels from a portion of Lake 

Michigan in Chicago, IL. 

DATES: This rule is effective from 8 a.m. 

(local) on August 22, 2005 until 8 a.m. 

(local) on October 22, 2005. Captain of 

the Port Lake Michigan or the on scene 

Patrol Commander may terminate this 

event at anytime. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of the docket (CGD09–

05–118], and are available for inspection 

or copying at Commanding Officer, U.S. 

Coast Guard Marine Safety Unit 

Chicago, 215 W. 83rd Street Suite D, 

Burr Ridge, IL, 60527, between 8 a.m. 

and 3 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

LTJG Cameron Land, U.S. Coast Guard 

Marine Safety Unit Chicago, at (630) 

986–2155. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing an NPRM. This safety 

zone is temporary in nature and limited 

time existed for an NPRM. The Coast 

Guard was not made aware that this 

event was to take place with sufficient 

time to allow for publication of an 

NPRM followed by a final rule. Under 

5 U.S.C. 553(d)(3), the Coast Guard finds 

that good cause exists for making this 

rule effective less than 30 days after 

publication in the Federal Register. 

Delaying this rule would be 

impracticable and immediate action is 

necessary to ensure the safety of 

personnel and vessels during the 

operational period. During the 

enforcement of this safety zone, 

comments will be accepted and 

reviewed and may result in a 

modification to the rule. 

Background and Purpose 

A temporary safety zone is necessary 

to ensure the safety of vessels and 

persons from the hazards associated 

with a construction project on a 

navigable waterway. The Captain of the 

Port Lake Michigan has determined this 

project in close proximity to watercraft 

(Burnham Harbor) pose significant risks 

to public safety and property. Blasting 

operations in close proximity to the 

water could easily result in serious 

injuries or fatalities. Establishing a 

safety zone to control vessel movement 

around the location of the blasting site 

will help ensure the safety of persons 

and property and minimize the 

associated risks. Entry into, transiting, 

or anchoring within the safety zone is 

prohibited unless authorized by the 

Captain of the Port Lake Michigan or his 

designated On-Scene Representative via 

VHF radio Channel 16. 

Discussion of Rule 

The safety zone will encompass all 

waters of Lake Michigan bounded by the 

arc of a circle with a radius of 150-feet 

with its center at the shoreline of 

Northerly Island in the approximate 

position 41°51′12′′ N, 087°36′30′′ W. 

These coordinates are based upon North 

American Datum 1983 (NAD 1983). The 

size of this zone was determined using 

the safety guidelines and safety plan 

provided by the construction contractor 

and local knowledge concerning wind, 

waves, and currents. All commercial 

and recreational vessels must contact