19692 Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Rules and Regulations 

1The NPRM is available at http:// 

www.regulations.gov/search/Regs/ 

home.html#documentDetail?R=0900006480a6a145. 

2Sections 216(i), 223(d), and 1614(a)(3) of the 

Act. See also §§ 404.1509, 404.1520, 416.909, and 

416.920 of our regulations. 

3This means that we will use these final rules on 

and after their effective date in any case in which 

we make a determination or decision. We expect 

that Federal courts will review our final decisions 

using the rules that were in effect at the time we 

diesel or biodiesel in quantities between 

5 percent and 20 percent.’’ The script 

underneath the black band must be 

centered horizontally, with 1⁄8 inch (.32 

cm) between each line. The bottom line 

of type is 1⁄4 inch (.64 cm) from the 

bottom of the label. All type should fall 

no closer than 3/16 inch (.48 cm) from 

the side edges of the label. 

* * * * * 

(b) Type size and setting—(1) For 

gasoline labels. The Helvetica series or 

equivalent type is used for all numbers 

and letters with the exception of the 

octane rating number. Helvetica is 

available in a variety of phototype 

setting systems, by linotype, and in a 

variety of computer desk-top and 

phototype setting systems. Its name may 

vary, but the type must conform in style 

and thickness to the sample provided 

here. The line ‘‘Minimum Octane 

Rating’’ is set in 12 point Helvetica Bold, 

all capitals, with letterspace set at 121⁄2

points. The line ‘‘(R+M)/2 METHOD’’ is 

set in 10 point Helvetica Bold, all 

capitals, with letterspace set at 101⁄2

points. The octane number is set in 96 

point Franklin gothic condensed with 1⁄8

inch (.32 cm) space between the 

numbers. 

(2) For alternative liquid automotive 

fuel labels (one principal component). 

Except as provided above, labels should 

conform to the following specifications. 

All type should be set in upper case (all 

caps) ‘‘Helvetica Black’’ or equivalent 

type throughout. Helvetica Black is 

available in a variety of computer desktop and phototype setting systems. Its 

name may vary, but the type must 

conform in style and thickness to the 

sample provided here. The spacing 

between letters and words should be set 

as ‘‘normal.’’ The type for the fuel name 

is 50 point (1⁄2 inch (1.27 cm) cap 

height) ‘‘Helvetica Black,’’ knocked out 

of a 1 inch (2.54 cm) deep band. The 

type for the words ‘‘MINIMUM’’ and the 

principal component is 24 point (1⁄4

inch (.64 cm) cap height). The type for 

percentage is 36 point (3⁄8 inch (.96 cm) 

cap height). 

(3) For alternative liquid automotive 

fuel labels (two components). All type 

should be set in upper case (all caps) 

‘‘Helvetica Black’’ or equivalent type 

throughout. Helvetica Black is available 

in a variety of computer desk-top and 

phototype setting systems. Its name may 

vary, but the type must conform in style 

and thickness to the sample provided 

here. The spacing between letters and 

words should be set as ‘‘normal.’’ The 

type for the fuel name is 50 point (1⁄2

inch (1.27 cm) cap height) ‘‘Helvetica 

Black,’’ knocked out of a 1 inch (2.54 

cm) deep band. All other type is 24 

point (1⁄4 inch (.64 cm) cap height). 

* * * * * 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2011–8097 Filed 4–7–11; 8:45 am] 

BILLING CODE 6750–01–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Parts 404 and 416 

[Docket No. SSA–2006–0114] 

RIN 0960–AD78 

Revised Medical Criteria for Evaluating 

Endocrine Disorders 

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 under 

titles II and XVI of the Social Security 

Act (Act) involving endocrine disorders 

in adults and children. The revisions 

reflect our adjudicative experience, 

advances in medical knowledge, 

information from medical experts, and 

comments we received from the public 

in response to an advance notice of 

proposed rulemaking (ANPRM), a notice 

of proposed rulemaking (NPRM), and at 

an outreach policy conference. 

DATES: These rules are effective June 7, 

2011. 

FOR FURTHER INFORMATION CONTACT: Judy 

Hicks, Social Insurance Specialist, 

Office of Medical Listings Improvement, 

Social Security Administration, 6401 

Security Boulevard, Baltimore, 

Maryland 21235–6401, (410) 965–1020. 

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: 

Background 

We are making final the rules for 

evaluating endocrine disorders that we 

proposed in an NPRM we published in 

the Federal Register on December 14, 

2009 (74 FR 66069). The preamble to the 

NPRM discussed the changes from the 

current rules and our reasons for 

proposing those changes. To the extent 

that we are adopting the proposed rules 

as published, we are not repeating that 

information here. Interested readers may 

refer to the preamble to the NPRM.1

What are the listings and how do we 

use them? 

Listings describe medical conditions 

that are so severe that we presume any 

person who has a medical condition(s) 

that satisfies the criteria of a listing is 

unable to perform any gainful activity 

and, therefore, is disabled. The inability 

to work must also have lasted or be 

expected to last for at least 12 

continuous months or be expected to 

result in death; we call this provision 

‘‘the duration requirement.’’ 2 Thus, the 

listings are special rules that provide us 

with a mechanism to identify claims 

that should clearly be allowed. We use 

listings only to allow claims. We do not 

deny any claim solely because a 

person’s medical condition(s) does not 

satisfy a listing. 

Why are we revising the listings for 

endocrine disorders? 

We are revising the listings for 

endocrine disorders because medical 

science has made significant advances 

in detecting endocrine disorders at 

earlier stages and newer treatments have 

resulted in better management of these 

conditions since we last published final 

rules making comprehensive revisions 

to the endocrine listings in 1985. 

Consequently, most endocrine disorders 

do not reach listing-level severity 

because they do not become sufficiently 

severe or do not remain at a sufficient 

level of severity long enough to meet 

our 12-month duration requirement. 

Therefore, we have determined that, 

with the exception of children under 

age 6 who have diabetes mellitus (DM) 

and require daily insulin, we should no 

longer have listings in sections 9.00 and 

109.00 based on endocrine disorders 

alone. 

When will we use these final rules? 

We will use these final rules 

beginning on their effective date. We 

will continue to use the current listings 

until the date these final rules become 

effective. We will apply the final rules 

to new applications filed on or after the 

effective date of the final rules and to 

claims that are pending on and after the 

effective date.3


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Rules and Regulations 19693 

issued the decisions. If a court reverses our final 

decision and remands a case for further 

administrative proceedings after the effective date 

of these final rules, we will apply these final rules 

to the entire period at issue in the decision we make 

after the court’s remand. 

4The definition of disability is different for 

children who claim disability benefits under title 

XVI, but the sequential evaluation process for 

children also includes a step at which we consider 

the particular functional effects of the child’s 

medical condition(s), called ‘‘functional 

equivalence.’’ Act, section 1614(a)(3)(C); §§ 416.906, 

416.924, and 416.926a. 

Public Comments on the NPRM 

In the NPRM, we provided the public 

a 60-day comment period, which ended 

on February 12, 2010. We received 16 

public comment letters. The comments 

came from national medical 

organizations, advocacy groups, a 

national group of Social Security 

claimants’ representatives, individual 

State agencies, a Congressman, and 

members of the public. 

We provide below summaries of the 

significant comments that were relevant 

to this rulemaking and our responses to 

those comments. We did not summarize 

or respond to some of the comments we 

received. Some commenters supported 

the proposed changes and noted 

provisions with which they agreed. We 

appreciate those comments, but they do 

not require a response. Some 

commenters also sent us comments on 

subjects that were unrelated to the 

proposed rules. These comments were 

outside the scope of the proposed 

rulemaking, and we have not responded 

to them. 

Comment: Several commenters asked 

us to continue to recognize DM as a 

disability and not to increase the burden 

on claimants to prove disability on the 

basis of DM. Another commenter, 

representing several physicians in a 

group practice, disagreed with ‘‘changes 

deleting diabetes.’’ That commenter said 

that a significant proportion of their 

patients have blindness, renal failure, 

vascular disease, and multiple 

amputations. 

Response: We will continue to 

recognize DM as a potential cause of 

disability, but we are removing the prior 

listings because they no longer 

accurately identify persons who are 

disabled. Contrary to what some of the 

commenters seemed to think, we will 

still consider DM to be a medically 

determinable impairment that can result 

in disability, and we will continue to 

consider its effects under our listings. 

For example, we have listings in other 

body systems for blindness, renal 

failure, vascular disease, and 

amputations. We are removing only the 

specific DM listings. 

When adults’ medical conditions do 

not satisfy a listing, we must assess the 

particular functional effects of their 

impairments; that is, we must determine 

their ‘‘residual functional capacity’’ 

(RFC). Considering the RFC, we then 

determine whether they can do any past 

relevant work, or if they cannot, any 

other work that exists in the national 

economy, considering their RFC, age, 

education, and previous work 

experience.4 Most persons with DM 

who qualified for disability benefits 

under the prior rules did so based on 

their RFC, not under the listings we are 

removing. Also, many persons with DM 

have other medical conditions that meet 

listings in other body systems due to 

complications of DM. 

When a person qualifies for disability 

benefits under a listing, we continue to 

use that same listing when we later 

determine if he or she is still disabled. 

See §§ 404.1594(c)(3)(i), 

416.994(b)(2)(iv), and 416.994a(b)(2). 

This rule applies even if we have 

removed or changed the listing since we 

last found that the beneficiary was 

disabled. For this reason, we will not 

find that a beneficiary’s disability has 

ended solely because we have removed 

the DM listings or any other endocrine 

disorder listing. Unless we are 

otherwise required to do so (for 

example, by statute), we do not 

readjudicate cases because we have 

revised our listings. 

Comment: Several commenters said 

that not all persons can control their DM 

all of the time and that treatment of any 

sort is often inadequate. One of these 

commenters stated that our proposal to 

eliminate all listings for DM did not 

consider the small subset of persons 

with DM who will continue to 

experience severe fluctuations in blood 

glucose levels despite their best efforts 

at treatment. This commenter 

recommended that we have listings that 

consider severe fluctuations in blood 

glucose levels and the accompanying 

health problems that limit a person’s 

ability to work. One commenter said 

that DM can never be controlled 

completely; another commenter thought 

that the proposed rules implied that DM 

was curable. 

Some commenters thought that we 

assumed that all claimants had full 

access to state-of-the-art healthcare. 

Some mentioned serious outcomes of 

long-term, chronic fluctuations in blood 

glucose on other body systems. Some 

also mentioned that some persons with 

fluctuations in blood glucose experience 

symptoms and signs that are not 

covered by listings in other body 

systems. One commenter was concerned 

that our proposal to remove the DM 

listings might imply to our adjudicators 

that we want them to deny more cases 

involving DM. Another commenter 

believed that the proposed rules implied 

that persons with uncontrolled DM 

must be noncompliant with treatment. 

This commenter recommended that we 

include substantial guidance on the 

complexity of managing and controlling 

DM and guidance about how DM can 

intrude on the ability to work. 

Response: We did not mean to give 

the impression in the NPRM that there 

are no persons with uncontrolled DM or 

that all persons have access to 

healthcare or the best possible 

treatment. We acknowledge that some 

persons do have difficulty controlling 

their blood glucose and that some of 

them will be disabled. We also agree 

with the commenters that there are valid 

reasons for some persons’ blood glucose 

levels to fluctuate, including 

hypoglycemia unawareness, mental 

impairments that interfere with their 

ability to adequately monitor and treat 

their conditions, and inadequate 

treatment. For those reasons, we include 

guidance about problems associated 

with fluctuating blood glucose levels 

and their effects, including diabetic 

ketoacidosis (DKA) and hypoglycemia. 

This guidance is in 9.00B5 for adults 

and 109.00B5 for children. 

We are not including a listing for 

fluctuating blood glucose levels and the 

medical problems it causes because the 

reasons are highly variable, and we 

cannot provide criteria that would 

reliably identify persons with listinglevel impairments based on fluctuating 

blood glucose levels. In order to 

determine whether persons with 

fluctuating blood glucose levels are 

disabled, we must assess an adult’s RFC 

or consider functional equivalence for a 

child. In making these findings, we 

consider the symptoms and signs of DM 

that the commenters named. We also 

have listings in other body systems for 

several of the serious effects of 

uncontrolled DM cited in the comment 

letters. For example, we evaluate 

diabetic nephropathy under our 

genitourinary listings (6.00 and 106.00), 

and peripheral neuropathies under our 

listings for neurological disorders (11.00 

and 111.00). 

Nevertheless, in response to these and 

other comments, we have added more 

guidance in final 9.00B5 and 109.00B5 

explaining that DM is chronic and that 

some persons with type 1 and type 2 

DM do not achieve good control of their 

disorder for a variety of valid reasons. 

We also indicate that both type 1 and 

type 2 DM can have serious, disabling 

complications that meet the duration 


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5See 74 FR at 66069. 

6 74 FR at 66072. 

7 70 FR at 46792. 

8 Ibid. at 46794. 9 74 FR 66070. 

requirement. This guidance will apply 

not only to DKA but also to other 

problems associated with uncontrolled 

and fluctuating blood glucose levels. We 

did not agree, however, that we should 

include guidance on the complexity of 

managing and controlling DM and 

guidance about how DM can intrude on 

the ability to work, which the last 

commenter recommended. We do not 

believe the recommended guidance is 

appropriate in the context of the 

listings. The commenter recognized that 

some of the concerns were more 

appropriate to discussions of RFC and 

other issues associated with later steps 

of the sequential evaluation process. 

We also indicated in the NPRM that 

we would publish a Social Security 

Ruling (SSR) with more detailed 

information about specific endocrine 

disorders, including DM, the types of 

impairments and limitations that result 

from these disorders, and how we 

determine whether persons who have 

DM and other endocrine disorders are 

disabled.5 The SSR will address some of 

the symptoms and signs of DM that are 

not covered by listings in other body 

systems. 

Comment: One commenter said that 

we did not present crucial information 

and data needed to support our proposal 

to remove the DM listing and, therefore, 

we should withdraw the proposal. 

Another commenter thought that the 

references we provided to support our 

proposal to remove the DM listings 

showed an absence of balance. This 

commenter stated that there is a 

substantial body of opinion that 

supports the existence of labile or brittle 

diabetes. To support this opinion, this 

commenter cited as examples two 2007 

articles that discuss ‘‘brittle’’ diabetes. 

Response: We disagree with both 

commenters. We believe that we 

provided substantial information to 

support the proposals and that the 

proposals were correct. In the NPRM, 

we explained that we used information 

from a variety of sources, including: 

• Medical experts in the field of 

endocrinology, experts in other related 

fields, advocacy groups for persons with 

DM, and persons with endocrine 

disorders and their families; 

• Persons who make disability 

determinations and decisions for us in 

State agencies and in our Office of 

Disability Adjudication and Review; 

and 

• The published sources we listed in 

the section of references at the end of 

the preamble. We listed 13 references in 

the NPRM, most of which were 

specifically about DM. We provided 

Internet links for as many of the 

references as possible and informed the 

public that we would make all of the 

references available to anyone who was 

interested in seeing them.6

We also explained that we received 

information from public comments that 

responded to an ANPRM that we 

published in the Federal Register on 

August 11, 2005.7 In the ANPRM, we 

announced our plans to update and 

revise the listings for the endocrine 

body system, we invited interested 

persons and organizations to send us 

written comments and suggestions, and 

we specifically cited our listings for DM. 

We also included citations to references 

we were considering at that time.8 In the 

NPRM, we provided an Internet link 

where interested members of the public 

could read all of the comments we 

received in response to the ANPRM. We 

also explained that we received 

comments and expert input at an 

outreach policy conference we hosted in 

Atlanta, GA. We provided an Internet 

link to the transcript of that conference 

that interested members of the public 

could use to read the opinions we 

received from medical professionals, 

advocates, persons with endocrine 

disorders and their families, and our 

adjudicators who spoke at the 

conference. 

We appreciated the opportunity to 

consider the articles the second 

commenter cited, but the 

endocrinologists, diabetologists, and 

other medical experts we consulted and 

our review of medical literature did not 

support the view that there is ‘‘brittle’’ 

DM. We believe that the sources we 

cited in the NPRM, together with the 

wide variety of other information we 

also described, represent the prevailing 

opinion of experts in the medical 

community and provide a balance of 

opinions. 

Comment: Three commenters thought 

that we should keep listing 9.08B for 

evaluating recurrent DKA in adults. 

These commenters noted that persons 

who have repeated episodes of DKA 

may develop other problems. One of 

these commenters said that we should 

keep all of prior listing 9.08. 

Response: We did not adopt the 

comments. We recognize the serious 

effects of DKA in sections 9.00B5a(i) 

and 109.00B5b. We explain in these 

final rules that DKA is a potentially lifethreatening condition resulting from a 

severe insulin deficiency and that it 

causes the chemical balance of the body 

to become dangerously hyperglycemic 

and acidic, which usually requires 

hospital treatment. 

As we explained in the NPRM and in 

our response to the comments above, 

the criteria in prior listing 9.08B 

reflected the earlier view that persons 

with wide fluctuations in their blood 

glucose levels had uncontrollable DM. 

According to the medical experts and 

relevant references we consulted, 

however, the listing reflected only 

inadequate glucose regulation. Prior 

listing 9.08B, therefore, included 

conditions that would not be disabling. 

With respect to keeping all of listing 

9.08, we explained in the NPRM that 

prior listings 9.08A and C were 

redundant because we have other 

listings that address the effects they 

cover.9 We will evaluate the 

impairments of persons who have 

difficulty regulating their blood glucose 

levels for valid reasons on an 

individualized basis. 

Comment: Three commenters 

suggested that we add a listing for 

persons who experience frequent 

episodes of severe hypoglycemia. They 

pointed out that each episode of 

hypoglycemia interferes with the ability 

to work while the person is 

experiencing the episode and that 

frequent severe episodes can effectively 

make a person unable to sustain work, 

especially since the episodes are 

unpredictable and would affect regular 

work attendance. Two commenters 

noted that some persons have 

‘‘hypoglycemia unawareness’’; that is, 

they lose all or most of their ability to 

detect early warning signs of oncoming 

hypoglycemia and consequently do not 

take steps to treat the episode when it 

is still early and mild. One commenter 

suggested listing criteria for 

hypoglycemia based on an average 

number of documented episodes per 

month despite best efforts to comply 

with treatment. 

Response: We did not adopt the 

comments recommending that we add a 

listing for severe hypoglycemia, but we 

did add a reference to hypoglycemia 

unawareness in final 9.00B5b and 

109.00B5c. As with DKA, we must make 

individualized determinations about 

disability for persons who experience 

frequent episodes. Moreover, as the 

commenters recognized, even severe 

hypoglycemia episodes can usually be 

treated readily, and most persons who 

experience hypoglycemia episodes are 

able to adequately recognize and treat 

their symptoms. We consider the effects 

that frequent episodes of hypoglycemia 

may have on functioning at each step of 

the sequential evaluation process, 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
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10 74 FR at 66071. 

including the steps regarding the ability 

to do past relevant work or other work. 

A listing based on an average of 

documented episodes would include 

some conditions that are not disabling, 

and accordingly, we did not adopt the 

suggestion. 

Comment: Two commenters requested 

that we include a listing for diabetic 

neuropathy. One of these commenters 

noted that sympathetic neuropathy, a 

type of diabetic neuropathy, is difficult 

to evaluate and asked that we not 

eliminate all listing provisions for 

evaluating this disorder. The other 

commenter believed that a reference to 

the neurological body system was not 

enough and that the criteria in listing 

11.04B were too vague for evaluating 

diabetic neuropathy. This commenter 

was also concerned that some of our 

adjudicators might not understand that 

neuropathy caused by DM is different 

from other types of neuropathy and that 

it does not have to result in amputation 

to be disabling. The commenter 

suggested that we should have a listing 

for diabetic neuropathy that addresses 

peripheral, autonomic, proximal, and 

focal neuropathies. In support of their 

comments, both commenters referred to 

remarks made by a speaker at the 

outreach policy conference in Atlanta. 

One commenter who cited the speaker’s 

remarks said that evaluating a ‘‘diabetic 

gut’’ is a very specialized and difficult 

procedure. The other commenter cited 

the speaker’s statement that a person 

who has not had an amputation can still 

be disabled by peripheral neuropathy. 

This commenter believed that some 

adjudicators and medical experts 

consider only amputations. 

Response: The DM listings we are 

removing did not include a provision 

for sympathetic neuropathy, so these 

final rules do not remove any existing 

provisions about that medical problem. 

We also do not agree that the speaker’s 

comments at the Atlanta outreach 

meeting support the suggestion that we 

add a DM listing for neuropathy. We 

reviewed the remarks to which the first 

commenter referred, and we believe that 

the doctor was referring to what he 

perceived as shortcomings in how we 

consider neuropathies, including nondiabetic neuropathies, in our 

neurological body system in 11.00 and 

111.00 of our listings. We will consider 

those remarks when we revise the 

neurological listings. Moreover, the 

doctor’s remarks discussed the 

variability of the effects of neuropathy 

on different persons who work at 

different types of jobs, and we believe 

that his remarks support our current 

policy of considering those effects on a 

case-by-case basis. 

We also do not agree that adjudicators 

and medical experts think that 

claimants with diabetic neuropathy 

must have an amputation before we find 

them disabled. To the contrary, prior 

listing 9.08A cross-referred to listing 

11.04B, which does not contain a 

criterion for amputation. Rather, that 

listing requires significant and 

persistent disorganization of motor 

function in two extremities, so it clearly 

includes persons who have not had 

amputations. We also provide in 11.00C 

that persistent disorganization of motor 

function may manifest as paresis, 

sensory disturbances, or other causes. 

These final rules do not affect the 

neurological body system, so current 

11.00C and listing 11.04B will still be 

applicable to persons with diabetic 

neuropathy. 

Finally, as one commenter noted, 

diabetic neuropathy can affect different 

parts of the body. We provide general 

guidance in final 9.00B for evaluating 

impairments that result from endocrine 

disorders under the listings for other 

body systems. We provide examples in 

9.00B5a(ii) regarding evaluation of 

diabetic peripheral neurovascular 

disease that results in amputation under 

1.00, diabetic gastroparesis that results 

in abnormal gastrointestinal motility 

under 5.00, and diabetic peripheral and 

sensory neuropathies under 11.00. This 

guidance indicates that we are not 

limited to any specific body system or 

listing in evaluating the complications 

of DM. We will also address diabetic 

neuropathies in the SSR we are 

preparing. 

Comment: Four commenters approved 

of proposed listing 109.08 for children 

who have not attained age 6 and who 

need daily insulin, but asked us to raise 

the age limit in the listing. Two of these 

commenters stated that the age limit in 

the proposed listing was too restrictive 

and excluded many children who 

clearly require constant adult 

supervision. One of these commenters 

noted that the developmental abilities of 

children vary greatly and that a child 

who has attained age 6 may well have 

the same medical need for adult help as 

younger children. Another commenter 

suggested that we change the rule to age 

9 because this is the age at which 

children generally begin to become able 

to take a significant role in their own 

care. This commenter believed that DM 

in all children below age 9 will meet the 

functional equivalence example 

requiring 24-hour-a-day supervision for 

medical reasons, which we cited as one 

justification for the proposed new 

listing. 20 CFR 416.926a(m)(5). Another 

commenter recommended that we apply 

the proposed listing to all children 

under age 18 who have DM and require 

daily insulin. The commenter asserted 

that many children age 6 and older lack 

the cognition to manage their daily 

insulin regimen without the significant 

involvement of an adult, and many 

families cannot afford the before- and 

after-school adult care that a child with 

DM may require. Another commenter 

noted that all children need a certain 

amount of adult supervision in 

managing DM, especially when they are 

ill. 

Response: Although we did not adopt 

the comments suggesting that we raise 

the age limit in listing 109.08, we did 

add further guidance to the rule to 

ensure that adjudicators appropriately 

consider the effects of DM in children 

age 6 and older. We agree with the 

commenters that children of any age 

require some level of adult supervision 

or support in caring for their DM. As we 

explained above, however, we must set 

listings at a level at which we can 

presume disability in all persons whose 

impairments meet the listing criteria. 

For the reasons we stated in the NPRM, 

we determined that the attainment of 

age 6 is the highest age at which we 

could have such a rule.10

We recognize that not all children age 

6 and older are capable of managing 

their own DM. In these children, 

however, the mere need for adult 

supervision does not establish 

disability; we need to determine the 

nature, frequency, and extent of the 

supervision they need along with any 

other relevant factors. Final listing 

109.08 presumes that children under 

age 6 cannot participate in their own 

care at the most basic level and are at 

risk of dying unless they have 24-houra-day adult supervision. Many children 

age 6 and older with DM that requires 

daily insulin participate in their own 

care at least at the basic level of alerting 

adults when they begin to experience 

hypoglycemia symptoms, and they often 

participate at higher levels. 

We agree, however, with the 

commenters that there are some 

children, including some adolescents, 

who have a medical need for 24-houra-day supervision; we must evaluate 

their DM on a more individualized 

basis. We stated in the NPRM that we 

would find such children disabled 

based on the example of functional 

equivalence in § 416.926a(m)(5). We 

also said that we expected there would 

be other children who do not need this 

level of help but who would 

nevertheless have impairments that 

functionally equal the listings for other 


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11 Ibid. 

12See for example, ‘‘Revised Medical Criteria for 

Evaluating Hearing Loss,’’ 75 FR 30693 (June 2, 

2010). 

reasons.11 We therefore included 

guidance in proposed (now final) 

section 109.00C explaining that it is 

possible for a child age 6 or older to 

have the same limitations that we 

presume for all children under age 6; for 

the same reason we referred to our rules 

for evaluating disability in children in 

§§ 416.924a and 416.926a. We 

nevertheless believe that our statement 

in the NPRM was correct; as children 

mature, they should be able to 

increasingly take part in their self-care 

activities related to managing their DM. 

As a consequence, we do not agree that 

the DM of all children between the ages 

of 6 and 18 will meet the functional 

equivalence example in 

§ 416.926a(m)(5) or that they will all be 

disabled for any other reason. Finally, 

with respect to the comment that many 

families cannot afford the before- and 

after-school adult care that a child with 

DM may require, the Act requires us to 

consider only the medical effects of the 

child’s impairment; we cannot consider 

a family’s ability to afford care for their 

children. 

Comment: One commenter asked us 

to acknowledge in the final rule the 

seriousness and difficulty of managing 

DM in children. Another commenter 

stated that many children experience 

significant day-to-day variability in their 

condition, which necessitates daily and 

often hourly decisionmaking and 

intervention either by an adult or under 

the close supervision of an adult. 

Response: We added language in 

109.00B5 and C to clarify these issues. 

We will also address them in more 

detail in the SSR that we will publish 

after these rules become effective. 

Other Comments 

Comment: One commenter suggested 

that we retain listings for complex 

endocrine disorders, such as diabetes 

insipidus (DI). 

Response: While it was not clear to us 

what the commenter meant by ‘‘complex 

endocrine disorders,’’ we did not adopt 

the suggestion to retain a listing for DI. 

Generally, medication will control the 

symptoms and signs of DI so they do not 

reach listing-level severity or remain at 

a sufficient level of severity long enough 

to meet our 12-month duration 

requirement. When DI is not controlled 

and problems ensue, we evaluate the 

effects in other body systems or on 

functioning. 

Other Changes 

We stated in the NPRM that, if we 

published the proposed rules as final 

rules, the rules would remain in effect 

for 8 years after the date they become 

effective, unless we extend them or 

revise and reissue them. In these final 

rules, we are revising the 8-year sunset 

date to 5 years to conform to the 

timeframes we provide in most of our 

recent listings revisions.12 We will 

monitor these rules and update them 

sooner if necessary. 

We are also making minor editorial 

changes to correct unintentional 

inconsistencies between 9.00 and 

109.00. 

What is our authority to make rules 

and set procedures for determining 

whether a person is disabled under our 

statutory definition? 

Under the Act, we have full power 

and authority to make rules and 

regulations and to establish necessary or 

appropriate procedures to carry out 

such provisions. Sections 205(a), 

702(a)(5), and 1631(d)(1). 

Regulatory Procedures 

Executive Order 12866 as supplemented 

by Executive Order 13563 

We have consulted with the Office of 

Management and Budget (OMB) and 

determined that these final rules meet 

the requirements for a significant 

regulatory action under Executive Order 

12866 as supplemented by Executive 

Order 13563 and were subject to OMB 

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. 

Therefore, a regulatory flexibility 

analysis was not required under the 

Regulatory Flexibility Act, as amended. 

Paperwork Reduction Act 

These rules do not create any new or 

affect any existing collections and, 

therefore, do not require Office of 

Management and Budget approval 

under the Paperwork Reduction Act. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social SecurityDisability Insurance; 96.002, Social SecurityRetirement Insurance; 96.004, Social 

Security-Survivors Insurance; and 96.006, 

Supplemental Security Income) 

List of Subjects 

20 CFR Part 404 

Administrative practice and 

procedure; Blind, Disability benefits; 

Old-Age, Survivors, and Disability 

Insurance; Reporting and recordkeeping 

requirements; Social Security. 

20 CFR Part 416 

Administrative practice and 

procedure; Blind; Disability benefits; 

Old Age, Public assistance programs; 

Reporting and recordkeeping 

requirements; Supplemental Security 

Income (SSI). 

Michael J. Astrue, 

Commissioner of Social Security. 

For the reasons set out in the 

preamble, we are amending 20 CFR part 

404 subpart P and part 416 subpart I as 

set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950–) 

■ 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), (i), and (j), 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), (i), and (j), 422(c), 423, 425, and 

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

Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. Amend 404.1525 by revising 

paragraph (c)(1) and the first sentence of 

paragraph (c)(3) to read as follows: 

§ 404.1525 Listing of Impairments in 

appendix 1. 

* * * * * 

(c) How do we use the listings? (1) 

Most body system sections in parts A 

and B of appendix 1 are in two parts: 

an introduction, followed by the 

specific listings. 

* * * * * 

(3) In most cases, the specific listings 

follow the introduction in each body 

system, after the heading, Category of 

Impairments. * * * 

* * * * * 

■ 3. Amend appendix 1 to subpart P of 

part 404 by: 

■ a. Revising item 10 of the introductory 

text before part A; 

■ b. Revising the table of contents entry 

for section 9.00 and section 9.00 in part 

A; 

■ c. Removing sections 9.01 through 

9.08 from part A; and 

■ d. Revising the table of contents entry 

for section 109.00 and section 109.00 in 

part B. 

The revisions read as follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

10. Endocrine Disorders (9.00 and 109.00): 

June 7, 2016. 

* * * * * 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Rules and Regulations 19697 

Part A 

* * * * * 

9.00 Endocrine Disorders 

A. What is an endocrine disorder? 

An endocrine disorder is a medical 

condition that causes a hormonal imbalance. 

When an endocrine gland functions 

abnormally, producing either too much of a 

specific hormone (hyperfunction) or too little 

(hypofunction), the hormonal imbalance can 

cause various complications in the body. The 

major glands of the endocrine system are the 

pituitary, thyroid, parathyroid, adrenal, and 

pancreas. 

B. How do we evaluate the effects of 

endocrine disorders? We evaluate 

impairments that result from endocrine 

disorders under the listings for other body 

systems. For example: 

1. Pituitary gland disorders can disrupt 

hormone production and normal functioning 

in other endocrine glands and in many body 

systems. The effects of pituitary gland 

disorders vary depending on which 

hormones are involved. For example, when 

pituitary hypofunction affects water and 

electrolyte balance in the kidney and leads to 

diabetes insipidus, we evaluate the effects of 

recurrent dehydration under 6.00. 

2. Thyroid gland disorders affect the 

sympathetic nervous system and normal 

metabolism. We evaluate thyroid-related 

changes in blood pressure and heart rate that 

cause arrhythmias or other cardiac 

dysfunction under 4.00; thyroid-related 

weight loss under 5.00; hypertensive 

cerebrovascular accidents (strokes) under 

11.00; and cognitive limitations, mood 

disorders, and anxiety under 12.00. 

3. Parathyroid gland disorders affect 

calcium levels in bone, blood, nerves, 

muscle, and other body tissues. We evaluate 

parathyroid-related osteoporosis and 

fractures under 1.00; abnormally elevated 

calcium levels in the blood (hypercalcemia) 

that lead to cataracts under 2.00; kidney 

failure under 6.00; and recurrent abnormally 

low blood calcium levels (hypocalcemia) that 

lead to increased excitability of nerves and 

muscles, such as tetany and muscle spasms, 

under 11.00. 

4. Adrenal gland disorders affect bone 

calcium levels, blood pressure, metabolism, 

and mental status. We evaluate adrenalrelated osteoporosis with fractures that 

compromises the ability to walk or to use the 

upper extremities under 1.00; adrenal-related 

hypertension that worsens heart failure or 

causes recurrent arrhythmias under 4.00; 

adrenal-related weight loss under 5.00; and 

mood disorders under 12.00. 

5. Diabetes mellitus and other pancreatic 

gland disorders disrupt the production of 

several hormones, including insulin, that 

regulate metabolism and digestion. Insulin is 

essential to the absorption of glucose from 

the bloodstream into body cells for 

conversion into cellular energy. The most 

common pancreatic gland disorder is 

diabetes mellitus (DM). There are two major 

types of DM: type 1 and type 2. Both type 

1 and type 2 DM are chronic disorders that 

can have serious disabling complications that 

meet the duration requirement. Type 1 DM— 

previously known as ‘‘juvenile diabetes’’ or 

‘‘insulin-dependent diabetes mellitus’’ 

(IDDM)—is an absolute deficiency of insulin 

production that commonly begins in 

childhood and continues throughout 

adulthood. Treatment of type 1 DM always 

requires lifelong daily insulin. With type 2 

DM—previously known as ‘‘adult-onset 

diabetes mellitus’’ or ‘‘non-insulin-dependent 

diabetes mellitus’’ (NIDDM)—the body’s cells 

resist the effects of insulin, impairing glucose 

absorption and metabolism. Treatment of 

type 2 DM generally requires lifestyle 

changes, such as increased exercise and 

dietary modification, and sometimes insulin 

in addition to other medications. While both 

type 1 and type 2 DM are usually controlled, 

some persons do not achieve good control for 

a variety of reasons including, but not limited 

to, hypoglycemia unawareness, other 

disorders that can affect blood glucose levels, 

inability to manage DM due to a mental 

disorder, or inadequate treatment. 

a. Hyperglycemia. Both types of DM cause 

hyperglycemia, which is an abnormally high 

level of blood glucose that may produce 

acute and long-term complications. Acute 

complications of hyperglycemia include 

diabetic ketoacidosis. Long-term 

complications of chronic hyperglycemia 

include many conditions affecting various 

body systems. 

(i) Diabetic ketoacidosis (DKA). DKA is an 

acute, potentially life-threatening 

complication of DM in which the chemical 

balance of the body becomes dangerously 

hyperglycemic and acidic. It results from a 

severe insulin deficiency, which can occur 

due to missed or inadequate daily insulin 

therapy or in association with an acute 

illness. It usually requires hospital treatment 

to correct the acute complications of 

dehydration, electrolyte imbalance, and 

insulin deficiency. You may have serious 

complications resulting from your treatment, 

which we evaluate under the affected body 

system. For example, we evaluate cardiac 

arrhythmias under 4.00, intestinal necrosis 

under 5.00, and cerebral edema and seizures 

under 11.00. Recurrent episodes of DKA may 

result from mood or eating disorders, which 

we evaluate under 12.00. 

(ii) Chronic hyperglycemia. Chronic 

hyperglycemia, which is longstanding 

abnormally high levels of blood glucose, 

leads to long-term diabetic complications by 

disrupting nerve and blood vessel 

functioning. This disruption can have many 

different effects in other body systems. For 

example, we evaluate diabetic peripheral 

neurovascular disease that leads to gangrene 

and subsequent amputation of an extremity 

under 1.00; diabetic retinopathy under 2.00; 

coronary artery disease and peripheral 

vascular disease under 4.00; diabetic 

gastroparesis that results in abnormal 

gastrointestinal motility under 5.00; diabetic 

nephropathy under 6.00; poorly healing 

bacterial and fungal skin infections under 

8.00; diabetic peripheral and sensory 

neuropathies under 11.00; and cognitive 

impairments, depression, and anxiety under 

12.00. 

b. Hypoglycemia. Persons with DM may 

experience episodes of hypoglycemia, which 

is an abnormally low level of blood glucose. 

Most adults recognize the symptoms of 

hypoglycemia and reverse them by 

consuming substances containing glucose; 

however, some do not take this step because 

of hypoglycemia unawareness. Severe 

hypoglycemia can lead to complications, 

including seizures or loss of consciousness, 

which we evaluate under 11.00, or altered 

mental status and cognitive deficits, which 

we evaluate under 12.00. 

C. How do we evaluate endocrine disorders 

that do not have effects that meet or 

medically equal the criteria of any listing in 

other body systems? If your impairment(s) 

does not meet or medically equal a listing in 

another body system, you may or may not 

have the residual functional capacity to 

engage in substantial gainful activity. In this 

situation, we proceed to the fourth and, if 

necessary, the fifth steps of the sequential 

evaluation process in §§ 404.1520 and 

416.920. When we decide whether you 

continue to be disabled, we use the rules in 

§§ 404.1594, 416.994, and 416.994a. 

* * * * * 

Part B 

* * * * * 

109.00 Endocrine Disorders 

A. What is an endocrine disorder? 

An endocrine disorder is a medical 

condition that causes a hormonal imbalance. 

When an endocrine gland functions 

abnormally, producing either too much of a 

specific hormone (hyperfunction) or too little 

(hypofunction), the hormonal imbalance can 

cause various complications in the body. The 

major glands of the endocrine system are the 

pituitary, thyroid, parathyroid, adrenal, and 

pancreas. 

B. How do we evaluate the effects of 

endocrine disorders? The only listing in this 

body system addresses children from birth to 

the attainment of age 6 who have diabetes 

mellitus (DM) and require daily insulin. We 

evaluate other impairments that result from 

endocrine disorders under the listings for 

other body systems. For example: 

1. Pituitary gland disorders can disrupt 

hormone production and normal functioning 

in other endocrine glands and in many body 

systems. The effects of pituitary gland 

disorders vary depending on which 

hormones are involved. For example, when 

pituitary growth hormone deficiency in 

growing children limits bone maturation and 

results in pathological short stature, we 

evaluate this linear growth impairment under 

100.00. When pituitary hypofunction affects 

water and electrolyte balance in the kidney 

and leads to diabetes insipidus, we evaluate 

the effects of recurrent dehydration under 

106.00. 

2. Thyroid gland disorders affect the 

sympathetic nervous system and normal 

metabolism. We evaluate thyroid-related 

changes in linear growth under 100.00; 

thyroid-related changes in blood pressure 

and heart rate that cause cardiac arrhythmias 

or other cardiac dysfunction under 104.00; 

thyroid-related weight loss under 105.00; and 

cognitive limitations, mood disorders, and 

anxiety under 112.00. 

3. Parathyroid gland disorders affect 

calcium levels in bone, blood, nerves, 

muscle, and other body tissues. We evaluate 


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19698 Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Rules and Regulations 

parathyroid-related osteoporosis and 

fractures under 101.00; abnormally elevated 

calcium levels in the blood (hypercalcemia) 

that lead to cataracts under 102.00; kidney 

failure under 106.00; and recurrent 

abnormally low blood calcium levels 

(hypocalcemia) that lead to increased 

excitability of nerves and muscles, such as 

tetany and muscle spasms, under 111.00. 

4. Adrenal gland disorders affect bone 

calcium levels, blood pressure, metabolism, 

and mental status. We evaluate adrenalrelated linear growth impairments under 

100.00; adrenal-related osteoporosis with 

fractures that compromises the ability to 

walk or to use the upper extremities under 

101.00; adrenal-related hypertension that 

worsens heart failure or causes recurrent 

arrhythmias under 104.00; adrenal-related 

weight loss under 105.00; and mood 

disorders under 112.00. 

5. Diabetes mellitus and other pancreatic 

gland disorders disrupt the production of 

several hormones, including insulin, that 

regulate metabolism and digestion. Insulin is 

essential to the absorption of glucose from 

the bloodstream into body cells for 

conversion into cellular energy. The most 

common pancreatic gland disorder is 

diabetes mellitus (DM). There are two major 

types of DM: type 1 and type 2. Both type 

1 and type 2 DM are chronic disorders that 

can have serious, disabling complications 

that meet the duration requirement. Type 1 

DM—previously known as ‘‘juvenile 

diabetes’’ or ‘‘insulin-dependent diabetes 

mellitus’’ (IDDM)—is an absolute deficiency 

of insulin secretion that commonly begins in 

childhood and continues throughout 

adulthood. Treatment of type 1 DM always 

requires lifelong daily insulin. With type 2 

DM—previously known as ‘‘adult-onset 

diabetes mellitus’’ or ‘‘non-insulin-dependent 

diabetes mellitus’’ (NIDDM)—the body’s cells 

resist the effects of insulin, impairing glucose 

absorption and metabolism. Type 2 is less 

common than type 1 DM in children, but 

physicians are increasingly diagnosing type 2 

DM before age 18. Treatment of type 2 DM 

generally requires lifestyle changes, such as 

increased exercise and dietary modification, 

and sometimes insulin in addition to other 

medications. While both type 1 and type 2 

DM are usually controlled, some children do 

not achieve good control for a variety of 

reasons including, but not limited to, 

hypoglycemia unawareness, other disorders 

that can affect blood glucose levels, inability 

to manage DM due to a mental disorder, or 

inadequate treatment. 

a. Hyperglycemia. Both types of DM cause 

hyperglycemia, which is an abnormally high 

level of blood glucose that may produce 

acute and long-term complications. Acute 

complications of hyperglycemia include 

diabetic ketoacidosis. Long-term 

complications of chronic hyperglycemia 

include many conditions affecting various 

body systems but are rare in children. 

b. Diabetic ketoacidosis (DKA). DKA is an 

acute, potentially life-threatening 

complication of DM in which the chemical 

balance of the body becomes dangerously 

hyperglycemic and acidic. It results from a 

severe insulin deficiency, which can occur 

due to missed or inadequate daily insulin 

therapy or in association with an acute 

illness. It usually requires hospital treatment 

to correct the acute complications of 

dehydration, electrolyte imbalance, and 

insulin deficiency. You may have serious 

complications resulting from your treatment, 

which we evaluate under the affected body 

system. For example, we evaluate cardiac 

arrhythmias under 104.00, intestinal necrosis 

under 105.00, and cerebral edema and 

seizures under 111.00. Recurrent episodes of 

DKA in adolescents may result from mood or 

eating disorders, which we evaluate under 

112.00. 

c. Hypoglycemia. Children with DM may 

experience episodes of hypoglycemia, which 

is an abnormally low level of blood glucose. 

Most children age 6 and older recognize the 

symptoms of hypoglycemia and reverse them 

by consuming substances containing glucose; 

however, some do not take this step because 

of hypoglycemia unawareness. Severe 

hypoglycemia can lead to complications, 

including seizures or loss of consciousness, 

which we evaluate under 111.00, or altered 

mental status, cognitive deficits, and 

permanent brain damage, which we evaluate 

under 112.00. 

C. How do we evaluate DM in children? 

Listing 109.08 is only for children with DM 

who have not attained age 6 and who require 

daily insulin. For all other children (that is, 

children with DM who are age 6 or older and 

require daily insulin, and children of any age 

with DM who do not require daily insulin), 

we follow our rules for determining whether 

the DM is severe, alone or in combination 

with another impairment, whether it meets or 

medically equals the criteria of a listing in 

another body system, or functionally equals 

the listings under the criteria in § 416.926a, 

considering the factors in § 416.924a. The 

management of DM in children can be 

complex and variable from day to day, and 

all children with DM require some level of 

adult supervision. For example, if a child age 

6 or older has a medical need for 24-houra-day adult supervision of insulin treatment, 

food intake, and physical activity to ensure 

survival, we will find that the child’s 

impairment functionally equals the listings 

based on the example in § 416.926a(m)(5). 

D. How do we evaluate other endocrine 

disorders that do not have effects that meet 

or medically equal the criteria of any listing 

in other body systems? If your impairment(s) 

does not meet or medically equal a listing in 

another body system, we will consider 

whether your impairment(s) functionally 

equals the listings under the criteria in 

§ 416.926a, considering the factors in 

§ 416.924a. When we decide whether you 

continue to be disabled, we use the rules in 

§ 416.994a. 

109.01 Category of Impairments, 

Endocrine 

109.08 Any type of diabetes mellitus in a 

child who requires daily insulin and has not 

attained age 6. Consider under a disability 

until the attainment of age 6. Thereafter, 

evaluate the diabetes mellitus according to 

the rules in 109.00B5 and C. 

* * * * * 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

■ 9. The authority citation for subpart I 

of part 416 continues to read as follows: 

Authority: Secs. 221(m), 702(a)(5), 1611, 

1614, 1619, 1631(a), (c), (d)(1), and (p) and 

1633 of the Social Security Act (42 U.S.C. 

421(m), 902(a)(5), 1382, 1382c, 1382h, 

1383(a), (c), (d)(1), and (p), and 1383b); secs. 

4(c) and 5, 6(c)–(e), 14(a), and 15, Pub. L. 98– 

460, 98 Stat. 1794, 1801, 1802, and 1808 (42 

U.S.C. 421 note, 423 note, and 1382h note). 

■ 10. Amend § 416.925 by revising 

paragraph (c)(1) and the first sentence of 

paragraph (c)(3) to read as follows: 

§ 416.925 Listing of Impairments in 

appendix 1 of subpart P of part 404 of this 

chapter. 

* * * * * 

(c) How do we use the listings? (1) 

Most body system sections in parts A 

and B of appendix 1 are in two parts: 

an introduction, followed by the 

specific listings. 

* * * * * 

(3) In most cases, the specific listings 

follow the introduction in each body 

system, after the heading, Category of 

Impairments. * * * 

* * * * * 

[FR Doc. 2011–8389 Filed 4–7–11; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0992] 

RIN 1625–AA00 

Safety Zone; Repair of High Voltage 

Transmission Lines to Logan 

International Airport, Saugus River, 

Saugus, MA 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the Saugus River, Lynn, Massachusetts, 

within the Captain of the Port (COTP) 

Boston Zone to allow for repair of high 

voltage transmission lines to Logan 

Airport. This safety zone is required to 

provide for the safety of life on 

navigable waters during the repair of 

high voltage transmission lines. 

Entering into, transiting through, 

mooring or anchoring within this zone 

is prohibited unless authorized by the 

COTP. 


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