15660 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Proposed Rules 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all The Boeing 

Company Model 727, 727C, 727–100, 727– 

100C, 727–200, and 727–200F series 

airplanes, certificated in any category. 

(d) Subject 

Joint Aircraft System Component (JASC)/ 

Air Transport Association (ATA) of America 

Code 57, Wings. 

(e) Unsafe Condition 

This AD was prompted by reports of 

spanwise cracks and corrosion in the wing 

center box upper skin and rear spar upper 

chord between left buttock line (LBL) 70.50 

and right buttock line (RBL) 70.50 at body 

station (STA) 870. We are issuing this AD to 

detect and correct cracking and corrosion of 

the upper skin and rear spar upper chord of 

the wing center box, which could result in 

loss of the airplane wing and consequent loss 

of control of the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Repetitive Inspections 

Except as specified in paragraph (h) of this 

AD, at the applicable time specified in 

paragraph 1.E., ‘‘Compliance,’’ of Boeing 

Special Attention Service Bulletin 727–57– 

0187, dated March 8, 2012: Inspect the wing 

center box between LBL 70.50 and RBL 

70.50, at STA 870, as specified in paragraphs 

(g)(1), (g)(2), (g)(3), (g)(4), and (g)(5) of this 

AD, as applicable, in accordance with the 

Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 727–57– 

0187, dated March 8, 2012. Repeat the 

inspections thereafter at the applicable times 

specified in paragraph 1.E., ‘‘Compliance,’’ of 

Boeing Special Attention Service Bulletin 

727–57–0187, dated March 8, 2012. If any 

crack, corrosion, or damage is found during 

any inspection required by this AD, before 

further flight, repair using a method 

approved in accordance with the procedures 

specified in paragraph (i) of this AD. 

(1) Do a high frequency eddy current 

(HFEC) or detailed inspection for cracking 

around the forward fastener row in the rear 

spar upper chord horizontal flange. 

(2) Do a low frequency eddy current 

inspection for cracking around the aft 

fastener row in the rear spar upper chord 

horizontal flange. 

(3) Do a detailed or HFEC inspection for 

cracking in the rear spar upper chord radius. 

(4) Do a detailed or HFEC inspection for 

cracking in the upper skin around the 

forward fastener row common to the rear spar 

upper chord horizontal flange. 

(5) Do a detailed inspection for damage, 

cracking, and corrosion in the pressure seal. 

(h) Exception to the Service Information 

Boeing Special Attention Service Bulletin 

727–57–0187, dated March 8, 2012, specifies 

compliance times ‘‘after the original issue 

date of this service bulletin.’’ However, this 

AD requires compliance within the specified 

compliance times ‘‘after the effective date of 

this AD.’’ 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in the 

Related Information section of this AD. 

Information may be emailed to: 9–ANMSeattle-ACO–AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD if it is approved by the 

Boeing Commercial Airplanes Organization 

Designation Authorization (ODA) that has 

been authorized by the Manager, Seattle 

ACO, to make those findings. For a repair 

method to be approved, the repair must meet 

the certification basis of the airplane, and the 

approval must specifically refer to this AD. 

(j) Related Information 

(1) For more information about this AD, 

contact Berhane Alazar, Aerospace Engineer, 

Airframe Branch, ANM–120S, FAA, Seattle 

Aircraft Certification Office, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

phone: (425) 917–6577; fax: (425) 917–6590; 

email: berhane.alazar@faa.gov. 

(2) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P. O. Box 3707, MC 2H–65, 

Seattle, WA 98124–2207; telephone 206– 

544–5000, extension 1; fax 206–766–5680; 

Internet https://www.myboeingfleet.com. You 

may review copies of the referenced service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Ave SW., Renton, WA. 

For information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on February 

28, 2013. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2013–05598 Filed 3–11–13; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

[CPSC Docket No. CPSC–2013–0010] 

16 CFR Part 1500 

Hazardous Substances and Articles; 

Supplemental Definition of ‘‘Strong 

Sensitizer’’ 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The U.S. Consumer Product 

Safety Commission (CPSC or 

Commission) proposes to update the 

supplemental definition of ‘‘strong 

sensitizer’’ under the Federal Hazardous 

Substances Act (FHSA). The proposed 

amendment clarifies or adds language to 

eliminate redundancy, remove certain 

subjective factors, incorporate new and 

anticipated technology, rank the criteria 

for classification of strong sensitizers in 

order of importance, define criteria for 

‘‘severity of reaction,’’ and indicate that 

a weight-of-evidence approach will be 

used to determine the strength of the 

sensitizer. 

DATES: Written comments must be 

received by May 28, 2013. 

ADDRESSES: You may submit comments 

identified by Docket No. CPSC–2013– 

0010, by any of the following methods: 

• Electronic Submissions 

Submit electronic comments in the 

following way: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

To ensure timely processing of 

comments, the Commission is no longer 

accepting comments submitted by 

electronic mail (email) except through 

www.regulations.gov. 

• Written Submissions 

Submit written submissions in the 

following way: 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions), 

preferably in five copies, to: Office of 

the Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814; telephone (301) 504–7923. 

Instructions: All submissions received 

must include the agency name and 

docket number for this proposed 

rulemaking. All comments received may 

be posted without change, including 

any personal identifiers, contact 

information, or other personal 

information provided, to http:// 

www.regulations.gov. Do not submit 

confidential business information, trade 

secret information, or other sensitive or 

protected information electronically. 


pmangrum on DSK3VPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Proposed Rules 15661 

Such information should be submitted 

in writing. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Joanna Matheson, Ph.D., Project 

Manager, Office of Hazard Identification 

and Reduction, U.S. Consumer Product 

Safety Commission, 5 Research Place, 

Rockville, MD 20850; telephone (301) 

987–2564; jmatheson@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

The FHSA, 15 U.S.C. 1261–1278, 

requires appropriate cautionary labeling 

on certain hazardous household 

products to alert consumers to the 

potential hazards that a product may 

present. Among the hazards addressed 

by the FHSA are products that are toxic, 

corrosive, irritants, flammable, 

combustible, or strong sensitizers. 

Included within the FHSA’s 

definition of ‘‘hazardous substance’’ is 

‘‘any substance or mixture of 

substances’’ that ‘‘is a strong sensitizer,’’ 

15 U.S.C. 1261(f)(1)(iv). Section 2(k) of 

the FHSA, 15 U.S.C. 1261(k), defines 

‘‘strong sensitizer’’ as: 

A substance which will cause on normal 

living tissue through an allergic or 

photodynamic process a hypersensitivity 

which becomes evident on reapplication of 

the same substance and which is designated 

as such by the Commission. Before 

designating any substance a strong sensitizer, 

the Commission, upon consideration of the 

frequency of occurrence and severity of the 

reaction, shall find that the substance has a 

significant potential for causing 

hypersensitivity. 

On August 12, 1961, the Food and 

Drug Administration (FDA) (which at 

that time administered the FHSA), 

issued regulations under the FHSA that 

supplemented the statutory definition of 

‘‘strong sensitizer.’’ The regulations also 

provided a list of substances that the 

FDA had determined met the statutory 

definition for ‘‘strong sensitizer.’’ The 

five substances identified were: (1) 

Paraphenylenediamine and products 

containing it; (2) powdered orris root 

and products containing it; (3) epoxy 

resins systems containing in any 

concentration ethylenediamine, 

diethylenetriamine, and diglycidyl 

ethers of molecular weight less than 

200; (4) formaldehyde and products 

containing 1 percent or more of 

formaldehyde; and (5) oil of bergamot 

and products containing 2 percent or 

more of oil of bergamot. No additional 

substances have been determined to be 

‘‘strong sensitizers’’ by the FDA or the 

Commission since promulgation of this 

regulation. 

In 1973, the responsibility for the 

administration of the FHSA was 

transferred to the Commission, and the 

supplemental definition of ‘‘strong 

sensitizer’’ was published in title 16 of 

the Code of Federal Regulations. On 

May 30, 1984, the Commission revoked 

the above supplemental definition of 

‘‘strong sensitizer.’’ 49 FR 22464. The 

Commission concluded at that time that 

the statutory definition of ‘‘strong 

sensitizer’’ was adequate for any future 

regulatory determination that a 

substance is a strong sensitizer. 

On August 14, 1986, the Commission 

issued a rule supplementing the 

definition of ‘‘strong sensitizer’’ in the 

FHSA, 51 FR 29094, which currently is 

in effect. 16 CFR 1500.3(c)(5). As 

recommended by a Technical Advisory 

Panel on Allergic Sensitization 

(TAPAS), the supplemental definition 

clarifies how the statutory definition 

should be interpreted and explains the 

factors the Commission will consider in 

determining whether a substance is a 

‘‘strong sensitizer.’’ The supplemental 

definition states that an ‘‘allergic’’ 

response is one that is directed by the 

immune system, such that a 

sensitization reaction could not be 

caused by an irritant or other 

nonallergenic qualities of the substance. 

The supplemental definition also 

clarifies that active sensitizers— 

substances that produce a sensitivity 

reaction solely as the result of a person’s 

first exposure to the substance as 

opposed to after reapplication of the 

same substance—are included within 

the class of substances that can be 

determined to be strong sensitizers. The 

supplemental definition did not address 

strong sensitizers that cause 

hypersensitivity by a photodynamic 

process, principally because 

Commission staff was unaware of any 

household product subject to the FHSA 

that would cause significant exposure of 

consumers to a photodynamic chemical. 

The current supplemental definition 

makes clear that a sensitivity reaction 

could occur after the sensitizer is 

applied to the body’s tissues by contact, 

ingestion, or inhalation; that relevant 

exposure is not limited to skin contact; 

and that targets for hypersensitivity 

reactions include the skin and other 

organ systems, such as the respiratory or 

gastrointestinal tracts, either alone or in 

combination. The supplemental 

definition states that the minimal 

severity of the reaction caused by the 

substance for purposes of determining 

whether the substance is a strong 

sensitizer is a clinically important 

allergic reaction and provides examples 

of such clinically important reactions. 

Whether a substance has a significant 

potential for causing hypersensitivity is 

a relative determination that must be 

made separately for each substance 

under consideration by the Commission. 

The supplemental definition sets forth 

the criteria to be considered in making 

this determination. Finally, the 

supplemental definition provides the 

quantitative and qualitative factors that 

the Commission should consider in 

determining that a substance is a 

‘‘strong’’ sensitizer, such as the 

frequency of occurrence and range of 

severity in normal and susceptible 

populations and the results of 

experimental assays in humans and 

animals. 

Recognizing that the science on 

sensitization has changed since 

promulgation of the supplemental 

definition in 1986, the CPSC convened 

a panel of scientific experts from 

academia, industry, and the federal 

government to examine the available 

scientific and medical information 

concerning sensitizers, and if 

appropriate, propose revisions to the 

supplemental definition of strong 

sensitizer. 

B. Effect of Strong Sensitizer 

Determination 

The Commission is proposing to 

revise its supplemental definition of 

strong sensitizer. Additional 

Commission action would be needed for 

any substance to be designated a strong 

sensitizer. In order for the Commission 

to issue a rule declaring any particular 

substance (or product containing that 

substance) to be a strong sensitizer, it 

must engage in notice and comment 

rulemaking, separate from this 

rulemaking, and make the findings 

specified in 15 U.S.C. 1261(k), i.e., that 

based upon consideration of the 

frequency of occurrence and the severity 

of the reaction, the substance has a 

significant potential for causing 

hypersensitivity. However, a 

determination that a substance is a 

strong sensitizer does not automatically 

trigger a labeling requirement for 

products containing that substance. 

Under the FHSA a substance (or product 

containing that substance) that is a 

hazardous substance requires 

appropriate labeling. 15 U.S.C. 1261(p). 

If manufacturers of products containing 

a designated strong sensitizer determine 

that the strong sensitizer in their 

products may cause substantial injury or 

illness as a result of reasonably 

foreseeable handling or use, that 

product would be a ‘‘hazardous 

substance’’ as defined under the FHSA, 

and therefore would warrant 


pmangrum on DSK3VPTVN1PROD with PROPOSALS
15662 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Proposed Rules 

1An ‘‘irritant response’’ is a nonimmune 

mediated response and one that results from direct 

injury to the tissue. An irritant is any agent that is 

capable of producing cell damage in any individual 

if applied for sufficient time and concentration. 

appropriate labeling. Alternatively, 

where there is uncertainty, the 

Commission has the option under 

section 3(a)(1) of the FHSA to determine 

through notice and comment 

rulemaking that a product containing a 

strong sensitizer is a ‘‘hazardous 

substance.’’ Hazardous substances 

intended or packaged in a form suitable 

for use in the household that do not bear 

the appropriate cautionary labeling 

would be considered ‘‘misbranded’’ in 

violation of the FHSA. 15 U.S.C. 

1261(p). 

Such cautionary labeling would be 

insufficient, however, if a toy or other 

article intended for the use of children 

is, bears, or contains a hazardous 

substance (as that term is defined in 

section 2(f) of the FHSA), and the 

hazardous substance is accessible to a 

child to whom the article is entrusted. 

Under that scenario, the toy or 

children’s article would be considered a 

‘‘banned hazardous substance’’ under 

section 2(q)(1)(A) of the FHSA unless a 

particular exemption applies. 15 U.S.C. 

1261(q)(1)(A). 

C. Proposed Amendment 

The proposed amendment to 16 CFR 

part 1500 clarifies or adds language to 

the supplemental definition of ‘‘strong 

sensitizer’’ to eliminate redundancy, 

remove certain subjective factors, 

incorporate new and anticipated 

technology, rank the criteria for 

classification of strong sensitizers in 

order of importance, define criteria for 

‘‘severity of reaction,’’ and indicate that 

a weight-of-evidence approach will be 

used to determine the strength of the 

sensitizer. 

1. Definition of sensitizer. The current 

definition of sensitizer in § 1500.3(c)(5) 

is, ‘‘a substance that will induce an 

immunologically-mediated (allergic) 

response, including allergic 

photosensitivity. The allergic reaction 

will become evident upon reexposure to 

the same substance. Occasionally, a 

sensitizer will induce and elicit an 

allergic response on first exposure by 

virtue of active sensitization.’’ 

The proposed amendment reflects the 

traditional definition for sensitization; 

sensitization is a multi-stage immune 

mediated process which occurs over a 

period of time. Under the proposed 

amendment, those substances that 

sensitize through atypical mechanisms, 

rather than by inducing an obvious 

‘‘immunologically-mediated response’’ 

will be captured by the assessment 

process. The proposed amendment also 

eliminates the last sentence of the 

current definition based on concerns 

that it may be misinterpreted such that 

substances that cause an irritant 

response only 1 (the response that is 

noted after the first exposure to a 

substance is more frequently an irritant 

response and not an allergic response) 

could be erroneously included in the 

category of ‘‘strong sensitizers.’’ 

Typically, allergic responses are the 

result of a two-step process: (1) 

Induction (sensitization) which requires 

sufficient or cumulative exposure to 

induce an immune response with few or 

no symptoms and (2) elicitation when 

an individual who has been sensitized 

demonstrates symptoms upon 

subsequent exposures. The phrase 

‘‘variable period of exposure’’ is 

included in the proposed amendment to 

reflect the latency period which is a 

characteristic in the development of 

sensitization. 

2. Definition of significant potential 

for causing hypersentivity. Currently, 16 

CFR 1500.3(c)(5)(iv) provides that ’’ 

‘significant potential for causing 

hypersensitivity’ is a relative 

determination that must be made 

separately for each substance. It may be 

based upon the chemical or functional 

properties of the substance, documented 

medical evidence of allergic reactions 

obtained from epidemiological studies 

surveys or individual case reports, 

controlled in vitro or in vivo 

experimental assays, or susceptibility 

profiles in normal or allergic subjects.’’ 

The proposed revision to this section 

reiterates the statutory requirement that 

before designating any substance a 

‘‘strong’’ sensitizer, the Commission 

must find that the substance has 

significant potential for causing 

hypersensitivity. The proposed revision 

adds qualifiers for susceptibility 

profiles—genetics, age, gender, and 

atopic status— to the list of information 

or data that may be considered in 

determining whether a substance has a 

significant potential for causing 

hypersensitivity; and the proposed 

revision also replaces the term ‘‘normal’’ 

with ‘‘non-sensitized.’’ These 

characteristics are well-known 

modifiers in the development and 

exacerbation of allergic responses to 

chemical sensitizers; and replacing the 

term ‘‘normal’’ with ‘‘non-sensitized’’ 

reflects more accurately what would be 

considered the general control 

population. 

The proposed revision of this section 

also incorporates a discussion of the 

factors to be considered in determining 

whether a substance is a ‘‘strong’’ 

sensitizer. The current supplemental 

definition of ‘‘strong sensitizer’’ 

contains a separate subsection that sets 

forth factors that should be considered 

in determining the strength of a 

sensitizer. (16 CFR 1500.3(c)(5)(ii)). The 

current section includes several factors 

that are subjective rather than 

quantitative (i.e., physical discomfort, 

distress, hardship) and allows for risk 

assessment considerations in 

connection with an analysis that should 

only be a hazard characterization step. 

The current definition of strong reads: 

In determining that a substance is a 

‘‘strong’’ sensitizer, the Commission shall 

consider the available data for a number of 

factors. These factors include any and or all 

of the following (if available): Quantitative or 

qualitative risk assessment, frequency of 

occurrence and range of severity of reactions 

in healthy or susceptible populations, the 

result of experimental assays in animals or 

humans (considering dose-response factors), 

with human data taking precedence over 

animal data, other data on potency or 

bioavailability of sensitizers, data on 

reactions to a cross-reacting substance or to 

a chemical that metabolizes or degrades to 

form the same or a cross-reacting substance, 

the threshold of human sensitivity, 

epidemiological studies, and other 

appropriate in vivo or in vitro test studies. 

The proposed amendment eliminates 

the ‘‘quantitative or qualitative risk 

assessment factor’’ because the 

Commission believes this terminology is 

a source of confusion in that it places a 

risk assessment step within the hazard 

identification step of the overall process 

of determining whether a product 

containing a strong sensitizer requires 

labeling. The proposed amendment 

makes clear that a weight-of-theevidence approach is to be used in 

determining the strength of a sensitizer 

because of the imprecise nature of some 

of the current factors and the potential 

lack of information or data available to 

permit useful consideration of certain 

factors. Rather than allowing an ‘‘any or 

all’’ approach to what factors would be 

considered by the Commission in 

determining whether a sensitizer is 

strong, the amendment ranks data 

sources in order of importance, 

following the FHSA preference for 

human data over animal data; and the 

amendment takes into consideration the 

value and relevance that certain data 

would provide in evaluating the 

potential of a substance to cause 

hypersensitivity. For example, the 

proposed amendment expresses a 

preference for general population 

epidemiological studies over 

occupational studies because the degree 

of sensitization in the workplace is 

likely to be greater than that of the 

general population, due to greater 


pmangrum on DSK3VPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Proposed Rules 15663 

2QSARs are mathematical models that relate a 

quantitative measure of chemical structure to 

biological activity. In silico data is a computational 

approach using sophisticated computer models for 

the determination of a sensitizing potential. Both of 

these approaches are evolving methodologies that 

have not yet been validated, but are being pursued 

as testing options that would reduce the numbers 

of expensive laboratory and animal experiments 

being carried out. 

exposure (both in time and 

concentration) to the sensitizing agent. 

The proposed amendment provides 

that for a substance to be considered a 

‘‘strong’’ sensitizer the substance must 

be found to produce a ‘‘clinically 

important reaction,’’ which is defined as 

a reaction with a significant impact on 

the quality of life. Examples of such 

reactions included in the proposed 

revision to this section are substantial 

physical discomfort or distress, 

substantial hardship, functional or 

structural impairment, or chronic 

morbidity. The proposed revision to this 

section also directs the Commission to 

consider the location of the 

hypersensitivity response, such as the 

face, hands, and feet, and the 

persistence of clinical manifestations in 

determining whether the substance 

produces a ‘‘clinically important 

reaction.’’ 

The proposed revision to this section 

adds several factors the Commission can 

consider in determining a substance’s 

sensitizing potential, for which 

validated methods currently do not exist 

but are in development, such as: 

Quantitative Structure-Activity 

Relationships (QSARs), and in silico 2

data, along with the caveat that using 

these techniques would be in addition 

to consideration of human and animal 

data. We expect that in vitro and in 

silico validated methods will be 

available as part of an integrated testing 

strategy within the next 5 years, and 

including these components in the 

amendment ensures that the definition 

is compatible with current science. The 

proposed revision also includes a 

definition of ‘‘bioavailability’’ (i.e., the 

dose of the substance available to 

interact with a tissue and that tissue’s 

ability to absorb the substance and the 

actual penetrating ability of the 

substance). 

3. Definition of Normal Living Tissue. 

Currently, 16 CFR 1500.3(c)(5)(v) 

defines normal living tissue as: 

the skin and other organ systems, such as the 

respiratory or gastrointestinal tract, either 

singularly or in combination, following 

sensitization by contact ingestion or 

inhalation. 

The proposed revision adds a specific 

reference to mucous membranes, such 

as ocular and oral systems, as types of 

normal living tissue upon which a 

substance can cause a hypersensitivity 

that warrants a determination that a 

substance is a ‘‘strong sensitizer.’’ 

4. Definition of Severity of Reaction. 

The current definition for severity of 

reaction at 16 CFR 1500.3(c)(5)(iii)) 

states that the minimal severity of a 

reaction for the purpose of designating 

a material as a ‘‘strong sensitizer’’ is a 

clinically important reaction, and 

provides examples of the types of 

illnesses that could satisfy this criteria, 

such as physical discomfort, distress, 

hardship, or functional or structural 

impairment. 

The proposed amendment eliminates 

this subsection and incorporates the 

factors to be considered in determining 

whether a substance is a ‘‘strong’’ 

sensitizer into the proposed revised 

section Significant potential for causing 

hypersensitivity. 

D. Staff Guidance and Notice of 

Availability 

Commission staff has developed a 

guidance document that is intended to 

clarify the ‘‘strong sensitizer’’ definition 

and assist manufacturers in 

understanding how CPSC staff would 

assess whether a substance and/or 

product containing that substance 

should be considered a ‘‘strong 

sensitizer.’’ A Notice of Availability is 

published elsewhere in this issue of the 

Federal Register, which provides a link 

to the location on the Commission’s 

Web site where the staff guidance 

document can be found. 

E. Impact on Small Businesses 

Under the Regulatory Flexibility Act 

(RFA), when an agency issues a 

proposed rule, it generally must prepare 

an initial regulatory flexibility analysis 

describing the impact the proposed rule 

is expected to have on small entities. 5 

U.S.C. 603. The RFA does not require a 

regulatory flexibility analysis if the head 

of the agency certifies that the rule will 

not have a significant effect on a 

substantial number of small entities. Id. 

605(b). 

The Commission’s Directorate for 

Economic Analysis prepared a 

preliminary assessment of the impact of 

revising the supplemental definition of 

‘‘strong sensitizer.’’ That assessment 

found that there would be little or no 

effect on small businesses and other 

entities because the proposed 

amendment, which simply modifies the 

existing supplemental definition of 

‘‘strong sensitizer,’’ will not result in 

product modifications to comply; nor 

will the revised supplemental definition 

impose any additional testing or 

recordkeeping burdens. The obligation 

to label a product as a ‘‘strong 

sensitizer’’ and any costs associated 

with that obligation will not arise until 

the Commission has designated a 

substance contained in the product as a 

‘‘strong sensitizer,’’ which would occur 

only in connection with a separate 

notice and comment rulemaking 

proceeding. Thereafter, we would assess 

the potential small business impact of 

designating the particular substance as a 

strong sensitizer. Moreover, the 

proposed amendment is not expected to 

impose any indirect burden on small 

businesses or other entities because it is 

not expected to lead to any additional 

substances being designated as strong 

sensitizers that would not be so 

designated in the absence of the 

amendment. Based upon the foregoing 

assessment, the Commission finds 

preliminarily that the proposed rule 

would not have a significant impact on 

a substantial number of small entities. 

F. Environmental Considerations 

Generally, CPSC rules are considered 

to ‘‘have little or no potential for 

affecting the human environment,’’ and 

environmental assessments and 

environmental impact statements are 

not usually prepared for these rules (see 

16 CFR 1021.5(c)(1)). The Commission 

does not expect the proposed rule to 

have any adverse impact on the 

environment under this categorical 

exclusion. 

G. Executive Orders 

According to Executive Order 12988 

(February 5, 1996), agencies must state 

in clear language the preemptive effect, 

if any, of new regulations. Section 18 of 

the FHSA addresses the preemptive 

effect of certain rules issued under the 

FHSA. 15 U.S.C. 1261n. Because this 

rulemaking would revise a regulatory 

definition rather than issue a labeling or 

banning requirement, section 18 of the 

FHSA does not provide for the proposed 

rule to have preemptive effect. 

H. Paperwork Reduction Act 

This rule would not impose any 

information collection requirements. 

Accordingly, this rule is not subject to 

the Paperwork Reduction Act, 44 U.S.C. 

3501–3520. 

I. Effective Date 

The Administrative Procedure Act 

generally requires that a substantive rule 

be published not less than 30 days 

before its effective date, unless the 

agency finds, for good cause shown, that 

a lesser time period is required. 5 U.S.C. 

553(d)(3). We propose that the rule 

would take effect 30 days after 


pmangrum on DSK3VPTVN1PROD with PROPOSALS
15664 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Proposed Rules 

publication of a final rule in the Federal 

Register. 

List of Subjects in 16 CFR Part 1500 

Consumer protection, Hazardous 

substances, Imports, Infants and 

children, Labeling, Law enforcement, 

Reporting and recordkeeping 

requirements, and Toys. 

Accordingly, 16 CFR part 1500 is 

proposed to be amended as follows: 

PART 1500—[AMENDED] 

■ 1. The authority citation for part 1500 

continues to reads as follows: 

Authority: 15 U.S.C. 1261–1278. 

■ 2. In § 1500.3, revise paragraph (c)(5) 

to read as follows: 

§ 1500.3 Definitions. 

* * * * * 

(c) * * * 

(5) The definition of strong sensitizer 

in section 2(k) of the Federal Hazardous 

Substances Act (restated in 16 CFR 

1500.3(b)(9)) is supplemented by the 

following definitions: 

(i) Sensitizer. A sensitizer is a 

substance that is capable of inducing a 

state of immunologically mediated 

hypersensitivity (including allergic 

photosensitivity) following a variable 

period of exposure to that substance. 

Hypersensitivity to a substance will 

become evident by an allergic reaction 

elicited upon reexposure to the same 

substance. 

(ii) Significant potential for causing 

hypersensitivity. Before designating any 

substance a ‘‘strong sensitizer,’’ the 

Commission shall find that the 

substance has significant potential for 

causing hypersensitivity. Significant 

potential for causing hypersensitivity is 

a relative determination that must be 

made separately for each substance. It 

may be based on chemical or functional 

properties of the substance; documented 

medical evidence of allergic reactions 

upon subsequent exposure to the same 

substance obtained from 

epidemiological surveys or individual 

case reports; controlled in vitro or in 

vivo experimental studies; and 

susceptibility profiles (e.g., genetics, 

age, gender, atopic status) in nonsensitized or allergic subjects. 

(A) In determining whether a 

substance is a ‘‘strong’’ sensitizer, the 

Commission shall consider the available 

data for a number of factors, following 

a weight-of-evidence approach. The 

following factors (if available), ranked in 

descending order of importance, should 

be considered: well-conducted clinical 

and diagnostic studies, epidemiological 

studies, with a preference for general 

population studies over occupational 

studies, well-conducted animal studies, 

well-conducted in vitro test studies, 

cross-reactivity data, and case histories. 

Criteria for a ‘‘well-conducted’’ study 

would include validated outcomes, 

relevant dosing and route of 

administration, and use of appropriate 

controls. Studies should be carried out 

according to national and/or 

international test guidelines and 

according to good laboratory practice 

(GLP), compliance with good clinical 

practice (GCP), and good 

epidemiological practice (GEP). 

(B) Before the Commission designates 

any substance a ‘‘strong’’ sensitizer, 

frequency of occurrence and range of 

severity of reactions in exposed 

subpopulations having average or high 

susceptibility will be considered. The 

minimal severity of a reaction for the 

purpose of designating a material a 

‘‘strong sensitizer’’ is a clinically 

important reaction. A clinically 

important reaction would be considered 

one with loss of function and significant 

impact on quality of life. Consideration 

should be given to the location of the 

hypersensitivity response, such as the 

face, hands, and feet and persistence of 

clinical manifestations. For example, 

strong sensitizers may produce 

substantial illness, including any or all 

of the following: substantial physical 

discomfort and distress, substantial 

hardship, functional or structural 

impairment, chronic morbidity. 

(C) Additional consideration may be 

given to Quantitative Structure-Activity 

Relationships (QSARs), in silico data, 

specific human sensitization threshold 

values, and other data on potency and 

sensitizer bioavailability, if data are 

available and methods are validated. 

Bioavailability is the dose of the 

allergen available to interact with a 

tissue. It is a reflection of how well the 

skin or another organ can absorb the 

allergen and the actual penetrating 

ability of the allergen, including factors 

such as size and composition of the 

chemical. 

(iii) Normal living tissue. The allergic 

hypersensitivity reaction occurs in 

normal living tissues, including the 

skin, mucous membranes (e.g., ocular, 

oral), and other organ systems, such as 

the respiratory tract, gastrointestinal 

tract, or either singularly or in 

combination, following sensitization by 

contact, ingestion, or inhalation. 

* * * * * 

Dated: March 7, 2013. 

Todd A. Stevenson, 

Secretary, U.S. Consumer Product Safety 

Commission. 

[FR Doc. 2013–05577 Filed 3–11–13; 8:45 am] 

BILLING CODE 6355–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R06–OAR–2009–0710; FRL–9789–4] 

Approval and Promulgation of Air 

Quality Implementation Plans; New 

Mexico; Interstate Transport of Fine 

Particulate Matter 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

a portion of a State Implementation Plan 

(SIP) submittal from the State of New 

Mexico to address Clean Air Act (CAA 

or Act) requirements in section 

110(a)(2)(D)(i)(I) that prohibit air 

emissions which will contribute 

significantly to nonattainment or 

interfere with maintenance in any other 

state for the 2006 fine particulate matter 

(PM2.5) national ambient air quality 

standards (NAAQS). EPA proposes to 

determine that the existing SIP for New 

Mexico contains adequate provisions to 

prohibit air emissions from significantly 

contributing to nonattainment or 

interfering with maintenance of the 

2006 24-hour PM2.5 NAAQS (2006 PM2.5

NAAQS) in any other state as required 

by section 110(a)(2)(D)(i)(I) of the Act. 

DATES: Comments must be received on 

or before April 11, 2013. 

ADDRESSES: Submit your comments, 

identified by Docket No. EPA–R06– 

OAR–2009–0710, by one of the 

following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Email: Mr. Guy Donaldson at 

donaldson.guy@epa.gov. Please also 

send a copy by email to the person 

listed in the FOR FURTHER INFORMATION

CONTACT section below. 

• Fax: Mr. Guy Donaldson, Chief, Air 

Planning Section (6PD–L), at fax 

number 214–665–7263. 

• Mail or Delivery: Mr. Guy 

Donaldson, Chief, Air Planning Section 

(6PD–L), Environmental Protection 

Agency, 1445 Ross Avenue, Suite 1200, 

Dallas, Texas 75202–2733. Deliveries 

are only accepted ruing the Regional 

Office’s normal hours of operation. 

Instructions: Direct your comments to 

Docket ID No. EPA–R06–OAR–2009– 


pmangrum on DSK3VPTVN1PROD with PROPOSALS