51384 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Proposed Rules 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

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

§ 39.13 [Amended] 

2. The Federal Aviation 

Administration (FAA) amends § 39.13 

by adding the following new 

airworthiness directive (AD): 

Boeing: Docket No. FAA–2006–25001; 

Directorate Identifier 2006–NM–079–AD. 

Comments Due Date 

(a) The FAA must receive comments on 

this AD action by September 29, 2008. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to all Boeing Model 

737–600, –700, –700C, –800, –900 and 

–900ER series airplanes, certificated in any 

category. 

Unsafe Condition 

(d) This AD results from a report that the 

top three inches of the aero/fire seals of the 

blocker doors on the thrust reverser torque 

boxes are not fireproof. We are issuing this 

AD to prevent a fire in the fan compartment 

(a fire zone) from migrating through the seal 

to a flammable fluid in the thrust reverser 

actuator compartment (a flammable fluid 

leakage zone), which could result in an 

uncontrolled fire. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Inspection To Determine Part Number (P/N) 

(f) Within 60 months or 8,200 flight cycles 

after the effective date of this AD, whichever 

occurs first: Perform a one-time detailed 

inspection to determine the color of the aero/ 

fire seals of the blocker doors on the thrust 

reverser torque boxes on the engines. For any 

aero/fire seal having a completely gray color 

(which is the color of seals with P/N 

315A2245–1 or 315A2245–2), with no red at 

the upper end of the seal, do the actions 

specified in paragraph (g) of this AD. For any 

aero/fire seal having a red color at the upper 

end of the seal (which indicates a different 

part number), no further action is required by 

this AD. A review of airplane maintenance 

records is acceptable in lieu of this 

inspection if the part number of the correct 

aero/fire seals (P/Ns 315A2245–7 or –8) can 

be conclusively determined to be installed 

from that review. 

Note 1: For the purposes of this AD, a 

detailed inspection is: ‘‘An intensive 

examination of a specific item, installation, 

or assembly to detect damage, failure, or 

irregularity. Available lighting is normally 

supplemented with a direct source of good 

lighting at an intensity deemed appropriate. 

Inspection aids such as mirror, magnifying 

lenses, etc., may be necessary. Surface 

cleaning and elaborate procedures may be 

required.’’ 

Replace the Aero/Fire Seals 

(g) For any aero/fire seal identified during 

the inspection/records check in paragraph (f) 

of this AD as having an affected P/N: Within 

60 months or 8,200 flight cycles after the 

effective date of this AD, whichever occurs 

first, replace the aero/fire seals of the blocker 

doors on the thrust reverser torque boxes on 

the engines with new, improved aero/fire 

seals in accordance with the 

Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 737–78– 

1074, Revision 1, dated September 15, 2005. 

Credit for Actions Done Using Previous 

Service Information 

(h) Replacements done before the effective 

date of this AD in accordance with the 

Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 737–78– 

1074, dated April 7, 2005, are acceptable for 

compliance with the requirements of 

paragraph (g) of this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(i)(1) The Manager, Seattle Aircraft 

Certification Office, FAA, ATTN: Samuel 

Spitzer, Aerospace Engineer, Propulsion 

Branch, ANM–140S, 1601 Lind Avenue, SW., 

Renton, Washington 98057–3356; telephone 

(425) 917–6510; fax (425) 917–6590; has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. 

(2) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Before using any approved AMOC on 

any airplane to which the AMOC applies, 

notify your appropriate principal inspector 

(PI) in the FAA Flight Standards District 

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

FSDO. 

Issued in Renton, Washington, on August 

25, 2008. 

Dionne Palermo, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. E8–20341 Filed 9–2–08; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1500 

Exemption From Classification as 

Banned Hazardous Substance; 

Proposed Exemption for Boston Billow 

Nursing Pillow and Substantially 

Similar Nursing Pillows 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Commission is proposing 

to exempt the Boston Billow Nursing 

Pillow and substantially similar nursing 

pillows from the Commission’s 

regulations banning infant cushions/ 

pillows set forth in the Commission’s 

regulations at 16 CFR 1500.18(a)(16)(i). 

DATES: Written comments in response to 

this notice must be received by October 

3, 2008. 

ADDRESSES: Comments should be 

submitted to the Office of the Secretary 

by e-mail at cpsc-os@cpsc.gov, or mailed 

or delivered, preferably in five copies, to 

the Office of the Secretary, Consumer 

Product Safety Commission, 4330 East 

West Highway, Bethesda, Maryland 

20814. Comments may also be filed by 

facsimile to (301) 504–0127. Comments 

should be captioned ‘‘Infant Cushions/ 

Pillows NPR.’’ 

FOR FURTHER INFORMATION CONTACT: 

Suad Wanna-Nakamura, Directorate for 

Health Sciences, U.S. Consumer Product 

Safety Commission, 4330 East West 

Highway, Bethesda, Maryland 20814; 

telephone (301) 504–7252; e-mail 

snakamura@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Between 1985 and 1992, there were 

35 infant deaths associated with the use 

of infant cushions/pillows (also known, 

among other names, as ‘‘baby beanbag 

pillows’’ and ‘‘beanbag cushions’’). In 

almost all of the cases where the infant’s 

position could be determined, the infant 

was in a prone, face down, position. 55 

FR 42202. The Commission initiated a 

rulemaking proceeding to determine 

whether a ban was necessary to address 

an unreasonable risk of injury and death 

associated with these types of infant 

cushions/pillows. Due to the number of 

infant deaths associated with these 

products, the Commission proposed a 

rule to ban infant cushions/pillows with 

certain characteristics. 56 FR 32352. On 

June 23, 1992, the Commission issued a 

rule codified at 16 CFR 

1500.18(a)(16)(i), banning infant 

cushions/pillows that: (1) Have a 

flexible fabric covering; (2) are loosely 


yshivers on PROD1PC62 with PROPOSALS
Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Proposed Rules 51385 

filled with a granular material, 

including but not limited to, 

polystyrene beads or pellets; (3) are 

easily flattened; (4) are capable of 

conforming to the body or face of an 

infant; and (5) are intended or promoted 

for use by children under one year of 

age. 57 FR 27912. 

On July 17, 2005, Boston Billows, Inc. 

(Boston Billows) submitted a petition 

requesting an amendment to 16 CFR 

1500.18(a)(16)(i)(A)–(E) to allow an 

exception to the ban. The petitioner is 

the manufacturer of the Boston Billow 

Nursing Pillow, a granularly filled, Cshaped pillow intended for use by 

mothers when breastfeeding. 

B. The ANPR 

The Commission issued an advance 

notice of proposed rulemaking (ANPR) 

on September 27, 2006, to assess 

whether a rulemaking was necessary to 

address any unreasonable risk of injury 

or death which may be associated with 

infant cushions/pillows. 71 FR 56418. 

In addition to the Boston Billow 

Nursing Pillow, which met the criteria 

of the ban, there appeared to be a 

proliferation of other infant cushions/ 

pillows or pillow-like products in the 

marketplace, including nursing pillows 

which met some, but not all, of the 

criteria set forth in the ban. The 

potential regulatory alternatives noted 

included whether to: (1) Amend the 

regulation to allow an exemption to the 

ban; (2) delete, revise or add criteria to 

the ban; (3) leave the existing regulation 

unchanged; or (4) repeal the existing 

regulation. Nine written comments were 

received in response to the ANPR in 

support of Boston Billows’ request for 

exemption from the ban. After review of 

the comments, incident reports and 

other available information, the 

Commission determined there was 

insufficient data or product information 

on infant cushions or pillow-like 

products, other than the Boston Billow 

Nursing Pillow, to proceed with further 

rulemaking on those products at this 

time. Accordingly, a notice terminating 

the rulemaking on infant cushions/ 

pillows or pillow-like products 

intended for use by infants, other than 

with respect to the Boston Billow 

Nursing Pillow and substantially similar 

nursing pillows, appears elsewhere in 

this Federal Register. 

C. The Proposed Exemption 

The ban on infant cushions/pillows 

was promulgated pursuant to the 

Federal Hazardous Substances Act 

(FHSA), 15 U.S.C. 1261 et seq. Section 

2(f)(1)(D) of the FHSA defines 

‘‘hazardous substance’’ to include any 

toy or other article intended for use by 

children which the Commission 

determines, by regulation, presents an 

electrical, mechanical, or thermal 

hazard. 15 U.S.C. 1261(f)(1)(D). An 

article may present a mechanical hazard 

if its design or manufacture presents an 

unreasonable risk of personal injury or 

illness during normal use or when 

subjected to reasonably foreseeable 

damage or abuse. 15 U.S.C. 1261(s). To 

grant Boston Billows’ request for an 

exemption, the Commission must find 

that the Boston Billow Nursing Pillow 

does not present an unreasonable risk of 

injury from the mechanical hazard that 

the banning rule was intended to 

prevent. 

Commission staff reviewed the 

incident data on infant cushions and 

nursing pillows for the period of 

January 1992 through June 2007. Staff 

also reviewed additional data from July 

2007 through May 2008. Since 1992, 

there have been no reported deaths 

associated with infant cushions meeting 

the definition of a banned infant 

cushion/pillow. However, staff 

identified 531 infant deaths associated 

with pillows and cushions that did not 

meet the definition of a banned infant 

cushion/pillow. (From January 1992 

through June 2007, there were 484 

deaths reported and from July 2007 

through May 2008, there were an 

additional 47 deaths reported.) The 

majority of these incidents involved 

adult pillows and sofa cushions which 

possess many of the same characteristics 

as the banned bean bag cushions. These 

products have soft covers and flexible 

filling material that can conform to an 

infant’s face. A variety of pillow types 

and cushions with different types of 

filling including foam, feathers, and 

polyester were involved in the 

incidents. In this data set, two infant 

deaths have been associated with a 

polyester filled nursing pillow (which 

does not meet the definition of a banned 

infant cushion/pillow). One incident 

occurred in 2001 when a four-monthold infant was placed to sleep on his 

stomach in a playpen with his head 

resting on the nursing pillow. The 

second incident occurred in 2007, when 

a 46-day-old infant was placed in a 

prone position inside a crib with his 

head propped on the nursing pillow. 

CPSC staff was also made aware of 

three additional deaths in 2006 where a 

nursing pillow was in the infant’s sleep 

environment. The pillows involved with 

these deaths were polyester filled 

crescent-shaped nursing pillows not 

subject to the CPSC’s infant cushion 

ban. The cause of these deaths in all 

cases was initially determined by the 

medical examiner to be Sudden Infant 

Death Syndrome (SIDS)/undetermined. 

In 2008, the New York Westchester 

County Child Fatality Review Team 

examined the case files for these deaths. 

Further investigation of these incidents, 

including review of documents and 

photographs from the New York 

Westchester County Child Fatality 

Review Team and investigator 

interviews reveals that in two of the 

three deaths, while nursing pillows 

were in the sleep environment, the 

deaths were deemed to be caused by 

SIDS/undetermined and could not be 

causally connected to nursing pillows. 

With regard to the third death, the 

infant was propped to sleep in a prone 

position on a crescent-shaped nursing 

pillow. In summary, from 1992 to the 

present, staff is aware of a total of three 

cases where infants died from 

suffocation after being placed to sleep in 

a prone position with their heads 

propped on polyester filled crescentshaped nursing pillows. 

Staff’s review revealed that in the vast 

majority of the 531 deaths associated 

with pillows and cushions, the infants 

were found in the prone position, lying 

on top of the pillow/cushion or with the 

head or neck propped on the pillow/ 

cushion. A quarter of the deaths 

occurred in infant cribs, bassinets, 

cradles and playpens, while the rest 

occurred outside the normal infant sleep 

areas, such as on adult beds, on sofas, 

or on the floor. As with the banned 

infant bean bag cushion, these pillows 

and cushions can cause death by 

suffocation/asphyxiation when an infant 

is placed to sleep face down on them. 

According to staff, the analysis of the 

data does not reveal an increased risk 

due to any specific type of pillow or 

cushion filling, but rather it is the 

softness and malleability which are 

inherent properties of pillows that are 

the primary risk factors. The 

comparative risk of suffocation based 

upon filling is unknown; however, the 

greatest common risk factor is that 

infants were found in the prone 

position, face down, in the majority of 

the 531 deaths. 

Prone sleeping is a high risk factor for 

infant suffocation on cushions/pillows. 

The limited physical and developmental 

capabilities of infants render them 

susceptible to danger from suffocation 

in certain sleeping environments. 

Physiological abnormalities and delays 

in the development of vital systems can 

further hamper an infant’s ability to 

react to a hazardous condition. Infants 

who are not placed on their backs are 

especially at risk for suffocation on any 

type of soft pillow, regardless of the 

type of filling. 

In 1992, the American Academy of 

Pediatrics, in an effort to reduce the risk 


yshivers on PROD1PC62 with PROPOSALS
51386 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Proposed Rules 

1On February 1, 2008, Acting Chairman Nancy 

Nord and Commissioner Thomas Moore voted 2–0 

to direct the Office of the General Counsel to 

prepare a notice of proposed rulemaking proposing 

an exemption for the Boston Billow Nursing Pillow 

and substantially similar nursing pillows. Acting 

Chairman Nord also voted to request ASTM to 

develop a product warning label for the product 

class. 

of SIDS, recommended that babies 

always be placed on their backs when 

put to sleep. As a result of this 

campaign, Sudden Infant Death 

Syndrome (SIDS) deaths between 1992 

and 2004 in the United States decreased 

from 5,000 per year to 2,246 per year 

(based on vital statistics data of the 

United States). Although there has been 

a steady decrease in SIDS deaths, staff 

found there has not been a similar 

decrease in infant deaths associated 

with pillows and cushions. Even though 

the recommendation to place infants to 

sleep on their backs is being promoted, 

staff believes that the data indicates that 

there are still a significant number of 

people who continue to place infants to 

sleep in the prone position. For this 

reason, staff recommends increased 

information dissemination targeted at 

the population of caregivers whose 

infants are not placed to sleep in the 

supine position. Increased compliance 

with the recommendation for supine 

sleep, as well as continued vigilance in 

ensuring a safe sleeping environment, 

would have benefits in reducing the risk 

of infant suffocation deaths caused by 

adult pillows, sofa cushions, and other 

pillows as well as further reducing 

incidents involving SIDS. 

In light of the ongoing risks posed by 

infant cushions/pillows when used in 

the sleep environment, the Commission 

found no justification for repealing the 

ban on infant cushions/pillows at this 

time. However, nursing pillows perform 

a related but different function than 

infant cushions/pillows. The purpose of 

nursing pillows is to provide a place for 

the mother to rest her arms while 

breastfeeding. The nursing pillow may 

also serve to give moldable but firm 

support to enhance comfort during 

extended periods when changing 

position during breastfeeding is 

difficult. The main risk of suffocation 

arises if the nursing pillow enters into 

the infant sleeping environment because 

suffocation can occur if children fall 

asleep on them in the prone position. 

However, an infant placed to sleep on 

any pillow or cushion, including a 

nursing pillow, in the prone position, is 

at risk for suffocation, regardless of size, 

type, shape of pillow or filling. Staff’s 

review showed that when used for its 

intended purpose—nursing—the risk of 

infant suffocation on nursing pillows, 

including the Boston Billow Nursing 

Pillow, is very low. Staff estimates that 

900,000 new nursing pillows are sold 

annually and that nursing pillows were 

used by approximately 1.8 million 

mothers in 2004. Exempting the Boston 

Billow Nursing Pillow would increase 

consumer choice by allowing consumers 

an alternative to the nursing pillows 

already in the marketplace. Based on the 

staff’s assessment, the Commission 

preliminarily concludes that an 

exemption from the ban on infant 

cushions/pillows should be granted for 

the Boston Billow Nursing Pillow and 

substantially similar nursing pillows.1

D. Regulatory Flexibility Act 

Certification 

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. 

The proposed exemption gives all 

companies more flexibility in the choice 

of material used in manufacturing 

nursing pillows. The exemption is 

deregulatory in nature and will not 

impose any additional costs on 

businesses of any size. Consequently, 

the Commission concludes that the 

proposed amendment exempting the 

Boston Billow Nursing Pillow and 

substantially similar nursing pillows 

would not have a significant impact on 

a substantial number of small entities. 

E. Environmental Considerations 

Generally, CPSC rules are considered 

to ‘‘have little or no potential for 

affecting the human environment,’’ and 

environmental assessments are not 

usually prepared for these rules (see 16 

CFR 1021.5(c)(1)). Nothing in this 

proposed rule alters that expectation. 

Therefore, the Commission does not 

expect the proposal to have any negative 

environmental impact. 

F. Executive Orders 

According to Executive Order 12988 

(February 5, 1996), agencies must state 

in clear language the preemptive effect, 

if any, of new regulations. The 

preemptive effect of this proposed 

regulation is stated in section 18 of the 

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

List of Subjects in 16 CFR Part 1500 

Consumer protection, Hazardous 

materials, Hazardous substances, 

Imports, Infants and children, Labeling, 

Law enforcement, and Toys. 

G. Conclusion 

For the reasons stated above, the 

Commission proposes to amend title 16 

of the Code of Federal Regulations as 

follows: 

PART 1500—HAZARDOUS 

SUBSTANCES AND ARTICLES: 

ADMINISTRATION AND 

ENFORCEMENT REGULATIONS 

1. The authority for part 1500 

continues to read as follows: 

Authority: 15 U.S.C. 1261–1278. 

2. Section 1500.86 is amended by 

adding a new paragraph (a)(9) to read as 

follows: 

§ 1500.86 Exemptions from classification 

as banned toy or other banned article for 

use by children. 

(a) * * * 

(9) Boston Billow Nursing Pillow and 

substantially similar nursing pillows 

that may otherwise meet the criteria of 

the banned infant cushion/pillow at 16 

CFR 1500.18(a)(16)(i). 

Dated: August 27, 2008. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. E8–20280 Filed 9–2–08; 8:45 am] 

BILLING CODE 6355–01–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1500 

Infant Cushions/Pillows; Termination 

of Rulemaking Other Than With 

Respect to Boston Billow Nursing 

Pillow and Substantially Similar 

Nursing Pillows 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Advance notice of proposed 

rulemaking; partial withdrawal. 

SUMMARY: On September 27, 2006, the 

Commission issued an advance notice of 

proposed rulemaking (ANPR) to assess 

whether a rulemaking was necessary to 

address any unreasonable risk of injury 

or death which may be associated with 

the proliferation of infant cushions/ 

pillows and pillow-like products 

intended for infants in the marketplace, 

including the Boston Billow Nursing 

Pillow. 71 FR 56418. After review of the 

comments, incident reports and other 

available information, the Commission 

has determined there is insufficient data 

or product information on infant 

cushions/pillows or pillow-like 


yshivers on PROD1PC62 with PROPOSALS