95-15077. Recreational Inflatable Personal Flotation Device Standards

[Federal Register Volume 60, Number 121 (Friday, June 23, 1995)]
[Rules and Regulations]
[Pages 32836-32860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15077]




[[Page 32835]]

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Part III





Department of Transportation





_______________________________________________________________________



Coast Guard



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46 CFR Part 160



Recreational Inflatable Personal Flotation Device Standards; Interim 
Rule



33 CFR Part 175, et al;



46 CFR Part 2, et al.



Inflatable Personal Flotation Devices (PFDs) for Recreational Boaters; 
Approval; Proposed Rule

Federal Register / Vol. 60, No. 121 / Friday, June 23, 1995 / Rules 
and Regulations 
[[Page 32836]] 

DEPARTMENT OF TRANSPORTATION

Coast Guard

46 CFR Part 160

[CGD 94-110]
RIN 2115-AE96


Recreational Inflatable Personal Flotation Device Standards

AGENCY: Coast Guard, DOT.

ACTION: Interim rule with request for comments.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing regulations for approval of 
inflatable personal flotation devices (PFDs) for recreational boaters. 
These regulations establish structural and performance standards for 
inflatable PFDs, as well as the procedures for Coast Guard approval of 
inflatable PFDs. These standards are intended to allow for approval of 
inflatable PFDs which should be more amenable to continuous wear by 
recreational boaters than currently approved PFDs, thereby increasing 
use of PFDs by the boating public and saving lives.

DATES: This rule is effective on July 24, 1995. The Director of the 
Federal Register approves as of July 24, 1995 the incorporation by 
reference of certain publications listed in the regulations. Comments 
must be received on or before October 23, 1995.

ADDRESSES: Comments may be mailed to the Executive Secretary, Marine 
Safety Council (G-LRA/3406) (CGD 94-110), U.S. Coast Guard 
Headquarters, 2100 Second Street SW., Washington, DC 20593-0001, or may 
be delivered to room 3406 at the same address between 8 a.m. and 3 
p.m., Monday through Friday, except Federal holidays. The telephone 
number is [phone]. Comments on collection-of-information 
requirements must be mailed also to the Office of Information and 
Regulatory Affairs, Office of Management and Budget, 725 17th Street 
NW., Washington, DC 20503, ATTN: Desk Officer, U.S. Coast Guard.
    The Executive Secretary maintains the public docket for this 
rulemaking. Comments will become part of this docket and will be 
available for inspection or copying at room 3406, U.S. Coast Guard 
Headquarters, between 8 a.m. and 3 p.m., Monday through Friday, except 
Federal holidays.
    A copy of the material listed in ``Incorporation by Reference'' of 
this preamble is available for inspection at room 1404, U.S. Coast 
Guard Headquarters.

FOR FURTHER INFORMATION CONTACT: Mr. Samuel E. Wehr, U.S. Coast Guard, 
Survival Systems Branch (G-MVI-3), telephone [phone], facsimile 
[phone], or electronic mail ``mvi-3/G-
[e-mail]''. A copy of this interim final rule may be 
obtained by calling the Coast Guard's toll-free Customer Infoline, 1-
800-368-5647. In Washington, DC, call 267-0780.
SUPPLEMENTARY INFORMATION:

Request for Comments

    The Coast Guard encourages interested persons to participate in 
this rulemaking by submitting written data, views, or arguments. 
Persons submitting comments should include their names and addresses, 
identify this rulemaking (CGD 94-110) and the specific section of this 
rule to which each comment applies, and give the reason for each 
comment. Please submit two copies of all comments and attachments in an 
unbound format, no larger than 8\1/2\ by 11 inches, suitable for 
copying and electronic filing. Persons wanting acknowledgment of 
receipt of comments should enclose stamped, self-addressed postcards or 
envelopes.
    The Coast Guard will consider all comments received during the 
comment period. It may change this rule in view of the comments.
    The Coast Guard plans no public hearing. Persons may request a 
public hearing by writing to the Marine Safety Council at the address 
under ADDRESSES. The request should include the reasons why a hearing 
would be beneficial. If it determines that the opportunity for oral 
presentations will aid this rulemaking, the Coast Guard will hold a 
public hearing at a time and place announced by a later notice in the 
Federal Register.

Drafting Information

    The principal persons involved in drafting this document are Mr. 
Samuel E. Wehr, Project Manager, U.S. Coast Guard, Office of Marine 
Safety, Security, and Environmental Protection, Survival Systems Branch 
(G-MVI-3) and Ms. Helen Boutrous, Project Counsel, Office of Chief 
Counsel.

Regulatory History

    On November 9, 1993, the Coast Guard published an Advance Notice of 
Proposed Rulemaking (ANPRM) entitled ``Inflatable Personal Flotation 
Devices'' in the Federal Register (58 FR 59428). The Coast Guard 
received nine letters commenting on the ANPRM. One of the comments 
requested a public hearing, however, after consideration, the Coast 
Guard determined that no new issues would have been raised which would 
have materially assisted the Coast Guard in developing this rule. 
Therefore, no public hearing was held.

Regulatory Information

    This rule is being published as an interim rule and is being made 
effective 30 days after the date of publication. The standards 
established by this IFR will give manufacturers the opportunity to make 
a significant number of Coast Guard-approved inflatable PFDs available 
to the boating public in 1996. Manufacturers require sufficient lead 
time to develop the PFDs in accordance with safety standards before 
they can actually offer products to boaters. It is the Coast Guard's 
position that boaters will be more likely to wear the less bulky 
inflatable PFDs than the more bulky designs currently available. 
Therefore, availability inflatable PFDs will save boaters lives.
    Most of the standards adopted by this rulemaking are Underwriters 
Laboratories (UL) standards for inflatable PFDs and PFD components (UL 
1180 and 1191) which were developed in accordance with the American 
National Standards Institute (ANSI) procedure for voluntary industry 
standards. In accordance with the ANSI procedures, interested parties 
were provided with an opportunity to participate in the development of 
the standards. The public was also given an opportunity to comment on 
the adoption of approval standards for inflatable PFDs in the ANPRM 
published on November 9, 1993 (58 FR 59428). All of the comments were 
generally in favor of the development of structural and performance 
standards for inflatable personal flotation devices (PFDs) and 
procedures for Coast Guard approval of inflatable PFDs. The ANPRM 
advised of the intention to use an industry consensus standard and 
encouraged interested, knowledgeable persons to participate in the ANSI 
standards making process. On February 24, 1994, notice was published in 
the Federal Register (59 FR 9015) of the Coast Guard's participation in 
the first consensus standards meeting with UL. This notice again 
invited interested technical experts knowledgeable in the field to 
participate in the meeting and process.
    This IFR affords the opportunity for the public to comment on, and 
the Coast Guard to revise, the standards before they are finalized. 
Comments are invited on all aspects of this rule, and the Coast Guard 
specifically requests comments on particular issues throughout this 
preamble. Furthermore, carriage of inflatable PFDs will not be 
mandatory for boat owners, rather they are an [[Page 32837]] allowable 
alternative to existing Coast Guard-approved PFDs. Coast Guard approval 
of inflatable PFDs represents a business opportunity for manufacturers, 
distributors, and retailers. For these reasons, the Coast Guard for 
good cause finds, under 5 U.S.C. 553(b)(B), that notice, and public 
procedure on the notice, before the effective date of this rule are 
unnecessary.

Background and Purpose

    The November 9, 1993, ANPRM discussed the Coast Guard's intention 
to adopt structural and performance standards for inflatable personal 
flotation devices (PFD) used on recreational boats, as well as the 
procedures for approval, and carriage requirements. The ANPRM discussed 
the Coast Guard's intention to participate in the development of an 
Underwriters Laboratories (UL) standard for inflatable PFDs, which 
would be the basis for Coast Guard approval of these devices. The UL 
standard (UL 1180) is complete. A Notice of Proposed Rulemaking (NPRM) 
which proposes complementary rules governing the carriage, use, 
registration, and recall of inflatable PFDs for recreational boats, is 
published elsewhere in today's edition of the Federal Register. More 
comprehensive procedures for approval of inflatable devices, and other 
PFDs as well, are included in the NPRM.
    These regulations are intended to allow approval of PFDs which may 
be more appealing to recreational boaters than currently approved PFDs, 
thereby increasing use of PFDs by the boating public and saving lives. 
However, the Coast Guard notes that the currently approved inherently 
buoyant PFDs have an excellent lifesaving record. The Coast Guard 
boating statistics show that the fatality rate has dropped from about 
20 to 4 (per 100,000 boats) over the past 25 years, and this decrease 
is in part due to use of these inherently buoyant PFDs. The Coast Guard 
also notes that inherently buoyant PFDs are more appropriate for non-
swimmers than inflatable PFDs. Moreover, there are a number of boating 
applications where inflatable PFDs are not suitable, as listed in the 
PFD information pamphlet. Therefore, inherently buoyant PFDs will 
continue to play a vital role in boating safety programs for the 
public.

Advisory Committee and Other Consultations

    In developing these regulations the Coast Guard consulted with the 
National Boating Safety Advisory Council (NBSAC) and the National 
Association of State Boating Law Administrators (NASBLA). In May 1994, 
NBSAC passed a resolution recommending approval for Type I, II, III, 
IV, and V inflatable PFDs. In 1988, 1993 and 1994, NASBLA also passed 
resolutions urging that such approvals be granted as soon as possible. 
Additionally, the National Transportation Safety Board has recommended 
that the Coast Guard approve inflatable PFDs.
    NBSAC formed a subcommittee to study the implementation of the 
various types of approvals that might be granted by the Coast Guard and 
developed an ``inflatable PFD objectives statement'' and ``performance 
goals''. Copies of these documents are included in the docket file for 
this rulemaking. The documents identified a number of goals that NBSAC 
determined to be appropriate in the effort to set standards for the 
manufacture and approval of inflatable PFDs. In November 1994, the full 
council passed a resolution supporting the objectives statement and 
goals. The regulations adopted by this IFR are fully consistent with 
the final resolution adopted by NBSAC.

Inflatable PFD Studies

    The Coast Guard has sponsored two studies on the suitability of 
inflatable PFDs in the recreational boating environment--a 1981 
Inflatable PFD Field Test, Report No. CG-M-84-1 and a 1993 study 
conducted by the BOAT/U.S. Foundation for Boating Safety. Each study 
involved the use of about 500 inflatable PFDs in a recreational boating 
environment. Copies of these studies are included in the docket file 
for this rulemaking. Initial review of these studies indicated that 
inflatable PFDs could not be approved without extensive servicing 
requirements or conditions on approval. However, as discussed below, 
developments in inflatable PFDs have allowed the Coast Guard to 
establish the approval standards for inflatable PFDs adopted in this 
IFR.

1981 Inflatable PFD Field Test

    The 1981 Inflatable PFD Field Test revealed that the PFDs used by 
the participants lacked an armed inflation mechanism nearly 20 percent 
of the time. Based on this information, the Coast Guard determined that 
it was not appropriate to approve inflatable PFDs without a mandatory 
structured servicing program. In 1981, no satisfactory servicing 
program was available, nor could one be developed at a reasonable cost 
for recreational boaters. Therefore, totally inflatable recreational 
PFD's were not approved.

BOAT/U.S. Study

    The 1993 BOAT/U.S. Foundation for Boating Safety, Inflatable PFD 
Study showed approximately the same result as the 1981 study discussed 
above. Boat/U.S. distributed inflatable PFDs to recreational boaters 
and asked them to use the PFDs during their boating activities. BOAT/
U.S. then recalled the PFDs in ``as is'' condition. After an initial 
visual examination, about 45 percent of the PFDs were judged to be 
improperly armed. Upon further evaluation, it was concluded that one-
third of the improperly armed PFDs may have appeared to the average 
boater as having been armed correctly, a potentially serious condition 
(p.8 of study). In addition, 11 percent of the PFDs which technicians 
judged to be properly armed, actually had spent inflation cartridges, a 
potentially very serious situation.
    Of the 458 inflatable PFDs tested by the BOAT/U.S. Foundation, 
technicians determined that:
    (a) 383 (84%) could be made operational when they were returned.
    (b) 40 (8.7%) were found to have operational deficiencies which 
could result in diminished performance of the PFD. Of these 40 
inflatable PFDs, 17 required a greater than average force to actuate 
the inflation assembly. Some of the PFDs were found to have air 
retention losses of over 20 percent after 24 hours and others had slow 
inflation times. The slow inflation and air loss were caused by 
secondary closures which failed to open or possible leaks in the 
inflation assembly. In particular, one manufacturer used snap closures 
that did not always open when the device was inflated.
    (c) 35 (7.6%) had various operational deficiencies which actually 
diminished their performance. Of these 35 inflatable PFDs, 19 were 
inoperable when returned for testing after use by the participants.

New Developments in Inflatable PFDs and UL Standards

    New developments in the manufacture of inflatable PFDs, along with 
work done in the area by UL since the testing was conducted in the 
above studies, have greatly improved the chances that inflatable PFDs 
will work when used and maintained by the average boater. The problems 
revealed by the two studies discussed above have been addressed in the 
UL standard. It is the Coast Guard's position that PFDs meeting the 
requirements of the new UL standard, along with certain additional 
requirements included in this IFR, do not have the problems that 
prevented [[Page 32838]] Coast Guard from approving recreational 
inflatable PFDs in the past.
    The Coast Guard is proceeding with approval at this time based on 
the development of much more ``user serviceable'' inflatable PFDs. With 
these user serviceable PFDs there is a good chance that the user of the 
PFD will (1) recognize when the PFD needs servicing; and (2) be able to 
perform the servicing correctly. These improved PFDs are equipped with 
inflation mechanisms (inflators) that are user-friendly. User-friendly 
features are often referred to as mechanisms that are designed with 
``good human factors.'' Better human factors relates to the ease with 
which boaters can determine when their inflatable PFD needs rearming 
and the ease with which they can correctly rearm their PFD. Good human 
factors design will decrease the incidence of unarmed inflatable PFDs 
that were evident in the studies discussed above. This IFR requires 
inflatable PFDs to have inflators that a high proportion of the user 
population can quickly and correctly rearm with little or no reference 
to instructions or training.
    In order to increase the likelihood that spent (or unarmed) 
inflators are readily distinguishable in actual use, the UL standards 
incorporated by this IFR require a status indicator that a high 
percentage of test subjects must correctly identify in the approval 
testing. Additionally, a high percentage of a pool of test subjects 
must be able to correctly rearm the device with no additional training, 
other than use of the owner's manual provided and toll-free calls to a 
manufacturer's help line, if one is available. The UL standard has two 
different levels for inflators, and the Coast Guard is allowing 
manufacturers to utilize different use restrictions and Type 
designations to alert boaters to the simplicity or complexity of the 
device that should be considered before purchase. The Coast Guard's 
goal is for PFDs to have inflators with such good human factors that 
boaters can tell if their PFD is armed as easily and quickly as they 
can tell the difference between a nickel and dime. This should then 
enable them to correctly rearm their inflatable PFDs almost every time.
    As discussed below, other problems revealed in the study have also 
been addressed.
    UL Standard 1180 includes a requirement for testing inflator 
assemblies after salt water spray tests to ensure that the inflators 
are capable of being easily actuated if left in a corrosive 
environment.
    Many of the problems associated with partial deflation over 24 
hours were attributed to sand or grit in the oral inflation tube, which 
allowed the valve in the tube to remain partially open and leak. The UL 
standard permits, but does not require, a dust cap on oral inflation 
tubes. Dust caps should prevent the entrance of some sand and grit into 
the inflator tube, and thus reduce the incidences of this minor 
problem. Other reasons for leaks included improper installation of the 
inflation assembly and holes in the bladder assembly itself. These 
problems will need to be dealt with by the boaters themselves as 
instructed by the owner's manual.
    UL standards 1180 and 1191 also include a number of tests to ensure 
the durability of the bladder. The label will include a warning to 
perform a service test at least once each year.

Industry Standards Development

    Underwriters Laboratories Inc. developed and revised UL standards 
1180 and 1191, respectively, which are incorporated by reference in 
this rule, over the past year. The Coast Guard participated in this 
standards development process, which included two UL meetings and two 
UL comment periods. At the first meeting, which was announced in the 
Federal Register (February 24, 1994; 59 FR 9015), participants 
discussed concepts for the various kinds of PFDs that should be 
included in the standards, their minimum performance, and the 
performance of critical components such as the inflation mechanisms. UL 
then formulated complete draft proposals for the inflatable PFDs and 
their components and requested comments. An ad hoc advisory committee 
meeting was then held to discuss the comments received in detail. The 
Coast Guard outlined the most important characteristics of inflatable 
PFDs that it would examine when considering the devices for USCG 
approval. UL's minutes of this meeting are included in the docket for 
this rulemaking. Subsequent to the ad hoc advisory committee meeting, 
UL proposed revised standards for inflatable PFDs and their components 
and invited comments. The Coast Guard commented on this revised 
proposal, and UL, after considering the industry and Coast Guard 
comments, adopted the standards incorporated by reference in this 
interim final rule.

Discussion of Comments

    The comments received in response to the ANPRM published November 
9, 1993, that pertain to the approval procedures and other issues 
regarding inflatable PFD use are discussed in the NPRM (CGD 93-055) 
published elsewhere in today's edition of the Federal Register. The 
comments that pertain to the standards for inflatable PFDs and this IFR 
are discussed below.
    The Coast Guard received eight letters commenting on the ANPRM 
before the close of the comment period. One supplemental letter that 
was received after the close of the comment period was also considered. 
The comments were received from a boat manufacturer, a cruise ship 
line, five PFD manufacturers and a boat owners association. All of the 
comments were generally in favor of the development of structural and 
performance standards for inflatable personal flotation devices (PFDs) 
and procedures for Coast Guard approval of inflatable PFDs.
    Each of the comment letters received addressed a variety of issues 
regarding the approval of inflatable PFDs. Most of these issues were 
raised in a series of questions posed in the ANPRM. The issues 
addressed by these comments are discussed below.

General Comments

    Most of the comments stated that because inflatable PFDs are 
lightweight and compact, and therefore cooler, they are more likely to 
be worn than most of the bulky inherently buoyant PFDs currently in 
use. These comments also stated, however, that increasing consumer 
interest is dependent upon lowering the relatively high cost of the 
inflatable models currently marketed. They acknowledged that Coast 
Guard approval of, and recommendations concerning, inflatable PFDs will 
also increase sales and help development of lower cost inflatable PFDs 
by increasing competition.
    The Coast Guard agrees with these comments, but notes that 
increased wearing of PFDs also requires changing boaters' attitudes 
about the need for and value of PFD use. The Coast Guard emphasizes 
that, as with all PFDs, for inflatable PFDs to save lives, they must be 
worn. But also, inflatable PFDs must be cared for to a greater extent 
than other PFDs. The Coast Guard encourages boaters, manufacturers, 
State boating officials and boating safety organizations to promote the 
proper care of inflatable PFDs and increased wearing of PFDs in 
general. One of the significant advantages of inflatable PFDs, and the 
reason the Coast Guard has determined that inflatable PFD standards 
should be established as soon as possible, is that inflatable PFDs are 
comfortable enough to wear at all times while on the water. While two 
studies have indicated that improved comfort alone may not 
significantly increase the wear rate for PFDs, the Coast Guard's 
position is that the combination of [[Page 32839]] increased comfort 
and boater awareness of the crucial importance of wearing a PFD will 
increase the numbers of boaters wearing PFDs and save lives. That is 
why the Coast Guard is requiring that educational pamphlets and 
manuals, highlighting the importance of wearing a PFD which is 
appropriate for the user and the activity, be supplied with all Coast 
Guard-approved PFDs. Through this IFR and several PFD awareness 
initiatives such as the annual National Safe Boating Week Campaign, the 
Coast Guard is seeking to increase boater awareness of the importance 
of wearing PFD.
    One PFD manufacturer stated that unfortunately the public perceives 
non-Coast Guard-approved safety equipment as inferior equipment. The 
comment pointed out the fact that the Coast Guard has not tried to 
prohibit, and has even strongly recommended that crew members working 
on deck on commercial vessels wear some type of PFD, including 
inflatable lifejackets which are not approved. To remedy this problem, 
the comment asked the Coast Guard to consider changing the PFD 
regulatory language from U.S. Coast Guard ``Approved'' to U.S. Coast 
Guard ``Required.''
    The Coast Guard agrees that generally, unapproved equipment is 
better than no equipment. However, unapproved equipment does not 
satisfy inspection or equipment requirements. The Coast Guard 
acknowledges the public's misperception regarding products that are not 
``Coast Guard-approved''. However, the Coast Guard is not adopting the 
recommendation to change ``Approved'' to ``Required.'' Such a change in 
terminology would be misleading because it would imply that many items 
of equipment which are available options for meeting the carriage 
requirements would be ``required'' on vessels. Moreover the change is 
not likely to correct the misperception.
    The comment also recommended that inflatable PFDs be considered as 
substitutes for inherently buoyant PFDs only in situations in which the 
vessel has space limitations which do not allow for the carriage of 
traditional Coast Guard-approved PFDs. The comment stated that all 
vessel operators should be allowed to petition the Coast Guard for an 
exemption from PFD carriage requirements which would allow the vessel 
to substitute inflatable lifejackets for traditional Coast Guard-
approved PFDs. The comment further suggested that granting such an 
exemption be conditioned on the vessel operator's completion of an 
educational course in the use and maintenance of inflatable 
lifejackets.
    The Coast Guard is not adopting these recommendations because the 
administrative burdens associated with granting individual exemptions 
and determining ``space limitations'' for all boat types would be 
unmanageable. Inflatable PFDs will be allowed to be carried in place of 
inherently buoyant devices based on their approval type (I, II, III, or 
V), with only Type Vs having some condition on their carriage. PFD 
types are discussed later in this preamble under ``PFD Approval Type 
vs. performance type''. Also, approval is limited to persons at least 
16 years of age and weighing more than 80 pounds. This limitation to 
adults is deemed necessary to restrict the use of these devices to 
those who are capable of using them in an emergency situation. As 
discussed above, the need for education will be addressed by pamphlets 
and manuals provided with the PFDs.
    Another PFD manufacturer cautioned against drafting fully 
inflatable PFD standards that would result in only unaffordable, 
``high-tech'' Coast Guard-approved inflatable PFDs.
    The Coast Guard agrees and is adopting standards for a range of 
devices with the minimum safety requirements necessary to meet the 
various needs of most recreational boaters.
    The boat manufacturer stated that inflatable PFDs are far easier to 
adjust than the approved PFDs now available, noting that this feature, 
among others, contributes to the convenience of inflatable PFDs and 
would increase their potential for use.
    The Coast Guard agrees with this comment. This IFR adopts standards 
intended to ensure that inflatable PFDs continue to have body straps 
and closures which are easy to adjust.
    The comment received from the cruise ship line noted that it 
operates two coastal cruise ships which carry 106 and 138 passengers 
respectively. According to the cruise line, ``expedition'' type cruises 
involve ferrying passengers in tenders to visit remote areas. All 
passengers are required to don PFDs before boarding the tenders. The 
comment stated that the ability to use less bulky inflatable PFDs would 
greatly enhance the process and improve passenger comfort.
    It must be noted that vessels operating as cruise ships are covered 
by PFD carriage requirements for commercial passenger carrying vessels, 
which are not the subject of this rulemaking project. The inflatable 
PFDs for such types of service may be approved under existing 
regulations in 46 CFR 160.176.

Specific Comments on Issues Raised in the ANPRM Self Inspection by 
Means of Indicating Devices

    The ANPRM stated that because recreational boaters do not always 
maintain inflatable PFDs in an overall serviceable condition, the 
inflation system should include an ``indicating device'' which would 
allow the boater to be reasonably sure that the PFD is ready to 
function and perform when used, or to identify whether the inflatable 
PFD requires servicing or rearming.
    One PFD manufacturer asserted that although a self-inspecting 
inflation system will indicate if the unit needs to be rearmed, the 
boater still has to be relied upon to look at the indicator each time 
the PFD is donned. Further, no self-inspection system will prevent a 
boater from donning a disarmed PFD.
    The Coast Guard acknowledges that self-inspection systems do not 
guarantee that boaters will not don a disarmed PFD. However, because of 
the ease of inspection, it is the Coast Guard's position that these 
systems will greatly assist boaters in determining whether their 
inflatable PFD is properly armed and will promote more frequent checks 
on the status of inflation systems. Making the task of checking the 
status of the inflation system easy, and maximizing the chances of 
making a correct determination, are two key elements in improving the 
readiness and safe use of inflatable PFDs. Accordingly, the standards 
adopted by this IFR require one of two levels of performance for self-
inspection systems that are designed with features to promote ease of 
use.
    The comment also stated that the new specifications should not 
prohibit the use of disposable, one-time inflation systems that can be 
replaced after each use, when the indicator shows that the inflation 
system has been used.
    The Coast Guard notes that disposable inflation mechanisms are 
currently the only available inflation systems that can provide 
complete arming status indication and the standards adopted in this IFR 
allow for the use of disposable inflation systems.
    A comment from another PFD manufacturer agreed with the 
desirability of self-inspection, but stated that any such requirements 
would be beyond the ``state-of-the-art,'' because there is no known 
reliable method to indicate the state of the CO2 cylinder charge 
without removing the cylinder and inspecting the piercing face for 
evidence of a puncture. Therefore, the [[Page 32840]] comment considers 
the ability to determine cylinder charge status as part of the self-
inspection criteria to be an unreasonable requirement.
    The Coast Guard disagrees. As stated above, affordable, disposable 
inflators have been made that accomplish this task, making such a 
requirement reasonable. Additionally, reusable inflators have been 
demonstrated which should be available in the near future.
    Another issue raised by this PFD manufacturer was that the 
inflatable PFD standard should not attempt to anticipate unlikely 
misuse, such as reinstallation of a spent cylinder, in the self-
inspection requirements.
    The Coast Guard notes that according to the PFD studies cited 
previously, users may have frequently reinstalled spent cylinders. The 
Coast Guard agrees that because of the limited number of systems 
available at this time which are capable of indicating the 
reinstallation of a spent cylinder, the standards should not require 
that all systems have such a capability. Only unconditionally approved 
PFDs (Type I, II, and III) must be capable of indicating this common 
misuse whether intentional or unintentional. Therefore, on these PFDs 
which do not have conditional approval, boaters will get the extra 
assurance of inflators that minimize possible misuse.
    Three comments from PFD manufacturers suggested that available 
inflation mechanisms which indicate the activation of automatic or 
manual inflation systems by the presence or absence of a pin or clip, 
or a port window subject to a change in color are sufficient to 
indicate that the cylinder has been spent.
    The two independent inflatable PFD studies mentioned above have 
shown the need for better human factors design in these systems. Under 
this IFR, the Coast Guard is adopting standards for systems that 
utilize user-installed pins or clips as a lower performing indicating 
system. The Coast Guard will continue to review new systems as they 
become available and, when appropriate, adopt upgraded standards as 
more designs become available that improve the chances of correct 
status determination of inflation system readiness.
    These same PFD manufacturers stated that self-inspection issues are 
best addressed in user manuals or labels on the inflatable PFD rather 
than through standards on PFD designs. The Coast Guard disagrees. While 
instructions and labels can help, they are a poor substitute for 
designs of emergency equipment that take human nature into account. 
Systems designed with good human factors have indicators that most 
users understand instinctively and aid in proper rearming and operation 
of PFD inflation systems, thereby enhancing the PFD's lifesaving 
potential.

PFDs Approved Only When Worn.

    In a discussion of the public's expected acceptance of inflatable 
PFDS, the November 9, 1993 ANPRM discussed industry's experience in 
marketing hybrid PFDs. The ANPRM stated that the hybrid PFD's lack of 
wide usage by the public may be due to the fact that hybrid PFDs do not 
count toward the satisfaction of carriage requirements unless they are 
worn. PFDs with such ``conditional approval'' are labelled ``approved 
only when worn''. This requirement was intended to ensure that these 
PFDs are properly maintained. The ANPRM suggested that if the inflation 
systems of inflatable PFDs were required to have indicating devices to 
show if the inflation system requires servicing or re-arming, the Coast 
Guard would consider not requiring inflatable PFDs to be worn. The 
ANPRM further suggested that an inflatable PFD which lacks an 
indicating device could be labelled as a Type V PFD and be approved 
only when worn, to increase the likelihood that such inflatable PFDs 
are maintained in a serviceable condition.
    Nearly all of the PFD manufacturers and the boat owners association 
were opposed to an ``approved only when worn'' requirement for 
inflatable PFDs, because requiring constant wear would be a deterrent 
to buyers. Another comment from a PFD manufacturer stated that an 
``approved only when worn'' criterion does not ensure that boaters will 
inspect their PFDs as was implied in the discussion of this issue in 
the ANPRM.
    The Coast Guard agrees that boaters were discouraged from buying 
those hybrid PFDs which are ``required to be worn,'' and that such a 
requirement only indirectly helps to encourage boaters to inspect their 
PFDs. Further, fewer sales of highly wearable inflatable PFDs will 
frustrate the Coast Guard's goal of increasing the total number of 
people wearing PFDs. Moreover, as discussed above, there have been many 
improvements to inflatable PFD designs. Therefore, the standards 
adopted by this IFR provide for approval of inflatable Type I, II, and 
III PFDs without conditions on their approval.
    However, the Coast Guard notes that several factors contributed to 
the negative reaction to conditional approval of hybrid PFDs. For 
instance, the hybrid PFD designs were hot, bulky, and expensive. It is 
the Coast Guard's position that conditional approval can play a 
valuable role in the approval of unique and novel inflatable PFD 
designs which are much more cool, comfortable and less expensive than 
the hybrid designs. This role is discussed below under ``PFD lifesaving 
potential evaluation'' in the discussion of rules section.
    A comment from the boat manufacturer stated that regulations need 
to be adopted requiring PFDs to be worn whenever an engine is in use, 
rather than the current requirement for PFDs to be on board.
    The Coast Guard, in a future rulemaking, may consider a requirement 
for boaters to wear a PFD whenever the engine is running for specific 
PFD designs on a case-by-case basis during approval, and will consider 
the desirability of wider application of such a restriction in the 
future.
    Another comment from a PFD manufacturer argued in favor of rules 
requiring individuals to wear a PFD, and allowing for the use of non-
approved devices, including inflatables.
    The Coast Guard is not adopting this suggestion. While Coast Guard 
regulations do not prohibit the carriage and use of non-approved PFDs, 
carrying such devices does not count toward meeting the carriage 
requirements. The quality and performance of PFDs that do not meet any 
specified standards is uncertain. The Coast Guard's position continues 
to be that in order to achieve the minimum acceptable level of safety 
and meet operational needs, only Coast Guard-approved devices, which 
must meet specified safety criteria, should be counted toward carriage 
requirements. A poorly manufactured device could fail to provide needed 
assistance, or a poorly designed device could actually perform such 
that the user is worse off than having no PFD.

Inflatable PFD Types

    The ANPRM also stated that approval of Type I and II, as well as 
Type V inflatable PFDs with conditions on their use or that are 
intended for use in specific activities, will provide more choices 
suitable for a variety of different boating activities.
    One comment from a PFD manufacturer stated that the Coast Guard 
should allow for approval of several inflatable PFD types rated at 
different levels of performance. The comment suggested that the highest 
performance inflatable PFD provide 35 pounds (150 N) of buoyancy, have 
dual chambers, an automatic, self-inspecting inflation system, and a 
high strength harness and lifting becket. The lowest performance 
inflatable PFD, according [[Page 32841]] to the comment, should provide 
17 pounds (75 N) of buoyancy, have a single chamber, manual inflation 
with no requirements for a self-inspecting inflation system, a lower 
strength plastic buckle, and its use would be restricted to inland, 
protected waters.
    The Coast Guard generally agrees with this comment and the concept 
of approving several types of PFDs (as discussed elsewhere), and 
standards for several types of devices are adopted in this IFR. 
However, the Coast Guard does not plan to approve PFDs with levels of 
performance which are as low as the manufacturer suggested.
    In addition, while allowing lower performing PFDs and restricting 
their use to certain waters appears desirable, there is presently no 
workable scheme for implementing such a concept. Therefore, the Coast 
Guard seeks comments on the desirability of future development of 
standards for such lower performing devices and appropriate 
restrictions to place on their use, such as the types of waters on 
which such devices should be allowed.
    Another PFD manufacturer stated that inflatable PFDs should be 
required to provide in-the-water survival characteristics which are at 
least equivalent to those currently required for approval of a Type I 
PFD. According to the comment, the difference in bulk between an 
inflatable PFD which provides 16 pounds (70 N) of buoyancy and one 
which provides 35 pounds (150 N) is not significant enough to affect 
wearability and therefore the Coast Guard should consider requiring 35 
pounds of buoyancy for inflatable PFDs to enhance safety. The comment 
also suggested that type classifications for inflatable PFDs should be 
based upon characteristics, other than buoyancy and associated in-the-
water performance, such as strength and intended use.
    In the standards adopted by the Coast Guard in this IFR, Type II 
PFDs are required to have an automatic inflation system and the same 
buoyancy as Type I inflatables (150 N). Therefore, Type II PFDs have 
in-water survival characteristics equivalent to current Type I PFDs, 
but, unlike Type I PFDs, have only one inflation chamber. Type III PFDs 
have the same buoyancy as Type I inherently buoyant PFDs (100 N, 22 
lb), but have less ability to turn the wearer face-up, and some designs 
may require the user to actuate the inflation system in order to float. 
Provision of a high strength harness and lifting becket is optional for 
all Types of inflatable devices. A range of Type V devices provide 
lower inflation system serviceability and indicator requirements than 
Types I, II and III inflatables. Belt-pack style designs which may 
require the user to complete the donning process after inflation, even 
after falling in the water, may also be approved under the alternate 
``Life-Saving Index'' (LSI) procedures and might be either Type III or 
Type V devices with conditions on their approvals such as approved only 
when worn. (LSI procedures are discussed below under ``PFD lifesaving 
potential evaluation'' in the ``Discussion of Rules'' section.)
    Another comment from a PFD manufacturer suggested that for a Type V 
inflatable PFD, manufacturers should be allowed to claim Type II 
performance when fully inflated, even if an automatic inflation system 
is not provided.
    The Coast Guard agrees. Under this IFR the label on a Type V PFD 
described by the comment may explain that the device provides Type II 
in-water performance only after being inflated by the user.

Two Inflation Chambers

    The ANPRM asked whether the standards should exempt all but the 
highest performing inflatable PFDs (Type I) from the requirement for 
two chambers, thereby reducing the cost of inflatable PFDs intended for 
most recreational boaters.
    Four of the PFD manufacturers and the boat owners association 
agreed that the requirement for two inflation chambers should apply to 
Type I devices only. The Coast Guard agrees, and this IFR the Coast 
Guard adopts standards which limit the requirement for two chambers to 
Type I inflatable PFDs.
    A PFD manufacturer asserted that dual chamber inflatable PFDs 
should have 100 percent redundant systems. The comment suggested that 
allowing dual chamber inflatables with a common membrane, rather than 
completely independent systems, seems to conflict with the purported 
reason for having dual chambers: to ensure that if any aspect of one 
system within a chamber fails, the other chamber will not be affected.
    While the Coast Guard agrees that completely independent chambers 
would provide an additional small increment of redundancy and thereby 
safety, such a requirement would present design problems and increase 
cost. For independent chambers to add significantly to the safety of 
the device, they would need to be separated by a cut- and puncture-
resistant layer, which could significantly reduce the wearability of 
inflatable PFDs. Therefore, it is the Coast Guard's position that the 
benefits of a requirement for a 100 percent redundant system are 
outweighed by the negative impacts on design and costs. However, 
manufacturers may provide such a system.

Restrictions for Non-Swimmers and Children

    The ANPRM solicited comments regarding appropriate restrictions to 
be placed on the use of inflatable PFDs by non-swimmers and children; 
whether an automatic inflation mechanism should be required on PFDs 
designed for non-swimmers and children; or whether there should be no 
approval of inflatable PFDs for people in these categories.
    One PFD manufacturer and the boat owners association stated that no 
restrictions should be placed on the use of inflatable PFDs by non-
swimmers or children. However, another PFD manufacturer noted that in 
attempting to design inflatable PFDs suitable for children, unique 
design problems would arise, such as a need for tamper-proofing. This 
comment concluded that at present, inflatable PFDs are not suitable for 
children. Another PFD manufacturer suggested allowing for orally 
inflatable PFDs for children. According to this comment, an adult would 
partially inflate the PFD prior to the child boarding the boat, 
providing the child with ``inherent buoyancy''. Two other PFD 
manufacturers suggested postponing development of approved inflatable 
PFD types for children. One of those comments stated that the 
desirability of an inflatable PFD standard for children should be 
considered only after a review of acceptance and reliability data 
gathered on adult users.
    The Coast Guard agrees with those comments that suggested that 
approval of inflatable PFDs for children is not appropriate at this 
time. The Coast Guard does not share the view that a partially inflated 
PFD provides inherent buoyancy. The issue of inflatable PFDs for 
children can be revisited after more experience is gained with the 
approval of inflatable PFDs for adults. Accordingly, this IFR adopts 
standards that address inflatable PFDs for adults only.
    One of the PFD manufacturers also suggested that a ``child'' be 
classified as a person under 12 years of age. The Coast Guard's 
position is that, because of the importance of understanding how to 
properly use PFDs, only persons over 16 years of age are considered 
adults.
    Regarding non-swimmers, one PFD manufacturer was opposed to a 
requirement for an automatic inflation [[Page 32842]] mechanism for 
non-swimmers and asserted that even the best automatic systems are 
prone to misfires or failures to fire. Several PFD manufacturers' 
comments seemed to favor requiring PFDs with automatic inflation 
mechanisms. One of those manufacturers favoring a requirement for an 
automatic inflation mechanism for non-swimmers suggested that 
alternatively, a non-swimmer should be required to wear the inflatable 
PFD fully inflated. Inflatable PFDs for non-swimmers, according to one 
of the manufacturers should provide a minimum of Type I performance. 
Two of these manufacturers pointed out, however, that law enforcement 
agencies will not be able to make a determination concerning a person's 
swimming abilities.
    The Coast Guard acknowledges that there is no practical way that 
law enforcement officials can conduct a field assessment of swimming 
abilities. This would make a restriction against use by non-swimmers 
unenforceable. Therefore the Coast Guard is not placing any 
restrictions on the use of inflatable PFDs by non-swimmers.
    One PFD manufacturer favored revising the PFD pamphlet to make 
boaters aware of the PFD's limitations by suggesting that they select 
an automatically inflatable PFD. Similarly, the boat owners association 
stated that non-swimmers should be made aware of the limitations of an 
inflatable PFD on the package at the point of purchase.
    In this interim final rule, the labeling and PFD information 
pamphlet for these PFDs are required to explicitly state that the 
devices are not recommended for use by non-swimmers.
    The Coast Guard considers the marking required to be on the PFDs 
and the required owner's manual and information pamphlet sufficient to 
inform adult non-swimmers of the pertinent facts regarding PFDs to 
enable them to make an informed choice when purchasing a PFD. The Coast 
Guard will review PFD information pamphlets to ensure that they include 
a clear statement regarding the risks a non-swimmer faces in using a 
particular type of inflatable PFD.

Self-Inspecting Inflation Systems

    The ANPRM also asked about the average boater's ability to 
determine whether an inflatable PFD is in a serviceable condition if it 
has a ``self-inspecting'' inflation system.
    Three PFD manufacturers and the boat owners association indicated 
that most recreational boaters have the ability to perform simple 
checks and tests to determine if a PFD is in a serviceable condition, 
even if it has only the simplest of indicators.
    The Coast Guard disagrees that most boaters can determine the 
condition of older style inflation systems (those inflators not meeting 
the higher standards adopted by this IFR). In an informal survey at the 
National Association of State Boating Law Administrators (NASBLA) 
annual meeting, only two out of 18 participants were able to correctly 
identify the serviceability of four older style inflation mechanisms. 
Therefore, in this IFR, the Coast Guard adopts new requirements and a 
new test for status indicator recognition which have been added to the 
UL standard adopted for inflation systems (UL 1191).
Inflatable PFD Complexity

    The ANPRM also asked whether inflatable PFDs are too complicated 
for some people to operate in an emergency situation.
    Comments received on this issue from three PFD manufacturers and 
the boat owners association acknowledged that there will always be some 
individuals who do not understand mechanisms, and indicated that 
foolproof-PFDs cannot be designed. However, these comments contended 
that most boaters would be able to operate an inflatable PFD in an 
emergency situation. One of the comments stated that people who have 
difficulty responding in an emergency are the ones who will refrain 
from choosing an inflatable PFD. Another PFD manufacturer felt that 
there is a greater likelihood that an inflatable PFD will be worn in 
anticipation of an emergency which removes the complication of donning 
it under the extreme conditions of an emergency.
    It is the Coast Guard's position that a strong Federal, State, and 
industry education effort is important in order to minimize unintended 
outcomes associated with people panicking upon sudden immersion or upon 
the malfunction of a manual or an auto-inflation mechanism. The 
marking, pamphlet, and manual instructions required to be provided with 
the PFDs will contribute significantly to this needed education. The 
Coast Guard will review the warning statements to ensure that the 
public is given sufficient information to enable them to determine 
whether use of an inflatable PFD is appropriate.

Inflatable PFD Costs

    The ANPRM also asked for comments on what price the average boater 
will pay to purchase an inflatable PFD.
    One PFD manufacturer stated that wide use of approved inflatable 
PFDs will occur only if they are priced much lower than the current 
non-approved inflatable PFDs. With their obvious advantages, according 
to the comment, inflatable PFDs are significantly more expensive than 
inherently buoyant PFDs that are sold at discount stores for less than 
15 dollars. Based on the company's market research, the manufacturer 
feels that the lowest performance inflatable PFD providing 17 pounds 
(75 N) of buoyancy, a single chamber, a plastic buckle harness (with 
approximately 150 pound (670 N) breaking strength), and a manual 
inflation system, must be priced at less than $40 in order for the 
industry to see growth in the market. A single cell inflatable PFD 
providing 35 pounds (150 N) of buoyancy with an automatic inflation 
mechanism and plastic buckles must be priced at less than $95.
    Two other comments from PFD manufacturers stated that it is 
unlikely that inflatable PFDs can be sold at a price which compares 
favorably with the price of existing inherently buoyant PFD types, but 
that sales of automatics with many features are more than double the 
sales of basic, manually inflated models. According to one of the 
comments, consumers tend to measure value according to obvious features 
of the inflatable PFD, rather than basic characteristics. Also, 
according to the comment, consumers may tend to consider all inflatable 
PFDs as equivalent, regardless of PFD type classification.
    Another comment from the boat owners association stated that the 
price for an approved inflatable PFD should be comparable to currently 
available Type I and II PFDs. Another PFD manufacturer stated that 
while some boaters will spend $150 or more for an inflatable PFD, the 
average boater will probably only pay $25 to $50 depending on features.
    The challenge, according to one of the other PFD manufacturers will 
be to avoid driving up costs by placing burdensome approval 
requirements on devices, such as increased numbers of chambers and high 
levels of destructive testing per lot manufactured. The comment also 
suggested that the higher cost of an inflatable PFD may encourage 
purchasers to properly care for their PFDs.
    The Coast Guard generally agrees with most of the comments but 
notes that there is no evidence which indicates that the high cost of 
an inflatable PFD will encourage proper care. The Coast Guard 
appreciates the cost and pricing information supplied by the comments. 
Such information is useful in [[Page 32843]] developing standards that 
are cost efficient and in conducting regulatory evaluations. However, 
it should be understood that the Coast Guard has no authority to 
implement, nor will it engage in, regulation or other control of the 
price of inflatable PFDs, beyond avoiding the imposition of costly 
requirements for these PFDs that do not further the goal of achieving 
an appropriate level of safety.

Service Life for Inflatable PFDs

    The ANPRM asked about the useful Service life that should be 
expected of inflatable PFDs.
    A PFD manufacturer stated that based on the company's experience 
with inflatable aviation life vests, the average, well-maintained 
inflatable PFD has a useful service life of just under 10 years. 
According to this comment, generally, within 10 years, an inflatable 
PFD will be rendered non-serviceable due to fabric seal failure or 
fabric deterioration. This comment further explained that inflatable 
PFDs that are not well-maintained will fail due to holes or punctures 
within an average of five years. Another PFD manufacturer estimated a 
service life of at least eight years. A third PFD manufacturer stated 
that an inflatable PFD should have a service life of three years or 
more if properly maintained. Another comment from the boat owners 
association indicated that service life will be determined by the 
quality of care provided to the PFDs.
    The Coast Guard is not prescribing a useful service life for 
inflatable PFDs. Instead, each manufacturer is given the flexibility to 
determine the service life appropriate to each inflatable PFD model and 
the manufacturer is required to state that service life in the owner's 
manual. The manufacturer must also provide information concerning 
appropriate care and storage of an inflatable PFD which will minimize 
damage or deterioration in the boating environment. The service life 
specified by the manufacturer is not an ``expiration date'' after which 
the PFD is no longer considered approved or serviceable. Rather, it is 
a guide for consumers making decisions about which PFD to buy, and how 
long they can expect it to be serviceable under the conditions 
described by the manufacturer.

Professional Servicing

    The ANPRM asked whether a requirement for professional servicing of 
inflatable PFDs at ``approved'' servicing facilities would be 
appropriate.
    Three inflatable PFD manufacturers supported professional PFD 
servicing; however, they suggested that professional servicing should 
not be mandatory and that the Federal government should not set up 
inspection facilities at taxpayer expense. Instead, the comments 
suggested that professional servicing be recommended rather than 
required and that the services be offered by the manufacturers or 
through licensed agents or both. One of these comments stated that the 
required owner's manual should provide instructions for owner 
inspection and identify where the owner can obtain help if needed. This 
comment further suggested that a fee schedule for common servicing 
procedures be provided if a manufacturer's toll free boater ``help 
line'' is not provided. Another of these comments stated that the Coast 
Guard should recommend annual user inspection for air leaks and that 
the manufacturer should offer servicing biannually at an affordable 
fee. The comment also stated that after 10 years the chamber should no 
longer be serviced and replacement should be recommended.
    Another comment from the boat owners association stated that 
professional servicing would be unnecessary if quality is held to a 
high standard, and that requiring professional servicing would greatly 
increase the cost of owning an inflatable PFD.
    The Coast Guard is not requiring professional servicing at this 
time. The PFD owner's manual is required to address both user servicing 
and provide information on how to obtain professional servicing. The 
Coast Guard strongly encourages manufacturers to offer professional 
servicing and to recommend it, in the owner's manual, no later than 
four years from the date of manufacture.
Discussion of Rules
    The requirements for inflatable PFDs for use by recreational 
boaters adopted by this IFR are based primarily on the UL industry 
consensus standard discussed earlier and existing regulations for 
hybrid and inflatable PFDs. In several areas the regulations depart 
from these requirements as discussed below.
Approval Procedures
    Many subparts of part 160 covering recreational PFDs require the 
use of recognized laboratories in conducting the tests and inspections 
required during the approval process. This rule requires that 
recognized laboratories enter into a memorandum of understanding (MOU) 
with the Coast Guard before conducting any approval activities with 
respect to an inflatable PFD. The NPRM (CGD 93-055) published elsewhere 
in today's edition of the Federal Register proposes the same 
requirement for other recreational PFDs. That NPRM contains a detailed 
discussion of the MOU requirements. The Coast Guard may modify the 
approval procedures for inflatable PFDs after consideration of the 
comments on the NPRM (CGD 93-055).
PFD Lifesaving Potential Evaluation

    As an alternative to meeting the minimum performance requirements 
in UL 1180 as modified by this IFR, the Coast Guard, is allowing for 
the approval of PFD designs that have been evaluated according to the 
design's overall lifesaving potential. Each design would be evaluated 
against the ``Life-Saving Index'' (LSI). Under this method, specified 
characteristics are evaluated using a formula that would result in a 
number between zero and one. This number represents the design's 
lifesaving potential. For example, a device with an LSI of 0.43 would 
provide the user with a 43 percent chance of surviving an accident in 
which there is a potential for drowning. The Coast Guard has developed 
an initial set of LSIs for a number of currently approved PFD's and 
several broad categories of inflatable PFDs. A report of this work is 
included in the docket file for this rulemaking. To ensure that the 
characteristics of the PFD designs approved actually increase the 
probability that the PFDs reduce drownings in recreational boating, 
only designs that are found to have an LSI that is at least equal to 
the LSI of a Type III inherently buoyant device would be approved.
    Using the formula in Sec. 160.076-27, the Coast Guard has 
calculated the LSI for a Type III inherently buoyant PFD after 
assigning values for the terms in the LSI equation. The Coast Guard has 
established 0.375 as the LSI for this type of PFD. The assigned values 
are based on the characteristics of that PFD design and are included in 
the regulatory evaluation on file for this rulemaking. As provided by 
Sec. 160.076-27, the Coast Guard will review the values used to 
calculate the Type III inherently buoyant PFD LSI annually, and publish 
any change of the LSI based on new boating statistics or other updated 
information.
    A manufacturer seeking approval using the LSI evaluation will 
assign values to the various terms of the LSI equation which represent 
the various characteristics of the intended users and the PFD design, 
such as whether the likely users are swimmers or non- 
[[Page 32844]] swimmers; the chances that the PFD will be worn; and the 
probability that the inflation system will be properly activated. The 
values assigned for the characteristics of the manufacturer's proposed 
design would be reviewed by the recognized laboratory. The LSI equation 
would then be solved for the design. If the LSI of the manufacturer's 
design equals or exceeds the Coast Guard's assigned LSI value for a 
Type III inherently buoyant PFD, the manufacturer would submit to the 
Commandant the calculations, the values assigned to each term, 
statements justifying those values, and an explanation of any 
assumptions used in performing the calculation. The Commandant would 
review the material submitted by the manufacturer. The Commandant may 
then approve designs determined to validly demonstrate an LSI that is 
at least equal to the Coast Guard's assigned LSI of a Type III 
inherently buoyant design. The designs approved under the LSI 
evaluation method would not be required to meet certain provisions of 
the construction and performance requirements of Sec. 160.076-23 and 
approval testing requirements of Sec. 160.076-25.
    One way to increase the LSI of a design is to require that the PFD 
be worn, and, accordingly, obtain approval for the device as a Type V 
PFD. For instance, preliminary calculations show that a belt-pack style 
PFD without conditional approval may have an LSI of 0.35. However, when 
the same PFD is approved only when worn, the belt-pack style PFD might 
have an LSI of 0.67. Therefore, manufacturers may designate conditions 
concerning use to achieve the LSI of a Type III inherently buoyant PFD. 
Manufacturers are free to fashion other methods that will enable their 
designs to achieve the required minimum LSI and submit the information 
for Commandant review.
    The Coast Guard anticipates that examples of designs that would be 
readily approved under the UL requirements as modified by this IFR are: 
Type I with automatic inflation and indicator (of cylinder seal); Type 
II with automatic inflation and indicator. Examples of designs that 
would probably not meet the UL requirements as modified by this IFR but 
that may be able to be approved under the LSI evaluation are: Type III 
PFDs with type II performance, but with manual inflation and indicator; 
Type III yoke style PFDs with automatic inflation and indicator; Type V 
PFD with type II performance and automatic or manual inflation but 
without indicator (of cylinder seal); Type V yoke style PFD with type 
III performance and automatic inflation but without indicator; Type V 
yoke style PFD with performance type III and with manual inflation, 
with or without indicator; and Type V belt-pack style PFD with 
performance type III.
    With the LSI evaluation, the Coast Guard will be able to approve 
unique and novel designs that offer lifesaving potential equal to or 
greater than that of approved devices, but that otherwise would not be 
made available to the boating public. These designs may prove to be 
very comfortable, affordable and popular with the boating public, and 
thereby increase the number of recreational boaters who wear PFDs. This 
will result in an increase in lives saved.
    Because the designs approved under the LSI evaluation will be new 
and perhaps novel, the Coast Guard, manufacturers, and the public will 
not have the same level of experience and knowledge with the designs 
that they have with devices approved under the UL requirements as 
modified by this IFR. Therefore, to ensure that only designs that 
provide a sufficient level of safety to the boating public continue to 
hold Coast Guard approval, the Commandant will annually review the 
designs approved under the LSI evaluation. At that time, the devices 
will be compared to other approved devices and the Coast Guard will 
evaluate the relative weight and values of the various characteristics 
that were initially used in the LSI calculation. Recognized 
laboratories will maintain a ranking of the PFDs approved under this 
method and submit the information to the Commandant to assist in the 
annual reviews. If after the review the Coast Guard determines that the 
device does not provide a minimum level of lifesaving potential as 
required by Sec. 160.076-27, the approval on that design may be 
terminated or suspended. To retain Coast Guard approval, the PFD design 
would have to be modified to meet the requirements of Sec. 160.076-27. 
However, if an approval is terminated or suspended, the manufacturer's 
inventory of completed PFDs could continue to be sold unless the Coast 
Guard determines that the design presents a significant hazard to users 
of those PFDs.

User Awareness

    The biggest problem in reducing the approximately 670 recreational 
boating drownings annually is that of getting the individual boater to 
take the preventive measure of wearing a PFD and, in the case of an 
inflatable PFD, keeping it in a serviceable condition. The approval of 
inflatables is not intended to make it easier for boaters to satisfy 
PFD carriage requirements, but rather to encourage boaters to change 
their current behavior patterns and provide them with a more convenient 
means to protect themselves from the tragedy of a serious boating 
accident. In establishing the LSI evaluation and conditional approvals, 
the Coast Guard hopes to approve new and unique designs that will 
encourage the wearing of PFDs by a greater number of boaters. This wide 
range of options should encourage boaters to make informed decisions 
that could save their lives.
    The Coast Guard seeks to develop an incentive system to get both 
boaters and manufacturers more involved in preventing drowning. As 
mentioned above, manufacturers will be able to obtain conditional 
approvals for PFDs which might otherwise fail to meet some of the more 
stringent requirements. The practical effect for boaters purchasing 
PFDs with conditional approvals which, for example, are approved only 
when worn, is that boaters will be given the option of buying a less 
expensive PFD. The manufacturer will be responsible for clearly 
communicating the boater's responsibility for compliance with the 
approval conditions or, if the boater fails to comply with the 
conditions, the need to provide an additional PFD, without conditional 
approval, to meet the carriage requirements.
    Since boaters appear to prefer unconditionally approved PFDs, this 
system will encourage manufacturers to develop innovative ways to 
increase the lifesaving potential of PFDs without relying on 
conditional approval.
    Also, conditional approval used in this way will raise the 
awareness of boaters as to what they can do to contribute to improving 
boating safety, and will give them more freedom of choice.

PFD Information Pamphlet

    Title 33 CFR 181, subpart G requires that an information pamphlet 
be provided with each PFD sold or offered for sale for use on 
recreational boats. UL standard 1180 does not yet contain pamphlet 
requirements for inflatable PFDs. However, UL has reserved a section 
and plans to add the pamphlet requirements at a later date. When an 
industry standard is available for such pamphlets the Coast Guard will 
review it and, if appropriate, propose it for incorporation in the 
Coast Guard rules. Section 160.076-35 established by this IFR requires 
inflatable PFD manufacturers to provide information pamphlets that have 
been submitted to and approved by the Commandant. The purpose of the 
information pamphlet is [[Page 32845]] to ensure that prospective PFD 
purchasers receive information at the point of purchase necessary to 
select PFDs that are appropriate for them and their boating activities. 
Factors for boaters to consider include their body type, ability to 
swim, and the types of activities in which they will participate. The 
manufacturer is required to include an explanation in the pamphlet of 
the necessity to maintain an inflatable PFD in operational condition, 
and that if the user fails to appropriately maintain an inflatable PFD, 
it will not provide adequate safety.
    Information in the pamphlets must be accessible to the prospective 
buyer at the point of sale. Once a pamphlet's contents are approved, 
each pamphlet provided by the manufacturer for the same PFD design must 
be printed exactly as approved by the Commandant or recognized 
laboratory. A sample layout with text is provided in appendix I to this 
IFR and copies may be obtained by contacting the Commandant as directed 
under FOR FURTHER INFORMATION CONTACT.

Owner's Manual

    The owner's manual required by UL 1180 and Sec. 160.076-37 must be 
submitted to the Coast Guard or recognized laboratory for review and 
approval. The Coast Guard will review the manual to ensure that it 
meets the requirements of Sec. 160.076-37 and UL 1180. The owner's 
manual must warn against hazardous misuse, such as wearing the PFD 
under restrictive clothing. This IFR allows the pamphlet and owner's 
manual to be combined if selection and warning information are included 
on the PFD packaging.

PFD Approval Type vs. Performance Type

    As written, UL 1180, which covers only wearable PFDs, designates 
PFDs in terms of their ``performance type''. The current Coast Guard 
PFD approval system designates PFDs in terms of a combination of the 
PFD's in-water performance and other characteristics. The Coast Guard 
approval types are: Types I, II, and III which are all wearable PFDs 
that have different in-water performance characteristics; Type IVs, 
which are all throwable PFDs; and Type Vs, which all have conditions on 
their approvals. Both the UL standard and this IFR introduce an 
additional classification factor forinflatable PFDs, i.e., their level 
of maintainability and serviceability.
    This IFR departs from the UL standard in two important ways, as 
discussed below.
    In the UL standard, PFDs with inflation system indicators with 2F 
and 3F use codes may be classified as performance Type II or III PFDs. 
However, the Coast Guard is requiring inflation system indicators with 
a 1F use code on all PFDs unless other features and methods are used to 
achieve the minimum LSI required by Sec. 160.076-27. It is the position 
of the Coast Guard that a design with an inflation system indicator 
with 2F or 3F use code needs additional features to achieve adequate 
overall lifesaving potential, as discussed in the regulatory analysis 
on file in the rulemaking docket.
    The other important departure from the UL standard in this IFR is 
that UL 1180 would allow belt-pack style PFDs that require secondary 
donning to be approved as performance type III PFDs. The Coast Guard's 
position, however, is that the difficulty in accomplishing second stage 
donning lowers the overall lifesaving potential of these PFDs. 
Therefore, additional features or methods are necessary to ensure that 
such a device provides adequate safety to the user. For example, a 
requirement that such PFDs be worn would elevate the LSI of the device 
such that it could be approved in accordance with the LSI requirements 
of Sec. 160.076-27.

Meeting Uninspected Commercial Vessel Carriage Requirements

    The Coast Guard is evaluating the desirability of allowing 
uninspected commercial vessels to use inflatable PFDs meeting the 
requirements of subpart 160.076 to meet the applicable PFD carriage 
requirements. Under the current regulations, these inflatable PFDs may 
only be carried and used on these vessels as additional equipment. 
Comments are therefore requested on two specific issues.
    For uninspected vessels not carrying passengers for hire, the Coast 
Guard encourages crew members working in exposed locations to wear a 
PFD. PFDs meeting the requirements of subpart 160.076 could be worn 
while working. However, it is the Coast Guard's position that these 
PFDs should not be the only type of PFD carried and used unless they 
have been shown to have adequate durability for the intended service. 
Commercial hybrid PFDs are more suitable as the only required PFD. The 
Coast Guard requests comments on this matter.
    Another matter on which the Coast Guard seeks comment pertains to 
uninspected vessels carrying passengers for hire. The Coast Guard is 
considering, as the subject of a future rulemaking, requiring the 
master to identify, by position, the person responsible for keeping the 
inflatable PFD devices serviceable and properly armed. Also, the Coast 
Guard seeks comments on whether the frequency of required inspections 
and checks should be established in the regulations. The Coast Guard 
seeks comments regarding these issues as well as the desirability of 
approving inflatable PFDs meeting the requirements of subpart 160.076 
as the sole PFD for each person on board.

Number of Lives To Be Saved

    In both 1992 and 1993, approximately 670 recreational boating 
fatalities due to drowning occurred each year. The Coast Guard 
estimates that if two-thirds of boaters wore the inflatable PFDs to be 
approved under this rule, there would be 210 fewer recreational boating 
fatalities due to drowning each year. Unfortunately, even if inflatable 
PFDs are accepted by boaters, it will take time for boaters to change 
their behavior and for inflatable PFDs to replace their current PFDs. 
There is also no guarantee that inflatable PFDs will be worn or that 
two-thirds of boaters will buy them. However, it is believed that by 
the end of 2007 approximately 210 lives per year can be saved if an 
average wear rate of 66 percent is achieved.

Other Additions and Exceptions to UL Standards

    In this IFR, the Coast Guard has supplemented the UL standards for 
inflatable PFDs and their components in several areas.
    In Sec. 160.076-3, the Coast Guard states that PFDs approved under 
subpart 160.076 may be used on recreational submersible vessels. Such 
PFDs would most likely be approved under the unique and novel 
provisions of the subpart as Type V PFDs.
    Under Sec. 160.076-21, inflation chamber materials must be of the 
same general quality as those used to pass the approval tests. Also, 
adhesives must be suitable for the intended application, and inflation 
mechanisms must be marked with a unique model number to prevent 
substitutions of less reliable devices (Sec. 160.076-31(f)).
    In Sec. 160.076-23, the design must not cause significant 
discomfort to the wearer during or after inflation; and fabrics must be 
treated to minimize unraveling.
    Donning time for unconditionally approved PFDs must be more 
carefully controlled than conditionally approved PFDs which are 
approved only when worn. In Sec. 160.076-25, donning time is relaxed 
for such conditionally approved PFDs because emergency donning should 
not be an issue. The PFD must [[Page 32846]] be able to be repacked by 
the test subjects used in the approval testing. Also, in this section 
the PFD must allow for good visibility by the wearer in the water, and 
survivor locating aids must be above the water. Finally, Type II PFDs 
must have an average freeboard of 110 mm (4.25 inches), which is 
consistent with Type I and III PFD requirements.
    In Sec. 160.076-39, required markings are specified for Type V 
conditionally approved PFDs. All inflatable PFDs must be marked with 
``not approved for use on commercial vessels'' and with the inflation 
system model number. Inflation systems must be marked with their unique 
model number to minimize the possibility of the user installing an 
inappropriate inflation system. Finally, in order to standardize a 
vital instruction, the manual inflation handle must be clearly marked 
``Jerk to inflate'' unless a universal symbol is used.

Production Quality Control and Laboratory Oversight

    Section 160.076-19 establishes production quality assurance and 
laboratory oversight requirements for inflatable PFDs that are 
essentially the same as the recently modified procedures for approval 
of hybrid PFDs in subpart 160.077 (59 FR 2482; January 9, 1995) with 
minor revisions to waterproof marking requirements.

Incorporation by Reference

    The following material is incorporated by reference in 
Sec. 160.076-11: Fully Inflatable Recreational Personal Flotation 
Devices (UL 1180), first edition, May 15, 1995; Components for Personal 
Flotation Devices (UL 1191), May 16, 1995; Marine Buoyant Devices (UL 
1123), February 17, 1995; American Society for Testing and Materials, 
ASTM D 751-79, Standard Methods of Testing Coated Fabrics, 1979; ASTM D 
1434-75, Gas Transmission Rate of Plastic Film and Sheeting, 1975; ASTM 
F 1166-88 Human Engineering Design of Marine Systems Equipment and 
Facilities, 1988; and Federal Standards, Federal Test Method Standard 
No. 191A, July 20, 1978. Copies of the material are available for 
inspection where indicated under ADDRESSES. Copies of the material are 
available from the sources listed in Sec. 160.076-11.
    The Director of the Federal Register has approved the material in 
Sec. 160.076-11 for incorporation by reference under 5 U.S.C. 552 and 1 
CFR part 51. The material is available as indicated in that section.

Regulatory Evaluation

    This rule is not a significant regulatory action under section 3(f) 
of Executive Order 12866 and does not require an assessment of 
potential costs and benefits under section 6(a)(3) of that order. It 
has not been reviewed by the Office of Management and Budget under that 
order. It is not significant under the regulatory policies and 
procedures of the Department of Transportation (DOT) (44 FR 11040; 
February 26, 1979).
    A Regulatory Evaluation under paragraph 10e of the DOT regulatory 
policies and procedures has been prepared and is available in the 
docket for inspection or copying where indicated under ADDRESSES. The 
Evaluation is summarized as follows.
    The requirements of this IFR open up a new marketing opportunity 
for inflatable PFD manufacturers by allowing them to obtain Coast Guard 
approval of recreational inflatable PFDs, if they so choose. The IFR 
will also allow boaters to purchase and use inflatable PFDs on their 
boats, if they wish to do so. Manufacturers may still make and sell 
unapproved inflatable PFDs, and boaters may continue to use such PFDs 
as additional equipment. Manufacturers who wish to obtain approval will 
have to pay for the approval testing at the recognized laboratory, pay 
the cost of the required quality control and oversight, and provide the 
information pamphlet and manuals required by this rule.
    The estimated total initial approval cost per inflatable PFD design 
is expected to be approximately $18,500, excluding the cost of 
inflation system acceptance which could be amortized over several 
designs of PFDs. Costs to approve other types of PFDs are approximately 
$6,000, excluding component acceptance costs. The additional cost to 
approve inflatable PFDs could easily be absorbed in the cost of the 
units produced. The cost increase per device would be small considering 
the number of devices which could be produced under authorization of 
each approval certificate. The Coast Guard anticipates that it will 
approve five to ten inflatable PFD designs within the first year after 
issuing this rule.
    Production inspection costs imposed by these regulations will be 
approximately $1,000 for the largest size lot of inflatable PFDs 
permitted. This cost is similar to that incurred for other types of 
approved PFDs.
    The retail cost, per device, is expected to be $50-$200 for 
inflatable PFDs. Currently approved PFDs range in price from $7-$200. 
Type I devices that could be replaced by inflatable PFDs have an 
average cost of about $40.
    If total costs for these requirements including overhead is $2.00 
per device, the total cost to the industry would be only $100,000 
annually if 50,000 units per year are produced. Comments are invited on 
this analysis.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the 
Coast Guard must consider the economic impact on small entities of a 
rule for which a general notice of proposed rulemaking is required. 
``Small entities'' may include (1) small businesses and not-for-profit 
organizations that are independently owned and operated and are not 
dominant in their fields and (2) governmental jurisdictions with 
populations of less than 50,000. This rule does not require a general 
notice of proposed rulemaking and, therefore, is exempt from the 
requirements of the Act. Although this rule is exempt, the Coast Guard 
has reviewed it for potential impact on small entities.
    The requirements of this IFR open up a new marketing opportunity 
for inflatable PFD manufacturers by allowing them to obtain Coast Guard 
approval of recreational inflatable PFDs. The IFR will also allow 
boaters to purchase and use inflatable PFDs on their boats. As 
discussed above, the economic impact of the new requirements are 
expected to be minimal.
    Therefore, the Coast Guard's position is that this rule will not 
have a significant economic impact on a substantial number of small 
entities. If, however, you think that your business or organization 
qualifies as a small entity and that this rule will have a significant 
economic impact on your business or organization, please submit a 
comment (see ADDRESSES) explaining why you think it qualifies and in 
what way and to what degree this rule will economically affect it.

Collection of Information

    Under the Paperwork Reduction Act (44 U.S. C. 3501 et seq.), the 
Office of Management and Budget (OMB) reviews each rule that contains a 
collection-of-information requirement to determine whether the 
practical value of the information is worth the burden imposed by its 
collection. Collection-of-information requirements include reporting, 
recordkeeping, notification, labelling, and other, similar 
requirements.
    This rule contains collection-of-information requirements in the 
[[Page 32847]] sections listed below. The following particulars apply:
    DOT No: 2115.
    OMB Control No.: 2115-0141, 2115-0576, and 2115-0577.

------------------------------------------------------------------------
                                                             OMB control
                   Paperwork requirements                        No.    
------------------------------------------------------------------------
a. Sec.  160.076-13........................................    2115-0619
b. Sec.  160.076-21........................................    2115-0619
c. Sec.  160.076-29........................................    2115-0619
d. Sec.  160.076-31........................................    2115-0619
e. Sec.  160.076-33........................................    2115-0619
f. Sec.  160.076-35........................................    2115-0619
g. Sec.  160.076-37........................................    2115-0619
h. Sec.  160.076-39........................................    2115-0619
------------------------------------------------------------------------

    Administration: U.S. Coast Guard.
    Title: Reporting and Recordkeeping Requirements for Fire Fighting 
Equipment, Structural Fire Protection Materials, Lifesaving Equipment, 
and Marine Sanitation Devices; Instructional Material for Lifesaving, 
Fire Protection, and Emergency Equipment; Identification of Lifesaving, 
Fire Protection, and Emergency Equipment.
    Need for Information: Production records are needed to verify 
compliance with the materials and quality control requirements in the 
production of this lifesaving equipment. Because PFDs are estimated to 
last up to 10 years, the Coast Guard is requiring manufacturers to 
retain production records for 120 months. Records that are also 
available from recognized laboratories are required to be retained for 
only 60 months (Sec. 160.076-33). Instructional materials are needed so 
that boaters can make an informed decision on the type of PFD best 
suited to their boating safety needs, and understand how to properly 
service their PFD or know when to get professional servicing or remove 
their inflatable PFD from service. Equipment identification (labelling) 
is needed to indicate that a PFD is Coast Guard approved, so that 
boaters know it is Coast Guard approved before buying it and to show 
boarding officers that the equipment meets the Coast Guard carriage 
requirements, any conditions on meeting those requirements, and so that 
boaters will be warned of possible dangerous conditions in using the 
PFDs. A Memorandum of Understanding (MOU) is needed to document the 
responsibilities of the laboratory and the Coast Guard in relation to 
equipment testing, inspection, and approval.
    Proposed Use of Information: Production records will be used to 
verify that suitable materials are used and that quality control is 
exercised in production of this lifesaving equipment. Instructional 
materials are used to inform boaters of the types of PFD best suited to 
their boating safety needs, and how to properly service or know when to 
get professional service or remove their inflatable PFD from service. 
Equipment identification will be used to indicate to boaters which 
inflatable PFDs are approved, allow boaters to show that the PFDs meet 
the Coast Guard carriage requirements, convey any conditions on meeting 
those requirements and warn of possible dangerous conditions in using 
the PFDs. An MOU formally documents the responsibilities of the 
laboratory and the responsibilities of the Coast Guard in relation to 
equipment testing, inspection, and approval.
    Frequency of Response: Production records are maintained by the 
manufacturers. No regular reporting is required. Instructional 
materials are provided with each PFD produced, but only reported to the 
recognized laboratory or the Coast Guard when approval is sought or 
when revised. Equipment identification is required on each PFD 
produced, but the initial label layout is the only response reported to 
the recognized laboratory or the Coast Guard when approval is sought or 
when revised.
    An MOU is required only once, when a laboratory seeks to become a 
recognized laboratory for a particular classification of equipment.
    Burden Estimate: The annual burden for the production of 50,000 
inflatable PFDs by five manufacturers is estimated at approximately 100 
hours for production records; 320 hours for instructional materials; 
and 83 hours for equipment identification industry-wide. The total 
annual burden for production of PFDs is estimated as 503 hours 
industry-wide.
    The Coast Guard estimates that no more than one MOU per year would 
be developed. Drafting of the MOU should not require more than two 
weeks of effort for one person, for an annual burden of 80 hours. 
Copies of existing MOUs may be obtained from the Coast Guard and 
modified to meet the needs of the inividual laboratory and the Coast 
Guard.
    Respondents: PFD production record respondents are the estimated 
five manufacturers that will produce Coast Guard approved inflatable 
PFDs for recreational boats.
    MOU respondents are laboratories that seek to become recognized 
independent laboratories.
    Form(s): No Federal forms are required.
    Average Burden Hours per Respondent: 101 hours annually for each of 
the five manufacturers producing PFDs.
    If the average recognized laboratory enters into a new or revised 
MOU once every five years, the average annual burden would be 16 hours.
    The Coast Guard has submitted the requirements to OMB for review 
under section 3504(h) of the Paperwork Reduction Act. Persons 
submitting comments on the requirements should submit their comments 
both to OMB and to the Coast Guard where indicated under ADDRESSES.

Federalism

    The Coast Guard has analyzed this rule under the principles and 
criteria contained in Executive Order 12612 and has determined that 
this rule does not have sufficient federalism implications to warrant 
the preparation of a Federalism Assessment. This rulemaking establishes 
procedures for Coast Guard approval of inflatable PFDs. The authority 
to establish these requirements are committed to the Coast Guard by 
Federal statutes. Furthermore, since PFDs are manufactured and used in 
the national marketplace, safety standards for PFDs should be national 
in scope to avoid burdensome variances. Therefore, the Coast Guard 
intends this rule to preempt State action on the same subject matter.

Environment

    The Coast Guard considered the environmental impact of this rule 
and concluded that under paragraph 2.B.2 of Commandant Instruction 
M16475.lB, this rule is categorically excluded from further 
environmental documentation. This rule has no environmental impact 
other than the beneficial impact of reducing the volume of unicellular 
plastic foam going into landfills as inherently buoyant devices are 
discarded when no longer serviceable. A ``Categorical Exclusion 
Determination'' is available in the docket for inspection or copying 
where indicated under ADDRESSES.

List of Subjects in 46 CFR Part 160

    Marine safety, Reporting and recordkeeping requirements, 
Incorporation by reference.

    For the reasons set out in the preamble, the Coast Guard amends 46 
CFR part 160 as follows:

PART 160--LIFESAVING EQUIPMENT

    1. The authority citation for Part 160 is revised to read as 
follows:

    Authority: 46 U.S.C. 2103, 3306, 3703 and 4302; E.O. 12234, 3 
CFR, 1980 Comp., p. 277; 49 CFR 1.46.

    [[Page 32848]] 2. Subpart 160.076, consisting of Secs. 160.076-1 
through 160.076-39, is added to read as follows:

Subpart 160.076--Inflatable Recreational Personal Flotation Devices

Sec.

160.076-1  Scope.
160.076-3  Applicability.
160.076-5  Definitions.
160.076-7  PFD approval Type.
160.076-9  Conditional approval.
160.076-11  Incorporation by reference.
160.076-13  Approval procedures for inflatable PFDs.
160.076-15  Suspension or termination of approval.
160.076-17  Approval of design or material changes.
160.076-19  Recognized laboratories.
160.076-21  Component materials.
160.076-23  Construction and performance requirements.
160.076-25  Approval testing.
160.076-27  LSI evaluation.
160.076-29  Production oversight.
160.076-31  Production tests and examinations.
160.076-33  Manufacturer records.
160.076-35  Information pamphlet.
160.076-37  Owner's manual.
160.076-39  Marking.

Subpart 160.076--Inflatable Recreational Personal Flotation Devices


Sec. 160.076-1  Scope.

    (a) This subpart contains structural and performance standards for 
approval of inflatable recreational personal flotation devices (PFDs), 
as well as requirements for production follow-up inspections, 
associated manuals, information pamphlets, and markings.
    (b) Inflatable PFDs approved under this subpart--
    (1) Rely entirely upon inflation for buoyancy; and
    (2) Are approved for use by adults only.


Sec. 160.076-3  Applicability.

    Inflatable PFDs approved under this subpart may be used to meet the 
carriage requirements of 33 CFR 175.15 and 175.17 on the following 
types of vessels only:
    (a) Recreational vessels.
    (b) Uninspected recreational submersible vessels.


Sec. 160.076-5  Definitions.

    As used in this part:
    Commandant means the Chief of the Survival Systems Branch, U.S. 
Coast Guard Office of Marine Safety, Security, and Environmental 
Protection. Address: Commandant (G-MVI-3/14), U.S. Coast Guard 
Headquarters, 2100 Second St. SW., Washington, DC 20593-0001; phone: 
202-267-1444; facsimile: 202-267-1069; electronic mail: ``mvi-3/G-
[e-mail]''.
    Conditional approval means a category of PFD which has condition(s) 
on its approval with which the user must comply in order for the PFD to 
be counted toward meeting the carriage requirements of the vessel being 
used. All conditionally approved PFDs are designated Approval Type V.
    First quality workmanship means construction which is free from any 
defect materially affecting appearance or serviceability.
    Inflation medium means any solid, liquid, or gas that, when 
activated, provides inflation for buoyancy.
    Inspector means a recognized laboratory representative assigned to 
perform, supervise or oversee the duties described in Secs. 160.076-29 
and 160.076-31 of this subpart or any Coast Guard representative 
performing duties related to the approval.
    LSI means the ``Life-Saving Index'', a number between zero and one, 
as determined in accordance with Sec. 160.076-27, that represents the 
overall lifesaving potential of a particular PFD design.
    MOU means memorandum of understanding which describes the approval 
functions a recognized independent laboratory performs for the Coast 
Guard, and the recognized independent laboratory's working arrangements 
with the Coast Guard.
    Performance type means the in-water performance classification of 
the PFD (I, II, or III).
    PFD means personal flotation device as defined in 33 CFR 175.13.
    PFD Approval Type means the Type designation assigned by the 
Commandant, as documented in the approval certificate for the PFD, 
based primarily on the in-water performance and serviceability of the 
PFD.
    Plans and specifications means the drawings, product description, 
construction specifications, and bill of materials submitted in 
accordance with Sec. 160.076-13 for approval of a PFD design.


Sec. 160.076-7  PFD approval Type.

    (a) An inflatable PFD may be approved without conditions as a Type 
I, II, or III PFD for persons over 36 kg (80 lb) if it--
    (1) Meets the requirements of this subpart other than the 
requirements of Sec. 160.076-27; or
    (2) Meets the requirements of Sec. 160.076-27 based on its 
Lifesaving Index (LSI).
    (b) Each inflatable PFD that can be demonstrated to meet the in-
water performance requirements of a type I, II or III PFD in UL 1180 
during approval testing and the applicable requirements of this subpart 
provided that certain conditions are placed on its use, may be approved 
as a Type V PFD. Each such PFD has conditional approval.


Sec. 160.076-9  Conditional approval.
    (a) A conditionally approved inflatable PFD is categorized as a 
Type V PFD and may be used to meet the Coast Guard PFD carriage 
requirements of 33 CFR part 175 only if the PFD is used in accordance 
with any requirements on the approval label. PFDs marked ``Approved 
only when worn'' must be worn whenever the vessel is underway and the 
intended wearer is not within an enclosed space if the PFD is intended 
to be used to satisfy the requirements of 33 CFR part 175. Note: 
Additional approved PFDs may be needed to satisfy the requirements of 
33 CFR part 175 if ``Approved only when worn'' PFDs are not worn.
    (b) Unless approved under the alternate LSI procedures in 
Sec. 160.076-27 without conditions, PFDs meeting the performance 
specifications for type I, II, or III PFDs in UL 1180 may be classified 
as Type V, conditionally approved PFDs when--
    (1) Indicator and serviceability use codes of less than 1F in 
accordance with UL 1191 are provided;
    (2) The device requires secondary donning; or
    (3) The Commandant determines that other performance or design 
characteristics of the PFD make such classification appropriate.


Sec. 160.076-11  Incorporation by reference.

    (a) Certain materials are incorporated by reference into this 
subpart with the approval of the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any 
edition other than the one listed in paragraph (b) of this section, the 
Coast Guard must publish notice of the change in the Federal Register, 
and the material must be available to the public. All approved material 
is available for inspection at the Office of the Federal Register, 800 
North Capitol Street NW., suite 700, Washington, DC and at the U.S. 
Coast Guard, Survival Systems Branch (G-MVI-3), 2100 Second Street, 
SW., Washington, DC 20593-0001, and is available from the sources 
indicated in paragraph (b) of this section.
    (b) The materials approved for incorporation by reference in this 
subpart, and the sections affected are:

                                                                                                                
[[Page 32849]]
                                                                                                                
                                American Society for Testing and Materials (ASTM)                               
                                                                                                                
1916 Race St., Philadelphia, PA 19103                                                                           
                                                                                                                
ASTM D 751-79  Standard Methods of Testing Coated Fabrics,    160.076-25;                                       
 1979.                                                                                                          
ASTM D 1434-75  Gas Transmission Rate of Plastic Film and     160.076-25;                                       
 Sheeting, 1975.                                                                                                
ASTM F 1166-88  Human Engineering Design for Marine Systems,  160.076-37.                                       
 Equipment and Facilities, 1988.                                                                                
                                                                                                                
                                                Federal Standards                                               
                                                                                                                
Naval Publications and Forms Center, Customer Service, Code                                                     
 1052, 5801 Tabor Ave., Philadelphia, PA 19120                                                                  
                                                                                                                
In Federal Test Method Standard No. 191A (dated July 20,                                                        
 1978) the following methods:                                                                                   
    (1) Method 5100, Strength and Elongation, Breaking of     160.076-25;                                       
     Woven Cloth; Grab Method.                                                                                  
    (2) Method 5132, Strength of Cloth, Tearing; Falling-     160.076-25;                                       
     Pendulum Method.                                                                                           
    (3) Method 5134, Strength of Cloth, Tearing; Tongue       160.076-25.                                       
     Method.                                                                                                    
                                                                                                                
                                         Underwriters Laboratories (UL)                                         
                                                                                                                
Underwriters Laboratories, Inc., P.O. Box 13995, Research                                                       
 Triangle Park, NC 27709-3995 (Phone [phone];                                                            
 Facsimile: [phone])                                                                                     
                                                                                                                
UL 1123, ``Marine Buoyant Devices'', February 17, 1995......  160.076-35;                                       
UL 1180, ``Fully Inflatable Recreational Personal Flotation   160.076-7; 160.076-21; 160.076-23; 160.076-25;    
 Devices'', May 15, 1995.                                      160.076-27; 160.076-29; 160.076-31; 160.076-37;  
                                                               160.076-39;                                      
UL 1191, ``Components for Personal Flotation Devices'', May   160.076-21; 160.076-25; 160.076-39.               
 16, 1995.                                                                                                      
                                                                                                                

Sec. 160.076-13  Approval procedures for inflatable PFDs.

    (a) Manufacturers seeking approval of an inflatable PFD design 
shall follow the procedures of this section and subpart 159.005 of this 
chapter.
    (b) Each application for approval of an inflatable PFD must contain 
the information specified in Sec. 159.005-5 of this chapter. The 
application must be submitted to a recognized laboratory. One copy of 
the application and, except as provided in paragraph (c)(2) of this 
section, a prototype PFD must be submitted to the Commandant for 
preapproval review. If a similar design has already been approved, the 
Commandant may authorize the recognized laboratory to waive the 
preapproval review under Secs. 159.005-5 and 159.005-7 of this chapter.
    (c) The application must include the following:
    (1) Plans and specifications containing the information required by 
Sec. 159.005-12 of this chapter, including drawings, product 
description, construction specifications, and bill of materials.
    (2) The information specified in Sec. 159.005-5(a)(2) (i) through 
(iii) of this chapter must be included in the application, except that, 
if preapproval review has been waived, the manufacturer is not required 
to send a prototype PFD sample to the Commandant.
    (3) The type of performance (Type I, II, or III) that the PFD is 
designed to provide along with the Approval Type sought (Type I, II, 
III, or V).
    (4) Any special purpose(s) for which the PFD is designed and the 
vessel(s) or vessel type(s) on which its use is intended.
    (5) Buoyancy, torque, and other relevant tolerances to be met 
during production.
    (6) The text of any optional marking to be included on the PFD in 
addition to the markings required by Sec. 160.076-39.
    (7) A draft of the information pamphlet required by Sec. 160.076-
35.
    (8) A draft of the owner's manual required by Sec. 160.076-37.
    (9) For any conditionally approved PFD, the intended approval 
condition(s).
    (10) Whether approval is sought under the LSI provisions of 
Sec. 160.076-27.
    (d) The description required by Sec. 159.005-9 of this chapter of 
quality control procedures may be omitted if the manufacturer's planned 
quality control procedures meet the requirements of Secs. 160.076-29 
and 160.076-31.
    (e) Manual and pamphlet. Before granting approval of a PFD design, 
the Commandant may require changes to the manual and information 
pamphlet submitted for review to ensure compliance with the 
requirements of Secs. 160.076-35 and 160.076-37.
    (f) Waiver of tests. A manufacturer may request that the Commandant 
waive any test prescribed for approval under this subpart. To request a 
waiver, the manufacturer must submit to the Commandant and the 
recognized laboratory, one of the following:
    (1) Satisfactory test results on a PFD of sufficiently similar 
design as determined by the Commandant.
    (2) Engineering analysis demonstrating that the test for which a 
waiver is requested is not appropriate for the particular design 
submitted for approval or that, because of its design or construction, 
it is not possible for the PFD to fail that test.
    (g) Alternative requirements. A PFD that does not meet the 
requirements of this subpart may be approved by the Commandant if the 
device--
    (1) Meets other requirements prescribed by the Commandant in place 
of or in addition to the requirements of this subpart; and
    (2) As determined by the Commandant, provides at least the same 
degree of safety provided by other PFDs that meet the requirements of 
this subpart.


Sec. 160.076-15  Suspension or termination of approval.

    As provided in Sec. 159.005-15 of this chapter, the Commandant may 
suspend or terminate the approval of an inflatable PFD design if the 
manufacturer fails to comply with this subpart or the recognized 
laboratory's accepted procedures or requirements.


Sec. 160.076-17  Approval of design or material changes.

    (a) The manufacturer must submit any proposed changes in design, 
material, or construction to the recognized laboratory and the 
Commandant for approval before changing PFD production methods.
    (b) Determinations of equivalence of design, construction, and 
materials may be made only by the Commandant or a designated 
representative.
Sec. 160.076-19  Recognized laboratories.

    (a) PFDs. The following laboratories are recognized under 
Sec. 159.010-9 of this chapter to perform the approval and production 
oversight functions required by this subpart:
    Underwriters Laboratories, Inc., 12 Laboratory Drive, P.O. Box 
13995, [[Page 32850]] Research Triangle Park, NC 27709-3995, (919) 549-
1400.
    (b) Components. The following laboratories are recognized under 
subpart 159.010 of this chapter and may perform the component material 
acceptance, production oversight, and certification functions required 
by Sec. 160.076-21(a)(1):
    Underwriters Laboratories, Inc., 12 Laboratory Drive, P.O. Box 
13995, Research Triangle Park, NC 27709-3995, [phone].


Sec. 160.076-21  Component materials.

    (a) Each component material used in the manufacturer of an 
inflatable PFD must--
    (1) Meet the applicable requirements of subpart 164.019 of this 
chapter, UL 1191, UL 1180, and this section; and
    (2) Be of good quality and suitable for the purpose intended.
    (b) The average permeability of inflation chamber material, 
determined in accordance with the procedures specified in Sec. 160.076-
25(d)(2)(iii) must not be more than 110% of the permeability of the 
materials determined in approval testing required by Sec. 160.076-
25(d)(2)(iii).
    (c) The average grab breaking strength and tear strength of the 
inflation chamber material, determined in accordance with the 
procedures specified in Secs. 160.076-25(d)(2)(i) and 160.076-
25(d)(2)(ii), must be at least 90% of the grab breaking strength and 
tear strength determined from testing required by Secs. 160.076-
25(d)(2)(i) and 160.076-25(d)(2)(ii). No individual sample result for 
breaking strength or tear strength may be more than 20% below the 
results obtained in approval testing.
    (d) Each adhesive must be waterproof, appropriate for use with the 
materials being bonded, durable over the expected range of temperatures 
and humidity in which the PFD may be used, and resistant to chemicals 
commonly encountered in recreational boating.
    (e) Unless approved under the provisions of Sec. 160.076-27, each 
manual, automatic, and manual-auto inflation mechanism on each 
unconditionally approved PFD must have an indicator and a 
serviceability rating consistent with use code 1F in accordance with UL 
1191.
    (f) Each manual, automatic, or manual-auto inflation mechanism must 
be marked in accordance with Sec. 160.076-39(e).


Sec. 160.076-23  Construction and performance requirements.

    (a) Each inflatable PFD design must--
    (1) Meet the requirements in UL 1180 applicable to the PFD 
performance type for which approval is sought, or the LSI requirements 
of Sec. 160.076-27;
    (2) Not cause significant discomfort to the wearer during and after 
inflation; and
    (3) Meet any additional requirements that the Commandant may 
prescribe to approve unique or novel designs.
    (b) All cut edges of textile materials must be permanently treated 
or sewn to minimize ravelling.


Sec. 160.076-25  Approval testing.

    (a) To obtain approval of an inflatable PFD design, approval tests 
specified in UL 1180 and this section must be conducted or supervised 
by a recognized laboratory using PFDs that have been constructed in 
accordance with the plans and specifications submitted with the 
application for approval.
    (b) Each PFD design must pass the tests required by UL 1180 and 
this section that are applicable to the PFD performance type for which 
approval is sought.
    (c) In addition to the testing requirements of UL 1180, each design 
tested must meet the following requirements during the test specified:
    (1) Donning test. (i) For unconditionally approved PFDs, the 
average time for donning on the first attempt, when tested in 
accordance with UL 1180 section 6.2, must not exceed 45 seconds. At 
least two-thirds of the subjects must successfully don the PFD on the 
first attempt.
    (ii) PFDs not intended for a special purpose for which conditional 
approval is sought, except belt-pack style PFDs, need not comply with 
the donning times specified in UL 1180 and paragraph (c)(1)(i) of this 
section, but must be able to be donned within an average of 1.5 
minutes.
    (iii) PFDs intended for a special purpose for which conditional 
approval is sought need not comply with the donning times specified in 
UL 1180 and paragraph (c)(1)(i) of this section, but must be able to be 
donned within an average of 2.0 minutes.
    (iv) Under UL 1180 section 6.2, the Commandant must be notified if 
more than one-fourth of any initial group of test subjects is 
disqualified based on tests with the reference vest.
    (2) Repack evaluation. Each test subject participating in the tests 
in UL 1180, section 6 shall demonstrate that he or she can repack the 
PFD such that it can be used in the manual activation tests, and 
donning tests in sections 6.2.3, 6.4.1, and 6.4.2.
    (3) Flotation stability static measurements. At the end of each 
test conducted in accordance with in UL 1180, section 6.9, for each 
subject--
    (i) The freeboard must be measured and reported;
    (ii) The subject when looking to the side, must be able to see the 
water's surface at a point within 3 m (10 ft.) from the subject's 
position and beyond; and
    (iii) If provided, the PFD light and at least 75% of the 
retroreflective material on the outside of the PFD must be above the 
water.
    (4) Average requirements. When conducting tests specified in UL 
1180, section 6.9--
    (i) The average freeboard for performance type II PFDs for all 
subjects must be 110 mm (4.25 in).
    (ii) For all subjects, the average of the lowest mark on a vertical 
scale, which is placed 6 m (20 ft.) from and in front of the subject 
such that the subject can see it without moving his or her head, must 
be no higher than 0.3 m (12 in.) from the water level.
    (d) Each PFD design must pass the following tests and evaluations:
    (1) Visual examination. The complete PFD must be visually examined 
for compliance with the construction and performance requirements of 
Secs. 160.076-21 and 160.076-23 and UL 1180 and 1191.
    (2) Inflation chamber properties. The following tests must be 
conducted after successful completion of all other approval tests. The 
test samples used in the following tests must come from one or more 
PFDs that were each used in all the Use Characteristics Tests required 
by UL 1180 section 6.
    (i) Grab breaking strength. The grab breaking strength of chamber 
materials must be determined in accordance with Method No. 5100 of 
Federal Test Method Standard 191 or ASTM D 751.
    (ii) Tear strength. The tear strength of chamber materials must be 
determined in accordance with Method No. 5132 or 5134 of Federal Test 
Method Standard 191 or ASTM D 751.
    (iii) Permeability. The permeability of chamber materials must be 
determined in accordance with ASTM D 1434 using CO2 as the test gas.
    (iv) Seam strength. The seam strength of the seams in each 
inflation chamber of at least one PFD must be determined in accordance 
with ASTM D 751 except that 25 by 200 mm (1 by 8 in.) samples may be 
used where insufficient length of straight seam is available.
    (e) Additional tests. The Commandant may prescribe additional tests 
for approval of novel or unique designs.


Sec. 160.076-27  LSI evaluation.

    (a) Each manufacturer seeking approval of a PFD design using the 
[[Page 32851]] Lifesaving Index (LSI) must demonstrate, to the 
satisfaction of the Commandant, a minimum overall lifesaving potential, 
and a minimum effectiveness and reliability of the PFD design in 
accordance with this section.
    (b) The manufacturer shall submit to the Commandant an analysis, 
accepted by a recognized laboratory, demonstrating the LSI of the 
design that includes--
    (1) The LSI calculations using the formula provided in paragraph 
(d) of this section, and the value assigned to each term of the 
calculation;
    (2) Statements justifying the value assigned to each term of the 
formula provided in paragraph (d) of this section; and
    (3) Explanation of any assumptions used in performing the required 
calculation.
    (c) Minimum LSI. Each PFD design approved under this section must 
be demonstrated to have an LSI that is not less than that of a Type III 
inherently buoyant PFD. The Commandant will determine the LSI of a Type 
III inherently buoyant PFD using the equation in paragraph (d) of this 
section and will publish the LSI value annually.
    (d) Equation and terms. (1) The LSI must be determined by the 
following equation:
[GRAPHIC][TIFF OMITTED]TR23JN95.014


Where:

Pi = Probability associated with the ith ou0tcome, where each 
outcome is a sequence of events where the PFD will aid in the user's 
survival. Each sequence of events must be mutually exclusive.

And Pi is defined by the following equations:

P1 = (S1)(WS1)(I1S1)(E)(R)
P2 = (S1)(WS1)(I2S1)(SA1S1)(SDS1)(E)(R)
P3 = (S1)(WS1)(I3S1)(SA1S1)(E)(R)
P4 = (S1)(WS1)(I3S1)(SA2S1)(ES1,I3)(R)
P5 = (S2)(WS2)(I1S2)(E)(R)
P6 = (S2)(WS2)(I2S2)(SA1S2)(SDS2)(E)(R)
P7 = (S2)(WS2)(I3S2)(SA1S2)(E)(R)
P8 = (S2)(WS2)(I3S2)(SA2S2)(ES2,I3)(R)
Pk = The probability of other sequences of events that 
significantly enhance the lifesaving potential of the PFD under 
consideration.
The terms used in the Pi equations are defined as follows:
S1 = Probability PFD user can swim.
S2 = Probability PFD user cannot swim.
W = Probability PFD is worn prior to an accident. (WS1 for 
swimmer; WS2 for non-swimmer)
I1 = Probability PFD is used in a fully inflated condition prior to 
accident.
I2 = Probability PFD is used in an uninflated condition prior to 
accident.
I3 = Probability PFD is used in a partially inflated condition prior to 
accident.
SA1 = Probability of PFD inflating, including the probabilities of 
correct inflator rearming; inflator status check; and inflator its 
activated automatically, manually, or orally, as applicable.
SA2 = Probability of PFD not inflating.
SD = Probability of completing the donning process after inflation, if 
required, when the PFD is worn. (SD = 1 when no additional donning 
required.)
E = Probability PFD is effective in the water when inflated. 
(ES1,I3, ES2,I3 for partially inflated PFD and swimmer, non-
swimmer, respectively)
R = Probability PFD is reliable.

    (2) Application of equation. To determine the LSI for a PFD using 
the equation in paragraph (d)(1) of this section, the calculations must 
be performed in accordance with the following:
    (i) For inherently buoyant PFDs, use only equations P1 and 
P5, with I1 equal to 1.
    (ii) For non-belt-style inflatable PFDs, all Pi equations 
apply.
    (iii) For belt-pack style PFDs, use only equations P1, 
P2, P5, and P6, with I1 meaning that the PFD is fully 
donned and inflated.
    (e) Minimum effectiveness and reliability. In addition to meeting 
the requirements of paragraph (c) of this section, each PFD design 
approved under this section must be demonstrated to possess the 
following characteristics:
    (1) Inflated in-water effectiveness (E), that is not less than that 
of--
    (i) A performance type I PFD in accordance with UL 1180 for Type I 
approval or equivalent;
    (ii) A performance type II PFD in accordance with UL 1180 for Type 
II approval or equivalent; or
    (iii) A performance type III PFD in accordance with UL 1180 for 
Type III approval or equivalent; and
    (2) Reliability (R) that is not less than that of--
    (i) A performance type I PFD in accordance with UL 1180 for Type I 
approval or equivalent; or
    (ii) A performance type II PFD in accordance with UL 1180 for Type 
II and III approval or equivalent.
    (f) Ranking. The recognized laboratory shall compile a ranking, 
according to the calculated LSI, of PFDs for which approval is sought 
under this section and submit to the Commandant the characteristics 
affecting wearability, effectiveness, and reliability of the PFDs 
ranked immediately above and immediately below the PFD for which 
approval is sought.
    (g) Review. The Commandant may annually review each analysis and 
design approved under this section to determine whether the design 
continues to provide the minimum LSI and level of effectiveness and 
reliability required by paragraphs (c) and (e) of this section. The 
Commandant will compare the values assigned to the characteristics of 
the device to the values assigned to other approved devices in 
determining whether the values were appropriately assigned and whether 
the LSI should be recalculated. Where recalculated LSIs of approved 
designs fall below the minimum required LSI established by the 
Commandant in accordance with paragraph (c) of this section, the 
approval will be terminated or suspended in accordance with 
Sec. 159.005-15 of this chapter.


Sec. 160.076-29  Production oversight.

    (a) Production tests and inspections must be conducted in 
accordance with this section and subpart 159.007 of this chapter unless 
the Commandant authorizes alternative tests and inspections. The 
Commandant may prescribe additional production tests and inspections 
necessary to maintain quality control and to monitor compliance with 
the requirements of this subpart.
    (b) Production oversight must be performed by the same laboratory 
that performs the approval tests unless the Commandant determines that 
the employees of an alternative laboratory have received training and 
have access to the same information as the inspectors of the laboratory 
that conducted the approval testing.
    (c) In addition to responsibilities set out in part 159 of this 
chapter and the accepted Laboratory Follow-up Procedures, each 
manufacturer of an inflatable PFD and each recognized laboratory 
inspector shall comply with the following, as applicable:
    (1) Manufacturer. Each manufacturer must--
    (i) Except as provided in paragraph (e)(2) of this section, perform 
all required tests and examinations on each PFD lot before any required 
inspector's tests and inspection of the lot;
    (ii) Follow established procedures for maintaining quality control 
of the materials used, manufacturing operations, and the finished 
product; [[Page 32852]] 
    (iii) Implement a continuing program of employee training and a 
program for maintaining production and test equipment;
    (iv) Admit the inspector to any place in the factory where work is 
done on PFDs or component materials, and where parts or completed PFDs 
are stored;
    (v) Have an inspector observe the production methods used in 
producing the first PFD lot and observe any revisions in production 
methods made thereafter; and
    (vi) Allow the inspector to take samples of completed PFDs or of 
component materials for tests required by this subpart and for tests 
relating to the safety of the design.
    (2) Recognized laboratory oversight. An inspector from a recognized 
laboratory shall oversee production in accordance with the MOU. During 
production oversight, the inspector shall not perform or supervise any 
production test or inspection unless--
    (i) The manufacturer has a valid approval certificate; and
    (ii) The inspector has first observed the manufacturer's production 
methods and any revisions to those methods.
    (3) The inspector must perform or supervise testing and inspection 
of at least one in each five lots of PFDs produced.
    (4) During each inspection, the inspector must check for compliance 
with the manufacturer's quality control procedures.
    (5) Except as provided in paragraph (c)(6) of this section, at 
least once each calendar quarter, the inspector must examine the 
manufacturer's records required by Sec. 160.076-33 and observe the 
manufacturer perform each of the tests required by Sec. 160.076-31(c).
    (6) If less than six lots are produced during a calendar year, only 
one lot inspection and one records' examination and test performance 
observation are required during that year. Each lot tested and 
inspected under paragraph (c)(3) of this section must be within seven 
lots of the previous lot inspected.
    (d) PFD lots. A lot number must be assigned in accordance with UL 
1180 to each group of PFDs produced. Lots must be numbered serially. A 
new lot must be started whenever any change in materials or a revision 
to a production method is made, and whenever any substantial 
discontinuity in the production process occurs. Changes in lots of 
component materials must be treated as changes in materials. The lot 
number assigned, along with the approval number, must enable the PFD 
manufacturer, by referring to the records required by this subpart, to 
determine the supplier of the components used in the PFD and the 
component supplier's identifying information for the component lot.
    (e) Samples. For the tests, examinations, and inspections required 
by Sec. 160.076-31, inspectors and manufacturers shall select samples 
as provided in this paragraph.
    (1) Samples shall be selected at random from a lot in which all 
PFDs or materials in the lot are available for selection. Except as 
provided in Sec. 160.076-31(c), samples must be selected from completed 
PFDs.
    (2) Different samples must be selected for the manufacturer's and 
inspector's tests, except, if the total production for any five 
consecutive lots does not exceed 250 PFDs, the manufacturer's and 
inspector's tests may be run on the same sample(s) at the same time.
    (3) The number of samples selected per lot must be at least equal 
to the applicable number required by Table 160.076-29A for 
manufacturers or Table 160.076-29B for inspectors.
    (4) The following additional requirements apply as indicated in 
Table 160.076-29A to individual sample selections by manufacturers:
    (i) Samples must be selected from each lot of incoming material. 
The tests required under paragraphs 160.076-25(d)(2)(i) through 
160.076-25(d)(2)(iv) prescribe the number of samples to select.
    (ii) Samples selected for the indicated tests may not be used for 
more than one test.
    (iii) If a sample fails the over-pressure test, the number of 
samples to be tested in the next lot produced must be at least two 
percent of the total number of PFDs in the lot or 10 PFDs, whichever is 
greater.
    (iv) The indicated test must be conducted at least once each 
calendar quarter or whenever a new lot of material is used or a 
production process is revised.
    (5) The following additional requirements apply as indicated in 
Table 160.076-29B to individual sample selections by inspectors:
    (i) Samples selected for the indicated tests may not be used for 
more than one test.
    (ii) The indicated test may be omitted if it was conducted by the 
manufacturer on the materials used and by the inspector on a previous 
lot within the past 12 months.
    (iii) One sample of each means of marking on each type of fabric or 
finish used in PFD construction must be tested at least every six 
months or whenever a new lot of materials is used.

                                 Table 160.076-29A--Manufacturer's Sampling Plan                                
----------------------------------------------------------------------------------------------------------------
                                                           Number of samples per lot--lot size:                 
                                         -----------------------------------------------------------------------
                                             1-100      101-200     201-300     301-500     501-750    751-1000 
----------------------------------------------------------------------------------------------------------------
Tests:                                                                                                          
                                                                                                                
                                         -----------------------------------------------------------------------
    Inflation Chamber Materials.........                                                                        
(5) See Note a                                                                                                  
                                                                                                                
                                         -----------------------------------------------------------------------
    Seam Strength.......................           1           1           2           2           3           4
    Over-pressure a c...................           1           2           3           4           6           8
                                                                                                                
                                         -----------------------------------------------------------------------
    Air Retention.......................                                                                        
(5) Every Device in the Lot                                                                                     
                                                                                                                
                                         -----------------------------------------------------------------------
    Buoyancy & Inflation, Medium                                                                                
     Retention..........................           1           2           3           4           6           8
                                                                                                                
                                         -----------------------------------------------------------------------
    Tensile Strength....................                                                                        
(5) See Note d                                                                                                  
                                         -----------------------------------------------------------------------
Detailed Product Examination............           2           2           3           4           6           8
Retest Sample Size b....................  ..........  ..........          13          13          20          20
                                                                                                                
                                         -----------------------------------------------------------------------
[[Page 32853]]
                                                                                                                
Final Lot Inspection....................                                                                        
(5) Every Device in the Lot                                                                                     
----------------------------------------------------------------------------------------------------------------
Notes to Table:                                                                                                 
a See \@ 160.076-29(e)(4)(i).                                                                                   
b See \@ 160.076-29(e)(4)(ii)                                                                                   
c See \@ 160.076-29(e)(4)(iii).                                                                                 
d See \@ 160.076-29(e)(4)(iv).                                                                                  


                                  Table 160.076-29B--Inspector's Sampling Plan                                  
----------------------------------------------------------------------------------------------------------------
                                                           Number of samples per lot--lot size:                 
                                         -----------------------------------------------------------------------
                                             1-100      101-200     201-300     301-500     501-750    751-1000 
----------------------------------------------------------------------------------------------------------------
Tests:                                                                                                          
    Over-pressure a.....................           1           1           2           2           3           4
    Air Retention.......................           1           1           2           2           3           4
    Buoyancy & Inflation, Medium                                                                                
     Retention..........................           1           1           2           2           3           4
    Tensile Strength....................                                                                        
(5) See Note b                                                                                                  
    Waterpoof marking...................                                                                        
(5) See Note c                                                                                                  
                                         -----------------------------------------------------------------------
Detailed Product Examinaton.............           1           1           1           2           2           3
Retest Sample Size a....................          10          10          13          13          20          20
Final Lot Inspection....................          10          15          20          25          27          30
----------------------------------------------------------------------------------------------------------------
Notes to Table:                                                                                                 
a See/@160.076-29(e)(5)(i).                                                                                     
b See/@160.076-29(e)(5)(ii).                                                                                    
c See/@160.076-29(e)(5)(iii).                                                                                   

  (f) Accept/reject criteria: manufacturer testing. (1) A PFD lot 
passes production testing if each sample passes each test.

    (2) In lots of 200 or less PFDs, the lot must be rejected if any 
sample fails one or more tests.

    (3) In lots of more than 200 PFDs, the lot must be rejected if--

    (i) One sample fails more than one test;

    (ii) More than one sample fails any test or combination of tests; 
or

    (iii) One sample fails one test and in redoing that test with the 
number of samples specified for retesting in Table 160.076-29A, one or 
more samples fail the retest.

    (4) A rejected PFD lot may be retested only if allowed under 
Sec. 160.076-31(e).

    (g) Accept/reject criteria: independent laboratory testing. (1) A 
lot passes production testing if each sample passes each test.

    (2) A lot must be rejected if--

    (i) A sample fails more than one test;

    (ii) More than one sample fails any test or combination of tests; 
or

    (iii) One sample fails one test and in redoing that test with the 
number of samples specified for retesting in Table 160.076-29B, one or 
more samples fail the test.

    (3) A rejected lot may be retested only if allowed under 
Sec. 160.076-31(e).

    (h) Facilities and equipment. (1) General. The manufacturer must 
provide the test equipment and facilities necessary for performing 
production tests, examinations, and inspections, unless Commandant has 
accepted testing at a location other than the manufacturer's facility.

    (2) Calibration. The manufacturer must have the calibration of all 
test equipment checked at least every six months by a weights and 
measures agency or the equipment manufacturer, distributor, or dealer.

    (3) Facilities. The manufacturer must provide a suitable place and 
the necessary equipment for the inspector to use in conducting or 
supervising tests. For the final lot inspection, the manufacturer must 
provide a suitable working environment and a smooth-top table for the 
inspector's use.


Sec. 160.076-31  Production tests and examinations.

    (a) Samples used in testing must be selected in accordance with 
Sec. 160.076-29(e).

    (b) On each sample selected--

    (1) The manufacturer must conduct the tests in paragraphs (c)(2) 
through (c)(8) of this section;

    (2) The recognized laboratory inspector must conduct or supervise 
the tests in paragraphs (c)(4) through (c)(8) of this section; and

    (3) In addition to meeting the requirements of this section, each 
test result must meet the requirements, if any, contained in the 
approved plans and specifications.

    (c) When conducting the tests specified by this paragraph, the 
following conditions must be met:
    (1) Inflation chamber materials. The average and individual results 
of testing the minimum number of samples prescribed by Sec. 160.076-
25(d)(2) must comply with the requirements in Sec. 160.076-21 (b) and 
(c) for permeability, grab strength, and tear strength. Lots not 
meeting this requirement must be rejected and, unless authorized by the 
Commandant, may not be subdivided and retested.
    (2) Seam strength. The seams in each inflation chamber of each 
sample must be tested in accordance with Sec. 160.076-25(d)(2)(iv). The 
results for each inflation chamber must be at least 90% of the results 
obtained in approval testing.
    (3) Over-pressure. Each sample must be tested in accordance with 
and meet UL 1180 section 7.15. Prior to initiating the test at the 
specified values, samples may be prestressed by inflating them to a 
greater pressure than the required test pressure.
    (4) Air retention. Each sample must be tested in accordance with 
and meet UL 1180 section 7.16. Prior to initiating the 
[[Page 32854]] test at the specified values, test samples may be 
prestressed by inflating to a pressure greater than the design 
pressure, but not exceeding 50 percent of the required pressure for the 
tests in paragraph (c)(3) of this section. No alternate test method may 
be used that decreases the length of the test unless authorized by the 
Commandant. Such alternative test must require a proportionately lower 
allowable pressure loss and the same percentage sensitivity and 
accuracy as the standard allowable loss measured with the standard 
instrumentation.
    (5) Buoyancy and inflation medium retention. Each sample must be 
tested in accordance with and meet UL 1180 section 7.2.2-7.2.10, except 
7.2.5. Each buoyancy value must fall within the tolerances specified in 
the approved plans and specifications.
    (6) Tensile strength. Each sample primary closure system must be 
tested in accordance with and meet UL 1180 section 7.4.1 and .2.
    (7) Detailed product examination. Each sample PFD must be 
disassembled to the extent necessary to determine compliance with the 
following:
    (i) All dimensions and seam allowances must be within tolerances 
prescribed in the approved plans and specifications.
    (ii) The torque of each screw type mechanical fastener must be 
within its tolerance as prescribed in the approved plans and 
specifications.
    (iii) The arrangement, markings, and workmanship must be as 
specified in the approved plans and specifications and this subpart.
    (iv) The PFD must not contain any apparent defects.
    (8) Waterproof marking test. Each sample must be completely 
submerged in 45-C (110-F) water with mild detergent for a minimum of 30 
minutes, and then removed and immediately placed on a hard surface. The 
markings must be vigorously rubbed with the fingers for 15 seconds, and 
then placed on a soft surface and rubbed again in the same manner. If 
the printing becomes illegible, the sample must be rejected.
    (d) Final lot examination and inspection--(1) General. On each PFD 
lot that passes production testing, the manufacturer shall perform a 
final lot examination and, on every fifth lot, a laboratory inspector 
shall perform a final lot inspection. Samples must be selected in 
accordance with paragraph Sec. 160.076-29(e). Each final lot must 
demonstrate--
    (i) First quality workmanship;
    (ii) That the general arrangement and attachment of all components, 
such as body straps, closures, inflation mechanisms, tie tapes, and 
drawstrings, are as specified in the approved plans and specifications;
    (iii) Compliance with the marking requirements in Sec. 160.076-39; 
and
    (iv) That the information pamphlet and owner's manual required by 
Sec. 160.076-35 and 160.076-37, respectively, are securely attached to 
the device, with the pamphlet selection information visible and 
accessible prior to purchase.
    (2) Accept/reject criteria. Each nonconforming PFD must be 
rejected. If three or more nonconforming PFDs are rejected for the same 
kind of defect, lot examination or inspection must be discontinued and 
the lot rejected.
    (3) Manufacturer examination. This examination must be conducted by 
a manufacturer's representative who is familiar with the approved plans 
and specifications, the functioning of the PFD and its components, and 
the production testing procedures. This person must not be responsible 
for meeting production schedules or be supervised by someone who is. 
This person must prepare and sign the record required by 159.007-13(a) 
of this chapter and 160.076-33(b).
    (4) Independent laboratory inspection. (i) The inspector must 
discontinue lot inspection and reject the lot if examination of 
individual PFDs or the records for the lot shows noncompliance with 
either this section or the laboratory's or the manufacturer's quality 
control procedures.
    (ii) If the inspector rejects a lot, the inspector must advise the 
Commandant or the recognized laboratory within 15 days.
    (iii) The inspector must prepare and sign the inspection record 
required by 159.007-13(a) of this chapter and 160.076-33(b). If the lot 
passes, the record must include the inspector's certification that the 
lot passed inspection and that no evidence of noncompliance with this 
section was observed.
    (e) Disposition of rejected PFD lot or PFD. (1) A rejected PFD lot 
may be resubmitted for testing, examination or inspection if the 
manufacturer first removes and destroys each defective PFD or, if 
authorized by the Commandant, reworks the lot to correct the defect.
    (2) Any PFD rejected in a final lot examination or inspection may 
be resubmitted for examination or inspection if all defects have been 
corrected and reexamination or reinspection is authorized by the 
Commandant.
    (3) A rejected lot or rejected PFD may not be sold or offered for 
sale under the representation that it meets this subpart or that it is 
Coast Guard-approved.


Sec. 160.076-33  Manufacturer records.

    (a) Each manufacturer of inflatable PFDs shall keep the records of 
production inspections and tests as required by Sec. 159.007-13 of this 
chapter, except that they must be retained for at least 120 months 
after the month in which the inspection or test was conducted.
    (b) In addition to the information required by Sec. 159.007-13 of 
this chapter, the manufacturer's records must also include the 
following information:
    (1) For each test, the serial number of the test instrument used if 
more than one test instrument was available.
    (2) For each test and inspection, the identification of the samples 
used, the lot number, the approval number, and the number of PFDs in 
the lot.
    (3) For each lot rejected, the cause for rejection, any corrective 
action taken, and the final disposition of the lot.
    (4) For all materials used in production the--
    (i) Name and address of the supplier;
    (ii) Date of purchase and receipt;
    (iii) Lot number; and
    (iv) Where required by Sec. 164.019-5 of this chapter, the 
certification received with standard components.
    (5) A copy of this subpart.
    (6) Each document incorporated by reference in Sec. 160.076-11.
    (7) A copy of the approved plans and specifications.
    (8) The approval certificate obtained in accordance with Sec. 2.75-
1 and 2.75-5 of this chapter.
    (9) Certificates evidencing calibration of test equipment, 
including the identity of the agency performing the calibration, date 
of calibration, and results.
    (c) A description or photographs of procedures and equipment used 
in testing required by Sec. 159.007-13(a)(4) of this chapter, is not 
required if the manufacturer's procedures and equipment meet the 
requirements of this subpart.
    (d) The records required by paragraph (b)(4) of this section must 
be kept for at least 120 months after preparation. All other records 
required by paragraph (b) of this section must be kept for at least 60 
months after the PFD approval expires or is terminated.
Sec. 160.076-35  Information pamphlet.

    A pamphlet that is consistent in format to that specified in UL 
1123 must be attached to each inflatable PFD sold or offered for sale 
in such a way that a prospective purchaser can read the pamphlet prior 
to purchase. The [[Page 32855]] pamphlet text and layout must be 
submitted to the Commandant for approval. The text must be printed in 
each pamphlet exactly as approved by the Commandant. Additional 
information, instructions, or illustrations must not be included within 
the approved text and layout. Sample pamphlet text and layout may be 
obtained by contacting the Commandant. This pamphlet may be combined 
with the manual required by Sec. 160.076-37 if PFD selection and 
warning information is provided on the PFD packaging in such a way that 
it remains visible until purchase.


Sec. 160.076-37  Owner's manual.

    (a) General. The manufacturer must provide an owner's manual with 
each inflatable PFD sold or offered for sale. A draft of the manual for 
each model must be submitted for approval in accordance with 
Sec. 160.076-13.
    (b) Manual contents. Each owner's manual must contain the 
information specified in UL 1180 section 11 and--
    (1) In addition to the information specified in UL 1180 section 
11.2, instructions that a user may need to partially deflate the PFD to 
climb out of the water unaided;
    (2) The manufacturer's expected service life of the device under 
normal use with a description of normal and abnormal use as well as 
conditions that are particularly deleterious;
    (3) Warnings about possible misuse which could be hazardous, such 
as a warning against wearing a PFD that has automatic inflation under 
restrictive clothing. Warnings must be presented in a format consistent 
with ASTM F 1166, section 29;
    (4) If the PFD is approved under the LSI provisions of 
Sec. 160.076-27, an estimate of the user's chances of survival if the 
user complies with the conditions and assumptions upon which approval 
of the PFD was based, and an estimate of the chances of survival if the 
user does not comply; and
    (5) If the PFD is conditionally approved, an explanation of the 
meaning of, and reasons for, the approval conditions.


Sec. 160.076-39  Marking.

    (a) General. Each inflatable PFD must be marked as specified in UL 
1180 section 10 and this section.
    (b) PFD Type. Based on its approval certificate, each PFD must be 
marked as follows--
    (l) ``Type I PFD'';
    (2) ``Type II PFD'';
    (3) ``Type III PFD''; or
    (4) ``Type V [insert exact text of description noted on the 
approval certificate, if any] PFD--[insert text required by paragraph 
(c) of this section]. This PFD provides in-water performance equivalent 
to a Type [insert performance type criteria noted on the approval 
certificate] PFD.''
    (c) Unless otherwise specified on its approval certificate, a Type 
V, conditionally approved inflatable PFD must be marked ``approved only 
when worn''.
    (d) Additional markings. (1) Unless otherwise noted on the approval 
certificate, each inflatable PFD must be marked with the following:
    (i) ``NOT APPROVED FOR USE ON COMMERCIAL VESSELS.''
    (ii) The unique model, style, or part number of the inflation 
mechanism approved for use on the PFD.
    (2) Additionally, where appropriate, each inflatable PFD must be 
marked with a permanent and prominent warning against any foreseeable 
misuse of the PFD that will result in a particularly hazardous 
condition, such as wearing an automatically activated belt-pack style 
PFD on the back.
    (e) Inflation mechanisms. Each manual, automatic, or manual-auto 
inflation mechanism must be permanently marked with its unique model 
number.
    (f) Unless marked with a universal symbol accepted by the 
Commandant, the inflation handle of a manual inflation mechanism must 
be marked ``Jerk to inflate''. The marking must be waterproof, 
permanent, and quickly readable from a distance of 1.5 m (5 feet).
    Dated: June 1, 1995.
J.C. Card,
Rear Admiral U.S. Coast Guard, Chief, Office of Marine Safety, Security 
and Environmental Protection.

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[FR Doc. 95-15077 Filed 6-22-95; 8:45 am]
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