Recreational Inflatable Personal Flotation Device Standards

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 (202) 267-1477. 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 (202) 267-1444, facsimile

(202) 267-1069, or electronic mail ``mvi-3/G-

M[email protected]''. 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-

M[email protected]''.

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 (919) 549-1400;

Facsimile: (919) 549-1842)

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, (919) 549-1400.

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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