(a) This subpart contains structural and performance standards for approval of Level 100 lifejackets, as well as requirements for production follow-up inspections, markings, information placards, and associated manuals.

(b) Lifejackets approved under this subpart must rely upon inherently buoyant material, inflation, or a combination to achieve the minimum buoyancy.

(c) Lifejackets approved under this subpart are intended to meet the carriage requirements for wearable PFDs for uninspected passenger vessels, uninspected commercial vessels over 40 ft (12m) and for inspected vessels.

The following definitions apply to this subpart:

Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509; email [email protected].

First quality workmanship means construction that is free from any defect materially affecting appearance or serviceability.

Inspector means a recognized laboratory representative assigned to perform, supervise, or oversee the duties described in § 160.255-15 or any Coast Guard representative performing duties related to the approval.

Recognized laboratory means an independent laboratory accepted by the Commandant in accordance with 46 CFR subpart 159.010, with a valid memorandum of understanding in accordance with 46 CFR 159.010-7.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062-2002; phone (847) 272-8800; website: www.ul.com.

(a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (“ANSI/CAN/UL 9595”); IBR approved for § 160.255-15(a).

(b) ANSI/CAN/UL 12402-4:2020, Standard for Safety Personal Flotation Devices—Part 4: Lifejackets, Performance Level 100—Safety Requirements, First Edition, July 9, 2020 (“ANSI/CAN/UL 12402-4”); IBR approved for §§ 160.255-7(a); 160.255-13(a) and (b); 160.255-17(a); 160.255-19; 160.255-21(a).

(a) Each Level 100 lifejacket design must—

(1) Meet the requirements in ANSI/CAN/UL 12402-4 (incorporated by reference, see § 160.255-5) for a Level 100 device, and the requirements of this subpart; and

(2) For novel or unique designs, meet any additional requirements that the Commandant may prescribe.

(b) Lifejackets must be of first quality workmanship and must be free from any defects materially affecting their appearance or serviceability.

(c) Lifejackets must not provide means intended for fastening or securing the device to a boat.

(a) Each application for approval of a Level 100 lifejacket must be submitted directly to a Coast Guard recognized laboratory.

(b) The recognized laboratory must determine if a lifejacket with novel design features requires a preliminary review by the Coast Guard prior to testing. Submissions requiring preliminary review must be sent to [email protected], and must include a full description and drawings. Pictures, samples, and preliminary test results may also be submitted.

(a) The approval inspections and tests, production inspections, tests, and quality control required by this subpart must be conducted by an independent laboratory recognized by the Coast Guard under 46 CFR subpart 159.010 to perform such functions. A list of recognized independent laboratories is available from the Commandant and online at https://cgmix.uscg.mil.

(b) The same laboratory that performs the approval tests must also perform production oversight unless the employees of the laboratory performing production oversight receive training and support equal to that of the laboratory that performed the approval testing, as determined by the Commandant.

(a) Each lifejacket must be certified by a recognized laboratory as meeting the requirements of ANSI/CAN/UL 12402-4 (incorporated by reference, see § 160.255-5). Approval tests specified in ANSI/CAN/UL 12402-4 must be conducted or supervised by a recognized laboratory using prototype lifejackets constructed in accordance with the plans and specifications submitted with the application for approval.

(b) Each lifejacket design must be visually examined for compliance with the construction and performance requirements of this subpart and ANSI/CAN/UL 12402-4 (incorporated by reference, see § 160.255-5).

(c) The Commandant may prescribe additional tests for approval of novel or unique designs.

(a) General. Production tests and inspections must be conducted in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.255-5), or an alternative follow-up procedure accepted by the Commandant. To maintain approval, the manufacturer must be in good standing under an accepted follow-up procedure.

(b) Manufacturer's inspection and tests. Manufacturers of approved lifejackets must maintain quality control of the materials used, manufacturing methods, and the finished product so as to meet the applicable requirements, and make sufficient inspections and tests of representative samples and components produced to maintain the quality of the finished product. Records of tests conducted by the manufacturer and records of materials, including affidavits by suppliers that applicable requirements are met, must be made available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request.

(c) Laboratory inspections and tests. The laboratory inspector will conduct examinations, inspections, and tests for listed and labeled devices, as required by the recognized laboratory, at the place of manufacture or other location at the option of the laboratory.

(d) Test facilities. The inspector must be admitted to any place in the factory where work is being done on listed and labeled products, and the inspector may take samples of parts or materials entering construction or final assemblies, for further examinations, inspections, or tests. The manufacturer must provide a suitable place and the apparatus necessary for the performance of the tests done at the place of manufacture.

(e) Additional tests, etc. Unannounced examinations, tests, and inspections of samples obtained either directly from the manufacturer or through commercial channels may be made to determine the suitability of a product for listing and labeling, or to determine conformance of a labeled product to the applicable requirements. These may be conducted by the recognized laboratory or the United States Coast Guard.

(a) Each lifejacket must be marked with the appropriate label as specified in Figure 6DV of ANSI/CAN/UL 12402-4 (incorporated by reference, see § 160.255-5).

(b) The Commandant may prescribe additional marking requirements for special purpose devices or unique or novel designs.

Each lifejacket sold or offered for sale must be provided with a placard that a prospective purchaser can read prior to purchase, as specified in Figure 8DV.1.1a and Figure 8DV.1.1b, Choose the Device You Will Want to Wear, of ANSI/CAN/UL 12402-4 (incorporated by reference, see § 160.255-5). The required placard text must be printed exactly as set out in ANSI/CAN/UL 12402-4, unless otherwise approved by the Commandant.

(a) An owner's manual in accordance with Figure 7DV of ANSI/CAN/UL 12402-4 (incorporated by reference, see § 160.255-5), must be provided with each inflatable lifejacket sold or offered for sale. The text of each manual is reviewed with the application for approval.

(b) The Commandant may prescribe additional information in the manual for special purpose devices or unique or novel designs.

(c) Additional information, instructions, or illustrations may be included in the owner's manual if there is no contradiction to the required information.

(a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized laboratory for approval before changing lifejacket production methods.

(b) Determinations of equivalence of design, construction, and materials must be made only by the Commandant or a designated representative.

As provided in 46 CFR 159.005-15, the Commandant may suspend or terminate the approval of a lifejacket design if the manufacturer fails to comply with this subpart or the recognized laboratory's accepted procedures or requirements.

(a) General. Each lifejacket that relies fully or partially on inflation and is approved under this subchapter must be serviced at approved facilities at 12-month intervals according to this section.

(1) Each manufacturer of an approved inflatable lifejacket must provide one or more Coast Guard-approved facilities for servicing those lifejackets. The manufacturer must notify the Commandant whenever an approved facility under its organization no longer provides servicing of a lifejacket make and model listed in the guidelines required by paragraph (d) of this section.

(2) Each manufacturer of an approved inflatable lifejacket must make replacement parts available to Coast Guard-approved independent servicing facilities.

(b) Servicing facilities. Each Coast Guard-approved servicing facility must meet the requirements of this paragraph and paragraph (d) of this section to receive and keep its approval for each make and model of lifejacket. Approval is obtained according to § 160.255-5(c).

(1) Each servicing facility must conduct lifejacket servicing according to its servicing guidelines and follow the procedures in the service manual required by this section.

(2) Each servicing facility must have a suitable site for servicing that must be clean, well lit, free from excessive dust, drafts, and strong sunlight, and have appropriate temperature and humidity control as specified in the service manual.

(3) Each servicing facility must have the appropriate service, repair, and test equipment and spare parts for performing required tests and repairs.

(4) Each servicing facility must have a current manufacturer's service manual for each make and model of lifejacket serviced.

(5) A servicing facility may have more than one servicing site provided that each site meets the requirements of paragraph (b)(2) of this section.

(6) Each servicing facility must be inspected at intervals not exceeding six months by an accepted independent laboratory, and a report of the inspections must be submitted to the Commandant at least annually. The report must contain enough information to show compliance with paragraphs (b)(1) through (4) of this section and paragraph (d) of this section. Where a facility uses more than one site the report must show compliance at each site at least biennially.

(c) Service manual. (1) Each manufacturer of an approved inflatable lifejacket must prepare a service manual for the lifejacket. The service manual must be approved by the Commandant according to § 160.176-5(b).

(2) The manufacturer must make the service manual, service manual revisions, and service bulletins available to each approved servicing facility.

(3) Each service manual must contain the following:

(i) Detailed procedures for inspecting, servicing, and repackaging the lifejacket;

(ii) A list of approved replacement parts and materials to be used for servicing and repairs, if any;

(iii) A requirement to mark the date and servicing facility name on each lifejacket serviced;

(iv) Frequency of servicing; and

(v) Any specific restrictions or special procedures prescribed by the Coast Guard or manufacturer.

(4) Each service manual revision and service bulletin which authorizes the modification of a lifejacket, or which affects a requirement under this subpart, must be approved by the Commandant. Other revisions and service bulletins are not required to be approved, but a copy of each must be sent to the Commandant when it is issued. At least once each year, the manufacturer must provide to the Commandant and to each servicing facility approved to service its lifejackets a bulletin listing each service manual revision and bulletin in effect.

(d) Servicing facilities guidelines. Each servicing facility must have written guidelines that include the following:

(1) Identification of each make and model of lifejacket that may be serviced by the facility as well as the manual and revision to be used for servicing;

(2) Identification of the person, by title or position, who is responsible for the servicing program;

(3) Training and qualifications of servicing technicians;

(4) Provisions for the facility to retain a copy of its current letter of approval from the Coast Guard at each site; and

(5) Requirements to—

(i) Ensure each inflatable lifejacket serviced under its Coast Guard approval is serviced in accordance with the manufacturer's service manual;

(ii) Keep servicing technicians informed of each approved servicing manual revision and bulletin and ensure servicing technicians understand each change and new technique related to the lifejackets serviced by the facility;

(iii) Calibrate each pressure gauge, weighing scale, and mechanically operated barometer at intervals of not more than one year;

(iv) Ensure each inflatable lifejacket serviced under the facility's Coast Guard approval is serviced by or under the supervision of a servicing technician who meets the requirements of paragraph (d)(3) of this section;

(v) Specify each make and model of lifejacket the facility is approved to service when it represents itself as approved by the U.S. Coast Guard; and

(vi) Not service any lifejacket for a U.S. registered commercial vessel, unless it is approved by the U.S. Coast Guard to service the make and model of lifejacket.

(e) Servicing records. Each servicing facility must maintain records of all completed servicing. These records must be retained for at least 5 years after they are made, be made available to any Coast Guard representative and independent laboratory inspector upon request, and include at least the following:

(1) Date of servicing, number of lifejackets serviced, lot identification, approval number, and test results data for the lifejackets serviced;

(2) Identification of the person conducting the servicing;

(3) Identity of the vessel receiving the serviced lifejackets; and

(4) Date of return to the vessel.