Collapse to view only § 164.019-11 - Certification (affidavits).

§ 164.019-1 - Scope.

(a) This subpart contains general requirements for standard personal flotation device (PFD) components, procedures for acceptance of non-standard PFD components, and production quality control requirements for all PFD components, used in the construction of PFDs approved under part 160 of this subchapter.

(b) Other subparts of this part contain specific requirements applicable to particular PFD components used in the construction of Coast Guard-approved PFDs.

(c) Part 160 of this chapter contains specific requirements and limitations concerning the use of PFD components in the construction of particular Coast Guard-approved PFDs.

§ 164.019-3 - Definitions.

Acceptance means certification by the Coast Guard that a component is suitable for use in the manufacture of Coast Guard-approved PFDs.

Commandant means the Chief of the Lifesaving and Fire Safety Division, Office of Engineering and Design Standards, U.S. Coast Guard. 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; telephone 202-372-1392.

Component manufacturer means either a component manufacturer or supplier seeking acceptance of a component, or a component manufacturer or supplier who has obtained acceptance of a component.

Inspector means a Coast Guard marine inspector, authorized representative of the Coast Guard, or a recognized laboratory representative.

Non-standard component means a PFD component which is equivalent in performance to a standard component.

PFD Type means the performance type designation as indicated in 33 CFR part 175 and this subchapter.

Standard component means a PFD component which complies in all respects with the material, construction, and performance requirements of a subpart of this part or part 160 of this chapter.

Use Code means an alphanumeric code assigned by the Commandant (CG-ENG-4) to a PFD component to designate the PFD Type(s) in which it may be used. Assigned Use Codes are listed in table 164.019-3.

Table 164.019-3

Use code PFD type acceptable for use 1I, II, and III. 2II and III. 3III. 4BIV (all Ring Buoys). 4BCIV (Buoyant Cushions). 4RBIV (Recreational Ring Buoys only). 5Wearable Type V (intended use must be specified). 5HV (Hybrid). 5RV (Recreational Style). 5SBV (Sailboard vests). 5WVV (Work vests). 6Special, limited, or restricted use. Suffix AAdult only. Suffix CChild only.
[CGD 84-068, 58 FR 29494, May 20, 1993, as amended by CGD 95-072, 60 FR 50467, Sept. 29, 1995; CGD 96-041, 61 FR 50734, Sept. 27, 1996; USCG-2006-25697; 71 FR 55747, Sept. 25, 2006; USCG-2009-0702, 74 FR 49238, Sept. 25, 2009; USCG-2013-0671, 78 FR 60162, Sept. 30, 2013]

§ 164.019-4 - Component requirements.

(a) PFDs may be constructed only with Coast Guard-accepted PFD components meeting the requirements of this subchapter.

(b) PFD components may be used in the construction of PFDs only in accordance with their Use Codes.

§ 164.019-5 - Standard components; acceptance criteria and procedures.

(a) General. Standard components used in the construction of PFDs must meet the applicable requirements of this part or part 160 and the documentation requirements of this section.

(b) Use Codes. Each standard component is assigned a Use Code as indicated in table 164.019-3. Additional Use Codes may be assigned by the Commandant.

(c) Method and documentation of acceptance. Except as provided in paragraph (d) of this section, the following requirements pertaining to the shipment of standard components must be met in order for the standard components to be considered Coast Guard-accepted standard components:

(1) Each shipment of standard components must be accompanied by an affidavit complying with § 164.019-11.

(2) A sample affidavit, or a copy of the affidavit, provided with the first shipment of standard components to a PFD manufacturer, must be provided to the Commandant.

(3) A revised sample affidavit, or a copy of the revised affidavit, must be provided to the Coast Guard any time the information on the affidavit accompanying a shipment of standard components materially changes.

(d) Exception. Affidavits are not required to be provided for standard components that are under the quality control oversight program of a recognized laboratory meeting the requirements of § 164.019-17.

(e) Suspension or termination of acceptance. The procedures in §§ 2.75-40 and 2.75-50 of this chapter for suspension and termination of approvals also apply to Coast Guard acceptances of PFD components.

§ 164.019-7 - Non-standard components; acceptance criteria and procedures.

(a) General. Non-standard components may be used in the construction of PFDs only if they have been accepted by the Coast Guard in accordance with the requirements of this section.

(b) Use Codes. Each non-standard component is assigned a Use Code as indicated in table 164.019-3. Additional Use Codes may be assigned by the Commandant.

(c) Request for acceptance. The component manufacturer or the recognized laboratory that performs the acceptance testing required by the applicable subpart of this part or part 160 of this chapter must submit, in writing, to the Commandant, a request for acceptance of any non-standard component. The request must include the information, supporting documentation, and samples required by this section.

(1) The request must include a statement of the intended use of the component by the PFD manufacturer, and the Use Code(s) for which acceptance is requested. Intended uses must be for one or more of the following—

(i) Outer Envelope Fabric (exterior fabrics on wearable PFDs);

(ii) Cover Fabric (for throwable PFDs);

(iii) Inner Envelope Fabric;

(iv) Closure (including zippers) or Adjustment Hardware;

(v) Body Strap;

(vi) Grab Strap (applies to buoyant cushions only);

(vii) Tie Tape;

(viii) Reinforcing Tape;

(ix) Thread:

(x) Flotation Foam; or

(xi) Other (specify).

(2) The request must include a statement identifying the component in detail and including the unique style, part, or model number, the identification data required by the applicable subpart of this part, and any other manufacturer's identifying data. No two components which differ in any way, e.g., size, material composition, construction, may utilize the same identification number.

(3) The report of a recognized laboratory's test data in accordance with the “acceptance tests” required by the applicable subpart of this part or part 160 must be submitted with the request. Each report must include the name of the laboratory and a description of the test equipment and test methods used, and must be signed and dated by an authorized laboratory official.

(4) A sample of each component that is being considered must be submitted with the request. Where the lightest and darkest colors are being tested, samples of both colors must be submitted. A one linear yard sample is required in the case of textiles.

(5) The request must include a list of all materials used in the construction of the particular component. The list must contain specific identification and quantity of all materials used.

(6) For hardware and other mechanical components, the request must include scaled drawings showing details and dimensions of the mechanism.

(7) A statement of dimensional and performance tolerances, as appropriate, that will be maintained in production must be submitted with request.

(8) The request must include a description of the quality control procedures that will be in effect during production.

(9) The request must include a detailed description of the recognized laboratory's procedures for oversight of the manufacturer's program of production quality control, including a description of the laboratory's certification marking(s).

(10) The request must include any appropriate installation or use guidelines for the component.

(d) Documentation of acceptance. When an acceptance is granted, the Commandant provides written notice to the applicant.

(e) Alternate requirements. A component that does not meet the requirements of this subchapter is eligible for acceptance if it—

(1) Meets other requirements prescribed by the Commandant in lieu of or in addition to the requirements of this subpart; and

(2) Provides at least the same degree of safety as provided by a component that does comply with this subpart.

(f) Additional tests and documentation. The Commandant may prescribe additional tests or request additional documentation, if necessary, to determine the acceptability or suitability of a particular product.

(g) Suspension or termination of acceptance. The producers in §§ 2.75-40 and 2.75-50 of this chapter for suspension and termination of approvals also apply to Coast Guard acceptances of PFD components.

[CGD 84-068, 58 FR 29494, May 20, 1993; 58 FR 32416, June 9, 1993]

§ 164.019-9 - Procedure for acceptance of revisions of design, process, or materials.

(a) The manufacturer shall not change the design, material, manufacturing process, or construction of a non-standard component unless it has been previously approved by the Commandant, in accordance with paragraph (b) of this section.

(b) The manufacturer or the recognized laboratory that performs the acceptance testing required by the applicable subpart of this part or part 160 of this chapter shall submit requests for acceptance of revisions in design, material, manufacturing process, or construction of a non-standard component in writing and describe the revision in detail similar to the original request for acceptance.

§ 164.019-11 - Certification (affidavits).

General. Affidavits required by § 164.019-5(c) must be notarized, and certify that a component complies in all respects with the material and construction requirements of a subpart of this part or part 160 of this chapter. Each affidavit must contain the following information:

(a) Name and address of company.

(b) Name and title of signing company official.

(c) Description of the component by use of the unique style, part, or model number and other applicable distinctive characteristics such as weight, size, denier, treatments or coatings, etc.

(d) Production data (to include lot, batch number, and quantity shipped) in sufficient detail to enable the manufacturer or purchaser to trace a shipment of components back to the lots of raw materials used in its manufacture.

(e) The intended use of the component, from the list in § 164.019-7(c)(1).

(f) The PFD Type(s) for which the component is a standard component, as determined by—

(1) The standard material component requirements of part 160 of this chapter with which the component complies; or

(2) The Use Code(s) of the component.

(g) A statement indicating the specific provision(s) of this subchapter with which the component complies.

(h) A copy of the records of all required production tests performed on the component lots that are covered by the affidavit.

§ 164.019-13 - Production quality control requirements.

(a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing operations, and the finished product.

(b) Recognized laboratory oversight. Each manufacturer of non-standard components shall supplement its procedures for assuring production quality control with a program of oversight by a recognized laboratory, as described in the oversight procedures submitted to the Coast Guard in accordance with § 164.019-7(c)(9). The laboratory's oversight program must be performed at the place of manufacture unless alternate procedures have been accepted by the Commandant.

(c) Production tests and inspections. Production tests and inspections must be conducted in accordance with this section and subpart 159.007 of this chapter.

(d) Responsibilities; component manufacturers. Each component manufacturer shall—

(1) Perform all production tests and inspections required by the applicable subpart of this part;

(2) Adhere to the accepted quality control procedures for the component as submitted to the Coast Guard in accordance with § 164.019-7(c)(8); and

(3) Establish a continuing program of employee training and a program for maintaining production and test equipment.

(e) Responsibilities; recognized laboratories. The same recognized laboratory that performed the acceptance testing shall, at least quarterly, or more frequently if required by the applicable subpart of this part or by the oversight procedures submitted in accordance with § 164.019-7(c)(9)—

(1) Audit the component manufacturer's records required by § 164.019-15;

(2) Perform, or supervise the performance of, the tests required by this section, the applicable subpart of this part, and the accepted quality control and oversight procedures; and

(3) Verify, during each inspection, compliance by the manufacturer with the manufacturer's established quality control program and provide a summary report of any noncompliance to the Commandant at least annually.

(f) Component lots—(1) Lot numbers. The manufacturer shall assign a lot number to each group of components manufactured. A new lot must be started whenever any change is made in materials, design, or production method, and whenever any substantial discontinuity in the manufacturing process (such as a change in shift) occurs. Changes in lots of incoming materials must be treated as changes in materials. Lots must be numbered serially. The lot number assigned, in combination with the unique product name or identification, must enable the component manufacturer (or supplier), by referring to the records required by this subpart, to determine the source(s) of all raw materials used in that lot.

(2) Lot size. The maximum lot size for any particular component must be as defined in the applicable subpart of this part.

(g) Samples. (1) Procedures for selection of test samples, and required sample sizes, must be in accordance with the applicable subpart of this part.

(2) The inspector shall select different samples than were tested by the manufacturer.

(h) Detailed product examination—(1) General. In addition to the tests and inspections required by the applicable subpart of this part, the manufacturer or the inspector shall examine each sample component to determine that—

(i) The construction, markings, and workmanship conform to the information submitted in the request for acceptance; and

(ii) The component is not otherwise defective.

(2) Inspection responsibility. The manufacturer shall ensure that the inspection required by paragraph (h)(1) of this section is performed by a manufacturer's representative familiar with the performance requirements for the component, and all of the production quality control requirements. The manufacturer's representative must not be responsible for meeting production schedules, or be subject to supervision by someone responsible for meeting production schedules.

(i) [Reserved]

(j) Accept/reject criteria. (1) A component lot passes production testing and is therefore accepted if each sample tested passes each test.

(2) A lot having a production test failure may be accepted if it meets the following additional test requirements.

(i) When the basis of acceptability is an average result, a second sampling with an identical number of samples is taken. The results of this second sampling must be averaged with the initial results. If the average result passes the test, then the lot may be accepted.

(ii) When the basis of acceptability is individual sample results, a second sampling is taken. The size of the second sampling must be as specified in the subpart of this part which covers the component. If each sample in this sampling passes the test, the lot may be accepted.

(3) A rejected lot of components may be resubmitted for testing, examination, or inspection if—

(i) The manufacturer first removes each component having the same type of defect or;

(ii) After obtaining authorization from the Commandant or the recognized laboratory, the manufacturer reworks the lot to correct the defect.

(4) A rejected lot or rejected component may not be sold or offered for sale with the representation that it meets the requirements of this subpart or is accepted by the Coast Guard, and may not be used in the construction of Coast Guard-approved PFDs.

(k) Facilities and equipment—(1) General. The manufacturer shall provide the test equipment and facilities for performing production tests, examinations, and inspections described in the applicable subpart of this part and in the quality control and oversight procedures submitted in accordance with § 164.019-7(c) (8) and (9).

(2) Calibration. The manufacturer shall have the calibration of all test equipment checked at least every 6 months by a weights and measures agency or by the equipment manufacturer, distributor, or dealer.

(3) Facilities for inspector's use. The manufacturer shall provide a suitable place and the necessary apparatus for the inspector to use in conducting or supervising tests. For the detailed product examination, the manufacturer shall provide a suitable working environment and a smooth-top table for the inspector's use.

(4) Access to facilities. The manufacturer shall permit the inspector to have access to any place in the factory where work is being done on PFD components or where components are stored. The inspector may take samples of parts or materials entering into production or completed components, for further examinations, inspections, or tests.

(l) [Reserved]

(m) Alternate procedures for standard components. In lieu of the quality control procedures specified in this section, manufacturers of standard components may follow the quality control procedures in a Federal or military specification with which the component is required to comply by this subchapter, or equivalent procedures accepted by the Commandant.

(n) Additional tests. The Commandant may prescribe additional production tests and inspections to maintain quality control. A representative of the Commandant may conduct inspections for compliance with the requirements of this subpart.

[CGD 84-068, 58 FR 29494, May 20, 1993; 58 FR 32416, June 9, 1993]

§ 164.019-15 - Component manufacturer records.

(a) Each component manufacturer shall retain records as required by § 159.007-13 of this chapter.

(b) The records required by paragraph (a) of this section must include the following information:

(1) For each test, the serial number of the test instrument used if there is more than one available.

(2) For each test and inspection, the identification of the samples used, the lot number, the unique component identification, and the quantity of the component in the lot.

(3) The cause for rejection, any corrective action taken, and the final disposition of each lot rejected.

(c) Manufacturers utilizing procedures and apparatus meeting the requirements of the applicable subpart of this part or the independent laboratory's accepted follow-up inspection procedures are not required to include the description of procedures or photographs or apparatus required by § 159.007-13 of this chapter in the manufacturers' records.

(d) In addition to the records required by paragraphs (a) and (b) of this section, each component manufacturer shall retain the following:

(1) Records for all materials used in production, including name and address of the supplier, date of purchase and receipt, and lot number.

(2) A copy of this subpart, and other subparts applicable to the component manufactured.

(3) Each document incorporated by reference in the applicable subpart(s) of this part.

(4) A copy of the accepted component specifications and identifying data.

(5) Records of calibration of all test equipment, including the identity of the agency performing the calibration, date of calibration, and results.

(e) Manufacturers shall retain the records required by paragraph (d)(1) of this section for at least 60 months.

(f) Upon request, manufacturers shall make available to the inspector or to the Commandant records of tests conducted by the manufacturer and records of materials entering into construction, including affidavits by suppliers certifying that applicable requirements are met.

§ 164.019-17 - Recognized laboratory.

(a) General. A laboratory may be designated as a recognized laboratory under this subpart if it is—

(1) Accepted by the Coast Guard as an independent laboratory under subpart 159.010 of this subchapter; and

(2) Established in the inspection of factory production, listing, and labeling, by having an existing program and standards for evaluation, listing, and marking components, that are acceptable to the Commandant.

(b) Designated recognized laboratories. A current listing of recognized laboratories is available from the Commandant upon request.