(c) Replacement parts shall be designed and constructed to permit easy installation and to maintain the effectiveness of the tube unit.

(d) The component parts of each tube unit shall be:

(1) Designed, constructed, and fitted to minimize the chance of hazard to the user;

(2) Assembled in a manner which permits easy access (1) for inspection and repair of functional parts and (ii) to parts which require periodic cleaning.

(e) The accuracy of gas detector tube units shall be such that measurements made by these units, when used in accordance with the applicant's instructions, produce measurements of contaminant concentrations within ±25 percent of the actual value at concentrations of 1, 2, and 5 times the test standard of the contaminant of interest, and within ±35 percent of the actual value at one-half the test standard.

(f) Gas detector tubes shall continue to meet the performance standards of this part from the date of manufacture until the expiration date, if the tubes are stored according to the applicant's instructions during the elapsed time. § 84.21 Length-of-stain type detector tubes.

(a) In addition to requirements stated in § 84.20, length-of-stain type detector tubes shall either:

(1) Produce a minimum length of stain such that the calibration point on the calibration chart or curve for a concentration equal to the test standard for the gas to be detected shall correspond to a strain length of 15 mm or greater;

the above requirement. Such tests must be reproducible by the Institute.

(b) Channeling of airflow through the detector tube shall be minimized so that the maximum variation of stain length around the circumference of the tube at the interface between stained and unstained reagent shall be such that:

where: AL:-L2-L1

L=The concentration value indicated by the length of stain at the side of the tube where the stain is farthest extended along the tube's longitudinal axis.

L=The concentration value indicated by the length of stain at the side of the tube where the stain is least extended along the tube's longitudinal axis. M=The median value between L, and La. (c) Gas detector tubes shall be assembled so that the packing which interfaces with the indicator reagent at the stained end of the tube is at a right angle to the longitudinal axis of the tube and shall be such that the distance along the tube's longitudinal axis from the point at which the packing is farthest extended toward the reagent to the point at which the packing is least extended toward the reagent shall not exceed 2 mm.

§ 84.22 Color-intensity type detector tubes.

In addition to requirements stated in § 84.20, color-intensity type detector tubes shall meet either of the following requirements:

(a) A sufficient number of color charts and sampling volume combinations shall be provided to:

(1) Cover the range from 0.5 to 1.5 times the test standard in increments not greater than 0.25 times the test standard.

(2) Cover the range from 1.5 to 3 times the test standard in increments not greater than 0.5 times the test standard.

(3) Cover the range from 3 to 5 times the test standard in increments not greater than the test standard.

A color comparison chart and corresponding sampling volume shall be provided for each of the discrete increments indicated above; or

(b) A sufficient number of color charts and sampling volume combinations shall be provided so that the following requirement is met when readings are obtained

(b) All applicant-supplied correction factors for temperature, relative humidity, pressure, and other pertinent variables shall be applied to the tube readings before evaluating such readings for accuracy.

(c) Routine calibration of each batch of tubes by the applicant shall be conducted at ambient room temperature in the range of 65-85° F. (18.3-29.5° C.). Relative humidities shall be adjusted approximately to 50 percent, except for cases in which the presence of a substantial amount of water vapor would result in unstable contaminant concentrations, interfere with concentration monitoring systems, or otherwise cause a disturbance of test conditions. In such cases, a lower relative humidity may be used.

(d) The applicant shall perform tube calibration tests on gas detector tubes from each batch of its tubes at concentrations of 0.5, 1, 2, and 5 times the test standard for the specific gas or vapor to be detected.

(e) Calibration concentrations shall be generated using one of the following methods:

(1) A dynamic contaminant generation system, as by a gas saturating method (employing the vapor pressure of the substance), permeation tube devices, or other instruments or devices which generate gases at a steady, measurable rate.

(2) An analyzed gas mixture from a pressurized cylinder.

(3) A static concentration system as one prepared by injecting a known mass

of a liquid contaminant into a sealed container of known volume and allowing time for evaporation and the equilibration of adsorption and desorption on container walls.

(4) Any other method approved by the Institute.

(f) Independent chemical or physical analysis shall be used by the applicant to verify the test concentration of the gas generated pursuant to paragraph (e) of this section, except in the case when no independent method of acceptable accuracy has been developed.

(g) The applicant shall test gas detector tubes in the presence of interfering gases to verify the applicant's stated interference levels and to determine what additional gases might also interfere with detector tube readings and to what degree such interferences might occur. § 84.24 Aspirating pumps.

(a) Aspirating pumps for drawing the air to be sampled with detector tubes shall be free from leakage which can result in erroneously low tube readings, and shall be calibrated by the applicant to sample at whatever flow rate is deemed appropriate by the applicant in order to assure accurate measurements.

(b) After the pump has been evacuated, leakage per minute shall not be more than 3 percent of the pump's volume capacity in a single stroke when the pump inlet is plugged.

(c) Flow control devices, if used, shall regulate the flow rate to within ±10 percent of the rate stated by the applicant for each flow rate control device.

(d) Pumps shall be calibrated by the applicant to insure that they are capable of sampling accurately the stated volume at the stated flow rate. Subsequent to a check of proper flow rate and volume, the pump shall be capable of drawing 100 full-capacity strokes of air without deviating more than ±10 percent from the calibration flow rate.

(e) The pump shall be capable of drawing the volume stated by the applicant to within ±5 percent of said volume. A properly maintained pump shall be able to continue to draw this volume throughout its normal working lifetime.

(f) The performance of the discharge check valve system shall be such that when 10 consecutive pump strokes are taken, the total volume of air drawn into the pump through its inlet minus the total volume discharged through the

pump inlet shall be within 5 percent of 10 times the pump's volume capacity for a single stroke.

Subpart C-Quality Control

§ 84.30 Filing quality control plans.

Quality control plans shall be filed by the applicant as a part of each application submitted pursuant to § 84.3.

§ 84.31 Contents of quality control plan.

(a) Each quality control plan shall contain provisions for the management of quality, including: (1) Requirements for the production of quality data and the use of quality control records; (2) control of engineering drawings, documentations, and changes; (3) control and calibration of measuring and test equipment; (4) control of purchased material to include incoming inspection; (5) batch identification, control of processes, manufacturing, fabrication, and assembly work conducted in the applicant's plant; (6) audit of final inspection of the completed product; and, (7) the organizational structure necessary to carry out these provisions.

(b) Each final inspection quality control plan shall include a procedure for the selection of a sample of detector tubes, pumps, and accessory equipment for testing in accordance with MILSTD-105D "Sampling Procedures and Tables for Inspection by Attributes," or MIL-STD-414, "Sampling Procedures and Tables for Inspection by Variables for Percent Defective," or from a combination of such sampling procedures, or equivalent plan approved by the Institute.

(c) The sampling plan shall include a list of the characteristics to be measured, inspected, or tested by the applicant. These characteristics shall be classified according to the potential effect of each defect and grouped into the following classes:

(1) Special. Tube reading accuracy.

(2) Critical. A defect which will make the product completely inoperative or render it unusable for its intended purpose.

(3) Major. A defect other than critical, that is likely to result in failure, or to reduce materially the usability of the detector tube system in its intended purpose.

(4) Minor. A defect that is not likely to reduce materially the usability of the detector tube system for its intended pur

pose, or is a departure from established standards having little bearing on the effective use or operation of the detector tube system.

(d) For each characteristic required to be tested or inspected, the test method to be used by the applicant for quality control inspection shall be described in detail.

(e) For those characteristics for which an alternate inspection level has been requested pursuant to paragraph (h) of this section, the alternate level proposed and supporting evidence for its selection shall be given.

(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics except where tests are destructive, and all defective items shall be rejected.

quality level

(g) The acceptable (AQL) for each special, critical, major or minor defect, so classified by the applicant shall be as follows:

(1) Special-6.5 percent.

(2) Critical-0 percent (where tests are nondestructive). 1.0 percent (where tests are destructive).

(3) Major-2.5 percent.
(4) Minor-4.0 percent.

(h) Inspection level II as described in MIL-STD-414 shall be used for special characteristics and destructive tests for critical characteristics except when the applicant's request for an alternate inspection level has been approved by the Institute. Inspection level II as described in MIL-STD-105, or inspection level IV as described in MIL-STD-414 shall be used for major and minor characteristics except when the applicant's request for an alternate inspection level has been approved by the Institute. The request for an alternate inspection level shall include sufficient evidence that smaller sample sizes are necessary and larger sampling risks can be tolerated.

§ 84.32 Approval of plan.

(a) Each quality control plan submitted in accordance with this subpart shall be reviewed by the Institute to determine its effectiveness in maintaining compliance with the construction and performance requirements set forth in subpart B of this part.

(b) In the event the quality control plan submitted by the applicant will not. in the opinion of the Institute, ensure adequate quality control, the Institute shall, as necessary, require the applicant

to modify the procedures and testing requirements of the plan prior to approval of the plan and issuance of any certificate.

(c) Approved quality control plans shall constitute a part of and be incorporated into any certificate issued by the Institute, and compliance with such plans by the applicant shall be a condition of certification.

§ 84.33

Quality control records.

(a) The applicant shall maintain quality control inspection records sufficient to carry out the procedures required in MIL-STD-105D or MILSTD-414.

(b) The Institute reserves the right, at reasonable times, to have its qualified representatives inspect, without prior notice, the applicant's quality control test methods, systems, equipment, and records, and to interview any employee or agent of the applicant who conducts quality control tests.

Incorporation by reference provision approved by the Director of the Federal Register March 5, 1973.

Authority for investigations. Advance notice of visits. Conduct of investigations. Provision of suitable space for employee interviews and examinations; identification of employees. Representatives of employers and employees; employee requests. 85.10 Imminent dangers. 85.11

85.9

Notification of determination to employers, affected employees, and Department of Labor. 85.12 Subsequent requests for health hazard evaluations.

AUTHORITY: The provisions of this Part 85 issued under the authority of section 8(g), 84 Stat. 1600; 29 U.S.C. 657(g).

SOURCE: 37 FR 23640, Nov. 7, 1972, unless otherwise noted.

§ 85.1 Applicability.

The provisions of this Part 85 are applicable to requests submitted by any employer or authorized representative of employees pursuant to section 20(a) (6) of the Occupational Safety and Health Act of 1970 for a determination

Any term defined in the Occupational Safety and Health Act of 1970 and not defined below shall have the meaning given it in the Act. As used in this part:

(a) "Act" means the Occupational Safety and Health Act of 1970 (29 U.S.C. 651, et seq.).

(b) "Authorized representative of employees" means any person or organization meeting the conditions specified in § 85.3(b) (4) (i), (ii), or (iii).

(c) "Investigation" includes a physical inspection of the place of employment pursuant to section 8 of the Act and means such inspection, sampling, observations, and other measurements reasonably necessary to determine whether any substance found in the place of employment for which the request is made has potentially toxic effects in such concentrations as used or found.

(d) "Health hazard evaluation" means the investigation and the determination of potentially toxic effects of any substance normally used or found in any place of employment to which the Act is applicable.

(e) "Place of employment" means any factory, plant, establishment, construction site, or other area, workplace, or environment where work is performed by any employee of an employer.

(f) "NIOSH" means the National Institute for Occupational Safety and Health.

(g) "NIOSH officer" means a person authorized by NIOSH to conduct investigations.

(h) "Substance means any chemical or biological agent which has the potential to produce toxic effects.

(1) "Toxic effects" are those which result in short- or long-term disease, bodily injury, affect health adversely, or endanger the life of man.

§ 85.3 Procedures for requesting health hazard evaluations.

(a) A request for a health hazard evaluation should be addressed to the

National Institute for Occupational Safety and Health, Hazard Evaluation Services Branch, U.S. Department of Health, Education, and Welfare, Cincinnati, Ohio 45202.

(b) A request for such an evaluation shall:

(1) Be in writing and signed by (1) the employer in whose place of employment the substance is normally found, or (ii) by an authorized representative of employees who are employed by such employer;

(2) State the requester's name, address, and telephone number, if any; the address of the place of employment where the substance is normally found; the specific workplace or workplaces involved, and the specific process or type of work which is the source of the substance or in which such substance is used;

(3) Specify with reasonable particularity the nature of the conditions, circumstances, or other grounds on which the request is made;

(4) State, where the requester is other than the employer:

(1) That he is an authorized representative, or an officer, of the organization representing the employees for purposes of collective bargaining; or

(ii) That he is an employee of the employer and is authorized by two or more employees employed in the workplace where the substance is normally found to represent them for purposes of the Act. Each such authorization shall be in writing and included in the request;

or

(ii) That he is one of three or less employees employed in the workplace where the substance is normally found.

(5) Indicate whether the requester or those persons who have authorized the requester to represent them desire that NIOSH not reveal their names to the employer.

(c) The request shall, if the information is known to the requester:

(1) Identify the potentially toxic substance or substances involved;

(2) State the trade name, chemical name, and the manufacturer of each such substance;

(3) State whether the substance or the container of such substance has a warning label; and

(4) Specify the physical form of the substance, number of people exposed, length of exposure (hours/day), and occupations of exposed employees.

NOTE: The National Institute for Occupational Safety and Health has developed a form, entitled "Request for Health Hazard Evaluation," to assist persons in requesting evaluations under this part. Forms are available upon request from NIOSH, Hazard Evaluation Services Branch, Cincinnati, Ohio 45202, or from the NIOSH representative in any Regional Office of the Department of Health, Education, and Welfare.

§ 85.4 Acting on requests.

(a) When a request meeting the requirements of this part has been submitted in accordance therewith and designated employees of NIOSH have conIcluded that there is reasonable cause to believe that an investigation is warranted, a NIOSH officer will inspect the place of employment, collect samples where appropriate and perform such tests as necessary, including medical examinations of employees, to the conduct of a health hazard evaluation.

(b) If there is no reasonable cause to conclude that an investigation is warranted, the requester shall be notified in writing of such decision.

(c) Investigations shall be conducted in accordance with the requirements of this part.

§ 85.5 Authority for investigations.

(a) Employees of the National Institute for Occupational Safety and Health who have been issued the NIOSH official credentials (consisting of HSM Form 599-2 entitled "Identification Record") are authorized by the Director, NIOSH, for the purposes of section 20(a) (6) of the Act and pursuant to section 8, to enter without delay and at reasonable times any place of employment for which a request has been submitted, to inspect and investigate during regular working hours and at other reasonable times, and within reasonable limits and in a reasonable manner, any such place of employment, and all pertinent conditions, structures, machines, apparatus, devices, equipment, and materials therein as may be directly related to the determination whether any substance normally found in the place of employment for which a request has been submitted has potentially toxic effects in such concentrations as used or found. In connection with any such investigation, such NIOSH employees may question privately any employer, owner, operator, agent, or employee and review records required by the Act and regulations, and other related records.