# Appendix — American Textile Mfrs. Institute, Inc. v. Donovan > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385006_2223%3A02 ## Record - **Collection:** Supreme Court brief - **Document type:** Appendix - **Published:** January 1, 1981 - **Citation:** 452 U.S. 490 ## Text IN THE Supreme Court of the United States OCTOBER TERM 1979 Nos. “W9«14 29 AMERICAN TEXTILE MANUFACTURERS INSTITUTE, INC., MILLIKEN & COMPANY, ARKWRIGHT MILLS, SPARTAN MILLS, BLAIR MILLS, INC., HERMITAGE, INC., DAN RIVER, INC., CONE MILLS CORPORATION, MAYFAIR MILLS, SPRINGS MILLS, INC., RIEGEL TEXTILE CORPORATION, FIELDCREST MILLS, INC., AND WEST POINT-PEPPERELL, INC., Petitioners, V. RAY MARSHALL, SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, Respondents. APPENDIX TO PETITION FOR WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT ROBERT H. Bork JOHN S. BATTLE, Jr. 142 Huntington Street ROBERT E. PAYNE New Haven, Connecticut 06511 THOMAS W. MCCANDLISH Counsel for American Textile McGuire, Woods & Battle Manufacturers Institute, Inc. 1400 Ross Building Richmond, Virginia 23219 GREGORY B. TOBIN Counsel for American Textile OGLETREE, DEAKINS, SMOAK, 1 — Manufacturers Institute, Inc. STEWART & EDWARDS and for 3920 First National Bank Tower Fieldcrest Mills, Inc. Atlanta, Georgia 30303 Counsel for American Textile Manufacturers Institute, Inc. (Counsel list continued on inside cover) LL ELL TL TLL ELEY SEALER ELLIE LIAL ETE DEIR DLT NL NEL OLD ETE TTT ETE IEE ANE: ROBERT T. THOMPSON Gary S. KLEIN Thompson, Mann & Hutson The Daniel Building—Suite 2222 Greenville, S. C. 29602 Counsel for Milliken and Company THOMAS A. EVINS CLYDE H. HAMILTON Butler, Means, Evins & Browne P. O. Box 451 Spartanburg, S. C. 29304 Counsel for Arkwright Mills JOSEPH K. MApDpDOox, JR. P. O. Box 5784 Spartanburg, S. C. 29304 Counsel for Spartan Mills ROBERT T. THOMPSON Gary S. KLEIN Thompson, Mann & Hutson The Daniel Building—Suite 2222 Greenville, S. C. 29602 Counsel for Blair Mills, Inc. ROBERT T. THOMPSON Gary S. KLEIN Thompson, Mann & Hutson The Daniel Building—Suite 2222 Greenville, S. C. 29602 Counsel for Hermitage, Inc. ROGER L. TUTTLE 2291 Memorial Drive Danville, Virginia 24541 Counsel for Dan River, Inc. SAMUEL K. ABRAMS BRIAN E. MORAN Baker & Hostetler 1776 K Street, N.W. Suite 900 Washington, D. C. 20006 Counsel for Cone Mills Corporation H. J. ELAM, III NEIL W. KOONCE Cone Mills Corporation 1201 Maple Street Greensboro, N. C. 27405 Counsel for Cone Mills Corporation THOMAS A. EvINS CLYDE H. HAMILTON Butler, Means, Evins & Browne P. O. Box 451 Spartanburg, S. C. 29304 Counsel for Mayfair Mills DAN M. Byrp, JR. J. SPRATT WHITE P. O. Box 70 Fort Mill, S. C. 29715 Counsel for Springs Mills, Inc. FRED M. RICHARDSON Lovic A. Brooks, Jr. CHARLES A. EDWARDS Constangy, Brooks & Smith 1900 Peachtree Center Building 230 Peachtree Street, N.W. Atlanta, Georgia 30303 Counsel for Riegel Textile Corporation RICHARD H. MONK, JR. C. POWERS DORSETT West Point-Pepperell, Inc. P. O. Box 71 West Point, Georgia 31833 Counsel for West Point- Pepperell, Inc. TABLE OF CONTENTS The Cotton Dust Standard (29 C.F.R. S EPEOD 6 ss bowwae 1 AFL-CIO v. Marshall and Cotton Warehouse Assoc. v. Marshall, Nos. 78-1562, 78-1736 (D. DC, filed Oct. 29, RP Pads CP WE 5 Ge ee ee 19 Order denying petitions for rehearing, filed Jan. 11, 1980...... 103 Order denying suggestions for rehearing en banc, filed Jan. 1 Be IEG 5.6 6956 OUTROS MOK RIAA Os aed Cae 104 Order directing Clerk to issue mandate, filed Jan. 22, 1980.... 106 OSHA Exhibit 6, No. 18, “Byssinosis—A Study of 10,133 Textile Workers,” by Imbus and Suh ................... 108 OSHA Exhibit 42B, Supplemental Submission to Statement and Testimony of Jack W. Whitworth, M.D. ................ 124 OSHA Exhibit 46, Statement of Charles F. Martin, M.D...... 126 OSHA Exhibit 2, Cotton Dust—Proposed Standards for Exposure and Notice of Hearing, p. 56500 .............. 137 OSHA Exhibit 6, No. 76, Excerpts from Technological Feasibility Assessment and Final Inflationary Impact SI 5 i i ESE vine h tees ee eee ee 138 OSHA Exhibit 60, Statement of Hovan Hocutt, pp. 18-19, FR BE isn oy sxe bss vase ae 152 OSHA Exhibit 62, Statement of Arthur Thomas, Attachment #1 155 OSHA Exhibit 42, Statement of Jack W. Whitworth, M.D... .. 157 OSHA Exhibit 47, Statement of Harold R. Imbus, M.D., SC.D. 172 OSHA Exhibit 63, Statement of John P. Figh .............. 188 | er rpm ins Aone ry 195 Hocutt Transcript pages 2488-89 ............ 0.0.0.0 c0eee 196 Hocutt Transcript pages 2514-15 ..........ccccssccevces 197 Pugh Tramsctigt pases ZaGG- TE. ek cc in cine benkenes 198 App. 1 CHAPTER XVII—OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION § 1910.1043 Cotton dust. (a) Scope and application. (1) This section applies to the control of employee exposure to cotton dust in all work- places, except as provided in paragraph (a) (2) of this sec- tion. (2) This section does not apply to: (i) The harvesting of cotton; (ii) the ginning of cotton (Exposure to cotton dust in cotton ginning is covered by § 1910.1046); (iii) mari- time operations covered by 29 CFR Parts 1915, 1916, 1917, 1918; (iv) the handling or processing of woven or knitted materials; and (v) the handling or processing of washed cotton. (3) This section provides mandatory requirements for the control of employee exposure to cotton dust. The man- datory nature of these requirements is not intended, how- ever, to discourage or inhibit the development of different, equally effective means of providing the required protection. The variance provisions of section 6(d) of the Act, and the implementing regulations in Part 1905 of this Title, provide a mechanism for employers to obtain variances from the provisions of this section where the employer has devel- oped alternative procedures which are “as safe and healthful as” those required by this section. As implemented by the procedural regulations in Part 1905 of this Title, the vari- ance provisions of the Act permit the flexibility which con- tributes to efficient compliance with the standard, To aid in the expeditious processing of variance applications, the procedures allow, where appropriate, for the grant of interim orders pending a decision on the merits of the variance as well as for the consideration of variances applicable to groups of employers. OSHA encourages interested em- App. 2 ployers to utilize the variance provisions of the Act where equally safe and healthful protective means are available. (b) Definitions. For the purpose of this section: “Assistant Secretary” means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor or designee; “Blow down” means the cleaning of equipment and sur- faces with compressed air. “Cotton dust” means dust present in the air during the handling or processing of cotton, which may contain a mixture of many substances including ground up plant mat- ter, fiber, bacteria, fungi, soil, pesticides, non-cotton plant matter and other contaminants which may have accumulated with the cotton during the growing, harvesting and subse- quent processing or storage periods. Any dust present during the handling and processing of cotton through the weaving or knitting of fabrics, and dust present in other operations or manufacturing processes using new or waste cotton fibers or cotton fiber by-products from textile mills are considered cotton dust. “Director” means the Director of the National Institute for Occupational Safety and Health (NIOSH), U.S. De- partment of Health, Education, and Welfare, or designee; “Lint-free respirable cotton dust” means particles of cot- ton dust of approximately 15 microns or less aerodynamic equivalent diameter; “Vertical elutriator cotton dust sampler” means a dust sampler which has a particle size cut-off at approximately 15 microns aerodynamic equivalent diameter when operat- ing at the flow rate of 7.4+0.2 liters per minute; “Yarn manufacturing” means all textile mill operations from opening to, but not including, slashing and weaving; “Washed cotton” means cotton which has been thoroughly washed in hot water and is known in the cotton textile trade App. 3 as purified or dyed. Washed cotton does not include steamed, autoclaved cotton or cotton washed solely in solvents. (c) Permissible exposure limits. (1) the employer shall assure that no employee who is exposed to cotton dust in yarn manufacturing is exposed to airborne concentrations of lint-free respirable cotton dust greater than 200 ug/m’ mean concentration, averaged over an eight-hour period, as measured by a vertical elutriator or a method of equivalent accuracy and precision. (2) The employer shall assure that no employee who is exposed to cotton dust in the textile processes known as slashing and weaving is exposed to airborne concentrations of lint-free respirable cotton dust greater than 750 ug/m’ mean concentration, averaged over an eight hour period, as measured by a vertical elutriator or a method of equivalent accuracy and precision. (3) The employer shall assure that no employee who is exposed to cotton dust (except for exposures in yarn manu- facturing and slashing and weaving covered by paragraphs (c)(1) and (c)(2) of this section is exposed to airborne concentrations of lint-free respirable cotton dust greater than 500 ug/m* mean concentration, averaged over an eight- hour period, as measured by a vertical elutriator or a method of equivalent accuracy and precision. (d) Exposure monitoring and measurement—(1) Gen- eral. (i) For the purposes of this section, employee exposure is that exposure which would occur if the employee were not using a respirator. (ii) ) The sampling device to be used shall be either the vertical elutriator cotton dust sampler or a method of equiva- lent accuracy and precision. (iii) If an alternative to the vertical elutriator cotton dust sampler is used, the employer shall establish equiva- lency by demonstrating that the alternative sampling App. 4 devices; (a) Collect respirable particulates in the same range as the vertical elutriator (approximately 15 microns) ; (b) Replicate exposure data in side-by-side field com- parisons; and (c) Are equivalent within an accuracy and precision range of plus or minus 25 percent for 95 percent of the samples over the range of 0.5 to 2 times the permissible ex- posure limit. (2) Initial monitoring. Each employer who has a place of employment in which cotton dust is present, shall conduct monitoring by obtaining measurements which are representa- tive of the exposure of all employees to airborne concentra- tions of lint-free respirable cotton dust over an eight-hour period. The sampling program shall include at least one determination during each shift for each work area. (3) Periodic monitoring. (i) The employer shall repeat the measurements required by paragraph (d)(2) of this section at least every six months. ii) Whenever there has been a production, process, or control change which may result in new or additional ex- posure to cotton dust, or whenever the employer has any other reason to suspect an increase in employee exposure, the employer shall repeat the monitoring and measurements required by paragraph (d)(2) of this section for those em- ployees affected by the change or increase. (4) Employee notification. (i) Within five working days after the receipt of monitoring results, the employer shall notify each employee in writing of the exposure measure- ments which represent that employee’s exposure. (ii) Whenever the results indicate that the employee’s exposure exceeds the applicable permissible exposure limit specified in paragraph (c) of this section, the employer shall include in the written notice a statement that the per- App. 5 missible exposure limit was exceeded and a description of the corrective action taken to reduce exposure below the permissible exposure limit. (e€) Methods of compliance—(1) Engineering and work practice controls. The employer shall institute engineering and work practice controls to reduce and maintain employee exposure to cotton dust at or below the permissible ex- posure limit specified in paragraph (c) of this section, ex- cept to the extent that the employer establishes that such controls are not feasible. (2) Whenever feasible engineering and work practice controls are not sufficient to reduce employee exposure to or below the permissible exposure limit, the employer shall nonetheless institute these controls to immediately reduce exposure to the lowest feasible level, and shall supplement these controls with the use of respirators which shall comply with the provisions of paragraph (f) of this section. (3) Compliance program. (i) Each employer shall establish and implement a written program sufficient to reduce exposures to or below the permissible exposure limit solely by means of engineering controls and work practices as required by paragraph (e) (1) of this section. (ii) The written program shall include at least the fol- lowing: (a) A description of each operation or process resulting in employee exposure to cotton dust; (6) Engineering plans and other studies used to deter- mine the controls for each process; (c) A report of the technology considered in meeting the permissible exposure limit; (d) Monitoring data obtained in accordance with para- graph (d) of this section; (e) A detailed schedule for development and implemen- tation of engineering and work practice controls, including App. 6 exposure levels projected to be achieved by such controls; (f) Work practice program; and (g) Other relevant information. (iii) The employer’s schedule as set forth in the compli- ance program, shal! project completion of the compliance program no later than September 4, 1982, (iv) The employer shall complete the Steps set forth in his program by the dates in the schedule. (v) Written programs shall be submitted, upon request, to the Assistant Secretary and the Director, and shall be available at the worksite for examination and copying by the Assistant Secretary, the Director, and any affected em- ployee or their designated representatives. (vi) The written programs required under paragraph (e€)(3) of this section shall be revised and updated at least every six months to reflect the current status of the program and current exposure levels. (4) Mechanical ventilation. When mechanical ventila- tion is used to control exposure, measurements which dem- onstrate the effectiveness of the system to control exposure, ‘such as capture velocity, duct velocity, or static pressure shall be made at least every six months. Measurements of the system’s effectiveness to control exposures shall also be made within five days of any change in production, proc- ess or control which may result in any increase in airborne concentrations of cotton dust. (f) Use of respirators—(1) General. Where the use of respirators is required under this section, the employer shall provide, at no cost to the employee, and assure the use of respirators which comply with the requirements of this para- graph (f). Respirators shall be used in the following circum- stances: (i) During the time periods necessary to install or imple- ment feasible engineering controls and work practice con- trols; App. 7 (ii) During maintenance and repair activities in which engineering and work practice controls are not feasible; (ili) In work situations where feasible engineering and work practice controls are not yet sufficient to reduce ex- posure to or below the permissible exposure limit; and ' (iv) In operations specified under paragraph (g) (1). (v) Whenever an employee requests a respirator. (2) Respirator selection. (i) Where respirators are re- quired under this section, the employer shall select the ap- propriate respirator from Table 1 below and shall assure that the employee uses the respirator provided. TABLE I Cotton dust concentration Required respirator Not greater than— (a) 5 X the applicable 1. Any dust respirator, including permissible exposure single use. limit. (b) 10 X the applicable 1. Any dust respirator, except sin- permissible exposure gle use or quarter mask; or limit. 2. Any supplied air respirator; or 3. Any self-contained breathing ap- paratus. (c) 100 X the applicable 1. High efficiency particulate filter permissible exposure respirator with a full facepiece; limit. or nt 2. Any supplied air respirator with full-facepiece, helmet or hood; or 3. Any self-contained breathing ap- paratus with full-facepiece. (d) Greater than 100 X the 1. A powered air-purifying respira- applicable permissible tor with high efficiency particu- exposure limit. late filter; or 2. A self-contained breathing ap- paratus with a full-facepiece op- App. 8 Cotton dust concentration Required respirator erated in pressure demand or other positive pressure mode; or 3. A type “C” supplied air respira- tor operated in pressure demand or other positive pressure mode; or 4. A combination respirator which includes a type C supplied-air respirator with a full-facepiece operated in pressure or continu- ous-flow mode and an auxiliary self-contained breathing appar- atus operated in pressure demand or other positive pressure mode. (ii) The employer shall select respirators from those tested and approved for protection against dust by the Na- tional Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11. (iii) Whenever respirators are required by this section for concentrations not greater than 5 x the applicable per- missible exposure limit, the employer shall provide and permit the employee to use, at the employee’s option, single use dust respirator in preference to any respirator specified in paragraph (a) of Table 1. (iv) Whenever respirators are required by this section for concentrations not greater than 100 x the applicable permis- sible exposure limit, the employer shall, upon the request of the employee, provide a powered air purifying respirator with a high efficiency particulate filter in lieu of the respira- tor specified in paragraphs (a), (b), or (c) of Table I. (v) Whenever a physician determines that an employee is unable to wear any form of respirator, including a power App. 9 air purifying respirator, the employee shall be given the opportunity to transfer to another position which is available or which later becomes available having a dust level at or below the PEL. The employer shall assure than an employee who is transferred due to an inability to wear a respirator suffers no loss of earnings or other employment rights or benefits as a result of the transfer. (vi) Until March 4, 1979, the employer shall provide any dust respirator, including single use, to all employees exposed to cotton dust, unless the employer has conducted the monitoring required by paragraph (d) (2) of this section or otherwise has monitored employee exposure. As soon as monitoring has been conducted, the employer shall select the appropirate respirator from Table I. (3) Respirator program, The employer shall institute a respirator program in accordance with § 1910.134 (b), (d), (e), and (f) of this part. (4) Respirator usage. (i) The employer shall assure that the respirator used by each employee exhibits minimum face- piece leakage and that the respirator is fitted properly. (ii) The employer shall allow each employee who uses a filter respirator, to change the filter elements whenever an increase in breathing resistance is detected by the employee. The employer shall maintain an adequate supply of filter ele- ments for this purpose. (iii) The employer shall allow employees who wear respirators to wash their faces and respirator face pieces to prevent skin irritation associated with respirator use. (g) Work practices. Each employer shall, regardless of the level of employee exposure, immediately establish and implement a written program of work practices, which shall minimize cotton dust exposure for each specific job. Where applicable, the following work practices shall be included in the work practices program: App. 10 (1) Compressed air “blow down” cleaning shall be pro- hibited, where alternative means are feasible. Where com- pressed air “blow down” is done, zespirators shall be worn by the employees performing the “blow down”, and employ- ees in the area whose presence is not required to perform the “blow down” shall be required to leave the area during this cleaning operation. (2) Cleaning of clothing or floors with compressed air shall be prohibited. (3) Floor sweeping shall be performed with a vacuum or with methods designed to minimize dispersal of dust. (4) Cotton and cotton waste shall be stacked, sorted, baled, dumped, removed or otherwise handled by mechani- cal means, except where the employer can show that it is infeasible to do so. Where infeasible, the method used for handling cotton and cotton waste shall be the method which reduces exposure to the lowest level feasible. (5) The employer shall inspect, clean, maintain, and re- pair, all engineering control equipment and ventilation systems including power sources, ducts, and filtration units of the equipment. (h) Medical surveillance—(1) General. (i) Each em- ployer who has a place of employment in which cotton dust is present shall institute a program of medical surveillance for all employees exposed to cotton dust. (ii) The employer shall assure that all medical examina- tions and procedures are performed by or under the super- vision of a licensed physician and are provided without cost to the employee. (ili) Persons other than licensed physicians, who ad- minister the pulmonary function testing required by this sec- tion shall complete a NIOSH approved training course in spirometry. App. 11 (2) Initial examinations. The employer shall provide each employee who is or may be exposed to cotton dust with an opportunity for medical surveillance. For new em- ployees this examination shall be provided prior to initial assignment. The medical surveillance shall include at least the following: (i) A medical history; (ii) The standardized questionnaire contained in Appen- dix B; and (iii) A pulmonary function measurement, including a determination of forced vital capacity (FVC) and ferced expiratory volume in 1 second (FEV:), and the percentage that the measured values of FEV and FVC differ from the predicted values, using the standard tables in Appendix C. The predicted FEV: and FVC for blacks shall be multiplied by 0.85 to adjust for ethnic differences. These determinations shall be made for each employee before the employee enters the workplace on the first day of the work week, following at least 35 hours after previous exposure to cotton dust. The tests shall be repeated during the shift, no sooner than 4 and no more than 10 hours after the beginning of the work shift; and, in any event, no more than one hour after cessation of exposure. (iv) Based upon the questionnaire results, each em- ployee shall be graded according to Schilling’s byssinosis classification system. (3) Periodic examinations. (i) The employer shall pro- vide annual medical surveillance for all employees exposed to cotton dust which shall include at least an update of the medical history and standardized questionnaire (the ab- breviated questionnaire, App. B-III) and the pulmonary function measurements in paragraph (h)(2) of this sec- tion. (ii) Medical surveillance as required in paragraph (h) App. 12 (3) (i) of this section shall be provided every six months for all employees in the following categories: (a) An FEV: of greater than 80 percent of the predicted value, but with an FEV: decrement of 5 percent or 200 ml. on a first working day; (b) An FEV: of less than 80 percent of the predicted value; or (c) Where, in the opinion of the physician, any signifi- cant change in questionnaire findings, pulmonary function results, or other diagnostic tests has occurred, (ii) An employee whose FEV: is less than 60 percent of the predicted value shall be referred to a physician for a detailed pulmonary examination. (iv) A comparison shall be made between the current examination results and those of previous examinations and a determination made by the physician as to whether there has been a significant change. (4) Information provided to the physician. The em- ployer shall provide the following information to the ex- amining physician: (i) A copy of this regulation and its Appendices; (ii) A description of the affected employee’s duties as they relate to the employee’s exposure; (iii) The employee’s exposure level or anticipated ex- posure level; (iv) A description of any personal protective equipment used or to be used; and (v) Information from previous medical examinations of the affected employee which is not readily available to the examining physician. (5) Physician’s written opinion. (i) The employer shall obtain and furnish the employee App. 13 with a copy of a written opinion from the examining phy- sician containing the following: (a) The results of the medical examination and tests; (b) The physician’s opinion as to whether the employee has any detected medical conditions which would place the employee at increased risk of material impairment of the employee’s health from exposure to cotton dust; (c) The physician’s recommended limitations upon the employee’s exposure to cotton dust or upon the employee’s use of respirators including a determination of whether an employee can wear a negative pressure respirator, and where the employee cannot, a determination of the em- ployee’s ability to wear a powered air purifying respirator; and (d) A statement that the employee has been informed by the physician of the results of the medical examination and any medical conditions which require further examina- tion or treatment. (ii) The written opinion obtained by the employer shall not reveal specific findings or diagnoses unrelated to occu- pational exposure. (i) Employee education and training — (1) Training program. (i) The employer shall provide a training program for all employees in all workplaces where cotton dust is present, and shall assure that each employee in these work- places is informed of the following: (a) The specific nature of the operations which could result in exposure to cotton dust at or above the permissible exposure limit; (b) The measures, including work practices required by paragraph (g) of this section, necessary to protect the em- ployee from exposures in excess of the permissible exposure limit; App. 14 (c) The purpose, proper use and limitations of respira- tors required by paragraph (f) of this section; (d) The purpose for and a description of the medical surveillance program required by paragraph (h) of this section and other information which will aid exposed em- ployees in understanding the hazards of cotton dust ex- posure; and (e) The contents of this standard and its appendices. (ii) The training program shall be provided prior to initial assignment and shall be repeated at least annually. (2) Access to training materials. (i) Each employer shall post a copy of this section with its appendices in a public location at the workplace, and shall, upon request, make copies available to employees. (ii) The employer shall provide all materials relating to the employee training and information program to the As- sistant Secretary and the Director upon request. (iii) In addition to the information required by para- graph (i)(1) of this section, the employer shall include as part of the training program, and shall distribute to em- ployees, any materials, pertaining to the Occupational Safety and Health Act, the regulations issued pursuant to that Act, and this cotton dust standard, which are made available to the employer by the Assistant Secretary. (j) Signs. The employer shall post the following warn- ing sign in each work area where the permissible exposure limit for cotton dust is exceeded: WARNING COTTON DUST WORK AREA MAY CAUSE ACUTE OR DELAYED LUNG INJURY ( BYSSINOSIS ) RESPIRATORS REQUIRED IN THIS AREA App. 15 (k) Recordkeeping—(1) Exposure measurements. (i) The employer shall establish and maintain an accurate record of all measurements required by paragraph (d) of this section. (ii) The record shall include: (a) A log containing the items listed in paragraph IV (a) of Appendix A, and the dates, number, duration, and results of each of the samples taken, including a description of the procedure used to de- termine representative employee exposures; (b) The type of protective devices worn, if any, and length of time worn; and | (c) The names, social security numbers, job classifica- tions, and exposure levels of employees whose exposure the measurement is intended to represent. (iii) The employer shall maintain this record for at least 20 years. (2) Medical surveillance. (i) The employer shall estab- lish and maintain an accurate medical record for each em- ployee subject to medical surveillance required by paragraph (h) of this section. (ii) The record shall include: (a) The name and social security number and description of the duties of the employee; (b) A copy of the medical examination results including the medical history, questionnaire responses, results of all tests, and the physician’s recommendation; (c) Acopy of the physician’s written opinion; (d) Any employee medical complaints related to expo- sure to cotton dust; (e) A copy of this standard and its appendices, except that the employer may keep one copy of the standard and the appendices for all employees, provided that he references App. 16 the standard and appendices in the medical surveillance record of each employee; and (f) A copy of the information provided to the physician as required by paragraph (h) (4) of this section. (iii) The employer shall maintain this record for at least 20 years. (3) Availability. (i) The employer shall make all rec- ords required to be maintained by paragraph (k) of this section available to the Assistant Secretary and the Director for examination and copying. (ii) The employer shall make employee exposure mea- surement records required by this section available to affected employees or their designated representatives for examination and copying. (iii) The employer shall make all records indicating a former employee’s own exposure to cotton dust available to the former employee or his designated representative for examination and copying. (iv) The employer shall make an employee’s medical records required to be maintained by this section, available to the affected employee or former employee or to a phy- sician or other individual designated by such affected em- ployee or former employees, for examination and copying. (4) Transfer of records, (i) Whenever the employer ceases to do business, the successor employer shall receive and retain all records required to be maintained by para- graph (k) of this section. (ii) Whenever the employer ceases to do business, and there is no successor employer to receive and retain the records for the prescribed period, these records shall be transmitted to the Director. (iii) At the expiration of the retention period for the records required to be maintained by this section, the em- App. 17 ployer shall notify the Director at least 3 months prior to the disposal of such records and shall transmit those records to the Director if he requests them within that period. (1) Observation of monitoring. (1) The employer shall provide affected employees or their designated representa- tives.an opportunity to observe any measuring or monitoring of employee exposure to cotton dust conducted pursuant to paragraph (d) of this section. (2) Whenever observation of the measuring or monitor- ing of employee exposure to cotton dust requires entry into an area where the use of personal protective equipment is re- quired, the employer shall provide the observer with and assure the use of such equipment and shall require the ob- server to comply with all other applicable safety and health procedures. (3) Without interfering with the measurement, observers shall be entitled to: (i) An explanation of the measurement procedures; (ii) An opportunity to observe all steps related to the measurement of airborne concentrations of cotton dust per- formed at the place of exposure; and (iii) An opportunity to record the results obtained. (m) Effective date—(1) General. This section is effec- tive September 4, 1978, except as otherwise provided below. (2) Startup dates. (i) Initial monitoring. The initial monitoring required by paragraph (d)(2) of this section shall be completed as soon as possible but no later than March 4, 1979. (ii) Methods of compliance: Engineering and work prac- tice controls. The engineering and work practice controls required by paragraph (e) of this section shall be imple- mented no later than September 4, 1982. (iii) Compliance program. The compliance program re- App. 18 quired by paragraph (e)(3) of this section shall be estab- lished no later than September 4, 1979. (iv) Respirators. The respirators required by paragraph (f) of this section shall be provided no later than October 4, 1978. Until March 4, 1979, the provisions of paragraph (£) (2) (vi) apply. (v) Work practices. The work practices required by paragraph (g) of this section shall be implemented no later than December 4, 1978. (vi) Medical surveillance. The medical surveillance re- quired by paragraph (h) of this section shall be completed no later than September 4, 1979. (vii) Employee education and training. The initial edu- cation and training required by paragraph (i) of this sec- tion shall be completed as soon as possible but no later than December 4, 1978. (n) Appendices. (i) Appendices B, C, and D to this section are incorporated as part of this section and the contents of these appendices are mandatory. (ii) Appendix A contains information which is not in- tended to create any additional obligations not otherwise im- posed or to detract from any existing obligations. 19 Notice: This opinion is subject to formal revision before publication in the Federal Reporter or U.S.App.D.C. Reports. Users are requested . to notify the Clerk of any formal errors in order that corrections may be made before the bound volumes go to press. United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 78-1562 AMERICAN FEDERATION OF LABOR & CONGRESS OF INDUSTRIAL ORGANIZATIONS, e¢ al., PETITIONERS Vv. RAY MARSHALL, SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, et al., RESPONDENTS No. 78-1786 COTTON WAREHOUSE ASSOCIATION, PETITIONER Vv. RAY MARSHALL, SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, AND EULA BINGHAM, ASSIST- ANT SECRETARY OF LABOR, U.S. DEPARTMENT OF LABOR AND OCCUPATIONAL SAFETY AND HEALTH ADMINISTRA- TION, U.S. DEPARTMENT OF LABOR Bills of costs must be filed within 14 days after entry of judgment. The court looks with disfavor upon motions to file bills of costs out of time. 20 No. 78-1979 AMERICAN TEXTILE MANUFACTURERS INSTITUTE, INC., PETITIONER Vv. Dr. EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR AND OCCUPA- TIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS AMERICAN FEDERATION OF LABOR AND CONGRESS OF IN- DUSTRIAL ORGANIZATIONS; INDUSTRIAL UNION DEPART- MENT, AFL-CIO; AND AMALGAMATED CLOTHING AND TEXTILE WORKERS UNION, AFL-CIO, CLC, INTERVENORS No. 78-1980 AMERICAN TEXTILE MANUFACTURERS INSTITUTE, INC., PETITIONER Vv. Dr. EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR AND OCCUPA- TIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS AFL-CIO, ETC., INTERVENORS 21 No. 78-1981 AMERICAN TEXTILE MANUFACTURERS INSTITUTE, INC., PETITIONER Vv. Dr. EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR AND OCCUPA- TIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS AFL-CIO, ETC., INTERVENORS No. 78-1982 MILLIKEN AND COMPANY, PETITIONER Vv. RAY MARSHALL, SECRETARY OF LABOR AND Dr. EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, RESPONDENTS No. 78-1983 ARKWRIGHT MILLS, PETITIONER Vv. F. RAY MARSHALL, SECRETARY, DEPARTMENT OF LABOR, AND EULA BINGHAM, ASSISTANT SECRETARY OF LABOR FOR OCCUPATIONAL SAFETY AND HEALTH, RESPONDENTS 22 No. 78-1984 SPARTAN MILLS, PETITIONER Vv. F. RAY MARSHALL, SECRETARY, DEPARTMENT OF LABOR, AND EULA BINGHAM, ASSISTANT SECRETARY OF LABOR 4 FOR OCCUPATIONAL SAFETY AND HEALTH, RESPONDENTS No. 78-1986 BLAIR MILLS, INC., PETITIONER v. F. RAY MARSHALL, SECRETARY, DEPARTMENT OF LABOR, AND EULA BINGHAM, ASSISTANT SECRETARY OF LABOR FOR OCCUPATIONAL SAFETY AND HEALTH, RESPONDENTS No. 78-1987 HERMITAGE, INC., PETITIONER v. F. RAY MARSHALL, SECRETARY, DEPARTMENT OF LABOR, AND EULA BINGHAM, ASSISTANT SECRETARY OF LABOR FOR OCCUPATIONAL SAFETY AND HEALTH, RESPONDENTS 23 No. 78-1988 DAN RIVER, INC., PETITIONER v. Dr. EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR AND OCCUPA- TIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS No. 78-1989 CONE MILLS CORPORATION, PETITIONER v. RAY MARSHALL, SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, AND EULA BINGHAM, ASSIST- ANT SECRETARY OF LABOR, UNITED STATES DEPART- MENT OF LABOR AND OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPART- MENT OF LABOR, RESPONDENTS No. 78-1990 MAYFAIR MILLS, PETITIONER V. F. RAY MARSHALL, SECRETARY, DEPARTMENT OF LABOR, AND EULA BINGHAM, ASSISTANT SECRETARY OF LABOR FOR OCCUPATIONAL SAFETY AND HEALTH, RESPONDENTS 24 No. 78-1991 SPRINGS MILLS, INC., PETITIONER Vv. RAY MARSHALL, SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, Dr. EULA BINGHAM, ASSIST- ANT SECRETARY OF LABOR, UNITED STATES DEPART- ‘MENT OF LABOR AND OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPART- MENT OF L.A29R, RESPONDENTS No. 78-1992 RIEGEL TEXTILE CORPORATION, PETITIONER Vv. RAY MARSHALL, SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, AND THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS ¢ No. 78-1993 FIELDCREST MILLS, INC., PETITIONER Vv. F. RAY MARSHALL, SECRETARY OF LABOR, AND DR. EULA BINGHAM, ASSISTANT SECRETARY OF LABOR FOR OC- CUPATIONAL SAFETY AND HEALTH, AND THE OCCUPA- TIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS = No. 78-2013 AMERICAN COTTON SHIPPERS ASSOCIATION, PETITIONER Vv. Dr. EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR, AND OCCUPA- TIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS No. 78-2014 NATIONAL COTTONSEED PRODUCTS ASSOCIATION, PETITIONER Vv. RAY MARSHALL, SECRETARY OF LABOR, UNITED STATES DEPARTMENT OF LABOR AND EULA BINGHAM, ASSIST- ANT SECRETARY OF LABOR, UNITED STATES DEPART- MENT OF LABOR, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, RESPONDENTS No. 78-2016 NATIONAL COTTON COUNCIL OF AMERICA, PETITIONER Vv. RAY MARSHALL, SECRETARY OF LABOR, EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DE- PARTMENT OF LABOR, RESPONDENTS 26 No. 78-2018 WEST POINT-PEPPERELL, INC., PETITIONER Vv. RAY MARSHALL, SECRETARY OF LABOR AND EULA BINGHAM, ASSISTANT SECRETARY OF LABOR, RESPONDENTS this date 10% No. aAv% ‘ No. Av% ‘ Odserved Predicted FEV Observed Predicted FEV, Nonbyssinotic (6,410) - 86.4 (1,334) 2.3 Byssinotic (al! graces) (302) 81.1 (lig) — 71.3 Prevalence (%) Byssinosis 26.2 a | ; 5 | Cotton & ] Cl Cotton/Synthetic ; 3 162 Average Prevalence: Cotton 5.2% Cotton/Synthetic 4.4% b ———— n 36 3.7 g 2.0 ” at Preparation Yarn Production Stashing Miscellancous ‘Weaving ; Fig. 1—Byssinosis prevalence by work area and raw material use. taale tery, tuastt, NSM 7 Wis ; L. saps * > 2% Ree Z, gi rer t. ‘A . Ae rf wA “ft 172 = i Tg LNA e i. TA “ 1 as SS _— (Z ASM ivy ft. a 44 —aVA fs Ca a fey f Ie Y/, VY Y Vp VZ 4 1 v4 s “af oe \ BY Y if, @ 4 +SM—77; }- td SGit— BR+SM 30 Male White ve. met. 29 2a2... 225 2% 262 .. 672 Non-white 247 333 308 78 45 41 62 65 Female White 141 206 253 nae 37 186 283 460 Non-white 354. 376 277 15 2 1 3 4 Table 3 is quite important to the discussion of contact with raw cotton trash dust as it tells us the numbers of people with complaints of chest tightness on Mondays or the first day of work after exposure which responses were elicited by the questionnaire. In brief, 3% or 199 indi- viduals of this population of 6,631 individuals were placed in Grades 1/2 and 1. This means then that a total of 6,432 employees surveyed had no complaints which could be interpreted as subjective symptoms of byssinosis. App. 129 TABLE 3 BYSSINOSIS BY SEX AND RACE Byssinosis Grade 0 Total Sex/ Race - (negative) 1/2 I Byssinosis % Male. White 2,395 56 33 89 3.6 Non-white 1,142 57 10 67 5.5 Female White 1,839 16 12 28 1.5 Non-white 1,056 11 4 15 1.4 Total 6,432 140 59 199 3.0 Further analysis shows that the prevalence of the sub- jective symptoms of byssinosis could be related to length of employment, and that this prevalence was higher in non- white males than in white males. However, the total num- bers of white males was much higher than non-white. These conclusions will become evident if you would take a moment to review Figure 1. Length c! fmployment fy cars) Fia I. Byssinusis prevalence v3. 20- length - of employment in cotton mills oO by sex and race : 15- © White male © Non-white mate y * Female 10-4 Gyssinosis Prevalence (2%) App. 130 Now let us consider the relationship of byssinosis and bronchitis grades. We found that when byssinosis grades were compared with bronchitis grades by sex and race that byssinosis grades increased as bronchitis grades increased. Bronchitis prevalence was small (less than 1% ) for those who did not give a history of subjective symptoms of byssi- nosis and much larger (greater than 25% ) for employees with byssinosis grades one-half and one. These factors are graphically pointed out in Figure 2 and says simply those people who complained of change in breathing on some Mondays, or every Monday also are noted to have bron- chitis. Figure 50 - Byssinosis Grade 2 % vA Bronchitis ae Prevalence - 0) vs. es: Byssinosis .ae4 crade by ™ re: sex and race Le, W — White 35 - 1d M male Eh N-W—Non-white Fs + eee M male Mig aa %s ae * W = White £ ts oa ‘ pie" F female z ¥ ¥ 213. N-W—Non-white ad é ioe ety , ey =~ 4) «(OF sfematle £ “4d eet de A 1s ——_ 5 ‘ Sige f ee i + Se He 15 - alles He iu ‘Sy me ft} ee ae Se to bees 10 Hoh Fi Sa ‘ Aged poe: ger | eas ery bh ; a8 ( : 1 Pars i PY Kies : te 4 Gad Bees oie a8 4 hak Bras 0- Re: w M Byssinosis and Workplace When it was established that there were some people with a history of complaints it became important to ascertain where these people spend their working lives. At the time of App. 131 this survey, accurate cotton dust measurements were not available. We simply divided the plants into three arbitrary groups representing three assumed levels for cotton dust. Workplace I represented Opening, Picking and Carding; Workplace 2—Spinning, Winding, Twisting; Workplace 3 —Spooling, Warping, Slashing, Weaving and other, such as CJoth Room or Maintenance. In such a division, one would expect the levels of raw cotton dust to be lower in Workplace 2 than Workplace 1 and lower in Workplace 3 than the other two. To be able to develop a true workplace history, only individuals with work histories entirely in each me of these three workplaces were considered. This gave us 5,458 individuals. In Figure 3 you will see that, as expected, the subjective symptoms of byssinosis were more prevalent in Workplace 1. This area primarily employs men, many of whom have been on these jobs for a considerable number of years. There were found to be /05 cases of byssinosis, grade 1/2 & 1 in Workplace 1. In terms of percentages, this repre- sented 64% of all those complaining of subjective symptoms of byssinosis. However, only 12% of the population were employed in these first few steps of cotton processing. g 68 } fui 3 ° Byssinosis Prevalence (%) 3 : : BES g 4 Worngtene ae vise !F female F female wv”. Wh! CUNO CU weRW Ww NW =, Fe a oe App. 132 Byssinosis and Smoking Habits Now let us look at Figure 4 in which we find a byssinosis prevalence, and a number of other factors; workplace, sex and smoking habits. The only significant association be- tween byssinosis and smoking habits were found for those males in Workplace 1. The Workplace 1 males did not possess smoking habits which differ greatly from the general male population except that the rate of heavy smoking was lower. Prevalence rates for byssinosis in this workplace loca- tion indicate possible interaction between the workplace and smoking habits. It is worth the comment that cigarette smoking habits and bronchitis seem to closely parallel complaints of byssi- nosis for those males who are employed in Workplace 1. The clinical observation that byssinosis complaints occur primarily in cigarette smokers is borne out by the finding that only 20% of those complaining of byssinosis were non- smokers. Figure 4 ' Byssinosis Prevalence vs. vorkplece by 40 “Sex and smoki habit g 39, Workplace 1 ‘ - soaker — Heavy smoker Byssinosis Prevslence (%) Workplace 2 Wvoraplace 3 re if sé X tA xa 2 & nw xX iA by | es | App. 133 Following completion of the questionnaires, spirograms were performed on each individual. Using the answers on the questionnaire and the result of spirograms, a decision was made to reinterview and retest those employees who were classified as having significant complaints and/or poor pulmonary function tests which did not meet pre-determined criteria. In using this type of separation procedure, approxi- mately 10% of our study population were re-examined. Those who were found to have any type of respiratory disease received further clinical evaluation. For, it is para- mount to recognize in a medical survey any disease which is found is important. Thus, although we were primarily interested in ascertaining the prevalence of byssinosis, other respiratory diseases which were uncovered were certainly of equal importance. Since 1973 the spirogram program has been continuing on an annual basis with the selection of certain employees for further clinical evaluations. The British Research Coun- cil Questionnaire has been administered as an initial ques- tionnaire for new people coming into the progr+m and has not been repeated except for those for whom additional evaluation is indicated. Final conclusions which were drawn from this study were that a majority of the complaints of byssinosis were found among the relatively small subset of employees located in the high dust work areas of Opening, Picking, and Carding. Byssinosis was significantly associated with bronchitis. Smoking was significantly associated with byssinosis for employees in Opening, Picking and Carding. While 3% of the population had subjective symptoms ( history) of byssinosis, only 0.8% indicated both subjective symptoms and objective signs (a 10% or greater drop during the workday of forced expiratory volume for one second [FEV:]}). App. 134 CONCLUSIONS With our four-year experience and conclusions as back- ground, I would like to comment on the medical surveil- lance program as it is proposed in the cotton dust standard. SPECIFIC COMMENTS ON MEDICAL SURVEILLANCE PROGRAM THE STANDARD QUESTIONNAIRE It is a valid tool when used for evaluating an untested population to establish an initial history, but it is lacking in flexibility, and in the future I am sure will be a victim of coaching. There are additional questionnaires which would aid in establishing history of change in respiratory function which should be acceptable from a clinical point of view. PERIODIC EXAMINATION This portion of the regulations would strain our already overtaxed resources. I do not feel that there is any rationale in providing an examination every six months for those with an FEV: greater than 80% of predicted with an FEV: decrement of 5% or for those employees whose FEV: is, for example, 70-79% if there is no further FEV: decrement. A spirogram is effort dependent and requires the coopera- tion of the individual to produce the maximum effort. We have found it next to impossible to maintain a 5% range, testing an individual from one part of the day to another. Actually, this degree of tolerance or low volume change would be difficult to maintain in a hospital laboratory setting using trained people for the test subjects. Objections are raised to (3) (a) and (b) as currently presented. These subparagraphs would dictate time and App. 135 effort being spent every six months in testing a large portion of the population, most of whom will be repeatedly found not to have pulmonary disease. A medical decision should be made concerning questionable spirograms as our atten- tion must be directed toward those workers who would require intervention. The basic phsiologic concept is that byssinosis is a re- versible bronchio-constricting airway condition. The suscep- tibility to the condition is on an individual basis, and many years of contact to raw cotton trash dust is required before any chronic irreversible changes can be noted. It would seem reasonable then to construct screening procedures for cotton textile manufacturing employees that have been developed for preventive medical and public health programs. Such a screening program would include the standard questionnaire initially, followed by pulmonary function tests. The analysis of this data would be used to identify those with respiratory complaints and/or poor spirograms. Re-question and re-test specific individuals to validate the questionnaires and test findings and make specific recommendations for future action would be re- quired. The bulk of the population then, whose examinations did not indicate immediate concern would be followed by an annual test schedule which would note any individual changes. Thus the entire population would be under regular ob- servation but the time would be available to care for those with specific needs. PHYSICIAN’S WRITTEN OPINION If the physician were supplied with a questionnaire and spirogram of the employee and asked to give an “opinion — '_ = App. 136 as to whether the employee has any detected medical condi- tion which would place the employee at increased risk of material impairment of health from exposure to cotton dust” as proposed, the physician would find it difficult to comply. In many instances I would foresee that the physician would require another physical examination and laboratory evalu- ation before attempting to give such an opinion. Again it would lead to a quandary because the physician could not always know what the term “Material Impairment” might imply. Neither is there a specific test for “exposure to cotton dust” as the chemical compounds which may have health effects have not been identified. Objections are raised to (h) (5) (ii) in that there seems to be a conflict with (h) (5) (i) and (a). The heading (h) (5) (ii) would limit the communica- tion between doctor and patient and would restrict health counseling only to the cotton dust exposure, eliminating the possibility of employment in a second job with another industry. Also, counseling on the best known pulmonary irritant, cigarette smoking, would apparently be eliminated. In conclusion, medical surveillance of our cotton textile employees is not an insolvable problem if factual informa- tion is taken into consideration and regulations are written so that we can comply with them from a professional as well as industrial management standpoint. App. 137 Exhibit 2 EXCERPT FROM FEDERAL REGISTER TUESDAY, DECEMBER 28, 1976 Part III DEPARTMENT OF LABOR Occupational Safety and Health Administration CoTTON Dust Proposed Standards for Exposure and Notice of Hearing * * * Byssinosis is a specific respiratory disease, the symptoms of which are attributable to the action of cotton dust on the respiratory passages. The effects of byssinosis can be tem- porary or permanent, depending upon the exposure and the individual, and can lead in time to chronic obstructive lung disease, primarily chronic bronchitis. (20, 21) Initially, the individual HOtiéés a tightness in the chest occurring on the first day of the work week. The tightness may be accom- panied by a measurable decrease in breathing capacity as measured by pulmonary function tests. Usually, the condi- tion is mild and temporary at first, tending in time to pro- gress to the stage where it bothers the workers on other days of the work week. This progression, which is char- acterized by constriction of the bronchial tubes of the lung, leads to a permanent narrowing of these airways. The in- dividual develops a chronic cough with a production of phlegm and increasing shortness of breath. At this stage, the condition is readily detectable by pulmonary function measurements. Total disability and even death may follow. The description of these detailed symptoms appeared as early as 1908 in the work of Collis. (/ 0) Exhibit 6, No. 76 July 26, 1976 Contract No. J-9-F-6-0035 RTI Project No. 44U-1204-1 COTTON DUST PART 1: CHAPTERS I-VI EXCERPTS FROM TECHNOLOGICAL FEASIBILITY ASSESSMENT AND FINAL INFLATIONARY IMPACT STATEMENT Prepared for: Occupational Safety and Health Administration U.S. Department of Labor RESEARCH TRIANGLE INSTITUTE Post Office Box 12194 Research Triangle Park, North Carolina 27709 App. 139 [I-15] TABLE I-6 TOTAL INSTALLED AND ANNUALIZED COMPLIANCE COSTS: ALL SECTORS (Costs in Millions of Dollars) Exposure Annualized Direct Total Industry Limit Installed Capital Operating Energy Annualized Sector (mg/m*) Cost Charge Cost Cost Cost Yarn 0.5 211.8 33.8 6.9 20.6 61.5 Production 0.2 984.4 158.3 15.6 67.9 241.6 0.1 2,802.7 450.6 23.3 147.0 620.6 Cotton 0.5 16.9 2.7 4.9 1.8 9.4 Ginning 0.2 292.2 47.0 13.2 30.3 90.4 0.1 343.6 hI 14.7 35.4 105.3 Cotton 0.5 9.1 1.5 1.7 0.6 3.7 Weaving 0.2 1,387.9 223.1 40.7 86.3 350.1 0.1 3,939.1 633.2 112.6 245.1 990.9 Waste 0.5 17.3 2.8 2.6 2.5 7.9 Processing 0.2 32.0 b Py | 2.9 4.7 12.8 0.1 56.1 9.0 3.4 8.2 20.6 Total 0.5 255.1 40.8 16.1 25.5 82.5 0.2 2,696.5 433.6 72.4 189.2 694.9 0.1 7,141.5 1,148.0 154.0 435.7 1,737.4 App. 140 I80°TES‘*T EZ'S6S'DI LO'SHZ'LOL 9B'PLS‘E SOP'EES OB PHZ'S OS‘ZOL'LE SL'BSTI — sg — wed SWOOT 9LO‘O6T §=8L°¥9L ESOT E16601 87699 167697 OS89% ZL8E — ress a nas sade, 6IS'SLI 66EL9 ODIEZT 86LPEL 80619 OZELEZ OE'CED POHL — — _ — SIMSIAT SvOTHI 7HL6b 86 £ S666 OLZOO] OIS‘OS LHI'SLI OD'ISE ESE TIS9 €8E1E LLSSh 880°9 s19j00dg SLO‘TI 7e°88 LO'SST v6L‘LI OO6'E OIOTE 6655S S979 609T OSES LOZII O79'T SJOPULAA (14/srqy (4A/ (14/- (901$) (4A sq (4A/ (44/ (901$) (AAs (AK/(1K/ (001$) dk ~ueul) qay e01$) jyidoD =—-uew) = Ay e01$) joidpD -uew) YMy I$) [HdoD suawdinby 40qvT 901) suo 40q70T =) suoH 40q7T =I) suon A8sauq -viadQ K8sauq §=-viadgC M8sauq -vsadC pup pup pup aoupu aoupu aoupu -ajUulD yy -ajunpy -ajunpy su /3WI | °0 el /BW 7'0 el /BUI ¢°0 (u1aeaM\) STOWLNOD ONIAANIONA UOA SLSOO AULSNGNI IWLOL [I-A aTav,L App. 141 (VI-8—VI-9] b. Economic Impact Analysis Procedure The economic impact analysis that follows in Section 2 assesses and evaluates the likely economic impact upon six industries (SIC Codes 2211, 2221, 2281, 2257, 2284, and 2296) and upon the U.S. economy of the three OSHA ex- posure limits for cotton dust of 0.5, 0.2 and 0.1 mg/m’. In Section 3, similar economic impact analyses are reported for the other cotton processing industries. Specifically, this chapter includes the analysis of impacts on: 1) Additional employment requirements. 2) Energy consumption. 3) Increases in production costs and consequent price increases by affected industries. 4) Capital requirements and capital financing problems. 5) Competition effects on profit and market structure. 6) Inflationary impact on consumer and U.S. economy. 7) Employment impact due to the contraction of output demand. 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Of this import figure, about $1.05 _ billion was attributable to manmade fiber products, about $536 million was cotton products, and $358 million was wool products. In 1971 imports of manmade fiber products into the U.S. increased 50 percent over the 1970 figure to over $1.55 billion, as compared to $590 million for cotton products, $292 million for wool products, $2.435 billion for the total imports of textile manufactures, and $2.9 billion for total textile imports. Textile manufactures, as discussed here, are essentially manufactured textile products and are a good measure of the foreign trade activity most central to the industries of interest in this study, namely SIC Codes 2211, 2221, and 2281. In this sense, textile manufactures consist of yarns, broadwoven fabrics, woven and knitted apparel, make-up goods (pillow cases, dish towels, other towels, table cloths, sheets, bedspreads, quilts, etc.), and miscellaneous items not classified elsewhere (woven elastic, fishing nets, etc.) See Tables C-25, C-26 and C-27 for additional data. Given these data, it is clear that the LTA, with its singu- lar emphasis upon cotton and cotton blends, was inadequate to control the growth rate of textile and apparel imports into the U.S. As a consequence, in 1971 President Nixon’s Administration led the negotiation of new bilateral trade agreements with five countries (Japan, Taiwan, Hong Kong, South Korea, and Malaysia) covering exports to the U.S. of wool and manmade fiber textiles and apparel, in addition to cotton textile and apparel products covered under the LTA. These agreements imposed trade limitations upon some eighteen classifications of textile and apparel products from Japan, covering some 50 percent of Japanese exports of wool and manmade fiber products to the U.S., and ten categories, covering about 80 percent of their U.S. App. 15i exports, for the other countries. These became effective on October 1, 1971. Under the terms of these agreements, Japan agreed to limit the rate of growth of exports of these classifications of textile and apparel products to the U.S. to 5 percent per year for man-made and one percent for woolen products for three years, while the other agreements were for five years and limited the rate of growth of exports of these products to the U.S. to approximately 7.5 percent per year. In 1973, additional agreements were negotiated with Singapore and Macao. These agreements were neither a comprehensive nor a long-run solution, and a more general international frame- work was sought. In the Multi-lateral Trade Negotiations in Geneva, which dealt with all international trade activities (including textiles and apparel), and in other negotiations, GATT developed the Arrangement Regarding International Trade in Textiles or the Multi-Fiber Arrangement Regard- ing International Trade in Textiles (MFA), which was accepted by the U.S. and became effective on J anuary 1, 1974. Under the MFA, the U.S. has negotiated bilateral agreements with some sixteen countries covering cotton, wool and manmade fiber products. The terms of each of these agreements differ somewhat, but the rate of growth of exports from these countries to the U.S. typically is in the six to seven percent range for included products. App. 152 Excerpts of Exhibit 60 [p. 1] STATEMENT OF HOVAN HOCUTT SENIOR VICE PRESIDENT, ENGINEERING PNEUMAFIL CORPORATION BEFORE THE PUBLIC HEARING CONCERNING THE PROPOSED CHANGES IN THE OSHA COTTON DUST STANDARD My name is Hovan Hocutt. I have a Bachelor of Science degree in Aeronautical Engineering from North Carolina State University and I am a licensed Professional Engineer. I have 134% years experience as factory engineer and officer of a woven asbestos brake lining factory where one of my responsibilities was the engineering control of asbestos dust. I am now Senior Vice President-Engineering of the Pneuma- fil Corporation, Charlotte, N. C. where I have been since 1950. Pneumafil Corporation was formed in 1946 to design and manufacture systems for the control of lint and dust in the textile yarn manufacturing industry. This has always been its primary business. We are in regular contact with leading manufacturers of cotton dust control systems in England, Germany, Switzerland, Hong Kong, Japan and other foreign countries. In June of 1972, Pneumafil Engineers began work on NIOSH Contract HSM 99-72-44 to determine what engi- neering controls would be necessary to achieve a dust level of 0.5 mg/M’ as measured by the vertical elutriator (VE) in the processing areas of opening, picking, carding, draw- ing and combing. Some investigation of dust capture de- vices and air quantities required to achieve 0.2 or 0.1 mg/M* VE was also included. App. 153 [18-19] Piva se 6. Obviously, based on this factual data it is economically and technically unfeasible to achieve a raw cotton dust level of 0.2 mg/M’* VE X in processes past roving. Also, the capacity of the dust control industry is reflected by the total sales of $12 million which represents the largest sales year ever. At best, this capacity could increase approximately two to three times with the new demand. This means that if sales were to reach $30 million, it would take at least eleven years to supply the equipment necessary to reach a level of 0.2 mg/M’ VE X in opening-carding only. “SES'VEE HHS = TOL ‘S8I‘S8I$ = Bulmulp ‘7 cy‘ecy‘gzg = Bur “pred “pes‘Z00'S$ = Buryoid ‘oce‘e69‘OI$ = Burusdo-prepueys x AA WI /3W 7'Q YIM coURTdWIOD spreMo] "v6PO8EOS$ = IIOL ‘Ipy‘OIZ$ = Buimesp ‘pr p‘cee‘zeg = Bu “pred ‘ZE0'S89'S$ = Jurpoid ‘Tys‘tSI‘Z1¢ = Surusdo-prepueis x AA .W/SUI C9 YMA cOURTduIOD spreMo]L ‘LL/11/Z 940309 ANsnpur ayy Aq poseyoind suiajsKs 1023U00 ysNp JO} pomoTTE Supas Supmoyjos ay; apnjo “uj jou Op $810} BY, *LL/11/Z JO se Ansnput oy) Uo yoeduN SMOUODS poyeuMse ou) yUaseIdal sandy say] V6TIEGVE S88S‘EP6'E O€P'PEI‘ISE OZrErG'LI 919°160'C Z6L‘9P0‘6rI [B10 LE6‘ISI'S vb6'vO7 69L‘09S‘ IP LEG'ISI'S vb6'vOZ 69L‘09S‘Ib BUIABI AA roa sete = — sor BIH “= Sulyseis X FA «W/3W O'1 X FA «W/32W0'T €59'867'€ 168°96¢ 868°998‘0E €59°867‘€ 168°96P 868°998'0E Te L-qng Suidse 4—Buruuids —_— — —- — — - Burdie yy S8v°LZE 881‘IZ 006'S96'Z S8v‘LZE 881‘IZ 006'S96‘Z Butjoods t+ 080°68€'I 006‘'S6 OOS‘ESE‘PI 080‘°68€'I 006‘S6 OOS‘ESE‘FI ZUIPUIA > = -- — — — — Sarysim c, 880°78s‘T £08‘6LE 86r°LIS‘El 880°78S‘T €08‘6LE S6rLIS‘EI Suruuidg x X FA sW/3W $0 VOL‘OSP'SZT ESL'IPZ'E E9L‘8OL‘8LZ 0€8‘760's I8L‘68€‘'I SZI‘619‘9L 1210. ,-qng _ Surrocy—Buuedo 8v1‘880'r €6L‘67r OZL‘691‘LE €89‘'8ZS vSL‘ZS LEL‘ZIP‘S BulA0Yy 67S‘EI8 878°L9 S9S‘bL8'9 _ — — Zuiquio> 9€6‘000‘S ZIL‘IIb E8r‘ZIZ'by SL0‘89€‘I ZZ9‘ZEI 8LL‘L69‘EI Suimelg I60'SLS‘ST OO00'EEE'Z [66'6rh‘06I ZLO‘96S‘9 6652071 O19°80S*LS q810.L-qng OvO'IvS‘OI €09‘LZS‘I S6p'898‘IZI 6SvISL‘€ 9v0‘ZL9 COL‘LEC‘*6Z BuIpsed IST‘Ove'e Svs‘ZPs L7S‘Z9L‘tp 0S9‘pS7z'z IvZ‘L6€ 6IS‘vI6‘IZ BuryoId 006‘061‘T ZS8‘79Z €L6‘818'SZ £96'68S ZIE‘EEI 88¢‘9S7'9 ZutusdO 40a JX /1is02D 40aZ/isoD 4803 409 X /is0D 40a X /1s0D s09 SSII01d ASsauq aouDuajujoW *dmbq Assauq aouDuajup py ‘dinbaZ ajuxay X FA &W/2W 7'0 X FA «W/3W $0 SWHLLSAS ‘TOALNOOD ISNd NO.LLOO SUVT1IOd/1LSOO App. 155 Excerpts from Exhibit 62 STATEMENT OF ARTHUR THOMAS SENIOR VICE PRESIDENT THE BAHNSON COMPANY SUBSIDIARY OF ENVIROTECH CORPORATION WINSTON-SALEM, NORTH CAROLINA BEFORE THE PUBLIC HEARING CONCERNING THE PROPOSED CHANGE IN THE OSHA COTTON DUST STANDARD * * * App. 156 UO} JOG 9JOW SUT}SOD [IW Jod sseuU0} voHeIesIje1 Poonper oy} pue ‘W'y'D Jed oom Zuysoo [ru od AyUeNb sre poonpes oy} 0} ONP st EW/OW Z’ JO} 3809 9804} YIM sul] JO no Jwadde EW/OW ¢° 10} 80D JWowdmby IoyDIg = JouedO uosesl Wy] (p ‘(e0k Jod GH Jed €6°8p$ = OL’ x 09° x OS‘9T 1$) “2604 JO 10}9e} PEO] WSBIOAR UE 7 “SIY OTL 10} UONEIOdO %09 UO poseq UONLIDTUJOY “sIY OOZ/ 10j woHBIsdO %00T uo paseq Ajddns sry ‘(‘s1y QOZL) 1e0k Jod GH Jod OS'9TI$¢ oO poseq ys0o ABIoUq (¢ ‘1800 SuTUONIpUOCD Je JO BH%E We poyemmoyeo yye ‘syed oseds opnjour pue Ajuo Zuruon!pucod sre uo o3e 4s09 souLUDJUTEW (Z ‘swioos juowdmbe jo uononysuoo yesouss pue ‘reed yoyims Tew WOIy SuLIM [eoL}Oe[o ‘sey SIoOUISUS SuTNSUOD % %/ “SUTUOHIpUOCS Ie spnour ys09 juoudmby (| SH.LON 8SL‘E6 661‘°L8L°9 916'198‘Z €Ss‘LOs‘€elI -TV.LOL 90€‘8Z 606‘P86'T IZ9‘EZL ZLb‘860'bZ BUIABOAA 0"! oe oe — —_ Surysels Ol 0996 8L8‘Z9r 6S6' IPE Sv8‘08L‘Ol [e10}-qng Surdse 4-suruurds ¢" — = se — suidie yy ¢ $88 €0€‘Er 068‘E€ 886‘0IZ'I Suljoods S° L62‘ ZSZ‘OIZ ILE‘p9l LOS‘E8Z‘S SUIPUL A ¢° —_ —_ — — SUNSIM |, y 8LZ‘b €ZE‘60Z 869'Erl OSE‘98Z‘b suruurds ¢ 766'SS ZIV‘6EE'b Y9EE‘96L‘T 9€S‘8Z9‘8L ye103-qng ZulAoYy-surusdO, . ySs‘€ 060‘E8I IZS‘POl yS8‘SLE‘S suLA0Y ¢ _ _ —_ — ZuIQqUiOD S 0776 I9€‘LEL vOr‘ZLZ vLy‘6z3‘ZI SuIMeIG S SIZ‘Er 196‘8Ib‘€ lIp‘6Ir'l 807‘EZP‘09 [#10}-qng ¢" €L9°EZ SPS‘ES8‘T vOr‘se9 8E8‘SIS‘8Z SuIpsreD ny €Le‘st SL6‘8ZZ'I 06‘079 016'S6S‘7Z SUTIN “4 ZLib SEv'9EE EOT‘E9I O9P‘TI€'6 Suuedg 8=AAS samodasso yy 4s0za 1soD 1s03 SS3I01g eu /3uI ayvig A3sauq aouDuajulD py juawmdindy ajuxay jaaaT 8unviado jonuuy jonuuy isnq (sxe]J0q) 1S0_D eoueldwoD Ayprumyp oaneoy pue omyesodwey poyeunsy AGNIS LOVdWI OINONOO” IWLV [| WeuNpPEyy 79 NqIXA 7, be App. 157 Exhibit 42 STATEMENT OF JACK W. WHITWORTH, M.D. MEDICAL DIRECTOR WESTPOINT PEPPERELL AMERICAN TEXTILE MANUFACTURERS INSTITUTE, INC. BEFORE THE PUBLIC HEARING CONCERNING THE PROPOSED CHANGE IN THE OSHA COTTON DUST STANDARD My name is Jack W. Whitworth, and I am currently the Medical Director of WestPoint Pepperell. My statement will be primarily directed to our medical surveillance program, including its development, as it relates to the proposed standard on cotton dust. I. DEVELOPMENT OF PROGRAM In 1969 and 1970 we at WestPoint Pepperell became aware, from studies that were being carried out by various investigators such as Dr. Bouhuys and others, that there could be a correlation between cotton dust exposure and lung disease. After corresponding with Dr. Bouhuys and searching the literature, particularly the British journals, we began to suspect that some of the pulmonary problems we had seen could represent symptoms of byssinosis. During the year 1970 a medical student was hired and trained to do pulmo- nary function tests. Some one thousand yarn manufacturing employees were tested and compared to some two or three hundred office workers, and we found that in fact there were some differences in lung function values in some in- dividuals in the two groups. The chronology of the development of our program from App. 158 this point was as follows: 1. Beginning in 1971-1972 dust level surveys were begun on a periodic basis-annually, or more often if a change in machinery and/or cleaning equipment occurred. Both per- sonal and area samplers, including the vertical elutriator, were used. 2. Beginning in 1971, with more emphasis on pre-existing pulmonary problems such as asthma, allergies, more de- tailed pulmonary histories and pulmonary function tests were done as a part of preemployment examinations on prospective employees who were to work in areas where there was exposure to cotton dust. Potential risk employees were assigned to lower dust areas. 3. Beginning in 1971, before the development of our general medical surveillance program, registered nurses in each mill were taught the symptomatology of byssinosis and suspected cases were referred to the medical department for further evaluation and possible transfer to lower dust areas when indicated. 4. During 1972, in preparation for a general pulmonary survey, a slide presentation involving an explanation of byssinosis and reasons for upcoming pulmonary function tes 3, questionnaires, and chest x-rays was shown in each mill to the affected employees. We also published numerous articles in our company newspaper dealing with the subject. 5. In an effort to assure obtaining more consistent data, we elected to use a team approach to acquire pulmonary data. Accordingly, in 1972, five individuals were hired and trained in pulmonary function testing and instructed in giving the Modified British Research Council Respiratory Questionnaire (Schilling questionnaire). 6. We had some 9,000 employees at WestPoint Pepperell who were exposed to some concentration of cotton dust, and ~ App. 159 in January of 1973 the team began a general pulmonary survey of this population. The surveillance program was carried out using standard procedures. A pre- and post-shift spirogram was done on Monday or first day back at work after an absence of approximately 40 hours from cotton dust exposure, using Jones Pulmonor II spirometers. The observed forced expiratory volume in one second (FEV:) and forced vital capacity (FVC) were recorded in cc’s, and using the Veterans Administration Cooperative Study (Kory) predicted volumes for age, sex, and height, the percent of predicted volume was recorded. The percentage (4) change between pre- and post-shift tests was figured. The standard questionnaire was administered during the same or the following week, and both the objective and sub- jective findings were keypunched for computer analysis. Byssinosis was graded, using the Schilling definitions of the grades of the subjective symptoms (historical byssinosis). Bronchitis, dyspnea, smoking, and chest illness were graded, using standard medically accepted definitions. Following the initial survey, those people with significant positive his- tories, low pulmonary function tests, and significant delta changes (10% loss or 15% gain) over the shift, were re- questioned and retested. Some were retested on several Mondays or “first days back at work.” The primary purpose for such retests was to try to establish the best individual baseline possible for future comparisons. Nevertheless, in a later discussion and analysis of the findings, only those re- sponses obtained on the very first interview and pulmonary function tests done during the general surveillance program will be used. By this method we can maintain a credible epidemiological approach, so that a reasonable comparison can be made with other studies. A respiratory protection program has also been adopted App. 160 by WestPoint Pepperell. High dust level areas have been designated by signs and employees working in those areas are informed that they will be furnished and required to wear respirators, either single use or replaceable cartridge type. Any person working outside these areas that so desires is also furnished a respirator free of charge. Explicit guide- lines have been developed and furnished each affected employee. Il. ANALYSIS OF GENERAL PULMONARY SURVEY In our first general pulmonary survey a total of 9,181 persons exposed to some level of cotton dust was studied. No one was excluded because of inability to perform perfect pul- monary function tests. Vigorous attempts to get the best possible data were carried out and most of the tests were felt to be reliable. We must remember, however, that for the great majority of the employees this was their first exposure to pulmonary function testing and it is well known that there is a learning curve for both the testors and those tested. In a continuing program such as this we do not have the luxury of being able to discard sub-standard tests, as is done in most epidemiologic studies. We got the best test possible and kept the results, because in the end we must be able to look not only at the group as a whole, but, for clinical pur- poses, at each individual as he or she progresses or degresses each year. I am convinced, as are most people who have ever done any pulmonary function testing, there is a very small percentage of individuals who will never be able to perform a completely satisfactory test. We must, however, keep the results for future comparison and hope that their same in- consistences are consistent each year. Then, at least we will be able to try to make some logical comparison. This is not said to excuse or defend a few poorer tests, but is a simple App. 161 o statement of fact I am sure everyone has found in their initial surveys and is given as an explanation of why the pulmonary function test of each individual was included in our study. This will certainly make our findings look poorer, rather than better. The questionnaires were done without encour- agement or discouragement by the individuals asking the questions, and only a simple explanation was given when requested and it was obvious that the question was not un- derstood. Of the 9,181 individuals studied, 124 or 1.35% gave positive answers to the questions related to byssinosis as graded by the Schilling method (Grade 1 /2, Grade I, or Grade IT). Of the 124 employees, 87 or 70.2% were Grade 1/2, 35 or 28.2% were Grade 1 and 2 or 1.6% (0.02% of all employees) were Grade 2. It must be stated and understood by everyone that we are talking here about subjective or “historical” symptoms, These classifications or grades by themselves are not, without more objective findings, indicative of any impairment or disability, This is particularly true in regard to Grade 1/2. In other words, a person can be in Grade 1 or 2 and have no objective evi- dence of disease. As was expected, the greater percentages of positive answers per number of people exposed per area were in yarn manufacturing (Opening thru roving) and this figure was 5.3%. Although spinning is considered a part of yarn manufacturing, it was separated for this analysis and Showed 1.10% of positive symptoms. Yarn preparation (spooling, twisting, warping, and winding) showed 0.74%. Slashing and weaving showed 0.61%. Cloth inspection, shop (mechanics, electricians, etc., who work part of their time in the processing areas) and all others, showed 0.88%. These people were exposed to a wide range of dust levels from 1 mg/M’, as measured by App. 162 tte verti elutriator. Of the 1,120 employees working in manufacturing (opening thru roving), 60 or 5.35% had positive responses to the questions relating to byssinosis. The mean dust level for each department was calculated and assigned the following ranges. The percentage of posi- tive responses per number of exposed individuals in each range are as follows: 1. In dust levels from 1 mg/M’, 7.14% had positive responses. Of the total number of employees (124) with positive symptoms in the entire survey, 60 or 48.38% were found in yarn manufacturing. Of these 60 individuals found in yarn manufacturing, 40 or 66.6% were Grade 1/2. Further, of those 60 individuals, 34 or 56.6% were in dust levels above 0.75 mg/M* and 26 or 43.3% were in levels below 0.75 mg/M’. Even though the population (1,120) in yarn manufactur- ing represents only 12.19% of the total survey population (9,181), we must recognize that this is the area of our primary concern. Our data showed that the majority of the individuals in Grade 1 were in yarn manufacturing. There- fore, in a medical surveillance program, particular emphasis should be given these areas, especially those with dust levels over 0.75 mg/M*’. So that no confusion or misunder- standing will arise regarding the 0.75 mg/M° dust level just mentioned, it must be understood that this is not recom- mended as the permissible exposure limit nor do we believe it to be the exact dose-response level. It is intended only as a point in the yarn manufacturing area at which medical App.163 surveillance should receive more emphasis. We do not know the exact dose-response level nor does anyone else. Our study has the same inherent weakness in regard to dose- response predictability that all others have—dust levels prior to the study are unknown for those individuals who have subjective and/or objective byssinotic symptoms. When equivalent dust level ranges in spinning are com- pared to those described in yarn manufacturing, the per- centage of positive responses diminish greatly: 1. In dust levels from 1 mg/M’, 1.07% had positive responses. Because of the abundance of starch in the atmosphere and the very low percentage (0.61%), of positive responses throughout weaving and slashing (0.6% ), it was felt that no good comparison could be made except as a whole. These data show that at some dust level between 1.0 mg/M* and .5 mg/M’ of cotton dust the percentage of posi- tive responses to the questions related to byssinosis drops sharply. These percentages are lower than those reported App. 164 in some other studies, but they accurately show the findings of our initial survey and it is our belief they more accurately represent the actual conditions. As for objective finding or pulmonary function test results on the initial survey, 1,085 of the 9,181 or 11.8% showed a 10% A change or loss in FEV: comparisons be- tween pre- and post-shift spirograms, The average FEV: % of predicted volume for the 9,181 employees was 86.5%. The average FVC % of predicted volume was 88.7%. We have approximately 40% black employees in our working population, and no correction factor for race was used at this point in time. Had the accepted correction factor of 12% to 15% been applied to the predicted volumes, these percentages would have been considerably higher. More- over, as no individuals were eliminated because of sub- standard tests, these figures, on an epidemiological basis, would have been even higher. On the initial survey the number of employees with a significant A % change over the shift was higher in (a) yarn manufacturing (opening thru roving) than in (b) spin- ning and the following operations. On repeat tests the per- centage of employees with repeated significant A % changes in (a) and (b) dropped considerably (11.8% to 7.0%), but the ratio between (a) and (b) remained approximately the same. We believe the causes for these significant de- creases in total percentages are improvements in testing techniques, and learning curves on individuals being tested. However, we also believe that portions of such decreases are because of improved work practices, improved cleaning systems, etc. The most provoking aspect of the whole analysis has been the lack of correlation between subjective and objective findings. This, of course, is not a new thing and has been discussed in numerous articles. No totally complete explana- App. 165 tion has ever been given to our knowledge, The correlation between individuals who have both subjective or historical symptoms and objective or significant pulmonary function decrements in A percentages (10% drop or more), has been less than 1% of the total population. Of the 6% who had significant A changes (10% drop), only 10% also had positive questionnaires. Of the 1.6% (retest) who had positive questionnaires, only 30% had significant A changes. In the subsequent retests, both subjective and objective, the number of employees showing positive response to the questions on chest tightness or breathlessness contained in the questionnaire (Schilling Grades 1/2, 1, 2) have in- creased slightly, but the number of employees with signifi- cant 10% A changes has decreased very significantly. On the initial survey the percentage was 11.8%. On followup, the percentage dropped to approximately 7% of the total population. There was a slight increase in the number of positive subjective or historical grades (1.35% to 1.60% D. We feel that this was due to better understanding of the questionnaire or, in some cases, a conditioned response. A conditioned response is defined as a situation in which answers to a questionnaire are exaggerated or understated because of reasons not related to health conditions. For example, an employee positively responds to the question- naire in order to be subject to transfer. We feel that Grade 1/2 byssinosis as defined by Schilling (“occasional chest tightness on Monday”) is very tenuous and fuzzy to interpret at best. Textile workers smoke con- siderably more on the weekend and along with other weekend situations makes for having unrelated Monday symptomatology. In fact we have never been able to cor- relate Grade 1/2 consistently with anything and we think App. 166 erroneous analyses and diagnoses arise because of the vague- ness of the Grade 1 /2 definition. III. DEFINITION OF COTTON DUST TOO BROAD “Any dust” in a textile plant is not necessarily of cotton origin and should not be so broadly classified. For instance, we know in a weave room the dust level is primarily starch. In spinning we see typical dust levels of .2 mg/M’ to .3 mg/M*, and yet in the subsequent process—weaving—the dust levels may be .5 mg/M’° to .7 mg/M’. We know no one has dumped additional cotton dust in the weave room; therefore, the additional component in weaving has to be starch. It is a fact that the incidence of subjective byssinotic symptoms in the weave room is extremely low, and is lower (0.6% ) than that found in any other area of yarn manu- facturing and yarn preparation. In view of these facts, weave rooms and cloth inspection rooms should be allowed higher levels. IV. RELEVANCE OF THE QUESTIONNAIRE AND PULMONARY FUNCTION TEST EVALUATION AS OUTLINED IN THE STANDARD: There is no question that a questionnaire has some value as a diagnostic tool, but it has been recognized for some time that the most commonly used questionnaires in textile sur- veillance programs (Modified Research Council or similar) are subject to lack of uniformity in response. Some employ- ees tend to minimize or exaggerate symptomatology. This may be done for a number of reasons. In order to achieve more consistent and open responses, we decided to try to develop an improved questionnaire. In 1975 we contacted Dr. Hans Weill of Tulane, and in a joint effort developed a modified questionnaire, which in our opinion, has definite advantages over the one in the proposed standard. We are App. 167 in the process of using this questionnaire now and hope to have a better evaluation of its results in the near future. We will be happy to share this questionnaire with OSHA for possible general recommendation. Regarding pulmonary function evaluation, we feel that a 5% 4 change in FEV: over the shift as being significant is too stringent. It is our understanding that most ordinary spirometers are allowed a 2% degree of variance within the spirometer itself. This leaves only a 3% variation tolerance for the testor and the individual tested; and, we would feel confortable in saying that there is no pulmonary function team in existence that can repeatedly test to such degrees of accuracy. We have tested many individuals on several different Mondays under similar circumstances and some- times they will have a 10% A change and sometimes they will not have any change. We are not certain that these individuals are true reactors. If they repeat the drop on several Mondays, this leaves less doubt. To our knowledge, there is no hard evidence that moderate reactors are at higher risk than nonreactors. We believe that the real em- _ phasis should be placed on getting the best pre-exposure baseline pulmonary function tests possible, and comparing these results with succeeding pre-exposure results on a periodic basis. This is where the real proof lies. Under the section on medical surveillance in the pro- posed standard, many statements are made which are ill- defined and unnecessary. The requirement that an individual with an FEV: of less than 80% predicted volume and a single delta change of 5%, be provided medical surveillance every six (6) months is unnecessary. With the test-retest variability, the idea of one 5% delta change over a shift requiring permanent placement of an individual on a six- month list has little validity and, if implemented, will cause App. 168 many unnecessary retests. Suppose this individual has a 0% delta change or a delta 5% increase in his next subsequent test. Do you continue to monitor this individual every six months or was the individual never a pulmonary function reactor? The same section requires repeat testing every six months on an individual who has FEV: of 79% of predicted vol- ume. Most surveillance teams use the Veterans Administra- tion Cooperative Study (Kory) nomograms to compute the percent of predicted volume. There are many normal in- dividuals not employed by the textile industry, as well as many employed by the textile industry, whose FEV: is 75% to 80%, and even 79%, or predicted volume using the Veterans Administration (VA) nomogram. The VA nomo- gram, however, admits to a standard error of estimate (SEE) as large as 0.52 liters on an FEV: prediction. Thus, at the very least, individuals whose FEV: was 75% to 80% of predicted volume in pre-employment testing, who had no history of asthma, allergy, chronic bronchitis, and who had not developed such history during their employment should have to be retested every six months if there is no change in their FEV: as their FEV: is clearly within allowance pro- vided by the standard error of estimate. With the level of test—retest variability, we recommend that the level of significant A change be set at 10% and more emphasis be placed on annual decline rates. V. PERMISSIBLE EXPOSURE LIMITS In our opinion, the permissible exposure limits of 0.2 mg/M? is totally unnecessary. Our initial pulmonary survey data shows that the highest prevalence rate of positive byssi- notic symptoms was found in yarn manufacturing. All other Studies, to our knowledge, show similar findings. However, App. 169 our data presented here show a drop in occurence of positive byssinotic symptoms between 1.0 mg/M® and 0.5 mg/M:° of cotton dust as measured by a vertical elutriator. In the area of most concern, yarn manufacturing, at a level of 0.5 ing/M* of cotton dust, the percentage of positive symp- toms was quite low. As expected, our data show that the percentage of posi- tive byssinotic symptoms are higher where the cotton dust levels are higher. However, our data also shows the per- centage of positive byssinotic symptoms diminished con- siderably when equal cotton dust level ranges are com- pared in the progressive steps of the manufacturing process. We know that the dust level is inflated with starch in the slashing and weaving areas, but there are only minor dilu- tion factors between carding and slashing except the man- made airborne fiber in blend mills. It would appear that the more active material is knocked out early in the yarn manu- facturing area. A probable explanation for this phenomenon is that in the yarn manufacturing process most of the bract, leaf, and stem particles are separated from the cotton fiber and deposited or left in this area. As the later yarn manufac- turing and yarn preparation processes speed up, a larger number of small, broken, fibers are slung out in the proc- esses and are picked up by the vertical elutriator, adding significantly to the sample weight. Many investigators be- lieve that the active agent in cotton dust is found exclusively in the bract, leaf and stem parts of the cotton plant, and that the lint or fibers do not contribute to any biochemical response in the lung. The addition of these small, micron size, non-active, broken lint fibers to the atmosphere may add to the sample weight, but not to the biologic activity of the dust. Our data presented here show that at some level of cotton App. 170 dust between 1.0 mg/M* and 0.5 mg/M’, as measured by the vertical elutriator, the percentage of positive byssinotic symptoms diminishes. At a level of 0.5 mg/M*’ of cotton dust, the percentage of positive byssinotic symptoms is ex- tremely low. With a good medical surveillance program, we are confident that those individuals with byssinotic symp- toms can be positively identified, carefully monitored, and therefore be protected from symptom progression with use of respirators and/or transfers to lower exposure areas. A good pre-employment appraisal with particular emphasis on evaluation of pre-existing pulmonary problems such as asthma, allergies, chronic bronchitis, smoking habits, etc., along with careful pulmonary function testing is essential in a medical surveillance program. This allows for pre-place- ment of potential risk employees in low risk areas and cer- tainly will diminish the number of people who become early reactors. A continuing medical surveillance program will then identify the few who develop any early reactivity over several years and allow for their protection prior to developing any permanent changes in their lungs. It should be emphasized strongly that early reactivity is reversible and not a permanent change. Therefore, we recommend that the standard not be lower than 0.5 mg/M* as measured by the vertical elutriator, and that respirators should not be required below this level except in those few individual cases identified as potential risks by subjective and/or objective symptomatology. VI. CONCLUSION AND SUMMARY 1. “Cotton dust” as defined in the standard should be more meaningfully and more accurately defined. 2. The MRC questionnaire as outlined in the proposed standard should be reappraised and modified. App. 171 3. The 5% A change in FEV: proposed as significant in the standard, should more realistically be 10% and greater emphasis should be placed on observing the annual decline rate in FEV:. 4. The proposed permissible exposure limit of 0.2 mg/M* is unnecessary to adequately protect individuals ex- posed to cotton dust, for a permanent permissible exposure limit of 0.5 mg/M’* would provide adequate protection when coupled with monitoring and a thorough medical surveil- lance program. 5. The permissible exposure limit for cotton dust in slashing and weaving should allow for the abundance of airborne starch and other elements in the environment and, thus, should be considerably higher than in other areas. App. 172 Exhibit 47 STATEMENT OF HAROLD R. IMBUS, MLD., Sc.D. MEDICAL DIRECTOR, BURLINGTON INDUSTRIES, INC. AT THE PUBLIC HEARING ON THE PROPOSED STANDARD FOR EXPOSURE TO COTTON DUST I am Dr. Harold Imbus. I am Medical Director of Bur- lington Industries. I joined the Company slightly over seven years ago and since that time I have been deeply involved with the Company’s respiratory surveillance program. The Company’s program has consisted of several aspects, namely: 1) Research and cooperation with universities, govern- ment agencies, and others, about the nature, incidence, and correction of the byssinosis problem. 2) An on-going medical surveillance program which in- volves testing of employees and prospective employees in plants where cotton yarn is spun. 3) An extensive program of dust monitoring. 4) A program aimed at lowering dust levels and exposure by engineering controls, work practices, and respirators. My primary emphasis here will be on the medical surveil- lance program and results thereof because it is the area that I have dealt with mostly. In the other aspects the Company has an extensive capital improvements program to control dust. Further, our Dr. Moon Suh wili discuss some research and statistical aspects of prevalence of the symptoms of byssinosis and Dr. John Neefus from Burlington Industries will discuss some aspects of environmental monitoring. Our medical surveillance program primarily consists of 1) pulmonary function testing and 2) questionnaires, on a App. 173 yearly basis, for all employees, and prior to the time of em- ployment for applicants. Employees of special concern after this testing are referred to independent medical consultants for evaluation and recommendations. We have approai- mately 12,500 employees included in the program who are tested each year, in addition to preemployment testing of applicants, and have administered well over 100,000 tests since the beginning of the program in 1970. Testing and minor counseling is performed by the plant nurse. Cases of more concern are seen by a member of the corporate medi- cal staff in Greensboro. To date, over 3,000 such individual interviews have been conducted by our corporate staff. Three hundred sixty-seven (367) of these individuals have been referred to independent consultants. In our original study [1] we found 460 out of 10,133 employees or 4.5% who complained of the Monday chest tightness which defines the byssinotic reactor under Schil- ling’s definition. It should be emphasized that these were individuals complaining of tightness in the chest on Monday and were not necessarily disabled or impaired—in fact, the majority of these individuals were not impaired or disabled. In addition, we found substantial declines for a number of employees in the one second forced expiratory volume (FEV:) from the beginning to six hours after the beginning of the shift. As the study indicates, a significant number of employees showed the symptoms of being byssinotic reactors based on their answers to the questionnaire and there was evidence of substantial pulmonary function reactivity in the various departments. Table 1 illustrates some of the progress that has been achieved as a result of our program. In our 1976 survey, we had 136 employees or slightly more than one percent (1.0% ) complaining of the Monday tightness of byssinosis App. 174 reaction versus the 4.5% in 1971. In 1976, the average change in FEV: from before to during the shift for all tested employees was 0.00% versus —1.7% in 1971. For prepara- tion areas in 1976 it was —0.54% versus —3.9% in 1971. Similar improvements are observed in yarn production, slashing, weaving and other areas. In 1971, approximately 18% of our employees tested showed a drop in their FEV: of 10% or more. In 1976, that figure was 7.4%, which is about the same as the number whose FEV: increased by a similar amount. I might add that our figures in respect to FEV: drop of 10% or more tend to be somewhat higher than others since we do not eliminate unsatisfactory results from our composite reporting as is customary in most re- search or epidemiological studies. Dust reductions have helped. However, these marked im- provements in symptoms and functional readings have been achieved in the face of the fact that only 28% of our areas (in most naturally low dust operations such as roving through spooling of blends) are at or below .2 mg/M’, while 38% are between .2 mg/M® and .5 mg/M’ and 34% are still above .5 mg/M’. As we bring all yarn production areas to .5 mg/M* or below in coming months it is my opinion that there will be very few reactors left at all. In addition to improvement brought about by lowering of dust levels, we believe that considerable improvement has been accomplished by: 1) Placement of healthy employees in cotton operations. 2) Transfers where feasible. 3) Wearing of respirators for susceptible employees and those working in the higher dust levels. 4) Counseling with employees regarding smoking, and early identification of and getting employees with early chronic lung disease under a program of care. App. 175 Byssinosis can and does result in chronic obstructive lung disease. We have certainly found evidence of this in our own Company and have reported so. However, if byssinosis resulting in chronic obstructive lung disease were as ram- pant as some lead us to believe, one would expect evidence of a very high incidence of chronic obstructive lung disease in the U.S. cotton textile industry. We have considerable evidence to the contrary. Dr. Hans Weill (2) in a Tulane University study of several textile mills concluded “no ex- cess of chronic obstructive pulmonary disease was detected in this population as indicated by low bronchitis prevalence and baseline pulmonary function measurements which com- pare favorably with expected values.” We have evaluated our results and have compared them with a study of an unpolluted Colorado city [3]. In that study, criteria of chronic obstructive lung disease was an FEV:/FVC ratio of less than 60%. In the Colorado study, the overall incidence of chronic obstructive lung disease in 609 persons was 6.8%. The comparable figure in 12,519 Burlington cotton plant employees in 1976 testing was 2.4%. I know that there are individuals who have serious chronic obstructive lung disease who have worked in cotton textile mills. One tends to assume the relationship between their work and their disease. This may or may not be so. One need only visit a respiratory clinic, however, to find many people suffering from a terrible disease, obstructive lung disease, which has reached epidemic proportions in our country. These people are from all walks of life, many who have never worked in a cotton mill and many who have lived and worked in nondusty environments. I make these remarks to in no way minimize the importance of byssinosis, but to put it in perspective. App. 176 The proposal for a .2 mg/M* or lower permissible ex- posure limit for cotton dust is based to a large extent upon the study done by the Duke/State of North Carolina J] group which indicates that allowance of the .5 mg/M° level is tantamount to allowing 26% of the employee population to develop symptoms of byssinosis, with for a .2 mg/M° level, the comparable figure of approximately 13%. It must be remembered that these figures are for historical byssinosis which is based solely upon Monday symptoms which are de- termined solely by a positive subjective response to a ques- tionnaire, and do not indicate irreversible disease. Let us look at the results of some other studies. I have already mentioned our data with respect to past and present prevalence. Dr. Moon Suh expands on this discussion in his Statistical analysis which reveals a 6% prevalence of his- torical byssinosis symptoms as determined by questionnaire at .5 mg/M’. In the textile manufacturing industry, several companies with active medical programs pooled data on the incidence of historical byssinosis (Grades 1/2, 1 and 2) on initial surveys. This represented an original questionnaire survey of 41,283 employees. Table 2 summarizes the findings. Overall incidence of all grades was 1.79%. The highest overall percentage incidence was in preparation (opening through roving), 4.3%. In not all cases were dust levels done at the time of the medical survey; however, it was pos- sible to assign dust levels for approximately haif, or 20,027, of these employees. Of these, 6,855 employees were working in dust levels above .5 milligram per cubic meter. Overall incidence was 3.17% byssinosis symptoms for this group, with the highest incidence, 31.9%, in drawing, and an average of 11.29% for 1,488 employees working in prepara- tion. Weaving, which represented 4,265 of these employees, App. 177 had an incidence of 0.6%. Another group of 13,172 em- ployees worked in dust levels at .5 milligram and below. Overall incidence of all the historical byssinosis for this group was 1.32%, with approximately 14% in roving and averaging 4.41% of 1,566 employees in opening through roving. Incidence in weaving was 0.7%. A third group of 21,256 employees for whom no dust level was assigned had an incidence of all grades historical byssinosis of 1.63%. Highest incidence was 5.1% in the opening and picking area, with an average of 2.38% of 5,537 employees in open- ing through roving. There was an incidence of 1.4% in weaving. Three thousand five hundred thirty-eight (3,538) of these 41,000 employees showed a drop in FEV: of 10%, or a total of 8.57%. More detailed summary of individual work areas is submitted in an Appendix to this report. A survey done by the ATMI in December, 1976 revealed that approximately 150,000 textile employees work in areas where they might be exposed to raw cotton dust. The survey which I have just cited of approximately 41,000 employees, therefore, represents over one/fourth of this population. Projecting the 1.79% of these employees to the U.S. cotton textile employment of 150,000 reveals that approximately 2,700 employees would be expected to have subjective symptoms of byssinosis, that is, Monday tightness. It is ob- vious from these figures that some of the projections by whatever means measured have been grossly exaggerated. Now, the above data indicates that, even after combining all those exposed to .5 mg/M!® and more, the employees with a potential problem are less than one/third of those projected by the Duke/State of North Carolina Study at .2mg/M’. Thus, I think it would be helpful here to review some of the various studies on a number of other investigators. The NIOSH “Criteria for a Recommended Standard-Oc- App. 178 cupational Exposure to Cotton Dust” reviews findings of various investigators with respect to correlation of cotton dust exposure and incidence of historical byssinosis. Most investigators have found an association between dustiness and incidence; however, to quote the document, “the slopes of the prevalence dustiness curve obtained by different in- vestigators vary considerably.” Thus the studies of Mer- chant [4] et al. and Molyneux and Berry [5] report pre- valence of 13% and 10% at .2 mg/M* and 26% and 40% at .5 mg/M’, respectively, while those of Fox [§] report a prevalence of 6% at .5 mg/M’, and a 40 year expected prevalence of 10% at .5 mg/M’. Our own studies revealed marked differences in prevalence per given dust level in various plants. Also, generally a tendency to have higher prevalence per unit amount of dust was found in the prepara- tion areas, versus the yarn processing areas; more where coarser cotton versus finer cotton is used, and more where all cotton versus cotton /synthetic blend is used. Work reported subsequent to the publication of the Cri- teria Document includes that of Noweir [Z] who found a prevalence of 7.1% historical bissinosis among 506 cotton textile workers where respirable dust levels ranced from .10 to 2.35 mg/M’® but were mostly above .26 mg/M’. More recent work done in Australia by Barnes and Simpson [8] indicates a prevalence of 2.4% of 493 workers, though levels did reach up to 8 mg/M*° total dust. The authors seemed surprised that they were not able to find a higher incidence after having read the American and British litera- ture. The point that is made by a comparison of the different results of these different investigators is that there is no dose-response curve applicable to the textile industry per se; that dose-response varies in many different situations. There- App. 179 fore, any attempt to extrapolate from dose-response data of a single investigator and apply it to the American Textile Industry is simply not valid. Moreover, all studies suffer from the same failing as far as determining a dose-response curve is concerned—there was absolutely no data which was available which showed the dust levels to which em- ployees were exposed prior to the study. Burlington Industries made its plants available for study of the byssinosis problem by the investigators from Duke and the State of North Carolina. It is this study which is widely cited as the reason for the proposed .2 mg/M! stand- ard. Summary and individual results were given to our medical department for follow-up. After it was determined by the investigators that byssinosis did exist in our plants, we established an annual pulmonary function questionnaire Screening program so that individual employees could be evaluated. This, therefore, offered opportunity for compari- son of our results with the investigators’. Table 3 presents the comparative results of two plants used for illustrative purposes. The results presented from Plant 1, which was a very dusty plant, are not entirely comparable in that steaming experiments had been done in this plant. However, steaming was stopped prior to widespread equipment changes which resulted in lower dust levels. Prior to these changes we took a survey of the day shift employees. As you can see, overall, we found 17% incidence of symptomatic byssinosis versus 27% from the Duke/State of North Carolina investigators. Actually, in preparation area our findings were 30% versus their 41%. Though there were some differences, we do not feel they were striking or not readily explainable by possible changes in personnel, equipment, survey technique, etc. These results are published in the British Journal of Indus- App. 180 trial Medicine [9]. The case with Plant 2 is entirely different. In 1971, the Duke/State of North Carolina group found 19.5% _his- torical byssinosis in the preparation area and a total of 6.2% throughout the plant. Subsequent surveys performed by us revealed 0 percent byssinosis. Our first reaction of course was to question our own techniques to see that ques- tionnaires were being properly administered. However, in subsequent years, the results were the same. This plant has remained essentially unchanged since the original survey and has dust levels in the .4 to .6 mg/M? range. In contrast to the first plant, it is a blend plant. We were somewhat concerned about the wide disparity that the different investigators obtained in this plant, while on the other hand, there did not seem to be such a glaring difference in the other plant (Plant 1). We reviewed the results given to us by: the Duke/State of North Carolina group and found that in the first plant, the Plant 1, only 44% of the cases were diagnosed as being Grade 1/2, whereas in the Plant 2, seventy-one percent (71%) were Grade 1/2. I believe that the use of Grade 1/2 pooled in with the percentages of those having historical byssinosis as a means of arriving at a dose-response curve has severe limitations. We feel that the validity of such dose-response curves and their validity as a means of setting a standard are open 10 challenge. Grade 1/2, in our experience, has not been very reproducible, even with the same investigator, and has been open to wide variations of interpretations by different in- vestigators. Furthermore, it is a projection of such investiga- tion as done at the Plant 2 onto a nation wide basis that leads to the erroneous assumption that many thousands have byssinosis. App. 181 In addition, we were able to take some of the cases who had been diagnosed as having byssinosis at Plant 2 original study and refer them to Dr. Mario Battigelli for evaluation. He will report on his negative findings of byssinosis in this testimony. Another question I would like to deal with is the question of reversibility of byssinosis. When we see figures of inci- dence of byssinosis, for example, 25% in certain areas, it is natural to assume that this represents one/fourth of the people having significant illness. I believe we would all agree that these people are at increased risk of illness when they develop this periodic chest tightness and/or pulmonary re- activity. However, many of these people exhibiting this are not in any way ill. The question arises, can you detect these people at a substantially early stage to keep them from de- veloping significant irreversible lung disease from their cotton dust exposure. We think we can and we have several tools in order to do this: 1) The questionnaire - periodic chest tightness. Although all our experience and data indicate little confidence in the Grade 1/2 or occasional byssinotic symptoms, the con- sistent complainer of a Grade 1 or 2 symptom as defined by questionnaire has, in our experience in many cases, been quite reliable. : 2) Pulmonary function reactivity, that is a decrement of FEV: of 10% or greater is also an indicator. We do not believe that a single drop of this magnitude, but a consistent demonstration of such drop, would be a hallmark of a pos- sible future problem. 3) Finally, and apparently ignored in the proposed standard, is serial determinations of pulmonary function, that is following people from year to year and determining whether they are losing pulmonary function at a faster rate App. 182 than they should. We believe that with proper utilization of these three tools it is unlikely that an employee will suffer damage from cotton dust without early detection. However, one major factor must be recognized. Approxi- mately 50% of our employees smoke. Smoking is associated with chronic obstructive lung disease which pathologically is indistinguishable from the chronic bronchitis of byssinosis. Studies have revealed general incidence of chronic obstruc- tive lung disease of 10-20%, or more. Therefore, we are going to have chronic obstructive lung disease, completely unrelated to byssinosis, no matter what we do. However, we believe that our program can in the long run substantially reduce this. We have been able to get a number of employees to stop smoking, to have better habits of care and to be de- tected at an early stage wherein they would not be otherwise. The average chest physician who sees a case of chronic ob- structive lung disease sees it at a very late stage. It is there- fore our policy to refer an employee working in cotton dust to a chest physician, at company expense, when he is ex- hibiting signs of developing chronic obstructive lung disease regardless of the suspected etiology. I would also like to comment on several other aspects of the proposed standard. Compulsory wearing of respirators above .2 milligram would in my opinion be disastrous to em- ployees, to companies and to OSHA. Well over 100,000 textile workers would be in respirators. What is so tragic about this is that it is not necessary. There are literally thou- sands of employees working in dust levels between .2 and -5 mg/M* who are showing no effect day in and day out. To require them to wear respirators because of an arbitrary number would just not be fair to them. We concede that there would be some level above which you must protect all employees, even at the risk of protecting some who may not App. 183 need it. This should be kept to a minimum. We would sug- gest .5 mg/M* for such a level, and would suggest compul- sory wearing of respirators for reactor employees below > mg/M’*. It.is difficult for me to understand why OSHA precludes the use of the single use respirator, particularly as NIOSH has approved their use. Two of these in particular now on the market are proven effective. Others in testimony here also indicate their effectiveness. It is very true that improper wearing of these respirators, breaking of straps, etc. can obviate their effectiveness. However, a protective device which is best is the one that is worn, and these are more apt to be worn than the very uncomfortable permanent respira- tors that are proposed in the standard. Another problem that I notice with the proposal is Sec- tion H(5)(i)(A). Requiring a physician’s written opinion for each employee is an extremely difficult requirement. I believe that most authorities in this field agree that para- medicals, that is, trained nurses and others can administer these examinations. We all agree that they should be under general supervision of a licensed physician, preferably one experienced in this field. However, there is no need for the physician to see every employee, and to require the physi- cian to provide an individual written opinion with respect to an employee that he has never seen, places him in con- siderable jeopardy from a medio-legal standpoint, and also provides a great deal of administrative difficulties. We op- erate cotton plants in six states and we train our nurses in our program. We supervise carefully by periodic visits, quality control, immediate availability of consultation by telephone, etc. However, to have a physician write a note for each employee in each of these states would be adminis- tratively and legally not feasible. We could not expect to rely upon local physicians to provide this service. I believe App. 184 with the current malpractice situation, they would be re- luctant. They certainly are too busy doing other more pro- ductive work to get involved with additional unnecessary paper work. I would like to make one last comment which concerns the OSHA definition of cotton dust. OSHA is faced with a difficult problem here since the causative agent is not known and since there are no practical field methods for differential analysis between the dust that is generated from cotton itself and other types of dust such as from air pollution, synthetic dust, size, etc. I can concur with the practical utilization of the OSHA definition. However, if one is to use a definition, then one must set reasonable dust level standards. For example, it is not unusual, as OSHA has indicated the Preamble to the Standard, to have community dust levels approaching .1 milligram per cubic meter. A standard there- fore of .2 mg/M’ may be represented by half dust not gen- erated from the process itself. Likewise, in weaving, a large percentage of the dust would be due to sizing. Therefore, OSHA’s definition is only logical to use when relatively achievable total airborne dust levels are set as the standard; in this case for most applications, with the exception of weaving, .5 mg/M’. For a standard as low as .2 mg/M’, I would consider it absolutely necessary to revise this defini- tion to make correction factors for the presence of synthetic, size, and community dust levels. In conclusion, I believe that there is a problem of bys- sinosis in the United States. It is my opinion, based upon our experience, that a standard is needed for respirable dust levels. The standard should include control of dust levels. In my opinion, a level of .5 mg/M* combined with an active medical surveillance program and a program involving transfers, respirators, counseling, and assistance to the sus- ceptible employee would be appropriate, generally achiev- App. 185 able and protective of the employee. The standard should be somewhat higher in weaving. The cotton dust standard has been a most difficult one for OSHA to develop and will present additional difficulties after weighing all of the evi- dence presented at this hearing. REFERENCES 1. Imbus, H.R., Suh, M.W.: Byssinosis—A Study of 10,133 Tex- tile Workers. Arch Environ Health 26: 183-91, 1973. 2. Weill, H.: Report to the American Textile Manufacturer’s In- stitute on a Study Entitled Assessment of Respiratory Response in Textile Workers Exposed to Low Levels of Cotton Dust. Tulane University School of Medicine, May 31, 1976. 3. Mueller, Robert E., Keble, David L., Plummer, Jerry, Walker, Strother H.: The Prevalence of Chronic Bronchitis, Chronic Airway Obstruction, and Respiratory Symptoms in a Colorado City: Amer. Rev. Resp. Dis., Vol. 103, pp. 209-228, 1971. 4. Merchant, James A., et al.: Dose Response Studies in Cotton Textile Workers. J. Occ. Med., Vol. 15, No. 3, March, 1973. 5. Berry, G., Molyneux, M.K.B., and Tombleson, J.B.L.: Rela- tionships Between Dust Level and Byssinosis and Bronchitis in Lancashire Cotton Mills. Br. Ind. Med., 31, 18-27, 1974. 6. Fox, A.J., Tombleson, J -B.L., Watt, A., Wilkie, A.J.: A Survey . of Respiratory Disease in Cotton Operatives—Part II. Symptoms, Dust Estimations and the Effects of the Smoking Habits. Br. J. Ind. Med., 30:46-59, 1973. 7. Noweir, M.: Epidemiological Studies in Cotton and Flax In- dustries. High Institute of Public Health, University of Alexandria, Alexandria, Egypt, U.A.R. The American Conference of Govern- mental Industrial Hygienists, Cincinnati, Ohio, 1975. 8. Barnes, Robert, Simpson, G.R.: Variations of Pulmonary Func- tion Amongst Workers in Cotton Mills. J. Occ. Med. Vol. 18, No. 8, August, 1976. 9. Imbus, H.R., Suh, M.W.: Steaming of C [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385006_2223%3A02. Public record. Not legal advice.