OSHA Instruction CPL 2-2.27 CH-1 JUN 3, 1985 Office of General Industry Compliance Assistance

Subject: Removal of Obsolete sections

A. Purpose. This notice transmits page changes which remove sections that contain policies and procedures superseded by guidelines set forth in the Field Operations Manual (FOM), OSHA instruction CPL 2.45A.

B. Scope. This notice applies OSHA-WIDE.

C. Action. Replace existing pages with the attached CH-1 pages as listed below:

Existing Pages Replacement Pages

5 through 18 5 through 18

D. Significant Changes. The instruction will be totally revised and reprinted at a later date. in the interim, the following sections are removed:

CPL 2-2.27, February 22, 1980: Paragraphs F.1, Applicability of the General Duty Clause, through F.8, Documentation of 29 CFR 1910.134 Violations and 5(a)(1) Violations for Exposing Employees, pages 6 through 12; and paragraph F.10, Correction of 5(a)(1) violations, pages 14 through 17.

E. Background. A decision was made at the time the FOM was revised to incorporate all policies and procedures of a nontechnical nature into that manual. When the FOM was published, numerous changes were made to existing health policy. These changes made the procedural sections of the instruction obsolete. To avoid confusion for directives users, it has become necessary to remove inapplicable sections from the instruction. The remainder of the instruction is

OSHA INSTRUCTION CPL 2-2.27 CH-1 JUN 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

still in effect until the directive has been totally revised and reprinted at a later date.

John B. Miles, Jr., Director Directorate of Field Operations

DISTRIBUTION: National, Regional and Area offices Compliance Officers State Designees NIOSH Regional Program Directors 7 (c) (1) Project Managers

OSHA INSTRUCTION CPL 2-2.27 CH-1 JUNE 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

Subject: Benzidine-Based Dyes: Direct Black 38, Direct Brown 95 and Direct Blue 6 Dyes

A. Purpose. This instruction provides guidelines to follow when issuing citations under Section 5(a)(1) of the Act, and pertinent standards of a general nature, for employee exposure to Direct Black 38, Direct Brown 95 and Direct Blue 6 benzidine-based dyes.

B. Scope. This instruction applies OSHA-wide.

C. Action. OSHA Regional Administrators/Area Directors shall assure that:

1. The guidelines in paragraphs F., G. and H. of this instruction are followed.

2. The carcinogenic hazard described in Appendix D of this instruction is appropriately considered in issuing citations.

D. Federal Program Change This instruction describes a Federal program change which affects State programs. Each Regional Administrator shall:

1. Ensure that this change is forwarded to each State designee.

2. Explain the technical content of the change to the State designee as requested.

3. Ensure that State designees are asked to acknowledge receipt of this Federal program change in writing, within 30 days of notification, to the Regional Administrator. This acknowledgment should include a description either of the State's plan to implement the change or of the reasons why the change should not apply to that State.

4. Advise State designees of the following:

a. In order to assure a sound and consistent

OSHA INSTRUCTION CPL 2-2.27 CH-1 JUNE 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

national enforcement and litigation strategy in relation to the complex issues addressed by this instruction, it is critical that initial Federal and State implementation of the instruction's purposes be carefully coordinated.

b. State Plan officials are asked to work closely with OSHA Regional staff in carrying out the procedures Outlined in this instruction, or comparable State Procedures

c. In addition, it is requested that upon completion of an inspection, each State consult with OSHA on enforcement strategy before proceeding with action on the case. To facilitate such consultation, until otherwise advised:

(1) State designees are asked to send to the OSHA Regional Administrator a copy of each entire case file and any proposed citations and Penalties originating from the case, prior to issuance of the citations and penalties.

(2) The Regional Administrator will forward the file and proposed citations and penalties to the Office of Field Coordination and Experimental Programs for review in conjunction with cases originating from other States and from OSHA Area Offices. The Office of Field Coordination and Experimental Programs will consult with the National Office of the Solicitor and the Directorate of Federal Compliance and State Programs in their review.

(3) Upon completion of the review, the Office of Field Coordination and Experimental Programs will arrange, through the Regional Administrator, for consultation with the State designee on the best strategy for handling this case in the light of other related developments

5. Review policies, instructions and guidelines issued.

OSHA INSTRUCTION CPL 2-2.27 CH-1 JUNE 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

by the State to determine that this change has been communicated to State program personnel. Routine monitoring activities (accompanied inspections and case file reviews) shall also be used to determine if this change has been implemented in actual performance.

E. Background. Based on available scientific evidence, OSHA has determined that employee exposure to the three benzidine-based dyes covered in this instruction presents a significant risk of cancer studies indicate that these dyes are carcinogenic in experimental animals. Additional studies indicate that these dyes are also metabolized in the body into benzidine, a human carcinogen. While OSHA has a specific standard to protect workers exposed to benzidine, these dyes cannot be covered under 29 CFR 1910.1010 Although there are many other benzidine-based dyes, the toxicity data for them are not as complete as for the three dyes covered by this directive. However, the agency recommends that the other benzidine-based dyes also be handled as carcinogens.

1. Health Effects.

a. In 1978 the National Cancer Institute (NCI) completed a 13-week subchronic study of Direct Blue 5, Direct Black 38, and Direct Brown 95 using Fischer 344 rats. The results demonstrate that these dyes are both tumorogenic and carcinogenic, inducing both hepatic neoplastic nodules and hepatocellular carcinomas, respectively. (For reference source, see E.7.a. of this instruction.)

b. An epidemiologic study by Yoshida, et al.(1971), demonstrated a probable association between bladder cancer and employee exposure to benzidine-based dyes. (For reference source, see E.7.b. of this instruction.)

2. Biological Response.

a. Metabolism studies in five species of animals and in humans indicate that each of the three

OSHA INSTRUCTION CPL 2-2.27 JUNE 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

dyes is metabolized to benzidine, a known carcinogen. (See Appendix D of this instruction.)

b. A study of Direct Black 38 demonstrated that this dye is mutagenic in the Salmonella test system. (See Appendix D of this instruction.)

3. Source of the Dyes. In the United States, as of August 1979, Fabricolor Incorporated, Paterson, New Jersey, is the only known manufacturer of Direct Black 38, Direct Brown 95 and Direct Blue 6. However, importation of these three dyes supplements domestic production. The "Health Hazard Alert: Benzidine Derived Dyes" contains a list of importers. The distributors have not been identified by OSHA.

4. Synonyms, Physical Properties, and Structural Formulas. The synonyms, physical properties and structural formulas of these three dyes are detailed in this instruction as follows:

a. Appendix A--Direct Black 38.

b. Appendix B-Direct Brown 95. c. Appendix C--Direct Blue 6.

5. Manufacturing Process.

a. Fabricolor uses hydrazobenzene instead of benzidine as a starting material for manufacturing the dyes. The hydrazobenzene is dumped into a closed tank (reaction vessel) where it undergoes rearrangement to benzidine dihydrochloride by reaction with a strong solution of hydrochloric acid in water.

NOTE: The benzidine standard is applicable to this stage of the manufacturing process and remains applicable up to the stage where the concentration of benzidine dihydrochoride drops below 0.1 percent by weight.

OSHA INSTRUCTION CPL 2-2.27 CH-1 JUNE 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

b. The benzidine dihydrochloride solution is then reacted with sodium nitrite solution to form the diazo compound. This reaction could be carried out by adding the sodium nitrite solution to the benzidine hydrochloride solution, or alternatively by pumping the benzidine hydorchloride solution into another closed tank containing the sodium nitrite solution. Synthesis of the desired dye is continued by pumping the diazo compound to other reaction vessels for coupling to other compounds.

c. After the final reaction is completed, the product is isolated from solution and moved to a filter press for filtering and the washing out of further impurities.

d. The dye is taken form the filter press in press cake form and dried. Drying may be performed on a drum dryer after recreating a slurry of the dye; or drying may be done with a tray or spray dryer.

e. The dried dye may be taken to a hammer mill and ground to a fine powder, or it may be taken directly to ribbon blender. Color blending, standardization by adding salts and dedusting by adding dedusting oil is performed at the blender. The dye is transferred form the blender into drums for shipping,

6. Uses. Some reported used for the three dyes (for reference source, see E.7.c of this instruction) are as follows:

a. Direct Black 38: Dyeing or staining of wool, silk, fibers for rope and matting, hogs hair, cotton and other cellulose, acetate, nylon and biological stains.

b. Direct Brown 95: Dyeing or staining silk, cotton, acetate, cellulose, wool, nylon, leather, paper and certain plastics.

OSHA INSTRUCTION CPL 2-2.27 CH-1 JUNE 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

c. Direct Blue 6: Dyeing or staining silk, wool, cotton, nylon, leather, paper, biological stains, and writing inks.

7. References.

a. Thirteen-week Subchronic Toxicity Studies of Direct Blue 6, Direct Black 38 and Direct Brown 95 Dyes. National Cancer Institute. Carcinogenesis Technical Report. DHEW Publication #"NIH" 78-1358, 19/8.

b. Yoshida, O., et al.: [Bladder cancer in workers of the dyeing industry.] Igaku No. Ayumi, Vol. 79, No. 7: 421-422, 1971. (Japanese)

c. The Colour Index: 1971, 3rd Ed. Lund, Humphries, Bradford, and London, eds. London, England: The Society of Dyers and Colourists-American Association of Textile Chemists and Colorists.

d. Current Intelligence Bulletin 24: April 17, 1978. Benzidine Derived Dyes. National Institute for Occupational Safety and Health/National Cancer Institute.

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9. Methods of Documenting Exposure

a. The compliance officer must rely heavily on procedures other than sampling and chemical analysis to document exposure to the dyes. For example, compliance officers must take photographs that show poor work practices, lack of or improperly designed engineering controls, improperly maintained engineering controls, improperly maintained systems and equipment for processing or using the dyes, contaminated surfaces and/or soiled employees. Other documentary methods include taking measurements showing inadequate ventilation; interviewing employees, employee representatives, and employers; etc.

b. However, in all cases samples shall be taken. Both bulk and air samples shall be taken when documenting exposure to the dyes by inhalation. When documenting exposure to the dyes by skin contact, bulk and wipe samples shall be taken and evidence demonstrating the contact shall be obtained; e.g., a photograph showing an employee's bare hand in contact with the dyes. When sampling:

OSHA INSTRUCTION CPL 2-2.27 CH-1 JUNE 3 1985 OFFICE OF GENERAL INDUSTRY COMPLIANCE ASSISTANCE

(1) The dyes should be sampled on glass fiber filters without organic binder at 2 liters per minute for a sampling time of 4 hours.

(2) Sample handling and shipment to the laboratory shall be that prescribed in the Industrial Hygiene Field Operations Manual. Following receipt of the samples in the laboratory, they will be analyzed by high performance liquid chromatography for the specific dyes requested.

(3) Wipe samples of the dyes on normal working surfaces shall be collected on glass fiber filters without organic binders. For rough surfaces on which a glass fiber filter may tend to fall apart, a fluoropore filter may be used to collect the wipe sample.

(4) Collection, handling and shipping of the wipe samples shall be as prescribed in Chapter VI of the IHFOM except for the type of filter used. The dyes may be sensitive to light: therefore, care should be taken not to expose the samples to high levels of indoor lighting or to direct sunlight.

(5) Regardless of whether air or wipe samples are to be analyzed, be sure to send bulk samples so that SLCAL can make up calibration curves.

c. These dyes have been shown to metabolize to benzidine, which may appear in the urine of exposed employees. Thus, some employers may be monitoring the benzidine in the urine of their employees who work with or around one or more of the dyes. With each employer, determine if this is the case. Where an employer does monitor the benzidine in employees's urine, and at least some results are positive, obtain copies of all result relevant to documenting exposure of employees to one or more of these dyes.

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G. National Office Review. Until instructed otherwise by the National Office, Area Offices conducting inspections where possible violations exist shall send copies of the entire case file dealing with violations and proposed citations to their Regional Offices, who will forward this material to the

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Office of Field Coordination and Experimental Programs prior to the issuance of any citations involving the three dyes covered in this instruction. The Office of Field Coordination and Experimental Programs will then consult with the National Office of the Solicitor in determining whether citations should be issued.

H. Expert Witnesses. The Directorate of Technical Support will assist the Regional Offices in locating expert witness. In the event that a 5(a)(1) citation is contested, the case file must contain an expert witness to testify before the review judge as to:

1. The fact that there is sufficient evidence to demonstrate that the dye or dyes involved in the citation present a significant cancer risk to humans.

2. The fact that the hazard is recognized in the industry, by the employer, or by a member of the health community who is associated with the employer or the industry.

3. The fact that methods of abatement presented in the citation are feasible.

Grover C. Wrenn Director, Federal Compliance and State Programs

DISTRIBUTION: National, Regional and Area Offices All Compliance Officer State Designees NIOSH Regional Program Directors