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###### Department of Labor

###### Occupational Safety and Health Administration 

          - 29 CFR Part 1910 
          - [Docket No. H-052G] 
          - RIN 1218-AB90 

# AGENCY:

Occupational Safety and Health Administration (OSHA), Labor. 

# ACTION:

Direct final rule; request for comments. 

# SUMMARY:

                        OSHA is issuing a direct final rule amending its occupational health standard for Cotton Dust, which was issued in 1978 and amended in 1985, to add cotton washed in a batch kier system to the types of washed cotton partially exempt from the cotton dust standard. This direct final rule follows the recommendation of the Task Force for Byssinosis Prevention, formerly known as the Industry/Government/Union Task Force for Washed Cotton Evaluation, which studies the health effects associated with the processing and use of washed cotton. This direct final rule is also consistent with a finding of OSHA's review of the cotton dust standard conducted pursuant to Section 610 of the Regulatory Flexibility Act and Section 5 of Executive Order 12866. See also the companion documents published in the Proposed Rules and Notices sections of today's                         **Federal Register**                        .                     

# DATES:

This direct final rule will be effective April 6, 2001 unless significant adverse comments are received by February 5, 2001. 

                        OSHA will publish a document in the                         **Federal Register**                         at least 30 days before the effective date of the direct final rule. The document will either confirm the effective date of the final rule or, if significant adverse comments are received, will withdraw the final rule.                     

# ADDRESSES:

                        Comments should be sent in quadruplicate to Docket No. H-052G, Docket Office, Room N2625; Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Ave., NW.,                               ( print page 76564)                            Washington DC 20210, (202-693-2350). Alternatively, one paper copy and one disc (3                        1/2                         inch floppy in WordPerfect 6.0, 8.0 or ASCII) may be sent to the Docket Office mailing address; or one copy faxed to 202-693-1648 and 3 paper copies mailed to the Docket Office mailing address, or one copy E-mailed to                         *ecomments.osha.gov*                         and one paper copy mailed to the Docket mailing address.                     

# FOR FURTHER INFORMATION CONTACT:

Dr. Steven Bayard, Director of the Office of Risk Assessment, Occupational Safety and Health Administration, U.S. Department of Labor, Room N-3718, 200 Constitution Avenue, NW., Washington, DC 20210, telephone: (202) 693-2275. 

# SUPPLEMENTARY INFORMATION:

## Introduction 

This direct final rule adds one additional method of washing cotton to the methods the rule already permits employers to use to achieve partial exemption from the cotton dust standard (see paragraph (n), 29 CFR 1910.1043). The additional method of washing cotton addressed by this notice is called batch kier washing, and a partial exemption from the standard for cotton washed using this method is supported by extensive scientific research, which has been published by the National Institute for Occupational Safety and Health in “Current Intelligent Bulletin 56—WASHED COTTON. A Review and Recommendations Regarding Batch Kier Washed Cotton” (Ex. 3-3Q, Docket H-052F). 

                    The change to the cotton dust standard achieved by this direct final rule find is supported by the relevant government agencies, industry groups, and the union representing textile workers. OSHA also considered this issue when it conducted its recent Regulatory Flexibility Act review (a section 610 “lookback” review) of the cotton dust standard which involved the publication of a                     **Federal Register**                     notice, the receipt of comments from interested parties, and the holding of public meetings. OSHA is aware of no opposition to the change that would be made by this direct final rule.                 

                    Therefore, OSHA considers this issue one that is appropriately addressed through the direct final rule process. However, if OSHA receives significant adverse comments on this direct final rule, it will withdraw the rule. OSHA would then proceed with the proposal on this matter published in the Proposed Rules section of today's                     **Federal Register**                    . Pursuant to that document, the Agency will consider all comments and evidence and determine whether to issue a subsequent final rule on this matter.                 

## Background 

In 1971, the Occupational Safety and Health Administration (OSHA) adopted a 1-mg/m3 (total dust) permissible exposure limit (PEL) for cotton dust. Subsequent OSHA rulemaking led to the promulgation of a comprehensive Federal occupational health standard for cotton dust in 1978 at 29 CFR 1910.1043 (43 FR 27351, June 23, 1978). In the 1978 standard, OSHA established different 8-hr time-weighted average (TWA) PELs for gravimetrically measured airborne cotton dust for different work areas of textile mills and included monitoring, medical, recordkeeping and other requirements. 

Based on “the effectiveness of the washing process in significantly reducing or eliminating the biological effects of cotton dust,” a provision of the 1978 standard exempted from the standard cotton “thoroughly washed in hot water” and “known in the cotton textile trade as purified or dyed” cotton (43 FR 27351, June 23, 1978). 

However, not all washing methods are effective in significantly reducing the biological effects of raw cotton, and some washing methods leave the cotton unworkable for spinning or weaving. In 1980, the tripartite “Industry/Government/Union Task Force for Washed Cotton Evaluation,” currently known as the “Task Force for Byssinosis Prevention,” was organized to study the issue of washed cotton and byssinosis and to find methods of washing that reduce cotton's biological effects yet leave the cotton workable. The Task Force includes representatives from the National Institute for Occupational Safety and Health (NIOSH), the Agriculture Research Service (U.S. Department of Agriculture), Cotton Incorporated, the Cotton Foundation (National Cotton Council), the American Textile Manufacturers Institute, the Union of Needletrades, Industrial and Textile Employees (UNITE) (the successor union to the Amalgamated Clothing and Textile Workers Union (ACTWU)), and OSHA. 

In 1985, on the basis of a review of the existing data, comments, and Task Force recommendations, OSHA substantially revised the washed cotton provision (1910.1043(n)) in the cotton dust standard (50 FR 51120, Dec. 13, 1985). The revised standard provides a complete exemption only for “medical grade (USP) cotton, that has been scoured, bleached and dyed, and mercerized yarn” (Paragraph (n)(3)). In addition, the 1985 standard provides partial exemptions for cotton washed in a continuous system, but provides no exemptions for batch kier washed cotton. 

                    Exemption from all requirements of the standard except for medical surveillance, medical recordkeeping and certain appendices is provided for higher grade cotton (low middling light spotted, or better,                     *i.e.,*                     color grade code 52 or better and leaf grade code 5 or better according to the current classification system (USDA 1993a)) that is washed: (1) On a continuous batt system or rayon rinse system, (2) with water, (3) at a temperature of no less than 60°C, (4) with a water-to-fiber ratio of no less than 40:1, and (5) with bacterial levels in the wash water controlled to limit bacterial contamination of cotton (paragraph (n)(4) of the standard).                 

Lower grade cotton (i.e., below color grade code 52 or below leaf grade code 5 by the current classification system) that is washed as specified in the preceding paragraph for higher grade washed cotton and that is also bleached is exempted from all requirements of the standard except for medical surveillance, recordkeeping, exposure monitoring and compliance with a 500 μg/m3 PEL for airborne dust measured by the vertical elutriator sampler, and certain appendices (paragraph (n)(5)). With respect to washed cotton of mixed grades, the 1985 revised standard specifies that the requirements for the grade with the most stringent requirements would apply (paragraph (n)(6)). 

Early batch kier washing trials were performed on systems involving hand loading of cotton fiber without prior mechanical opening or prewetting. Use of this approach resulted in the incomplete wetting of cotton fibers during the washing process, which probably explains the higher dust levels and the human reactivity observed in these early studies of batch kier washing. 

                    In 1988, Task Force investigators visited two companies utilizing batch kier processes with automated systems for mechanically opening and thoroughly wetting cotton fiber during the kier-loading process (Perkins & Berni, 1991, Ex.3-30). To evaluate the effectiveness of batch kier washing using this state-of-the-art opening and wetting technology, arrangements were made to wash cotton on one of these commercial systems for comparison with the same cotton washed using the continuous process partially exempted by the revised 1985 standard. Washings in the batch kier system were done                           ( print page 76565)                        under two different sets of conditions: (1) at 60 °C with a 50:1 water-to-fiber ratio, and (2) at 93 °C with a 17:1 water-to-fiber ratio. The study used cotton of grade code 52 to serve as a worst case test.                 

The study demonstrated that washing in the batch kier system under the conditions described above resulted in a substantial and statistically significant reduction (a reduction of at least 50%) of card-generated airborne cotton dust under both conditions. In addition, the three different wash treatments (two types of batch kier and continuous batt) were highly effective and statistically equivalent in reducing the endotoxin content of card-generated airborne elutriated dust. As a result, the concentration of airborne endotoxin was very effectively reduced by all three washing methods, from more than 300 ng/m3 for the unwashed cotton (at a dust level of 1.98 mg/m3) to less than 10 ng/m3 for each of the washed cottons (at dust levels ranging from 0.35 mg/m3 to 0.89 mg/m3). 

These low airborne endotoxin levels generated during card processing of the washed cottons were all below a relative “threshold” for acute airway response in humans described previously by NIOSH investigators in this same setting (Castellan et al. 1987, Ex. 3-5). Most investigators believe that keeping endotoxin levels low is crucial to avoiding byssinosis. 

To further assess the effectiveness of washing cotton in modern batch kier systems, another blend of predominantly color grade code 52 and leaf grade code 5 cotton (grown in Texas) was washed on a batch kier system operated by another company (Jacobs et al. 1993, Ex. 3-19; Perkins and Olenchock 1995, Ex. 3-31). Washing, done at 60 °C and using a 40:1 water-to-fiber ratio, as stipulated in the revised 1985 standard for continuous wash systems, and at 93 °C and a 17:1 water-to-fiber ratio, resulted in a reduction of at least 50% in dust-generating capacity (compared with that of the unwashed cotton) under identical carding rates and ventilation conditions. 

On the basis of human ventilatory responses to experimental exposures to dust from this washed cotton, Jacobs and colleagues concluded that these results “suggest that modern batch kier systems can effectively remove the acute pulmonary toxicity of cottons washed at 60 °C and a 40:1 water-to-fiber ratio” (Jacobs et al. 1993, Ex. 3-19, p. 276). 

A substantial body of experimental evidence now exists on this issue. The evidence indicates that, with respect to the removal of potential respiratory toxicity, cotton washed in batch kier systems (using modern equipment that assures thorough wetting of the cotton fiber and no reuse of wash or rinse water) is equivalent to cotton washed on a continuous batt system, which was approved by OSHA for partial exemption under the washed cotton provisions (paragraph (n)) of the current cotton dust standard. 

During OSHA's review of the Cotton Dust standard pursuant to Section 610 of the Regulatory Flexibility Act and E.O. 12866, OSHA requested comment on the washed cotton issue (63 FR 34140, June 23, 1998). OSHA received written comment from interested parties on the standard generally and on this issue, and held two public meetings in connection with the review. Based on the evidence discussed above, both the industry/government/union “Task Force for Byssinosis Prevention” Ex. (3-5F) and NIOSH (Ex. 3-3) submitted comments recommending that cotton washed in a batch kier system be treated by the standard in the same way as cotton mildly washed in a continuous system. The National Cotton Council of America urged OSHA in written comments and at a public meeting to amend the standard to partially exempt cotton washed in a batch kier system (Ex. 3-5). These comments and the Task Force report (Ex. 3-5Q) are located in OSHA's Docket Office, Docket No. H-052-F. 

                    OSHA has now completed its lookback review of the cotton dust standard pursuant to the RFA and E.O. 12866. The Notices section of today's                     **Federal Register**                     announces the availability of the final report of that review, “Regulatory Review of OSHA's Cotton Dust Standard.” That review concludes that the Agency is justified in extending the washed cotton partial exemption in the cotton dust standard to include cotton mildly washed in a batch kier system (Ex., p. 58).                 

The studies demonstrate that raw cotton washed in the batch kier process according to the specified protocol results in the elimination or a substantial reduction in the significant risk of byssinosis, if employers using such washed cotton comply with the medical surveillance and certain recordkeeping requirements of the standard, and with Appendices B, C, and D of the standard. The batch kier process is as effective in this regard as other washing methods that OSHA has already partially exempted from the cotton dust standard. This conclusion is supported by NIOSH, and by the joint government, union, and industry Task Force for Byssinosis Prevention. 

Accordingly, OSHA is amending the cotton dust standard to add washing in a modern batch kier system as an acceptable method of washing cotton under paragraph (n)(4) of the 1985 cotton dust standard, which will qualify cotton washed in this system for partial exemption from that standard. This amendment is being issued as a direct final rule because doing so is widely endorsed, well supported, and non-controversial. 

In order to accomplish this change, OSHA is amending paragraph (n)(4) of 29 CFR 1910.1043 to include the new partial exemption for batch kier washed cotton. The standard will continue to partially exempt cotton washed through the continuous batt or rayon rinse systems. OSHA is also reorganizing paragraph (n)(4) to improve clarity. 

By this action OSHA is responding to the requirements of the Regulatory Flexibility Act and Executive Order 12866 that Agencies review their regulations to determine their effectiveness and to implement any changes indicated by the review that will make the regulation more flexible and efficient for stakeholders and small businesses while maintaining needed protections for workers. Reliance on the direct final rule approach is also an example of OSHA's Reinvention Initiative which emphasizes flexible and efficient methods of achieving results. 

## Economic and Technical Feasibility 

OSHA concludes that adding the batch kier washed cotton method to the list of methods already partially exempted by paragraph (n)(4) of the cotton dust standard (29 CFR 1910.1043) is both economically and technically feasible. The addition creates no new requirements and imposes no new compliance obligations on employers. Instead, it merely permits an additional type of washing to qualify for partial exemption from the cotton dust standard based on evidence that batch kier washing is as effective as other partially exempted washing methods in protecting employee health. No one is required to use the new method. Employers may choose to use the newly approved method, but they are not required to use it if they do not believe it is more advantageous than existing practices. Thus, this regulatory action reduces the burden on employers wishing to avail themselves of it, but continues to provide protections for employees. Accordingly, no further analysis of the feasibility of this direct final rule is required by the OSH Act. 

## Regulatory Flexibility Act: Certification of No Significant Impact 

                    In accordance with the Regulatory Flexibility Act, as amended (5 U.S.C.                           ( print page 76566)                        601-612), OSHA has evaluated the effects of the batch kier washing amendment on small entities. No small business is required to adopt this washing method or to purchase cotton washed by this method and all employers may continue to use their existing practices to comply with the cotton dust standard. A small business may choose to adopt this method of washing cotton or to purchase cotton washed by this method if it finds that a cost saving or other advantage is created by doing so. Based on this finding, OSHA certifies that this amendment to paragraph (n)(4) of 29 CFR 1910.1043 will not have a significant impact on a substantial number of small entities.                 

## Executive Order 12866

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether a regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines a “significant regulatory action” as one that is likely to result in a rule that may: 

1. Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities; 

2. Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; 

3. Materially alter the budgetary impact of entitlements, grants, user fees, or land programs or the rights and obligations of recipients thereof; or 

4. Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. 

For the reasons just discussed, this direct final rule causes none of these impacts. Some cotton mills may choose to use cotton washed by this newly permitted method to save control costs otherwise required by the cotton dust standard. Consequently, this direct final rule is not a significant regulatory action and therefore does not require an Economic Analysis under Executive Order 12866. 

## Unfunded Mandates 

This direct final rule, which amends a paragraph of the Cotton Dust standard, has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA) (U.S.C. 1501 et seq.). For the purposes of the UMRA, the Agency certifies that the final standard does not impose any Federal mandate that may result in increased expenditures by State, local, or tribal governments, or increased expenditures by the private sector, of more than $100 million in any year. 

## Federalism 

This amendment has been reviewed under Executive Order 13132 (Aug. 11, 1999) on Federalism. That order requires that agencies, to the extent possible, refrain from limiting state policy options, consult with States prior to taking any actions that would restrict state policy options, and take such actions only when there is clear constitutional authority and the presence of a problem of national scope. The Order provides for preemption of State law only if there is a clear Congressional intent for the Agency to do so. Any such preemption is to be limited to the extent possible. 

Section 18 of the Occupational Safety and Health Act (OSHA Act) expresses Congress' intent to preempt State laws relating to issues on which Federal OSHA has promulgated occupational safety and health standards. Under the OSH Act, a State can avoid preemption on issues covered by Federal standards only if it submits, and obtains Federal approval of, a plan for the development of such standards and their enforcement. Occupational safety and health standards developed by such Plan States must, among other things, be at least as effective in providing safe and healthful employment and places of employment as the Federal standards. When such standards are applicable to products distributed or used in interstate commerce, they may not unduly burden commerce and must be justified by compelling local conditions. 

This amendment to paragraph (n)(4) of the cotton dust standard was developed based on scientific research and merely grants an extra option and increased flexibility to cotton processors and textile mills. In connection with the Regulatory Flexibility Act review, OSHA held a public meeting in Atlanta, GA which is in the region where most textile industry facilities are located. State Plan states are free to adopt this amendment or an alternative that is at least as effective in protecting worker health. 

## State Plan Standards 

The 25 States with their own OSHA approved occupational safety and health plans must adopt an equivalent amendment or one that is at least as protective to employees within six months of the publication date of this final standard. These States are: Alaska, Arizona, California, Connecticut (for State and local government employees only), Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, New York (for State and local government employees only), North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington and Wyoming. 

## Paperwork Reduction Act 

The information requirements contained in the cotton dust standard have been approved by the Office of Management and Budget pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-30). The approval is in effect until January 31, 2002 pursuant to OMB Control No. 1218-0061 (29 CFR 1910.8). The approval covers the paperwork required to achieve a washed cotton partial exemption from the standard. This amendment adds no additional information collection requirements and instead merely adds an alternative method for achieving the washed cotton exemption. Consequently, the Paperwork Reduction Act of 1995 does not require OSHA to take any further action on this matter at this time. 

## Public Participation 

Interested persons are requested to submit written data, views and arguments concerning this direct final rule. These comments must be received by February 5, 2001 and submitted in quadruplicate to Docket No. H-052G, Docket Office; Room N2625; Occupational Safety and Health Administration; U.S. Department of Labor, 200 Constitution Ave., N.W., Washington, D.C. 20210. 

                    Alternatively, one paper copy and one disc (3                    1/2                     inch floppy in Wordperfect 6.0, 8.0 or ASCII) may be sent to that address, or one copy faxed to (202) 693-1648 and 3 paper copies mailed to the Docket Office mailing address; or one copy E-mailed to                     *ecomments.osha.gov*                     and one paper copy mailed to the Docket Office mailing address.                 

All written comments received within the specified comment period will be made a part of the record and will be available for public inspection and copying at the above Docket Office address. 

                    OSHA requests comments on all issues related to granting cotton washed in the batch kier system with a partial exemption from OSHA's cotton dust standard and on the Agency's findings that there are no negative economic, environmental or other regulatory impacts of this action on the regulated community. OSHA is not requesting                           ( print page 76567)                        comment on any issues or opening the record for any issue other than those related to this amendment to paragraph (n)(4) of 29 CFR 1910.1043.                 

                    If OSHA receives no significant adverse comment on this amendment, OSHA will publish a                     **Federal Register**                     document confirming the effective date of this direct final rule. Such confirmation may include minor stylistic or technical changes to the amendment that appear to be clearly justified. For the purposes of legal review, OSHA views the date of confirmation of the effective date of this amendment as the date of issuance.                 

                    If OSHA receives significant adverse comments on this amendment, it will withdraw the amendment and proceed with the proposed rule addressing the batch kier washing issue published in the Proposed Rules section of today's                     **Federal Register**                    .                 

# List of Subjects in 29 CFR Part 1910

      - Cotton dust
      - Hazardous substances
      - Occupational safety and health
      - Reporting and recordkeeping requirements

## Authority and Signature 

This document was prepared under the direction of Charles N. Jeffress, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue, NW., Washington, DC. 20210. 

This action is taken pursuant to sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657), Section 4 of the Administrative Procedure Act (5 U.S.C. 553), Secretary of Labor's Order No. 3-2000 (65 FR 50017, August 16, 2000) and 29 CFR part 1911. 

Signed at Washington, DC, this 4th day of December, 2000. 

Charles N. Jeffress, 

Assistant Secretary of Labor. 

Part 1910 of Title 29 of the Code of Federal Regulations is hereby amended as set forth below: 

# PART 1910—(AMENDED) 

1. The authority citation for Subpart Z of Part 1910 is revised to read as follows: 

Authority:Sections 4, 6 and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657; Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 6-96 (62 FR 111) or 3-2000 (65 FR 50017) as applicable; and 29 CFR part 1911. 

All of subpart Z issued under sec. 6(b) of the Occupational Safety and Health Act, except those substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The latter were issued under sec. 6(a) (29 U.S.C. 655(a)). 

Section 1910.1000, and Table Z-1, Z-2, and Z-3 and 1910.1043 (n) also issued under 5 U.S.C. 553. 

Section 1910.1000, and Tables Z-1, Z-2, and Z-3 not issued under 29 CFR part 1911 except for the arsenic (organic compounds), benzene, and cotton dust listings. 

Section 1910.1001 also issued under section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 333) and 5 U.S.C. 553. 

Section 1910.1002 not issued under 29 U.S.C. 655 or 29 CFR part 1911; also issued under 5 U.S.C. 553. 

Sections 1910.1018, 1910.1029 and 1910.1200 are also issued under 29 U.S.C. 653. 

2. Paragraph (n)(4) of § 1910.1043 is revised to read as follows: 

§ 1910.1043

* * * * *

(n) * * *

                            (4)                             *Higher grade washed cotton.*                             The handling or processing of cotton classed as “low middling light spotted or better” (color grade 52 or better and leaf grade code 5 or better according to the 1993 USDA classification system) shall be exempt from all provisions of the standard except the requirements of paragraphs (h) medical surveillance, (k)(2) through (4) recordkeeping—medical records, and Appendices B, C, and D of this section, if they have been washed on one of the following systems:                         

(i) On a continuous batt system or a rayon rinse system including the following conditions: 

(A) With water; 

(B) At a temperature of no less than 60 °C; 

(C) With a water-to-fiber ratio of no less than 40:1; and 

(D) With the bacterial levels in the wash water controlled to limit bacterial contamination of the cotton. 

(ii) On a batch kier washing system including the following conditions: 

(A) With water; 

(B) With cotton fiber mechanically opened and thoroughly prewetted before forming the cake; 

(C) For low-temperature processing, at a temperature of no less than 60 °C with a water-to-fiber ratio of no less than 40:1; or, for high-temperature processing, at a temperature of no less than 93 °C with a water-to-fiber ratio of no less than 15:1; 

(D) With a minimum of one wash cycle followed by two rinse cycles for each batch, using fresh water in each cycle, and 

(E) With bacterial levels in the wash water controlled to limit bacterial contamination of the cotton. 

* * * * *

[FR Doc. 00-31186 Filed 12-6-00; 8:45 am] 

BILLING CODE 4510-26-P