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August 30, 2002

Docket No. R-02B
OSHA Docket Office
Occupational Safety and Health Administration
Department of Labor
2000 Constitution Avenue, N.W., Room N-2625
Washington, D.C. 20210

Re: Docket No. R-02B, Response to Proposed Rule --Occupational Injury and Illness Recording and Reporting Requirements

To Whom It May Concern:

The Society of the Plastics Industry, Inc. (SPI) is submitting these comments in response to the Occupational Safety and Health Administration's (OSHA) proposed Occupational Injury and Illness Recording and Reporting Requirements - Proposed Rule. 67 Fed. Reg. 44124 (July 1, 2002). SPI sincerely appreciates the decision by OSHA to re-examine the issues raised in its July 1, 2002 Notice of Proposed Rulemaking (NPRM)1. SPI and its members are committed to protecting the health and safety of the industry's workers.

Founded in 1937, the Society of the Plastics Industry, Inc. is the trade association representing one of the largest manufacturing industries in the United States. SPI's 1,500 members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers and raw material suppliers. The U.S. plastics industry employs more than 1.5 million workers and provides more than $330 billion in annual shipments.

I. INTRODUCTION

SPI recognizes that the Injury and Illness Recordkeeping System established by the Occupational Safety and Health Administration (OSHA) under 29 CFR 1904 (Section 1904) provides information which is useful to employers, employees and OSHA in advancing workplace health and safety. OSHA has stated2 that the purpose of Section 1904 is to provide information that it deems necessary to: 1) enforce the Occupational Safety and Health Act (OSH Act);3 2) develop information regarding the causes and prevention of occupational accidents and illnesses;4 and 3) maintain a program for the collection, compilation and analysis of occupational safety and health statistics.5 Accordingly, SPI has a strong interest in ensuring that the health and safety statistics upon which OSHA relies in setting policy and pursuing the spectrum of available interventions are both accurate and meaningful. Otherwise, there is a strong probability that inaccurate, incomplete or otherwise misleading data will result in a misallocation of limited resources by OSHA and employers.

II. SUMMARY OF SPI'S POSITION

Assuming that OSHA retains the hearing loss column, SPI supports the proposed delay of its implementation until January 1, 2004. The one year delay would: provide adequate time for OSHA to update and distribute the OSHA Form 300 and 300S; provide adequate time for employers to update their recordkeeping software and retrain those responsible for recordkeeping; provide OSHA with valuable input from stakeholders; minimize confusion, including the increased number of hearing cases that would be expected during the first (changeover) year of the new criteria for hearing loss; and make more efficient use of resources.

With respect to MSDs, SPI not only supports the proposed one year delay in the three MSD provisions but believes they should be revoked. SPI would, in principle, support a data collection system that clearly and meaningfully defines, identifies and characterizes those work-related injuries and illnesses that the Department of Labor currently refers to as work-related "musculoskeletal disorders" or WMSDs. However, for two distinct reasons, the delayed MSD column would not support such a system. First, after careful analysis, we have come to the conclusion that the current level of scientific knowledge is inadequate to provide a workable definition of WMSDs that would permit employers to reliably distinguish WMSDs from other MSDs. Second, the statistics generated by aggregating the broad variety of conditions referred to as WMSDs into a single column would not be useful in characterizing these conditions (e.g., by body part involved, nature of the particular injury or illness), distinguishing WMSDs caused by work from WMSDs that represent pre-existing conditions aggravated by work, calculating meaningful incidence rates or determining causal factors. In other words, SPI does not believe that OSHA would be collecting the information needed to determine what caused these conditions, how to prevent these conditions and how any interventions should be prioritized.

The complexities of evaluating the generally subjective symptoms characteristic of MSDs, combined with the multi-factorial causation characteristic of MSDs, inevitably result in a high degree of inaccuracy and inconsistency in diagnosing MSDs, distinguishing discomfort from a recognized injury or illness, and determining the cause(s) of MSDs, even among the relatively small group of medical professionals trained in this area. Rather than expanding OSHA's reliance on such a flawed system, and imposing the associated paperwork burden on employers, we believe a far more useful and effective approach would be to further refine the data collection system and capabilities of the Bureau of Labor Statistics (BLS). We believe OSHA, BLS and the National Advisory Committee on Ergonomics, currently being formed by the Department of Labor, should work together to develop a meaningful WMSD component to the BLS annual survey tool, subject it to public input and then a pilot test, and then finalize the survey tool for inclusion in the BLS annual workplace safety and health survey.

III. ANY OSHA MANDATE TO COLLECT MSD DATA MUST BE BASED ON OSHA'S AUTHORITY UNDER THE OSH ACT

A. OSHA's Statutory Authority

Section 8(c)(2) of the OSH Act authorizes and directs the Secretary of Labor ("the Secretary," whose authority is delegated to the Assistant Secretary of Labor for Occupational Safety and Health, as the head of OSHA) to adopt regulations that require employers to:

maintain accurate records of … work-related deaths, injuries and illnesses other than minor injuries requiring only first aid treatment and which do not involve medical treatment, loss of consciousness, restriction of work or motion, or transfer to another job.6 [Emphasis added.]

Section 24(a) of the OSH Act directs the Secretary to:

compile accurate statistics on work injuries or and illnesses which shall include all disabling, serious, or significant injuries and illnesses … other than minor injuries requiring only first aid treatment and which do not involve medical treatment, loss of consciousness, restriction of work or motion, or transfer to another job.7 [Emphasis added.]

Further guidance as to what is appropriately included within this statistical program is provided by Sections 8(c)(1) and 8(d) of the OSH Act. Section 8(c)(1) provides, in relevant part, as follows:

Each employer shall make, keep and preserve, and make available to the Secretary ... such records regarding his activities relating to this Act as the Secretary … may prescribe by regulation as necessary or appropriate for the enforcement of this Act or for developing information regarding the causes and prevention of occupational accidents and illnesses.

Being sensitive to the burden that might be imposed by various data collection requirements, Congress adopted the following language as Section 8(d) of the OSH Act:

Any information obtained by the Secretary … under this Act shall be obtained with a minimum burden upon employers, especially those operating small businesses. Unnecessary duplication of efforts in obtaining information shall be reduced to the maximum extent feasible.8

In other words, OSHA's data collection authority with respect to MSDs is limited to the collection of:

1) accurate data;
2) on WMSDs;
3) which constitute serious injuries or illnesses; and
4) which data OSHA reasonably determines: a) to be necessary to accomplish its statutory mandate; and b) not to be available from other sources.

B. OSHA Must Limit Its Recordkeeping Requirements To Work-Related Injuries And Illnesses

OSHA's authority under Sections 8(c) and 24 of the OSH Act is limited to the maintenance and collection of data on "work-related" injuries and illnesses. In adopting the January 19th9 Rule, OSHA substantially modified the process for determining work relatedness for an MSD so that the determination would be made using the same criteria as were applicable to any other injury or illness.10 In addition, the January 19th Rule substantially narrows the scope of the "geographic presumption" so as to eliminate the work-relatedness presumptions based on administrative convenience and a bias to err on the side of over-recording.11

Under the standard approach to determining work-relatedness, the threshold question is whether an MSD resulted from or was significantly aggravated by an event or exposure in the work environment.12 If so, the MSD is presumed to be work-related unless one of the exemptions applies.

OSHA previously concluded that preponderance of the scientific evidence supports a multifactorial model of MSD causation involving both biomechanical and psychosocial factors.13 The agency has also acknowledged that workplace psychosocial factors are outside its jurisdiction. Therefore, absent a proper determination by a qualified expert that a particular MSD either would not have occurred or would not have been as severe in the absence of workplace exposure to identified biomechanical risk factors, the MSD is not and should not be considered work-related. Even where that determination is made, we question whether an MSD is properly viewed as a WMSD where the overwhelming causal contribution is psychosocial factors.

For most types of injuries and illnesses, when there is a causal link between a workplace event or exposure and the injury or illness, it is generally fairly straightforward to establish that link, and it generally is not multi-factorial. However, that has not been the case with MSDs. The 1997 NIOSH Review,14 the 1998 NAS Report,15 and the rescinded OSHA Ergonomics Program Standard acknowledged that MSDs have etiologic factors other than work.16 MSD's are well-known to have a multiplicity of causative factors.

Unfortunately, the current level of scientific knowledge is inadequate to enable an employer or an expert to consistently make an accurate determination as to causation for an MSD. Restricting the recording of WMSDs to the limited number of cases for which this level of proof may be available is likely to result in incomplete and misleading data. Accordingly, we believe the prudent and only permissible course of action is to delete the MSD column.

C. OSHA May Only Require Employers To Maintain Accurate Records

As noted above, Sections 8(c)(2) and 24(a) of the OSH Act direct OSHA to establish rules for the maintenance of accurate records on work-related injuries and illnesses. Where, as in the case of WMSDs, it is not feasible for employers to maintain accurate records for particular conditions, we believe OSHA would be acting outside its authority to nevertheless require employers to make an additional entry into a special WMSD column based on their best guesses as to the cause(s) of the conditions and whether they are work-related.

D. OSHA's Requirement For An Additional MSD Column Must Further The Purposes of The Act

Section 24(a) of the OSH Act grants OSHA the authority is to adopt an "effective program of collection, compilation and analysis of occupational safety and health statistics," including "accurate statistics on work injuries and illnesses." Considered in conjunction with OSHA's previously discussed statutory authority and the applicable principles of administrative law, we believe it is clear that the data collection requirements imposed on employers by OSHA under Section 1904 must be reasonably necessary or appropriate for OSHA to carry out its responsibilities under the OSH Act.

As currently used, the term MSD refers to a broad spectrum of physical conditions which may affect any tissue of the musculoskeletal system. The specific diagnoses which this term encompasses can have vastly different characteristics, can be caused by significantly different types of exposures types, and can require substantially different prevention measures and treatments.17

If all cases falling within the multitude of conditions collectively referred to as "MSDs" are grouped into a single column, and this data is collected through the annual BLS survey, the result is likely to be the projection by BLS of a relatively large and unreliable set of numbers allegedly representing recordable WMSDs. The numbers would be meaningless in the sense that they fail to provide OSHA or other interested parties with the information needed to determine the frequency, incident rate, causation or means of preventing any particular condition - e.g., carpal tunnel syndrome, epicondylitis.

Furthermore, the statistics on recordable WMSDs generated by the compilation of the employer coded data on the BLS counterpart to the OSHA 300S are likely to be less reliable than the currently available numbers generated by the compilation of the BLS case study survey. This is because the raw data used in the BLS case study survey was reviewed and entered by BLS coders. Those individuals are more likely than the personnel responsible for recordkeeping at the average employer to have received consistent training on how to code cases, and to have performed that task on an ongoing basis. In other words, retention of the MSD column would impose a substantial burden on almost all employers to separately identify each condition determined, albeit unreliably, to be a WMSD. Implementation of this requirement would not add any reliable or useful information to the existing data base of scientific knowledge. We, therefore, support OSHA's re-examination of this requirement and believe the MSD column should be eliminated from Section 1904 and the associated forms.

IV. THERE NEEDS TO BE A CLEAR SEPARATION BETWEEN THE RESCINDED ERGONOMICS STANDARD AND SECTION 1904

A. Overview

On June 29, 2001, Labor Secretary Elaine Chao announced that:

Until a definition [of WMSD] is agreed upon, the data collected will not help us target the injuries that need to be eliminated.18

In the July 1, 2002 NPRM, OSHA stated:19

OSHA found that no single definition of "ergonomic injury" was appropriate for all contexts. The Agency stated that it would work closely with stakeholders to develop definitions for MSDs as part of its overall effort to develop industry-or-task specific guidance materials.

The quoted language suggests that it is not possible, given the current state of the science, to develop a workable, universal definition of MSD for purposes of Section 1904. Furthermore, we believe that treating the terms "ergonomic injury" and "MSD" as interchangeable creates confusion and unjustified expectations. As noted by AIHA, the term "ergonomic injury' is inappropriate and confusing. Ergonomics is a multidisciplinary field that draws on the sciences of physiology, biomechanics and engineering. Ergonomics does not cause the injury, but the application of ergonomics principles may help to prevent it.

The term "ergonomics injury" is confusing because it seems to imply that there is a well-defined set of conditions caused by a well-defined set of ergonomic risk factors. In fact, the conditions are highly variable and subjective, there is no universally recognized set of ergonomic risk factors, and there is no universally recognized definition for any ergonomic risk factors.

One of the fundamental problems underlying the entire issue of an MSD column is the manner in which the information is used. Particularly during the OSHA ergonomics rulemaking, some discussions appeared to suggest that the annual number of lost work day MSD cases projected by BLS should be viewed as the number of injuries and illnesses that (immediately) would have been prevented by the implementation of the rescinded Ergonomics Program Standard. Clearly, that view did not reflect sound science. Furthermore, it ignored OSHA's estimates that only one-half of the attempted ergonomic interventions would be successful, and that it would take ten years to reduce the number of WMSDs by 25%.

We believe there must be a clear separation of MSD statistics from assertions that those MSDs are the injuries or illnesses that could and would be prevented by an ergonomics program, or even by a comprehensive safety and health program.

B. References to the Rescinded Ergonomics Program Standard to Define a WMSD Are Inappropriate and Likely to Confuse Recordkeepers

A review of the preamble to the January 19th Rule confirms that the manner in which it addressed MSDs was directly tied to the rescinded Ergonomics Program Standard. In that preamble, OSHA stated that in some cases it may be unclear whether the MSD results from work-related exposure. In such cases, the preamble instructs the employer to "consider the employee report, the ergonomic risk factors present in the employees job, and other available information."20 With the rescission of the Ergonomics Program Standard, there are no definitions of "ergonomic risk factors" and there is a significant question as to whether that is an appropriate term. SPI recommends that this issue be discussed and clarified for the regulated community.

V. OSHA'S SUGGESTIONS TO REDEFINE THE TERM MSD OR CREATE A SUBSET OF MSDS THAT WOULD NARROW THE SCOPE OF THE CASES THAT WOULD BE IDENTIFIED IN THE "MSD" COLUMN

A. Overview

In the notice of proposed rulemaking, OSHA acknowledged that it has received comments from a number of stakeholders suggesting that the term MSD should be re-defined or subdivided according to criteria that would limit the "MSD column" to injuries or illnesses that might be effectively addressed by an ergonomics program or ergonomics guidelines. The two approaches raised for discussion by OSHA were: 1) limiting the column to MSDs caused by repetitive motion activities (rather than single incident events); and 2) limiting the column to MSDs caused by routine activities. While we view this concept as having greater merit than one with a column for all MSDs, it does not cure the underlying fundamental problem posed by the lack of adequate science to determine causation. What this narrower approach may do is to establish a screening device that excludes certain cases from the "MSD column" that are not likely to be effectively addressed by an ergonomics program or ergonomics guidelines. For this approach to have any validity, however, it would be critical that OSHA establish quantified definitions for the screening terms - "routine" and "repetitive motion." Otherwise, the entities covered by the rule would have no reasonable basis for determining when the requirement to record this subset of MSDs applied to them, and the uniformity of approach required to have accurate national statistics would not be achieved.

B. The Definition of Repetitive Motion

OSHA did not include a definition of the term "repetitive motion" in the NPRM. BLS defines "repetitive motion" as follows: 21

23 Repetitive motion applies when an injury or illness resulted from bodily motion which imposed stress or strain upon some part of the body due to a task's repetitive nature.

Instances of carpal tunnel syndrome (CTS) from typing or any type of keyentry, including the use of calculators or nonscanning cash registers are coded 231. CTS resulting from cutting with a knife, repeated use of a power tool should be coded Repetitive use of tool (232).

If an injury or illness resulted from prolonged vibration in long distance driving, the event should be coded in event group 061, Rubbed, abraded, or jarred by vehicle or mobile equipment vibration.

There is a general principle, violated by the BLS definition, that a word should not be used to define itself. We believe it is clear that the foregoing definition would need to be significantly modified so that the word "repetitive" is appropriately quantified rather than relying on the "I know it when I see it" approach.

C. The Definition of Routine

OSHA did not include a definition of the term "routine" in the NPRM. In the context of defining the term "restricted duty," Section 1904 defines an employee's routine functions as "those work activities the employee regularly performs at least once per week."22 It seems clear that the use of the term "routine" in the context of "restricted duty" should have no bearing on how it is used in the context of screening out MSDs from a modified MSD column. A task that is performed once per week would not be expected to be the type of task likely to cause an MSD or be effectively addressed by an ergonomics program or ergonomics guidelines. Furthermore, the insertion of the word "regularly" in the phrase "regularly performs at least once per week" creates an unresolved ambiguity that has been raised with OSHA and we see no reason to import that type of problem into another section of the rule.

If OSHA decides to include a separate column for a subset of WMSDs, we believe the covered conditions should be limited to repetitive strain injuries (RSI) sustained in frequently performed tasks (20 or greater % of the time) or constantly performed tasks (>60% of the time). The column should exclude cases with acute musculoskeletal disorders because they are presumably one-time events not effectively addressed by an ergonomics program or ergonomics guidelines. Identifying RSIs in the column would highlight the cases that, if work-related, would be most likely to benefit from industry or task-specific guidance materials.

VI. THE STATISTICS ON MSDS THAT WOULD BE PUBLISHED BY BLS ON THE BASIS OF THE MSD COLUMN WOULD NOT COMPLY WITH THE OMB QUALITY GUIDELINES

By October 1, 2002, OSHA must be in compliance with the "Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, And Integrity of Information Disseminated By Federal Agencies."23 This document directs each Federal agency to issue its own information quality guidelines in order to ensure that the information it disseminates achieves maximum quality, objectivity, utility and integrity.

Implementing Public Law 106-554,24 the OMB Guidelines direct that information published by Federal agencies achieve a standard of quality that incorporates utility, objectivity and integrity. OMB defines utility in terms of the usefulness of the information to the intended users, including the public. The current MSD column does not appear to satisfy that criterion given Secretary Chao's statement that the data that would be collected by the MSD column "will not help us target the injuries that need to be eliminated." OMB's quality guidelines define "objectivity" as information that is "presented in an accurate, clear, complete and unbiased manner, and as a matter of substance, is accurate, reliable and unbiased." Based on the previous discussion, we do not believe the MSD column satisfies this criterion.

Finally, OMB notes that "the more important the information, the higher the quality standards to which it should be held" - as is the case with "influential, scientific, financial, or statistical information" such as nationwide MSD statistics.

VII. OSHA AND BLS SHOULD WORK TOGETHER TO IMPLEMENT SOME OF THE RECOMMENDATIONS OF THE NATIONAL ACADEMY OF SCIENCES

In 2001, The National Research Council of the National Academy of Sciences (NAS) issued a report titled "Musculoskeletal Disorders And The Workplace: Lower Back And Upper Extremiti

es." In that report, NAS made the following recommendations regarding improved data collection:

1) Revise the injury or illness coding system designed by BLS to facilitate comparisons with health survey data that are based on the current diagnostic practices of the medical community.

2) Refine the characterization of exposures associated with MSDs, including enhanced quantification.

3) Refine the collection of injury and illness information to include demographic variables such as age, gender, race, time on job, and occupation as well as other critical variables such as event, source, nature, body part involved, and rotation schedule.

The NPRM is unclear as to the extent to which BLS has been involved in this proceeding. BLS appears to be the only agency in a position to collect useful nation-wide data on WMSDs. That circumstance suggests that OSHA and BLS should be partners in this rulemaking. We believe the types of refinements to the BLS survey recommended by the NAS would be far more effective than the subject MSD column in developing useful information on the cause and prevention of MSDs.

VIII. CONCLUSION

For the foregoing reasons, SPI believes OSHA should not simply delay but eliminate the definition of the term "MSD," the MSD column, and the provision that excludes MSDs from the category of privacy concern cases. The data derived from the MSD column would be neither reliable nor useful, and could easily lead to confusion and misinterpretation. Even if the level of scientific knowledge improved to the point where employers could reliably determine the cause(s) of MSDs, we do not believe there is any utility in the collection of data that could only be used to generate aggregate statistics on all WMSDs. To be useful in developing information on the causes and prevention of injuries and illnesses, and how to prioritize prevention efforts, it would be necessary to break down that heterogeneous mass of data by affected body part, nature of the injury, nature of the activity being performed, initial injury versus aggravation of pre-existing injury, etc.

Meanwhile, we believe a far more useful and effective approach to the issue would be to further refine the data collection system and capabilities of the Bureau of Labor Statistics (BLS). We believe OSHA, BLS and the National Advisory Committee on Ergonomics should work together to develop a meaningful WMSD component to the BLS annual survey tool, subject it to public input and then a pilot test, and then finalize the survey tool for inclusion in the BLS annual workplace safety and health survey.

If a hearing loss column is retained, we strongly believe its effective date should be delayed until January 2004 to permit it to be implemented in an efficient manner and to avoid the confusion associated with the one-time bubble of cases expected to be created by the changeover to the new criteria for recording hearing loss in 2003.

Thank you for your consideration of our comments. Should you have any questions, or if we can provide further information, please contact me.

Respectfully submitted,

Maureen A. Healey
Vice President - Government Affairs

Of Counsel:

Lawrence P. Halprin, Esq.
Keller and Heckman LLP
Suite 500 West
Washington, D.C. 20001
Phone: (202) 434-4177
Fax: (202) 434-4646
E-Mail: Halprin @ khlaw.com


1. 67 Fed. Reg. 44124 (July 1, 2002).

2. 29 C.F.R. §1904.1 (1982) citing to 47 Fed. Reg. 145 (Jan. 5, 1982).

3. See Section 8(c)(1) of the OSH Act.

4. See Section 8(c)(1) of the OSH Act.

5. See Section 24(a) of the OSH Act.

6. 29 U.S.C. § 657(c)(2).

7. 29 U.S.C. § 673(a).

8. This principle is also reflected in the following applicable requirements of the Paperwork Reduction Act. Pursuant to 5 C.F.R. 1320.9, OSHA must certify to OMB and provide a record, which supports a certification that, the proposed collection of information: 1) Reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including … small entities . . . ; and 2) is written using plain, coherent and unambiguous terminology and is understandable to those who are to respond.

9. 66 Fed. Reg. 5915-6135 (January 19, 2001).

10. 66 Fed. Reg. 6017, col. 3.

11. We do not believe the significance of these changes have been fully communicated to the regulated community, and have a concern that they may not be reflected in the approach taken by OSHA compliance officers.

12. 66 Fed. Reg. 6017, col. 3. WMSDs are MSDs that would not have occurred or would have been significantly less severe but for an event or exposure in the workplace - excluding events or exposures that are excluded from the definition of work-related.

13. 65 Fed.Reg. 68531, col. 1. For purposes of this discussion, the term "psychosocial factors" refers to the external aspects of the psychological and social work environment that cause the worker to experience stress.

14. "Musculoskeletal Disorders (MSDs) and Workplace Factors: A Critical Overview of Epidemiologic Evidence For Work-Related Musculoskeletal Disorders of The Neck, Upper Extremity, and Low Back" (1997) NIOSH Publication 97-141 of Ch.1. ("One important reason for the controversy surrounding work-related MSDs is their multifactorial nature").

15. "Work-Related Musculoskeletal Disorders: A Review of the Evidence," National Academy Press (1998) at p. 23 "Research can … consider the influence of multiple factors (mechanical, work, social, etc.) on symptoms, injury, reporting, and disability …".

16. 65 Fed. Reg. 68262 et seq., citing several studies acknowledging that non-work factors are also causative factors in MSDs.

17. See Testimony of Charles P. Prezzia, M.D., M.P.H. - OSHA Hearings - Chicago, Illinois - April 18, 2000.

18. OSHA National News Press Release, USDL 01-201, June 29, 2001, "OSHA Rule On Record Keeping For Workplace Injuries To Go Into Effect as Scheduled."

19. 67 Fed. Reg. 44124, col. 3.

20. 66 Fed. Reg. at 6018, col. 1.

21. "Occupational Injury and Illness Classification Manual," U.S. Department Of Labor, Bureau of Labor Statistics (December 1992) at DE-6.

22. Section 1904.7(b)(4)(ii).

23. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, And Integrity of Information Disseminated By Federal Agencies, OMB (October 1, 2001).

24. Specifically, the OMB Guidelines implement Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001.


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