_________________________________
:
SECRETARY OF LABOR, :
:
Complainant, :
:
v. : OSHRC Docket No. 89-0265
:
PEPPERIDGE FARM, INC. , :
:
Respondent. :
_________________________________:
Before: WEISBERG, Chairman; MONTOYA and GUTTMAN, Commissioners
BY THE COMMISSION:
DECISION
INTRODUCTION
This case concerns Pepperidge Farm Inc.'s Downingtown, Pennsylvania plant, where it produced a variety of cookies and other baked goods.[1] The Secretary of Labor issued citations for numerous alleged "egregious willful" violations of the Occupational Safety and Health Act ("the Act"), 29 U.S.C.§§ 651-678. The basic issues are whether Commission Judge David G. Oringer erred in:
(1) finding "willfulness" regarding 176 recordkeeping violations under 29 C.F.R. § 1904.2(a), and assessing instance-by-instance penalties totaling $289,603.00 (Citation 1, Item 1);
(2) finding recognized hazards and willfulness regarding 21 alleged lifting violations under section 5(a)(1)[2] of the Act, 29 U.S.C. § 654(a)(1), and assessing instance-by-instance penalties totaling $105,000 (Citation 1, Item 3); and
(3) vacating 175 alleged willful repetitive motion violations under section 5(a)(1) of the Act and proposed instance-by-instance penalties totaling $875,000, on the ground that the Secretary failed to establish a feasible means of abating the cited conditions (Citation 1, Item 2).[3]
This case is among the most lengthy and complex to come before the Commission. The Labor Department's Occupational Safety and Health Administration ("OSHA") began its inspection of the Downingtown plant on June 23, 1988, and it continued in September and October. OSHA issued the citations on December 13, 1988. There were 62 days of hearing before Judge Oringer between June 25, 1990, and October 22, 1991. The hearing generated more than 11,000 pages of transcript and over 400 exhibits, including approximately 60 scientific studies and articles. Judge Oringer's decision, which issued on March 23, 1993, was 244 pages. Following a remand to Judge Frye for resolution of the sanctions issue, the Commission issued directions for review in September 1993. The Commission held oral argument in this case on September 20, 1996.[4]
For the reasons explained below, we affirm the judge's disposition of the recordkeeping items cited under section 5(a)(2).
In this case,[5] the Commission considers for the first time whether the Secretary may apply section 5(a)(1), the Act's general duty clause, to issues of "ergonomics." That term has been defined as the "science concerned with how to fit a job to a worker's anatomical, physiological, and psychological characteristics in a way that will enhance human efficiency and well-being."[6] The lifting items here involve employees lifting 100-pound bags of sugar, 68-pound blocks of butter, roll stock weighing up to 165 pounds, and cookie tins weighing up to 38 pounds. The repetitive motion items involve employees performing in quick succession assembly line tasks, such as dropping paper cups from a stack with one hand and filling them with baked cookies with the other hand.
We find that the Secretary may utilize section 5(a)(1) to address lifting and repetitive motion hazards. In regard to the lifting tasks, Pepperidge did not seek review of the judge's finding that a hazard exists. Pepperidge did challenge his finding that it had recognized the hazard. We find that Pepperidge recognized the existence of numerous lifting hazards at the Downingtown plant, based on the memoranda and testimony of its corporate ergonomist, Ms. Jane Teed-Sparling, its own medical records of lifting injuries to employees, and memoranda from its workers' compensation carrier, Liberty Mutual Insurance Company. We reject the arguments that we should not consider that evidence in deciding the question.
The other issues on review regarding lifting are whether the violations were willful, and what penalties are appropriate. We affirm the judge's finding that the violations were willful. Pepperidge was initially warned of injuries from lifting hazards four years before the inspection, and given recommendations on abatement actions to be taken. Despite continued warnings, including identification of alternative solutions, Pepperidge's employees continued to lift weights deemed excessive until after the inspection.
As to penalties for the lifting violations, the Chairman and Commissioner Guttman have divergent views, but agree to assess a total penalty of $20,000 in this case. For the reasons discussed in their separate opinions at the end of this decision, Chairman Weisberg would uphold the judge's finding of 21 willful violations based on the 21 employees exposed to the recognized hazards, while Commissioner Guttman would find four willful violations based on the number of different lifting tasks which were cited.
With regard to the alleged repetitive motion injuries, we find that the evidence shows that a substantial number of the alleged injuries, particularly carpal tunnel syndrome, did occur among the workers at Downingtown. This conclusion is supported by the medical records, the testimony of Pepperidge's own medical team regarding the medical records, and the views of outside medical professionals. As to the repetitive motion hazards, we have reviewed the testimony and scientific studies in evidence regarding whether the kinds of repetitive jobs at issue here substantially contribute to the development of carpal tunnel syndrome and other upper extremity musculo-skeletal disorders ("UEMSDs"). We find that such jobs can be a substantial contributing factor in these injuries. This view is supported by the clinical and epidemiological evidence discussed below, and by UEMSD incidence rate comparisons between Pepperidge's biscuit line workers and other populations. It is also supported by Pepperidge's own medical records, which contain reports of clinicians who examined and treated employees and reported a causal connection between the jobs and the development of their UEMSDs.
We find multiple bases for concluding that Pepperidge recognized the hazards at issue. These include memoranda by Pepperidge's corporate ergonomist and the medical records of injured employees, as well as testimony by both Pepperidge's medical director and its chief nurse at the plant. We also find that the hazards were causing serious physical harm up to and including disabling conditions requiring surgical correction and even termination of employment.
Finally, we find that abatement of the hazard here can be required under section 5(a)(1) but that the Secretary has failed to meet her burden of showing that further abatement action was required in light of what had already been undertaken. We conclude that the appropriate response to the hazard at Downingtown was a process that included actions selected from a menu of alternatives. The question of the appropriateness of the abatement here turns on the extent to which Pepperidge implemented the recommendations provided by its corporate ergonomist and the extent to which specific further actions urged by the Secretary were required to be undertaken. We conclude that the Secretary has not shown that the additional steps proposed by the Secretary and not taken by Pepperidge were feasible and that their efficacy in reducing the hazard was so compelling that the failure to have implemented them by the time of the inspection rendered Pepperidge's process inadequate.
I. RECORDKEEPING
Introduction
An employer covered by the Act must record and report occupational injuries and illnesses "for enforcement of the [A]ct, for developing information regarding the causes and prevention of occupational accidents and illnesses, and for maintaining a program of collection, compilation, and analysis of occupational safety and health statistics." 29 C.F.R. § 1904.1. These recordkeeping requirements "are a cornerstone of the Act and play a crucial role in providing the information necessary to make workplaces safer and healthier." General Motors Corp., Inland Div., 8 BNA OSHC 2036, 2041, 1980 CCH OSHD ¶ 24,743, p. 30,470 (No. 76-5033, 1980).
The cited regulation, 29 C.F.R. § 1904.2(a),[7] requires employers to "enter each recordable injury and illness" on the OSHA No. 200 form ("OSHA 200") or an equivalent. A recordable occupational injury is defined in section 1904.12(c) as any occupational injury or illness which results in a fatality, lost workdays, transfer to another job, termination of employment, medical treatment (other than first aid), loss of consciousness, restriction of work, or restriction of motion. At the hearing, the Secretary alleged that Pepperidge had committed 179 separate "egregious" willful violations of section 1904.2(a) by either improperly recording or failing to record occupational injuries and illnesses on its equivalent of the OSHA 200 between January 1986 and September 14, 1988, when OSHA began its detailed inspection of the records. The Secretary proposed a penalty of $2000 for each instance. The judge affirmed 176 of those items as willful violations, vacated three of them, and assessed a total penalty of $289,603. At issue on review is whether the judge erred in finding that the violations were willful and whether the total penalty assessed by the judge was appropriate. Pepperidge does not dispute the existence of the violations on review.
Background
Between January 1986 and September 14, 1988, Pepperidge's Downingtown plant entered a total of 435 injuries on its OSHA 200 form.[8] The judge found that during this time Pepperidge failed to properly record 74 injuries or illnesses and totally failed to record 102 injuries or illnesses. The 102 unrecorded injuries and illnesses cited by OSHA represent approximately 19 percent of the actual total of 537 injuries and illnesses that occurred during this time and the 74 improperly recorded injuries and illnesses represent approximately 14 percent. Included in these 176 recording errors are 87 cases where Pepperidge failed to correctly identify lost workdays, including restricted workdays, or approximately 32 percent of the actual total of 275.[9]
Janice Taplar, a personnel assistant, was responsible for OSHA recordkeeping at the Downingtown plant during this time. Taplar's training consisted of a "very basic review of an OSHA [200] log and the instructions on the back of it." She was not given any other written materials and there is no indication that she had any other OSHA recordkeeping experience. The judge found, and Pepperidge does not dispute, that Taplar had some basic misconceptions about her OSHA recordkeeping duties that would have been corrected by a careful reading of the OSHA 200 form and accompanying instructions. For example, she was not aware of the duty to update the log if lost workdays or restricted work activity occurred or continued after an initial entry was made or that all recordable injuries and illnesses had to be recorded within six days of learning of their occurrence.[10] Taplar testified that prior to the inspection, she had not used the illness side of the log at all. Taplar also incorrectly believed that a case was not recordable unless it was compensable for workers' compensation purposes. She also was not aware before the inspection that she was required to record repetitive motion injuries as occupational illnesses.
Taplar's other duties may have made it difficult for her to maintain accurate records. She was responsible for a large number of personnel, safety, and other related matters.[11] As a result, she was three months behind in filling out the OSHA 200 form when OSHA inspected in June 1988. Taplar did manage to keep up to date other safety recordkeeping on which the Downingtown plant placed a higher priority. She timely filed a monthly report for use in a safety competition among Pepperidge plants based on lost workdays and she also submitted lost workday information for a National Safety Council competition every month.
R. Scott Maxwell, the plant's Manager of Human Resources and chief safety officer, was Taplar's supervisor. Maxwell trained Taplar in OSHA recordkeeping and had previously been responsible for it himself.[12] Maxwell had no copies of OSHA regulations or other government documents regarding OSHA recordkeeping in his department, except for an unidentified U.S. Department of Labor Bureau of Labor Statistics ("BLS") guideline that he was unaware of until he prepared for his deposition in this case. Pepperidge's own detailed manual entitled "Occupational Injury and Illness Recordkeeping and Reporting," dated 1977, was kept at Pepperidge's corporate headquarters and was never distributed to Pepperidge's plants. Maxwell testified that prior to December 6, 1988, no employee at Pepperidge's Downingtown plant had attended any courses, seminars, lectures, classes, or meetings that focused on OSHA recordkeeping. Taplar never supplied Maxwell with a copy of the OSHA 200 logs or the summary of the logs. Prior to December of 1988 there was no procedure to monitor the accuracy of the OSHA 200 forms once they were completed.
In contrast, Pepperidge's higher management had expressed interest in OSHA recordkeeping during the period in question. On October 22, 1987, Pepperidge's Corporate Manager of Human Resources, Steve Larson, directed a memorandum to Pepperidge's "Principal Human Resources Representatives," asking them to "review the requirements" for OSHA recordkeeping "with those responsible for completing the Log and Summary, OSHA No. 200 and the Supplementary Record, OSHA No. 101." (Government Exhibit ("GX") 11). Attached to Larson's memorandum was the Bureau of Labor Statistics guide titled A Brief Guide to Recordkeeping Requirements for Occupational Injuries and Illnesses (OMB No. 1220-0029, June 1986) (Effective April 1986)[13] ("BLS brief guide"). (GX 10). Larson distributed these materials at the direction of Dennis Dougherty, Pepperidge Farm's Vice President of Human Resources at its Norwalk, Connecticut headquarters.
On November 4, 1987, Fred Wahl, Jr., the Corporate Director of Safety for Pepperidge Farm's corporate parent, Campbell Soup Company, directed a memorandum to the "Plant Managers" of Pepperidge Farm and other Campbell Soup affiliates, consisting of an "**IMPORTANT ** MESSAGE ON OSHA RECORDKEEPING." (GX 7) (emphasis in original). After noting OSHA's "major emphasis on industry's strict adherence to their recordkeeping requirements," the memorandum stated that "[o]ver the last few months they have levied fines of hundreds of thousands and even millions of dollars for improper recording of occupational injuries and illnesses." The memorandum further stated that "[i]t is imperative that all OSHA recordkeeping requirements be accurate within Campbell Soup Company." (Emphasis in original). It instructed that the BLS Brief Guide, which was attached to the memorandum, "should be followed very closely!" Wahl also instructed plant managers that "[a]fter reviewing your records and insuring that they are in accordance with OSHA requirements, I recommend that you cross check the OSHA logs with your workers' compensation files to [e]nsure that they match (go back 5 years)." He stated that "[t]his is a critical concern and should be undertaken without delay!" (Emphasis in original).
On December 4, 1987, Wahl issued a follow-up memorandum to all Human Resource Managers, including Maxwell, with copies to Dougherty and Larson. (GX 9). In it, he reminded the managers of his initial recommendation to review and correct all records, then requested that copies of each plant's OSHA 200 logs for the past five years be sent to him. According to Maxwell, who recalls the request, but not the memorandum, copies of the Downingtown plant's OSHA 200 logs were indeed supplied to Wahl; Wahl, however, testified that he did not review these records nor did he assign anyone in his office to do so.
Between 1976, when Maxwell was first trained at Pepperidge in OSHA recordkeeping, until after the citations were issued in December 1988, Maxwell never received any instructions from his superior to cross check the worker's compensation logs and the OSHA 200 logs. Prior to December 1988, there were no procedures in the Downingtown plant to monitor the accuracy of the OSHA 200 forms once they were completed. Maxwell could not recall receiving either the memoranda from Larson, the November 4 memoranda from Wahl, or a copy of the OSHA recordkeeping guide, and Taplar testified that she had not seen these documents. Maxwell had no discussions with Larson regarding OSHA recordkeeping between the time of Larson's October 1987 memorandum and the start of the OSHA inspection. Neither Maxwell or Taplar knew the whereabouts of any BLS materials until well after the citations were issued.
Maxwell had submitted the OSHA 200 logs for the last five years from Downingtown to Campbell Soup's headquarters. Although the December 4 memorandum notes that "[i]t has been one month since I sent a notice to all locations outlining the need to review and correct, if needed, your OSHA records," the Downingtown plant did not perform any audit of OSHA recordkeeping practices or of its OSHA 200 logs, nor was any additional recordkeeping training provided to Pepperidge Farm employees, until after the beginning of the overall OSHA inspection in June 1988. Dennis Dougherty, Pepperidge Farm's Vice-President for Human Resources and chief executive officer in the safety area, simply interpreted the December 4 memorandum as a "straightforward informational request . . . to the human resources managers, and I didn't believe it required any action on my part." He also testified that no action was taken by him or by anyone on his staff in response to the November 4 memorandum. Dougherty stated that no response was necessary because Larson had distributed copies of the BLS brief guide to all Pepperidge Farm human resources representatives on October 22, 1987.
Willfulness
A violation is willful if it is committed with intentional, knowing, or voluntary disregard for the requirements of the Act or with plain indifference to employee safety. E.g., Valdak Corp., 17 BNA OSHC 1135, 1136, 1993-95 CCH OSHD ¶ 30,759, p. 42,740 (No. 93-239, 1995), aff'd, 73 F.3d 1466 (8th Cir. 1996). The Third Circuit, the jurisdiction in which this case arises, has held that a willful violation is characterized by an "obstinate refusal to comply" with safety and health requirements that "differs little from" the Commission and majority-circuit test. Universal Auto Radiator Mfg. v. Marshall, 631 F.2d 20, 23 (3d Cir. 1980) (quoting Babcock & Wilcox v. OSHRC, 622 F.2d 1160, 1167-68 (3d Cir. 1980)). "It is differentiated from other types of violations by a 'heightened awareness -- of the illegality of the conduct or conditions -- and by a state of mind -- conscious disregard or plain indifference.'" Calang Corp., 14 BNA OSHC 1789, 1791, 1987-90 CCH OSHD ¶ 29,080, p. 38,870 (No. 85-319, 1990) (quoting Williams Enterp., 13 BNA OSHC 1249, 1256-57, 1986-87 CCH OSHD ¶ 27,893, p. 36,589 (No. 85-355, 1987)).
We conclude that Pepperidge's failures to record here are properly characterized as willful. The evidence establishes that Pepperidge was plainly indifferent to its recordkeeping responsibilities. The record clearly demonstrates that various officials in the management of both Pepperidge's Downingtown facility and Pepperidge's corporate headquarters as well as Pepperidge's parent, Campbell Soup, had a heightened awareness of the requirements of section 1904.2(a). Company officials were aware that OSHA put a major emphasis on industry's strict adherence to OSHA recordkeeping requirements. Nevertheless, Taplar, the employee who actually made the recordkeeping entries, as well as her supervisor, Maxwell, lacked basic training in what injuries and other details to enter on the OSHA 200 form.[14] Tapler and Maxwell did not have access to or were not aware of basic recordkeeping information, particularly the BLS brief guide. Even so, most of the 176 misrecorded or unrecorded conditions reflect a failure to follow the specific instructions found on the back of the OSHA 200 form to enter injuries and illnesses that involve lost workdays, restricted work, or "repeated motion." Pepperidge's recordkeeping failures involving repetitive motion illnesses are particularly troubling here. As the judge found, at least 50 of the violations involve repetitive motion illnesses. As we will discuss in greater detail below, repetitive motion or carpal tunnel disorders, many requiring surgery, affected Pepperidge's Downingtown employees at an extraordinarily high rate. Better recordkeeping might have led to more efficient identification and correction of hazards that may have caused those repetitive motion injuries. See General Dynamics Corp., Electric Boat Div., 15 BNA OSHC 2122, 2128 n.13, 1991-93 CCH OSHD ¶ 29,952, p. 40,955 n.13 (No. 87-1195, 1993).
Even after Wahl's urgent warning in November 1987 that the records must be accurate or huge fines might be assessed by OSHA, no one at Pepperidge checked the accuracy or timeliness of Downingtown's OSHA 200s. No changes were made to Downingtown's recordkeeping methods. Pepperidge was three months behind in entering cases when OSHA inspected in June 1988. At the same time, Pepperidge was keeping current on other safety recordkeeping matters for competitions. An indifferent attitude toward OSHA recordkeeping is well established on this record.[15]
The circumstances are in contrast to Caterpillar, Inc., 15 BNA OSHC 2153, 1991-93 CCH OSHD ¶ 29,962 (No. 87-922, 1993), and a number of other cases in which the Commission found that the Secretary failed to establish willfulness.[16] In Caterpillar, the Commission found that the recordkeeping violations resulted from the failure of company officials to provide proper directions to Dr. Neu, the person responsible for Caterpillar's recordkeeping, but held that those officials' omissions and misdirections did not demonstrate intentional disregard or plain indifference. Dr. Neu was, at least initially, supplied with some of the material published by the BLS to assist in filling out the OSHA 200. Over time, through the neglect of company officials, Dr. Neu had modified Caterpillar's criteria in determining what was recordable on the OSHA 200 log along the lines of Caterpillar's internal reporting system in an effort to achieve the goal of company-wide consistency in recording. Dr. Neu made an effort to maintain records of employee injuries and illnesses, although his adherence to Caterpillar's guidelines instead of OSHA's recordkeeping requirements led to Caterpillar's recordkeeping violations Id. at 2157-58, 2176, 1991-93 CCH OSHD at pp. 40,990-91, 41,010. By contrast, Taplar's recording errors were not the result of misguided attempt to conform recordkeeping to the wrong model. They were due to a lack of commitment to OSHA recordkeeping and a lack of understanding of what should be recorded. Company officials made no attempt to remedy this despite their heightened awareness of OSHA recordkeeping requirements.
The Commission's decision in Kohler Co., 16 BNA OSHC 1769, 1993-95 CCH OSHD ¶ 30,457 (No. 88-237, 1994), is also distinguishable. In Kohler, the Commission found that recordkeeping violations were not willful but were caused by the employer's "simple inadvertence." The nurses responsible for recordkeeping had received a two-hour training session on a recordkeeping system that the Commission described as being "excellent" in part. Here, Taplar's training clearly was inadequate. Also, the 277 recordkeeping errors in Kohler represented approximately 11 percent of the total of 2,475 injuries and illnesses. By contrast, the 176 recordkeeping errors at issue here represent approximately 33 percent of the total of 537 injuries and illnesses. Finally, unlike this case, Kohler's management was not shown to have had a heightened awareness of the requirements of section 1904.2(a).
Our finding of willfulness here would not be justified if Pepperidge made a good faith effort to comply with the recordkeeping requirements, even if its efforts did not result in full compliance with its recordkeeping responsibilities. The test of good faith in this regard is an objective one--whether the employer's efforts to comply were reasonable under the circumstances. Tampa Shipyards, Inc., 15 BNA OSHC 1533, 1541, 1991-93 CCH OSHD ¶ 29,617, p. 40,104 (No. 86-360, 1992) (consolidated). The record shows that Pepperidge had not previously received recordkeeping citations as a result of earlier OSHA inspections. This evidence, however, does not overcome the profound recordkeeping shortcomings here. See Seibel Modern Mfg. & Welding Corp.,15 BNA OSHC 1218, 1223-24, 1991-93 CCH OSHD ¶ 29,442, pp. 39,679-81 (No. 88-821, 1991) (employer cannot infer from uneventful prior inspections that there was no hazard). Nor does Commission case law require a prior citation as a prerequisite to a finding of willfulness. Woolston Construction Co., 15 BNA OSHC 1114, 1119, 1991-93 CCH OSHD ¶ 29,394, p. 39,570 (No. 88-1877, 1991), aff'd without published opinion, No. 91-1413 (D.C. Cir., May 22, 1992) (1992 WL 117669). The company memoranda from Larson and Wahl is some evidence of good faith, showing that the company was aware of its recordkeeping responsibilities. However, the response to the memoranda by Pepperidge's Downingtown plant is even more probative of its commitment to good recordkeeping. Cf., Morrison-Knudsen Co./Yonkers Contrac. Co., A Joint Venture, 16 BNA OSHC 1105, 1127, 1993-95 CCH OSHD ¶ 30,048, p. 41,285 (No. 88-572, 1993) (willful violation found in part where employer apparently ignored its own safety program; safety program is evidence employer was aware of the cited standard and its requirements). As we have found, there was no response to Wahl's repeated requests that OSHA records be reviewed and corrected.[17] Pepperidge contends that the absence of an intent to deceive shows good faith. However, here the misrecording is the result of plain indifference. See Ensign- Bickford Company v. OSHRC, 717 F.2d 1419, 1422-23 (D.C. Cir. 1983), cert. denied, 466 U.S. 937 (1984).
Because Pepperidge did not have reason to believe that its OSHA recordkeeping system actually was adequate after it received Wahl's warnings, its failure to respond to those warnings bespeaks indifference to, and even conscious disregard of, OSHA's recordkeeping requirements. That failure also negates Pepperidge's claim that it made good faith efforts.
Penalty
Under section 17(j) of the Act, an appropriate penalty is determined by considering the size of the employer, the gravity of the violation, the good faith demonstrated by the employer, and the employer's history of previous violations. 29 U.S.C. § 666(j). Commission precedent provides that the Secretary has discretion to cite each failure to record as a separate violation. E.g., Caterpillar, 15 BNA OSHC at 2173, 1991-93 CCH OSHD at p. 41,007. The Act gives the Commission, rather than the Secretary, the discretion to assess the penalties it finds appropriate. E.g., Hern Iron Works, Inc., 16 BNA OSHC 1619, 1621-23, 1993-95 CCH OSHD ¶ 30,363, pp. 41,881-83 (No. 88-1962, 1994). "[A]lthough the Secretary may cite separate omissions to record injuries as separate violations, he may not exact a total penalty that is inappropriate in light of the four factors listed in section 17(j) of the Act." Caterpillar, 15 BNA OSHC at 2173, 1991-93 CCH OSHD at p. 41,007.
As mentioned above, Judge Oringer assessed separate penalties for the 176 violations for a total penalty of $289,603. He based his penalty assessments on the testimony of H. Berrien Zettler, OSHA's Deputy Director of Compliance Programs,[18] the willful nature of the violations, and the "factors outlined in § 17(j) of the Act." The judge found that the recordkeeping errors could be loosely divided into three groups for penalty purposes. The first group is comprised of complete failures to record occupational injuries or illnesses, despite documentation of their recordability. He determined that a penalty range of $1800 to $2000 was appropriate for this group.[19] The $1400 to $1600 penalty range cases involved injuries or illnesses that were recorded on the log, but were erroneously classified as not resulting in lost workdays. The $1000 to $1200 group involved injuries or illnesses in which the actual number of lost workdays or restricted work activity days was under reported. In each of these groups the judge assessed the actual penalty for a violation based on the nature of the recordkeeping error involved, adjusting the penalty based on how extensive the consequences of the errors were. He found that twelve violations did not fit neatly into any of the three groups above because although they were recorded as injuries with lost workdays, the number of lost workdays and restricted workdays recorded was incorrect. He assessed penalties for them ranging from $1300 to $1700. He also found that three other items were so minor that a penalty of $1 was appropriate.
We find that the penalties assessed by the judge were appropriate under the penalty factors set forth in section 17(j) of the Act and under the principles set forth in Caterpillar. Pepperidge is a very large employer with approximately 1500 employees at this location alone. It had a minimal history of violations company wide and no prior history of recordkeeping violations at the Downingtown plant. Gravity, generally the principal factor to be considered in penalty assessment, is low because recordkeeping violations bear only tangentially on the normal determinants of gravity: the number of employees exposed, the duration and degree of exposure, and the relative likelihood of an accident. E.g., Caterpillar, Id. at 2178, 1991-93 CCH OSHD at p. 41,012. We see little basis for giving Pepperidge credit for good faith. The great bulk of its failures to record were clear violations of either the OSHA regulations or the instructions on the back of the OSHA 200. Pepperidge's failure to provide proper recordkeeping training, its failure to provide reference materials on recordkeeping to the employees who kept records and its failure to respond to Wahl's request to review and correct its records, further support our finding of Pepperidge's lack of good faith. Moreover, Pepperidge's failures occurred despite its ability to maintain other records accurately as well as its management's acknowledgment of its recordkeeping responsibilities shown by Larson's and Wahl's letters.
We find that the range of penalties in the judge's assessments was an appropriate response to the obviousness of the recordability of injuries or illnesses. We note that the judge's total penalty assessment was approximately ten times what the Commission had assessed for somewhat similar violations in Caterpillar, where the Commission found the violations to be non-serious rather than willful. The Act provides that a willful violation is subject to a penalty up to ten times as high as for a serious or non-serious violation. Thus, Judge Oringer's assessment is roughly proportional to the assessment in Caterpillar, considering that he found these violations willful. We concur in the judge's assessment of the highest penalties for Pepperidge's failure to record injuries and illnesses that were clearly recordable under the language of the recordkeeping regulations because they resulted in lost workdays or restriction of work. Pepperidge argues that penalties assessed by the judge are inappropriate "because Judge Oringer did not evaluate under the statutory criteria either the total $289,603 penalty or the . . . penalties for individual items" (emphasis in original). However, the judge stated that he considered the section 17(j) criteria. In addition, the judge discussed in detail the relevant facts regarding each item. Accordingly, we find that the total penalty assessed by the judge is appropriate in light of the four factors listed in section 17(j) of the Act.
Pepperidge makes a number of arguments attacking the propriety of the Secretary's instance-by-instance policy. It claims that the policy is invalid because the Secretary did not follow the notice and comment procedures of the Administrative Procedure Act ("APA"), 5 U.S.C. § 551 et seq., in adopting it, and that even if rulemaking were unnecessary, the policy is still unenforceable because the Secretary did not give advance notification of it in the Federal Register. Pepperidge also points out that section 17(a) of the Act does not include language comparable to that of the Federal Coal Mine Health and Safety Act of 1969, which provides that: "Each occurrence of a violation of a mandatory health or safety standard may constitute a separate offense." 30 U.S.C. § 820(a). Pepperidge also argues that the Secretary's policy contravenes the Act "by effectively adding a new category of violation to the four authorized by section 17." Finally, Pepperidge contends that the express language of 17(j) directing the Commission to consider the "size of the business of the employer" and the "gravity of the violation" when assessing penalties would be extraneous if the number of violations found under section 17(a) would equal the number of employees exposed.
The Commission has considered and rejected most of these arguments in Caterpillar. It held that the lack of APA rulemaking did not invalidate the instance-by-instance policy because the Act does not limit the Secretary's discretion to cite separate violations of standards instance-by-instance, and the Secretary need not engage in rulemaking to exercise that discretion. Id. at 2171-73, 1991-93 CCH OSHD at pp. 41,004-07. The Commission held that the Secretary was not required to publish the policy in the Federal Register because it is contained in his Field Operations Manual ("FOM"), now the Field Inspection Reference Manual ("FIRM") (OSHA Instruction CPL 2.103 (September 26, 1994)) and in other instructions to OSHA staff such as OSHA Instruction CPL 2.80, Handling of Cases To Be Proposed for Violation-By-Violation Penalties (October 1, 1990). There is no requirement that the Secretary publish in the Federal Register the FOM or other instructions to her staff. DeKalb Forge Co., 13 BNA OSHC 1146, 1986-87 CCH OSHD ¶ 27,842 (No. 83-299, 1987).
The Commission also addressed Pepperidge's statutory concerns in Caterpillar, holding that the absence of "separate offense" language in section 17(a) of the Act does not prohibit separate penalties and that the Secretary may cite separate, erroneous entries on an OSHA 200 form as separate violations. 15 BNA OSHC at 2172-73, 1991-93 CCH OSHD at pp. 41,005-07. Finally, the Commission held in Caterpillar that the section 17(j) penalty "factors can be applied to citations that involve numerous failures to comply with a standard or to just one failure to comply." 15 BNA OSHC at 2173, 1991-93 CCH OSHD at p. 41,007.[20]
We therefore find that Judge Oringer provided a sufficient basis for the penalties he assessed, that his overall penalty is appropriate and his methodology is reasonable.
II. THE LIFTING TASKS
In items 3(a) through 3(d) and 3(f) of willful citation 1,[21] the Secretary alleged that Pepperidge Farm committed 21 separate violations of section 5(a)(1) of the Act by requiring 21 employees to perform excessive lifts. Judge Oringer affirmed each item and assessed the Secretary's proposed penalty of $5,000 for each item for a total penalty of $105,000. Four types of lifts were involved. Items 3(a) and 3(b) involved lifting rolls of foil, label, and cardboard stock, weighing 165, 120, and 70 pounds respectively.[22] The stock is used to make bags for Pepperidge's products. Employees lifted the rolls from pallets or skids onto a dolly and then rolled it to a bag forming machine.[23] The six employees performing this task lifted the stock up to six times a shift during each of three shifts.[24] Item 3(c) involved employees lifting 100-pound sugar bags "a few times an hour" from a pallet where they were stacked eight high to the edge of a hopper or pulverizer, cutting the bag open, and dumping in its contents. The Secretary cited Pepperidge for exposing three employees to this hazard. Item 3(d) involved the six employees who lifted 68-pound blocks of butter to a height of either 36 or 52 inches and placed them into a mixer. Item 3(f) involved employees lifting metal tins filled with cookies from heights between 13 to 74 inches. The tins weighed between 27 to 38 pounds[25] when filled and 16 pounds when empty. Six employees routinely handled these tins twice in a three minute period, once when full and once when empty.
To establish a violation of section 5(a)(1) of the Act, the Secretary must prove that: (1) a condition or activity in the employer's workplace presented a hazard to employees, (2) the cited employer or the employer's industry recognized the hazard, (3) the hazard was causing or likely to cause death or serious physical harm,[26] and (4) feasible means existed to eliminate or materially reduce the hazard. General Dynamics Land Systems Div., Inc., 15 BNA OSHC 1275, 1280, 1991-93 CCH OSHD ¶ 29,467, p. 39,752 (No. 83-1293, 1991), aff'd without published opinion, 985 F.2d 560 (6th Cir. 1993). The judge found that documents from Pepperidge's corporate ergonomist and its insurance carrier, testimony from the OSHA compliance officer, Pepperidge employees, and the corporate ergonomist, as well as the injuries sustained by employees while performing these lifting tasks demonstrated that the tasks exposed employees to hazards causing serious physical harm and that Pepperidge recognized them. The judge found that feasible methods of abating these hazards were established by memoranda from the corporate ergonomist and insurance carrier, and by the various methods that Pepperidge ultimately employed to abate these lifting hazards. Neither party sought our review of the judge's finding that a hazard existed.[27] At issue here are whether the lifting hazards were recognized, whether the violations, if any, were willful, and whether the penalties assessed by the judge were appropriate. For the reasons that follow, we affirm the violations as willful.
Recognition of the Hazard
Under section 5(a)(1) of the Act, "[a] hazard is deemed 'recognized' when the potential danger of a condition or activity is either actually known to the particular employer or generally known in the industry." St. Joe Minerals v. OSHRC, 647 F.2d 840, 845 (8th Cir. 1981) (citing Usery v. Marquette Cement Mfg. Co., 568 F.2d 902, 910 (2d Cir. 1977)).
Pepperidge was informed by both its workers' compensation insurance carrier, Liberty Mutual, and Jane Teed-Sparling, the corporate ergonomist from Pepperidge's corporate parent Campbell Soup, that Pepperidge employees were exposed to lifting hazards when performing the cited tasks. The record shows that beginning in August 1984, approximately four years before OSHA's inspection at the Downingtown plant, Pepperidge's corporate headquarters was told that its employees were exposed to back and shoulder injuries from lifting the cookie tins and sugar bags. (GX 287). Memoranda to the same effect for the sugar bag lifts followed in 1985 and 1986. (GX 193, 282). In her 1986 ergonomic studies of the Pepperidge plants in Richmond, Utah and one under construction in Lakeland, Florida, Teed-Sparling found that lifting 68-pound blocks of butter was hazardous and so informed the Downingtown plant physician. (GX 174, 175, 177). Teed-Sparling had later evaluated at the Downingtown plant in 1987 the roll stock, sugar bag, and cookie tin lifts and reported her findings that these were hazardous tasks to the plant's management. She made further recommendations on the tasks in 1988. (GX 179). We discuss separately whether Pepperidge recognized that each lifting task was hazardous.
Sugar
The evidence overwhelmingly establishes that Pepperidge recognized that requiring employees to lift 100-pound bags of sugar exposed them to a hazard. Both corporate ergonomist Teed-Sparling and Liberty Mutual had informed Pepperidge about the problems with lifting the sugar. As early as August 1984, Pepperidge's Norwalk, Connecticut headquarters was advised to use 50-pound bags instead of 100-pound bags at its plants to reduce employee exposures to lifting injuries. (GX 287). Similar memoranda were sent to Downingtown in January 1985, June 1986, April 1987, and May 1988. (GX 40, 192, 193, 282). In Teed-Sparling's April 8, 1987 report to Downingtown Biscuit Operations Manager George Litvak about the Downingtown plant, she described the task of lifting 100-pound bags of sugar as "extremely excessive"[28] based on Liberty Mutual's material handling task evaluation software program.[29] (GX 39). Teed-Sparling described her lifting advice as a "'pallet of recommendations'; maybe one cheap one, one medium cost, one really expensive one."[30] The recommendations included: "[i]nstal[lation of] a scissors lift under the product pallet to eliminate low lifts initiated under 31 inches so that bags are transferred in one motion," installation of a "Coleman Vac Up manipulator" to lift and handle the bags, and expanding "the bulk metering system to include additional high volume ingredients such as sugar." Teed-Sparling had investigated the use of lighter 50-pound bags instead of 100-pound bags but did not include this option because of the cost. Litvak testified that he had made the decision that switching from 100 to 50-pound bags at $173,700 per year was too costly "bearing in mind that there were other less-costly solutions." A May 7, 1987 Pepperidge memorandum from Litvak to Dale Stokes, plant manager at the Downingtown plant, regarding in part the "exposure to back injury due to lifting 100 lb. bags of sugar" noted that "[t]hree possible solutions" included converting to 50-pound bags, the Coleman Vac-Up Manipulator, and the expansion of the bulk metering system, but indicated that there were no plans at that time to attempt to fund any of these projects. (GX 41).
Notwithstanding all the recommendations, employees were required to lift the 100-pound bags until two scissor lifts were purchased and installed some time after May 1989. Following the OSHA inspection, Pepperidge did eventually switch to 50-pound bags of sugar by the fall of 1990, six years after the recommendation was first made.[31] In addition, shortly after Teed-Sparling issued her April 8, 1987 report, Pepperidge installed two pallet stands that placed the sugar bags twelve inches higher (Teed-Sparling had not recommended installing pallet stands). Also, by May 1988, Pepperidge transferred one of its scissor lifts to the scaling operation in response to Teed-Sparling's recommendation that scissor lifts be installed. However, these actions did not alter the fact that employees were still lifting 100-pound sugar bags at the time of the OSHA inspection in the fall of 1988.
Cookie Tins
The evidence establishes that Pepperidge recognized the hazards involved in lifting the cookie tins. It received information about the hazards of lifting tins from Liberty Mutual, Teed-Sparling, and through injuries suffered by employees. As early as 1984, Pepperidge was informed that its employees were incurring back and shoulder injuries from lifting cookie tins. (GX 287, 288). In her April 8, 1987 memorandum, Teed-Sparling noted that "ergonomic redesign is required to eliminate the excessive aspects of" tin handling, and made recommendations as to how this could be accomplished, including the use of plastic tins. (GX 39). Three Pepperidge employees received back injuries lifting tins. (GX 67). John Starcheski, who was injured on October 26, 1987, and Linda Hardy, who was injured on February 11, 1988, both experienced "low back pain" while lifting tins. Starcheski was on light duty for a short period. Sandra May was lifting tins in the assortment line on October 30, 1987, when she "felt a sharp pain in the middle of her back." Her injury was described as "upper back pain." The task of lifting cookie tins had not changed by the time of the OSHA inspection.[32]
Butter
Although the record does not contain a report evaluating the lifting of 68-pound blocks of butter at Downingtown, studies of the same task were conducted for other Pepperidge plants. Teed-Sparling had conducted an ergonomic analysis at Pepperidge's Richmond, Utah plant because of an increase in employee "complaints of cumulative trauma disorders of the upper extremities (repetitive motion injuries)." (GX 174). Also, Teed-Sparling had prepared a report including ergonomic recommendations for the plant to be constructed in Lakeland, Florida. Her ergonomic recommendations were "based on prevention of back and upper extremity injuries in high risk jobs identified from existing Pepperidge Farm bakery and biscuit plant data." (GX 175). In the November 4, 1986 memorandum from Teed-Sparling to S. Dufner, the manager of human resources at the Richmond plant, Teed-Sparling listed the lifting of 68-pound blocks of butter as being "excessive" and its lifting a "[h]armful aspect[] of the job."[33] (GX 174). She recommended the purchase of an ingredient dumper "to mechanically dump excess weight ingredients." Teed-Sparling included this memorandum in a November 24, 1986 memorandum to Dr. Robert Snyder, the Downingtown plant physician, in which she stated that the Richmond memorandum "represent[ed] the areas of concern which should be addressed at Downingtown." (GX 177). In the December 1986 memorandum regarding the Lakeland plant, Teed-Sparling recommended the use of mechanical devices to handle the heaviest items, including "68 lb. blocks of butter," to the Manager of Project Engineering at the Pepperidge Farm Corporate Headquarters.[34] At the time of the inspection, employees were still lifting 68 pound blocks of butter, and no actions had been taken to alter this task.
Roll Stock
The record indicates that Pepperidge became aware of the lifting hazards in the roll stock area through suggestions by Liberty Mutual as well as by Teed-Sparling's efforts. Pepperidge was first informed of the hazard by the report Teed-Sparling issued to Litvak on April 8, 1987, in which she described roll stock lifting as "extremely excessive." (GX 39). She recommended that Pepperidge use a mechanical device to move the stock. When Teed-Sparling returned to Downingtown on February 4, 1988, she found that employees were using "comp vests," also known as back braces, when performing lifting tasks, an action she described in a February 10, 1988 memorandum as a "band aid approach."[35] (GX 27). According to Teed-Sparling, to maximize any benefits possible from fits of the back braces, employees should be given "biomechanical training from the medical department on proper lifting techniques" and told that "the [c]omp [v]est is not a machismo placebo that makes them strong weight lifters." In a February 29, 1988 memorandum to L.B. Suchowolec, Vice-President of Human Development and Training at Campbell's Soup, she stated that "no action" had been taken on the lifting problems she reported on at Downingtown with the exception of having employees wear back braces.[36] (GX 179).
Pepperidge became further aware of this lifting hazard from the back injury sustained by its employee Walter Ed Davis, who was injured in October 1987 when he "was lifting a roll of label paper onto a cart when he lost control of the roll and twisted his back." (GX 67). The injury, which was eventually diagnosed as a ruptured disk, resulted in Davis being out of work for nearly a year. A second employee, Harold Trego, was injured in June 1988 as he lowered a 120 pound roll to the floor. The injury was described as a "low back strain" both by Pepperidge and in an orthopedist's letter. (GX 67).
Pepperidge also received notice of the roll stock lifting hazard through reports from the Hazard Hounds, a "quality safety circle," established by Pepperidge to encourage employee involvement in solving safety problems.[37] According to the November 11, 1988 minutes of this group, management had accepted their proposals to purchase web and skid or pallet dollies for use in lifting the roll stock.[38] (RX 52, tab 26). The dollies were not delivered until after the inspection, in December 1988 and January 1989. The memoranda submitted by Teed-Sparling and Liberty Mutual, the employee injuries, and the activities of the employee safety group are more than enough to establish that Pepperidge recognized the hazards of lifting roll stock.
Discussion
Pepperidge argues that the bulk of the evidence relied on by the judge cannot be used against a respondent to find recognition. It is true that the Commission and the courts have been reluctant to rely solely on voluntary safety efforts by an employer to find that the employer recognized a hazardous condition. See, e.g., General Motors Corp., GM Parts Div., 11 BNA OSHC 2062, 2065-66, 1984-85 CCH OSHD ¶ 26,961, p. 34,611-12 (No. 78-1443, 1984), aff'd , 764 F.2d 32 (1st Cir. 1985); Cotter & Co. v. OSHRC, 598 F.2d 911, 914-15 (5th Cir. 1979); Diebold, Inc. v. Marshall, 585 F.2d 1327, 1337-38 (6th Cir. 1978). The rationale is that such reliance would "dissuade employers from taking voluntary protective measures beyond those the law requires." Waldon Healthcare Center, 16 BNA OSHC 1052, 1061, 1993-95 CCH OSHD ¶ 30,021, p. 41,154 (No. 89-2804, 1993) (consolidated), (citing Kastalon, Inc., 12 BNA OSHC 1928, 1932, 1986-87 CCH OSHD ¶ 27,643, p. 35,975 (No. 79-3561, 1986) (consolidated)); see also Diebold. Consequently, the Commission has required other independent evidence of recognition before it will rely on such efforts. Trinity Indus., 15 BNA OSHC 1481, 1485 n.8, 1992 CCH OSHD ¶ 29,582, p. 40,035 n.8 (No. 88-2691, 1992). Pepperidge invokes this precedent in arguing that the Commission should not rely on the evidence of Teed-Sparling's activities and memoranda as well as those of Liberty Mutual.
While we are troubled and reluctant to rely solely on an employer's voluntary safety efforts where there is no other evidence of a hazard, this case does not present that issue. First, there is evidence that Pepperidge was actually aware of the existence of the four lifting hazards through the injuries suffered by employees performing each of the four lifting tasks. Indeed, as early as 1984, Pepperidge's Norwalk, Connecticut headquarters was made aware of employee injuries from the sugar and cookie tin lifting tasks. Second, in contrast to the actions in the cases relied on by Pepperidge (e.g., the purchase of safety shoes in G.M. Parts), the evidence we rely on here is more accurately described as memoranda and warnings that went unheeded rather than safety actions or efforts. Third, this record shows substantial recognition of the lifting hazards from multiple sources. Pepperidge received warnings of the cited conditions from its insurance carrier, its ergonomist, and its employees. Teed-Sparling warned Pepperidge about all four lifting tasks. Liberty Mutual warned Pepperidge about the sugar, cookie tin, and roll stock lifting tasks. Finally, the Hazard Hounds employee safety group identified roll stock lifting as being a hazardous task.[39]
Having found that the hazard was recognized, we affirm that part of the judge's decision finding violations of the general duty clause for Pepperidge's failure to free its workplace of lifting hazards. We next consider whether the violations were willful.
Willfulness
We have already set forth the standard for finding willfulness in the recordkeeping section. Where, as here, the violation is of the general duty clause, we have held that "the Secretary's burden of proving willfulness is notably more difficult when an employer is charged with a violation of section 5(a)(1) . . . there must be evidence apart from that establishing knowledge of the hazard, from which it may be concluded that the employer intentionally disregarded or was indifferent to the safety of its employees." General Dynamics Land Systems Div., 15 BNA OSHC at 1287, 1991-93 CCH OSHD at p. 39,759.
As we found, Pepperidge recognized the existence of lifting hazards at its Downingtown plant. In our view, the same evidence that supports a finding of recognition establishes the first element of the willfulness test -- that Pepperidge had a heightened awareness of the lifting hazards at the Downingtown plant. Pepperidge's failure to take corrective action to materially reduce or abate these known lifting hazards demonstrates its intentional disregard or plain indifference to employee safety.
The record demonstrates that beginning in 1984, Pepperidge's corporate management received notice of the presence of lifting hazards. Pepperidge was first made aware of problems involved in lifting sugar and cookie tins. In 1986, Pepperidge's corporate management received notice of the problems posed by lifting butter. In April 1987, Pepperidge's Downingtown plant received direct notice of the problems of lifting roll stock, sugar, and cookie tins. The series of memoranda from Teed-Sparling and Liberty Mutual detailing the lifting problems did not just tell Pepperidge that a problem existed, the memoranda also informed Pepperidge how to remove the problem.
Despite receiving this specific information, Pepperidge did not act with dispatch. It was first notified of the hazard of lifting 100-pound bags of sugar in August 1984 and was advised to switch to 50-pound bags. It received further notification of the hazard in January 1985, June 1986, April 1987, and May 1988. Pepperidge was also told of the hazard by corporate ergonomist Teed-Sparling in November 1986. She recommended a mechanical ingredient dumper. More information was received from Teed-Sparling in December 1986, April 1987, and February 1988. Teed-Sparling's April 1987 memorandum specifically recommended the scissor lifts that were later used at the Downingtown plant. Litvak's May 1987 memorandum shows that Pepperidge looked into this lifting hazard, but notes that there were no plans to fund any "[e]rgonomic [c]onsiderations" in the biscuit plant. Despite these repeated warnings, Pepperidge did not fully abate this hazard until at least the acquisition of scissors lifts approximately five years after the first warning.
Memoranda from both Liberty Mutual and Teed-Sparling warned Pepperidge of the hazard of lifting filled cookie tins as early as 1984. In her April 1987 memorandum, Teed-Sparling had recommended reducing the stack height and reducing the weight of the trays to 24 pounds as well as reducing the weight of the tins by using plastic trays instead. Pepperidge implemented the use of plastic trays, but not until 1990, about six years after it was first warned about the hazard. During this long wait at least three Pepperidge employees suffered injuries lifting the cookie tins.
As we concluded in considering whether Pepperidge recognized the hazards of lifting butter, Pepperidge's corporate management was aware of the hazard of lifting the 68-pound blocks of butter as early as November 1986. By the spring of 1987, both Downingtown and the rest of the corporation were aware of lifting hazards generally through the efforts of Teed-Sparling and Liberty Mutual. Yet Pepperidge did nothing to address these hazards until it implemented the use of lift carts some time after the fall 1989 OSHA follow-up inspection, nearly three years after an employee at Downingtown was injured lifting butter.
The April 1987 memorandum from corporate ergonomist Teed-Sparling noted the hazards of lifting rolls of stock. (GX 39). The memorandum recommended the use of a mechanical device to address the lifting hazard. Despite this warning and the October 1987 back injury to Davis that prohibited him from working for nearly a year, Pepperidge did not have the mechanical devices needed to address this hazard in place at the time of the inspection and did not fully provide them until January 1989, more than a year and a half after Teed-Sparling's initial memorandum.
A finding of willfulness here would not be justified if Pepperidge made a good faith effort to remove these lifting hazards, even though its efforts were not entirely effective or complete. The test of good faith in this regard is an objective one--whether the employer's efforts to comply were reasonable under the circumstances. See Tampa Shipyards, 15 BNA OSHC at 1541, 1991-93 CCH OSHD at p. 40,104. The record shows that Pepperidge did take some action after it received written memoranda detailing the lifting hazards, but before it abated the hazards after the inspection. Pepperidge generally attempted to address the lifting hazards by instituting a back brace program by at least the time Teed-Sparling returned to Downingtown in February 1988. However, the record shows that the back braces were ineffective, that management recognized this (RX 52, tab 14), and that Teed-Sparling even viewed the braces as potentially harmful. For the sugar bag lifts, Pepperidge obtained pallet stands by mid-1987 to place the sugar bags twelve inches higher. It also began using fruit grade sugar for some operations possibly as early as mid-1987 and had transferred one scissor lift to the operation by May 1988 which partially eliminated the handling of the 100-pound bags. For the cookie tins, Pepperidge obtained sample plastic trays between late 1987 and early 1988 but did not find them acceptable. For roll stock handling, one of Pepperidge's employee safety groups began researching mechanical means of abating this lifting hazard by mid-spring 1988. However, these measures fall far short of an objectively reasonable attempt at compliance. Pepperidge employees were still performing the same hazardous tasks at the time of the inspection. Pepperidge's various budgetary and other reasons for not taking the steps recommended to abate the hazards, particularly the time Pepperidge took to abate the hazards, fail to suggest an objectively reasonable good faith effort to comply with the Act.
In sum, for the roll stock, butter, and tin lifting tasks, no abatement measures had been implemented by the time of the inspection and citation in late 1988. Pepperidge did not complete abatement measures for roll stock until January 1989, no earlier than the fall of 1989 for butter, and some time in 1990 for the cookie tins. For the sugar lifting tasks, although Pepperidge placed the sugar on top of pallet stands to facilitate the lift, employees were still required to lift the 100-pound bags, and 50-pound bags and scissor lifts were not implemented until 1990, well after the citation was issued.
The Commission has not always been willing to base a willful violation on an employers' failure to follow an outside consultant's advice in determining willfulness.[40] Falcon Steel Co., 16 BNA OSHC 1179, 1182, 1993-95 CCH OSHD ¶ 30,059, pp. 41,330-31 (No. 89-2883, 1993) (consolidated) (finding of willfulness was based on "the uncompromising language of the standard itself" rather than on Falcon's hiring of a safety consultant). Here, however, we conclude, based on our earlier discussion of the use of the Teed-Sparling and Liberty Mutual memoranda and recommendations to establish recognition, that this same evidence can be used to establish willfulness, particularly where the employer's response to safety recommendations may be fairly characterized as dilatory. See Empire Detroit Steel Div. v. OSHRC, 579 F.2d 378, 385-86 (6th Cir. 1978) (willful violation found where employer failed to take corrective action against a known hazard).
We therefore affirm the judge's finding of willful violations for each of the cited lifting tasks.[41]
Penalties
Both Chairman Weisberg and Commissioner Guttman agree that section 5(a)(1) was willfully violated but disagree on the proper number of violations of section 5(a)(1) that occurred. As discussed in their separate concurrences at the end of this decision, Chairman Weisberg would find that there were 21 separate violations of section 5(a)(1) based upon the 21 cited employees being exposed to hazards that are inherently individual in nature. Commissioner Guttman would find that there are only four separate violations of section 5(a)(1) based on the four different types of lifting tasks that were cited. However, in order to avoid an impasse in this case, Chairman Weisberg and Commissioner Guttman agree to assess a lesser penalty of $20,000 for the willful violations of section 5(a)(1) described in citation 1, items 3(a)-(d) and (f).
III. UPPER EXTREMITY MUSCULO-SKELETAL DISORDERS
This item alleged 175 separate willful violations of section 5(a)(1), in that 175 employees "were required to perform tasks involving repetitive motions in postures resulting in stresses that had caused, were causing or were likely to cause cumulative trauma disorders." The proposed penalties were $5,000 per instance, for a total of $875,000. The employees worked beside conveyor belts in the Biscuit Division of the Downingtown plant. They assembled, packed, and packaged baked cookies.
A violation of section 5(a)(1) of the Act exists where: (1) a condition or activity in the employer's workplace presents a hazard to employees, (2) the cited employer or the employer's industry recognizes the hazard, (3) the hazard is causing or likely to cause death or serious physical harm, and (4) feasible means exist to eliminate or materially reduce the hazard. E.g., General Dynamics Land Systems Div.,15 BNA OSHC at 1280, 1991-93 CCH OSHD at p. 39,752; Kastalon, 12 BNA OSHC at 1931, 1986-87 CCH OSHD at p. 35,973; Pelron Corp., 12 BNA OSHC 1833, 1835, 1986-87 CCH OSHD ¶ 27,605, p. 35,871 (No. 82-388, 1986).
The judge found that a recognized hazard created by repetitive motion existed in Pepperidge's plant, and that it was causing or likely to cause serious physical harm. He vacated the item in its entirety, however, on the ground that the Secretary had failed to prove a feasible means of abatement.
Following a review of the tasks performed by the workers at Downingtown and the injuries which allegedly resulted from these tasks, we begin with the highly contested issue of whether a hazard exists. To address this issue we review l) the legal test for the existence of a hazard under section 5(a)(1); 2) the evidence on the existence of the alleged injury here; and 3) evidence regarding the cause of the alleged injuries. We then turn to the three further elements of a section 5(a)(1) violation.
We affirm the judge's ultimate finding that the citation should be dismissed. In doing so, we agree with the judge's predicate findings that a hazard existed, was recognized, and was causing serious physical harm. We disagree with his finding that the Secretary's proposed method of abatement of the hazard here is inappropriate under section 5(a)(1); however, we find that the Secretary has failed to meet her burden of showing that actions not taken by Pepperidge to abate the hazard at Downingtown were feasible and likely to materially reduce the hazard.
A. The Biscuit Lines
The employees at issue here all worked on lines in the Biscuit Division, where Pepperidge produced thirty to forty types of cookies and four types of Goldfish crackers. Lines 1 and 2 produced non-chocolate variety cookies. Line 3 produced Goldfish crackers. Lines 5 and 6 produced sandwich-type cookies including cookies with chocolate fillings. Downingtown also had an assortment line where different combinations of cookies were packed and packaged. Line 4 is not in issue, as Pepperidge had discontinued it before OSHA's inspection.
On lines 1, 2, 5, and 6, several employees stood by each side of a moving conveyor belt that carried baked cookies. They were called "cuppers." They held a stack of paper cups in one hand (typically their left) and, with the motion of that thumb, slid off one cup at a time. The cups dropped onto the conveyor belt, and the cuppers picked up cookies from the belt with their other hand and placed them in the cups.
The chocolate-filled sandwich cookies on lines 5 and 6 were capped manually before cupping. The top of those cookies traveled on an upper conveyor, and the bottom traveled on a lower conveyor. Employees called "cappers" took the cookie top and placed it on the cookie bottom. There were usually between six and ten employees performing capping on each line.
At the downstream end of the cupping operation a worker called a "straightener" made sure that all the cookies were properly seated in the cups and that the cups were aligned properly for the next step. If the cookies were destined for the assortment line, employees called "tinners" would remove the cupped cookies from a conveyor and put them in tins for transport to that line. The other cups of cookies were fed automatically into a bagging machine. A bag machine operator tended that machine and made sure the cups were fed properly. Once bagged, the cookies continued on a conveyor to locations where employees picked up the bags and put them into cardboard cartons for shipment.
The employees rotated from one job position to another, all within the biscuit lines. Generally, they rotated every twenty minutes, but on the assortment line they rotated once an hour. The employees worked 8-hour shifts, five days a week, not including overtime. They had a half-hour lunch break and two 15-minute breaks. Thus, they actually performed their functions for seven hours per shift. During their breaks they were replaced by relief workers, who worked a total of 5« hours each day. There were three shifts a day, around the clock -- the a.m., p.m., and night owl shifts.
Daniel Habes, an ergonomist for the National Institute for Occupational Safety and Health ("NIOSH") who testified for the Secretary, estimated the number of repetitive motions that employees would make at different positions on the lines, and the average overall number per day.[42] Habes' specific estimates are questioned by Pepperidge.[43] However, they are sufficient to indicate the general order of magnitude of the repetitions.
Overall, Habes calculated, the group of employees who rotated through the seventeen positions on line 5 and the two positions on line 3 averaged 20,800 repetitions over a full rotation. (There were nine capping, five cupping, one straightening and two tinning positions on line 5 and two packing positions on line 3.)[44] A few of the capping jobs were being done at twice that rate or more. The cupping jobs also were more repetitive than average. Other jobs such as straightening and tinning involved much less repetition. Habes noted that in their seven hours of actual work, that group of employees actually had twenty-one discrete tasks, so they would repeat two positions each day. Depending on which positions they repeated, their overall repetitions would increase or decrease by up to about 1000.
Another group of employees rotated among the seventeen positions on line 6 (seven capping and three cupping positions, plus several straightening and other less highly repetitive positions). Habes calculated that the average number of repetitions per employee among those seventeen positions was 17,496.
Comparing those calculations to ones he had done previously concerning all the lines, Habes gave the opinion that lines 5 and 6 were representative of all the lines regarding the number of repetitions, except line 1, which moved slower. The Secretary alleged 175 instances of violation because 175 employees were scheduled to work there on October 5, 1988, when OSHA Industrial Hygienist (IH) Roman Siletsky conducted his inspection. Overall, 350 employees worked in the division, according to Pepperidge.
B. The Alleged Injuries
The kinds of ailments that Pepperidge's employees are alleged to have suffered are commonly referred to by various names including upper extremity musculo-skeletal disorders ("UEMSDs"), cumulative trauma disorders ("CTDs"), or repetitive strain injuries (RSIs). We will use the term UEMSDs because it describes the conditions without suggesting a cause.
A specific UEMSD that allegedly resulted in disability and surgery for numerous Pepperidge employees is carpal tunnel syndrome ("CTS"). As explained by the physicians in this case, CTS consists of a constellation of symptoms including numbness and tingling in fingers, loss of muscle strength in the hand, discomfort in the hand, wrist and arm (even the shoulder and neck in many patients). It is due to compression ("entrapment") of the median nerve, which runs through the carpal tunnel, including the wrist. In most cases it results in abnormal nerve conduction which may be measured by electrodiagnostic tests. (Tr. 5214 (Harrison), 9769-70 (Nathan), 10,164-65 (Hadler)).[45]
Other UEMSDs from which certain Pepperidge employees allegedly suffered were tendinitis (including epicondylitis), tenosynovitis (including DeQuervain's disease), trigger finger, and ganglionic cysts. As they relate to UEMSDs, those terms may be defined as follows. Tendinitis is the inflammation of a tendon. Webster's Third New Intl. Dictionary 2355 (1986). Epicondylitis is tendinitis at the elbow. Stedman's Medical Dictionary 470 (1976). Tenosynovitis is inflammation of a tendon sheath. Webster's at 2356. DeQuervain's disease is tenosynovitis of a thumb. Stedman's at 404. Trigger finger is a disorder in which a finger extends or flexes with a snap. Webster's at 2444. A ganglionic cyst is "a small cystic tumor containing viscid fluid and connected either with a joint membrane or tendon sheath," typically at the wrist. Id. at 934.
C. Key Witnesses
For ease of reference we include here a brief description of the key witnesses referred to below.
Dr. Nortin M. Hadler testified for Pepperidge. He is a board-certified rheumatologist and a clinician. He is Professor of Medicine and Senior Attending Rheumatologist at the University of North Carolina (Chapel Hill) and North Carolina Memorial Hospital. The patients he examines and treats primarily suffer from upper extremity musculo-skeletal disorders or problems. Dr. Hadler is a member of the editorial boards of the Annals of Internal Medicine and the Journal of Occupational Medicine.
Dr. Peter A. Nathan also testified for Pepperidge. He is a hand surgeon in Portland, Oregon, and a researcher in the field of the relationship of work to UEMSDs, and he has done research on both the epidemiology of carpal tunnel syndrome and its physiological attributes. He is board-certified in both Orthopedic Surgery and Hand Surgery.
Dr. Barbara A. Silverstein testified for the Secretary as a rebuttal witness regarding Dr. Hadler's testimony. She holds a Doctorate in Epidemiology and two master's degrees --one in nursing and one in environmental and industrial health. At the time she testified, she was research director of the Safety and Health Assessment and Research Program for the State of Washington's Department of Labor and Industries. (Subsequently, Dr. Silverstein became head of OSHA's ergonomics standard effort as a special assistant to the Assistant Secretary of Labor for OSHA from 1993 to 1995).
Dr. Robert G. Feldman testified as a rebuttal witness for the Secretary regarding Dr. Nathan's testimony. Dr. Feldman is a professor of neurology and Chairman of that department at Boston University, and he is a lecturer in neurology and occupational health at Harvard Medical School. Dr. Feldman directs an occupational neurology clinic and is medical director of the Occupational Health Program at the University Hospital in Boston.
Dr. Robert Snyder, Pepperidge's Medical Director at the Downingtown plant from about June 1986 to December 1990, was called to the stand by the Secretary not as an expert but as an adverse witness. He is board certified in emergency medicine. Dr. Snyder supervised nurses and the occasional physicians at the plant who interviewed, examined, diagnosed, and treated employees.
Dr. Robert Harrison testified as an expert witness for the Secretary. He is an assistant clinical professor at the University of California in San Francisco, where he directs the occupational medicine clinic and teaches medical school courses in occupational medicine. He is the only witness who is board certified in occupational health. He also is board certified in internal medicine and holds a master's degree in public health.
Jane Teed-Sparling, called by the Secretary as an adverse witness, was the corporate ergonomist for Pepperidge Farm's parent company, Campbell Soup Co. She holds a bachelor's degree in mechanical engineering from the University of Delaware and worked for Campbell Soup as a design engineer and project engineer from 1979 until she became its corporate ergonomist in approximately September 1985. She has no academic background in ergonomics -- she received basic education in ergonomics from Liberty Mutual Insurance Company staff who worked with Pepperidge.
Daniel Habes has been an industrial engineer in the Applied Psychology and Ergonomics Branch of NIOSH since 1977. He holds a master's of science degree in engineering from the University of Michigan. He is not certified as a professional engineer; there are no licenses or certifications in the field of ergonomics.
Dr. Vernon Putz-Anderson has been Chief of the Psychophysiology and Biomechanics Section of the Applied Psychology and Ergonomics Branch at NIOSH since 1979. He holds a Ph.D. degree from the University of Wisconsin in human factors and applied experimental psychology. He has published extensively in the field of ergonomics. He has taught courses on musculoskeletal problems at the University of Cincinnati.
D. Applicability of Section 5(a)(1) to Ergonomic Hazards
At the threshold, Pepperidge and supporting amici argue that the undefined nature of the hazard (assuming it exists) precludes regulation under section 5(a)(1). In a related vein, they argue that the hazard is so undefined and/or controverted that a finding of violation would defy constitutional requirements of notice and due process. Finally, they argue that the Secretary's evidence of hazard must be gauged by the "significant risk test" articulated in Kastalon, Inc. 12 BNA OSHC at 1931, 1986-87 CCH OSHD at p. 35,974.
Pepperidge argues that the hazard here cannot be regulated because, as it correctly points out, no one could testify as to when repetitive motion becomes a hazard or precisely how much Pepperidge should have reduced its employees' repetitive motion. While knowledge of the threshold for injury may be essential in some cases, however, the Commission has never held that certainty as to the threshold level for injury is a prerequisite to regulation under the general duty clause.
Pepperidge cites to our decision in Kastalon, which drew on the Supreme Court's decision in Industrial Union Dept. v. American Petroleum Inst., 448 U.S. 607 (1980) ("Benzene") for the proposition that the Secretary must show that a condition poses a significant risk before it can be regulated under section 5(a)(1).[46] Kastalon addressed the issue of potential employee exposure to a suspected human carcinogen commonly called "MOCA." We noted that the Supreme Court's decision in Benzene held that to establish a significant risk of harm regarding an alleged carcinogen the Secretary seeks to regulate by rule, she must present "a body of reputable scientific thought," and that the Court "noted that animal studies, epidemiological evidence and worker mortality rates could be used to establish the existence of a significant risk." 12 BNA OSHC at 1935, 1986-87 CCH OSHD at p. 35,977 (citing 448 U.S. at 656 & n.64).
The evidence of hazard in Kastalon was based on extrapolation from animal tests and concerned "potential" injury. In contrast, this case stems from allegations of actual injury to humans. The inability to quantify a threshold may be of great significance when there is little evidence that the putative hazard may cause injury to humans,[47] or where the question is whether it should be presumed that the risk should be controlled to the full extent feasible.[48] It is of less significance where, as here, human injury is allegedly manifest. Thus, where substantial injury is actually occurring, neither precedent nor common sense require that the finding of hazard be foresworn until there is determination of the threshold at which there occurs a substantial risk of injury.
Pepperidge further points out, however, and the Secretary's experts agree, that non-workplace factors may cause or contribute to the illnesses at issue, and that individuals differ in their susceptibility to potential causal factors. However, such characteristics (and the inability to determine threshold of harm) are not unique to putative ergonomic hazards, but inhere in other workplace hazards as well. For example, some or all of these characteristics obtain for many chemical, toxic and other workplace hazards.[49] Thus, to preclude the application of section 5(a)(1) to a hazard with the characteristics cited by Pepperidge would be to preclude the use of section 5(a)(1) for many occupational ills.[50] To be clear, characteristics such as those identified by Pepperidge may (as discussed later) bear on questions of causation or feasibility of abatement. They do not, however, ipso facto preclude the possibility of regulation under section 5(a)(1).
Respondent and supporting amici correctly point out that a cornerstone of section 5(a)(1) is the principle that employers should not be penalized for failing to take actions for which they lacked reasonable notice. Thus, they note, citing our precedent, a "broad generic definition of the hazard" is unacceptable because it does not "identify conditions or practices over which the employer can reasonably be expected to exercise control." E.g., Davey Tree Expert Co., 11 BNA OSHC 1898, 1983-84 CCH OSHD ¶ 26,852 (No. 77-2350, 1984). Pepperidge also cites Diebold, for the proposition that substantial dispute in the scientific community about whether jobs cause UEMSDs demonstrates that the general duty clause does not provide employers with the notice of ergonomic violations required by the Constitution. We agree with Pepperidge that the ability of an employer to identify a hazard and the state of scientific understanding are relevant to the question of notice. In the discussion that follows these factors play central roles.
E. Existence of a Hazard
The first element of a section 5(a)(1) violation is the existence of a hazard, which turns on two factors, first, actual or potential physical harm, and second, a sufficient causal connection between the harm and the workplace.
The Secretary alleges that the dozens of reported UEMSDs at the Pepperidge Downingtown plant are instances of cumulative trauma disorders, and were caused or abetted by workplace tasks involving repetitive motion. Pepperidge responds by questioning both the existence of the UEMSDs and their cause, arguing that the "totality of the record did not establish that a cognizable causal connection existed between the cited Pepperidge tasks and the alleged instances of UEMSDs." (Pepperidge Brief at 41). The issues joined by the parties, therefore, include both the existence of injury here and the role of the workplace in causing injury of the kinds alleged.
The record contains several kinds of evidence that bear on the issues:[51]
1. The testimony (and supporting documentation) of expert witnesses, including medical doctors presented by Pepperidge (Drs. Hadler and Nathan) and the Secretary (Drs. Harrison and Feldman), and an epidemiologist (Dr. Silverstein) and two ergonomists (Putz-Anderson and Habes) presented by the Secretary.
2. The testimony of some of the workers who reported injury, and Pepperidge Farm's medical records on all of them.
3. The testimony of individuals who acted in expert capacities in regard to the alleged hazards at Downingtown, but who were not put forth as expert witnesses. These included the corporate ergonomist (Ms. Teed-Sparling) and Pepperidge's doctor (Dr. Snyder) and nurses relied on by Pepperidge to diagnose and treat Pepperidge's workers. In addition, the record contains evidence of the findings of the outside physicians and technicians called on for further examination and treatment.
4. Pepperidge's own contemporaneous assessment of the alleged hazard.
Judge Oringer's conclusion that a hazard exists relied primarily on the medical records and the findings of those who examined and treated the workers (slip op. at 233). On review, Pepperidge argues that the judge's finding of hazard must be considered in light of the testimony of experts who questioned generally the existence and cause of these types of injuries. The point is well taken, and we consider the testimony of those experts presented by Pepperidge. We note additionally that the record here concerns a topic which, we presume, is the object of continuing and vigorous research. At the same time, however, we are mindful that we are called upon to decide this case -- whether a hazard existed at Downingtown based on the evidence in the record here. Before we begin to consider evidence of cause, we consider the evidence of alleged effect.
1. The Existence of Injury: The Evidence of Effect
The Secretary states that in 1986-88, 68 Downingtown employees developed UEMSDs.[52] At hearing, the Secretary sought to show these injuries through the medical records; the testimony of Pepperidge's plant physician (Dr. Snyder), nurse(s), and workers; and the testimony of Dr. Robert Harrison about the medical records.
Dr. Harrison, a professor of occupational medicine, and clinician with experience with UEMSD patients, reviewed the medical files and examined eight of the Pepperidge workers. He testified that his review showed that the patients had UEMSDs. Dr. Snyder's testimony was consistent with Dr. Harrison. In addition, a sample of those workers who reported injury testified to their injuries at hearing. They also provided testimony that, in some cases, they were advised by the Pepperidge medical staff that it would not be in their best interests to return to work because of their injury.
The medical records also evidenced examinations, tests, diagnoses, and treatments provided by members of an outside panel of physicians and surgeons (approved by Pepperidge's workmen's compensation insurance carrier, Liberty Mutual). When some of the employees were suspected of having CTS, electrodiagnostic tests were performed, and the results were reviewed by a neurologist. Where the results indicated CTS, some of the employees were referred to a hand surgeon. The panel of 12 to 15 doctors included three hand surgeons who performed carpal tunnel releases and other surgery on the employees. The judge's decision reviews a sample of the medical records. (Slip op. at 193-201).
Pepperidge questions the bona fides of the UEMSDs alleged here, stating that "the actual diagnoses in the employees' medical records are unreliable . . . ." (Pepperidge Brief at 41). It relies on Dr. Hadler's testimony, including both his review of the medical records here and his overview of the nature of alleged UEMSD injuries. Dr. Hadler's review of the Downingtown medical records led him to conclude that the records, containing 190 diagnostic labels, were too fragmentary to evidence certain diagnoses. He questioned the carpal tunnel diagnoses because the reported surgery success rate differed significantly from that found in the case of properly diagnosed carpal tunnel syndrome.
Pepperidge argues that "most of the alleged UEMSDs experienced by Pepperidge employees were, at best, sporadic soft tissue syndromes of the types which are common among the general population." (Pepperidge Brief at 41). Dr. Hadler explained that the term "cumulative trauma disorder" has been used to embrace a variety of complaints or ills, and is not a part of medical terminology.[53] (Tr. 10,105). Injuries lumped together as CTDs include soft tissue injury (or "tendon disorders"), nerve disorders, and neurovascular ills. Drs. Hadler and Nathan state that soft tissue ills often cannot be diagnosed with certainty and may be no more than normal aches and pains.[54] Thus, in Pepperidge's view, an upsurge in reported ills, as occurred at Downingtown, may not reflect the occurrence of real injury so much as psychosocial suggestion that prompts the reporting of aches and pains that otherwise would be coped with.
Pepperidge argues that the injuries alleged here may be essentially dismissed as questionable reports of soft tissue ills; however, carpal tunnel syndrome (a nerve disorder) was the single most identified injury at Pepperidge, representing almost half of the injured workers at issue. The experts appear to agree that CTS is susceptible to reliable diagnosis. The majority of those with carpal tunnel syndrome, Dr. Hadler acknowledged, "have a physiologically demonstrable abnormality. The nerve conducts normally until it goes to the wrist, and then it doesn't conduct normally across the wrist." (Tr. 10,164). Carpal tunnel syndrome, he explained, "can be defined by clinical and electrodiagnostic criteria of substantial sensitivity and specificity."[55] At oral argument, Pepperidge agreed that "the diagnoses were generally accurate when it comes to carpal tunnel syndrome which required surgery." (Oral Argument Tr. 42). Pepperidge reported that 28 employees underwent 42 separate surgical procedures, including 32 carpal tunnel releases. These injuries, again, were diagnosed by Pepperidge's panel of doctors.
In light of the above, we find that the existence of carpal tunnel syndrome among the employees at Downingtown has been established on this record. Moreover, the existence of soft tissue ills at Downingtown is supported by the Downingtown medical records, by the testimony of Drs. Harrison and Snyder, and the testimony of the workers who reported injury. We additionally find the reservations raised by Drs. Hadler and Nathan about the reliability of soft tissue injury diagnoses inadequate to rebut the contemporaneous clinical evidence of injury here. (We note Dr. Nathan testified that generally he was not in a position to "second guess the Pepperidge Farm physicians and the physicians to whom the employees were referred as to whether the employees had the particular upper extremity musculo-skeletal disorders for which they were diagnosed." (Tr. 10,008). We therefore conclude that injury, particularly carpal tunnel syndrome, existed among the Downingtown workers.[56] This being the case, the question of the cause(s) of such injury, needs to be addressed.
2. Causation
Introduction
We turn now to the second prong of the inquiry into the existence of a hazard -- the causal connection between the physical harm to employees and the workplace. The record evidence indicates that the majority of UEMSDs have as yet no underlying medical condition clearly associated with them and may be related to a host of factors other than the workplace.[57] These factors include aging, acute trauma (e.g., a blow to the wrist), medical conditions (e.g., diabetes mellitus, gout, rheumatoid arthritis), extracurricular activities (e.g., bowling, gardening, playing a musical instrument), and sex ( both gender and factors such as birth control pill use and pregnancy). Thus, to determine whether workplace activities may cause UEMSDs, it is necessary to determine whether workplace activities are associated with UEMSDs, but also to disentangle other potential causes (or "confounders").
At the threshold, the parties dispute the kinds of evidence and expertise that are relevant to this task. Pepperidge's experts are medical doctors, and Pepperidge argues that medical expertise is essential to a supportable claim of causality, particularly an understanding of the biological relation between cause and effect. At the same time, Pepperidge, through its expert Dr. Nortin Hadler, contends that many reports of workplace- related UEMSDs are "iatrogenic"-- a creation of psychosocial suggestion in which the mainstream medical profession itself plays a prominent role. The Secretary, for her part, presented experts with backgrounds in epidemiology and ergonomics as well as medicine. These approaches include differing disciplines and alternative perspectives within disciplines.
As we discuss below, the record shows that no single discipline or perspective appears to have all the answers to the questions of causality such as exist here. Medical clinicians see only portions of the population; their understanding may be biased (in the technical sense of the term, and referred to as selection or accrual bias) by the happenstance of patient selection. Epidemiologists, on the other hand, focus on a broader population and provide an alternative means of approaching causal connection. As Pepperidge points out, however, the best that can be shown by epidemiological research is likely to be an association between factors. Of course, not every association equates to the demonstration of causality. This is particularly so where, as in this case, there are many alternative factors that might cause or facilitate UEMSDs. Moreover, there is dispute here about whether the research that has been done even consistently shows associations and, if so, whether the research is well founded.
In resolving this dispute, we must recognize the limitations of science, but also recognize, as the Benzene decision and much public health decision making has, that there are illnesses or hazards that need to be addressed even in the face of imperfect understanding. Society of Plastics Indus., Inc. v. OSHA, 509 F.2d 1301, 1308 (2nd Cir.), cert. denied, 421 US 992 (1975) (under the Act, "it remains the duty of the Secretary to act to protect the workingman, and to act even in circumstances where existing methodology or research is deficient"). At the same time, we must recognize that decisions based on imperfect knowledge can compound harm, as well as alleviate it, and there must be sufficient clarity in the state of knowledge to provide notice to employers of their obligations under the Act.
In analyzing the record evidence of causation we will group that evidence into several categories: clinical evidence pertaining to Pepperidge's own employees, the opinions of the clinical experts who testified here, the rate of injury at Downingtown, epidemiological research, studies of the effect of intervention on injury, evidence on the biological plausibility of the Secretary's position, and other research or testimony bearing on the issue of causation. Some of the witnesses spoke to more than one of these categories.[58]
a. Clinical Evidence Regarding Injuries
To Pepperidge's Employees
The Secretary called on Dr. Snyder, Pepperidge's medical director at the Downingtown plant, as an adverse witness.[59] In addition to Dr. Snyder and his staff, as noted above the patients were referred to an outside panel of medical doctors under the auspices of Pepperidge's insurance carrier (Liberty Mutual). This panel included several hand surgeons and several specialists in rheumatology and confirmed the existence of UEMSDs in the Pepperidge workforce. Judge Oringer's decision reviews a sample of the medical files. The Secretary also called on Dr. Harrison to testify on the contents of the medical records.
Judge Oringer found, and the record shows, that in the course of diagnosing UEMSDs Pepperidge's own medical staff attributed their cause to the tasks at Downingtown. At the hearing Dr. Snyder testified that "there is no question that repetitive motion plays a part in this." (Tr. 4802). Dr. Harrison read into the record the findings and opinions of the treating physicians and nurses reflected in Pepperidge's medical records, and he interpreted them.[60] Dr. Harrison testified that Pepperidge's medical records provided a sufficient basis for him to form his own opinion as to the specific UEMSD that each of the 68 employees suffered, and the cause of that UEMSD. His opinion was that the cause of each employee's UEMSD was their repetitive motion jobs on the cookie lines at Downingtown.[61]
Pepperidge's records reveal many instances where the physicians and nurses who examined and treated the employees attributed their UEMSDs to their biscuit line jobs. For example, Judge Oringer noted the statement of Pepperidge panel physician Ward regarding the first employee, A1, that her "symptoms are consistent with irritation of her ulnar nerve or left cubital tunnel syndrome. This is unrelated to her previous problem [CTS]. However, I feel it is caused by her work." (Emphasis in original).[62]
The judge found the opinions of the medical personnel treating the employees "deserve great weight insofar as the etiology of the entire spectrum of injuries and/or illnesses" involved here. (Slip op. at 193). The judge summarized his views:
[The employees] were sent to various panel physicians . . . . Some were specialists in rheumatology; others were surgeons who performed carpal tunnel releases and other surgery on the employees and some who were expert in performing electromyographic studies. These physicians found the upper extremity musculo-skeletal disorders of the employees occupationally related . . . and all of these physicians personally examined and treated the employees complaining of these upper extremity musculo-skeletal disorders . . . . I conclude that most, if not all of these physicians, including Dr. Snyder, had the opinion that these conditions were for the most part, occupationally related.
In sum, the medical personnel who treated the injured workers at Downingtown were of the view that the injuries were substantially caused by work tasks.
b. Opinions of Expert Clinicians
We turn now to the views of several clinicians who offered testimony pertinent to the question of causality--Drs. Hadler and Nathan for Pepperidge and Drs. Harrison and Feldman for the Secretary. At the outset, we note that experts caution that clinical evidence may have limited value in the assessment of cause, because of bias (selection or accrual) that may inhere in judgments arrived at from patient populations derived from practice. (E.g., Tr. 10,510, 10,599). Thus, the patient populations of a particular clinician may differ as to average age or other characteristics from the employees in the production line at Downingtown.[63]
Dr. Hadler offered extensive testimony both from his own experience and regarding certain studies.[64] Dr. Hadler's opinion was that the "CTD hypothesis" is "highly untenable" for carpal tunnel syndrome and "very marginal" for tendinitis. (Tr. 10,255-56). However, Dr. Hadler's overall testimony leads us to question the fit between the assumptions he employed and the facts in this case.[65]
Dr. Hadler testified that in his opinion most of the UEMSDs at issue were merely soft tissue injuries.[66] (E.g., Tr. 10,223, Pepperidge Brief at 41). However, as we have already found, numerous injuries at Downingtown were CTS, which Dr. Hadler admits is diagnosable. Thus, assuming Dr. Hadler is correct that reported soft tissue ills typically reflect normal aches and pains, this observation does not cover the facts here.
Dr. Hadler testified that "repetitive motion where the usages in and of themselves are comfortable and customary, does not increase the likelihood that individuals will suffer carpal tunnel syndrome."[67] (Tr. 10,189). "Comfortable and customary," he explained, means "things that any one of us could do without discomfort; that any one of us would be willing to do without fear." Id. Dr. Hadler acknowledged the term is not used by others and the judge noted that its "exact meaning" is hard to understand. Dr. Hadler did provide context for comfortable and customary activity, contrasting it to violent actions such as a blow to the wrist or the use of a jackhammer. He testified that "having looked at the tasks from which this sample emerged [Pepperidge jobs], they are well within my concept of comfortable and customary elements." (Tr. 10,319-20). At the hearing, Hadler testified that he does not know whether performing biscuit line jobs for a full shift, as the employees do, would be comfortable for them. He agreed that the employees who do those jobs would be the ones best able to know whether the jobs are comfortable. (Tr. 10,508). We also note that Dr. Hadler himself has acknowledged in his writings that the inquiry must be not just whether a given task is comfortable and customary but also whether repetition of that task can lead to musculoskeletal damage over time.[68]
In any event, numerous employees testified in effect that their repetitive motions were not comfortable. Irene Anderson, a production helper in the biscuit packaging department for 12 years, testified that she had complained to Pepperidge managers about line speeds "many times."[69] Other employees testified to the same effect. For example, line leader Polly Slonaker testified that she passed on to managers complaints she received from various employees, before OSHA's inspection, that the line speeds were too fast. Line leader Diane Gillie, a 13-year veteran of the biscuit lines, testified that she reported the same kind of complaints from line workers to Area Manager Tim Conway. Rosemary Ford, who had worked in the biscuit lines for 19 years, the last six or so years as a relief worker, testified that she had complained to line leaders about excessive line speeds. Barbara Stoltzfus, also a veteran of 19 years in the biscuit lines, testified that she had complained to Conway about line speeds several times during the last few years, that she believed she had complained about them during departmental meetings in the presence of supervisor Debbie Hall and Human Resources Manager Scot Maxwell, and that she had complained to her line leaders about them as well.
Further, Pepperidge's corporate ergonomist Teed-Sparling identified among the employees' jobs numerous "harmful postures, documented from ergonomic research, leading to repetitive motion injuries of the upper extremities."(GX 39). And Dr. Silverstein, after viewing the same videotape that Dr. Hadler saw, was of the opinion that the capping, cupping, tinning, case packing, and assortment line packing and boxing were not comfortable, given the repetitive nature of the activity and the length of time that they had to be performed.
In sum, the record evidence does not support a finding that these jobs were comfortable and customary, and accordingly, Dr. Hadler's thesis falls short of rebutting the Secretary's evidence as to causation.[70]
Dr. Peter Nathan is another clinician who appeared as Pepperidge's witness and testified generally on UEMSDs.[71] Dr. Nathan testified that the work performed by the Pepperidge employees could cause tendinitis, including DeQuervain's disease, and possibly trigger finger, both of which appear in this record. (Tr. 10,009-10). Dr. Nathan testified that the primary causes of carpal tunnel syndrome were aging and obesity, but stated that "in the vast majority of individuals" repetitive motion is not responsible for CTS. He agreed that symptoms in those who have underlying slowing of nerve conduction might only appear with work duties. (Tr. 10,009).
Dr. Feldman, the Secretary's witness, testified in response to the judge's query concerning "what is the majority opinion in the field" that "it is the common opinion and consensus that repetitive motion and work of this nature is a causative factor in median nerve entrapment and carpal tunnel syndrome." (Tr. 10,979-80). He testified, "I find it inconceivable that carpal tunnel syndrome can occur in an individual whose history indicates hyperextension and hyperflexing [and] the problem that they have is not related to that activity." (Tr. 10,971).
We find that the weight of the clinical opinions here support the proposition that at least some of the UEMSDs were caused by the work. Testimony of three of the four expert clinicians supported the proposition that repetitive motion may cause some of the kinds of injuries at Downingtown. Further, Dr. Hadler's hypothesis that UEMSDs cannot be caused by customary and comfortable actions does not fit the case here where there is ample testimony by those on the scene -- including Pepperidge's corporate ergonomist and workers -- that the tasks at issue were not comfortable particularly in light of the high number of repetitions. Similarly, Dr. Hadler's view that reports of workplace related UEMSDs are typically claimed soft tissue ills that are a function of psychosocial factors does not fit a case such as this where many instances of carpal tunnel syndrome were diagnosed.
c. Injury Incidence at Downingtown
Drs. Harrison and Silverstein undertook to calculate the incidence of carpal tunnel syndrome of biscuit line employees at Downingtown and relate it to that found in other populations. Data on the rate of occurrence of illness is an essential tool in understanding causation. Researchers refer to the prevalence and/or incidence of a disease, the former being a snapshot of an illness' presence in a population at a point in time, the latter being a measure of the number who develop an illness in a given period. When data for a given population are known, they can be compared to those experienced in further populations. The parties agree that the baseline study for carpal tunnel syndrome is a study conducted by the Mayo Clinic of the general population in the Rochester, Minnesota area in 1961-1980. (E.g., Tr. 10,227). The study found an age adjusted incidence of 105 instances of carpal tunnel per 100,000 person years (or about 1 for every 1,000 persons per year), with the rate for men at 52 and that for women at 149. Dr. Silverstein calculated the incidences at Downingtown to be 7.5 per hundred worker years for 1987, and 12.5 per hundred worker years for 1988, and an overall rate of 7.0 per hundred worker years for the 1986-88 period. Based on this data she calculated that the Pepperidge working women had 28.16 times the incidence of carpal tunnel experienced by the working women in Washington state (GX 321), and 41.41 times the women in the Mayo Clinic study.[72]
Pepperidge questions the calculations on several grounds. First, it notes that incidence data alone do not prove causation, a point with which the Secretary agrees. Next, it notes that the rate of reporting CTS has been "increasing dramatically" and it is therefore inappropriate to compare 1986-88 Downingtown data with 1961-1980 Mayo Clinic data.[73] This point is also well taken. Dr. Silverstein testified, however, that based on the assumption that the Mayo clinic data showed a 30 percent increase in the rate from 1976-80, she assumed two further 30 percent increases. Pepperidge also states that the reported injuries may have reflected the UEMSD awareness program conducted at Downingtown. It is possible, and Dr. Silverstein agreed, that increased reporting reflected increased awareness. However, as we have found, reports at Downingtown also reflect real injury.
Pepperidge's primary critique involves the role of confounders. Through cross-examination, Pepperidge identified alternative factors with which many of the injured were associated. Dr. Harrison, who reviewed the medical files, testified that he did not believe these identified factors were responsible for any of the injuries at Downingtown. Dr. Silverstein, Pepperidge notes, did not rule out the possibility that non-occupational factors could have contributed to causation of carpal tunnel syndrome cases at Downingtown. Pepperidge further notes that the Mayo Clinic study involved the entire population, including young girls (which presumably reduced the incidence there, since CTS increases with age).
While the record does show that those injured at Downingtown were exposed to other potential causes, Pepperidge did not undertake to show, and the record provides no clear basis for concluding, that confounders were present at Downingtown in nearly sufficient degree to explain differences between Downingtown and other populations of the magnitudes shown. Thus, for example, some of those who were injured at Downingtown had hobbies that have been associated with CTS, but Pepperidge did not argue, and it is not evident from the record, that the Pepperidge population engaged in such hobbies to a significantly greater extent than did those in the comparison population.[74]
In sum, Pepperidge raises reasonable questions about the calculations. However, the incidence of carpal tunnel injury at Downingtown is substantially in excess of that found in other populations. While Pepperidge points out, and it is undisputed, that many factors other than work may cause carpal tunnel, there is nothing that has been pointed to in the record to indicate that these other factors were present at Downingtown in sufficiently disproportionate measure to explain the high incidence rate at Downingtown.
d. Epidemiological Evidence
There are several types of epidemiological studies, each with limits and advantages.[75] A cohort (or prospective) study involves the selection of one group of individuals exposed to the hypothesized hazard and a second (control) group of non-exposed individuals, both of which are followed over time. The populations are followed to compare the incidence of disease that develops. In a case control study individuals who are known to have already developed disease are compared with a control group who do not have it, with the investigation focused on potential differences in past exposure. In a cross-sectional study a population is selected to determine the presence (or absence) of disease and exposure at a snapshot in time. The majority of the studies in the record are cross-sectional, but the experts agreed that the ideal test of causality would be large-scale prospective cohort studies with well-defined measures of exposure and health effect.[76]
Limits are inherent in research on workplace populations. Workforces consist of populations of human beings who differ in many ways, whose jobs may change, and who may leave the workplace altogether. In the case of UEMSD research there is also difficulty in defining and measuring work,[77] agreement that there are a large number of potential factors that may cause UEMSDs, and questions about the efficacy of diagnostic tools.
The Secretary's Dr. Silverstein was the sole witness presented as an epidemiologist to testify here. She testified both on her own research and her conclusion, based on the range of epidemiological research, that repetition is likely to have caused injury at Downingtown. However, epidemiological research was addressed to some degree by all the expert witnesses; on behalf of Pepperidge Dr. Hadler offered testimony critiquing Dr. Silverstein's views of the epidemiological literature, and Dr. Nathan testified about his own study of worker populations.
Pepperidge questions the probative value of epidemiology in demonstrating causality. Pepperidge says that as a non-physician, Dr. Silverstein could not provide "legally sufficient rebuttal" to Dr. Hadler's medical opinion on the causality of UEMSDs. Pepperidge states that epidemiological evidence that Pepperidge employees experienced a higher incidence of UEMSDs than those in comparable settings "establishes nothing more than an association between the work duties and the injuries," and that "[s]uch an association falls far short of what is required under the Occupational Safety and Health Act . . . ." Alternatively, Pepperidge argues that the epidemiological research of record supports its views, and not the Secretary's.
At the threshold, we reject Pepperidge's argument that epidemiological research may be of no probative value in a case such as this. Pending clear understanding of biological cause, medical and public health practitioners have relied on epidemiological data to understand and prevent ills.[78] We also note that Pepperidge's argument that as a non- physician Dr. Silverstein could not provide legally sufficient rebuttal to Dr. Hadler misses the mark. Dr. Silverstein did not purport to testify as an expert on diagnosing UEMSDs or on the biology of UEMSDs. Rather, as an epidemiologist, she sought to testify on what could be known based on data related to the association of UEMSD injury -- as diagnosed by others -- with potential causal factors. Pepperidge does not question that Dr. Silverstein is a qualified epidemiologist who, in fact, has performed UEMSD research that is recognized as central to the developing body of research literature.[79]
In light of the significant number of epidemiological studies in the record, their disparity in design, quality, and outcome, and dispute among the experts as to their quality and import, we discuss Dr. Susan Stock's meta-analysis as a means of focusing on the most relevant epidemiological data in the record. A meta-analysis combines data from different studies to draw conclusions based on a larger population than any one study can analyze. (Tr. 10,633-34). In 1991, Dr. Stock, then a resident in community medicine at McMaster University, Hamilton, Ontario, Canada, published a meta-analysis of studies conducted by other researchers on the relationship between workplace factors and the development of UEMSDs. Susan R. Stock, M.D., Workplace Ergonomic Factors in the Development of Musculoskeletal Disorders of the Neck and Upper Limbs: A Meta-Analysis, 19 Am. J. Indus. Med. 87-107 (1991) ("Stock") (GX 310).
Stock reviewed 54 studies based on screening criteria, and assessed them for validity, compared the study findings (to the extent data permitted), and evaluated the surviving studies to assess causality. In assessing validity, studies were rated on: selection bias, nonrespondent bias, comparability of study and control groups, accounting for confounders, validity of exposure and outcome measures, and blinding of assessors. In assessing causality, Stock looked at evidence of temporal relationship, strength of relationship, dose response, and the ruling out of competing hypotheses.
Ultimately, three studies met Stock's inclusion criteria: studies by witnesses Nathan[80] and Silverstein[81] and a study by Finnish researchers. (GX 154). Stock found that all three studies "found a statistically significant relationship between exposure and at least one of the relevant primary outcomes." (Stock at 95). Stock concluded that:
There is strong evidence of a causal relationship between repetitive, forceful work and the development of musculo-skeletal disorders of the tendons and tendon sheaths in the hands and wrists and between those exposures and carpal tunnel syndrome. The study by Silverstein et al was the only one that met the criteria needed to make causal inferences and was the most methodologically rigorous.
(Id. at 100).
Dr. Silverstein's study examined the prevalence of CTS among 652 workers in jobs where the specific hand force and repetitiveness characteristics were estimated. The study population performed 39 different jobs at seven different industrial sites.[82] The jobs were categorized into four exposure groups, ranging from low force/low repetition to high force/high repetition. Workers in the low/force low repetition group served as an internal comparison group for the other three groups.
Dr. Silverstein found that CTS was strongly associated with high-force high repetitive jobs and to a lesser extent with low force/high repetitive and high force/ low repetitive jobs. Repetitiveness appeared to be a stronger risk factor than force. Neither posture nor gender were major confounding variables. Vibration, however, appeared to be an important confounder.
While Dr. Hadler had initially critiqued the Silverstein research in his published work, he acknowledged its strengths in his testimony. On cross-examination, he agreed that the participation rate was "good," and "one of the many good features of this study" (Tr. 10,404-05) and that the study had "many strengths" including its treatment of gender as a potential confounder. While his articles criticized Dr. Silverstein's failure to consider the subjects' prior medical history of UEMSDs, on cross-examination he acknowledged that that deficiency was not critical. (Tr. 10,412).
The most troubling concern raised by Dr. Hadler involved Silverstein's failure to employ electrodiagnostic testing in diagnosing CTS.[83] On behalf of his position, Dr. Hadler cited a study of CTS patients which compared electrodiagnostic testing with alternatives. (RX 79).[84] The study casts doubt on the utility of traditional methods, but did find that the use of the Tinel's sign test[85] was "not that bad." (Tr. 10,182). Dr. Silverstein testified that she did not require electrodiagnostic testing because the aim was to find the simplest measures used by clinicians for diagnosis, based on the literature available in 1981-82. She employed other measures including the Tinel's test.
Dr. Nathan, who had extensive experience with electrodiagnostics, testified that CTS can be diagnosed solely on the basis of symptoms and signs "in most instances" without regard to nerve conduction.[86] We also note that the Mayo Clinic study, discussed above, the "gold standard" did not require electrodiagnostic testing.[87] In light of the testimony of Dr. Nathan, and evidence such as the Mayo Clinic study, we conclude that the Silverstein research should not be excluded on the basis of its failure to employ electrodiagnostic testing.
Before leaving the Silverstein study, however, a further issue involves the fit between Dr. Silverstein's research results and the facts here. The Silverstein research found a significant effect when those involved in low repetition/low force jobs were compared to those involved in high repetition/high force jobs. Silverstein acknowledged, "that the data is less convincing when high repetition work alone [without high force] is involved."[88] (Tr. 10,794). Dr. Silverstein testified, however, that in her opinion the biscuit line jobs were a contributing cause of the employees' CTS, even assuming that all those jobs were "low-force" under the criteria of her studies.[89] (Tr. 10,899-900).
Weighing Dr. Silverstein's testimony, Dr. Hadler's rebuttal testimony, and Stock's analysis, we conclude that the Silverstein study is substantial evidence that repetition causes UEMSDs. In doing so we note that her research does not represent a clear fit with the facts here.
The Nathan study, (supra, note 80), was a cross-sectional survey of 471 workers (in the electronics, steel, plastic, and sausage/meat packaging industries) to determine how many had an abnormality of the median nerve. The study found that impaired sensory conduction of the median nerve was common among workers from all of the 27 occupations studied. When the workers were grouped into five groups, "Administrative/clerical" (Class I/very light resistance/low repetition) had a significantly lower proportion of slowing than "Grinder" (Class V/very heavy resistance/high repetition). However, when hands, instead of persons, were examined the only significant inter-class difference was between Class I and Class III (Assembly line/moderate resistance/moderately high repetition). Nathan explained that since Class V included nearly equally vigorous use of both hands, the absence of an inconsistency between I and V in both cases was itself an inconsistency because of which he was "unable to establish any consistent association between the occurrence of impaired sensory conduction . . . and occupational class or the level of hand activity." (RX 45 at 169). At the hearing, he explained that the most significant finding was that slowing was associated with aging. If work were a factor, then the dominant hand would slow more with age.
The Nathan study is used affirmatively by both parties. Pepperidge relies on Dr. Nathan's just quoted finding that there was no showing of significant difference among groups when hands were the measure. The Secretary and Stock explain that the Nathan study is evidence of the UEMSD hypothesis because it found a statistically significant difference between the lowest physical stress jobs and the highest when persons were the measure. (E.g. Tr. 10,013-14; GX 310 at 93).[90]
In addition, Stock found four "major flaws" in the Nathan study,[91] while none were found in the Silverstein study and two in the Finnish study. Dr. Silverstein also found flaws in the Nathan study because of potential selection bias, failure to describe the categories in quantitative ways and failure to describe how long a person had been on a particular job studied.
The Finnish study which Stock singled out compared the prevalence of UEMSDs among 152 female assembly-line packers in a food production factory with the rate among 133 shop assistants. The latter group served the public in "a big department store chain" and their "movements of hands varied and were nonrepetitive." Tuulikki Luopajarvi, et al., Prevalence of Tenosynovitis and Other Injuries of the Upper Extremities in Repetitive Work, 1979 Scan. J. Work Envi. & Health 48-55 (1979) (GX 154). The study concluded that "assembly-line packers had significantly more, and more severe, disorders in the neck and upper extremities than shop assistants of the same age." Dr. Stock found two major flaws in the study: failure to eliminate all possible confounders and to blind the assessors. Still, she considered it superior in methodology and validity to Dr. Nathan's study.(Stock at 93-94 and Table III).
There are many other epidemiological studies in the record.[92] We have reviewed them and the testimony concerning them.[93] The opposing experts took several approaches to the further studies in the record. First, they touted studies whose results arguably supported their view. Second, they sought to identify biases in studies which might contradict their position. Studies were routinely critiqued because: l) the population selected for study was said to be unrepresentative or too small, 2) potential confounders were not adequately considered, and 3) the sources of basic data were questionable or not apparent -- for example, the composition of the subject population, the way in which putatively hazardous tasks were defined and measured, and the way in which injury was defined and/or diagnosed.[94]
Third, the experts sought to explain how results relied on affirmatively by the opposition actually supported their position. Where the Secretary's witnesses pointed to results that showed injury, Pepperidge's witnesses pointed to seemingly low incidences of injury. Pepperidge also pointed out that in some studies injury was so reportedly widespread as to confirm Pepperidge's view that reports must represent the reporting of normal aches and pains.[95]
Dr. Silverstein, for the Secretary's part, similarly stated that studies relied on by Dr. Hadler did show a relation between repetition and UEMSDs. Dr. Silverstein also sought to counter negative inferences from two kinds of results. She explained that studies that did not specifically address CTS were therefore not probative on the causes of CTS. She also explained that studies (including her own) which indicated that incidence of UEMSDs declined with years on the job did so because of the healthy worker effect (employees with UEMSD's left the job sooner; healthy workers stayed).
Pepperidge asserts that the scientific articles "end up canceling each other out" -- not without some good reason. Moreover, given the limitations of this record, and the conflicting expert opinions discussed above, we conclude that more detailed discussion of the studies in the record would shed more heat than light.
To summarize the epidemiological evidence, while there was no unanimity of opinion in the record, we find Dr. Silverstein's testimony to be the most persuasive. We reach this conclusion both because she actually testified at the hearing (and thus was subject to cross-examination) and because her primary study was identified by the Stock meta-analysis as the most reliable. The evidence presented by Dr. Silverstein supports the existence of a causal connection between the work performed and UEMSDs.
e. Intervention Studies
An important indication of the plausibility of a causal connection is the effect of an intervention to reduce or eliminate exposure to the putative hazard. Dr. Hadler's categories of evidence, consistent with this principle, include studies of "ergonomic interventions."[96] Dr. Hadler testified as to five studies that he identified as ergonomic interventions. As Dr. Silverstein noted, however, two of these studies were not properly characterized as ergonomic interventions.[97] A third study Dr. Hadler relied on was a study by Dr. Silverstein of hand-wrist disorders among investment casting plant workers.[98] That study reported that interventions had not been effective. Dr. Silverstein countered, however, that the interventions did not include reductions in force or repetitiveness.[99]
The other two studies Dr. Hadler cited ("Oxenburgh" and "Greene") are not in the record. Dr. Silverstein testified, however, that the Oxenburgh study actually found that during a 2-year period in which changes were made in an office environment the severity of the CTD problems decreased. Because these two studies were not put into the record, and in light of Dr. Silverstein's testimony, it is difficult to give any weight to them.
We also note Teed-Sparling's testimony on interventions. In response to a cross-examination suggestion that her recommendations did not go far enough, Teed-Sparling testified that "a drastic reduction in repetitive motion injuries" had occurred when similar steps were undertaken at the Pepperidge poultry processing plant in Worthington, Minnesota.[100] (Tr. 3480-81). In light of all the above, we conclude that this record reflects only limited study of the effects of interventions; however, it does include Teed-Sparling's unrebutted testimony that the intervention proposed at Downingtown had been found to work elsewhere.[101]
f. Biological Plausibility
The biological plausibility of any theory of causation is relevant in assessing that theory. In this regard, Dr. Nathan, in addition to the epidemiological study discussed supra, studied the location of slowing in the nerve in the presence of carpal tunnel syndrome.[102] He reported that the slowing occurred most frequently at a distance two to four centimeters from the point where the wrist bends. Dr. Nathan testified that this finding evidenced that bending of the wrist did not cause carpal tunnel, because the slowing, and associated lesion, would be closer to the point where the nerve bends.
Dr. Feldman, who, like Dr. Nathan, had many years of clinical and research experience with UEMSDs, gave testimony in rebuttal to Dr. Nathan. Dr. Feldman did not disagree with Dr. Nathan's finding that the slowing of the median nerve is generally "determined at the distal end of the transverse ligament." However, he questioned the inferences to be drawn from the finding. He explained that while distal wrist crease may serve as a "general landmark," he did not believe the surface crease of the skin would be related predictably to the anatomy within the hand.
We are not in a position to assess the ultimate implication of Dr. Nathan's research. However, as noted supra, Dr. Nathan elsewhere agreed that some of the injuries here (DeQuervain's disease and trigger finger) could have been caused by the tasks at Downingtown. Thus, Dr. Nathan, in effect, endorses the biological plausibility of some of the injuries here.
In addition, alternative hypotheses of the biological plausibility of UEMSDs were presented. Stock summarizes them as follows (GX 310 at 88):
It is further hypothesized that rapid, repetitive, and/or forceful movements, particularly if they are associated with high static load or awkward postures, may lead to localized muscle fatigue, with ischemia and metabolic changes that impair muscle enzyme function. The affected muscles and tendons are then more susceptible to microtears and inflammatory changes resulting in pain and impaired function. The inflamed or thickened tendons or tendon sheaths may also compress adjacent peripheral nerves [Chaffin, 1973; Hagberg, 1982, 1984; Feldman et al., 1983].
Similarly, a manual edited by Dr. Putz-Anderson, an ergonomist witness for the Secretary, explains (Ex. GX 168 at 24):
the more repetitive the task, the more rapid and frequent are the muscle contractions. Muscles required to contract at a high velocity develop less tension than when contracting at a slower rate. Hence, tasks requiring high rates of repetition require more muscle effort, and consequently more time for recovery, than less repetitive tasks. In this manner tasks with high repetition rates can become sources of trauma even when the required forces are minimal and normally safe.
(Footnote omitted). More generally, the record shows that while there is question about the causal role of work activities, with limited exception (notably Dr. Nathan on carpel tunnel) this questioning is not cast in terms of biological implausibility.[103] Thus, with note of Dr. Nathan's research, and his view that some UEMSDs here could be work-related, we find that the evidence of biological plausibility is not inconsistent with the finding of hazard here.
g. A Note on the Australian Experience and Further Evidence
The initial body of data relied on by Dr. Hadler is the "RSI [repetition strain injury] epidemic" that occurred in Australia, during the mid-1980s, as discussed in articles from Australian medical publications, and by Dr. Hadler himself.[104] The epidemic, Dr. Hadler explained, spread to up to 30 percent of the "high tech" workforces in the states of New South Wales and Victoria, and then abated. In retrospect, Dr. Hadler testified, it did so in the absence of pathologically demonstrable ills (often in the seeming absence of effort at competent diagnoses). The epidemic evidently yielded few instances of actual CTS; Dr. Hadler and Pepperidge therefore cite it as evidence that carpal tunnel is not work-related. (E.g., Tr. 10,195-96). Dr. Hadler stated that the epidemic shows that workplace outbreaks of UEMSDs result largely from psychosocial factors. In the Australian case, the possible psychosocial factors included extensive publicity, warnings about arm pain from Australian medical and official sources, labor-management relations, and other el