NATIONAL COTTONSEED PRODUCTS ASSOCIATION, PETITIONER V. ANN
MCLAUGHLIN, SECRETARY OF LABOR, ET AL.

   No. 87-1214

   In the Supreme Court of the United States

   October Term, 1987

   On Petition for a Writ of Certiorari to the United States Court of
Appeals for the District of Columbia Circuit

   Brief for the Federal Respondents in Opposition

            TABLE OF CONTENTS
   Question presented
   Opinions below
   Jurisdiction
   Statement
   Argument
   Conclusion

                            OPINIONS BELOW

   The opinion of the court of appeals (Pet. App. 1a-23a) is reported
at 825 F.2d 482.  The Secretary of Labor's amended cotton dust
standard and statement of reasons in support of the regulation appear
at 50 Fed. Reg. 51120-51179 (1985).

                             JURISDICTION

   The judgment of the court of appeals (Pet. App. 24a-25a) was
entered on August 7, 1987.  A timely petition for rehearing, with
suggestion of rehearing en banc, was denied on October 23, 1987 (Pet.
App. 26a-27a).  The petition for a writ of certiorari was filed on
January 20, 1988.  This Court's jurisdiction is invoked under 28
U.S.C. 1254(1).

                          QUESTION PRESENTED

   Whether the Occupational Safety and Health Administration's cotton
dust standard properly requires monitoring and medical testing of
cottonseed processing employees, in order to protect the health of
especially susceptible employees and to check the accuracy of the risk
assumptions underlying removal of a longstanding exposure limit.

                               STATEMENT

   1. The Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et
seq. (the Act), empowers the Secretary of Labor to adopt occupational
safety and health standards, which are defined by Section 3(8) of the
Act as requirements "reasonably necessary or appropriate to provide
safe or healthful employment and places of employment" (29 U.S.C.
652(8)).  Section 6(a) required the Secretary, within two years of the
Act's enactment and without formal rulemaking proceedings, to adopt as
occupational safety or health standards existing "national consensus"
or "established Federal standards" (29 U.S.C. 655(a)).  In addition,
Section 6(b) of the Act authorizes the Secretary to promulgate, modify
or revoke standards, through notice and comment rulemaking (29 U.S.C.
655(b)).  Whenever a rule promulgated pursuant to Section 6(b)(8)
"differs substantially from an existing national consensus standard,"
the Secretary must set forth in the Federal Register the reasons the
rule adopted will "better effectuate the purposes of" the Act (29
U.S.C. 655(b)(8)).  Section 6(b)(5) requires that in regulating
exposure to "toxic materials or harmful physical agents," the
Secretary must promulgate the standard which, "on the basis of the
best available evidence," will provide the greatest level of
protection feasible (29 U.S.C. 655(b)(5)).  Where appropriate,
standards also "shall prescribe * * * medical examinations or other
tests" at employers' expense, "in order to most effectively determine
whether the health of * * * employees is adversely affected by * * *
exposure" to a regulated hazard (29 U.S.C. 655(b)(7)).

   2. In 1971, pursuant to Section 6(a), the Secretary adopted the
standard established under the Walsh-Healey Act, 41 U.S.C. 35(e), of
1000 ug/m3 (micrograms per cubic meter) as the industry-wide standard
governing exposure to airborne concentrations of cotton dust (Pet.
App. 3a).  In 1976, the Occupational Safety and Health Administration
(OSHA) announced its intention to promulgate a permanent Section 6(b)
cotton dust standard (41 Fed. Reg. 56498), and after amassing a
voluminous record, published a final rule in 1978 convering all
aspects of cotton dust exposure in textile and non-textile industries
(43 Fed. Reg. 27350).  /1/ For the cottonseed processing industry, in
which petitioner's members are engaged, the 1978 standard prescribed a
permissible exposure limit (PEL) of 500 ug/m3 and required cottonseed
oil mills to institute medical surveillance programs, providing for
initial placement and annual medical screening of employees (Pet. App.
3a).  /2/

   This standard never took effect for cottonseed processing and other
non-textile industries, however, because of litigation before the
court of appeals and this Court.  AFL-CIO v. Marshall, 617 F.2d 636
(D.C. Cir. 1979), aff'd in part and vacated in part sub nom. American
Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490 (1981).  /3/
Accordingly, the cottonseed processing industry has remained
continuously subject to the Section 6(a) PEL of 1000 ug/m3 (Pet. App.
3a).

   On remand from the litigation, the Secretary reviewed a number of
cross-sectional health studies of American and foreign cottonseed
processing workers, as well as medical expert testimony regarding
health risks and protective measures (Pet. App. 7a;  50 Fed. Reg.
51133-51137 (1985);  48 Fed. Reg. 26966-26967 (1983)).  The studies of
domestic cottonseed workers uniformly demonstrated that a number of
cottonseed workers manifest impaired lung function at current levels
of cotton dust exposure in cottonseed oil mills, which is especially
linked to length of employment, exposure at early steps of processing,
general and specific allergies, and smoking (Pet. App. 7a;  50 Fed.
Reg. 51133-51134 (1985)).  There was, however, no affirmative evidence
of increased prevalences of byssinosis, /4/ or of a dose-response
relationship at current exposure levels (ibid.).  Studies of foreign
cottonseed workers, however, showed increased prevalences of
byssinosis and other chronic lung disease at very high exposure levels
(Pet. App. 7a, 8a;  50 Fed. Reg. 51133, 51135 (1985)).  All medical
experts agreed that the dust in cottonseed oil mills is not a "mere
nuisance," but rather has "'some biologic activity of a kind similar
to that found in cotton textile mills'" (Pet. App. 7a;  50 Fed. Reg.
51134-51135 (1985) (citation omitted)).  These experts unanimously
recommended medical surveillance of those working in the cottonseed
industry to protect the health of especially susceptible workers and
to develop an appropriate evidentiary base for making an accurate
assessment of true risk (Pet. App. 7a;  50 Fed. Reg. 51134 (1985)).
/5/

   Applying the significant risk analysis mandated by Industrial Union
Dep't v. American Petroleum Inst., 448 U.S. 607 (1980) (hereinafter
Benzene), /6/ the Secretary found that there was "not sufficient
evidence of significant risk (within the cottonseed industry) which
could be substantially reduced by lowering exposure limits" (50 Fed.
Reg. 51135 (1985)).  The Secretary therefore declined to establish a
new, lower Section 6(b) exposure limit (ibid.).  Similarly, the
Secretary concluded from the same evidence that removal of the
existing Section 6(a) PEL would not lead to significant health risk
(50 Fed. Reg. 51136 (1985)).

   The Secretary concluded, however, that he could find no significant
risk in removing the existing PEL only if a "backstop" program of
medical monitoring of employees was retained, in order to assess the
correctness of that judgment and to protect unusually susceptible
workers (50 Fed. Reg. 51135-51136 (1985)).  Accordingly, the Secretary
imposed on the industry the medical surveillance and related
recordkeeping requirements of the cotton dust standard.  /7/ The
Secretary found direct support for this action in a passage in Benzene
(448 U.S. at 657-658), where this Court approved in dictum "a backstop
in the form of monitoring and medical testing," imposed in conjunction
with standards set at exposure levels below those of significant risk.
 Such monitoring allows OSHA to "'keep a constant check on the
validity of the assumptions made in developing the permissible
exposure limit, giving it a sound evidentiary basis for decreasing the
limit if it was initially set too high'" and to "'ensure that workers
who were unusually susceptible * * * could be removed from exposure
before they had suffered any permanent damage'" (50 Fed. Reg. 51135
(1985) (quoting 448 U.S. at 658)).

   This dictum applied here, the Secretary explained, because the
decision to remove exposure limits was based on less-than-perfect
evidence and two of the reasons cited by Benzene for a medical
surveillance backstop were directly implicated by the record.
Specifically, a backstop was necessary to "check on the validity of
the assumption()" that deregulation would not lead to significant
health risks, since exposures might rise after the PEL was removed and
the foreign studies showed an increased incidence of chronic lung
disease at higher exposure levels, and thus an affirmative
dose-response relationship (50 Fed. Reg. 51135 (1985)).  Moreover,
there was a clear medical need for such monitoring to identify and
protect especially susceptible workers who, even at current exposure
levels, had been shown to be at risk (id. at 51136).  Accordingly, the
Secretary determined not to exempt the cottonseed processing industry
from the medical surveillance requirements of the cotton dust
standard.

   3. Petitioner National Cottonseed Products Association sought
review, pursuant to 29 U.S.C. 655(f), of the cotton dust standard as
it applies to the cottonseed processing industry.  The court of
appeals upheld the medical surveillance requirements as "sanction(ed)"
by "an unusually precise dictum in Benzene" (Pet. App. 4a).  The court
explained that the Benzene Court specifically addressed the
Secretary's regulatory options where she is "uncertain whether the
residual risk (at the selected exposure level is) significant" (id. at
6a).  In such circumstances, the Secretary has authority, as explained
in Benzene, to require backstop employee health monitoring to check
the validity of the assumptions regarding the exposure limit selected,
to develop sound evidence for changing the exposure limit, and to
"ensure that unusually susceptible workers could be removed from
exposure before they suffered permanent damage" (ibid., citing
Benzene, 448 U.S. at 657-658).  Thus, Benzene permits "backstop
monitoring" where the "'less-than-perfect'" evidence upon which OSHA
relies "indicates * * * a real possibility of significant health risks
under the other aspects of the standard adopted (here, no regulation
at all)" (Pet. App. 8a).

   The court also found the evidence in the rulemaking record
sufficient to "invoke the conditions suggested by * * * Benzene for a
backstop monitoring requirement" (Pet. App. 8a).  The studies of
cottonseed workers and experts' testimony disclosed that, at existing
exposure levels, domestic cottonseed workers as a group suffer from
decreased lung function, even though they do not experience an
increased incidence of byssinosis (id. at 7a).  And a subset of
hypersensitive workers suffer from respiratory ailments (id. at 4a,
7a).  Moreover, foreign cottonseed workers subject to higher doses
than domestic workers experience significant health effects,
suggesting a dose-response relationship (id. at 7a).  Thus, the
Secretary appropriately concluded that "the risk of material harm to
cottonseed workers would not be 'significant' even without a PEL, so
long as medical surveillance was retained as a 'backstop'" (id. at 4a
(quotation in original)).

   Responding to petitioner's argument that medical surveillance may
be required only where OSHA identifies some "'reasonably attainable
level'" at which harm will occur, the court of appeals noted that OSHA
was hampered in making such a determination here because of the
"ambiguous relation between reality and the pre-existing regulation"
(Pet. App. 6a).  /8/ The court of appeals concluded, however, that
application of the Benzene dictum was justified by the evidence of
risk before OSHA, from which it reasonably inferred that exposures
might rise, to the detriment of worker health, with the removal of
exposure limits (id. at 6a-7a).  The court agreed with the Secretary
that under these circumstances, medical surveillance was necessary
both to protect worker health and to provide an evidentiary basis for
assessing the validity of the assumptions upon which OSHA relied in
eliminating the PEL.  /9/

                               ARGUMENT

   The decision of the court of appeals is correct and does not
conflict with any decision of this Court or of any other court of
appeals.  Accordingly, the petition for a writ of certiorari should be
denied.

   1. The court below correctly held that the Secretary's decision to
require "backstop" medical surveillance of cottonseed industry workers
falls squarely within an "unusually precise" dictum in the Benzene
decision.  The central thrust of the pertinent passage (448 U.S. at
657-658) is that backstop monitoring may be required even at exposure
levels with respect to which no significant risk is shown.  To justify
such "backstop" monitoring, the Secretary must reasonably conclude,
based on the best available evidence, that there is residual risk at
those lower exposure levels which warrants prophylactic regulatory
action.  See 448 U.S. at 657-658.  As the court of appeals held, the
Secretary properly found that the rulemaking record invoked precisely
the same conditions identified in Benzene as warranting backstop
monitoring.  /10/

   First, as the court found, the record conclusively established a
class of unusually susceptible cottonseed workers who suffered
impaired lung function even at current levels of cotton dust exposure.
 As in Benzene, medical surveillance would protect their health by
permitting their removal from exposure.  See Pet. App. 6a;  compare 50
Fed. Reg. 51135-51136 (1985) (monitoring allows removal of unusually
susceptible persons from particularly dusty jobs);  Benzene, 448 U.S.
at 658 (footnote omitted) (monitoring "could ensure that workers who
were unusually susceptible to benzene could be removed from exposure
before they had suffered any permanent damage").  /11/

   The record also demonstrated clear increased prevalences of
byssinosis and other chronic lung diseases among workers in foreign
cottonseed oil mills, where exposure levels are higher.  Given the
real possibility that exposures in American cottonseed mills might
rise with the removal of the Section 6(a) PEL, /12/ backstop
monitoring was necessary to check the validity of the basic assumption
that elimination of the PEL would not give rise to significant risk.
There is thus no merit to petitioner's contention (Pet. 12-13) that
the court below sanctioned impermissible employer-financed data
gathering of merely possible health risks.  See Pet. App. 7a;  50 Fed.
Reg. 51136 (1985) (medical surveillance "provide(s) a backstop if
(OSHA's) judgment (on significant risk) is incorrect");  Benzene, 448
U.S. at 658 (footnote omitted) (OSHA "could keep a constant check on
the validity of the assumptions made in developing the permissible
exposure limit, giving it a sound evidentiary basis for decreasing the
limit if * * * initially set too high").  This Court specifically
approved this "type of information-gathering" as contemplated by
Section 6(b)(7), "which empowers the Secretary to require medical
examinations to be furnished to employees exposed to certain hazards
and potential hazards, 'in order to most effectively determine'"
whether worker health is adversely affected by such exposure.
Benzene, 448 U.S. at 658 n.66 (citations omitted;  emphasis added).
Thus, the Secretary properly concluded that significant risk would not
result from removal of the Section 6(a) PEL only if conditioned on
backstop medical surveillance.  /13/ In these circumstances, the court
of appeals correctly held that Benzene's "unusually precise dictum"
specifically sanctions the backstop medical surveillance standard
imposed on the cottonseed industry in this case.  /14/

   2. Nor does the decision of the court below conflict with Texas
Independent Ginners Ass'n v. Marshall, 630 F.2d 398 (5th Cir. 1980),
as petitioner asserts (Pet. 11-12).  First, the nature of the
regulatory actions and their stated justifications are quite
different.  The cotton ginning standard imposed a number of work
practices and other protective measures in addition to medical
testing.  /15/ See 630 F.2d at 402-403.  The Secretary rested the
standard's requirements on a finding of health hazards at existing
unregulated exposure levels.  The First Circuit rejected the standard
in its entirety because it concluded that the Secretary's finding --
characterized as "OSHA's findings of a significant risk of a material
health impairment" (id. at 407) -- was not based on substantial
evidence but rather on "assumptions without an adequate evidentiary
basis" (id. at 409).  The Fifth Circuit nowhere discussed or even
alluded to the circumstances under which the Secretary may require
medical surveillance as a backstop to permitted exposure at levels
with respect to which no significant risk is shown.  This omission is
understandable since the Secretary did not justify the requirement on
"backstop" grounds either in rulemaking or in the court of appeals.
/16/

   Ginners is also distinguishable from the decision below, because,
as the Fifth Circuit noted, "the 1971 (Section 6(a)) PEL never applied
to the ginning industry * * * " (630 F.2d at 403 n.20), and thus the
case did not implicate the provision of the Act which permits
modification or revocation of a Section 6(a) standard only if "the
rule as adopted will better effectuate the purposes" of the Act (29
U.S.C. 655(b)(8)).  By contrast, the cottonseed industry has been
continuously subject to the Section 6(a) PEL.  Thus, to eliminate the
Section 6(a) PEL applicable to the cottonseed industry, the Secretary
was obligated to find that the evidence "affirmatively indicate(s)"
that significant risk is "unlikely to exist" at exposures likely to
prevail after the PEL was eliminated.  See 50 Fed. Reg. 51132 (1985).
As explained above, the Secretary determined that this judgment could
be made if, and only if, conditioned on the availability of backstop
medical surveillance.  No PEL, combined with medical surveillance,
results in both considerable savings to the industry and protection
for highly susceptible workers and reevaluation of risk, thus better
effectuating the Act's goal of protecting employee helath.  See id. at
51135-51136.  In Ginners, on the other hand, the court had no occasion
to consider the circumstances under which a Section 6(a) exposure
limit could properly be revoked or the link between revocation of a
Section 6(a) limit and retention of medical monitoring as a backstop
to that determination.

                              CONCLUSION

   The petition for a writ of certiorari should be denied.

   Respectfully submitted.

   CHARLES FRIED

      Solicitor General

   GEORGE R. SALEM

      Solicitor of Labor

   ALLEN H. FELDMAN

      Associate Solicitor for Special Appellate and Supreme Court
      Litigation

   MARY-HELEN MAUTNER

      Counsel for Appellate Litigation

   CHRISTINE L. OWENS

      Attorney Department of Labor

   APRIL 1988

   /1/ The toxic nature of cotton dust, its acute and chronic effects
on pulmonary function, and the history of its regulation are fully
discussed in American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S.
490 (1981).

   /2/ Cottonseed processing involves breaking down untreated
cottonseed into linters (coarse fuzz) and seed hulls and kernels.  The
process is dusty and the linters contain contaminants similar to those
in baled cotton fibers.  After cleaning, linters are baled and the
seed remanents are used ot produce cottonseed oil and meal.  43 Fed.
Reg. 27350, 27369 (1978).

   /3/ The court of appeals remanded the record for cottonseed
processing only for reconsideration of the standard's economic
feasibility.  AFL-CIO v. Marshall, 617 F.2d at 669.  Thereafter, when
this Court remanded the other non-textile segments for reconsideration
in light of Industrial Union Dep't v. American Petroleum Inst., 448
U.S. 607 (1980), see Cotton Warehouse Ass'n v. Marshall, 449 U.S. 809
(1980), the Secretary undertook a similar reveiw for cottonseed
processing too.

   /4/ Byssinosis, also known as "brown lung" disease, is a
respiratory ailment characterized by coughing, breathlessness or
tightness of the chest.  See 50 Fed. Reg. 51125 (1985).

   /5/ One expert stressed that the true risk for cottonseed workers
may be underestimated by the large cross-sectional studies in the
record (50 Fed. Reg. 51133-51134 (1985)).  He noted that medical
surveillance would provide the type of longitudinal data necessary to
make an accurate assumption about the real level of risk in cottonseed
oil mills (ibid.).

   /6/ The Secretary described his analytical approach to the
significant risk analysis, including the factors to be taken into
account in making rational policy judgments regarding risk, at 50 Fed.
Reg. 51131 (1985).

   /7/ These provisions, set out at 29 C.F.R. 1910.1043(h)(2) and
(k)(2)-(4), require employers to provide initial placement medical
screening, followed by routine screening every two years, except for
those employees as to whom the results of testing indicate that more
regular testing (i.e., every six months) is appropriate.  The tests
include completion of a prescribed questionnaire;  objective pulmonary
function tests;  and completion of a physician's report containing
specified information.  The recordkeeping requirements of Section
1910.1043(k)(2)-(4) are keyed to these medical screening provisions.

   /8/ The court noted general agreement that the cottonseed industry
"has not complied with the 1000 ug/m3" PEL, but stressed that "there
is no concession that the regulations of the past 16 years have been
absolutely without effect," and that one study found that 16 of 18
mills maintained mean exposure levels at or below the PEL (Pet. App.
6a).

   /9/ The court also rejected petitioner's claims that compliance
with the medical surveillance requirements is not technologically or
economically feasible for the industry.  Petitioner does not seek
review of this aspect of the court's ruling, although it asserts that
medical surveillance is costly and inconvenient (Pet. 14).  The court
of appeals upheld OSHA's conclusion that the costs of compliance here
with the medical surveillance requirements were minuscule (slightly
over $70,000 annually, or less than 0.01% of the industry's annual
gross revenues of $777.6 million), finding that any errors made by
OSHA in its cost analysis were "trivial" and inconsequential (Pet.
App. 11a-12a).

   /10/ Section 6(f) of the Act, 29 U.S.C. 655(f), prescribes
"substantial evidence" review of the Secretary's determinations.  The
court below carefully reviewed the evidence upon which the Secretary
had relied in this case, as well as contradictory evidence in the
record, and found the evidence supported the medical surveillance
standard.  Petitioner does not challenge the court's decision on
substantial evidence grounds.

   /11/ Numerous decisions uphold the imposition of medical testing
and other remedial requirements at action levels lower than
established exposure limits, in order to protect especially
susceptible workers.  See, e.g., GAF Corp. v. Occupational Safety &
Health Review Comm'n, 561 F.2d 913 (D.C. Cir. 1977) (cited approvingly
in the Benzene discussion of backstop surveillance, upholding the
requirement of medical examinations for employees exposed to any
airborne concentrations of asbestos);  Forging Indus. Ass'n v.
Secretary of Labor, 773 F.2d 1436, 1443-1444 (4th Cir. 1985) (en banc)
(upholding hearing conservation amendment to noise exposure standard,
providing for testing and appropriate follow-up measures, as needed,
for employees exposed to noise levels at action levels below the PEL);
 United Steelworkers v. Marshall, 647 F.2d 1189, 1237 (D.C. Cir.
1980), cert. denied, 453 U.S. 913 (1981) (upholding the medical
removal provisions of the lead standard, keyed to the results of
medical surveillance and biological monitoring of employees exposed to
lead concentrations significantly lower than the PEL).

   /12/ Petitioner argues (Pet. 14) that industry was not in
compliance with the existing PEL, and thus that it was unreasonable to
assume that elimination of the PEL might lead to material health
impairment.  The court of appeals correctly rejected this argument,
stressing that because "there is no concession that the regulations of
the past 16 years have been absolutely without effect," and, in fact,
some record evidence reflects substantial compliance, the Secretary
could "fairly infer" that removal of the PEL could result in increased
exposure (Pet. App. 6a).

   /13/ Seizing on the precise fact situation described in Benzene,
petitioner argues that the dictum must be read in exceedingly literal
fashion, and that backstop monitoring may only be imposed as an
adjunct to a PEL or at levels at which significant risk is identified
(Pet. 10-11).  The court of appeals rightly rejected this constrained
approach, which would effectively rob the dictum of its meaning.  As
the court of appeals noted, this Court plainly did not confine
backstop monitoring to the precise facts of its hypothetical, nor is
there any sound reason to do so.  Rather, the court of appeals
correctly recognized that deleting an exposure limit, like lowering or
raising a limit, is a regulatory judgment with respect to which
imposition of medical surveillance as a backstop may be appropriate
(Pet. App. 8a).

   /14/ Petition erroneously argues (Pet. 11) that this Court would
have upheld the medical surveillance requirements in Benzene if it
believed that medical surveillance could be imposed in the absence of
a PEL.  But this Court specifically noted in Benzene that it was
dealing only with the exposure limits set by the Secretary, and
declined to rule on any other aspects of the standard.  See, e.g., 448
U.S. at 630 n.30.

   /15/ In addition to medical surveillance, the cotton ginning
standard required work practice plans to minimize employee exposure to
cotton dust;  employee training programs;  provision of disposable
respirator masks to all employees desiring them and air powered air
purifying respirators to certain other employees;  and posting of
workplace warnings regarding the dangers of cotton dust.  See 43 Fed.
Reg. 27418 (1978);  Ginners, 630 F.2d at 402-403.

   /16/ Ginners was briefed and argued before Benzene was decided,
even though it was issued shortly after Benzene.