[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Notices]
[Pages 31159-31181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14723]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
Supplement to California State Plan; Approval
AGENCY: Occupational Safety and Health Administration, Labor.
ACTION: Approval; California State Standard on Hazard Communication
Incorporating Proposition 65.
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SUMMARY: This notice approves, subject to certain conditions, the
California Hazard Communication Standard, including its incorporation
of the occupational applications of the California Safe Drinking Water
and Toxic Enforcement Act (Proposition 65). Where a State standard
adopted pursuant to an OSHA-approved State plan differs substantially
from a comparable Federal standard, the Occupational Safety and Health
Act of 1970 (the OSH Act) requires that the State standard be ``at
least as effective'' in providing safe and healthful places of
employment. In addition, if the standard is applicable to a product
distributed or used in interstate commerce, it must be required by
compelling local conditions and not pose an undue burden on commerce.
After consideration of public comments and review of the record,
OSHA is approving the California standard, with the following
conditions, which are applicable to all enforcement actions brought
under the authority of the State plan, whether by California agencies
or private plaintiffs:
(1) Employers covered by Proposition 65 may comply with the
occupational requirements of that law by complying with the OSHA or
Cal/OSHA Hazard Communication provisions, as explicitly provided in the
State's regulations.
(2) The designated State agency, Cal/OSHA, is responsible for
assuring that enforcement of its general Hazard Communication Standard
and Proposition 65 results in ``at least as effective'' worker
protection; the agency must take appropriate action to assure that
court decisions in supplemental enforcement actions do not result in a
less effective standard or in inconsistencies with the conditions under
which the standard is Federally approved.
(3) The State standard, including Proposition 65 in its
occupational aspects, may not be enforced against out-of-state
manufacturers because a State plan may not regulate conduct occurring
outside the State.
These conditions are based on OSHA's understanding of the State's
regulations and on general State plan law. Finally, Proposition 65 also
is applicable to non-occupational (i.e. consumer and environmental)
exposures. OSHA has no authority to address Proposition 65's non-
occupational applications; consequently, they are not at issue in this
decision and will be unaffected by it.
EFFECTIVE DATE: June 6, 1997.
FOR FURTHER INFORMATION CONTACT: Bonnie Friedman, Director, Office of
Information and Consumer Affairs, Occupational Safety and Health
Administration, U.S. Department of Labor, Room N-3647, 200 Constitution
Avenue, N.W., Washington, DC 20210. Telephone: (202) 219-8148.
SUPPLEMENTARY INFORMATION:
Contents of OSHA'S Decision
I. Background
A. Pertinent Legal Authority
B. Description of the California State Plan Supplement
1. Federal and State Hazard Communication Standards
2. Proposition 65
3. OSHA Review and Public Comment
II. Summary and Explanation of Legal Issues
A. Applicability of Product Clause to Proposition 65
Requirements
B. Overview: OSHA Review of State Standards Under the Product
Clause
C. Burden of Proof
D. Application of the California Standard to Out-of-State
Manufacturers and Distributors
E. Designated State Agency
F. Exemption for Public Sector Employers
III. Summary and Explanation of Remaining Issues Under Section 18
A. Compelling Local Conditions
1. Overview
2. Commentor Rebuttal Arguments
B. Remaining 18(c)(2) Issues
1. Overview
2. Businesses Can Comply With Proposition 65 by Using Methods
Prescribed by the Federal Hazard Communication Standard
3. Comparison of Coverage Under Federal Standard and Proposition
65
Overview
Mixtures
Articles
Pesticides
Aflatoxins
California Non-Chemical Manufacturers
4. Substantive Differences Between the Federal and General
California Standards
Trade Secrets
California's Omission of Federal Exemptions and Exclusions
[[Page 31160]]
California's Requirement for Use of Lay Terminology on MSDSs
5. Supplemental Enforcement
Effectiveness
Product Clause
C. Inspections, Employer/Employee Rights
D. Qualified Personnel
IV. Decision
V. Location of Supplement for Inspection and Copying
References to the record are made in the text of this decision. The
docket number in this case is T-032. References to exhibits in the
docket appear as ``Ex. ________.'' Exhibit 18 contains all of the
public comments filed. Each individual comment has been assigned a
number and this notice will refer to individual comments by these
numbers--``Ex. 18-________.''
I. Background
A. Pertinent Legal Authority
The Occupational Safety and Health Act generally preempts any State
occupational safety and health standard that addresses an issue covered
by an OSHA standard, unless a State plan has been submitted and
approved. See Gade v. National Solid Wastes Management Association, 505
U.S. 88 (1992). Once a State plan is approved, the bar of preemption is
removed and the State is then able to adopt and enforce standards under
its own legislative and administrative authority. As a consequence, any
State standard or policy promulgated under an approved State plan
becomes enforceable upon State promulgation. Newly-adopted State
standards must be submitted for OSHA review and subsequent approval
under procedures set forth in 29 CFR Part 1953 and OSHA Directive STP
2-1.117, but are enforceable by the State prior to Federal review and
approval. See Florida Citrus Packers v. California, 549 F. Supp. 213
(N.D. Cal. 1982); Chemical Manufacturers Association v. California
Health and Welfare Agency, No. CIV. S-88-1615 LKK (E. D. Cal. 1994). On
May 1, 1973, OSHA published its initial approval of the California
State plan in the Federal Register. 38 FR 10717, 29 CFR Part 1952,
Subpart K.
The requirements for adoption and enforcement of safety and health
standards by a State with an approved State plan are set forth in
Section 18(c) of the OSH Act and in 29 CFR Parts 1902, 1952 and 1953.
OSHA regulations require States to respond to the adoption of new or
revised permanent Federal standards by promulgating comparable
standards. As explained in more detail in section B, OSHA adopted a
hazard communication standard in November 1983. California adopted its
own hazard communication standard in 1981 and revised it, in response
to the Federal standard, in November 1985. California submitted its
Hazard Communication Standard to OSHA for approval on January 30, 1986.
On January 30, 1992, the State submitted changes to this standard by
incorporating relevant provisions of the Safe Drinking Water and Toxic
Enforcement Act (Proposition 65). See California Health and Welfare
Code Secs. 25249.5-25249.13.
Under Section 18(c) of the Act and OSHA's regulations, State plans
and plan changes must meet certain criteria before they are approved.
The principal criteria are:
The State must designate a State agency or agencies which
is responsible for administering the plan throughout the State. 29
U.S.C. Sec. 667(c)(1).
If a State standard is not identical to Federal standards,
the State standard (and its enforcement) must be at least as effective
as the comparable Federal standard. Moreover, if a non-identical State
standard is applicable to products distributed or used in interstate
commerce, it must be required by compelling local conditions and must
not unduly burden interstate commerce. (This latter requirement is
commonly referred to as the ``product clause.'') 29 U.S.C.
Sec. 667(c)(2).
The State must provide for a right of entry and inspection
of all workplaces which is at least as effective as that provided in
section 8 of the Act and must prohibit advance notice of inspections.
29 U.S.C. Sec. 667(c)(3).
The responsible State agency or agencies must have ``the
legal authority and qualified personnel necessary for the enforcement
of such standards and adequate funding.'' 29 U.S.C. Sec. 667(c) (4)-
(5).
To the extent the State's constitutional law permits, it
must establish a comprehensive occupational safety and health program
for employees of public agencies of the State and its political
subdivisions which is at least as effective as the standards contained
in an approved plan. 29 CFR Sec. 1952.11.
In enacting the State plan system, Congress' intention was to
encourage the States ``to assume the fullest responsibility for the
administration and enforcement of their occupational safety and health
laws.'' 29 U.S.C. Sec. 651(b)(11); 29 CFR Sec. 1902.1. Consistent with
this Congressional declaration, OSHA has interpreted the OSH Act to
recognize that States with approved State plans retain broad power to
fashion State standards. As President Reagan noted in Executive Order
12612 (October 26, 1987), ``[t]he nature of our constitutional system
encourages a healthy diversity in the public policies adopted by the
people of the several States according to their own conditions, needs,
and desires. In the search for enlightened public policy, individual
States and communities are free to experiment with a variety of
approaches to public issues.'' Section 18 of the OSH Act reflects this
``search for enlightened public policy'' not by delegating Federal
authority to the States but by removing the bar of preemption through
plan approval and, thus, allowing States to administer their own
workers' protection laws so long as they meet the floor established by
the Federal OSHA program.
B. Description of the California State Plan Supplement
1. Federal and State Hazard Communication Standards
On September 10, 1980, the Governor of California signed the
Hazardous Information and Training Act. California Labor Code,
Secs. 6360-6399. This Act instructed the Director of Industrial
Relations, the State's designee responsible for operation of the OSHA-
approved State plan (known as Cal/OSHA) to establish a list of
hazardous substances and to issue a standard setting forth employers'
duties toward their employees under that Act. The standard, General
Industry Safety Order 5194 (8 CCR Sec. 5194), was adopted by the State
in 1981. Both the Director's initial list and the standard became
effective on February 21, 1983.
Federal OSHA promulgated a hazard communication standard (29 CFR
Sec. 1910.1200) in November 1983. The State amended its law in 1985,
and, after a period for public review and comment, the California
Standards Board adopted a revised standard for hazard communication on
October 24, 1985. The standard became effective on November 22, 1985.
By letter dated January 30, 1986, with attachments, from Dorothy H.
Fowler, Assistant Program Manager, to then Regional Administrator,
Russell B. Swanson, the State submitted the standard and incorporated
the standard as part of its occupational safety and health plan.
In addition to the supplemental provisions of Proposition 65, the
State Hazard Communication Standard differs from the Federal standard
in a few minor respects:
(1) The State standard requires that each Material Safety Data
Sheet contain certain information including Chemical Abstracts Service
(CAS) name (unless its disclosure could reveal a trade secret),
[[Page 31161]]
while the Federal standard does not require inclusion of the CAS;
(2) The State standard specifically requires a description in lay
terms of the particular potential health risks posed by the hazardous
substance, while the Federal standard more broadly requires
``appropriate'' hazard warnings;
(3) While the Federal standard allows for release of trade secret
information to health professionals who enter into confidentiality
agreements, the California standard allows access to such information
to safety professionals as well; and
(4) The State standard does not include some of the exemptions and
exceptions added to the Federal standard in 1994.
See Section II.B.4.
Cal/OSHA enforces the California Hazard Communication Standard,
like its other standards, under approved procedures similar to those of
Federal OSHA. Safety and health inspectors from the Division of
Occupational Safety and Health conduct on-site inspections in response
to complaints of workplace hazards or when the establishment is
selected for a programmed inspection based on objective criteria, etc.
Employer and employee representatives may accompany the inspector. If
violations are noted, a citation and proposed penalties are issued to
the employer, who has the right of appeal to the California
Occupational Safety and Health Appeals Board and thereafter to the
courts.
2. Proposition 65
In a 1986 referendum, voters of the State of California adopted
Proposition 65, the ``Safe Drinking Water and Toxic Enforcement Act.''
Proposition 65 and implementing regulations require any business with
ten or more employees that ``knowingly and intentionally'' exposes an
individual to a chemical known to the State to cause cancer or
reproductive toxicity to provide the individual with a ``clear and
reasonable'' warning. California Health and Safety Code sections
25249.5 through 25249.13; 22 CCR Secs. 12000 et seq. In accordance with
Proposition 65, the State annually publishes a list of chemicals known
to cause cancer or reproductive toxicity. 22 CCR Sec. 12000.
Proposition 65 applies broadly to all exposures to listed chemicals;
consequently, the law has consumer and environmental applications, as
well as the occupational exposures relevant here. Under the Office of
Environmental Health Hazard Assessment (OEHHA) regulations, a
``consumer product'' exposure is ``an exposure which results from a
person's acquisition, purchase, storage, consumption, or other
reasonably foreseeable use of a consumer good, or any exposure that
results from receiving a consumer service.'' 22 CCR Sec. 12601(b). An
``occupational exposure'' is ``an exposure, in the workplace of the
employer causing the exposure, to any employee.'' 22 CCR Sec. 12601(c).
``Environmental exposures'' include exposures resulting from contact
with environmental media such as air, water, soil, vegetation, or
natural or artificial substances. 22 CCR Sec. 12601(d). OSHA has no
authority to address Proposition 65's consumer and environmental
applications; consequently, they are not at issue in this decision and
will be unaffected by it.
Proposition 65 was passed by referendum of the voters of California
in 1986. On January 23, 1991, the California Court of Appeal ordered
the California Occupational Safety and Health Standards Board to amend
the State's Hazard Communication standard to incorporate the
occupational warning protections of Proposition 65. See California
Labor Federation, AFL-CIO v. California Occupational Safety and Health
Standards Board, 221 Cal. App. 3d 1547 (1990).1 These
changes were adopted on an emergency basis on May 16, 1991, and became
effective on May 31, 1991. A permanent standard became effective on
December 17, 1991. On January 30, 1992, the State submitted amendments
to its Hazard Communication Standard, adapting both the substantive
requirements and enforcement mechanism of Proposition 65 and OEHHA's
implementing regulations, for application to the workplace. Ex. 4.
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\1\ In 1988, the Chemical Manufacturers Association (and other
plaintiffs) challenged the applicability of Proposition 65 in the
workplace, arguing that the law was preempted because it was not a
part of the approved State plan. In 1994, the U.S. District Court
for the Eastern District of California ruled that the plaintiffs, as
a result of the State's incorporation of Proposition 65 into the
State plan, did not have standing to pursue their action and that
the issues were not ripe for review. Chemical Manufacturers
Association v. California Health and Welfare Agency, slip op. at 15-
25.
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Two State agencies have been authorized to issue regulations
interpreting and implementing Proposition 65's occupational aspects. As
discussed in greater detail in Section III.B.2, Cal/OSHA and OEHHA
regulations governing occupational exposures provide three alternative
methods of complying with Proposition 65:
(1) Warnings may be given through the label of a product;
(2) Warnings may be given via a workplace sign; or
(3) The general California or Federal Hazard Communication Standard
may be followed.
See 8 CCR Secs. 5194(b)(6) (B)-(C) and 22 CCR Sec. 12601(c).
Compliance with Section 12601(c)--which allows use of California or
Federal hazard communication methods--is a defense to supplemental
enforcement actions brought under Proposition 65. 8 CCR
Sec. 5194(b)(6)(E). The regulations also provide sample language for
the label and sign warnings. 2 The sample label and sign
language, however, represents a ``safe harbor'' method of providing
Proposition 65 warnings. Again, compliance with either the Federal or
general State hazard communication procedures constitutes compliance
with Proposition 65 and is a defense to any enforcement action. 8 CCR
Sec. 5194(b)(6) (B), (C), (E); 22 CCR Sec. 12601(c)(1)(C).
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\2\ For labels, the warnings which are deemed to meet the
requirements of Proposition 65 are: ``WARNING: This product contains
a chemical known to the State of California to cause cancer,'' or
``WARNING: This product contains a chemical known to the State of
California to cause birth defects or other reproductive harm.'' For
signs, the language deemed to meet the requirements is: ``WARNING:
This area contains a chemical known to the State of California to
cause cancer,'' or ``WARNING: This area contains a chemical known to
the State of California to cause birth defects or other reproductive
harm.''
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The Proposition 65 requirements of the California standard are
enforceable with regard to occupational hazards through the usual
California State plan system of inspections, citations and proposed
penalties which has been determined to be at least as effective as
Federal OSHA enforcement. 38 FR 10717 (May 1, 1973). The Cal/OSHA
enforcement directive on hazard communication (Policy and Procedure C-
43) provides that a covered employer may comply with the incorporated
Proposition 65 requirements by including the substance in the
employer's Hazard Communication Program. In addition, the Cal/OSHA
standard incorporates the enforcement mechanism of Proposition 65,
which provides for supplemental judicial enforcement by allowing the
State Attorney General, district attorneys, city attorneys, city
prosecutors, or ``any person in the public interest'' to file civil
lawsuits against alleged violators. Private plaintiffs bringing actions
must first give notice to the Attorney General and appropriate local
prosecutors, and may proceed if those officials do not bring an action
in court within sixty days.
Proposition 65 provides for penalties of up to $2500 per day, per
violation. A
[[Page 31162]]
private plaintiff may obtain up to 25% of penalties levied against a
company found in violation of Proposition 65 for failing to provide
required warnings. Private actions with regard to occupational
exposures have been brought in California courts, and many more have
been settled on varying bases prior to trial or prior to initiation of
formal court action.
3. OSHA Review and Public Comment
On April 18, 1995, the Coalition of Manufacturers for the
Responsible Administration of Proposition 65 (the Coalition), filed a
petition with OSHA requesting that the Plan change submitting the
California Hazard Communication Standard with its incorporation of
Proposition 65 be rejected. Ex. 8. The Coalition argued that the
substantive and enforcement aspects of Proposition 65 unduly burden
interstate commerce. Various parties wrote to OSHA to express support
for, or opposition to, the Coalition's petition. Exs. 9-16. Other
parties expressed concern to OSHA about the continued enforceability of
the private right of action provisions of Proposition 65 in the
workplace during the pendency of the OSHA review process.
On September 13, 1996, OSHA requested public comment (61 FR 48443)
as to whether to approve the California Hazard Communication Standard
incorporating Proposition 65 pursuant to 29 CFR parts 1902 and 1953.
OSHA had preliminarily determined that the California plan change was
at least as effective as the Federal standard and was applicable to
products used or distributed in interstate commerce. OSHA sought
comment on these determinations as well as the ``product clause''
requirements for standards which differ from the relevant Federal
standard--i.e. whether the State standard is required by compelling
local conditions or poses any undue burden on interstate commerce. (As
discussed in Section II.B, in its Directive STP 2-1.117 governing the
review of different State standards, OSHA specifically stated that
public comment would constitute its initial means of assessing the
product clause implications of a State standard and that absent record
evidence to the contrary a State standard would be presumed to meet the
test.)
Following OSHA's September 13, 1996 request for comment on the
proposed standard, 207 commentors submitted statements. Many of the
commentors opposing the standard are companies which have experienced,
or fear experiencing, private enforcement lawsuits under Proposition
65. In a number of these cases, the commentor did not make it clear
whether the company involved had been sued under Proposition 65's
occupational, consumer or environmental applications. E.g., Ex. 18-2,
18-23, 18-127, 18-130, 18-133. As noted previously, OSHA's decision can
have no effect upon enforcement actions alleging consumer or
environmental exposures.
II. Summary and Explanation of Legal Issues
The comments filed with OSHA presented a variety of issues, each of
which will be discussed below. Section III of this notice discusses the
more specific provisions of the California standard in light of the
requirements of Section 18 of the OSH Act, particularly the product
clause. In this Section, however, OSHA will discuss several general
legal questions at issue here.
Some commentors have raised issues involving application of the OSH
Act's ``product clause'' to the Proposition 65 elements of the
California standard. First, several commentors have questioned whether
OSHA should apply the product clause to Proposition 65's substantive
requirements and enforcement methods. See Section II.A. Second, OSHA
provides an overview of the product clause and outlines the principles
OSHA will apply in analyzing product clause issues. See Section II.B.
Third, OSHA historically has treated State standards as presumptively
compliant with the product clause. OSHA Instruction STP 2-1.117 (August
31, 1984); see, e.g., 62 FR 3312 (January 22, 1997) (approval of
Washington State standard amendments for acrylonitrile, 1,2-dibromo-3-
chloropropane, and confined space). A few commentors maintain that
California must bear the burden of proof on this issue under the
Administrative Procedure Act (APA). See Section II.C. Section II.D
discusses a jurisdictional issue: whether California may, under the
auspices of its OSHA-approved State plan, apply its standard to out-of-
state manufacturers. Some commentors argue that Proposition 65's
supplemental enforcement mechanism violates Section 18's requirement
that a ``designated State agency'' bear responsibility for
administering a State plan. See Section II.E. Finally, Section II.F
addresses Proposition 65's exemption for public sector employers.
A. Applicability of Product Clause to Proposition 65 Requirements
Cal/OSHA, writing on behalf of itself, the State Attorney General,
and OEHHA, maintains that the product clause does not apply to the
substantive requirements imposed by Proposition 65. Ex. 6; see also
Exs. 18-61, 18-62, 18-111, 18-155. Some commentors (e.g. Ex. 18-155)
also have argued that, even assuming the product clause applies to the
substantive provisions of Proposition 65, it does not apply to the
law's supplemental enforcement provisions. 3 Because OSHA
finds that Proposition 65's supplemental enforcement provisions do not
violate the product clause (see Section III.B.5, below), it is not
necessary for OSHA to decide whether State enforcement may, in some
cases, be subject to the product clause. Accordingly, the remainder of
this section will address only Cal/OSHA's argument about the product
clause's applicability to Proposition 65's substantive provisions.
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\3\ This argument rests upon the language of Section 18(c)(2):
[T]he text of the Occupational Safety and Health Act is clear
that the product clause and its two-part test do not even apply to
enforcement. Rather, Sec. 667(c)(2) requires ``standards (and
the[ir] enforcement)'' to be at least as effective as Federal
standards, but the product clause applies only to ``standards,'' and
makes no mention of enforcement. Thus, OSHA need only consider
whether the enforcement of California's HCS and Prop 65 is ``at
least as effective'' as Federal OSHA, and OSHA need not concern
itself with whether the private right of action in any way burdens
interstate commerce.
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Ex. 18-155, page 9.
Relying upon statements made in Congressional debate leading to
enactment of the OSH Act in 1970, California argues that the product
clause was intended only ``to limit states from imposing different
product design standards for the safety of products,'' specifically
machinery products. Ex. 6, pages 21-22. In contrast,
Far from requiring changes to equipment or products moving in
interstate commerce, Proposition 65's warning requirement only
requires that warnings be given somehow. They need not be given by a
product label, or even through the [Hazard Communication Standard].
Compliance may be obtained where the employer posts an appropriate
sign meeting all of the requirements set forth in 22 CCR
Sec. 12601(c). This could be accomplished without making any change
to the MSDS, and results in complete compliance with Proposition 65.
Ex. 6, pages 21-22. Other supporters of the proposed standard argue,
more generally, that the product clause does not apply to warning
requirements because warnings (e.g. labels, signs, material safety data
sheets, training) do not affect product design. E.g. Exs. 18-61, 18-62.
As other commentors (e.g. Exs. 18-58, 18-148, 18-153, 18-154, 18-
156) point out, however, in its Hazard Communication Standard
rulemakings,
[[Page 31163]]
OSHA determined that the product clause is applicable to substantive
State hazard communication requirements ``[b]ecause the Hazard
Communication Standard is `applicable to products' in the sense that it
permits the distribution and use of hazardous chemicals in commerce
only if they are in labeled containers accompanied by material safety
data sheets[.]'' 48 FR 53280, 53323 (November 25, 1983). Similarly, in
its decision approving California's ethylene dibromide standard, OSHA
found the product clause applicable because ``the standard establishes
conditions and procedures which restrict the `manufacture, reaction,
packaging, repackaging, storage, transportation, sale, handling and
use' of the chemical product, ethylene dibromide (EDB), as well as the
handling and exposures which may result after EDB has been applied as a
fumigant to fruit products.'' 48 FR 8610, 8611 (March 1, 1983).
OSHA continues to believe that the product clause applies to
substantive State hazard communication requirements. As several
commentors note (e.g. Exs. 18-41, 18-153), Section 18(c) is phrased
broadly. On its face, the statute says simply that the product clause
applies to all standards which are ``applicable to products which are
distributed or used in interstate commerce[.]'' 29 U.S.C.
Sec. 667(c)(2). It is undisputed that the California standard may, in
certain circumstances, apply to products ``distributed or used in
interstate commerce'' because California employers may receive goods
from out-of-state suppliers. Thus, the standard comes within the plain
language of Section 18(c). OSHA's current interpretation of the product
clause is most consistent with this statutory language. See generally
Sutherland Statutory Construction, Secs. 45.02, 46.01 (4th ed. 1984).
4
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\4\ As discussed in Section II.B, however, the legislative
history of the product clause is a helpful aid in understanding the
somewhat ambiguous structure of the product clause ``test,'' which
requires an examination of compelling local conditions and the
extent of any burden on commerce.
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B. Overview: OSHA Review of State Standards Under the Product
Clause
OSHA's decision on the approvability of the California standard
involves the relationship between the State police power to regulate
health and safety and the Federal power to regulate commerce.
Throughout the history of the United States, the States and localities
traditionally have used their police powers to protect the health and
safety of their citizens. Medtronic v. Lohr, Inc., ______ U.S. ______,
116 S. Ct. 2240, 2245 (1996). At the same time, the Commerce Clause of
the U.S. Constitution provides that ``Congress shall have power * * *
to regulate commerce with foreign nations, and among the several
states[.]'' Article I, section 8.
In the absence of a Federal statute specifically addressing the
issue, the Federal courts have interpreted the Commerce Clause to
limit, implicitly, the power of the States to regulate interstate
commerce. Under this ``dormant commerce clause,'' the courts have
``distinguished between State statutes that burden interstate
transactions only incidentally, and those that affirmatively
discriminate against such transactions.'' Maine v. Taylor, 477 U.S.
131, 138 (1986). As the Court stated in Taylor, ``[t]he limitation
imposed by the Commerce Clause on State regulatory power `is by no
means absolute,' and `the States retain authority under their general
police powers to regulate matters of ``legitimate local concern,'' even
though interstate commerce may be affected.'.'' Id., citing Lewis v. BT
Investment Managers, Inc., 447 U.S. 27, 36 (1980); see also Brown-
Forman Distillers Corp. v. New York State Liquor Authority, 476 U.S.
573, 579 (1986); Kleenwell Biohazard Waste v. Nelson, 48 F.2d 391, 398
(9th Cir.), cert denied 115 S. Ct. 2580 (1995) (footnote omitted). In
reviewing State legislation under the dormant commerce clause, courts
consider both the nature and importance of the local interest and any
burden on commerce. The case law recognizes that a State has an
important stake in promoting the health of its citizens through
measures that do not discriminate against or impermissibly restrict
interstate commerce. Id.; see also Taylor, 477 U.S. 131.
In the OSH Act, Congress has enacted a statute, and the preemptive
effect of that statute turns on Congressional intent. See generally
Medtronic; Gade, 505 U.S. 88. The language of the product clause must
be read against the backdrop of longstanding judicial deference to
State sovereignty in the area of health protection. Medtronic, 116 S.
Ct. at 2250. In Gade, the Court held that the OSH Act preempts States
without State plans from enforcing occupational safety and health
standards on issues addressed by Federal standard; laws of general
applicability are not preempted. 505 U.S. at 97, 107-108.
As discussed in Section I.A, Section 18 of the OSH Act removes the
bar of Federal preemption for approved State plans, restoring to the
States the police power to protect occupational safety and health,
provided that the requirements of Section 18 are met. See also Gade,
505 U.S. at 102 (describing Section 18 as giving ``States the option of
pre-empting Federal regulations by developing their own occupational
safety and health programs'').
The ability of the States to devise and develop occupational safety
or health approaches is limited by the requirements of Section 18(c),
including the product clause, which requires that State standards
applicable to products not unduly burden interstate commerce, and that
they be justified by ``compelling local conditions.'' At the same time,
however, Section 18 specifically allows States to adopt and enforce
standards and enforcement procedures which are more stringent in
protecting worker safety and health than those of Federal OSHA. The
Act's drafters clearly envisioned the ``at least as effective''
requirement as providing a floor, not a ceiling, for future worker
protections efforts by State plan States. See Senate Committee on Labor
and Public Welfare, Legislative History of the Occupational Safety and
Health Act of 1970 at 297, 1035 (92d Congress, 1st Session, June 1971)
(Legislative History). Thus, State standards must pass the ``product
clause'' test, but the States also are free to devise not only more
stringent substantive standards but also supplementary enforcement
procedures. See Legislative History at 1035 (OSH act does ``not
envision a complete takeover of the field by the Federal government'';
OSHA's responsibility is ``merely to see to it that certain minimum
requirements were met and that beyond those the health and safety of
most workers would be left to [the] states''). The flexibility granted
the States under Section 18 also is in keeping with Congress' stated
purpose of ``encouraging the States to assume the fullest
responsibility for the administration and enforcement of their
occupational safety and health laws' and its intent to allow the States
``to conduct experimental and demonstration projects in connection
therewith[.]'' 29 USC Sec. 651(b)(11).
The OSH Act's product clause reflects in substantial part
terminology and principles developed by the Federal courts in applying
the dormant aspects of the Commerce Clause. Notwithstanding the limits
of the dormant commerce clause, Congress may grant to the States
greater powers to regulate commerce than they otherwise would possess.
Maine v. Taylor, 477 U.S. at 138-39; citing Southern Pacific Co. v.
Arizona ex rel. Sullivan, 325 U.S. 761, 769 (1945); see also Florida
Citrus Packers v. California, 549 F. Supp. at 215. In Citrus Packers,
[[Page 31164]]
the court found that Section 18 of the OSH Act represents ``a broad
grant of regulatory power to the states'' and, thus, ``an attack based
upon unduly burdening commerce is limited to those situations where the
product standard applies.'' 549 F. Supp. at 216. The similarity in
language between Section 18(c)(2) and dormant commerce clause
principles, then, suggests that a principal function of the product
clause is to ensure that Section 18 is not read as a grant of power to
violate normal Commerce Clause restrictions.
Thus, OSHA agrees with those commentors (e.g., Exs. 18-40, 18-160,
18-163, 18-164, 18-167, 18-174) who have argued that dormant commerce
clause case law is relevant to analysis of issues under the product
clause. That said, however, OSHA concludes that Congress authorized the
agency to give somewhat more strict review under Section 18(c)(2) to
State standards that address issues covered by a Federal standard than
a court would give under the dormant commerce clause. This conclusion
is supported by the limited legislative history of the product clause
and the different structural positions presented. In dormant commerce
clause cases, courts are considering State attempts to promote health
and safety or other local interests in the absence of Federal
regulation. Under Section 18(c)(2), on the other hand, the Federal
standard provides a uniform floor of protection.
Although there is no committee report explaining the language, the
limited Congressional floor discussion concerning the product clause
focused on possible State design requirements for machinery products
and the possible economic waste resulting from non-uniform State
requirements. See, e.g., Legislative History at 500-501, 1042
(statements of Representative Railsback and Senator Saxbe). Absent some
indication of protectionist discrimination, it is doubtful that a court
would reject a State safety requirement because it led to ``economic
waste.'' See, e.g., South Carolina State Highway Dep't v. Barnwell
Bros., 303 U.S. 177 (1938) (upholding State regulation of weight and
width of trucks); compare Kassel v. Consolidated Freightways Corp., 450
U.S. 662 (1981) (rejecting similar statute where majority of justices
found that the State statute either created a disproportionate burden
for out-of-state interests or was protectionist in intent); National
Paint & Coatings Ass'n v. City of Chicago, 45 F.3d 1124, (7th Cir.
1995) (sustaining city ban on spray paint, despite possibility that it
was ``economic folly''). The examples considered by Congress suggest
that it envisioned OSHA's disapproval of State standards under some
circumstances in which the courts would uphold a State law against a
dormant commerce clause challenge.
At the same time, the Congressional intent to allow States the
flexibility to develop their own occupational safety and health plans,
with the Federal standards as a ``floor'' rather than a ``ceiling,''
must be kept in mind. OSHA's interpretation of the product clause
should be ``consistent with both federalism concerns and the historic
primacy of State regulation of matters of health and safety,'' see
Medtronic, 116 S. Ct. at 2250, and with Congress' use of terminology
which harkens back to dormant commerce clause principles.
Accordingly, in analyzing differences between Federal and State
standards under the product clause, OSHA will first determine whether
the State standard is required by compelling local conditions.
Consistent with the State historic power to regulate health and safety,
a State standard that advances the health and safety of the State's
workforce meets this test, provided that the standard does not promote
or result in economic protectionism. As discussed in the next section,
OSHA will accept the State's determination on this point, in the
absence of evidence to the contrary. Thus, OSHA will not simply defer
to the State's determination, but will consider ``rebuttal'' evidence
and arguments. In addition, even if a State standard is required by
compelling local conditions, OSHA must determine whether the standard
imposes an undue burden upon commerce. The burden of establishing an
undue burden will be upon the opponents of a State standard (see also
Section D); OSHA will consider any alleged burdens in light of the
importance of the State interest involved.
OSHA will consider the specific ``compelling local conditions''
underlying the California standard in Section III.A. Here, however,
OSHA notes that many commentors opposing the standard interpret the
phrase ``compelling local conditions'' to be limited to interests which
are ``unique'' to California.5 E.g. Exs. 18-41, 18-58. OSHA
disagrees. Conditions unique to a given State are a sufficient, but not
a necessary, basis for a finding of compelling local conditions.
Although its focus in past State plan supplement decisions has been on
the conditions prevailing in the State involved [see, e.g., 48 FR 8610
(decision approving California ethylene dibromide standard)], OSHA has
never said that a State must establish that the conditions of concern
to the State's lawmakers are not prevalent in any other State as well.
Such an interpretation would be inconsistent with the plain meaning of
``compelling''; more than one State may have a compelling interest in
regulating particular safety issues. Simply put, ``compelling local
conditions'' are compelling conditions which exist locally.
---------------------------------------------------------------------------
\5\ Industry commentors also have maintained that Proposition
65's exemption for public sector and some small employers
demonstrates that there is no compelling need for the law. OSHA
discusses this argument in Section II.A.2.
---------------------------------------------------------------------------
Requiring a State to establish unique local conditions also would
be inconsistent with the courts' treatment of this issue under the
dormant commerce clause. Under the dormant commerce clause, courts look
for ``local'' conditions which may be, but frequently are not, unique
to the State involved. E.g. Maine v. Taylor, 477 U.S. 131 (upholding
discriminatory Maine statute banning importation of baitfish);
Kleenwell Biohazard Waste, 48 F.3d at 396 (upholding State concern with
ensuring safe disposal of solid waste).
C. Burden of Proof
A few commentors assert that California should bear the burden of
proving that its proposed standard is at least as effective as the
Federal standard and does not violate the product clause. E.g. Ex. 18-
160 6 at pages 2-4 and 18-174 at pages 4-5. This argument
relies upon Section 556(d) of the Administrative Procedure Act (APA), 5
USC Sec. 556(d), and the Supreme Court's decision in Director, OWCP v.
Greenwich Collieries, 512 U.S. 267, 114 S. Ct. 2251 (1994). California,
in response, argues that Section 556(d) is not applicable to these
proceedings because no formal hearing is involved. Ex. 22. The AFL-CIO
(Ex. 18-155) points out that the applicable OSHA Instruction, STP 2-
1.117 (August 31, 1984) effectively places the burden of proof upon
opponents of a State standard for purposes of the effectiveness and
product clause tests:
\6\ Shell Oil and Elf Atochem further assert that California
must meet its burden of proof by ``more than a mere preponderance of
the evidence.'' Ex. 18-160, pages 7-8. The burden of proof under the
APA is preponderance of the evidence. Greenwich Collieries, 114 S.
Ct. at 2257; Steadman v. SEC, 450 U.S. 91, 95 (1981). OSHA has not
changed that test by regulation or policy.
---------------------------------------------------------------------------
In the absence of record evidence to the contrary (including
evidence developed by or submitted to OSHA during its review of the
standard), the State standard shall be presumed to be 'at least as
effective' as the Federal standard and shall be presumed to be in
compliance with the product clause test of section 18(c)(2) of the
Act.
[[Page 31165]]
STP 2-1.117, page 2.
Initially, OSHA notes its agreement with California that Section
556(d) of the APA does not apply to this decision to approve the State
standard. Section 556(d) applies only ``to hearings required by section
553 or 554 of this title to be conducted in accordance with this
section.'' This decision involves no hearing, and Sections 553 and 554
do not apply. Section 553 applies only to rulemakings. This decision is
not a rulemaking, but rather an ``order'' within the nomenclature of
the APA. The decision is a final disposition in an agency process
respecting the ``grant'' or ``conditioning'' of an agency ``approval''
or ``other form of permission.'' 5 U.S.C. Secs. 551 (6)-(9).
Section 554 does not apply because that section applies only to
adjudications ``required by statute to be determined on the record
after opportunity for agency hearing.'' The OSH Act requires ``due
notice and opportunity for a hearing'' before OSHA rejects a State plan
or plan modification, but requires no hearing before OSHA approves a
plan or modification. 29 USC Sec. 667(d). The statutory language quoted
above regarding plan rejection proceedings may be insufficient, by
itself, to trigger application of Section 554 or 556. See Chemical
Waste Management v. EPA, 873 F.2d 1477, 1480-82 (D.C. Cir. 1989); U.S.
Lines v. FMC, 584 F.2d 519, 536 (D.C. Cir. 1978). OSHA, however, has by
regulation made Section 556 applicable to rejection proceedings. 29 CFR
Secs. 1902.17-18, 1953.41(d)(2). The regulations expressly authorize,
on the other hand, a decision to approve a State plan or modification
without a formal hearing. 29 CFR Secs. 1902.11, 1902.13. It is
therefore abundantly clear that Section 556(d) does not apply here.
The formal distinction between the process for approving or
rejecting a State standard under an approved State plan reflects the
real difference between these decisions under the framework of Section
18 and the Federal system. A modification to an approved State plan
takes effect prior to and pending OSHA review of the modification. A
decision to reject the modification works an abrupt change in the
status quo and overrides the determination of a sovereign State. A
decision to approve, on the other hand, leaves the status quo and the
State's determination unchanged. In effect the decision is not to
institute the formal trial-type proceedings required for rejection.
OSHA's historic placement of the burden of proof upon parties
opposing a State standard is consistent with Section 18(c)(2), the
applicable regulations, the APA, and the case law. As was discussed in
the preceding section, the product clause reflects in substantial part
dormant commerce clause case law. Under that case law, the burden of
persuasion rests upon the party claiming that a State regulation
violates the dormant commerce clause (unless there is evidence of
protectionist discrimination by the State). Pacific Northwest Venison
Producers v. Smitch, 20 F.3d 1008, 1012 (9th Cir.), cert denied ______
U.S. ______, 115 S. Ct. 297 (1994), citing Northwest Central Pipeline
Corp. v. State Corp. Comm'n of Kansas, 489 U.S. 493, 525-26 (1989);
Maine v. Taylor, 477 U.S. at 138; Minnesota v. Clover Leaf Creamery
Co., 449 U.S. 456, 471 (1981).
In addition, under the dormant commerce clause, the judgments of
State lawmakers about the necessity or wisdom of non-discriminatory
laws are entitled to considerable, and perhaps total, deference from
the courts: if a State articulates a legitimate, non-discriminatory
local interest to support an enacted law, ``courts should not `second-
guess the empirical judgments of lawmakers concerning the utility of
legislation.' '' CTS Corp. v. Dynamics Corp. of America, 481 U.S. 69,
92 (1987), citing Justice Brennan's concurring opinion in Kassel, 450
U.S. at 679; Pacific Northwest Venison Producers, 20 F.3d at 1012.
Because of the similarities between dormant commerce clause
principles and the product clause, OSHA believes it is appropriate to
apply the same burdens of proof and persuasion as are applied under the
dormant commerce clause. Nevertheless, because OSHA also concludes that
Congress intended State standards to be subject to somewhat greater
scrutiny than they might receive by the courts applying the dormant
commerce clause (see Section II.B, above), OSHA will not defer to a
State's legislative judgment regarding local conditions to the extent a
court might. The agency will presume that a State standard meets the
requirements of Section 18(c)(2), but that presumption may be rebutted
with appropriate evidence.
This overall approach is in harmony with the idea that Congress, by
enacting the product clause, intended to recognize that States adopting
State plans retain broad regulatory power over workplace safety and
health, but not to allow the States to engage in regulation which
otherwise would violate the dormant commerce clause. Imposing the
burden of persuasion upon parties opposing a State regulation also is
consistent with the basic nature of the ``defense'' available under the
dormant commerce clause or product clause; these are affirmative
defenses. See, e.g., NLRB v. Jones & Laughlin Steel Corp., 301 U.S. 1,
25 (1937) (treating constitutional challenge to National Labor
Relations Act as affirmative defense). Under the APA, the party
presenting an affirmative defense bears the burden of persuasion.
Greenwich Collieries, 114 S. Ct. at 2257-58; NLRB v. Transportation
Management Corp., 462 U.S. 393 (1983).
In keeping with the principles applied under the dormant commerce
clause and the nature of the product clause ``defense,'' parties
opposing a State standard should bear the burden of proving violations
of Section 18(c)(2), unless there is evidence that the standard is
linked to economic protectionism. Here, there is no evidence that the
voters of California were motivated by economic protectionism in
passing Proposition 65.7 The law, as enacted, applies with
equal force to in-state and out-of-state businesses. In addition,
although several commentors rely upon dormant commerce clause case law
involving discriminatory statutes (e.g., Exs. 18-40, 18-160), they
presented no evidence suggesting the statute is discriminatory. See
also Ex. 22 (Attachment B, description of ballot initiative). Opponents
of the California standard, therefore, bear the burden of proving that
it does not satisfy Section 18(c)(2).
---------------------------------------------------------------------------
\7\ As discussed in Section II.D, Proposition 65 as incorporated
into the State plan can apply only to California employers. When
determining whether the statute was motivated by economic
protectionism, however, it is appropriate to examine the intent
behind the statute as a whole, not simply its occupational
applications. The remaining discussion in this section, therefore,
should be understood in this light.
---------------------------------------------------------------------------
D. Application of the California Standard to Out-of-State Manufacturers
and Distributors
Several commentors raised the issue of whether supplemental
enforcement of Proposition 65 against out-of-state manufacturers and
distributors 8 is in accordance with Federal and State
requirements. Section 18(b) of the Act provides that ``[a]ny State
which * * * desires to assume responsibility for development and
enforcement therein of occupational safety and health standards * * *
shall submit a State plan[.]'' Section 18(c)(1) of the Act and 29 CFR
Sec. 1902.3(b) require that a State plan designate the agency or
agencies responsible for administering the plan throughout the State.
---------------------------------------------------------------------------
\8\ Whenever this decision uses the word ``manufacturers'' or
``vendors,'' it is intended to include distributors.
---------------------------------------------------------------------------
[[Page 31166]]
To date, Cal/OSHA itself has not enforced its Hazard Communication
Standard, including Proposition 65, against out-of-state vendors.
However, private parties have instituted enforcement actions against
out-of-state manufacturers in their role as vendors of products to
which employees of other employers are exposed in California.
Several commentors cite statements by various California officials
which appear to indicate that Proposition 65 as incorporated into the
State plan may not be enforced against out-of-state vendors. Exs. 18-
153, 18-154, 18-162, 18-174. While Proposition 65 itself applies to any
``business'' exposing an individual to a hazardous substance, the
regulation incorporating Proposition 65 into California's Hazard
Communication Standard states that an ``employer which is a person in
the course of doing business . . . is subject to [Proposition 65].'' 8
CCR Sec. 5194(b)(6)(A). The Initial Statement of Reasons issued by the
Cal/OSHA Standards Board in adopting Proposition 65 said that the
purpose of the incorporation was so ``employers in California who come
within the scope of Proposition 65 will be prohibited from knowingly
and intentionally exposing their employees[.]'' Ex. 18-156.
In addition, some commentors cite an October 1, 1992 letter from
Steve Jablonsky, Executive Officer of the Cal/OSHA Standards Board, to
OSHA, which states that employers need not rely on suppliers in order
to comply with Proposition 65 as incorporated into the State plan. Mr.
Jablonsky stated that employers could comply with Proposition 65 in
various ways, including compliance with the general hazard
communication provisions and posting of signs in the workplace. Exs.
18-156, 18-162, 18-174. Similarly, a February 16, 1996 letter from John
Howard, Chief, Division of Occupational Safety and Health, to OSHA
indicated that there should be no effect on out-of-state employers
because signs in the workplace, which are the responsibility of the
California employer of the exposed employees, would be sufficient
warnings. Ex. 6. In addition, in October 1992, when moving to dismiss
Chemical Manufacturers Association, et al. v. California Health and
Welfare Agency, the California Attorney General noted that Proposition
65 does not place any burdens on out-of-state suppliers. Ex. 18-174.
Commentors claim that private enforcement appears to place full
responsibility for warning California employees upon out-of-state
manufacturers and that application of the standard against out-of-state
manufacturers is inconsistent with California's past statements on this
subject. Exs. 18-81, 18-153, 18-154, 18-162. Organization Resource
Counselors maintains that product manufacturers who distribute signs
for workplace postings are sued despite providing the signs. Ex. 18-
150. Others note that the California Attorney General argued, in
Industrial Truck Association, Inc. v. Henry, that the State standard
authorizes enforcement of Proposition 65 against out-of-state
manufacturers who supply their products to California employers. Exs.
18-153, 18-154, 18-162, 18-174.
Some commentors assert that Proposition 65 as incorporated into the
State standard should not be enforced against out-of-state
manufacturers because a State plan by definition can only be enforced
against in-State employers. Shell Oil Company and Elf Atochem North
America maintain that a State plan cannot reach beyond its own borders
to bring enforcement actions against employers for conduct that
occurred in workplaces in other States covered by their own State
programs or Federal OSHA. Ex. 18-160. Melvin B. Young notes that this
is the only part of any State plan which provides for enforcement
against businesses outside of the State. Ex. 18-142.
California's response relies upon the fact that Federal OSHA also
imposes duties on manufacturers and that the courts have upheld such
requirements. Ex. 22. See General Carbon Company v. Occupational Safety
and Health Review Commission, 860 F.2d 479 (D.C. Cir. 1988). Others who
support enforcement of the standards against out-of-state employers
maintain that manufacturers are in the best position to assess the
hazards and effectively communicate them. In these commentors' views,
if manufacturers are not held responsible for exposures to their
products, the burden will fall on tens of thousands of California
employers. E.g., Ex. 18-167.
OSHA finds that under its requirements governing State plans, a
State plan may only enforce its standards within its borders. This
conclusion is based upon the language of Section 18 of the OSH Act.
Section 18(b) provides that a State may ``assume responsibility for
development and enforcement therein of occupational safety and health
standards'' (emphasis added). 29 U.S.C. Sec. 667(b). Similarly, Section
18(c)(1)'s requirement for a designated State agency assigns
responsibility to that agency for enforcing the State plan ``throughout
the State[.]'' 29 U.S.C. Sec. 667(c)(1); see also 29 CFR
Sec. 1902.3(b). Clearly, although Congress provided broad powers to the
States under Section 18, these powers did not extend to enforcing State
laws outside of the State's boundaries.
OSHA's conclusion on this point also is consistent with the
practical aspects of the State plan system. No other State plans
enforce their occupational safety and health standards against
employers who do not have workplaces in the State. Some States have
adopted standards which differ from Federal standards and which
indirectly affect (but do not regulate) out-of-state manufacturers, and
these standards have been reviewed and approved under the product
clause requirements of Section 18(c)(2) of the Act. See, e.g., 51 FR
17684 (approval of Arizona's short-handled hoe standard); see also OSHA
Directive STP 2-1.117. However, in these cases, the State does not take
action against out-of-state manufacturers but against those in-state
employers who use the affected product. Although, as noted in
California's response, the Federal and other State-plan Hazard
Communication Standards do impose responsibilities on manufacturers,
State plans do not issue citations against out-of-state manufacturers
for incomplete or inaccurate Material Safety Data Sheets (MSDS) used by
in-state employers. Rather, the State would refer the matter to the
Federal Area Office or other State plan in whose jurisdiction the
manufacturer operates. Similarly, if Federal OSHA finds during an
inspection that an MSDS used by an employer is incomplete or inaccurate
and the manufacturer or supplier is located in a State with an approved
State plan, OSHA would refer the matter to the State plan. OSHA
Instruction CPL 2-2.38C, page 18 (October 22, 1990).
Out-of-state chemical manufacturers and distributors are subject to
the Federal Hazard Communication Standard, or to the State plan
standard for the State in which they are located. Allowing application
of the California standard out-of-state would mean that out-of-state
manufacturers are subject to duplicative regulation. As the Supreme
Court noted in Gade, ``the OSH Act as a whole evidences Congress'
intent to avoid subjecting workers and employers to duplicative
regulation[.]'' 505 U.S. at 100.
Based upon the information in the record, it is unclear to OSHA
whether the State, by its incorporation of Proposition 65 into the
State plan, intended to apply Proposition 65 to out-of-state employers
in their role as vendors. On the one hand, a facial understanding of
the regulatory language suggests, as some commentors argue, that the
State standard applies only to ``employers'' who expose their own
``employees,'' in the employer's
[[Page 31167]]
own workplace, to Proposition 65 chemicals. 8 CCR Sec. 5194(b), 22 CCR
Sec. 12601(c). On the other hand, some statements from California
agencies, especially the Attorney General's statements in the
Industrial Truck Association case, appear to endorse the idea of out-
of-state application of the State plan.
Whatever the truth may be about the State's intentions here, the
OSH Act does not permit out-of-state enforcement of a State's laws
under the auspices of an approved State plan. Therefore, Proposition 65
as incorporated into the State plan may only be enforced against in-
State employers. The State may, of course, apply its laws to all
workplaces within California, including those maintained by
manufacturers or distributors incorporated in other States; in that
situation, the ``out-of-state'' business also would be an ``in-state''
employer. Additionally, OSHA is addressing only the State's authority
under the State plan. This decision leaves open the possibility that
the State may have other legal authority under which it can apply
Proposition 65 to out-of-state businesses. OSHA has no authority to
resolve that question. Most important, as OSHA has noted previously,
Proposition 65 applies to consumer and environmental exposures. This
decision does not affect actions brought under these aspects of the
law.
E. Designated State Agency
Several commentors addressed the issue of whether Proposition 65's
provision for supplemental enforcement violates the OSH Act's criteria
for a designated State agency. Section 18(c)(1) of the OSH Act and
regulations at 29 CFR Sec. 1902.3(b) require that a plan designate a
State agency or agencies as the agency or agencies responsible for
administering the plan throughout the State. Although Section
1902.3(b)(3) allows an agency to delegate its authority through an
interagency agreement, the State designee must retain legal authority
to assure that standards and enforcement provided by the second agency
meet Federal effectiveness criteria.
Commentors raised two issues regarding the relation of Proposition
65 to these criteria. The first issue involves the diversity of
agencies involved in the enforcement of Proposition 65, including the
OEHHA, the State Attorney General and local prosecutors. The
Proposition 65 regulations which were incorporated into the California
Hazard Communication Standard were originally promulgated by OEHHA. The
State Attorney General has interpreted Proposition 65 when representing
the State in lawsuits in filed against it. The Attorney General and
District Attorneys may also initiate enforcement actions under
Proposition 65. Some commentors contend that because these agencies may
take action independently of Cal/OSHA, their role does not meet the
criteria in Section 18(c)(1) of the Act and 29 CFR Sec. 1902.3(b). Exs.
18-41, 18-88, 18-127, 18-156, 18-164, 18-174, 18-191, 18-201.
Some commentors allege that these agencies have not issued
appropriate guidance to employers on complying with Proposition 65. For
example, Ashland Chemical Company comments that it sought confirmation
from the Attorney General that its warnings were acceptable under
Proposition 65 and did not receive a reply. Ex. 18-191. Commentors have
also pointed out that California agencies have issued conflicting
interpretations about Proposition 65 in its workplace application. The
Coalition notes that an October 1, 1992 letter from Steve Jablonsky,
Executive Officer of the Cal/OSHA Standards Board, to OSHA states that
employers need not rely on suppliers in order to comply with
Proposition 65 as incorporated into the State plan. However, the
Attorney General argued in Industrial Truck Association, Inc. v. Henry
that Proposition 65 does apply to out-of-state manufacturers who supply
their products to California employers. Ex. 18-174.
Some commentors also maintain that the private right of action
authorized by Proposition 65 as included in the California Hazard
Communication Standard violates the requirement for a designated agency
because the designee does not retain authority over private enforcement
actions. Exs. 18-81, 18-96, 18-121, 18-144, 18-147, 18-150, 18-160, 18-
164, 18-169, 18-173, 18-174, 18-191, 18-201, 18-204. These commentors
assert that the negotiation of settlements between plaintiffs and
employers results in different requirements for different employers, so
that employers cannot be aware in advance of the requirements placed
upon them. According to these comments, no California agency has, or is
willing to exercise, an oversight role of private litigation which
would provide consistent and coherent interpretations. Some commentors
also claim that the absence of a private right of action under the
Federal OSH Act indicates that Congress did not favor occupational
safety and health enforcement by private parties. Therefore, according
to these commentors, OSHA should not approve a private right of action
in a State plan.
Other commentors maintain that nothing in the OSH Act precludes a
State from allowing private rights of enforcement under a State plan,
and as long as the basic plan meets the criteria for a designated
agency, any additional enforcement would only increase effectiveness.
Exs. 18-155, 18-168.
In response to the comments, the State of California (Ex. 22) notes
that Cal/OSHA remains responsible for the administration and
enforcement of standards set forth in the plan. OEHHA does not have
authority to make changes to the State plan; any change in the
Proposition 65 regulations would have to be adopted by the Standards
Board. On the issue of private litigation, the State asserts that since
private enforcement only applies to Proposition 65, the standard
remains as effective as the Federal. Cal/OSHA also points out that
courts have the authority to stay litigation of some Proposition 65
occupational exposure claims, pending resolution by Cal/OSHA of issues
within its expertise. This has been done in As You Sow v. Turco
Products. The State contends that Cal/OSHA should not be held
responsible for suits of private parties or settlements reached without
court involvement.
OSHA finds that neither a distribution of functions among agencies
nor private rights of action are prohibited under State plan
provisions. OSHA has approved a provision for court prosecution of
occupational safety and health cases by local prosecutors under the
Virginia State plan (see 41 FR 42655; September 28, 1976). Although the
Federal Occupational Safety and Health Act does not authorize private
enforcement, OSHA State plans do not operate under a delegation of
Federal authority but under a system which allows them to enact and
enforce their own laws and standards under State authority. Therefore,
nothing in the Act prevents States with approved plans from legislating
such a supplemental private right of action in their own programs. In
fact, other State plans include OSHA-approved provisions for private
rights of action in cases of alleged discrimination against employees
for exercising their rights under the plans.
In the case of Proposition 65, private enforcement is supplemental
to, not a substitute for, enforcement by Cal/OSHA. Private enforcement,
therefore, should not detract from Cal/OSHA's responsibilities to
enforce State standards. In addition, OSHA notes that California is
required under Proposition 97 to ``take all steps necessary to prevent
withdrawal of approval for the
[[Page 31168]]
State plan by the Federal government.'' California Labor Code
Sec. 50.7(d).
However, under the Act and OSHA regulations, the designated agency
must retain overall authority for administration of all aspects of the
State plan. State designees are required to take appropriate and
necessary administrative, legislative or judicial action to correct any
deficiencies in their enforcement programs resulting from adverse
administrative or judicial determinations. See 29 CFR
Sec. 1902.37(b)(14).) Therefore, OSHA expects Cal/OSHA to ensure that
enforcement of the standard remains at least as effective as the
Federal Hazard Communication Standard and consistent with the
conditions under which the standard is Federally approved by taking
appropriate action when necessary to address adverse court decisions in
private party suits, Cal/OSHA enforcement actions or State Attorney
General or local prosecutors' actions. Failure to pursue necessary
remedies would result in OSHA's reconsideration of its approval of the
standard.
F. Exemption for Public Sector Employers
Section 18(c)(6) of the Act and regulations at 29 CFR
Sec. 1902.3(l) require that a State plan must, to the extent permitted
by its constitutional law, establish and maintain an effective and
comprehensive occupational safety and health program applicable to all
employees of public agencies of the State and its political
subdivisions, which is as effective as the standards contained in the
plan.
The Coalition asserts that the exemption of public sector agencies
from providing Proposition 65 warnings violates this criterion. Ex. 18-
174. In its response, the State of California maintains that since
State and local government employees are covered by the other hazard
communication provisions, their lack of coverage under the supplemental
provisions should not pose a problem. The State also notes that
government employees would receive warnings from other businesses which
supply products to public agencies. In addition, the State contends
that because government officials are accountable to the public in
other ways, it is not necessary for them to be subject to the
requirements of Proposition 65 as well. Ex. 22.
The basic warning requirements of the Hazard Communication Standard
and Cal/OSHA's enforcement of the standard do apply to public sector
employers. As discussed below, the chemicals covered by, and the
warning requirements of, Proposition 65 do not differ significantly
from, and thus are not significantly more protective than, California's
other hazard communication requirements. Moreover, because compliance
with Proposition 65 can be achieved via use of the measures provided in
the Cal/OSHA or Federal Hazard Communication Standard (see Section
III.B.2), public sector employers will, in fact, be in compliance with
Proposition 65 for all substances covered by the general California
standard if they comply with the general standard. As a practical
matter, this means that public sector employers will only be exempt
from Proposition 65 warning requirements relating to a few substances
(e.g. aflatoxins, discussed in Section III.B.3, below). Therefore, OSHA
finds that California's protection of these employees is as effective
as its protection of private sector employees, meeting the criterion in
section 18(c)(6) of the Act.
OSHA has never required States to use the same enforcement methods
in the public sector as they do in the private sector. Nevada, among
other States, imposes penalties upon public sector employers only for
serious violations. 46 FR 42843 (August 25, 1981). California itself
does not have financial penalties for public sector employers. See
California Labor Code Sec. 6434. OSHA also has approved other State
plans which lack public sector penalties. E.g. 44 FR 44 28327 (May 15,
1979) (Maryland). Therefore, OSHA finds that the exemption of public
agencies from suits under Proposition 65 is not in violation of OSHA
requirements for public sector programs, particularly as public sector
employers are subject to enforcement actions by Cal/OSHA for non-
compliance with the general State Hazard Communication Standard. In
addition, Federal requirements which would force a State to submit to
private suit raise issues under the Eleventh Amendment. See Seminole
Tribe of Florida v. Florida, 116 S. Ct 1114 (1996).
III. Summary and Explanation of Remaining Issues Under Section 18
In this Section, OSHA will analyze the remaining issues, which
involve combined legal and factual questions arising under the various
provisions of Section 18(c)(2). Initially, OSHA notes that although
many comments assume significant differences between the substantive
provisions of Proposition 65 and the Federal standard, OSHA's detailed
analysis of the California regulations and the record discloses that
most of these alleged differences do not, in fact, exist. With a few
exceptions, Proposition 65 and the Federal standard cover the same
chemicals and the same concentrations of chemicals. See Section
III.B.3.
Whenever chemicals are covered by both Proposition 65 and the
Federal standard, they will be covered by the general State standard.
In that situation, employers must comply with the State standard's
general (i.e. non-Proposition 65) hazard communication requirements,
which are virtually identical to the Federal standard's requirements.
In those relatively few cases where a chemical is not covered by
Federal or State hazard communication requirements, businesses can
comply with Proposition 65's occupational aspects by applying Federal
hazard communication methods to those chemicals. Consequently,
Proposition 65, in practice, should impose only minor additional
requirements. See Section III.B.3.
Procedurally, there are several differences between the Federal and
State standards. Most obviously, the State standard provides for
supplemental enforcement by private parties; the Federal standard does
not. OSHA concludes, however, that these procedural differences do not
require rejection of the California standard. See Section III.B.5.
Accordingly, and as set forth below, OSHA is approving the
California standard, including Proposition 65. This approval, though,
is contingent upon OSHA's understanding of Proposition 65's compliance
provisions and the conclusion that the State cannot apply Proposition
65 to out-of-state businesses under the auspices of the State plan.
OSHA also expects Cal/OSHA to exercise its role as the designated State
agency to ensure that Proposition 65's enforcement comports with these
understandings and does not result in a less effective standard.
A. Compelling Local Conditions
1. Overview
As outlined in Section II.B, OSHA's analysis under the product
clause first requires it to consider whether ``compelling local
conditions'' support the California standard. OSHA finds that the State
plan requirements presently under review, including the general
California Hazard Communication Standard and the occupational aspects
of Proposition 65, are justified by compelling local health and safety
concerns.
When Proposition 65 was adopted by the voters of the State of
California in 1986, the law's public-health objectives
[[Page 31169]]
were succinctly set forth in the ballot initiative and in the law's
preamble, which found that the ``lives of innocent people are being
jeopardized'' by the lack of information about toxins; that ``hazardous
chemicals pose a serious threat to their well-being;'' and that
conventional enforcement efforts by public agencies ``have failed to
provide them with adequate protection.'' Ex. 22, Attachment B.
``Right to know'' laws like Proposition 65 promote the general
public's knowledge about safety and health issues. By ensuring that
people have information about hazards and risks associated with
chemicals, these laws allow workers and other persons to protect
themselves against hazardous exposures and resulting illnesses. Right-
to-know laws also encourage the market to reformulate hazardous
products to reduce or eliminate the risks associated with a product's
use. Absent access to relevant information about chemical hazards and
risks, workers cannot protect themselves or the public at large from
potentially devastating exposures.
Access by workers and their representatives to information about
toxic substances in the workplace is an issue recognized by OSHA, by
Congress, and generally by the occupational safety and health community
as a central element in any effort to provide for safe and healthful
workplaces throughout the nation. Congress included in OSHA's standard-
setting authority an explicit requirement to ``prescribe the use of
labels or other appropriate forms of warning'' for the protection of
workers from the hazards of chemicals in their workplaces. 29 U.S.C.
Sec. 655(b)(7). In promulgating the Federal HCS in 1983, OSHA
extensively reviewed available statistics and documented an
unacceptably high incidence of chemically-related illnesses and
injuries. 48 FR 53282 (1983). OSHA also found--with substantial support
not only from workers, other government agencies and public interest
groups, but from many industry members and trade associations--that
implementation of appropriate hazard communication in the nation's
workplaces ``would serve to decrease the number of such incidents by
providing employees with the information they need to help protect
themselves, and ensure that their employers are providing them with the
proper protection.'' Id. The crucial importance of hazard communication
was well-recognized in OSHA's 1989 Safety and Health Program Management
Guidelines, which provide that one of the cornerstones of effective
protection of worker safety and health is ensuring that workers have
adequate information to protect themselves and others:
The commitment and cooperation of employees in preventing and
controlling exposure to hazards is critical, not only for their own
safety and health but for that of others as well. That commitment
and cooperation depends on their understanding what hazards they may
be exposed to, why the hazards pose a threat, and how they can
protect themselves and others from the hazards.
See 59 FR 3904.
Right-to-know laws also enhance the ability of the public and
individuals to ensure that their government (Federal, State or local)
acts appropriately to protect their interests. Committee on Risk
Perception and Communication, National Research Council,9
Improving Risk Communication 111 (National Academy Press, 1989) (``[a]
central premise of democratic government--the existence of an informed
electorate--implies a free flow of information''). By enacting
Proposition 65, the voters sought to exercise their right and
responsibility to oversee the functioning of their government. Thus,
the principles which led California voters to enact Proposition 65 in
1986--the perceived threat to the ``lives of innocent people'' and
their well-being, the lack of information about hazardous chemicals,
and the failure of ``conventional enforcement efforts by public
agencies'' (Ex. 22, Attachment B)--are widely known and accepted.
---------------------------------------------------------------------------
\9\ The National Research Council comprises councils of the
National Academy of Sciences, the National Academy of Engineering,
and the Institute of Medicine.
---------------------------------------------------------------------------
One factor OSHA has historically considered in determining whether
a State's interest is a compelling one is the extent to which the
industrial hazard sought to be addressed is prevalent within the State.
Here, the standard at issue relates not to a particular trade but to
the hazard posed by toxic chemicals used throughout industry. Although
the commentors raise some arguments against a finding of compelling
local conditions (see discussion in Section III.A.2 and discussion
below), none question the State's interest in hazard communication or
the extent of hazardous exposures in California. Moreover, it is
obvious that California, with an economy larger than that of most of
the world's nations, has within its jurisdiction a significant portion
of the toxic exposures occurring daily in the United States. See also
48 FR 8610 (decision approving California ethylene dibromide standard
and noting extent of relevant exposure within State). The number of
out-of-state businesses responding to OSHA's request for comments, and
the volume of chemical shipments to California suggested in their
submissions, also attest to the number of occupational chemical
exposures likely to occur within the State.
California's interest in protecting the public's ``right to know''
is particularly compelling here because it is acting not only to
protect the general public health and safety, but to protect the rights
of individual citizens to make informed decisions about matters
affecting their own health and welfare. Just as a patient has the right
to consent to, or refuse, medical treatment, see Cruzan v. Director,
Missouri Dep't of Health, 497 U.S. 261, 269 1990) citing Schloendorff
v. Society of New York Hospital, 105 N. E. 92, 93 (1914) (``Every human
being of adult years and sound mind has a right to determine what shall
be done with his own body''), so, more generally, persons have a right
to understand the hazards to which they are exposed and determine
whether they wish to take any risk involved.
Dormant commerce clause case law also supports OSHA's analysis. As
OSHA discussed in Section III.A., there is no evidence that the
California voters harbored any intent to discriminate against out-of-
state employers or manufacturers; to the contrary, the law on its face
is fully applicable to all private sector businesses which meet the
ten-employee size limit. Instead, California voters appear to have been
exclusively concerned with public health and safety, which undeniably
constitutes a ``legitimate'' or ``compelling'' objective within the
meaning of dormant commerce clause decisions. See, e.g. Kleenwell
Biohazard Waste v. Nelson, 48 F.3d 391, 397 (9th Cir. 1995)
(``[r]egulations that touch on safety are those that the Court has been
most reluctant to invalidate''), citing Raymond Motor Trans. Co. v.
Rice, 434 U.S. 429 (1978); see generally Goehring v. Brophy, 94 F.3d
1294, 1300 (9th Cir. 1996) (``Public health and well-being have been
recognized as compelling governmental interests in a variety of
contexts''). Consequently, under the dormant commerce clause,
California's non-discriminatory intent would lead the courts to uphold
Proposition 65.
Finally, the primary difference between the California and Federal
standards is the California standard's incorporation of Proposition
65's provision for citizen enforcement of disclosure laws to augment
the scarce resources available to regulatory agencies and public
prosecutors. Thus, California may reasonably conclude that enactment of
Proposition 65 should lead
[[Page 31170]]
to more effective enforcement of the measures prescribed in the Federal
standard and improved dissemination of information about hazardous
chemicals. (By way of example, in Section III.B.5, OSHA discusses an
instance in which an employer who was not in compliance with the
general California (or Federal) standard was brought into compliance as
a result of a private enforcement action.) This additional enforcement
mechanism also is entirely consistent with the employee-protection
concerns that motivated Congress in 1970 and that remain relevant
today. In 1970, Congress found safety and health inspectors in
``critically short supply[.]'' Legislative History at 161. Today, there
are two thousand Federal and State plan inspectors, who must cover more
than six million workplaces. Neither OSHA nor Cal/OSHA has ``the
resources to find every violation of every law,'' Carnation Co. v.
Sec'y., 641 F.2d 801, 805 (9th Cir. 1981).
OSHA emphasizes that private suits under Proposition 65 form a
supplement, not a substitute, to conventional enforcement of the
State's Hazard Communication Standard already being provided by Cal/
OSHA. Indeed, the California standard reflects OSHA's previous findings
in its hazard communication rulemakings because the primary focus of
the State standard is a close adaptation of the Federal standard. Under
the applicable regulations, compliance with the measures prescribed by
the Federal standard is an acceptable means of compliance with
Proposition 65. See Section III.B.2. Accordingly, the State's further
incorporation of Proposition 65 into the standard simply provides a
supplemental method of ensuring that the standard, as a whole,
functions effectively.
Other State plans approved by OSHA contain private rights of action
intended to supplement the anti-discrimination provisions of the State
plan. North Carolina Code Sec. 95-243; California Labor Code
Sec. 98.7(f). Whether such supplements are a useful or appropriate
addition to State plan authority is a matter for the State to decide.
In the present case, OSHA accepts the judgment of California voters
that compelling local conditions justify the inclusion of Proposition
65's additional enforcement remedies into the State plan.
It is true, as several industry commentors point out, that the
Federal OSH Act contains no private rights of action or citizen suit
provisions. Exs. 18-41, 58, 65, 96, 139, 150, 160, 162, 165. As OSHA
explained in Section I.A, however, the OSH Act specifically allows
States to adopt and enforce standards and enforcement procedures which
are more stringent in protecting worker safety and health than those of
Federal OSHA. The OSH Act, therefore, does not bar the States from
adopting supplemental enforcement mechanisms.
As OSHA noted at the outset, the voters of California have a
compelling interest in protecting their right to information about
possible risks to their safety and health. Id.; compare C & A Carbone
v. Town of Clarkstown, 511 U.S. 383, 409 (1994) (rejecting a
discriminatory town regulation governing solid waste disposal because
the town had ``any number of nondiscriminatory alternatives * * *
[including] uniform safety regulations enacted without the object to
discriminate''). There is no indication in the statutory language of
Section 18(c)(2) or the legislative history of the Act that Congress
intended to bar a State's voters from determining how to best protect
their right to make informed decisions. Rather, the limited legislative
history shows that Congress simply wanted ``to prevent States from
making unreasonable limitations[.]'' Legislative History at 501
(statement of Senator Saxbe).
2. Commentor Rebuttal Arguments
As discussed in Sections II.B and II.C, OSHA will presume in the
absence of evidence to the contrary that a State's law enacted to
foster its workers' safety and health meets the product clause's
requirement for compelling local conditions. Industry commentors raised
two arguments to rebut the idea that Proposition 65 is supported by
compelling local conditions. First, as OSHA outlined and rejected in
Section II.B, industry commentors have alleged that California must
establish conditions unique to California in order to support approval
of the standard. Second, the commentors also assert that the State's
failure to apply Proposition 65 to public sector employers (and small
businesses) constitutes evidence that California has no compelling
local need for Proposition 65. E.g., Exs. 18-150, 18-174. Organization
Resource Counselors (ORC) (Ex. 18-150) states that these exemptions
effectively exclude 50% of California employees from coverage.
California, in response, says that ``while the exemption for small
businesses may cover a large number of businesses, such businesses are
responsible for a relatively small share of the handling of hazardous
chemicals.'' Ex. 22, pages 11-12. California maintains that the law
applies ``to the big businesses that produce more than 90% of all
hazardous waste in California.'' Id., citing Proposition 65 ballot
argument, Attachment B to Exhibit 22.
Proposition 65's exemptions do not provide evidence of
discriminatory intent, and do not undermine California's putative
interest in protecting its workers' safety and health. The exemption
for businesses employing ten persons or fewer applies to all such
businesses, regardless of whether they are located inside or outside of
the State. Moreover, even assuming that ORC has correctly estimated the
percentage of employees covered, its comment does not address the
percentage of employees exposed to covered chemicals. No inference,
then, can be drawn regarding the intent of California's voters in
passing Proposition 65, or the effect of the exemptions.
Finally, as outlined in Section C, there are, in fact, few
differences between the occupational aspects of Proposition 65 and the
Federal or general State standard. As a practical matter, the effect of
the public sector and small business exemptions is to free these
entities from the threat of supplemental enforcement. OSHA concludes
that it is within the voters' discretion to conclude that small
businesses should not be subject to the penalties available under
Proposition 65. Employees working for these businesses will still be
protected by the general California standard.
B. Remaining Section 18(c)(2) Issues
1. Overview
The following sections of OSHA's decision analyze the remaining
issues arising under Section 18(c)(2) of the Act: whether the
California standard is at least as effective as the Federal standard,
and whether the California standard imposes an undue burden upon
commerce.
Commentors have argued that the Proposition 65 components of the
California standard require warnings for chemicals not covered by the
Federal Hazard Communication Standard and that Proposition 65's warning
requirements are in addition to those required by the Federal standard.
Section II.B.2 addresses OSHA's reasons for concluding that use of the
measures prescribed by the Federal or general California Hazard
Communication Standard will constitute compliance with Proposition 65.
Section III.B.3 discusses coverage issues. First, OSHA addresses its
reasons for concluding that almost all of the chemicals and
concentrations of chemicals covered by Proposition 65 are covered by
the Federal standard as well. Second, the
[[Page 31171]]
decision addresses Proposition 65's applicability to California
manufacturers other than chemical manufacturers. Section III.B.4
discusses the substantive differences between the Federal and general
California hazard communication standards, including the argument by
some commentors that the California standard does not protect trade
secrets as effectively as the Federal standard. Section III.B.5
discusses Proposition 65's supplemental enforcement provision.
2. Businesses Can Comply With Proposition 65 by Using Methods
Prescribed by the Federal Hazard Communication Standard
Although there are minor differences, discussed in the next
section, between the coverage of the Proposition 65 elements of the
State plan and the Federal standard, the requirements for compliance
are the same. Some commentors have argued that the Proposition 65
elements of the California standard require businesses to provide
warnings which are not required by the Federal Hazard Communication
Standard. The particular focus of these comments is upon the
possibility that Proposition 65 requires a ``safe harbor'' label where
the Federal standard would not, or where the Federal standard would
require only Material Safety Data Sheet. E.g. Exs. 18-3, 18-149, 18-
162.
Other commentors point out that the California standard, as
discussed in Section III, permits businesses to comply with Proposition
65 by complying with the general State or Federal standards. Exs. 18-
61, 18-143, 18-155. OSHA agrees with the latter commentors and is
noting this understanding as a basis for its approval of the standard.
OSHA's analysis of the California standard is as follows.
Section 5194(b)(6) of the standard, 8 CCR Sec. 5194(b)(6),
incorporates Proposition 65 and outlines the various permutations
possible between the remainder of the California standard and its
Proposition 65 elements. Admittedly, Section 5194(b)(6) is not a model
of clarity. As OSHA's analysis of the regulations shows (see below),
however, when a chemical is covered solely by the Proposition 65 list,
businesses may comply with Proposition 65 by complying with the Federal
Hazard Communication Standard. And when a chemical is covered both by
Proposition 65 and the general State standard, businesses must comply
with Proposition 65 by complying with the general State standard, which
is virtually identical to the Federal Hazard Communication Standard.
(For the minor differences, see Sections III.B.3 and 4.)
Section 5194(b)(6) divides exposures into three types:
(1) Section 5194(b)(6)(B) covers exposures to chemicals which
appear on the Proposition 65 list and which are subject to general
State hazard communication requirements. For these exposures,
businesses must comply with the general State hazard communication
requirements.
(2) Section 5194(b)(6)(C) covers exposures to chemicals which
appear on the Proposition 65 list but which would not otherwise be
subject to general State hazard communication requirements. For these
exposures, businesses have a choice between several alternative methods
of compliance, one of which is compliance with the information,
training and labeling requirements of the Federal Hazard Communication
Standard.
(3) Section 5194(b)(6)(D) covers exposures to chemicals which do
not appear on the Proposition 65 list. These exposures are not relevant
to OSHA's analysis here.
As a practical matter, almost all chemicals covered by Proposition
65 will be covered by the Federal and general State hazard
communication requirements and, therefore, will be subject to Section
5194(b)(6)(B). For these exposures, compliance with subsections (d)
through (k) of the California standard [8 CCR Secs. 5194 (d)-(k)] is
``deemed compliance with the Act.'' 8 CCR Sec. 5194(b)(6)(B). With some
slight variations discussed elsewhere in this decision (see Section
III.B.4), Sections 5194(d) through (I) track the provisions of the
Federal Hazard Communication standard at 29 CFR Sec. 1910.1200(d)-(I).
Section 5194(k) sets forth five appendices. Appendices A-D appear to be
identical to Appendices A-D to 29 CFR Sec. 1910.1200, the Federal
standard.10
---------------------------------------------------------------------------
\10\ There is no Section 5194(j). Appendix E consists of
Proposition 65 regulations from Title 22 of the California Code of
Regulations, which ``are printed in this Appendix because they
provide terms and provisions referred to in subsection (b)(6)
(emphasis added). Appendix E also includes all of the regulations
governing warnings for consumer and environmental exposures. 22 CCR
Secs. 12601(b), (d). OSHA interprets the California standard to
include these provisions solely for the purpose of providing easy
access to code sections referenced in the Standard.
---------------------------------------------------------------------------
In those rare situations involving exposures to chemicals which
appear on the Proposition 65 list but which are not covered by the
Federal or general State standards, Section 5194(b)(6)(C) will govern.
Under that regulation, employers must provide ``a warning to employees
in compliance with California Code of Regulations Title 22 (22 CCR)
Section 12601(c)'' (the OEHHA regulations implementing Proposition 65)
or comply with the requirements of Sections 5194(d)-(k). 8 CCR
Secs. 5194(b)(6)(C). Under Section 12601(c), compliance with
Proposition 65 can be achieved via compliance with the Federal (or, if
the business so chooses, the general State) Hazard Communication
Standard. 22 CCR Sec. 12601(C)(1)(c).
Section 12601(c) begins with the statement:
Warnings for occupational exposures which include the methods of
transmission and the warning messages as specified by this subdivision
shall be deemed clear and reasonable.
The remainder of Section 12601(c) sets forth three alternative
methods of providing acceptable warnings:
1. The business may place on the product's or substance's label a
warning which complies with the criteria for consumer product warnings
[see 22 CCR Secs. 12601 (b)(1)(A), (b) (3)-(4), (c)(1)(A), (c)(2)]; or
2. The business may post a clear and conspicuous workplace sign
[see 22 CCR Secs. 12601(c)(1)(B)]; or
3. The business may comply with the information, training, and
labeling requirements of the Federal Hazard Communication Standard, the
California Hazard Communication Standard, or (in cases involving
pesticides) California's Pesticides and Worker Safety requirements [see
22 CCR Sec. 12601(c)(1)(C)].
Except in the case of pesticides (discussed in Section III.B.3), then,
Section 12601(c) provides that compliance with the measures provided by
the Federal Hazard Communication Standard constitutes compliance with
Proposition 65.
Although California's statements about the proper interpretation of
its standard have been ambiguous, OSHA believes the foregoing
understanding is consistent with the State's interpretations. In its
February 16, 1996 submission (Ex. 6), Cal/OSHA (on behalf of itself,
OEHHA and the Attorney General), stated that:
[T]he Cal-HCS allows compliance to be achieved either through
compliance with subsections (d) through (k) of the HCS, or, where
the HCS would not require a warning, either through the methods set
forth in subsections (d) through (k) or the alternative warning
methods in 22 CCR Sec. 12601(c).
Under the ``HCS Method,'' ``a company may simply give the Proposition
65 warning through a method that complies with the HCS.'' Ex. 6, page
6; see also Ex. 6, pages 7-9; Ex. 18-174A,
[[Page 31172]]
Attachment 5, page 3) (Letter from California DOSH to parties in AYS v.
Turco). Such methods generally would include providing relevant
material safety data sheets, labels, and (for employers) training.
Similarly, California states that if a business chooses to comply with
Section 12601(c),
Sec. 12601(c) itself refers back to the HCS warning methods by
providing that compliance may be achieved through `a warning to the
exposed employee about the chemical in question that fully complies
with all information, training and labeling requirements of the
Federal Hazard Communication Standard'' * * *. However, the
regulation does not provide specific safe harbor warning language
where the HCS method is used to give the warning.
Ex. 6, page 11; see also Cal/OSHA Enforcement Directive, Policy and
Procedure C-43. Similarly, Section 5194(b)(6)(E) provides that
compliance with the Federal Hazard Communication Standard ``shall be
deemed a defense'' in any enforcement action brought under Proposition
65. Id., incorporating 22 CCR Sec. 12601(C)(1)(c).
California does point out that while the language of any ``hazard
warning'' ``need satisfy only the more general standard of
Sec. 5194(c)''--i.e. ``Any words, pictures, symbols or combination
thereof appearing on a label or other appropriate form of warning which
convey the health hazards and physical hazards of the substance(s) in
the container(s)--such a warning must be ``clear and reasonable'' to
meet the requirements of Proposition 65. See Ex. 6 page 9; see also 29
CFR Sec. 1910.1200(c).
One commentor, Dow Chemical (Ex. 18-162, page 9), seizes upon a
similar statement by OEHHA in its promulgation of 22 CCR Sec. 12601(c)
(see Ex. 18-174A, Attachment 2 at page 37) to argue that California
will not, in fact, recognize compliance with the Federal standard as
compliance with Proposition 65. In its statement however, OEHHA's focus
was upon the fact that the Federal standard requires only an
``appropriate'' warning and does not prescribe specific warning
language; 11 thus, OEHHA believed that California would have
to independently evaluate Federal label or MSDS warnings to determine
if they were ``clear and reasonable'' in accordance with Proposition
65's requirements. In OSHA's view, Dow's comment misses a central
point. The Federal standard does not prescribe specific warning
language. That fact, however, is not a license for businesses to create
unclear or unreasonable warnings. An unclear or unreasonable warning
would not meet Federal requirements. Thus, there is no substantive
distinction between the Proposition 65's requirement of a ``clear and
reasonable'' warning and the Federal (and State) requirement of an
``appropriate'' warning. Compliance with the Federal standard, then,
constitutes compliance with the Proposition 65.12 As stated
previously, however, in most cases chemicals on the Proposition 65 list
will be subject to the general State Hazard Communication Standard and,
therefore, employers will have to comply with the State standard. No
commentor has pointed to any significant differences between the
labeling and MSDS requirements of the two standards. Compare 29 CFR
Secs. 1910.1200 (f)-(g) with 8 CCR Secs. 5194 (f)-(g); see also
discussion of trade secrets (California requirement of CAS numbers) in
Section III.B.4. Proposition 65, therefore, does not undermine
effectiveness or result in an undue burden on commerce.13
---------------------------------------------------------------------------
\11\ OEHHA also noted that there might be situations in which
the Federal standard would not apply to particular employees, but
Proposition 65 would. OEHHA did not want Section 12601(c) to be
understood to relieve businesses of the duty of providing warnings
to these additional employees. Ex. 18-174A, Attachment 2 at page 37.
\12\ For example, it appears that several businesses have been
sued because the warnings they provided were phrased in ``and/or''
terms and, thus, did not specify whether the chemical involved was a
carcinogen or a reproductive toxicant. E.g. Ex. 18-39. An ``and/or''
warning also would fail to meet the requirements of the Federal
standard because it does not ``convey the specific physical and
health hazard(s)[.]'' 29 CFR Sec. 1910.1200(c) (emphasis added).
\13\ Assuming, for purposes of argument, that the California
standard did require businesses to add a consumer ``safe harbor''
label warning to a product for which the Federal standard would
require only an MSDS, OSHA finds that such a requirement neither
undermines effectiveness nor constitutes a violation of the product
clause. Although some commentors asserted that these labels result
in ``over warning,'' the record contains no copies of labels which
would undermine the effectiveness of the Federal standard and there
is no evidence demonstrating the burden on commerce which has
resulted. Most of the commentors' complaints, in any case, focus on
the requirements imposed by voluntary settlements, a subject we
discuss below.
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3. Comparison of Coverage Under Federal Standard and Proposition 65
Overview: OSHA has identified three general areas in which the
California standard, including Proposition 65, differs from the Federal
standard. In sections three through five, OSHA will discuss these
differences and analyze them in light of the requirements of Section 18
of the OSH Act.
Before proceeding to these differences, however, it is important to
recognize the overall similarities between the State and Federal
standards. In particular, many commentors maintain that the chemicals
and concentrations of chemicals covered by Proposition 65 and the
Federal standard differ significantly. See, for example, Exs. 18-153,
18-154, 18-162, 18-164, 18-165, 18-166. This is understandable,
particularly in light of the fact that the California standard's
incorporation of Proposition 65 specifically provides for ``Exposures
Subject to Proposition 65 Only.'' 8 CCR Sec. 5194(b)(6)(B). However,
once the Federal and State standards are analyzed, it becomes apparent
that they are, in fact, quite similar. Most important, both standards
require appropriate warnings whenever there is reliable scientific
evidence to support the view that a particular chemical is hazardous.
As a consequence, both standards, with a few exceptions, cover the same
chemicals and concentrations of chemicals.
Under the Federal standard, covered businesses must take
appropriate steps to communicate possible chemical health hazards
(including carcinogens and reproductive toxins) whenever
a. A chemical appears on certain ``floor'' lists referenced in
the standard; or
b. ``There is statistically significant evidence based on at
least one study conducted in accordance with established scientific
principles that acute or chronic health effects may occur in exposed
employees'' [see 29 CFR Sec. 1910.1200(c)]
See 29 CFR Sec. 1910.1200(c), (d) (3)-(4). The general California
standard is equally specific. 8 CCR Secs. 5194(c), (d) (3)-(4).
Accordingly, Federal and State hazard communication coverage is not
limited to specific lists of chemicals but is broad and flexible enough
to take into account any chemical which, whether listed or not, meets
the ``one study'' test.
Proposition 65 relies upon a list of chemicals. The Proposition 65
``list'' is based in part upon the ``floor'' lists used in the Federal
standard and in part upon the State's evaluation of scientific
evidence. See generally California Health and Welfare Code
Secs. 25249.8 (a)-(b).
Much of the confusion in the comments over the chemical coverage
issue appears to reflect an undue focus upon comparing the floor lists
referenced in the Federal standard with the Proposition 65
list.14 Although there
[[Page 31173]]
is a great deal of overlap between these Federal and Proposition 65
lists, preoccupation with them overlooks the fact that even if a
chemical is not on the Federal floor list, it must be classified as a
hazardous chemical under the Federal standard if there is at least one
scientifically valid study to support a finding that the chemical poses
a health hazard to employees. Similarly, chemicals are placed on the
Proposition 65 list only after a finding by the State (or another
Federal agency) that valid scientific evidence supports their
classification as a carcinogen or reproductive hazard.15
---------------------------------------------------------------------------
\14\ The existence of the Proposition 65 list represents another
difference between the California and Federal standard, but the list
itself does not violate the product clause. There is no evidence
that California's preparation of a list of hazardous chemicals
results in a less effective standard or imposes a burden upon
commerce. Indeed, the list as a supplement to the general hazard
communication requirements should benefit both workers and
businesses by providing another, comprehensive resource for
obtaining information about certain substances.
\15\ For example, Dow Chemical Company cites fifteen substances
which, it states, ``are treated as carcinogens by Prop. 65 but are
not similarly classified by OSHA/NTP/IARC[.]'' Ex. 18-162, page 14
footnote 6. Although it is not entirely clear, this statement
suggests that Dow believes hazard communication about cancer risk is
unnecessary unless a chemical is specifically recognized as a
carcinogen by IARC, NTP or an OSHA standard. This focus misses the
``one study'' requirement of Section 1910.1200(c). The flaw in Dow's
analysis is apparent when at least one of its sample chemicals,
captan, is considered. Captan's primary use is as a pesticide and
that use generally would be regulated by the U.S. Environmental
Protection Agency rather than OSHA. See OSHA's 1994 preamble to the
Hazard Communication Standard, 59 FR 6126, page 6143 (February 9,
1994). OSHA, however, would regulate the manufacture and formulation
of captan and its non-pesticidal uses and recognized the possibility
that it is a carcinogen in its 1992 proposed rule on air
contaminants, noting that animal studies have been contradictory but
that ``high doses caused significant incidences of'' cancer in mice.
See 57 FR 26002 (June 12, 1992). Thus, there appears to be
``statistically significant evidence based on at least one study''
that captan is a carcinogen and subject to OSHA hazard communication
requirements.
---------------------------------------------------------------------------
Proposition 65 requires the California Governor to compose (and
regularly update) a list of chemicals known to be carcinogens or
reproductive toxins. The statute established four mechanisms for
including a particular chemical on this list. First, Proposition 65
created an initial list, which consisted of chemicals automatically
included by virtue of their recognition as carcinogens or reproductive
toxins by the International Agency for Research on Cancer (IARC) or
OSHA. See California Health and Safety Code Sec. 25249.8(a),
incorporating California Labor Code Secs. 6382 (b)(1), (d); see also
AFL-CIO v. Deukmejian, No. C002364 (California Court of Appeals, 1989).
As the court in AFL-CIO recognized, the initial Proposition 65 list
simply mirrored the Federal floor listing references to carcinogens
identified by the National Toxicology Program (NTP) or IARC and to
carcinogens or reproductive toxins otherwise covered by OSHA (under 29
CFR Part 1910 subpart Z). See 29 CFR Secs. 1910.1200(d) (3)-(4) and
Appendix A. Consequently, the initial Proposition 65 list represented
chemicals which would be covered under the Federal standard.
Proposition 65 also provides three methods of supplementing the
initial list. These three methods rely upon scientific evidence that a
chemical causes cancer or reproductive toxicity and, thus, again mirror
the Federal standard. Under California Health and Safety Code Section
25249.8(b), a chemical is listed if, ``in the opinion of the state's
qualified experts''
a. ``Scientifically valid testing'' shows that the chemical
causes cancer or reproductive toxicity;
b. ``A body considered to be authoritative by'' the State's
experts formally identifies the chemical as a carcinogen or
reproductive toxin [hereafter, ``authoritative bodies mechanism''];
or
c. A State or Federal agency has ``formally required'' the
chemical to be labeled or identified as a carcinogen or reproductive
toxin [hereafter, ``formally required to be labeled mechanism''].
The California Code of Regulations, see 22 CCR Secs. 12301-12306,
implements these provisions by creating a ``Science Advisory Board''
(SAB) which, in turn, comprises two committees: the ``Carcinogen
Identification Committee'' and the ``Developmental and Reproductive
Toxicant (DART) Identification Committee.'' 22 CCR Sec. 12302(a). The
committee members are the ``State's qualified experts'' in their
relevant fields for purposes of Proposition 65. See 22 CCR Sec. 12301-
2. They advise and assist the California lead agency, the Office of
Environmental Health Hazard Assessment (OEHHA), in implementing
Proposition 65. 22 CCR Sec. 12305.
As is clear from the statute, when the committees themselves
determine that a particular chemical causes cancer or reproductive
toxicity, they must rely upon ``scientifically valid testing.''
California Health and Welfare Code Sec. 25249.8(b); 8 CCR Secs. 12305
(a)(1), (b)(1). This same ``scientifically valid testing'' would
trigger the Federal standard's requirement for hazard communication
when ``there is statistically significant evidence based on at least
one study conducted in accordance with established scientific
principles'' of a potential health hazard. Here again, then,
Proposition 65 would not apply to chemicals not covered by the Federal
standard.
The committees similarly must rely upon valid scientific evidence
when they identify a chemical through Proposition 65's authoritative
bodies mechanism.16 To rely upon an authoritative body's
identification of a chemical as hazardous, the committees must find
``sufficient evidence'' of carcinogenicity or reproductive toxicity
from studies in humans or in experimental animals. 22 CCR Sec. 12306
(e)-(g). Moreover, OEHHA can reject a chemical ``if scientifically
valid data which were not considered by the authoritative body clearly
establish that the chemical does not satisfy the criteria'' of
subsections (e) and (g). 22 CCR Sec. 12306 (f), (h). OEHHA also affords
all interested persons an opportunity to object to a chemical's listing
on ``the basis * * * that there is no substantial evidence that the
criteria identified in subsection (e) or in subsection (g) have been
satisfied.'' 22 CCR Sec. 12306(I). The ``scientifically valid data''
required when the committees identify a chemical for listing under the
authoritative bodies mechanism would activate hazard communication
requirements under the Federal standard as well.
---------------------------------------------------------------------------
\16\ As of September 1996, California had identified five
``authoritative bodies'': IARC; the National Institute for
Occupational Safety and Health (NIOSH); the National Toxicology
Program (NTP); the U.S. Environmental Protection Agency (USEPA); and
the U.S. Food and Drug Administration (USFDA). 22 CCR Sec. 12306(l).
Here again, there is considerable overlap between the Federal and
State standards: the Federal standard similarly explicitly
recognizes IARC and NTP as authoritative sources for identifying
hazardous chemicals. See 29 CFR Secs. 1910.1200(d)(4)(I)-(ii) and
Appendix A. In addition, OSHA has consistently relied upon
information provided by NIOSH in promulgating hazard communication
requirements. See, for example, the preamble to the 1994 amendments
to the Federal standard, 59 FR 6126, 6150-51, 6154 (February 9,
1994). The Federal standard does not similarly require reliance upon
``lists'' compiled by USEPA or USFDA. However, because those
agencies base their determinations upon scientific evidence, it is
highly likely that the Federal standard would treat a chemical as
hazardous if those agencies determined it to be so. (As a practical
matter, however, such chemicals might be exempted under 29 CFR
Sec. 1910.1200(b)(6), a question addressed below).
---------------------------------------------------------------------------
Finally, under 22 CCR Sec. 12902, OEHHA can identify a chemical
pursuant to Proposition 65's ``formally required to be labeled''
mechanism when ``substantial evidence exists to support a finding that
the chemical meets the requirements of this section.'' Labeling
requirements imposed by a State or Federal agency would have to be
based upon at least some scientific evidence; thus, the Federal
standard would cover these chemicals if they were not excluded for
other reasons.
Thus, regardless of the mechanism used to list a chemical under
Proposition 65, the ultimate question is whether there is scientific
evidence to support a finding that a chemical is a carcinogen or
reproductive toxin.
[[Page 31174]]
Because the Federal standard requires hazard communication so long as
there is one reliable scientific study to support the requirement, it
is no less expansive than Proposition 65 with regard to cancer and
reproductive hazards. 29 CFR Secs. 1910.1200(c) (definition of ``health
hazard''), 1910.1200(d).
Indeed, the Federal standard may, if anything, encompass more
chemicals than Proposition 65:
The results of any studies which are designed and conducted
according to established scientific principles, and which report
statistically significant conclusions regarding the health effects
of a chemical, shall be a sufficient basis for a hazard
determination and reported on any material safety data sheet. 29 CFR
Sec. 1910.1200, Appendix B, paragraph 4. Businesses also may report
``other scientifically valid studies which tend to refute the
findings of hazard,'' but the existence of refuting studies does not
dissolve the obligation to report the hazard. Id. In contrast, it
appears that, except for its initial listing mechanism, Proposition
65 requires that the weight of the evidence support the placement of
a substance on the statutory list.17
\17\ Under the non-Proposition 65 elements of the California
standard, of course, businesses would be required to educate workers
about hazards covered by the Federal standard, regardless of
Proposition 65's applicability.
---------------------------------------------------------------------------
The only exceptions to this general principle involve certain
chemicals or concentrations of chemicals which are exempted from
coverage under the Federal standard in some circumstances. OSHA will
discuss these in the next sections and analyze them in light of
``effectiveness'' and ``undue burden'' requirements of Section
18(c)(2).
Mixtures: Under the Federal standard, chemicals present at certain
low concentration levels in ``mixtures'' may not be subject to hazard
communication requirements. Some commentors (e.g. 18-65, 18-96) allege
that Proposition 65 requires businesses to provide a warning for such
chemicals when the Federal standard would not. To some degree, these
commentors misunderstand the Federal requirements; they are correct,
however, to the extent that Proposition 65 allocates the burden of
proof differently than the Federal standard does. This different
allocation of burden of proof, however, does not violate Section 18 of
the Act. See below.
A ``mixture,'' under the Federal standard, is ``any combination of
two or more chemicals if the combination is not, in whole or in part,
the result of a chemical reaction.'' 29 CFR Sec. 1910.1200(c). Section
1910.1200(d) requires businesses to determine the hazards of chemical
mixtures. It further provides, with respect to health hazards
associated with untested mixtures, that ``the mixture shall be assumed
to present the same health hazards as do the components which comprise
one percent (by weight or volume) or greater of the mixture, except
that the mixture shall be assumed to present a carcinogenic hazard if
it contains a component in concentrations of 0.1 percent or greater
which is considered to be a carcinogen under paragraph (d)(4) of this
section[.]'' 29 CFR Sec. 1910.1200(d)(5)(ii). In the case of mixtures
containing chemicals in concentrations of less than one percent (or in
the case of carcinogens, less than 0.1 percent), businesses must
communicate hazards if they have evidence that the chemical involved
``could be released in concentrations which would exceed an established
OSHA permissible exposure limit or ACGIH Threshold Limit Value, or
could present a health risk to employees in those concentrations[.]''
29 CFR Sec. 1910.1200(d)(5)(ii) (emphasis added).
Thus, under the Federal standard, a business must follow hazard
communication requirements a) whenever a reproductive toxin is present
in a mixture at a concentration of one percent; b) whenever a
carcinogen is present at a concentration of 0.1% or greater; or c)
whenever either hazard is present at any concentration and there is
evidence that an exposure limit will be exceeded or a possible health
risk posed.
Proposition 65 similarly exempts certain chemical mixtures from
coverage, but the relevant exemption is phrased differently: a chemical
exposure is exempted from coverage if ``the person responsible'' for
the exposure can show that:
a. ``The exposure poses no significant risk assuming lifetime
exposure at the level in question for substances known to the state
to cause cancer'' and
b. ``That the exposure will have no observable effect assuming
exposure at one thousand (1,000) times the level in question for
substances known to the state to cause reproductive toxicity[.]''
California Health and Welfare Code Sec. 25249.10(c); see also 8 CCR
Sec. 5194(b)(6)(D).
Some commentors appear to interpret the Federal standard's
reference to ``a concentration of one percent'' (or .1%) as a ``cut
off'' point at which no hazard communication warning is required. E.g.
18-106. This understanding is not quite correct. Both the Federal
standard and Proposition 65 require hazard communication whenever a
chemical poses a health risk, regardless of its concentration in a
mixture. Similarly, both provide an exemption from coverage for
chemicals which do not pose a health risk to workers. The central
difference between the two standards is in the allocation of burden of
proof: the California standard imposes the burden of proof upon the
business causing the exposure; the Federal standard does not. In
essence, the substance of the two standards is the same but the
procedures used to apply them differ.
The contrasting burdens of proof under the Federal and California
standards do not provide any basis for OSHA to reject the California
supplement. It cannot logically be argued that imposing the burden of
proof upon business will result in less effective protection for
workers. If anything, reversal of the burden of proof should result in
more effective protection by requiring employers to provide a warning
unless they have some affirmative proof that a substance is not
hazardous in a particular concentration.
This difference between the standards also does not create an undue
burden on commerce. First, the Supreme Court has held that a State
statute's creation of a presumption which may be rebutted by a
defendant does not offend the dormant commerce clause. See Atlantic
Coast Line R. Co. v. Ford, 287 U.S. 502, 509 (1933). In keeping with
OSHA's earlier statements (see Section II.B) about the importance of
dormant commerce clause case law in analyzing OSH Act product clause
issues, OSHA finds that California's decision to shift the initial
burden of proof to defendants does not impose an undue burden on
commerce.18
---------------------------------------------------------------------------
\18\ Shell Oil also maintains that Proposition 65's rebuttable
presumption offends Federal APA and the due process clause of the
fourteenth amendment to the U.S. Constitution. 18-160, page 21. The
Federal APA does not apply to State proceedings. See 5 U.S.C.
Sec. 551; Day v. Shalala, 23 F.3d 1052, 1064 (6th Cir. 1994).
Rebuttable statutory presumptions do not offend due process, when
there is a rational connection between ``the fact proved and the
fact inferred.'' Atlantic Coast Line, 287 U.S. at 508-9 (upholding
presumption of negligence where railroad company failed to give
prescribed warning signals); see also Usery v. Turner-Elkhorn Mining
Company, 428 U.S. 1, 28 (1976) (upholding various presumptions under
Federal Black Lung Benefits Act). The presumption created by
Proposition 65 is rational because there is a logical connection
between the fact that a particular substance is hazardous (the fact
proved by the substance's presence on the Proposition 65 list) and
``the fact inferred''--that the substance is hazardous in a
particular mixture. Id.
---------------------------------------------------------------------------
Second, even assuming this statutory presumption theoretically
could impose an undue burden on commerce, there is no evidence to
support such a burden in this case. Although many commentors
[[Page 31175]]
complained generally about the burden imposed by Proposition 65's ``no
significant risk'' option, none provided sufficient information
addressing the specific point at issue here--that is, whether any
business producing a mixture with a chemical which would not require
hazard communication under the Federal standard was required by
Proposition 65 to provide a warning. Rather, the examples provided by
the commentors tend to bolster the opposite point of view.
One commentor, Chemspec, for example, stated that it was ``sued by
a private bounty-hunter under California's Proposition 65 for our
products that contain nitrilotriacetic acid and its salt (NTA), which
appear on the Proposition 65 chemical list'' as a carcinogen. In
response to the threatened suit, the Chemspec states, it produced two
consultant reports demonstrating that not ``only did both risk
assessments predict exposures well below any warning threshold, both
independent risk assessments cross-correlated. The bounty-hunter,
however, simply dismissed the results out of hand, and threatened to
leave the question to a `battle of experts' trial.'' Ex. 18-127; see
also Ex. 18-174, page 47.
The lawsuit against Chemspec involved nitrilotriacetic acid (NTA),
trisodium nitrilotriacetate (NTA-Na3) and 1, 4-Dioxane. Ex.
18-174B, Attachment 25, Exhibit 3 (settlement agreement). One
consultant's report (18-127A) addresses NTA-Na3 and
indicates that Chemspec primarily sells two carpet cleaning agents in
California, ``powdered Formula 90 and liquid Formula 77,'' which
``typically contain 4.6 percent NTA-Na3 and 6.5 percent NTA-
Na3 respectively.'' The second consultant's report addresses
NTA, with respect to a variety of both consumer and occupational
products.19 The consultant's analysis indicates that NTA's
concentration in all of these products is .1% or greater. See 18-127B,
pages 14-20.
---------------------------------------------------------------------------
\19\ Neither consultant's report addresses 1, 4-Dioxane and
neither Chemspec nor the Coalition mention this chemical in their
comments. Consequently, even assuming that the private plaintiff's
complaints about NTA and NTA-Na3 were without merit under
Proposition 65, OSHA could not conclude that the lawsuit, as a
whole, had no legal basis. Similarly, to the extent the private
lawsuit was based upon consumer product exposure, OSHA's review of
the California standard could have no effect.
---------------------------------------------------------------------------
Given the fact that NTA and NTA-Na3 are present in these
products at concentrations of 0.1% or greater, the Federal Hazard
Communication Standard requires appropriate hazard warnings regardless
of the consultant's predictions about ultimate exposure. See General
Carbon Co. v. Occupational Safety & Health Review Comm'n, 860 F.2d 479,
483-85 (D.C. Cir. 1988) (accepting OSHA's interpretation of standard as
requiring manufacturer to label product, even where product, as
ultimately used by worker, might not pose a hazard). Although it is not
entirely clear from Chemspec's comments or the remaining material in
the record,20 it is possible that Chemspec believes the low
concentrations and exposure assessments relieve it of any burden to
provide hazard warnings. This, if true, would be an incorrect
assumption.
---------------------------------------------------------------------------
\20\ Although the Coalition maintains that Chemspec ``labeled
their products and distributed MSDSs in full compliance with the
Federal standard'' (Ex. 18-174, page 47), the Coalition does not
state whether ``full compliance'' included labeling and MSDSs for
all of the chemicals and products involved in this lawsuit. Chemspec
itself does not address this issue and there is no indication that
it ever attempted to argue that, because it was in ``full
compliance'' with the Federal standard, it was in compliance with
Proposition 65. As discussed in Section III.B.2, where, as here, a
chemical is covered by both Proposition 65 and general State--and
Federal--hazard communication requirements, compliance with the
general State standard constitutes compliance with Proposition 65,
and the compliance requirements of the State and Federal standards
are virtually identical. The omission of this issue from Chemspec's
or the Coalition's discussion suggests that Chemspec might have
believed the Federal standard imposed no obligations for the
particular products in question. On the other hand, the record
contains MSDSs for two, and a label for one, of Chemspec's products,
all of which contain what appear to be hazard communication warnings
for the chemicals involved here. Ex. 18-127, 18-127A. Because the
lawsuit involved twenty-one other products, however, OSHA cannot
determine whether Chemspec believes it was in compliance with the
Federal standard.
---------------------------------------------------------------------------
Articles: The Coalition (Ex. 18-174) alleges that Proposition 65
treats ``articles'' differently than the Federal standard. OSHA
concludes that this is a distinction without a difference.
The Federal standard defines an ``article'' as:
a manufactured item other than a fluid or particle: (I) Which is
formed to a specific shape or design during manufacture; (ii) which
has end use function(s) dependent in whole or in part upon its shape
or design during end use; and (iii) which under normal conditions of
use does not release more than very small quantities, e.g., minute
or trace amounts of a hazardous chemical (as determined under
paragraph (d) of this section), and does not pose a physical hazard
or health risk to employees.
29 CFR Sec. 1910.1200(c). Articles are specifically exempt from
coverage under the Federal standard; however, manufacturers bear the
burden of proving that the product is an article as defined in Section
1910.1200(c). 29 CFR Sec. 1910.1200(b)(6)(iv). Establishing exemption
requires the manufacturer to show, inter alia, that the product poses
no health risk. Sec'y of Labor v. Holly Springs, 16 BNA OSHC 1856 (June
16, 1984).
Proposition 65 does not have a similarly explicit exemption for
``articles''; however, as a practical matter, a manufacturer can
establish a California exemption for a product which is a Federal
``article'' by showing that the product poses no significant risk (or
no observable effect, in the case of reproductive toxins). Under both
the Federal and California standards, then, the manufacturer bears the
burden of proving that the product poses no health risk and the
distinction, as initially noted, is one without a
difference.21
---------------------------------------------------------------------------
\21\ It is true that the California standard outlines specific
requirements for proving ``no significant risk'' and the Federal
does not. See 22 CCR Secs. 12705-12821. OSHA, however, has never
dictated to the States exactly how they must interpret phrases such
as ``no significant risk.'' In any case, no commentor has come
forward with evidence comparing the burdens of proving ``no
significant risk'' under the State and Federal standards.
---------------------------------------------------------------------------
Pesticides: The Federal standard exempts from labeling requirements
``[a]ny pesticide as such term is defined in the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136 et seq.), when
subject to the labeling requirements of that act and labeling
regulations issued under that Act by the Environmental Protection
Agency.'' 29 CFR Sec. 1910.1200(b)(5)(I). In its 1994 amendment of the
Federal standard, OSHA further indicated that, following EPA's
promulgation of its Worker Protection Standard for Agricultural
Pesticides, OSHA agreed ``not to cite employers who are covered under
EPA's final rule with regard to hazard communication requirements for
pesticides.'' 59 FR 6126, 6143 (February 9, 1994).
The Western Wood Preservers Institute (Ex. 18-2) objects to
Proposition 65's application to arsenically-treated wood
products.22 The Institute also outlined a settlement
agreement it reached with a private plaintiff, under which members of
the industry provide Proposition 65 warnings via ink stamps or end
tags. In this context, arsenic is a pesticide and thus would be subject
to regulation by EPA rather than OSHA. The National Cotton Council (Ex.
18-159) objected
[[Page 31176]]
more broadly to Proposition 65's application to pesticides, noting that
``the Federal HCS does not require labeling of pesticides[], which are
covered by U.S. EPA regulations, whereas the CA Governor's List[] * * *
includes many pesticides.'' [footnotes omitted].
---------------------------------------------------------------------------
\22\ In terms of product clause analysis, WWPI's comments focus
solely on an alleged burden placed upon out-of-state manufacturers
shipping treated wood into California. OSHA's finding that
California may not apply its State plan standards to out-of-state
manufacturers should ameliorate WWPI's concern. In addition, these
products have consumer uses which are not addressed by this
decision.
---------------------------------------------------------------------------
OSHA finds that neither comment provides a basis for rejecting the
State standard. First, where pesticides are concerned, compliance with
Proposition 65 in the occupational setting is based upon compliance
with California's Pesticides and Worker Safety Requirements. See 3 CCR
Secs. 6701-6761, as incorporated into the State plan by 8 CCR
Sec. 5194(b)(6)(C) and 22 CCR Sec. 12601(c)(1)(C). Neither the Western
Wood Preservers nor the Cotton Council alleges that compliance with
California's worker pesticide regulations has proven burdensome in the
past.23 With respect to the settlement outlined by the Wood
Preservers, the comment provides insufficient information for OSHA to
determine whether occupational exposures were involved; assuming they
were, however, Section 12601(c) of OEHHA's occupational regulations
provides that compliance with California's worker pesticide regulations
constitutes compliance with Proposition 65. The Institute's member
companies, therefore, faced no additional compliance burden under
Proposition 65 which they did not face as a result of the worker
pesticide regulations. The voluntary settlement reached by the
Institute does not negate the defense available through Section
12601(c). The industry simply failed to avail itself of that defense.
---------------------------------------------------------------------------
\23\ California promulgated the regulations referenced in
Section 12601(c) in 1988.
---------------------------------------------------------------------------
Second, to the extent these commentors object to ``labeling''
requirements allegedly imposed by Proposition 65, they overlook the
Ninth Circuit's decision in Chemical Specialties Manufacturers Ass'n v.
Allenby, 958 F.2d 941 (9th Cir. 1992), cert. denied 506 U.S. 825
(1992). In CSMA, the court found that Proposition 65 does not require
labeling and that, if it did, the law would be preempted by the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA). 958 F.2d at 945.
Consequently, pesticide manufacturers and users cannot be required by
private plaintiffs enforcing Proposition 65 to provide particular
labeling.
Aflatoxins: The National Cotton Council (18-154) argues that
Proposition 65 covers aflatoxins, a biological hazard, whereas the
Federal standard does not. The Council is correct. The Federal Hazard
Communication Standard does not require warnings for aflatoxins or
other biological hazards. This is because aflatoxins do not come within
the scope of the Federal standard, which was ``intended to address
comprehensively the issue of evaluating the potential hazards of
chemicals, and communicating information concerning hazards'' (emphasis
added). 29 CFR Sec. 1910.1200(a)(2). In 1994, OSHA specifically amended
the standard to reflect this fact, adding Section 1910.1200(b)(6)(xii),
which exempts biological hazards. 29 CFR Sec. 1910.1200(b)(6)(xii).
OSHA then explained that:
Although OSHA has never considered either radioactivity or
biological hazards to be covered by the HCS, OSHA has received
inquiries regarding such coverage, and therefore added specific
exemptions for these types of hazards in the NPRM. * * * OSHA
believes that this particular rulemaking is more appropriately
limited to chemical hazards, although OSHA does not discourage
employers from including coverage of such agents in their hazard
communication programs.
59 FR 6126, 6155 (February 9, 1994).
It is unclear whether Cal/OSH's incorporation of Proposition 65
into the State plan was intended in bring aflatoxins (and other
biological hazards) within the scope of the State plan. In practical
terms, aflatoxins would be unlikely to present an occupational hazard;
their presence on the Proposition 65 most likely relates to the hazard
they present in consumer products which, as stated previously, will not
be affected by OSHA's decision. If the State does not intend to bring
aflatoxins within the scope of the State plan, California need not
establish that Proposition 65's coverage of biological hazards meets
the requirements of Section 18(c)(2).
If the State does intend to apply its Hazard Communication Standard
to biological occupational hazards, OSHA finds that Section 18(c)(2)
does not prohibit the State from doing so. As OSHA stated in the 1994
preamble, the Federal exclusion of biological hazards was not intended
to discourage employers from including these hazards in their hazard
communication programs. A State standard covering biological hazards is
more effective than a Federal standard which does not cover such
hazards. In addition, there is no evidence that coverage of biological
hazards would impose an undue burden on commerce. Only one commentor
(the Cotton Council) raised this issue and it presented no evidence of
Proposition 65 enforcement actions involving occupational biological
hazards.
California Non-Chemical Manufacturers: The Coalition argues that
the California standard increases the kinds of products to which hazard
communication requirements apply by requiring manufacturers other than
chemical manufacturers (e.g. truck manufacturers) to provide warnings.
Ex. 18-174, page 28. Based upon OSHA's findings on the out-of-state
manufacturers issue (see Section II.D), the State plan will not
regulate out-of-state vendors; this finding may moot the bulk of the
Coalition's objections. The question remains, however, whether the
California standard covers in-state manufacturers other than chemical
manufacturers (hereafter ``non-chemical'' manufacturers), which would
make its coverage more expansive than the Federal standard, which
applies only to chemical manufacturers as manufacturers. As discussed
in Section II.D, above, California's position on application of its
standard to non-chemical manufacturers is unclear. On the one hand,
California's incorporation of Proposition 65 imposes the law's
obligations upon ``employers'' (8 CCR Sec. 5194(b)(6)) and defines an
``occupational exposure'' as one occurring ``in the workplace of the
employer causing the exposure, to any employee.'' 22 CCR Sec. 12601(c),
as incorporated into the California standard by 8 CCR
Sec. 5194(b)(6)(C). This regulatory language suggests that the State
plan would subject a manufacturer to Proposition 65 requirements only
if the manufacturer was an ``employer'' within the meaning of the State
plan and only with respect to the manufacturers' particular employees.
On the other hand, the California Attorney General has argued that
the State plan's Proposition 65 requirements also apply to
manufacturers other than chemical manufacturers (hereafter ``non-
chemical manufacturers''). The Attorney General's position appears to
be based upon the fact that some products of non-chemical manufacturers
may be combined with a chemical to produce a hazardous chemical. For
example, an industrial truck uses diesel fuel, which produces exhaust
which is a hazardous chemical. See Ex. 18-156. The Attorney General
also has taken the position that Section 12601(c)'s definition of an
``occupational exposure'' does not limit the State plan's Proposition
65 coverage to the duties owed by manufacturers to their own employees.
Rather, the Attorney General has maintained that the State plan imposes
obligations upon manufacturers in their relation to the employees of
other businesses.
[[Page 31177]]
Consequently, it appears that California may extend hazard
communication requirements to non-chemical manufacturers in their role
as manufacturers, which exceeds the scope of the Federal
standard.24 Ex. 18-174, Attachment 31.
---------------------------------------------------------------------------
\24\ California has the power to impose hazard communication
requirements obligations upon all employers (in their role as
employers) located within the State. The California standard does
not exceed the Federal in this respect. Equally clearly, and as
discussed above, it cannot impose such obligations upon out-of-state
employers under the State plan.
---------------------------------------------------------------------------
OSHA finds that this potential difference in coverage between the
Federal and State standards does not violate Section 18(c). Facially,
application of hazard communication requirements to non-chemical
manufacturers should lead to more, not less, effective protection for
employees and there is no evidence suggesting otherwise. Accordingly,
OSHA finds that this requirement does not result in less effective
protection. Application of Proposition 65 to California non-chemical
manufacturers also does not violate the product clause.
Proposition 65, by its terms, applies only to exposures occurring
within California. Goods which are manufactured in California by
California employers and which remain in that State do not enter
interstate commerce, and requirements applicable to such products do
not constitute a burden on interstate commerce. Although some
manufacturers maintain that they cannot distinguish between goods that
will be shipped to points in California and goods that will be shipped
elsewhere (and they therefore may elect to apply Proposition 65
warnings to all products regardless of destination), the manufacturer's
voluntary assumption of such a task is not imposed by Proposition 65's
terms. Finally, even assuming that non-chemical manufacturers are
induced by Proposition 65 to provide labeling not otherwise required by
hazard communication requirements, they have submitted no concrete
evidence establishing the extent of the burden imposed.
4. Substantive Differences Between the Federal and General
California Standards
In addition to the objections raised to the Proposition 65 elements
of the California standard, commentors have objected to several parts
of the general (i.e. non-Proposition 65) California standard. These
objections relate to trade secret issues; the failure of the State
standard to exclude all substances excluded by the Federal standard;
and a requirement in the State standard that potential health risks be
described ``in lay terms.''
Trade Secrets: Some commentors allege that the California Hazard
Communication Standard does not provide adequate protection for trade
secrets, as required by OSHA. OSHA's general State plan regulations at
29 CFR Sec. 1902.4(c)(viii) require that a State plan provide adequate
safeguards to protect trade secrets, by such means as limiting access
to such trade secrets to authorized State officers or employees and by
providing for the issuance of appropriate orders to protect the
confidentiality of trade secrets.
Shell Oil Company and Elf Atochem North America, Inc., maintain
that the California standard does not meet this criterion because it
allows access to trade secrets by safety professionals who are not
State officials or employers. Ex. 18-160. Other commentors assert that
the California requirement that Material Safety Data Sheets (MSDS)
contain the Chemical Abstract Service number will jeopardize trade
secrets by allowing outsiders to determine the composition of products.
Exs. 18-40, 18-154. The Federal standard does not require inclusion of
the CAS number. The Color Pigments Manufacturers Association alleges
that the California standard fails to require health and safety
professionals to treat trade secrets confidentially. Ex. 18-40.
The California Hazard Communication Standard allows disclosure of
information to both safety and health professionals, while the Federal
Hazard Communication Standard requires disclosure only to health
professionals. The inclusion of health professionals in the Federal
standard extends trade secret access beyond State officials and
employers, the groups previously listed in the general State plan
regulation. The State argues that its provision further broadening
access to safety professionals is more protective of worker safety,
because many safety and health programs are managed by safety
professionals who have both safety and health expertise. Importantly,
the State requires all persons receiving such trade secret information
to treat it confidentially 8 CCR Sec. 5194(I)(3)(E). OSHA finds that
California has adequate reason to extend disclosure to safety
professionals and that this extension of access does not result in less
effective protection of trade secrets. In addition, while requiring
that CAS numbers be included on a MSDS, the standard also provides an
exemption for trade secrets. 8 CCR Sec. 5194(I)(1). Therefore, OSHA
finds that the State standard's protection of trade secrets is in
accordance with State plan requirements.
California's Omission of Federal Exemptions and Exclusions: The
Chemical Manufacturers Association (CMA) generally protests that the
California standard does not include ``the exemptions and exception
added to the Federal HCS in 1994.'' Ex. 18-154, page 12. One of these
differences, the Federal exclusion of biological hazards, is discussed
above (see ``Aflatoxins''). In any case, however, CMA does not explain
how this difference results in a less effective standard or produces a
burden on commerce and, in fact, states that the differences between
the Federal and general California standard ``in practice * * * have
not presented significant problems for employers and manufacturers.''
Id., page 4. Logically, if California's standard is stricter than the
Federal standard, it should result in more effective protection for
workers. OSHA therefore concludes that California's failure to adopt
all of the exemptions or exceptions added to the Federal standard in
1994 does not require rejection of the standard.
California's Requirement for Use of Lay Terminology on MSDSs: The
general California standard requires that an MSDS include ``[a]
description in lay terms, if not otherwise provided, * * * of the
specific potential health risks posed by the hazardous substance
intended to alert any person reading the information.'' 8 CCR
Sec. 5194(g)(2)(M). The Federal standard does not include this
language, but does require that the MSDS describe ``[t]he health
hazards of the hazardous chemical, including signs and symptoms of
exposure, and any medical conditions which are generally recognized as
being aggravated by exposure to the chemical.'' 29 CFR
Sec. 1910.1200(g)(2)(iv). The Chemical Manufacturers Association
objects to the California requirement but, again, does not explain how
it could result in less effective protection or impose an undue burden
upon commerce. Ex. 18-154, page 12. See also Ex. 18-121. California's
requirement for the use of lay terminology on MSDSs does not appear to
undermine the potential effectiveness of its standard. Indeed, in a
1990 grant program announcement, OSHA recognized that the use of lay
language on MSDSs may enhance worker understanding of hazards. 55 FR
18195 (May 1, 1990). There also is no evidence that a requirement for
the use of lay terminology would pose an undue burden on commerce. As
similarly discussed in the context of Proposition 65 (see Section
III.B.2), ``appropriate'' hazard warnings should be ``clear and
reasonable'; warnings which use lay
[[Page 31178]]
terminology should meet both requirements.
5. Supplemental Enforcement
The most extensive comments to OSHA about Proposition 65 have come
from businesses concerned about their vulnerability to lawsuits brought
by private plaintiffs under Proposition 65. Commentors also have raised
some objections to the participation of the California Attorney General
and local prosecutors in Proposition 65 actions, which are discussed in
Section II.E.
Proposition 65's supplemental enforcement provisions are the one
area where the California standard does differ, clearly and
significantly, from the Federal standard. OSHA nevertheless finds that
this private right of action does not render the California standard
unapprovable. The OSH Act does not prohibit the States from fashioning
their own enforcement strategies and the private right of enforcement,
as a supplement to standard Cal/OSHA enforcement, violates none of the
provisions of Section 18. OSHA notes that Cal/OSHA continues to enforce
its Hazard Communication Standard, issuing, for example, citations for
almost 1000 violations of the standard during Fiscal Year 1996.
Before outlining its decision on this issue in more detail, OSHA
notes initially that most of the anecdotal evidence supplied by
commentors about the burdens created by this private right of
enforcement involved consumer or environmental (either in addition to,
or instead of, occupational) exposures to chemicals. E.g. Exs. 18-133,
18-137, 18-149, 18-162. Again, OSHA's decision on the approvability of
the State occupational standard cannot affect Proposition 65's consumer
and environmental applications.
Effectiveness: Industry commentors generally maintain that
Proposition 65's supplemental enforcement provision does not enhance
the California standard's effectiveness and may, in fact, render the
standard less effective. E.g. Exs. 18-65, 18-143, 18-150, 18-160, 18-
162, 18-174. Most of the comments also involve other allegations of
Section 18 violations. For example, some commentors believe that
Proposition 65 enforcement is less effective because Cal/OSHA generally
is not involved in the suits or because private plaintiffs do not meet
the OSH Act's requirement for ``qualified personnel.'' These issues are
discussed separately, above.
The remaining general allegation of ineffectiveness involves some
commentors' beliefs that most lawsuits brought by private plaintiffs
under Proposition 65 are frivolous. As noted previously, much of this
anecdotal evidence appears to concern lawsuits involving consumer or
environmental exposures, which are beyond OSHA's jurisdiction. In
addition, OSHA's review was made more difficult by a general failure to
the commentors to provide specific information. In many cases,
commentors alleged that they were in compliance with the Federal
standard and were unfairly sued by private plaintiffs. Their comments,
however, did not provide sufficient information for OSHA to determine
whether they were, in fact, in compliance with the Federal standard.
Moreover, based upon the evidence in the comments, none of the
commentors alleging that Proposition 65 supplemental lawsuits are
frivolous has ever actually moved a California court to dismiss a
lawsuit as frivolous. Many have accepted settlements that imposed
requirements equal to or beyond those asked by the California Hazard
Communication Standard and Proposition 65.25
---------------------------------------------------------------------------
\25\ The only commenter to address this issue states that no
defendant has ever moved to dismiss a suit he filed as frivolous.
The record contains no evidence contradicting this assertion. Ex.
18-167.
---------------------------------------------------------------------------
On its face, a supplemental enforcement provision should make a
State standard more, not less, effective because it provides an
additional method of ensuring that a standard is followed. If a
defendant subject to a Proposition 65 lawsuit believes that the
complaint is frivolous, it should bring that complaint to the attention
of the court considering the lawsuit. In any case, given the absence of
specific information about the lawsuits involved, OSHA cannot determine
that private lawsuits filed under Proposition 65 have resulted in less
effective worker protection.
On the other hand, there does appear to be some evidence that
Proposition 65's supplemental enforcement provision has led to better
enforcement of California's Hazard Communication Standard generally.
For example, the Environmental Defense Fund et al. (Ex. 18-163) note
the case of Gonzalez v. Rubber Stampede, Alameda Superior Court No.
714908-3), in which a company which initially had no hazard
communication program was sued by one of its workers. Settlement of the
lawsuit led to the company's agreement to hire a hazard communication
consultant and to implement the consultant's recommendations within
ninety days. See Exs. 18-163 (page 10, note 15) and 18-155C (page 30).
Similarly, in Badenell v. Zurn Industries et al., No. 92-2993 (C.D.
Cal.), Wilkinson Regulator, a manufacturer of brass parts, was sued
under Proposition 65 by four workers, two of whom had elevated blood
lead levels requiring medical intervention. The company was not
following the Cal/OSHA lead standard and its hazard communication
program apparently did not include information about lead. The Federal
court ordered Wilkinson to request inspections by Cal/OSHA and the
company ultimately agreed to comply with all OSHA-recommended
procedures and to adhere to the lead standard. Wilkinson also was
charged with violating Proposition 65's environmental exposure
provisions by dumping lead-laden rinse water; the court ordered the
company to clean up any lead contamination that resulted from that
activity. Ex. 18-163, page 10 n. 15; see also Ex. 18-155C, page 24.
Cal/OSHA's resources, like those of any government agency, are
necessarily limited. Accord Carnation Co. v. Sec'y., 641 F.2d 801, 805
(9th Cir. 1981). Given this fact, both Federal and State laws provide
an incentive for voluntary compliance. The State may reasonably
determine that supplemental private enforcement will produce Hazard
Communication Standard compliance at more workplaces than Cal/OSHA
could expect to visit, as it apparently did in the cases involving
Wilkinson and Rubber Stampede.
In sum, commentors opposing the standard have produced no reliable
evidence showing that Proposition 65's supplemental enforcement option
has resulted in less effective protection for workers, and the
available evidence indicates that California could reasonably conclude
that this enforcement method has resulted in increased protection for
some workers.
Product Clause: The primary objection raised by industry commentors
to Proposition 65's supplemental enforcement mechanism is an alleged
burden on commerce created by the burden of litigating cases in
California. See, e.g. Exs. 18-23, 18-40, 18-41, 18-58, 18-65, 18-75.
Many of these comments relate to the burden imposed upon out-of-state
businesses. OSHA's finding that supplemental lawsuits cannot be brought
against out-of-state businesses under the auspices of the State plan
(see Section II.D, above), therefore, moots many of these comments.
None of the comments establish a violation of the product clause.
The commentors generally cite two competing burdens in this respect:
they either may settle cases brought by private plaintiffs and avoid
the costs of litigation, or they may litigate cases (and
[[Page 31179]]
possibly avoid any award of damages). OSHA finds that any burden
imposed by voluntary settlements reached between businesses and private
plaintiffs in individual cases is not an undue burden on commerce for
purposes of the product clause. Although some commentors attempt to
characterize such settlements as ``extortion'' (Exs. 18-92, 18-145, 18-
162), there is no evidence to support the idea that these settlements
have been involuntary. Nor can OSHA assume, in the absence of specific
information, that cases that are voluntarily settled are without merit.
The litigation costs cited by the commentors (e.g. Exs. 18-23, 18-
40, 18-41, 18-58, 18-65, 18-75, 18-164) also do not establish an undue
burden on commerce. To begin with, it seems questionable whether the
burden of litigating a case could constitute a burden on ``commerce,''
if the substantive requirements at issue in the litigation are
legitimate State requirements. In fact, no commentor cited, and OSHA
could not locate, any cases specifically addressing the general
question of whether a law's enforcement provisions can burden commerce
if its substantive provisions do not. The Supreme Court has rejected
the argument that a State statute shifting attorney fees violates the
dormant commerce clause. Missouri, Kansas & Texas Railway Co. of Texas
v. Harris, 234 U.S. 412, 416 (1914). Proposition 65's provision for
attorney's fees, therefore, does not constitute an undue burden on
commerce. The only other relevant cases are two decisions addressing
the question of whether an award of punitive damages could create an
undue burden on commerce. Both courts rejected this idea. Daugherty v.
Firestone Tire & Rubber Co., 85 F.R.D. 693 (U.S. District Court for the
Northern District of Georgia, 1980); Brotherton v. Celotex Corp., 493
A.2d 1337 (Superior Court of New Jersey, Law Division, March 15, 1985).
These decisions suggest that the penalties available under Proposition
65 also do not constitute an undue burden on commerce.
The dearth of relevant case law on this enforcement issue reflects
the fact that the courts, in considering cases under the Commerce
Clause, do not consider the enforcement provisions of particular laws.
Rather, these decisions focus on burdens posed by the substantive
aspects of particular laws. The courts' focus on the substantive
aspects of laws is logical because the burden of litigating a case is
not a burden on ``commerce.'' The product clause, like the Commerce
Clause, ``protects the interstate market, not particular interstate
firms[.] '' Exxon Corp. v. Governor of Maryland, 437 U.S. 117, 127-28
(1978); Kleenwell Biohazard Waste, 48 F.3d at 397.
Although burdens on individual businesses could, in some
circumstances, add up to a burden on the interstate market, the purely
anecdotal evidence in this record does not support such a finding. OSHA
received 156 comments from opponents of the standard, but only about
fifteen provided specific information about particular lawsuits and the
burdens allegedly imposed. Most of these lawsuits involved out-of-state
businesses, many of whom should be exempt from enforcement under the
auspices of the State plan, as discussed in Section II.D. Almost all of
these lawsuits, as stated before, involved voluntary settlements, which
have limited relevance to OSHA's consideration of product clause
issues. Many cases involved consumer and environmental exposures; the
expenses associated with settlements or litigation of such cases are
not imposed by Proposition 65's occupational applications.
For example, one lawsuit brought to OSHA's attention was As You Sow
v. Shell Oil, Inc. This case is now pending before the San Francisco
Superior Court. Although this suit appears to have occupational
aspects, the plaintiff's arguments also focus on potential exposure to
consumers. See Ex. 18-174A, Attachment 3 (plaintiff's pleading), pages
3, 5, 14-15, 26. Furthermore, several of the issues pending before the
court appear to turn on the proper interpretation of Proposition 65 and
OEHHA regulations--e.g. what does it mean to ``knowingly and
intentionally'' expose someone to a Proposition 65 chemical? Issues
relating to consumer exposures are beyond OSHA's jurisdiction. Some
additional issues do involve the intersection between Proposition 65
and the Federal Hazard Communication Standard--i.e. As You Sow argues
that Shell's warning system does not comply with the Federal standard
(and therefore does not comply with Proposition 65); Shell argues that
it does. See Ex. 18-174A, Attachment 3, pages 18, 27-28 and Ex. 18-
174B, Attachment 12 (defendant's pleading), pages 20-31. However, OSHA
has no evidence showing that the California court is not capable of
resolving the contested issues fairly and reasonably.
Finally, even where the commentors do provide information about
expenses associated with lawsuits which were, at least in part, related
to occupational exposures, the evidence is insufficient to allow OSHA
to judge the quality and extent of any burden imposed. For example, one
of the few cases about which information is available is As You Sow's
lawsuit against Chemspec. See Exs. 18-127, 18-174 (pages 47-48).
Chemspec itself provided no specific information about the financial
burden imposed by the settlement. However, the Coalition states that
Chemspec paid $12,000 in `` [d]irect costs of settlement'' and $40,000
``to rework labels, MSDSs, and reformulated [sic] products[.] ''
Neither Chemspec nor the Coalition provided information regarding
Chemspec's financial condition or the extent to which Chemspec
manufactured or sold listed chemicals, which makes it impossible for
OSHA to determine the relative burden imposed. In addition, it is
unclear whether Chemspec was in compliance with the Federal standard
for the chemicals in question prior to the settlement of the lawsuit.
See Section III.B.2. Finally, as noted in Section III.B.3, some of the
products involved in the lawsuit were consumer products; to the extent
the settlement and other expenses reflect costs attributable to
Proposition 65's consumer applications, those expenses are not relevant
to OSHA's consideration under the product clause.
Accordingly, there is insufficient evidence in the record to allow
OSHA to find that the occupational aspects of Proposition 65 have
created an undue burden on interstate commerce.
C. Inspections, Employer/Employee Rights
Some commentors also addressed whether Proposition 65's private
enforcement mechanism, as incorporated into the State plan, meets OSHA
requirements for enforcement under a State plan, including employer and
employee rights. Section 18(c)(3) of the OSH Act requires State plans
to provide for a ``right of entry and inspection of all workplaces''
which is at least as effective as the provisions of the Act. OSHA
regulations require that a State plan: provide for inspection of
covered workplaces in the State where there are reasonable grounds to
believe a hazard exists (29 CFR Sec. 1902.4(c)(2)(I)); provide an
opportunity for employees and their representatives to bring possible
violations to the attention of the State agency with enforcement
responsibility (29 CFR 1902.4(c)(2)(ii)); provide for an employer to
have the right of review of violations alleged by the State, abatement
periods, and proposed penalties (29 CFR 1902.4(c)(2)(xii)); and for
employees or their representatives to
[[Page 31180]]
have an opportunity to participate in review proceedings (29 CFR
1902.4(c)(2)(xii)).
Several industry commentors allege that because the Proposition 65
supplemental enforcement provisions do not involve on-site inspections,
walkaround by employer and employee representatives, and administrative
review, they do not meet these criteria and should not be approved.
Exs. 18-41, 18-58, 18-59, 18-65, 18-81, 18-96, 18-121, 18-134, 18-142,
18-144, 18-148, 18-150, 18-152, 18-153, 18-154, 18-160, 18-164, 18-169,
18-174. (No workers or organizations representing their interest
complained about the rights afforded employees, however.) Some
commentors believe that businesses are not given adequate notice of
alleged Proposition 65 violations and a reasonable amount of time to
abate them. The Industrial Truck Association asserted that OSHA cannot
enforce without conducting an inspection and that the agency therefore
cannot authorize such enforcement by a State plan. Ex. 18-160.
Cal/OSHA in its response asserts that as long as it continues to
enforce the Hazard Communication Standard in accordance with its
approved inspection procedures, supplemental private enforcement does
not need to meet the criteria. (Ex. 22)
As discussed in Section I.A, State plans do not operate under a
delegation of Federal authority but under their own authority, and
therefore they may use methods of enforcement not included in the
Federal Act. OSHA finds that the private enforcement mechanism of
Proposition 65 incorporated into the State plan serves only to
supplement the enforcement provided by Cal/OSHA and therefore does not
need to include the same enforcement mechanisms used by Cal/OSHA.
Regular State plan enforcement of the Hazard Communication Standard,
including Proposition 65, is still available. Employees continue to
have the right to file complaints with Cal/OSHA regarding alleged
hazard communication violations, including violations of Proposition
65, and to participate in inspections and review proceedings. In
addition, employees have the right to file suits under Proposition 65
and may file amicus briefs in third-party actions. Significantly,
neither workers nor organizations representing their interests
complained of the rights afforded to employees under Proposition 65's
supplemental enforcement provision.
While Proposition 65 does not provide for the setting of specific
abatement dates, employers must be served with a ``Notice of Intent to
Sue'' before a private suit is filed. Some commentors have stated that
these notices have been inadequate in the past. E.g. 18-133, 18-144,
18-164, 18-207. Employers, of course, have all rights available under
the judicial system in enforcement proceedings and may bring any
inadequacies in the notices of intent to sue to the attention of the
courts. Moreover, California recently adopted regulations which clarify
the notice requirements and require greater specificity than some
previous notices of intent contained. See 22 CCR Sec. 12903 (effective
April 22, 1997). These new regulations should alleviate the concerns
raised in the comments.
D. Qualified Personnel
Some commentors have questioned whether Proposition 65 as
incorporated into the California Hazard Communication Standard complies
with the OSHA requirement that State plans be enforced by qualified
personnel. Section 18(c)(4) of the OSH Act and 29 CFR Sec. 1902.3(h)
require that the designated agency or agencies have a sufficient number
of adequately trained and qualified personnel necessary for the
enforcement of standards. Several commentors pointed out that the
prosecutors and private citizens bringing enforcement actions under
Proposition 65 need not have specific training or expertise in
occupational safety and health. Ex 18-63, 18-150, 18-160, 18-162, 18-
166, 18-174. In its response, California maintains that as long as the
basic hazard communication requirements are enforced by qualified Cal/
OSHA personnel, the supplemental enforcement need not meet these
criteria.
OSHA finds that since the designated agency, which enforces hazard
communication requirements comparable to those of Federal OSHA, does
have qualified personnel to enforce those requirements, there is no
violation of this requirement. In addition, while actions under
Proposition 65 may be brought by prosecutors or private citizens, the
decisions in these cases are made by State courts, which are also the
final arbiters in contested Cal/OSHA enforcement actions.
IV. Decision
Based upon the analysis set forth in Sections II and III, OSHA
approves the California standard, including Proposition 65 and its
supplemental enforcement provision, but subject to the following
conditions, which are applicable to all enforcement actions brought
under the authority of the State plan, whether by California agencies
or private plaintiffs:
Employers covered by Proposition 65 may comply with the
occupational requirements of that law by complying with the measures
provided by the OSHA or Cal/OSHA Hazard Communication Standard, as
provided in the State's regulations.
The designated State agency, Cal/OSHA, is responsible for
assuring that enforcement of its general Hazard Communication Standard
and Proposition 65 results in ``at least as effective'' worker
protection; the agency must take appropriate action to assure that
court decisions in supplemental enforcement actions do not result in a
less effective standard or in inconsistencies with the conditions under
which the standard is federally approved.
The State standard, including Proposition 65 in its
occupational aspects, may not be enforced against out-of-state
manufacturers because a State plan may not regulate conduct occurring
outside the State.
With these conditions in mind, OSHA has determined that:
(1) The California standard is at least as effective as Federal
OSHA's Hazard Communication Standard. With a few additions which do not
undermine (and may enhance) protection of employees' rights to know
about workplace hazards, the standard covers the same chemicals and
concentration of chemicals as are covered by the Federal standard.
Similarly, the California standard, like the Federal standard, requires
clear and reasonable communication of hazard information. The standard
also adequately protects business trade secrets. Finally, the evidence
available to OSHA does not show that supplemental enforcement of
Proposition 65 has resulted in less effective enforcement of hazard
communication requirements.
(2) The substantive hazard communication requirements contained in
the California standard are applicable to products which are
distributed or used in interstate commerce. Consistent with the
principle set forth in the 1983 Federal Hazard Communication Standard,
OSHA finds that the standard is applicable to products in the sense
that it permits the distribution and use of hazardous chemicals in
commerce only if they are in labeled containers accompanied by material
safety data sheets.
(3) The California standard does not pose an undue burden on
interstate commerce. The substantive differences
[[Page 31181]]
between the general hazard communication requirements and the Federal
hazard communication standard have not been shown to pose a burden on
commerce. In addition, the substantive requirements of Proposition 65
may be met by compliance with the general Federal and State hazard
communication requirements, thus not posing any additional burden on
employers. Finally, based on the evidence in this record, neither
financial burdens associated with voluntary settlement of Proposition
65 cases nor the burden of litigating cases has been shown to create an
undue burden on interstate commerce within the meaning of the product
clause.
(4) The California standard is required by compelling local
conditions. The voters of California have a legitimate and compelling
local interest in determining how their right to hazard information can
best be protected.
(5) The California standard also complies with the remaining
requirements of Section 18 of the Act. Cal/OSHA, as the designated
State agency, is responsible for the effective administration of the
plan throughout the State. This designation meets the requirements of
Section 18(c)(1). The State also has adequately trained personnel for
the enforcement of the standard, pursuant to Section 18(c)(4). Finally,
both the administrative system available under the general California
standard and the judicial enforcement available under Proposition 65's
supplemental enforcement mechanism adequately protect the rights of
employers and employees.
OSHA, accordingly, approves the California Hazard Communication
Standard, including its incorporation of Proposition 65, subject to the
stated conditions. Finally, as noted at the outset of this decision,
OSHA has no authority to address Proposition 65's consumer and
environmental applications, and this decision does not affect those
applications.
V. Location of Supplement for Inspection and Copying
A copy of the California Hazard Communication standard may be
inspected and copied during normal business hours at the following
locations: Office of the Regional Administrator, OSHA, 71 Stevenson
Street, Suite 415, San Francisco, California 94105; and California
Division of Occupational Safety and Health, Department of Industrial
Relations, 45 Fremont Street, Room 1200, San Francisco, California
94105; Office of the Director, Federal-State Operations, OSHA, U.S.
Department of Labor, Room N-3700, 200 Constitution Avenue, NW,
Washington, DC 20210.
Authority: Sec. 18, 84 Stat. 1608 (29 U.S.C. 667); 29 CFR part
1902, Secretary of Labor's Order No. 1-90 (55 FR 9033).
Signed in Washington, D.C., this 2nd day of June, 1997.
Greg Watchman,
Acting Assistant Secretary.
[FR Doc. 97-14723 Filed 6-5-97; 8:45 am]
BILLING CODE 4510-26-P