DATE: November 8, 1995
CASE NO: 95-TSC-9
In the Matter of:
STEVEN E. BALOG,
Complainant,
v.
MED-SAFE SYSTEMS, INC.,
Respondent.
DECISION DENYING RESPONDENT'S MOTION FOR SUMMARY
DECISION
This matter arises under the Toxic Substances Control Act,
15 U.S.C. §2601 et seq. ("TSCA"). Complainant,
Steven Balog, has timely appealed the determination of Linda M.
Burleson, District Director, dated March 3, 1995, which has been
construed to be a request for hearing. The above-entitled matter
was received by the undersigned Administrative Law Judge on March
22, 1995.
Procedural History
On March 30, 1995, the undersigned issued a "Notice of
Hearing and Order" setting this matter for hearing at San Diego,
California on Tuesday, April 25, 1995, at 9:00 a.m. On April 20,
1995, the undersigned received a letter from Respondent's
counsel, stating that certain allegations made by Complainant,
Steven E. Balog, did not come within the jurisdiction of the
TSCA.
As a result of the letter received from Respondent's
counsel, the hearing date of April 25, 1995, was stricken. The
undersigned allowed Respondent to file a motion for summary
judgment, as well as allowing counsel for Complainant to file a
response thereto. The undersigned has received both documents,
as well as Respondent's reply to Claimant's response, and
Claimant's supplemental brief.
Thereafter, on August 24, 1995, the undersigned entered a
Notice of Oral Argument on Motion for Summary Decision and Notice
of Prehearing Conference. Said oral argument and conference were
scheduled for Wednesday, September 27, 1995, at 10:30 a.m. The
Respondent's memorandum was received on September 11, 1995; and
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the Complainant's reply was received on September 25, 1995. In
addition thereto, counsel for Complainant advised the undersigned
that she was undergoing a surgical procedure which had been
scheduled and then rescheduled. As a result thereof, the oral
argument and prehearing conference were continued. Subsequently,
the undersigned received a letter from Complainant's counsel,
stating that she was willing to waive oral argument.
On October 6, 1995, the undersigned directed a letter to
Respondent's counsel, indicating the undersigned's belief that
the motion could be decided without the benefit of oral argument.
Respondent's Statement of Position, agreeing to a waiver of oral
argument, was received on October 20, 1995. Based thereon, the
undersigned issued an Order Striking Oral Argument and Closing
Record, reflecting the agreement of the parties and closing the
record concerning Respondent's motion for summary decision.
Summary of the Case
Complainant was employed by Respondent as a Senior Quality
Assurance Engineer, from September, 1991, to January, 1995.
Respondent is in the business of manufacturing and distributing
medical devices. Complainant's duties with Respondent included,
inter alia, the oversight of the calibration system for
the company's testing equipment and interpretation of test
protocols for regulatory compliance.
One of the major products which Respondent manufactures and
distributes is the "sharps collector." This is a rigid plastic
container used by medical facilities for the safe storage and
disposal of syringes, needles, razor blades, and scalpels after
they have become contaminated through their intended use. The
manufacture of such sharps collectors are regulated by the Food
and Drug Administration (FDA) as class II medical devices.
Complainant alleges that soon after his work for Respondent
began, he noticed that Respondent routinely failed to follow its
own minimum standards for the wall thickness of the manufactured
sharps collectors. It is asserted that the wall thickness of
these devices fell to as low as .028 whereas Respondent had
warranted to the FDA that such thickness would not go below
.050.[1]
Complainant states that he recognized this deficiency in
wall thickness as a potential hazard to the ultimate users of the
sharps collectors. He alleges that he informed his immediate
supervisor of these problems, as well as other management at
Respondent's business. Respondent denies that Complainant in any
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way informed management of the problem.
After several years of these alleged Complaints to
management, Complainant apparently took his complaints to Becton
Dickinson, Respondent's sole customer with regards to the sale
and distribution of the sharps collectors, on December 13, 1994.
According to Complainant, Becton Dickinson informed him that they
would follow through with the necessary notification of the
proper governmental agencies. Complainant himself did not go to
any such agency with this information.
On December 20, 1994, Becton Dickinson notified Respondent
that on information from a whistleblower, it had investigated the
complaints concerning the sharps collectors. According to
Complainant, the FDA has subsequently investigated the matter,
and Becton Dickinson issued a voluntary recall of the allegedly
defective sharps collectors in July, 1995.
Claimant contends that he was locked out of his office
without notice on December 23, 1994. On December 27, 1994, he
was placed on paid leave for two weeks and on January 23, 1995,
he was placed on administrative leave without pay. Complainant
alleges that he was finally terminated on February 9, 1995. He
believes that these actions of Respondent are the result of his
disclosure of information to Becton Dickinson, and that such
actions by Respondent violate the so-called "whistleblower
protection" provisions of two federal statutory acts.
DISCUSSIONLegal Standard for Granting Summary Judgment
The Procedures for the Handling of Discrimination Complaints
Under Federal Employee Protection Statutes, 29 C.F.R. Part 24, do
not specifically provide for summary decision. However, it is
well settled that an administrative law judge assigned to such a
case is authorized to entertain and rule on appropriately filed
motions pursuant to the regulations at 29 C.F.R. Part 18.
SeeHoward v. TVA, 90-ERA-24 (Sec'y July 3, 1991),
slip op. at 4; Eisner v. United States Environmental
Protection Agency, 90-SWD-2 (Sec'y Dec. 8, 1992).
Under the Rules of Practice and Procedure for Administrative
Hearings Before the Office of Administrative Law Judges, "[a]ny
party may, at least twenty (20) days before the date fixed for
any hearing, move with or without supporting affidavits for a
summary decision on all or any part of the proceeding." 29
[PAGE 4]
C.F.R. §18.40(a). "The administrative law judge may enter
summary judgment for either party if the pleadings, affidavits,
material obtained by discovery or otherwise, or matters
officially noticed show that there is no genuine issue as to any
material fact and that a party is entitled to summary decision."
29 C.F.R. § 18.40(d). As the Benefits Review Board remarked
in Hall v. Newport News Shipbuilding & Dry Dock Co., 24
BRBS 1 (1990),
The purpose of the summary judgment procedure . . .
under Section 18.40, is to promptly dispose of actions
in which there is no genuine issue as to any material
fact. Not only must there be no genuine issue as to
the evidentiary facts, but there must also be no
controversy regarding inferences to be drawn from them.
In determining if summary judgment is appropriate, the
court must look at the record in the light most
favorable to the party opposing the motion, and must
draw all inferences favorable to the party opposing the
motion. To defeat a motion for summary judgment, the
party opposing must establish the existence of a
genuine issue of fact which is both material and
genuine, material in the sense of affecting the outcome
of the litigation, and genuine in the sense of there
being sufficient evidence to support the alleged
factual dispute.
Id. at 4 (citations omitted).
Whistleblower Protection
The so-called "whistleblower" laws consist of Federal
employee protection provisions which are incorporated into
several Federal statutory acts. Such acts include the Safe Water
Drinking Act, the Water Pollution Control Act, the Toxic
Substances Control Act, the Solid Waste Disposal Act, the Clean
Air Act, and the Energy Reorganization Act of 1974. In general,
the employee protection provisions of these acts:
provide that no employer subject to the provisions of
the Federal statute of which these protective
provisions are a part may discharge any employee or
otherwise discriminate against any employee with
respect to the employee's compensation, terms,
conditions, or privileges of employment because the
employee, or any person acting pursuant to the
employee's request, engaged in any of the activities
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specified in paragraph (b) of this section.
29 C.F.R. §24.2(a). As further stated in paragraph (b) of
this section of the regulations:
any person is deemed to have violated the particular
federal law and these regulations if such person
intimidates, threatens, restrains, coerces, blacklists,
discharges, or in any other manner discriminates
against any employee who has:
(1) Commenced or caused to be commenced, or
is about to commence or cause to be commenced
a proceeding under one of the Federal
statutes listed in § 24.1 or a
proceeding for the administration or
enforcement of any requirement imposed under
such Federal statute;
(2) Testified or is about to testify in any
such proceeding; or
(3) Assisted or participated, or is about to
assist or participate in any manner in such a
proceeding or in any other action to carry
out the purposes of such Federal statute.
29 C.F.R. §24.2(b).
Complainant originally alleged that his discharge violated
the employee protection provision of the Toxic Substances Control
Act ("TSCA"). 15 U.S.C. § 2601 et seq. Subsequent to
Respondent's motion for summary decision, Complainant has further
alleged that his discharge also violated a similar provision of
the Solid Waste Disposal Act ("SWDA").[2] 42 U.S.C. § 6901
et seq. The undersigned notes that the employee
protection provisions of each act are substantially similar to
the provision of the regulations quoted above. See 15
U.S.C. §2622; 42 U.S.C. §6971.
Respondent's Arguments
Respondent presents numerous arguments in favor of its
motion for summary decision. Each particular argument will be
addressed separately herein.
SHARPS COLLECTORS ARE NOT COVERED UNDER THE TSCA
Respondent's first argument in favor of summary judgment is
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based upon the assertion that sharps collectors are not regulated
under the TSCA. Therefore, the argument goes, Complainant's
conduct did not in any way relate to the purposes of the act as
required for implication of its employee protection provision.
Respondent argues that sharps collectors are specifically
excluded from coverage under the TSCA, and are instead regulated
by the FDA. In its Statement of Position, Respondent states that
Section 2602(2)(B)(vi) "expressly provides that the definition of
'toxic substances' under the TSCA does not include drugs or
medical devices as defined by the federal Food, Drug and Cosmetic
Act."[3] Therefore, because sharps collectors are regulated
under this act, they can not be regulated under the TSCA.
To support this argument, Respondent cites portions of the
legislative history of the TSCA. In particular, the House of
Representatives noted that in adopting the Federal Food, Drug and
Cosmetic Act's definitions of "food additive," "drug,"
"cosmetic," and "device," the "Committee has made the exclusion
of these items from the bill [the TSCA] coextensive with the
authority to regulate them under the Federal Food, Drug and
Cosmetic Act." H. Rep. No. 94-1341, 94th Cong., 2d Sess., at 10
(July 14, 1976).
The undersigned believes that Respondent is only partly
correct in its interpretation of this section of the TSCA and the
legislative history surrounding it. Section 2602(2)(B)(vi)
excludes from the term "chemical substance," any "food additive,
drug, cosmetic, or device . . ." as those terms are defined in
the Federal Food, Drug and Cosmetic Act. 15 U.S.C. §
2602(2)(B)(vi). I find, as Respondent argues, that sharps
collectors are indeed devices specifically excluded from the term
"chemical substance," as they are properly regulated by the FDA.
Based upon the legislative history, it is clear that sharps
collectors can not therefore be regulated under the TSCA as
"chemical substances."
However, Respondent's error is in its conclusion that if
something is excluded from the definition of a "chemical
substance," it must therefore be excluded from coverage under the
TSCA altogether. On the contrary, there are many other items
which can and should be regulated under the TSCA which are not in
fact "chemical substances." One need only look to the regulatory
power granted to the Environmental Protection Agency (EPA)
pursuant to the TSCA to find examples of such items.
One striking example which the undersigned finds to be of
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particular importance to the finding contained herein, is found
at Section 2605 of the TSCA. This section specifically allows
the Administrator of the EPA to take certain actions if "there is
a reasonable basis to conclude that the manufacture, processing,
distribution in commerce, use, or disposal of a chemical
substance or mixture, or that any combination of such activities,
presents
or will present an unreasonable risk of injury to health or the
environment. . . ." 15 U.S.C. § 2605(a) (emphasis added).
If such a finding is made, the Administrator is empowered to
enact:
(3) A requirement that such substance or mixture or
any article containing such substance or mixture
be marked with or accompanied by clear and adequate
warnings and instructions with respect to its use,
distribution in commerce, or disposal or with
respect to any combination of such activities.
. . .
(6)(A) A requirement prohibiting or otherwise
regulating any manner or method of disposal of such
substance or mixture, or of any article containing
such substance or mixture, by its manufacturer or
processor or by any other person who uses, or disposes
of, it for commercial purposes.
15 U.S.C. §§ 2605(a)(3), 2605(a)(6)(A) (emphasis
added). Therefore, it is abundantly clear that the EPA has
regulatory authority under the TSCA over any article containing
"chemical substances," even though that article itself is not
such a substance.
Therefore, it must be determined whether, when used as
intended, sharps collectors contain a "chemical substance" or
mixture. If so, the undersigned believes that they may be
properly regulated under the TSCA. Indeed, if the items
contained in a sharp collector are "chemical substances," and
the EPA found that the disposal thereof was dangerous to the
health or environment, it appears that under Section
2605(a)(6)(A), the EPA could completely prohibit the use of
sharps collectors for disposal purposes. There certainly could
be no greater regulatory power over sharps collectors than this.
DO SHARPS COLLECTORS CONTAIN A "CHEMICAL SUBSTANCE"?
As noted above, the sole purpose for sharps collectors is
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the storage and disposal of medical instruments after use. Such
instruments include needles, scalpels, syringes, and razor
blades. As Complainant points out, these instruments become
contaminated with blood and bodily fluids after use. The
undersigned takes judicial notice as to the health hazards which
may be caused by human exposure to these contaminated
instruments. It is obvious that medical personnel could be
endangered by one prick of a needle used in the treatment of an
HIV infected patient. Consequently, sharps collectors, after
their intended use, hold toxic substances which are injurious to
the health of medical personnel. But are these toxic substances
considered to be "chemical substances" under the TSCA?
Respondent argues in its statement of position, that the
language and history of the TSCA indicates that bodily fluids are
not "chemical substances" under the TSCA. Respondent cites
numerous provisions in the Act indicating that the statute's
focus is upon the regulation of new chemicals being "produced,"
"manufactured," "distributed," and placed in "interstate
commerce." According to Respondent, the focus of the TSCA is not
on infectious bodily wastes or fluids.
The undersigned finds that the statutory language of the Act
clearly indicates to the contrary. The TSCA specifically defines
a chemical substance as "any organic or inorganic
substance of a particular molecular identity . . . ." 15 U.S.C.
§ 2602(2)(A) (emphasis added). The generally accepted
definition of "organic" is "of, relating to, or arising in a
bodily organ."[4]
The clear language of the TSCA therefore indicates that the
focus of the TSCA is on bodily fluids, as well as new chemicals
being produced, manufactured, and distributed. Under this
language, contaminated bodily fluids obviously fall within the
definition of a "chemical substances," regardless of the fact
that they are created by the human body, rather than by any
manufacturing process.
Nor can it be argued that interstate commerce is not
affected by the use of sharps collectors in the storage and
disposal of medical waste contaminated with bodily fluids. The
disposal of any kind of waste, especially potentially hazardous
waste, undoubtedly has substantial effects on interstate
commerce. This finding is strongly supported by the expansive
definition of "interstate commerce" applied by the United States
Supreme Court over the past sixty (60) years.
Therefore, the undersigned finds that after being put to
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their proper use, sharps collectors contain and store "chemical
substances" for subsequent disposal. As such, the sharps
collectors, although not considered chemical substances
themselves,
are indeed capable of being regulated under the TSCA. Based
thereon, Respondent's argument for summary decision due to a lack
of jurisdiction under the TSCA, must be denied.
CLAIMANT'S ACTIVITY WAS NOT PROTECTED
Respondent also argues that Claimant's activities in
disclosing the information concerning the sharps collectors, is
not protected activity under the TSCA. The employee protection
provision of the TSCA provides that:
No employer may discharge any employee or otherwise
discriminate against any employee with respect to the
employee's compensation, terms, conditions or
privileges of employment because the employee (or any
person acting pursuant to a request of the employee)
has:
(1) commenced, caused to be commenced, or is
about to commence or cause to be commenced a
proceeding under this chapter;
(2) testified or is about to testify in any
such proceeding; or
(3) assisted or participated or is about to
assist or participate in any manner in such a
proceeding or in any other action to carry
out the purposes of this chapter.
15 U.S.C. §2622. In determining whether Complainant's
actions may fall under one or more of these "protected
activities," the undersigned notes that the employee protection
provisions of the environmental statutes have traditionally been
construed broadly. Jenkins v. U.S. Environmental Protection
Agency, 92-CAA-6 (Sec'y May 18, 1994).
Claimant alleges that when he went to Becton Dickinson with
the information, he was told that "they" (Becton Dickinson) would
inform the appropriate agency. Whether this truly occurred of
course, is a factual question, the resolution of which is not
proper in a ruling on a motion for summary decision. Therefore,
the undersigned must view the facts in the light most favorable
[PAGE 10]
to the nonmoving party, and must assume that this factual
allegation by Complainant is true.
As such, the undersigned finds that "acting pursuant to the
request of the employee," Becton Dickinson agreed to assist in an
"action to carry out the purposes of this chapter."
Quoting 15 U.S.C. §2622. As discussed above, one of
the major purposes of the TSCA is the safe disposal of "chemical
substances," including medical wastes, the toxic bodily fluids
found thereon, and the sharps collectors used to store such
waste. By informing the FDA, and initiating a voluntary recall
of the sharps collectors, Becton Dickinson was assisting in an
action to insure the health and safety of medical personnel
handling the defective sharps containers and overseeing their
disposal.[5]
Furthermore, the Complainant has alleged that he brought
complaints concerning the faulty sharps collectors to the
attention of Respondent's management. Although Respondent denies
this assertion, the undersigned again emphasizes that the facts
must be viewed in the light most favorable to Complainant.
It is well established that making internal safety
complaints is a "protected activity" under the environmental
statutes. SeeMackowiak v. University Nuclear Systems,
Inc., 735 F.2d 1159 (9th Cir. 1984). In fact, as cited by
Respondent, the Third Circuit has stated:
Employees should not be discouraged from the normal
route of pursuing internal remedies before going public
with their good faith allegations. Indeed, it is most
appropriate, both in terms of efficiency and economics,
as well as congenial with inherent corporate structure,
that employees notify management of their observations
of the corporation's failures before formal
investigations and litigation are initiated, so as to
facilitate prompt voluntary remediation and compliance.
. . .
Passaic Valley Sewerage Commissioners v. Department of
Labor, 992 F.2d 474, 479 (3rd Cir. 1993), cert denied,
114 S. Ct. 439 (1993).
Respondent does present several cases which purportedly
stand for the proposition that complaints made by an employee to
his employer's customer are not protected activity. However, the
undersigned notes that these cases involved circumstances in
which the complainant failed to first bring his complaints to the
[PAGE 11]
attention of the employer's management. Here, Complainant has at
least alleged that he did so. The issue as to whether he
actually did this is a factual one properly resolved after a
formal hearing in this matter. If indeed Complainant did make
internal safety complaints, and Respondent's management failed to
act on those complaints, the undersigned believes that
Complainant would be completely warranted in going forward with
those complaints to Becton Dickinson.[6]
Based upon the foregoing, the undersigned cannot say that,
as a matter of law, Complainant did not further an action or
proceeding in furtherance of the purposes of the TSCA, or that
his actions in doing so were not "protected activity" under the
statute. Therefore, the undersigned finds that summary decision
in favor of Respondent is inappropriate and that the motion must
be denied.
APPLICABILITY OF THE SWDA
Respondent has also objected to Complainant's allegation of
protection under the whistleblower provision of the SWDA, or
RCRA. In particular, Respondent presents several arguments,
including: Complainant waited too long to present this issue, the
two claims cannot be presented at the same time, medical waste is
not covered under the SWDA, the SWDA has been preempted in
California, etc. However, the undersigned notes that the
protection and remedies provided by the SWDA are similar, if not
the same, as those under the TSCA. Because the undersigned has
found that Complainant has properly alleged protection under the
TSCA, concurrent applicability of the SWDA is irrelevant and
unnecessary.
Necessity of a Hearing
In a letter dated September 26, 1995, counsel for
Complainant asserts that there is no need for an evidentiary
hearing in this matter. She argues that Respondent has not
disputed the factual allegations of Complainant contained in his
declarations, and that the legal issues have been fully briefed.
However, as found above, the undersigned feels that there
are numerous factual issues which do require resolution.
Additionally, as Respondent correctly notes in its Statement of
Position, Complainant has not moved this court for summary
decision in his favor. The undersigned finds that summary
decision in favor of either party, based upon the record
presented, is inappropriate. Therefore, this matter will be
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called for formal hearing at the date and time identified below.
ORDERIT IS HEREBY ORDERED that:
1. Respondent's Motion for Summary Decision, filed May 1,
1995, shall be denied; and
2. This matter will be called for hearing (trial) at a
mutually convenient date and time to be determined by this office
and the parties.
SAMUEL J. SMITH
Administrative Law Judge
[ENDNOTES]
[1] These figures are taken from Complainant's Opposition Brief
of May 15, 1995. It is unclear what the units are for these
measurements, but it is irrelevant to this ruling on the motion
for summary decision.
[2] Complainant identifies the SWDA as the Resource Conservation
and Recovery Act ("RCRA"). The RCRA is simply another name for
the SWDA. See 42 U.S.C. § 6901.
[3] Respondent's use of the phrase "toxic substances" is
incorrect and misleading. This particular section defines the
phrase "chemical substances" and the exclusions thereto.
[4] Webster's Ninth New Collegiate Dictionary 831 (9th ed. 1990).
[5] The undersigned notes Respondent's argument that the EPA has
done nothing, nor have they been contacted, in regards to the
sharps collectors. However, such action by the EPA is not
required by the Act. Rather, all that is required is that Becton
Dickinson, acting upon the information provided by Complainant,
"participated in an action to carry out the purposes of [the
TSCA]."
[6] The undersigned notes that there is some authority for
finding that complaint's made directly to a customer, without
first informing company management, may nonetheless be protected
activity under the TSCA. However, resolution of this issue is
not proper at this time, but is best left to resolution after a
hearing.
