[Federal Register Volume 59, Number 233 (Tuesday, December 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29569]
[[Page Unknown]]
[Federal Register: December 6, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 761
[OPPTS-66019; FRL-4904-5]
RIN 2070-AB20
Polychlorinated Biphenyls; Manufacturing, Processing, and
Distribution in Commerce; Proposed Decisions on Exemption Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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SUMMARY: Section 6(e) of the Toxic Substances Control Act (TSCA) bans
the manufacture, processing, distribution in commerce, and the use of
PCBs unless the PCBs are totally enclosed. Section 6(e) gives EPA
authority, however, to allow these activities if the Administrator
finds that they will not present an unreasonable risk of injury to
health and the environment. This proposed rule addresses 19 individual
petitions under TSCA section 6(e)(3)(B) for exemptions from the
prohibition against the manufacture, processing, and distribution in
commerce of polychlorinated biphenyls (PCBs). In this proposed rule EPA
proposes to deny eight petitions and to grant seven petitions; four
petitions were withdrawn by the petitioners.
DATES: Written main comments on this proposed rule must be received by
February 6, 1995. If requested in writing by December 20, 1994, an
informal hearing will be held in Washington, DC on a date to be
announced later.
ADDRESSES: Comments should reference docket #OPPTS-66019 and should be
sent to TSCA Nonconfidential Information Center, EPA/Office of
Pollution Prevention and Toxics, Room B-607, Northeast Mall, 401 M
Street, SW, Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental
Assistance Division (7408), Office of Pollution Prevention and Toxics,
Rm. E-543B, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551,
FAX: (202)554-5603 (document requests only).
SUPPLEMENTARY INFORMATION: Section 6(e) of the Toxic Substances Control
Act (TSCA) bans the manufacture, processing, distribution in commerce,
and the use of PCBs unless the PCBs are totally enclosed. Section 6(e)
gives EPA authority, however, to authorize these PCB activities if the
Administrator finds that they will not present an unreasonable risk of
injury to health or the environment. TSCA provides that EPA may set
terms and conditions, including recordkeeping and reporting
requirements, for granting an exemption.
I. Background
A. Statutory Authority
Section 6(e) of TSCA, 15 U.S.C. 2605(e), generally prohibits the
manufacture of PCBs after January 1, 1979, the processing and
distribution in commerce of PCBs after July 1, 1979, and the use of
PCBs after October 11, 1977, unless otherwise permitted. While section
6(e)(2)(A) of TSCA bans the use of PCBs in any manner other than a
totally enclosed manner, section 6(e)(2)(B) provides that the
Administrator may by rule authorize the use of PCBs if such use will
not present an unreasonable risk of injury to health or the
environment. Section 6(e)(3)(A) of TSCA prohibits the manufacture,
processing, and distribution in commerce of PCBs except for the
distribution in commerce of PCBs that were sold for purposes other than
resale before July 1, 1979. Section 6(e)(3)(B) provides that any person
may petition the Administrator for an exemption from the prohibition on
the manufacture, processing, and distribution in commerce of PCBs. The
Administrator may by rule grant an exemption if the Administrator finds
that:
(i) an unreasonable risk of injury to health or the environment
would not result, and (ii) good faith efforts have been made to
develop a chemical substance which does not present an unreasonable
risk of injury to health or the environment and which may be
substituted for such polychlorinated biphenyl. (15 U.S.C.
2605(e)(3)(B)(i)-(ii)).
The Administrator may set terms and conditions for an exemption and may
grant an exemption for not more than 1 year.
Section 6(e)(1) also authorizes EPA to regulate the disposal of
PCBs consistent with the provisions in section 6(e)(2) and (3). EPA has
issued a regulation that authorizes the import for disposal of PCBs
with concentrations below 50 ppm. PCBs with greater concentrations,
currently may only be imported for disposal pursuant to an exemption
granted by EPA based upon the criteria discussed above.
B. Regulatory Authority
EPA's Interim Procedural Rules for manufacturing, processing, and
distribution in commerce exemptions describes the required content for
the manufacturing, processing, and distribution in commerce exemption
petitions and the procedures EPA follows in rulemaking on exemption
petitions. Those rules are codified at 40 CFR 750.10 through 750.41.
These rules were amended effective April 11, 1994, by notice in the
Federal Register (59 FR 16991). EPA's Procedural Rule for rulemaking
under section 6 of TSCA, which governs use authorizations for PCBs, is
found at 40 CFR 750.1 through 750.9.
C. History of this Rulemaking
EPA received for consideration 18 new exemption petitions and 1
renewal petition under TSCA section 6(e)(3)(B) which are the subject of
this proposed rule. The requests for exemption are as follows:
1. S.D. Myers submitted four individual petitions seeking approvals
to import PCB Transformers from Canada for disposal, to import PCB
Capacitors from Canada for metal recovery and disposal, to import PCB
fluids from Canada for disposal, and to import PCB containing light
ballasts from Canada for disposal.
2. Electrical Apparatus Service Association (EASA) submitted a
petition seeking to renew their approval to process and distribute in
commerce for reuse non-porous component parts from PCB-Contaminated
Transformers that have been double washed/rinsed.
3. MTM Research Chemicals, Inc. submitted a petition seeking
approval to export PCBs that had been shipped illegally to the United
States and also to import four PCBs (less than 500 grams per chemical)
to be distributed in commerce for use in microscopy (this petition was
withdrawn by the petitioner).
4. Sigma-Aldrich Corporation submitted a petition seeking approval
to process and distribute in commerce for export small quantities of
PCBs for research and development.
5. Millipore Corporation in conjunction with Immunosystems Inc.
submitted two petitions, one petition seeking approval to process and
distribute in commerce for export small quantities of PCBs for research
and development and the other petition seeking approval to process and
distribute in commerce small quantities of PCBs for research and
development, characterized as the development of a PCB product (the
second petition was withdrawn by the petitioner).
6. Triangle Labs submitted a petition seeking approval to import
small quantities of PCBs in water, soil and air matrices for purposes
of analysis (this petition was withdrawn by the petitioner).
7. General Electric submitted a petition seeking approval to
manufacture small quantities of PCBs for use on-site in EPA-authorized
research activities.
8. Edwin Kraemer submitted a petition seeking approval to process
and distribute in commerce products made from PCB-contaminated fluff.
9. Jaco Analytical Laboratory submitted a petition seeking approval
to import transformer oil samples for testing.
10. ENSR submitted a petition seeking approval to use carbon drums
to filter PCBs from silicone-filled transformers and to transfer these
drums between customers as in-service equipment (this petition was
withdrawn by the petitioner).
11. Chemsyn Science Laboratories submitted a petition seeking
approval to manufacture and import PCBs for export and domestic use for
the production of analytical standards.
12. Dangerous Goods Consultants submitted a petition seeking
approval to import laboratory samples from Canada for treatability.
13. Supelco, Inc. submitted a petition seeking to manufacture small
quantities of PCBs for research and development.
14. National Institute of Standards and Technology submitted a
petition seeking to export small quantities of PCBs for research and
development.
15. ERTHCO Environmental Service, Inc. submitted a petition seeking
to import transformer oil samples for analysis.
II. Findings Necessary to Grant Petitions
A. Unreasonable Risk Finding
Before granting an exemption petition, section 6(e)(3)(B)(i) of
TSCA requires the Administrator to find that granting an exemption
would not result in an unreasonable risk of injury to health or the
environment in the United States. Consistent with the principle that
persons seeking an exemption from a legislative prohibition bear the
burden of demonstrating eligibility for that exemption, EPA has
interpreted this provision to require a petitioner to demonstrate that
the proposed activity would not pose an unreasonable risk.
To determine whether a risk is unreasonable, EPA balances the
probability that harm will occur to health or the environment against
the benefits to society from granting or denying each petition. (See
generally, 15 U.S.C. 2605(c)(1).) Specifically, EPA considers the
following factors:
1. Effects of PCBs on human health and the environment. In deciding
whether to grant an exemption, EPA considers the magnitude of exposure
and the effects of PCBs on humans and the environment.
a. Health effects. EPA has determined that PCBs are toxic and
persistent. PCBs can enter the body through the lungs, gastrointestinal
tract, and skin, can circulate throughout the body, and can be stored
in the fatty tissue.
b. Environmental effects. Certain PCB congeners are among the most
stable chemicals known, which decompose very slowly once they are
released in the environment. PCBs are absorbed and stored in the fatty
tissue of higher organisms as they bioaccumulate up the food chain
through invertebrates, fish, and mammals. This ultimately results in
human exposure through consumption of PCB-containing food sources.
c. Risks. Toxicity and exposure are the two basic components of
risk. Based on animal data, EPA concluded that in addition to
chloracne, PCBs may cause developmental toxicity, reproductive effects,
and oncogenicity in humans. EPA also concluded that PCBs present a
hazard to the environment.
A lengthy discussion of these factors is provided in the preamble
to the August 24, 1988 proposed exemption rule (53 FR 32327).
2. Benefits and costs. The benefits to society of granting an
exemption vary, depending on the activity for which the exemption is
requested. The reasonably ascertainable costs of denying an exemption
vary, depending on the individual petition. EPA has taken benefits and
costs into consideration when evaluating each exemption petition.
B. Good Faith Efforts Finding
Section 6(e)(3)(B)(ii) of TSCA also requires the Administrator to
find that ``good faith efforts have been made to develop a chemical
substance which does not present an unreasonable risk of injury to
health or the environment and which may be substituted for [PCBs].''
Based upon general legal principles allocating the burden of proof to
the person seeking to qualify for an exemption, EPA has interpreted
this provision to require that a petitioner has the burden of
demonstrating that it has made the requisite good faith efforts. EPA
considers several factors in determining whether good faith efforts
have been made. For each petition, EPA considers the kind of exemption
the petitioner is requesting and whether the petitioner expended time
and effort to develop or search for a substitute. In each case, the
burden is on the petitioner to show specifically what they did to
substitute non-PCB material for PCBs or to show why it was not feasible
to substitute non-PCBs for PCBs. To satisfy this finding for requests
for an exemption to import PCBs, a petitioner must show why such
activity must occur in the United States and what steps will be taken
to eliminate the need to import PCBs in the future.
III. Explanation of Class Exemption for Research and Development
Distinct from its authority to exempt PCBs from the ban on
manufacturing, processing, and distribution in commerce, EPA may also
authorize the use of PCBs. EPA authorized, indefinitely, the use of
PCBs in small quantities for research and development in the Use
Authorization Rule, 40 CFR 761.30(j), published in the Federal Register
of July 10, 1984 (49 FR 28154). ``Small quantities for research and
development'' is defined at 40 CFR 761.3 as ``any quantity of PCBs (1)
that is originally packaged in one or more hermetically sealed
containers of a volume of no more than 5.0 milliliters, and (2) that is
used only for purposes of scientific experimentation or analysis, or
chemical research on, or analysis of PCBs, but not for research or
analysis for the development of a PCB product.''
The processing and distribution in commerce of PCBs in small
quantities for use in research and development is allowed under a class
exemption in the PCB Exemptions Rule, 40 CFR 761.80(g), published in
the Federal Register of August 8, 1986 (51 FR 28556). This rule
eliminated the need for each person who wishes to process and
distribute small quantities of PCBs in commerce for research and
development to file an individual exemption petition. EPA placed the
following terms and conditions on the class exemption: That all
processors and distributors maintain records of their PCB activities
for a period of 5 years; and that any person or company that expects to
distribute in commerce 100 grams (0.22 lb.) or more of PCBs for
research and development within a 1-year period must report to EPA and
identify the sites of PCB activities and the quantities of PCBs to be
distributed in commerce. The processor or distributor could process and
distribute PCBs in commerce and, provided it gives proper prior
notification to EPA, increase the amounts of PCBs that are processed
and distributed in commerce, until EPA takes action to issue a final
rule that changes (e.g., terminates) the applicability of the exemption
at Sec. 761.80(g) to the processor or distributor.
In granting a class exemption, EPA retains the authority to
terminate the class exemption, or to exclude any distributor from the
class exemption, upon determining the activities allowed in the class
exemption will pose an unreasonable risk of injury to health or the
environment. Any changes in the disposition of the class exemption, or
the status of individuals within the class exemption, will be
accomplished through notice and comment rulemaking and members of the
class will be allowed to continue activities until a final rule is
promulgated.
IV. Disposition of Pending Exemption Petitions
A. Import
EPA received eight exemption petitions to import PCBs. Two of these
petitions were withdrawn by the petitioners.
1. S.D.Myers, Inc. (Myers). EPA has received a total of four
petitions from S.D. Myers, Inc. of Talmadge, Ohio, to import large
volumes of PCB waste from Canada for disposal. The first petition was
received by EPA on May 15, 1991, the second and third were both
received on September 9, 1992, and the fourth was received on October
27, 1993.
a. Current petitions. Myers processes PCBs for disposal. It has
received approval from EPA to: disassemble, decontaminate, and recycle
capacitors, to operate a mobile PCB disposal process, and it has
received interim approval to commercially store PCBs.
The petition received on May 15, 1991 (Petition 1) is to import
drained PCB Transformers from Canada for purposes of disposal at Myers'
facility in Talmadge, Ohio. The petition requests a 5-year exemption,
without a limit on quantity. Petition 1 cites data that 21,000 PCB
Transformers are in storage for disposal in Canada, and that an
additional 10,000 PCB Transformers are still in service, but could be
imported for disposal. Myers estimates that if all 31,000 transformers
were imported into the United States, approximately 1.8 million pounds
of PCBs in those transformers would enter the United States. Once at
Myers' facility, the transformers would be disposed of in accordance
with Myers' permit from EPA Region V. The transformers would be
disassembled, metallic portions would be decontaminated and
subsequently smelted for metal recovery, and residual PCBs and porous
materials would be shipped off site to a TSCA-permitted incinerator.
Myers' second petition, received on September 9, 1992, (Petition 2)
is to import intact, non-leaking PCB Capacitors from Canada for
disposal. The capacitors would be disposed of by Myers through a
disassembly, decontamination, and materials recycling process similar
to its transformer process. Myers is permitted by EPA Region V to
process capacitors for disposal. Petition 2 requests a 5-year
exemption, with no limit on quantity. Myers states that there are 18.6
million pounds of PCB capacitors in Canada, and estimates that 13
million pounds of PCB waste requiring incineration would be generated
by the processing of these capacitors at its facility.
The third petition, also received on September 9, 1992, (Petition
3) is a request to import askarel PCB liquids (500 ppm and over) from
Canada to the United States for purposes of disposal. The petition
cites data that 40 million pounds of high-concentration fluid is
present in Canada. Myers would transport the PCBs to a TSCA-approved
incinerator for disposal. The PCBs would not be disposed of at Myers'
Talmadge, Ohio, facility, but some might be stored there before being
incinerated elsewhere. Myers is a permitted PCB transporter and has
interim approval as a commercial storer of PCBs. Petition 3 also
requests a 5-year period with no limit on quantity.
Myers' fourth petition, received by EPA on October 27, 1993,
(Petition 4) is to import intact, non-leaking PCB-containing
fluorescent light ballasts from Canada for disposal. The ballasts would
be taken to Myers' facility, where they would be processed to recover
reclaimable metals, and the contaminated materials remaining would be
shipped off site to a TSCA-approved incinerator. EPA Region V has
permitted Myers' ballast disposal method. Myers is requesting an
exemption for a 5-year period, and estimates that 60 million pounds of
PCB containing light ballasts are present in Canada [Canadian
Government data from 1991 actually estimates that there are 60 million
units present in Canada, which have a total weight of 220 million
pounds (see ``Canadian PCB Summary: A Summary of National PCB
Inventory'' January, 1991)]. Myers provides estimates that indicate
about 20 percent of the ballast weight would consist of unrecoverable
PCB waste [44 million pounds] requiring incineration.
In all four petitions, Myers asserts that since EPA has permitted
their disposal processes based on the fact that these processes do not
pose an unreasonable risk of injury to health or the environment, this
finding should be applied to any PCB waste imported from Canada for
purposes of disposal. Petition 3, which does not involve in-house
disposal activities but only transportation and storage, cites the
overall safety record and safety procedures of the company as grounds
for a no unreasonable risk finding, and specifically asserts that
Myers' PCB tank truck fleet ``has not had an accident or spill when
moving PCBs.''
In terms of benefits, Myers estimates in Petition 1 that by
importing all of Canada's PCB transformers, it would generate $180
million in service fees, and an additional $20 million in scrap metal
sales. Petitions 2, 3 and 4 are estimated to generate revenues of $46
million, $30 million, and $45 million, respectively. Myers estimates
that Petition 3 would earn a profit of $20 million for Myers and the
incinerators (the other petitions do not provide profit estimates). In
addition, Petitions 2 and 4 state that each would create an additional
20 jobs. Other benefits mentioned in the petitions include speeding the
removal of PCBs from North America and a lowering of disposal costs for
companies in Canada.
In response to the good faith efforts criteria of TSCA section
6(e)(3)(B)(ii) have been met, Myers maintains in all four petitions
that this criteria is not applicable to his petitions. Petition 1 does,
however, go on to state that Myers has investigated the possibility of
destroying these wastes in Canada, but concluded that it would not be
politically or economically feasible to do so.
b. Proposed decision on petitions. EPA proposes to deny all four
petitions from S.D. Myers. EPA has determined that the petitioner has
failed to establish that there is no unreasonable risk as required in
TSCA section 6(e)(3)(B). The petitioner has not demonstrated how the
benefits accruing from granting these petitions would outweigh the
risks inherent in the importation of PCB waste as proposed by
petitioner. In addition, EPA believes that the petitioner has failed to
demonstrate that it has made a good faith efforts to investigate and
develop alternatives to import.
EPA has already made a general determination that the import of
PCBs into the United States and the distribution in commerce of PCBs
present an unreasonable risk of injury to human health and the
environment [See 40 CFR 761.20 and 44 FR 31514, May 31, 1979]. EPA has
also stated that ``[i]t is the clear intent of TSCA to minimize the
addition of PCBs to the environment of the United States.'' Id.
Moreover, while EPA believes that there is always some risk inherent in
the import of any quantity of PCBs, the large quantities that Myers
would import significantly increases the risk.
All four of Myers' petitions would involve the importation,
transportation, and disposal of very large quantities of PCB waste.
Taken together, they would account for most of Canada's PCB fluids at
concentrations over 500 ppm, as well as all of its PCB Transformers,
PCB Capacitors and PCB-containing fluorescent light ballasts. Myers
indicates in the four petitions that over a 5 year period it wishes to
import a total of approximately 300 million pounds of PCB waste for
disposal. Based on the data supplied in the petitions and supplemental
information (see note to docket ``Calculations''), EPA calculates that
the four petitions could involve the importation of up to 457 million
pounds of PCB waste into the United States, for disposal either at
Myers' Talmadge, Ohio facility, or, in the case of Petition 3, at an
unspecified TSCA-approved incinerator.
Prior to disposal, Myers would transport large quantities of PCB
waste through the United States either to the Ohio site or to an
incinerator. Subsequent to Myers' disposal activity in Ohio, an
additional 60 to 90 million pounds of concentrated PCB waste (not
counting any additional solvents and process waste that Myers would
generate) would have to be transported from Ohio to a TSCA-approved
incinerator. Currently, the closest available incinerator is located in
Coffeyville, Kansas (Aptus, Inc.). In information supplemental to the
petitions, Myers estimates that an average truckload for such waste
would weigh 40,000 pounds. Using this estimate, EPA calculates that
7,500 to 11,750 truckloads of waste would be shipped to Talmadge, and
an additional 1,500 to 2,250 truckloads would be shipped from Talmadge
for incineration.
Myers has failed to demonstrate that the proposed activity would
not pose a risk to health and environment in the United States. The
introduction and disposal of large volumes of PCBs would pose some risk
of exposure, even if the PCBs are disposed of in an EPA-permitted
facility such as Myers' Ohio facility or other TSCA-approved
incinerator. In addition, the large volumes of PCBs that would be
transported to various facilities in different parts of the United
States pose a potential risk of spills or other exposure to PCBs
despite the past safety record of the transporting company.
Myers also has failed to submit adequate information with respect
to the benefits of the proposed activity. Myers states that one of the
benefits would be additional revenues for the company. With the
exception of Petition 3, however, Myers has provided revenue
information only with respect to gross revenues. Gross revenue
estimates tend to overinflate the actual financial benefit to the
petitioner. To properly evaluate the financial impacts, EPA needs
additional information regarding any costs that might offset projected
gross revenues.
In addition, Myers has failed to substantiate its claim that the
United States would benefit by the removal of PCBs that are stored in
Canada and the elimination of possible risk of crossborder
contamination. EPA acknowledges that there is a possibility that some
PCBs stored in Canada could pose some risk to health or environment in
the United States. Myers, however, has not presented factual
information to demonstrate why PCBs stored in Canada pose such a risk
or to show the extent of the risk to health and environment in the
United States.
The Canadian government regulates the storage and disposal of PCBs
in that country which should provide adequate protection against
releases or spills that could threaten the United States. Moreover,
Canada possesses a domestic disposal facility, and is in the process of
expanding its PCB disposal resources (Memo from Bryan to Greenwood,
June 25, 1991). The government also has some mobile disposal
facilities. Id. Some of these facilities may be available to dispose of
the PCBs that Myers proposes to import into the United States.
Myers also states that lowered disposal costs for Canadian
companies constitute an additional benefit of the proposed activities.
Under TSCA, however, EPA does not consider benefits that may occur
accrue to foreign businesses, just as it does not consider risks that
do not threaten domestic health or the environment.
EPA is proposing to deny Myers' petitions because Myers has failed
to demonstrate that the risks of the proposed activity are reasonable
when weighed against the benefits, particularly in view of the limited
information available to substantiate the alleged benefits.
Myers contends that the proposed disposal activities do not pose an
unreasonable risk by noting that the facilities that would dispose of
the PCBs are permitted by EPA pursuant to 40 CFR 761.60(e). Section
761.60(e) authorizes EPA to issue a permit if the method of destroying
PCBs will not present an unreasonable risk of injury to health or the
environment. Under this provision, EPA weighs the risk of the disposal
methodology against the benefits to the health and environment in the
United States. The fact that EPA has determined that the benefits
outweigh the risks when the activity involves the disposal of domestic
PCBs that are already present in the United States, however, does not
demonstrate that the benefits outweigh the risks when the activity
involves disposing of foreign PCBs that would be introduced into this
country. The introduction of additional PCBs that would otherwise not
be in the United States adds an additional factor to the risk/benefit
equation.
EPA further finds grounds to deny the petitions based on the good
faith efforts criteria of TSCA section 6(e)(3)(B)(ii). Petition 1
maintains that this criteria is ``not really applicable,'' in that
Myers only wishes to import PCBs for disposal, and not for use in
commerce; however, the petition does go on to discuss other disposal
options. The subsequent three petitions simply state that the good
faith efforts criteria does not apply, and provide no discussion of
alternatives. While, strictly speaking, section 6(e)(3)(B)(ii) refers
to finding substitute chemicals, EPA believes that under this section
it must generally consider the issues of the availability of
alternatives, and the overall necessity for granting an exemption. The
alternative to importation of Canadian PCB waste into the United States
for destruction is to destroy those wastes in Canada itself. Myers
maintains in Petition 1 that it has investigated the possibility of
setting up a facility in Canada to recycle/destroy PCB Transformers,
and it concluded that it would be uneconomical and politically
difficult to establish a facility in Canada. However, Myers fails to
demonstrate that establishing a facility in Canada is not feasible;
rather, Myers only forwards arguments as to why doing so is less
expedient and less profitable for Myers than importing the waste to its
existing facility in the United States. Myers does not provide any
evidence that it made substantial good faith efforts to pursue such an
option before it petitioned the Agency for this exemption. More
importantly, Canada already possess a domestic disposal facility, and
is in the process of expanding its PCB disposal resources. There are no
technological barriers to the effective destruction of PCBs in Canada
that would necessitate their shipment to the United States for safe
disposal. Myers has not demonstrated the necessity for the PCBs in
question to be imported to the United States for disposal, and
accordingly EPA finds that all four petitions have failed to meet the
good faith efforts criteria.
Although Myers has not submitted adequate information to allow the
Agency to make the requisite findings for these four specific
exemptions to import Canadian PCBs for disposal, EPA is considering
whether to amend existing PCB disposal rules to modify the general
restriction on the import of PCBs with 50 ppm or greater for disposal.
EPA believes that opening the border to allow import for disposal may
have far-reaching consequences and that it is preferable to raise the
issue of the transboundry movement of PCB waste generally in the
proposed disposal rules rather than to examine it in isolation in the
context of individual company's petitions for exemption. In the
proposed disposal rules, EPA is requesting comment on the circumstances
under which the United States border should be opened to the
transboundry shipments of PCBs for disposal. The proposal, if
finalized, would retain the general prohibitions on import of PCB
wastes at concentrations of 50 ppm or greater, with certain exceptions
described in more detail in the preamble to the proposed disposal rule.
2. Gene Rideout Dangerous Goods Consultants, Inc. (DGC). On
December 27, 1993, Dangerous Goods submitted an exemption petition to
import laboratory samples from Canada for treatability studies. DGC is
a consulting firm which is based in Ontario, Canada, and which also is
incorporated in the state of New Jersey.
a. Current petition. The petitioner requests to import PCB waste
samples, primarily soil samples, not to exceed 5 kilograms total
weight. DGC estimates that samples would be shipped no more than once a
week. Assuming weekly shipments of 5 kilograms each, approximately 260
kilograms of soil and other media would be imported annually. If
granted an exemption, DGC expresses an intent to renew their exemption
for up to 5 years. Treatability analysis would be conducted at
unidentified client laboratories in the United States (DGC is a
consulting firm and does not operate its own laboratory facilities).
The petitioner claims that PCBs in the waste samples would normally be
destroyed during treatment and analysis, but if any remained, the
residuals could be returned to Canada if EPA so stipulates. According
to DGC, the capability to treat/analyze such PCB waste samples does not
exist in Canada at this time, but at least one U.S. laboratory
possesses such technology. DGC believes that such capability should be
developed in Canada within 4 or 5 years time. DGC does not claim any
economic losses to the United States would result from a petition
denial, but it maintains that without this exemption, PCB-contaminated
soil in Canada will remain untreated until Canada develops this
laboratory technology domestically.
b. Proposed decision on petition. EPA proposes to deny this
exemption petition. EPA has determined that, in general, the import
(manufacture) of PCBs into the United States and the distribution in
commerce of PCBs present an unreasonable risk of injury to health and
the environment [See 40 CFR 761.20 and 44 FR 31514, May 31, 1979]. EPA
has also stated that ``[i]t is the clear intent of TSCA to minimize the
addition of PCBs to the environment of the United States.'' Id. DGC has
not demonstrated what benefits would accrue to the United States
through the granting of its petition, and how those benefits would
outweigh the risk inherent in importation of PCB wastes. Accordingly,
EPA cannot make the finding that granting this petition will not
present an unreasonable risk of injury to health or the environment.
In addition, EPA finds that the petitioner has failed to satisfy
the good faith efforts criterion, i.e., DGC has not demonstrated that
there is no viable alternative to importing these samples into the
United States. According to the Canadian Association for Environmental
Analytical Laboratories, there are laboratories within Canada capable
of conducting PCB analysis. The petition does not provide any details
on the unidentified U.S. laboratory's techniques, why the Canadian
laboratories are unable to provide such analysis, or why developing
such technologies would take Canadian laboratories so long. Further,
the petition fails to justify how the shipment of individual laboratory
samples to the United States will expedite the cleanup of PCB-
contaminated sites in Canada: cleanup of these sites will not occur
until the Canadians develop their own domestic ability to apply such
technologies in situ on a large commercial scale. EPA notes that the
primary reason it closed the border in 1980 was to encourage foreign
countries to develop their own capacity for properly handling and
disposing of PCB waste. [See 45 FR 29115, May 1, 1980]. The Agency
believes that granting this petition might actually hinder Canadian
efforts to develop a domestic treatment capability.
3. Jaco Analytical Laboratory, Inc. (Jaco). On June 14, 1993, Jaco
(formerly National Chem Lab) submitted an exemption petition to import
oil samples from transformers from Canadian utilities to test for PCBs,
and to return (export) to the Canadian utilities any unused samples
that test positive for PCBs following their analysis. On May 13 1994,
Jaco amended its petition and notified EPA that National Chem Lab has
been acquired by Jaco.
a. Current petition. The sample sizes would be 2.5 milliliters per
sample of oil. These samples would then be analyzed for PCB content.
Following their analysis, waste oil 499 ppm or less would be recycled
in a high efficiency boiler at Big Stone Utility; and waste oil 500 ppm
or greater would be sent to Aptus for incineration. Jaco estimates that
based on a submittal rate of 50,000 samples per year, the total volume
of PCBs to be imported would be 6 gallons. Jaco maintains that
historical laboratory data indicates that less than 5 percent of the
samples are in the PCB classification (over 50 ppm). In addition, Jaco
estimates that their volume of waste oil greater than 499 ppm would
only increase by 3 gallons annually.
During analysis, Jaco states that the 1 microliter injected into
the Gas Chromatograph (GC) is destroyed in the destructive detector and
the residual oil from this process contains no PCBs since the
extraction process removes the PCBs from the oil. Further, the 9.4
milliliters of 2,2,4-trimethylpentane that is used in the extraction
process and remaining after the GC sample is run, is separated from the
acid and reclaimed in a distillation process for reuse. This recycling
of the solvent used in the extraction eliminates the need for solvent
disposal.
Jaco states that the economic consequences of denial would be
greater for the Canadian utilities. In their petition, Jaco indicates
that Canadian utilities currently pay $100.00 per sample, while Jaco's
cost is $15.00 per sample. Jaco maintains that denial of their petition
would limit the growth of Jaco (4 additional jobs) and the number of
non-farm jobs available in Eastern Washington State.
b. Proposed decision on petition. EPA proposes to deny this
exemption petition. EPA has determined that the petitioner has failed
to establish that there is no unreasonable risk as required in TSCA
section 6(e)(3)(B). The petitioner has not demonstrated how the
benefits accruing from granting these petitions would outweigh the
risks inherent in importation of PCB waste.
EPA has determined that the import (manufacture) of PCBs into the
United States and the distribution in commerce of PCBs present an
unreasonable risk of injury to health and the environment (See 40 CFR
761.20 and 44 FR 31514 and 31537, May 31, 1979). EPA has also stated
that ``[i]t is the clear intent of TSCA to minimize the addition of
PCBs to the environment of the United States.'' Id. In 1980, EPA issued
a policy that encouraged foreign countries to develop their own
capacity for properly handling and disposing of PCB waste. (See 45 FR
29115, May 1, 1980).
Further, EPA has determined that the petitioner has not met the
good faith efforts criterion. Although no non-PCB substitutes can be
used for the analysis of PCBs, the petitioner has not demonstrated or
provided any convincing rationale as to why there is a necessity for
the PCBs to be imported into the United States, solely for the purpose
of analysis. According to the Canadian Association for Environmental
Analytical Laboratories (CAEL), there are analytical laboratories
within Canada for conducting PCB analysis (See CAEL lists of accredited
and certified labs - January, 1994). EPA does not want to encourage the
expansion of PCB products or PCB services for companies when there are
feasible alternatives already in place.
4. ERTHCO Environmental Service, Inc. (ERTHCO). On March 4, 1994,
ERTHCO submitted an exemption petition requesting to import from the
Philippines samples of oil for PCB analysis.
a. Current petition. The petitioner states that the oil samples
from transformers and other electrical equipment would be in vials of 5
milliliter or less. These samples would be collected from clients of
their Manila Branch Office and submitted through the Rancho Cordova/
Sacramento Office to Analytical Associates Inc. located at 4011 Power
Inn Road, Suite G, Sacramento, CA, 95826.
The petitioner states that the analytical evaluations (e.g.,
dielectric breakdown voltage, acid number, dissipation factor, etc.) of
these samples is in an effort to assist power utilities in
understanding the inner performance of their electrical equipment. The
petitioner expects that a maximum of 3 liters of fluid (250 ml or 50
samples less than 5 milliliters), with a PCB concentration range from 0
to 100 percent, would be imported in 1 year.
The petitioner states that PCB release prevention measures would be
implemented for their shipments. In addition, the petitioner would
require all contracting laboratories to handle the samples in an
environmentally sound manner, throughout the process and up to final
disposal.
The petitioner states that the no unreasonable risk criteria would
be met because no handling of the PCBs would take place outside of an
experienced laboratory. Transportation of the samples would be
according to International Air Transportation Authority (IATA)
guidelines. In quantifying the economic consequences if their petition
were denied, the petitioner states that there is major economic benefit
to be realized, but an accurate estimate of the economic impact cannot
be given at this time. Moreover, the petitioner believes that it may be
liable if this activity is not allowed because the petitioner's
operation in the Philippines would not be able to properly determine
risks to personnel safety and the environment.
b. Proposed decision on petition. EPA proposes to deny ERTHCO's
exemption petition. EPA has determined that the petitioner has failed
to establish that there is no unreasonable risk as required in TSCA
section 6(e)(3)(B). The petitioner has not demonstrated how the
benefits accruing from granting these petitions would outweigh the
risks inherent in importation of PCB waste.
EPA has determined that the import (manufacture) of PCBs into the
United States and the distribution in commerce of PCBs present an
unreasonable risk of injury to health and the environment (See 40 CFR
761.20 and 44 FR 31514 and 31537, May 31, 1979). EPA has also stated
that ``[i]t is the clear intent of TSCA to minimize the addition of
PCBs to the environment of the United States.'' Id. In 1980, EPA issued
a policy that encouraged foreign countries to develop their own
capacity for properly handling and disposing of PCB waste. (See 45 FR
29115, May 1, 1980).
Further, EPA has determined that the petitioner has not met the
good faith efforts criterion. Although no non-PCB substitutes can be
used for the analysis of PCBs, the petitioner has not demonstrated or
provided any convincing rationale as to why there is a necessity for
the PCBs to be imported into the United States, solely for the purpose
of analysis. EPA does not want to encourage the expansion of PCB
products or PCB services in the United States when there are feasible
alternatives already in place.
C. Export
EPA received four petitions to export PCBs. One of these petitions
was withdrawn by the petitioner.
1. Sigma-Aldrich Corporation (Sigma-Aldrich). On May 6, 1992,
Sigma-Aldrich submitted an exemption petition to export small
quantities of PCBs for research and development to the international
monitoring community for use in the identification and quantification
of environmental contaminants. On May 24, 1994, Sigma-Aldrich submitted
an amendment to its petition.
a. Current petition. Sigma-Aldrich states that they obtain PCBs for
environmental monitoring purposes from companies already exempted by
EPA. These PCBs are analyzed for quality control by highly trained
chemists using gas chromatography and then prepared as analytical
reference standards.
The PCB standards are prepared in concentrations not exceeding
1,000 micrograms per milliliter in organic solvent. The standards will
be packaged in volumes of 1 milliliter in flame sealed amber glass
ampules. The ampules will be packaged using die-cut cardboard inserts
that hold the ampules securely in place inside a rigid cardboard box
which will be overpacked in a box that has been tested, certified and
labelled according to Department of Transportation (DOT)
specifications. Sigma-Aldrich also states that all shipping will be
done in observance of all domestic and foreign transportation
requirements. The processing of these standards will be performed at
the Sigma-Aldrich facility at 3500 DeKalb Street, St. Louis, Missouri.
The maximum total volume of PCB solution will not exceed 5 liters and
the maximum total PCB volume contained in the solution will not exceed
5 milliliters. Sigma-Aldrich estimates that the total amount of PCBs to
be exported in 1 year will not exceed 100 grams or 0.220 pounds.
According to Sigma-Aldrich the analytical work will generate a
wastestream that contains a maximum of 2.5 milligrams of PCBs, while
the processing wastestream will not exceed 5.0 milligrams of PCBs.
Sigma-Aldrich states that these wastestreams will be handled in
accordance with 40 CFR part 761, subpart K. In its petition, Sigma-
Aldrich also states that through customer screening they will ensure
proper handling of the materials by qualified personnel. Sigma-Aldrich
estimates that denial of this petition will result in a loss in revenue
of $60,000 per year.
In a letter dated March 24, 1994, Sigma-Aldrich amended their
petition to include an exemption to export small quantities of Carbon
14-labelled PCBs for sale to foreign customers for use in the
performance of metabolic and environmental fate studies. Sigma-Aldrich
synthesizes Carbon 14-labeled PCBs in small quantities for metabolism
and environmental research according to their existing exemption.
Sigma-Aldrich's existing exemption for manufacturing PCBs for these
products is in the name of Pathfinder Laboratory which is now the
Radiochemicals Department of Sigma Chemical Company (part of Sigma-
Aldrich Corporation).
The petitioner states that these Carbon-14 PCBs are analyzed by
highly trained chemists using high pressure liquid chromatography in a
quality control laboratory. Packaging for these items consists of
flame-sealed glass ampules containing less than 0.5 milliliters of
solvent. The primary container is overpacked using packing material and
a second box that is DOT specified and labeled. The petitioner also
states that if the petition is granted, applicable foreign requirements
for air, land and water transportation will be followed. In addition,
the wastestream that is produced during the synthesis and analysis will
be absorbed on silica gel and solidified in concrete prior to storage
in compliance with Nuclear Regulatory Commission requirements. The
activity for this petition will be conducted at 11542 Fort Mims Drive,
St. Louis, Missouri.
The petitioner maintains that the total number of ampules to be
distributed in a year will not exceed 500, at less than 5 milligrams of
PCBs per ampule. The petitioner also states that through a customer
screening procedure, the PCBs would be handled by qualified personnel
and should not present a risk of injury to health or the environment.
The petitioner estimates that denial of this petition would result in a
loss of up to $100,000 per year in sales from foreign distributors.
b. Proposed decision on petition. EPA proposes to grant the Sigma-
Aldrich an exemption for 1 year to export small quantities of PCBs for
research and development under Sec. 761.80(c). The Agency generally
treats petitions for exemption to export PCBs more stringently than
petitions to distribute PCBs within the United States. This is because
once the PCBs cross beyond our borders, the United States loses its
ability to monitor the handling and distribution activities, to inspect
the receiving facilities for any regulatory violations, or to protect
health or the environment from releases of those PCBs that might lead
to additional PCB contamination in this country. However, EPA believes
that those concerns are mitigated in the export of PCBs in small
quantities for research and development particularly given the
viscosity, quantity, marking, and packaging of the PCBs, as well as the
careful handling of the PCBs by trained personnel as described in the
petition and amendment. Since there are no substitutes for PCB
analytical samples, the good faith efforts finding has been met.
Sigma-Aldrich would be prohibited from exporting PCBs in excess of
the amounts and quantities specified in its petition (i.e., less than
100 grams/year - Petition 1 and less than 2.5 grams/year - Amendment),
and would be required to petition EPA and obtain an exemption prior to
an increase in the quantity or a change in the manner of handling PCBs
under the Sigma-Aldrich exemption. EPA would consider any such change
as a new exemption petition and address the request by rulemaking. If
Sigma-Aldrich were to wish to continue its export activities beyond the
1-year timeframe under the EPA approved exemption, a certified letter,
pursuant to the amended Interim Procedural Rules, would have to be
submitted to EPA at least 6 months prior to the expiration of the
exemption.
2. Millipore Corporation and ImmunoSystems, Inc. On May 6, 1992,
Millipore Corporation and ImmunoSystems, Inc. requested an exemption to
process and distribute in commerce for export small quantities of PCBs
for research and development.
a. Current petition. The petitioners seek to process and distribute
for export small quantities of PCBs for research and development.
Specifically, the petitioners seek to export their product, the
EnviroGard PCB Test Kit to 42 of their international
distribution subsidiaries. The petitioners state that the
EnviroGard PCB Test Kit is an immunoassay-based test kit for
the analysis of PCBs in soils, water, oil and other liquids. The
petitioner currently processes and distributes in commerce small
quantities of PCBs under the class exemption at 40 CFR 761.80(g).
The components of the kits which contain PCBs (Aroclor 1248) are
EnviroGard PCB Positive Calibrators at 7 ppm, 10 ppm and 45
ppm in methanol. The EnviroGard PCB Test Kit is an analytical
test kit that is used by trained professional chemists and engineers
who are involved in the remediation of PCBs.
The petitioners predict that 250 to 500 kits will be sold overseas
per year. Based on these numbers each kit would contain 6.7 micrograms
of Aroclor 1248 in 0.3 milliliters of methanol, yielding a total of
0.0017 to 0.00335 grams of Aroclor 1248 in 75 to 150 milliliters of
methanol exported in a year. The petitioners state that the kits will
expand existing conventional technologies such as gas chromatography
and mass spectroscopy by offering a safe, reliable, economic, and
expedient way of screening negative samples from positive samples.
Positive samples are later confirmed with conventional techniques and
are disposed of in accordance with applicable regulations.
There are no substitutes available which can be used to accurately
determine the presence of PCBs, since known concentrations of PCBs must
be used in the calibrators that contain known concentrations of PCBs.
The petitioners estimate that the cost of denial of this petition could
cause a loss in revenue amounting to $0.25 million the first year and
$2 to 4 million in 5 years.
b. Proposed decision on petition. EPA proposes to grant Millipore
Corporation and ImmunoSystems, Inc. an exemption for 1 year to export
small quantities of PCB for research and development under
Sec. 761.80(c). As stated above, EPA generally treats petitions for
exemption to export PCBs more stringently than petitions to distribute
PCBs within the United States. This is because once the PCBs cross
beyond our borders, the United States loses its ability to monitor the
handling and the distribution activities, to inspect the receiving
facilities for any regulatory violations, or to protect health or the
environment from releases of those PCBs that might lead to additional
PCB contamination in this country. However, EPA believes that those
concerns are mitigated in the export of PCBs in small quantities for
research and development particularly given the viscosity and quantity
of the PCBs involved, as well as the careful handling of the PCBs by
trained personnel as described in the petition. Further, since no PCB
substitutes exist that can be used to determine the presence of PCBs,
the good faith efforts criterion has been met.
The petitioners would be prohibited from exporting PCBs in excess
of the amounts and quantities specified in their exemption petition,
and would be required to petition EPA to obtain an exemption prior to
an increase in the quantity or a change in the manner of handling PCBs
under the Millipore/ImmunoSystems exemption. EPA would consider any
such change as a new exemption petition and address the request by
rulemaking. If the petitioners were to wish to continue its export
activities beyond the 1-year timeframe under the EPA approved
exemption, a certified letter, pursuant to the amended Interim
Procedural Rules, would have to be submitted at least 6 months prior to
the expiration of the exemption.
3. National Institute of Standards and Technology (NIST). On July
1, 1991, NIST submitted an exemption petition to export small
quantities of PCBs for research and development to the international
monitoring community for use in the identification and quantification
of environmental contaminants.
a. Current petition. NIST currently offers for sale Standard
Reference Materials (SRMs) that were produced and/or characterized with
financial support from U.S. Government Agencies, including EPA. These
SRMs were used for environmental monitoring and research. The
petitioner states that these SRMs in the form of Aroclor mixtures and
as individual isomers, both neat and in solution are distributed in
sealed 2 milliliter ampules pursuant to the class exemption at 40 CFR
761.80(g).
NIST states that the PCBs they analyze are obtained from commercial
sources. Once received, these PCBs are analyzed by their Organic
Analytical Division and/or the Gas and Particulate Science Division.
The petitioner maintains that the material is handled by professional
scientists and technicians. Once the analysis is complete, the
petitioner states that the liquids are packaged in hermetically sealed
ampules and the sediment is contained in amber bottles by trained staff
following proper safety precautions. The materials are packaged using
the NIST logo which indicates the presence of PCBs. The petitioner
states that the PCB materials received for SRM development are analyzed
for their content only, no residual material is produced. Each SRM is
accompanied by a certificate that provides the results of the
characterization and indicates the intended use of the material. In
addition, the petitioner states that because of their congressional
mandate to serve as the nation's physical laboratory and the legal
ramifications of a certified NIST SRM, other governments, industry and
others seek out NIST for its SRMs.
The petitioner states that estimating the economic consequences of
denying their petition is difficult to quantify. However, when
monitoring the import of goods and produce containing PCBs residues,
the petitioner believes an inaccurate PCB analysis could cost human
lives and billions of dollars in produce.
b. Proposed decision on petition. EPA proposes to grant the NIST's
petition. The Agency generally treats petitions for exemption to export
PCBs more stringently than petitions to distribute PCBs within the
United States. This is because once the PCBs cross beyond our borders,
the United States loses its ability to monitor the handling and
distribution activities, to inspect the receiving facilities for any
regulatory violations, or to protect health or the environment from
releases of those PCBs that might lead to additional PCB contamination
in this country. However, EPA believes that those concerns are
mitigated in the export of PCBs in small quantities for research and
development particularly given the viscosity, quantity, and packaging
of the PCBs, as well as the careful handling of the PCBs by trained
personnel as described in the petition. Since there are no substitutes
for PCB analytical samples, the good faith efforts finding has been
met.
NIST would be prohibited from exporting PCBs in excess of the
amounts and quantities specified in its petition (i.e., less than 500
grams/year), and would be required to petition EPA and obtain an
exemption prior to an increase in the quantity or a change in the
manner of handling PCBs under the NIST exemption. EPA would consider
any such change as a new exemption petition and address the request by
rulemaking. If NIST were to wish to continue its export activities
beyond the 1-year timeframe under the EPA approved exemption, a
certified letter, pursuant to the amended Interim Procedural Rules,
would have to be submitted to EPA at least 6 months prior to the
expiration of the exemption.
D. Processing and Distribution in Commerce
EPA received one petition requesting an exemption to allow the
processing and distribution in commerce of PCBs.
Edwin C. Kraemer. On January 30, 1993, Edwin C. Kraemer requested
an exemption to process and distribute in commerce products made from
PCB containing car shredder waste or fluff.
a. Current petition. In the petition, Edwin Kraemer states that he
seeks to use a procedure that converts car shredder waste or fluff
(less than 50 ppm) into a product filler which will constitute a
commodity in trade. The process Mr. Kraemer proposes to use is a
mechanical process which specializes in grinding to a microstructure
size resulting in filler material. Mr. Kraemer maintains that these
fillers can be flame retarding, lightweight, compressible, absorbent,
and have sound proofing, thermal insulating and energy absorbing
characteristics. As described in the petition, items to be manufactured
using this process include, but are not limited to: product filler,
absorbent, solid bulk filler, substitute for concrete fill, ceiling
tile, adobe block, brick, concrete block, insulation panels for walls
and ceilings, packaging, furniture and mattress stuffing, gymnastics
mats, safety barriers, sound insulation, replacement for asbestos,
injection moulding filler, fire retardant coating, plaster board or
building panel filler.
Mr. Kraemer proposes to conduct his initial work using material
from the Orange County Steel Salvage Company which he states is
considered one of the most contaminated sites in the country where
50,000 tons of contaminated material has been stockpiled. Based on the
50,000 tons of contaminated material, Mr. Kraemer estimates that
10,000,000 lbs. will be processed onsite at a concentration of 30 ppm
PCBS, for a total of 300 lbs of PCBs. Mr. Kraemer also asserts that the
PCB contamination is not the result of shredding appliances, motors and
transformers or PCB Items, but is actually attributable to the use of
plastics and finishes in products.
The petitioner maintains that due to the low concentrations and the
anticipated nonfriable uses, that any release of PCBs to the
environment is unlikely. In addition, the petitioner states that the
predictable and anticipated level of inadvertently generated PCBs in
any end product will be kept under 25 ppm; therefore, the manufacturing
or processing for commercial purposes of products with PCB
concentrations of less than 50 ppm should be excluded from the
prohibitions of TSCA section 6(e)(2) and (3). The petitioner states
that he does not see a need for any special labelling, disposal and
recordkeeping requirements, since he is not producing a PCB Item,
article, equipment or container.
The petitioner states that denial of this petition would eliminate
a potential $18.5 million (cost for disposal) savings for the State of
California and a potential $50 million in profit. If the exemption is
granted and the process is successful, the petitioner states that it
would generate employment, eliminate a hazardous waste, recycle a
strategic material, conserve landfill space and protect the environment
and public safety on a long term basis.
b. Proposed decision on petition. EPA proposes to deny the petition
submitted by Edwin C. Kraemer. Although EPA agrees that conversion of
fluff into viable products for trade might ameliorate the disposal
problem in the area of PCB-contaminated fluff, EPA would not be able to
make a finding of no unreasonable risk to health and the environment in
this instance due to insufficient data to support such a finding. EPA
encourages the petitioner to continue to pursue research in this area
in order to generate more data in support of this petition. The good
faith efforts criterion would have been met because the use of a
substitute is not applicable in this instance in that this proposal
seeks to provide an alternative to disposal for PCB-contaminated fluff.
E. Manufacture
EPA received two petitions to manufacture PCBs.
1. General Electric (GE). On November 16, 1992, GE submitted a
petition to manufacture small quantities of PCBs for use on-site in
EPA- authorized research activities.
a. Current petition. GE seeks to synthesize small quantities of
PCBs for use on-site in EPA-authorized activities. In the petition GE
states that ongoing and future research involving the remediation of
PCB-contaminated media requires ready access to a supply of individual
PCB congeners of a known quality and quantity, which is currently not
readily available commercially. This activity would be conducted at GE-
Corporate Research and Development, River and Van Antwerp Roads,
Niskayuna, New York, 12309.
The petitioner states that the PCB congeners will be synthesized
only as necessary for specific EPA-authorized research experiments
while the amount of PCBs to be synthesized will be determined by the
project specific requirements. The petitioner estimates that the total
amount of PCBs to be synthesized will be limited to 2 kilograms per
year, and the total amount of PCBs synthesized with bench-scale
laboratory procedures will be limited to a maximum theoretical yield of
150 grams or less per experiment.
The petitioner maintains that the accidental release of PCBs is
prevented by the use of apparatus such as condensers, cold traps,
molecular sieves, or filters for retaining all reactants and reaction
products. Also, reaction products and waste materials will be analyzed
for PCB content, handled and disposed of in accordance with applicable
regulations.
As described in the petition, PCB congeners are needed for research
into developing alternative PCB remediation methods and innovative PCB
destruction methods; therefore, use of a PCB substitute would not be
feasible.
b. Proposed decision on petition. EPA proposes to grant GE an
exemption for 1 year to manufacture small quantities of PCBs for use
on-site in EPA-authorized activities. Because the research is being
conducted by highly trained and experienced professionals under
controlled conditions and only small quantities are involved, EPA finds
that no unreasonable risk will result from granting an exemption to GE
to manufacture small quantities of PCBs for use on-site in EPA-
authorized research activities. The good faith effort criterion has
been met, because for research in development of alternative PCB
remediation methods and PCB destruction methods, use of a PCB
substitute may not be possible.
GE would be prohibited from manufacturing PCBs in excess of the
amounts and quantities specified in their exemption petition, and would
be required to petition EPA to obtain an exemption prior to an increase
in the quantity or a change in the manner of handling PCBs under the GE
exemption. EPA will consider any such change as a new exemption
petition and address the request by rulemaking. If GE were to wish to
continue its export activities beyond the 1-year timeframe according to
the EPA approved exemption, a certified letter, pursuant to the amended
Interim Procedural Rules, would have to be submitted at least 6 months
prior to the expiration of the exemption.
2. Supelco Inc. (Supelco). On July 31, 1990, Supelco submitted a
petition to manufacture PCBs in small quantities for use in research
and development.
a. Current petition. Supelco seeks approval to manufacture
individual pure PCB isomers in quantities of 0.02 to 0.04 pounds (i.e.,
10 to 20 grams) each at its Supelco Park facility in Bellefonte, PA.
The petitioner estimates that a 10 to 20 gram production lot of an
individual pure PCB isomer would represent a 3 to 5 year supply. Total
annual production is projected at less than 1 pound (i.e., 454 grams).
The PCBs would be diluted in the microgram range and packaged for
distribution in sealed vials for solids and amber ampules for liquids
in either 5 milliliter or 1 milliliter quantities. Waste materials from
the manufacture of PCBs would be manifested off-site for incineration
in accordance with TSCA regulations.
To produce unsymmetrical PCBs, Supelco proposes to use a modified
Gomberg-Bachmann reaction. An aromatic amine, an organic nitrite, and
excess substrate are heated for several hours. Distillation under
vacuum removes the remaining substrate. Column chromatography and/or
high pressure liquid chromatography yields the product. Supelco asserts
the merits of the method are that most of the starting materials are
readily available from commercial sources, the synthesis is a simple
one-step reaction, the final products following chromatography are
sufficiently pure (>97 percent), and the yields are relatively good (30
to 35 percent).
To produce symmetrical PCBs, Supelco proposes to use replacement
reaction of biphenylsulfonic acid with carbon tetrachloride. The
reactants are heated in a Parr reactor for several hours at 250 deg. C
and, after removal of excess solvent, the final product is obtained in
high purity (>98 percent) and high yield (>80 percent).
The synthesis of PCBs would be conducted in a controlled access
laboratory that has been constructed for the preparation of hazardous
chemicals by specially trained personnel in compliance with the
Occupational Safety and Health Administration's (OSHA's) requirements
at 29 CFR part 1910, subpart Z. Standards would be distributed in
sealed glass ampules, no larger than 5 milliliters, to analytical
laboratories with personnel trained in the handling of hazardous
materials. Processing and distribution in commerce activities would be
conducted pursuant to the class exemption at Sec. 761.80(g), and
although processing activities would be expected to reach a maximum of
150 grams, distribution activities would not be expected to exceed 100
grams and therefore would not trigger the reporting requirement of the
class exemption.
Supelco maintains that since it has been selected as the private
industry participant in a Cooperative Research and Development
Agreement (CRADA) to produce and distribute organic quality control
samples for EPA's EMSL-Cincinnati laboratory, the consequences of EPA's
denial of its exemption would be a serious inconvenience to the EPA and
an economic loss of not less than $100,000 annually in potential sales
to Supelco, Inc.
b. Proposed decision on petition. EPA proposes to grant Supelco an
exemption for 1 year to manufacture PCBs for use in small quantities
for research and development under Sec. 761.80(f) . EPA believes that,
due to the careful handling of PCBs by trained personnel as
demonstrated in the petition, there would be no unreasonable risk
presented by granting this exemption petition request. All
manufacturing, processing and distribution activities would be
performed at the Supelco, Inc. facility at Supelco Park, Bellefonte,
PA.
Since no PCB substitutes exist for analytical standards, the good
faith effort criterion does not apply. Granting an exemption would
benefit society by allowing important health, environmental, and
analytical research to continue.
EPA proposes to prohibit Supelco from manufacturing PCBs in excess
of the amounts and quantities specified in its petition (i.e., not to
exceed 1 pound). Further exemptions beyond the 1-year period would be
subject to the amended Interim Procedural Rules at 40 CFR part 750.
Supelco would be required to petition EPA to increase the amount of
PCBs handled, and to change the type of activities, the procedures for
handling the PCBs, and any other term under the Supelco exemption. EPA
would consider any such change as a new exemption petition and address
the request by rulemaking. If Supelco were to wish to continue its
manufacturing activities beyond the 1-year timeframe, a letter sent by
certified mail would have to be received by EPA at least 6 months prior
to the expiration of the exemption pursuant to the amended Interim
Procedural Rules.
F. Manufacture, Import and Export
EPA received one petition to manufacture, import and export PCBs.
Chemsyn Science Laboratories (Chemsyn). On October 22, 1993,
Chemsyn Science Laboratories submitted an exemption petition to
manufacture/import and export PCBs in small quantities for research and
development. Chemsyn is a manufacturer of chemical samples based in
Lenexa, Kansas, and associated with Wellington Laboratories in Ontario,
Canada. Chemsyn distributors are located in the United States, the
Netherlands, Spain, Japan, and Italy. Chemsyn manufactures small
quantity, high purity chemicals for use by industry, universities,
government agencies, etc., for basic scientific research. Chemsyn
produces standards such as radiolabelled, stable isotope labeled, and
unlabelled environmental contaminants, including dibenzo-p-dioxins,
chlorinated dibenzofurans, and EPA Method 1613 and 513 Standard
Solutions. Samples are intended exclusively for laboratory
applications.
a. Current petition. Chemsyn wishes to add PCB analytical standards
to its current selection of environmental contaminant standards. The
petition estimates that not more than 50 grams of PCBs would be
produced annually. Chemsyn will produce each PCB congener in milligram
quantities, and then diluted to the necessary concentration for the
appropriate standard. Chemsyn also will import some standards
containing PCBs that will be made in Canada by its partner, Wellington
Laboratories. All the PCB standards will be flame sealed in 2 ml
ampoules, and will contain less than 1 g PCB per vial
dissolved in 1.2 ml solvent. The PCB standards will be packaged and
shipped in accordance with DOT shipping requirements. Chemsyn
literature indicates that all toxic preparations are shipped with
documentation sheets describing known hazards. Chemsyn expects
production waste generation to be minimal due to the small production
rate and batch size involved. These wastes will be treated as PCB
wastes. Chemsyn asserts that it has a highly trained staff, including
chemists involved in the development of PCB chemistry and standards
with Midwest Research Institute. Chemsyn estimates annual sales from
PCB standards would be approximately $30,000.
b. Proposed decision on petition. EPA proposes to grant the Chemsyn
petition for manufacture, import, and export PCBs. EPA has previously
established the need for analytical standards [49 FR 28154, July 10,
1984]. Because of this need, the small quantity limitations, and the
carefully controlled conditions of PCB manufacture, EPA finds that no
unreasonable risk would result from granting an exemption to Chemsyn to
manufacture PCBs in small quantities for research or development. This
finding also applies to the import of samples from Chemsyn's Canadian
partner, Wellington Laboratories, provided that the imported samples
are prepared, packaged, and labeled in the same manner as domestically
produced samples. Because the manufacture of these analytical standards
is being conducted by highly trained and experienced professionals
under controlled conditions and only small quantities are involved, EPA
finds that no unreasonable risk would result from granting this
exemption. As such, EPA does not believe that the importation of these
standards, when compared with their domestic manufacture, would pose
any added risk to health or the environment.
The Agency generally treats petitions for exemption to export PCBs
more stringently than petitions to distribute PCBs within the United
States. This is because once the PCBs cross beyond our borders, the
United States loses its ability to monitor the handling and
distribution activities, to inspect the receiving facilities for any
regulatory violations, or to protect health or the environment from
releases of those PCBs that might lead to additional PCB contamination
in this country. However, EPA believes that those concerns are
mitigated in the export of PCBs in small quantities for research and
development particularly given the quantity, marking, and packaging of
the PCBs, as well as the careful handling of the PCBs by trained
laboratory personnel. This finding would be consistent with previous
determinations regarding the export of PCB analytical samples for
research and development [49 FR 28154].
EPA has determined that the good faith efforts finding would be met
for petitions to manufacture, import, distribute or export PCBs in
small quantities on projects consistent with the overall purposes of
section 6(e) of TSCA, such as using PCBs as standards for the purpose
of measuring PCB concentrations or using PCBs in the study of health
and environmental effects of PCBs, because, in these cases, there are
no PCB substitutes. There will always be a need for pure analytical
standards to be developed to support laboratory analysis for PCBs.
Also, pure PCBs are needed in critical health and environmental
research because commercial PCBs contain mixtures of isomers and
contaminants which may adversely affect experimental research.
Chemsyn would be prohibited from exporting PCBs in excess of the
amounts and quantities specified in its petition (i.e., less than 50
grams/year), and would be required to petition EPA and obtain an
exemption prior to an increase in the quantity or a change in the
manner of handling PCBs under the Chemsyn exemption. EPA would consider
any such change as a new exemption petition and address the request by
rulemaking. If Chemsyn were to wish to continue its export activities
beyond the 1-year timeframe under the EPA approved exemption, a
certified letter, pursuant to the amended Interim Procedural Rules,
must be submitted to EPA at least 6 months prior to the expiration of
the exemption.
G. Processing and Distribution in Commerce of PCB in Buying and Selling
Transformers
1. Electric Apparatus Service Association (EASA). On July 3, 1991,
EASA submitted a petition requesting the renewal of their exemption
which was originally granted in the May 22, 1990 Federal Register (55
FR 21023). This exemption allowed EASA members, for a period of 1 year,
to process and distribute in commerce for reuse non-porous component
parts from PCB-Contaminated Transformers that have been double washed
and rinsed.
a. Background. EPA determined in granting the original exemption
that, due to the non-porous nature of these component parts and, also,
because of the relatively small amounts of PCBs involved, the activity
of reusing component parts presents no unreasonable risk to health and
the environment.
Regarding the benefits to society of granting this exemption, EASA
maintained that, without access to their stockpiles of component parts,
both economic loss to the member companies and detriment to the society
would be incurred. EASA asserted that its members may be put out of
business if reuse of these components were prohibited, due to their
inability to repair transformers during the activities of buying and
selling used transformers and servicing customers' transformers.
Although EPA made no judgement regarding this claim, EPA
acknowledged that without stocks of component parts, many transformers
could not be repaired promptly and equipment users could experience
interruptions of electrical services and could be forced to prematurely
dispose of reusable units.
To support its claim of good faith efforts to reduce inventories of
PCB-contaminated components, EASA submitted evidence of their efforts
to develop a double-rinse method to remove PCBs from the non-porous
component parts that would be reused on the PCB-Contaminated
Transformers. This double-rinse procedure employs a protocol similar to
that in EPA's Spill Cleanup Policy (40 CFR part 761, subpart G). EASA
maintained that the introduction of double-rinsed, non-porous component
parts back onto the PCB-Contaminated Transformers would not change the
original parts per million PCB content of the transformer into which
the component part is incorporated.
EPA concluded that the processing and distribution in commerce of
the PCB residues on non-porous, double-rinsed transformer component
parts as well as the buying and selling of PCB or PCB-Contaminated
Transformers that have been serviced with double-rinsed, non-porous
parts, meets both the no unreasonable risk and good faith effort
criteria. EPA granted this class exemption for 1 year.
EPA decided that in future requests for renewal of their (EASA)
exemption, that EPA would consider the petitioner's evidence of no
unreasonable risk and good faith efforts by evaluating whether
stockpiles of component parts have been effectively decontaminated and
also whether inventories of PCB and PCB-Contaminated Transformers in
EASA's contained storage areas have been reduced.
b. Current petition. In this petition EASA seeks to renew their
exemption to process and distribute in commerce for reuse non-porous
component parts from PCB-Contaminated Transformers that have been
double washed/rinsed as granted in the May 22, 1990 FR 21023.
EASA has submitted two additional reports from T R Service Company
to support that the double wash/rinse method is effective to
decontaminate non-porous components. As described in the renewal
petition, one report showed that 20 samples were taken from 10
transformers and all showed PCB concentrations of less than 10
micrograms per 100 square centimeters.
On June 12, 1990 the petitioner stated that it surveyed its members
and of those that responded, only 20 percent were still handling
mineral oil transformers 50 ppm or greater. In the petitioner's opinion
the number of members with inventories of 50 ppm to less than 500 ppm
has decreased significantly.
c. Proposed decision on petition. EPA proposes to grant EASA's
request for renewal of their exemption. EPA believes that EASA has
fulfilled their responsibility in seeking to renew their exemption by
demonstrating efficacy, a reduction in inventory and all other
conditions as set forth in their original exemption.
V. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order.
Pursuant to terms of this Executive Order, it has been determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
B. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility Act (the Act), 5 U.S.C. 603,
EPA must perform a regulatory flexibility analysis for all rules that
are likely to have a ``significant impact on a substantial number of
small entities.'' Pursuant to section 605(b) of the Regulatory
Flexibility Act, which provides that section 603 of the Act ``shall not
apply to any proposed or final rule if the Agency certifies that the
rule will not, if promulgated, have a significant economic impact on a
substantial number of small entities'', EPA certifies that this rule
will not have a significant impact on a substantial number of small
entities. In addition, EPA is sending a copy of this rule to the Chief
Counsel for Advocacy of the Small Business Administration. Section
6(e)(3)(A) and (B) of TSCA and EPA's PCB Ban Rule, 40 CFR part 761,
prohibits the manufacture, processing, and distribution in commerce of
PCBs. This rule, under section 6(e)(3)(B) of TSCA, would exempt persons
from these prohibitions where petitioners have demonstrated that
granting an exemption would not result in an unreasonable risk of
injury to health or the environment and that they have made good faith
efforts to develop substitutes for PCBs. Both small and large
businesses must meet the same statutory standard. Thus, even if EPA
believed that it was an economically desirable policy to grant an
exemption petition for a small business, it could do so only if the
small business met the requirements set forth in TSCA. This rule would
not add to the burden placed on small businesses, it would only remove
the prohibition placed on such businesses through granting an
exemption. In essence, any impact from granting or denying a petition
would only affect the petitioner.
Owners of individual small businesses who elect to petition the
Administrator to engage in activities otherwise banned by the statute
have already considered the economic consequences of conducting these
activities, and nonetheless have opted to pursue an authorization for
these activities. Finally, because this rule basically would benefit
some small entities, without imposing direct economic costs on others,
EPA believes that it is appropriate to certify that this rule will not
have a significant economic impact on a substantial number of small
entities.
C. Paperwork Reduction Act
The Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.,
authorizes the Director of the Office of Management and Budget to
review certain information collection requests by Federal Agencies.
Under OMB Control Number 2070-0021, OMB has approved a general
information collection request submitted by EPA for purposes of
collecting information for rulemakings on PCB exemption petitions, and
for any recordkeeping or reporting conditions to PCB exemption
petitions granted by EPA.
Public reporting burden for this collection of information is
estimated to average five hours per response, including time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
VI. Official Rulemaking Record
All of the information previously submitted and filed in docket
number OPTS-66001, 66002, 66008-66008K (manufacturing, processing, and
distribution in commerce exemptions) has been consolidated into docket
number OPTS-66011. EPA has established this consolidated docket for the
convenience of the public but did not rely upon information in that
docket when proposing this rule.
A public record, along with a complete index, is available for
inspection in the Nonconfidential Information Center, Monday through
Friday (excluding holidays) from 12 noon - 4:00 p.m. in Room G-102,
Northeast Mall (401 M St., SW., Washington, DC).
The following material is cited in the Index to the Rulemaking
Record for Polychlorinated Biphenyls, Manufacturing, Processing, and
Distribution in Commerce; Exemptions, Docket Number OPTS 66011 at A2-
File (Insert the date of this final rule).
List of Subjects in 40 CFR Part 761
Environmental protection, Hazardous substances, Labeling,
Polychlorinated biphenyls, Reporting and recordkeeping requirements.
Dated: November 23, 1994.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR chapter I, subchapter R is proposed to be amended
as follows:
PART 761--[AMENDED]
1. The authority citation for part 761 continues to read as
follows:
Authority: 15 U.S.C. 2605, 2607, 2611, 2614 and 2616.
2. In Sec. 761.80 by adding paragraphs (c)(3), (c)(4), (c)(5),
(f)(9), (f)(10) and (m)(8) and by revising paragraphs (h) and (n) to
read as follows:
Sec. 761.80 Manufacturing, processing and distribution in commerce
exemptions.
* * * * *
(c) * * *
(3) Sigma-Aldrich Corporation, St. Louis, MO, 63103.
(4) Millipore Corporation and ImmunoSystems Inc., Bedford, MA,
01730 and Scarborough, ME, 04074.
(5) National Institute of Standards and Technology, Gaithersburg,
MD, 20899.
* * * * *
(f) * * *
(9) General Electric Company, Schenectady, NY,12301.
(10) Supelco Inc., Bellefonte, PA, 16823-0048.
* * * * *
(h) The Administrator grants the following petitioners a class
exemption for 1 year to process and distribute in commerce non-porous
transformer component parts which have been decontaminated of PCB
residues and to buy and sell PCB Transformers or PCB-Contaminated
Transformers to which only double-rinsed, non-porous component parts
have been added:
(1) Electrical Apparatus Service Association, St. Louis, MO,63123.
(2) [Reserved]
* * * * *
(m) * * *
(8) Chemsyn Science Laboratories, Lenexa, KS, 66215.
(n) The 1-year exemption granted to petitioners in paragraphs (a)
through (c)(1), (d), (f), and (m)(1) through (m)(6) of this section
shall be renewed automatically as long as there is no increase in the
amount of PCBs to be processed and distributed, imported
(manufactured), or exported, nor any change in the manner of processing
and distributing, importing (manufacturing), or exporting of PCBs. If
there is such a change, a new exemption petition must be submitted to
EPA and it will be addressed through rulemaking. In such a case, the
activities granted under the existing exemption may continue until the
new petition is addressed by rulemaking, but must conform to the terms
of the existing exemption approved by EPA. The 1-year exemption granted
to petitioners in paragraphs (c)(2), (3), (4) and (5), (f)(9) and (10),
(h) and (m)(7) and (8) of this section may be extended pursuant to
Sec. 750.11(e) or Sec. 750.31(e).
* * * * *
[FR Doc. 94-29569 Filed 11-30-94; 8:45 am]
BILLING CODE 6560-50-F