[Federal Register Volume 59, Number 69 (Monday, April 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8465]
[[Page Unknown]]
[Federal Register: April 11, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 750 and 761
[OPPTS-66011A; FRL 4766-5]
RIN 2070-AB20
Polychlorinated Biphenyls; Exemptions From Prohibition Against
Manufacturing, Processing, and Distribution in Commerce, and Use
Authorization
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final 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 authorize these activities if the Administrator
finds that they will not present an unreasonable risk of injury to
health and the environment. This final rule addresses six 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 final rule, EPA
denies two petitions and grants three petitions; the sixth petition has
been withdrawn by the petitioner. EPA is also promulgating one use
authorization under TSCA section 6(e)(2)(B). In addition, EPA is
amending the Interim Procedural Rules at 40 CFR part 750 to require
certain petitioners to reapply for EPA approval to continue PCB
activities that EPA has previously approved.
DATES: This final rule shall become effective May 25, 1994. In
accordance with 40 CFR 23.5 (50 FR 7271), this rule shall be
promulgated for purposes of judicial review at 1 p.m. eastern daylight
time on April 25, 1994.
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 authorized. 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 in a manner other than
totally enclosed. 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.
B. Regulatory Authority
EPA's Interim Procedural Rule 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 were published initially in the Federal Register
of November 1, 1978 (43 FR 50905), and of May 31, 1979 (44 FR 31558)
and are codified at 40 CFR 750.10 through 750.41. 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 six new exemption petitions under
TSCA section 6(e)(3)(B) which are the subject of this final rule. The
requests for exemption are as follows:
1. Petition for approval to distribute in commerce for export small
quantities of PCBs for the purpose of research and development (ManTech
Environmental Technology Inc., petitioner).
2. Petition for approval to process and distribute in commerce for
export small quantities of PCBs for the purpose of research and
development (Restek Corporation, petitioner).
3. Petition for approval to import from Canada, PCBs in oil and
soil for laboratory analysis, and to export the unused portions of
these samples following their analysis (National Chem Lab, petitioner).
4. Petition for approval to import capacitors and voltage
transformers, which were inadvertently shipped into Canada, back to the
United States for the purpose of disposal (General Motors, petitioner).
The General Motors' petition was subsequently withdrawn.
5. Petition for approval to distribute in commerce for export PCB-
Contaminated Transformers for salvage to the Far East (Joseph Simon
Sons, petitioner).
6. Petition for approval to process and distribute in commerce
analytical reference samples derived from actual waste materials (R.T.
Corporation, petitioner).
The proposed rule for these exemption petitions and the amendment
to the Interim Procedural Rules were published on March 2, 1992 (57 FR
7349). No substantive comments were received on the proposal that would
impact EPA's decision to grant or deny a particular exemption petition.
However, the Small Business Administration commented on whether EPA had
properly exercised its certification authority under the Regulatory
Flexibility Act (RFA) and had fully articulated its reasons for
certifying there was no significant impact on a substantial number of
small entities. This comment resulted in changes to the language under
unit VIII.B. of the preamble to this final rule, where the authority to
make the certification under the RFA and EPA's rationale for the
certification is stated more precisely. In addition, comments were
received concerning the Interim Procedural Rules. (See unit VII -
Changes to the Interim Procedural Rules).
II. Unreasonable Risk Finding
Section 6(e)(3)(B)(i) of TSCA requires a petitioner to demonstrate
that granting an exemption would not result in an unreasonable risk of
injury to health or the environment.
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.
Specifically, EPA considers the following factors:
A. 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.
1. 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.
2. 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.
3. 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) (Docket
No. OPTS 66008F).
B. 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 petitioner. EPA has taken benefits and costs into
consideration when evaluating each exemption petition.
III. Good Faith Efforts Finding
Section 6(e)(3)(B)(ii) of TSCA requires petitioners to demonstrate
a good faith effort 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. EPA considers several factors in
determining whether a petitioner has demonstrated good faith efforts.
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 it 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.
IV. 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 (Docket No. OPTS 66008B). ``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 five (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 via 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) (Docket No. OPTS 66008E). This
rule eliminated the need for each person who processes and distributes
PCBs in commerce to file an individual exemption petition. EPA placed
the following terms and conditions on the class exemption: (a) That all
processors and distributors maintain records of their PCB activities
for a period of 5 years; and (b) that any person or company that
expects to distribute in commerce 100 grams (0.22 lb.) or more of PCBs
for research and development in 1 year must report to EPA and identify
the sites of PCB activities and the quantities of PCBs to be
distributed in commerce. At that time EPA stated it would automatically
renew the class exemption unless the petitioner changed the quantity of
PCBs or manner of processing and distributing PCBs in commerce. 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 that 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 published
in a notice of proposed rulemaking; and members of the class will be
allowed to continue activities until a final rule is promulgated.
V. Disposition of Pending Exemption Petitions
A. Import
EPA received one exemption petition to import PCBs.
General Motors Corp. (GMC). On August 31, 1987, GMC requested an
exemption to import PCBs into the United States from Canada, solely for
the purpose of disposal, in indoor constant voltage transformers. On
February 14, 1991, GMC withdrew this petition. As a result, no action
was taken by EPA on the GMC exemption petition.
B. Import and Export
EPA received one exemption petition to import and export PCBs.
National Chem Lab. On December 3, 1987, EPA received a petition
from National Chem Lab to import small test samples of oil and soil
from Canadian Electric Utilities, and to export these samples following
their analysis.
a. Current petition. The sample sizes would be less than 6
milliliters per sample of oil and less than 4 ounces of soil. These
samples would then be analyzed for PCB content. Following their
analysis these small laboratory test samples would be exported back to
the utility that submitted them. National Chem Lab estimates that 5.072
ounces by volume or 0.283 pounds by weight of PCBs would be utilized
per year. These figures were based on a sample submittal rate of 10,000
per year with 15 percent of the submitted samples containing PCB
concentrations over 50 ppm.
The residue that evolves from distillation of the solvent used in
the extraction process would be packaged in a common Department of
Transportation (DOT) approved container and sent to an incinerator for
disposal as required by the PCB disposal rules of 40 CFR 761.60. The
extremely small amounts of PCBs that would be retained by National Chem
Lab in testing for a contamination level would be disposed of in the
United States as required in the PCB disposal rules. The economic
consequences of denial would cost National Chem Lab an estimated income
of $150,000 per year and result in a staffing level of three fewer
employees. National Chem Lab also maintained that this exemption would
enable it to expand its facilities and generate jobs in an area of
Eastern Washington which badly needs jobs in non-agricultural
enterprises.
b. Decision on petition. EPA has determined to deny this exemption
petition. 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, 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 closed the
border to encourage foreign countries to develop their own capacity for
properly handling and disposing of PCB waste. (See 45 FR 29115, May 1,
1980, filed at Docket No. OPTS 66008). Also, National Chem Lab has
failed to provide evidence that both Canadian and provincial border
officials will accept the PCBs when they are returned to Canada upon
completion of the PCB analysis.
Further, EPA has determined that the petitioner has not met the
good faith efforts criterion. Although no non-PCB substitutes for PCB
analytical standards currently exist, 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, there are analytical
laboratories within Canada for conducting PCB analysis (See Docket No.
OPTS 66011). EPA does not want to encourage the expansion of PCB
products or PCB services for companies when there are feasible
alternatives already in place.
Implied in the petitioner's exemption application is a request to
export the samples after analysis. Since EPA is denying the request to
import, it is not addressing the request to export the samples back to
their site of generation after analysis. No comments were submitted to
EPA for further consideration during the comment period.
C. Export
EPA received two petitions relating to PCBs involved in research
and development. Also, the same petitioners requested to export the
PCBs. These petitions are discussed in this section. In addition, this
section addresses the petition to export and distribute in commerce
drained PCB-Contaminated Transformers.
1. ManTech Environmental Technology, Inc. and Subsidiary (ManTech).
On November 16, 1987, NSIT (formerly known as Northrop Services, Inc.)
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. The annual export amount is estimated to be less than 500
grams of PCBs. On February 12, 1991, NSIT amended its petition and
notified EPA that the company name had been changed to ManTech.
a. Current petition. ManTech obtains PCBs for environmental
monitoring purposes and prepares analytical reference standards which
are provided for a charge to laboratories engaged in monitoring
activities.
The PCB standards will be available in solution (1.5 ml each) or in
neat, essentially pure form in 50 to 100 mg aliquots. PCBs in the form
of Aroclor mixtures as well as individual isomers, will be distributed
in sealed 2-ml ampuls in accordance with the class exemption
requirements. The total amount of PCBs to be exported in 1 year will
not exceed 500 grams.
The standards will be packaged in sealed, glass primary ampules,
labeled and placed in heat-sealed bags with appropriate labelling. The
neat standards will then be wrapped individually in several layers of
absorbent packaging material, placed in a secondary heat-sealed bag,
and then in a standard corrugated cardboard container which will be
filled with cushioning material and sealed with reinforced paper tape.
Solution standards will be placed in the first heat-sealed bag,
then placed in form-fitting styrofoam containers which are wrapped in
cellucrepe material and placed in a secondary heat-sealed bag. They
will then be inserted into a padded mailer and sealed with fiberglass
tape.
According to the letter submitted by ManTech on February 21, 1991,
there is a charge for the standards which should accrue an estimated
amount of $60,000 per year in sales from the foreign distribution of
the analytical samples.
In its petition ManTech also states that it will support and
encourage good quality assurance practices to several thousand
laboratories in 93 foreign countries.
b. Decision on petition. EPA has determined to grant the ManTech
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, marking, 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. No comments were submitted to EPA for further
consideration during the comment period.
ManTech is prohibited from exporting PCBs in excess of the amounts
and quantities specified in its petition (i.e., less than 500 grams/
year), and will 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 ManTech exemption. EPA will consider any such
change as a new exemption petition and address the request by
rulemaking. If ManTech wishes 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
promulgated in this rule, must be submitted to EPA at least 6 months
prior to the expiration of the exemption.
2. Restek Corporation. On June 8, 1990, Restek requested an
exemption to process and distribute in commerce for export small
quantities of PCBs for research and development to calibrate analytical
instruments.
a. Current petition. Restek seeks to process and distribute small
quantities (less than 100 grams/year) of PCBs for research and
development under 40 CFR 761.80. The PCBs will be purchased from
companies already exempted by EPA, then diluted to a concentration of
1,000 g/mL in solvent. The only processing will be to prepare
gravimetric standards of the PCBs. The concentration of these standards
will be verified by gas chromatography. Once verified, these solutions
will be packaged in a flame-sealed, amber glass ampul in volumes of 1
milliliter. The sealed ampuls will be overwrapped in a plastic tube
with adequate cushioning to prevent damage during shipment. These
solutions will be shipped via common carrier domestically and exported
to foreign customers. Restek will comply with all relevant DOT and
overseas shipping regulations.
All processing and distribution will be performed at the Restek
facility at 110 Benner Circle, Bellefonte, PA. The estimated amount of
PCBs to be processed and distributed in commerce, both domestic and
foreign, will not exceed 100 grams per year. Restek states that the
small amounts of laboratory waste generated during the production
procedures will be collected and disposed of in accordance with all
Federal, State, and local regulations, and the total amount of waste
will be less than 1 gram per year. Restek states that all PCBs will be
handled by qualified organic chemists.
There are no substitutes available which can be used to calibrate
analytical instrumentation for PCBs. Restek estimates that the cost of
denial of this petition could cause a loss of business amounting to
$280,000 per year.
b. Decision on petition. EPA has determined to grant the Restek
petition. 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, quantity,
marking, and packaging 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 for analytical standards of
PCBs, the good faith efforts criterion has been met. No comments were
submitted to EPA for further consideration during the comment period.
Restek is prohibited from exporting PCBs in excess of the amounts
and quantities specified in their exemption petition (less than 100
grams/year), and will 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 Restek exemption. EPA will consider
any such change as a new exemption petition and address the request by
rulemaking. If Restek wishes 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
promulgated in this rule, must be submitted at least 6 months prior to
the expiration of the exemption.
3. Joseph Simon Sons, Inc.. On April 9, 1987, Joseph Simon Sons,
Inc. requested an exemption to distribute in commerce and export for
disposal PCB-Contaminated Transformers that have been drained of all
free-flowing liquids.
a. Current petition. The drained electrical transformers would be
packaged in shipping containers at locations in the states of Utah,
California, and Washington and then shipped to the Far East for
salvage. To ensure that all the drained electrical transformers being
exported had contained fluid with a PCB concentration of less than 500
ppm, Joseph Simon Sons would require its customers to provide
analytical reports showing the serial number of each unit and the PCB
concentration. The estimated pounds of drained electrical transformers
to be processed from each of the 3 states identified would be 1 million
pounds.
b. Decision on petition. EPA has determined to deny this request
for an exemption. EPA has determined, due to the large amounts of PCBs
and the availability of an alternative option, namely reclassifying the
transformers to non-PCB status, that this petition fails the
unreasonable risk and good faith efforts criteria as required in TSCA
section 6(e)(3)(B). EPA is very stringent regarding the export of PCBs
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. Thus,
EPA has found that the manufacturing, processing and distribution in
commerce of PCBs and PCB Items for export in concentrations of 50 ppm
or greater present an unreasonable risk of injury to health and the
environment within the United States (40 CFR 761.20).
This petition requests to export a large amount, approximately 3
million pounds, of drained PCB-Contaminated Electric Equipment to the
Far East for salvage. Generally, EPA does not allow export of PCB-
contaminated equipment for disposal because some countries have failed
to develop safe methods of PCB disposal and salvaging, and because EPA
has limited ability to ensure that such activities, including reuse of
the salvaged material, does not present an unreasonable risk of injury
to health and the environment in the United States.
The Agency has previously recognized that PCB contamination is a
global problem, and that use and other activities connected with PCBs
outside the United States may lead to additional PCB contamination of
this country. EPA concluded in 1979 that the distribution in commerce
of certain PCBs for export constitutes an unreasonable risk of injury
to health and the environment in the United States (44 FR 31514, May
31, 1979) and maintains that the activities proposed by the petitioner
would present an unreasonable risk.
Further, in determining whether good faith efforts have been taken
to develop a substitute for PCBs, EPA considers whether alternatives
are available to the person requesting an exemption. In this case,
there is a safer alternative available to petitioners, namely that the
transformer be reclassified to non-PCB status through a drain, flush,
and refill process according to 40 CFR 761.30(a)(2)(v). Such non-PCB
transformers could then be exported for any purpose according to 40 CFR
761.20(b)(2). Because a readily available substitute for PCB-
contaminated equipment exists, namely decontaminated equipment, the
good faith efforts criterion has not been met. No comments were
submitted to EPA for further consideration during the comment period.
D. Processing and Distribution in Commerce
EPA received one petition requesting an exemption to allow the
processing and/or distribution in commerce of PCBs.
R.T. Corporation (RT Corp.). On March 31, 1989, RT Corp. requested
an exemption to process and distribute in commerce PCBs as analytical
reference samples derived from actual waste materials. Even if RT Corp.
obtains such an exemption, use of such samples is banned unless
authorized by rule. EPA is creating such a use authorization in this
rule. (See unit VI. of this preamble for a further discussion.)
a. Current petition. RT Corp. seeks to blend samples containing
PCBs in various materials that have been taken from spills and
Superfund sites, duplicating real world laboratory situations. These
samples will provide EPA, contract labs, and other facilities with
interlaboratory comparability and access to real world references. RT
Corp. states that these procedures will be done under controlled
conditions by trained and experienced personnel using practices that
are designed to minimize human and environmental exposure to hazardous
substances. An estimated annual amount of approximately .5 pound of PCB
samples will be distributed in commerce to environmental analytical
laboratories in small quantities for inhouse Quality Assurance/Quality
Control programs by Federal, State and municipal governments, and other
clients wanting to ensure the accuracy of their analytical results.
These reference samples, which average 50 grams in weight, will be
blended to homogeneity, packaged into 10 to 50 gram aliquots, and then
marketed exclusively to laboratories. The total estimated annual amount
of PCB-Contaminated material at <500 ppm="" concentration="" levels="" to="" be="" allowed="" under="" the="" exemption="" will="" be="" between="" 500="" to="" 1,000="" pounds.="" this="" equates="" to="" approximately="" .5="" pound="" of="" pure="" pcbs.="" the="" values="" of="" the="" analytes="" of="" interest="" are="" determined="" by="" a="" round-robin="" analysis="" by="" as="" many="" laboratories="" as="" necessary="" to="" attain="" a="" 95="" percent="" level="" of="" confidence.="" rt="" corp.="" states="" that="" these="" samples="" will="" be="" shipped="" in="" accordance="" with="" all="" dot="" shipping="" requirements="" and="" that="" they="" will="" be="" packaged="" in="" hermetically="" sealed="" containers="" bearing="" the="" pcb="" warning="" label.="" once="" the="" pcbs="" are="" distributed="" in="" commerce,="" the="" risk="" of="" exposure="" to="" humans="" and="" the="" environment="" will="" be="" minimized="" by="" the="" small="" quantities="" of="" pcbs="" used="" in="" most="" applications,="" by="" the="" matrix="" containing="" the="" pcbs,="" and="" by="" the="" careful="" handling="" procedures="" typical="" of="" laboratory="" work.="" b.="" decision="" on="" petition.="" epa="" has="" determined="" to="" grant="" the="" rt="" corp.="" petition.="" epa="" believes="" that,="" due="" to="" the="" small="" quantities="" of="" pcbs="" in="" these="" reference="" samples="" as="" well="" as="" the="" careful="" handling="" of="" the="" pcbs="" by="" trained="" personnel,="" there="" is="" no="" unreasonable="" risk="" presented="" by="" granting="" this="" exemption="" petition="" request.="" the="" good="" faith="" efforts="" criterion="" has="" been="" met="" because="" there="" are="" no="" substitutes="" for="" the="" ``real="" world''="" waste="" samples="" of="" pcb="" material="" associated="" with="" this="" activity.="" rt="" corp.="" must="" comply="" with="" all="" federal,="" state,="" and="" local="" laws="" governing="" the="" handling="" of="" these="" samples.="" in="" addition,="" once="" the="" use="" of="" the="" samples="" is="" complete,="" all="" of="" the="" disposal="" requirements="" contained="" in="" 40="" cfr="" part="" 761="" apply.="" one="" commenter="" to="" the="" proposal="" expressed="" support="" for="" issuing="" this="" use="" authorization.="" however,="" it="" was="" also="" suggested="" by="" this="" commenter="" that="" epa="" broaden="" this="" authorization="" to="" include="" samples="" processed="" and="" distributed="" in="" connection="" with="" r&d="" activities.="" as="" noted="" by="" the="" commenter,="" epa="" has="" already="" solicited="" comments="" on="" this="" revision="" in="" the="" june="" 10,="" 1991="" advance="" notice="" of="" proposed="" rulemaking="" (anprm)="" with="" respect="" to="" amendments="" to="" the="" pcb="" disposal="" rules.="" a="" broader="" application="" of="" this="" use="" authorization="" is="" more="" appropriately="" addressed="" by="" the="" proposed="" disposal="" amendments="" in="" that="" the="" agency="" will="" be="" able="" to="" obtain="" more="" extensive="" public="" comment="" and="" conduct="" a="" more="" comprehensive="" review="" of="" this="" issue.="" rt="" corp.="" is="" prohibited="" from="" distributing="" in="" commerce="" pcbs="" in="" excess="" of="" the="" amounts="" and="" quantities="" specified="" in="" this="" petition="" (i.e.,="" less="" than="" .5="" pound="" of="" pcbs),="" and="" will="" 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="" rt="" corp.="" exemption.="" epa="" will="" consider="" any="" such="" change="" a="" new="" exemption="" petition="" and="" address="" the="" request="" by="" rulemaking.="" if="" rt="" corp.="" wishes="" to="" continue="" its="" processing="" and="" distribution="" activities="" beyond="" the="" 1-year="" timeframe,="" according="" to="" the="" epa="" approved="" exemption,="" a="" certified="" letter,="" pursuant="" to="" the="" amended="" interim="" procedural="" rules="" promulgated="" in="" this="" rule,="" must="" be="" submitted="" at="" least="" 6="" months="" prior="" to="" the="" expiration="" of="" the="" exemption.="" vi.="" use="" authorization="" for="" analytical="" reference="" samples="" derived="" from="" waste="" materials="" epa="" is="" granting="" a="" use="" authorization="" for="" analytical="" reference="" samples="" that="" contain="" pcbs="" and="" are="" derived="" from="" waste="" materials="" provided="" that="" the="" samples="" have="" been="" processed="" and="" distributed="" in="" commerce="" pursuant="" to="" an="" exemption="" granted="" under="" tsca="" section="" 6(e)(3)(b).="" as="" discussed="" above,="" epa="" has="" already="" granted="" an="" authorization="" for="" the="" use="" of="" pcbs="" in="" small="" quantities="" for="" research="" and="" development="" (40="" cfr="" 761.30(j)).="" also="" discussed="" above="" are="" the="" reasons="" epa="" is="" granting="" an="" exemption="" for="" analytical="" reference="" samples="" derived="" from="" waste="" materials.="" these="" samples="" do="" not="" fit="" the="" definition="" for="" the="" use="" authorization="" granted="" under="" 40="" cfr="" 761.30(j),="" and="" therefore,="" use="" of="" these="" samples="" requires="" an="" authorization.="" epa="" has="" determined="" to="" authorize="" the="" use="" of="" pcb="" analytical="" reference="" samples="" derived="" from="" waste="" materials="" when="" the="" samples="" have="" been="" processed="" and="" distributed="" in="" commerce="" pursuant="" to="" an="" exemption="" granted="" under="" tsca="" section="" 6(e)(3)(b).="" epa="" has="" determined="" that="" the="" use="" of="" such="" samples="" will="" not="" present="" an="" unreasonable="" risk="" of="" injury="" to="" health="" or="" the="" environment="" because="" such="" samples="" will="" be="" handled="" by="" laboratories="" that="" have="" established="" procedures="" for="" handling="" pcbs.="" further,="" epa="" has="" determined="" that="" the="" use="" of="" such="" samples="" will="" further="" efforts="" to="" implement,="" comply="" with,="" and="" enforce="" the="" requirements="" for="" pcbs="" under="" tsca.="" once="" the="" use="" of="" such="" samples="" is="" over,="" persons="" who="" have="" used="" the="" samples="" are="" subject="" to="" any="" federal,="" state,="" and="" local="" law="" governing="" the="" disposal="" of="" the="" pcbs,="" including="" the="" rules="" found="" in="" 40="" cfr="" part="" 761.="" vii.="" changes="" to="" interim="" procedural="" rule="" in="" this="" rule,="" epa="" is="" adopting="" procedures="" for="" renewing="" exemptions.="" a="" petitioner="" granted="" an="" exemption="" in="" this="" rule="" or="" in="" any="" future="" rule,="" and="" who="" wishes="" to="" renew="" that="" exemption,="" must="" submit="" a="" letter="" by="" certified="" mail="" to="" epa="" stating="" that="" a="" renewal="" is="" desired="" and="" certifying="" that="" the="" specific="" type(s)="" of="" pcb="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" the="" amount="" of="" pcbs="" handled,="" and="" all="" other="" activities="" specified="" in="" the="" original="" exemption="" request="" have="" not="" been="" changed.="" to="" provide="" epa="" with="" sufficient="" time="" to="" include="" the="" renewal="" submission="" in="" the="" next="" pcb="" exemption="" rulemaking,="" the="" request="" and="" certification="" must="" be="" sent="" by="" certified="" mail="" and="" received="" by="" epa="" at="" least="" 6="" months="" prior="" to="" the="" expiration="" date="" of="" the="" existing="" exemption.="" if="" the="" renewal="" submission="" is="" not="" received="" at="" least="" 6="" months="" prior="" to="" the="" expiration="" date,="" the="" original="" exemption="" activities="" must="" cease="" at="" the="" 1-year="" expiration="" date.="" if="" there="" are="" any="" increases="" from="" the="" original="" petition="" in="" the="" amounts="" of="" pcbs="" or="" any="" changes="" in="" the="" manner="" in="" which="" they="" are="" handled,="" epa="" will="" consider="" the="" submission="" to="" be="" a="" petition="" for="" a="" new="" exemption.="" this="" amendment="" does="" not="" affect="" exemption="" petitions="" granted="" under="" sec.="" 761.80(g)="" or="" petitions="" granted="" by="" epa="" prior="" to="" the="" effective="" date="" of="" this="" final="" rule,="" provided="" the="" type="" of="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" and="" any="" other="" terms="" of="" the="" exemption="" have="" not="" changed.="" however,="" any="" petitioner="" granted="" an="" exemption="" in="" a="" prior="" rule="" who="" wishes="" to="" alter="" the="" activities="" as="" previously="" approved="" by="" the="" agency="" in="" granting="" the="" exemption="" must="" submit="" a="" new="" petition="" and="" must="" refrain="" from="" any="" of="" the="" new="" activities="" until="" epa="" makes="" a="" determination="" on="" that="" petition="" by="" rulemaking.="" epa="" will="" review="" the="" new="" petition="" during="" the="" next="" rulemaking="" process="" and="" determine="" whether="" to="" grant="" or="" deny="" the="" exemption.="" a="" commenter="" suggested="" epa="" refine="" its="" procedures="" and="" the="" time="" it="" takes="" to="" respond="" to="" an="" exemption="" petition.="" ideally,="" epa="" would="" like="" to="" respond="" to="" exemption="" petitions="" more="" expeditiously;="" however,="" this="" is="" not="" practical.="" several="" factors="" influence="" the="" review="" and="" processing="" of="" exemptions,="" such="" as,="" the="" complexity="" of="" issues,="" the="" number="" of="" petitions="" and="" the="" structure="" of="" the="" rulemaking="" process.="" although="" the="" schedule="" for="" responding="" to="" exemption="" petitions="" may="" not="" be="" aggressive="" enough="" for="" some,="" in="" this="" rulemaking,="" epa="" has,="" to="" the="" extent="" possible,="" modified="" the="" filing="" procedures="" for="" the="" exemption="" rulemaking="" process.="" one="" commenter="" suggested="" that="" to="" relieve="" the="" resource="" burden="" necessary="" to="" carry="" out="" the="" rulemaking="" process,="" epa="" should="" also="" automatically="" renew="" petitions="" that="" are="" based="" on="" a="" renewal="" letter,="" and="" that="" involve="" minor="" changes="" that="" do="" not="" present="" an="" unreasonable="" risk="" to="" health="" and="" the="" environment.="" epa="" agrees="" that="" allowing="" automatic="" renewal="" for="" minor="" changes="" would="" provide="" more="" flexibility.="" however,="" tsca="" only="" authorizes="" the="" administrator="" to="" grant="" exemptions="" by="" rule,="" if="" he/she="" determines="" the="" activity="" in="" question="" does="" not="" present="" an="" unreasonable="" risk="" to="" health="" and="" the="" environment="" and="" that="" the="" petitioner="" has="" met="" the="" good="" faith="" effort="" criteria="" (15="" u.s.c.="" 6(e)(3)(b)).="" consequently,="" the="" administrator="" cannot="" forego="" rulemaking="" and="" renew="" all="" exemptions="" automatically="" without="" an="" analysis="" of="" risk="" as="" suggested="" by="" the="" commenter.="" viii.="" 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="" the="" 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="" prepared="" an="" initial="" regulatory="" flexibility="" analysis,="" which="" describes="" the="" impacts="" of="" the="" rule="" on="" small="" business="" entities="" in="" connection="" with="" the="" proposed="" rulemaking.="" in="" this="" analysis,="" epa="" tried="" to="" estimate="" the="" cost="" of="" this="" proposed="" rule="" on="" the="" small="" businesses="" whose="" petitions="" epa="" has="" denied.="" for="" purposes="" of="" this="" regulatory="" flexibility="" analysis,="" epa="" considers="" a="" small="" business="" to="" be="" one="" whose="" annual="" sales="" revenues="" were="" less="" than="" $40="" million.="" this="" cutoff="" is="" in="" accordance="" with="" epa's="" definition="" of="" a="" small="" business="" for="" purposes="" of="" reporting="" under="" section="" 8(a)="" of="" tsca,="" which="" was="" published="" in="" the="" federal="" register="" of="" november="" 16,="" 1984="" (49="" fr="" 45430).="" 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,''="" the="" administrator="" 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.="" epa="" further="" notes="" that="" section="" 606="" of="" the="" act="" states="" that="" the="" requirements="" of="" section="" 603="" do="" not="" alter="" in="" any="" manner="" standards="" otherwise="" applicable="" by="" law="" to="" agency="" action.="" current="" law,="" 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.="" 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="" omb="" 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="" 5="" 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.="" ix.="" official="" rulemaking="" record="" for="" the="" convenience="" of="" the="" public="" and="" epa,="" all="" of="" the="" information="" originally="" submitted="" and="" filed="" in="" dockets="" number="" opts-66001,="" 66002,="" 66008-66008k="" (manufacturing,="" processing,="" and="" distribution="" in="" commerce="" exemptions)="" is="" being="" consolidated="" into="" this="" docket="" (docket="" number="" opts-="" 66011).="" public="" comments="" are="" not="" listed="" because="" these="" documents="" are="" exempt="" from="" federal="" register="" listing="" under="" tsca="" section="" 19(a)(3).="" a="" public="" record,="" along="" with="" a="" complete="" index,="" is="" available="" for="" inspection="" in="" the="" non-confidential="" information="" center,="" monday="" through="" friday="" (excluding="" holidays)="" from="" 12="" noon="" to="" 4="" p.m.="" in="" room="" g-102="" (401="" m="" st.,="" sw.,="" washington,="" dc).="" previous="" rulemaking="" record="" previous="" rulemaking="" related="" to="" exemptions="" are="" 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.="" list="" of="" subjects="" 40="" cfr="" part="" 750="" adminstrative="" practice="" and="" procedure,="" chemicals,="" environmental="" protection,="" hazardous="" substances.="" 40="" cfr="" part="" 761="" environmental="" protection,="" hazardous="" substances,="" labeling,="" polychlorinated="" biphenyls,="" reporting="" and="" recordkeeping="" requirements.="" dated:="" march="" 30,="" 1994.="" lynn="" r.="" goldman,="" assistant="" administrator="" for="" prevention,="" pesticides="" and="" toxic="" substances.="" therefore,="" 40="" cfr="" chapter="" i,="" subchapter="" r="" is="" amended="" as="" follows:="" part="" 750--[amended]="" 1.="" in="" part="" 750.="" a.="" the="" authority="" citation="" for="" part="" 750="" continues="" to="" read="" as="" follows:="" authority:="" 15="" u.s.c.="" 2605.="" b.="" in="" sec.="" 750.11="" by="" removing="" paragraph="" (b),="" by="" redesignating="" paragraphs="" (c)="" and="" (d)="" as="" paragraphs="" (b)="" and="" (c),="" respectively,="" by="" revising="" newly="" designated="" paragraph="" (b),="" by="" designating="" the="" undesignated="" text="" appearing="" at="" the="" end="" of="" the="" section="" as="" paragraph="" (d)="" and="" revising="" it,="" and="" by="" adding="" new="" paragraph="" (e)="" to="" read="" as="" follows:="" sec.="" 750.11="" filing="" of="" petitions="" for="" exemption.="" *="" *="" *="" *="" *="" (b)="" where="" to="" file.="" all="" petitions="" must="" be="" submitted="" to="" the="" following="" location:="" oppt="" document="" control="" officer="" (7407),="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" d.c.="" 20460.="" *="" *="" *="" *="" *="" (d)="" request="" for="" further="" information.="" the="" agency="" reserves="" the="" right="" to="" request="" further="" information="" as="" to="" each="" petition="" prior="" to="" or="" after="" publication="" of="" the="" notice="" of="" proposed="" rulemaking="" required="" by="" sec.="" 750.13.="" (e)="" renewal="" requests.="" (1)="" any="" petitioner="" who="" has="" been="" granted="" an="" exemption="" under="" section="" 6(e)(3)(b)="" of="" tsca,="" on="" or="" after="" may="" 25,="" 1994,="" and="" who="" seeks="" to="" renew="" that="" exemption="" without="" changing="" its="" terms,="" must="" submit="" a="" letter="" by="" certified="" mail="" to="" epa="" requesting="" that="" the="" exemption="" be="" granted="" for="" the="" following="" year.="" (i)="" this="" letter="" must="" contain="" a="" certification="" by="" the="" petitioner="" that="" the="" type="" of="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" the="" amount="" of="" pcbs="" handled,="" and="" any="" other="" aspect="" of="" the="" exemption="" have="" not="" changed="" from="" the="" original="" exemption="" petition="" request.="" (ii)="" this="" letter="" must="" be="" received="" by="" epa="" at="" least="" 6="" months="" prior="" to="" the="" expiration="" of="" the="" existing="" exemption.="" (iii)="" if="" a="" petitioner="" fails="" to="" make="" a="" submission="" or="" the="" submission="" is="" not="" timely="" under="" this="" section,="" the="" exemption="" will="" expire="" 1="" year="" from="" the="" effective="" date="" of="" granting="" that="" exemption.="" (iv)="" epa="" will="" address="" a="" timely="" submission="" of="" a="" renewal="" request="" by="" rulemaking="" and="" either="" grant="" or="" deny="" the="" request.="" (2)="" any="" petitioner="" who="" has="" been="" granted="" an="" exemption="" on="" or="" after="" may="" 25,="" 1994,="" and="" who="" seeks="" to="" increase="" the="" amount="" of="" pcbs="" handled="" or="" to="" change="" the="" type="" of="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" and="" any="" other="" aspect="" of="" their="" existing="" exemption="" must="" submit="" a="" new="" exemption="" petition="" to="" epa.="" the="" existing="" exemption="" activity="" may="" continue="" until="" the="" new="" submission="" is="" addressed="" by="" rulemaking,="" provided="" the="" activity="" conforms="" to="" the="" terms="" of="" the="" current="" exemption="" approved="" by="" epa,="" and="" the="" petitioner="" complies="" with="" the="" conditions="" of="" paragraph="" (e)(1)="" of="" this="" section.="" (3)="" any="" petitioner="" who="" has="" been="" granted="" a="" tsca="" section="" 6(e)(3)(b)="" exemption="" in="" a="" rule="" prior="" to="" may="" 25,="" 1994,="" and="" who="" seeks="" to="" increase="" the="" amount="" of="" pcbs="" handled="" or="" to="" change="" the="" type="" of="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" and="" any="" other="" aspect="" of="" their="" existing="" exemption="" must="" submit="" a="" new="" exemption="" petition="" to="" epa.="" the="" existing="" exemption="" activity="" may="" continue="" until="" the="" new="" submission="" is="" addressed="" by="" rulemaking,="" provided="" the="" activity="" conforms="" to="" the="" terms="" of="" the="" original="" exemption="" approved="" by="" epa.="" secs.="" 750.13="" and="" 750.14="" [amended]="" c.="" in="" secs.="" 750.13="" and="" 750.14="" change="" the="" reference="" ``sec.="" 750.11(d)''="" to="" read="" ``sec.="" 750.11(c)''.="" d.="" section="" 750.31="" is="" amended="" by="" removing="" paragraph="" (b),="" by="" redesignating="" paragraphs="" (c),="" (d)="" and="" (e)="" as="" paragraphs="" (b),="" (c)="" and="" (d),="" respectively,="" by="" revising="" newly="" designated="" paragraph="" (b),="" and="" by="" adding="" a="" new="" paragraph="" (e)="" to="" read="" as="" follows:="" sec.="" 750.31="" filing="" of="" petitions="" for="" exemption.="" *="" *="" *="" *="" *="" (b)="" where="" to="" file.="" all="" petitions="" must="" be="" submitted="" to="" the="" following="" location:="" oppt="" document="" control="" officer="" (7407),="" east="" tower,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" *="" *="" *="" *="" *="" (e)="" renewal="" requests.="" (1)="" any="" petitioner="" who="" has="" been="" granted="" an="" exemption="" under="" 40="" cfr="" 761.80,="" except="" paragraph="" (g)="" of="" 40="" cfr="" 761.80,="" on="" or="" after="" may="" 25,="" 1994,="" and="" who="" seeks="" to="" renew="" that="" exemption="" without="" changing="" its="" terms,="" must="" submit="" a="" letter="" by="" certified="" mail="" to="" epa="" requesting="" that="" the="" exemption="" be="" granted="" for="" the="" following="" year.="" (i)="" this="" letter="" must="" contain="" a="" certification="" by="" the="" petitioner="" that="" the="" type="" of="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" the="" amount="" of="" pcbs="" handled,="" and="" any="" other="" aspect="" of="" the="" exemption="" have="" not="" changed="" from="" the="" original="" exemption="" petition="" request.="" (ii)="" this="" letter="" must="" be="" received="" by="" epa="" at="" least="" 6="" months="" prior="" to="" the="" expiration="" of="" the="" existing="" exemption.="" (iii)="" if="" a="" petitioner="" fails="" to="" make="" a="" submission="" or="" the="" submission="" is="" not="" timely="" under="" this="" section,="" the="" exemption="" will="" expire="" 1="" year="" from="" the="" effective="" date="" of="" granting="" that="" exemption.="" (iv)="" epa="" will="" address="" a="" timely="" submission="" of="" a="" renewal="" request="" by="" rulemaking="" and="" either="" grant="" or="" deny="" the="" request.="" (2)="" any="" petitioner="" who="" has="" been="" granted="" an="" exemption="" on="" or="" after="" may="" 25,="" 1994,="" and="" who="" seeks="" to="" increase="" the="" amount="" of="" pcbs="" handled="" or="" to="" change="" the="" type="" of="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" and="" any="" other="" aspect="" of="" their="" existing="" exemption="" must="" submit="" a="" new="" exemption="" petition="" to="" epa.="" the="" existing="" exemption="" activity="" may="" continue="" until="" the="" new="" submission="" is="" addressed="" by="" rulemaking,="" provided="" the="" activity="" conforms="" to="" the="" terms="" of="" the="" current="" exemption="" approved="" by="" epa,="" and="" the="" petitioner="" complies="" with="" the="" conditions="" of="" paragraph="" (e)(1)="" of="" this="" section.="" (3)="" any="" petitioner="" who="" has="" been="" granted="" a="" tsca="" section="" 6(e)(3)(b)="" exemption="" in="" a="" rule="" prior="" to="" may="" 25,="" 1994,="" and="" who="" seeks="" to="" increase="" the="" amount="" of="" pcbs="" handled="" or="" to="" change="" the="" type="" of="" activities,="" the="" procedures="" for="" handling="" the="" pcbs,="" and="" any="" other="" aspect="" of="" their="" existing="" exemption="" must="" submit="" a="" new="" exemption="" petition="" to="" epa.="" the="" existing="" exemption="" activity="" may="" continue="" until="" the="" new="" submission="" is="" addressed="" by="" rulemaking,="" provided="" the="" activity="" conforms="" to="" the="" terms="" of="" the="" original="" exemption="" approved="" by="" epa.="" part="" 761--[amended]="" 2.="" in="" part="" 761="" a.="" the="" authority="" citation="" for="" part="" 761="" continues="" to="" read="" as="" follows:="" authority:="" 15="" u.s.c.="" 2605,="" 2607,="" 2611,="" 2614="" and="" 2616.="" b.="" in="" sec.="" 761.30="" by="" adding="" paragraph="" (p)="" to="" read="" as="" follows:="" sec.="" 761.30="" authorizations.="" *="" *="" *="" *="" *="" (p)="" analytical="" reference="" samples.="" pcbs="" in="" analytical="" reference="" samples="" derived="" from="" waste="" materials="" may="" be="" used="" only="" when="" the="" samples="" originated="" from="" a="" person="" who="" has="" been="" granted="" an="" exemption="" to="" process="" and="" distribute="" in="" commerce="" such="" samples="" under="" tsca="" section="" 6(e)(3)(b).="" once="" the="" use="" of="" such="" samples="" is="" completed,="" disposal="" of="" such="" samples="" is="" governed="" by="" all="" applicable="" federal,="" state,="" and="" local="" laws,="" including="" the="" rules="" contained="" in="" this="" part.="" c.="" in="" sec.="" 761.80="" by="" adding="" paragraphs="" (c)(2)="" and="" (m)(7)="" and="" by="" revising="" paragraphs="" (h)="" and="" (n)="" to="" read="" as="" follows:="" sec.="" 761.80="" manufacturing,="" processing="" and="" distribution="" in="" commerce="" exemptions.="" *="" *="" *="" *="" *="" (c)="" *="" *="" *="" (2)="" mantech,="" research="" triangle="" park,="" nc="" 27709.="" *="" *="" *="" *="" *="" (h)="" the="" administrator="" grants="" the="" following="" petitioners="" an="" exemption="" for="" 1="" year="" to="" process="" and="" distribute="" in="" commerce="" pcbs="" for="" analytical="" reference="" samples="" derived="" from="" actual="" waste="" materials:="" (1)="" r.t.="" corporation,="" laramie,="" wy="" 82070.="" (2)="" [reserved]="" *="" *="" *="" *="" *="" (m)="" *="" *="" *="" (7)="" restek="" corporation,="" bellefonte,="" pa="" 16823.="" (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="" an="" exemption="" 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),="" (h)="" and="" (m)(7)="" of="" this="" section="" may="" be="" extended="" pursuant="" to="" 40="" cfr="" 750.11(e)="" or="" 750.31(e).="" *="" *="" *="" *="" *="" [fr="" doc.="" 94-8465="" filed="" 4-8-94;="" 8:45="" am]="" billing="" code="" 6560-50-f="">