[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been withdrawn by the petitioner.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