Polychlorinated Biphenyls; Exemptions From Prohibition Against Manufacturing, Processing, and Distribution in Commerce, and Use Authorization

Federal RegisterApr 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been withdrawn by the petitioner.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

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.