[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Proposed Rules]
[Pages 69358-69364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32079]



[[Page 69357]]

_______________________________________________________________________

Part III





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 761



Use Authorization for, and Distribution in Commerce of, Non-liquid 
Polychlorinated Biphenyls; Notice of Availability; Partial Reopening of 
Comment Period; Proposed Rule

  Federal Register / Vol. 64, No. 237 / Friday, December 10, 1999 / 
Proposed Rule  

[[Page 69358]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 761

[OPPTS-66009F; FRL-6064-7]
RIN 2070-AD27


Use Authorization for, and Distribution in Commerce of, Non-
liquid Polychlorinated Biphenyls; Notice of Availability; Partial 
Reopening of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of data availability; partial reopening 
of comment period.

-----------------------------------------------------------------------

SUMMARY: This action announces the availability of data that were 
submitted to EPA after the comment period closed for the December 6, 
1994 proposal on the disposal of polychlorinated biphenyls (PCBs). This 
action also solicits additional information on the potential risks of 
exposure to PCBs, and the use and concentration of PCBs found in 
certain non-liquid PCB (NLPCB) applications. In the proposal of 
December 6, 1994, EPA solicited comment on a provision that would 
authorize the use of certain NLPCB applications (i.e., proposed 
Sec. 761.30(q)). In addition to authorizing these uses, the proposed 
provision would have required compliance with several conditions (e.g., 
notification, marking, air monitoring and standard wipe tests, 
remediation, repair and/or removal, reporting and recordkeeping 
requirements). EPA is particularly interested in data regarding the PCB 
concentration and route(s) of exposure to PCBs found in the NLPCB 
applications that are the subject of this action and the associated 
risks of exposure. This action starts a 120-day data submission period 
which will be followed by an additional 90-day period for public 
comment on existing and new data submissions. Since EPA may rely on the 
data submissions that are generated as a result of this action to 
develop a final rule to authorize the use of these NLPCB applications, 
the Agency is providing the additional 90-day comment period for 
parties who are interested in reviewing and commenting on any of the 
existing or newly submitted data.

DATES: Data submissions must be received by EPA on or before April 10, 
2000. Comments must be received by EPA on or before July 7, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number OPPTS-66009F in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Christine Augustyniak, Associate Director, Environmental Assistance 
Division (Mail Code 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, 
e-mail: TSCA-H[email protected].
    For technical information contact: Peggy Reynolds, Environmental 
Protection Agency, (Mail Code 7404), 401 M St., SW., Washington, DC 
20460; telephone: (202) 260-3965, fax: (202) 260-1724, e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be affected by this supplemental action if you own, use, 
process or distribute PCBs in commerce. Affected categories and 
entities include:

 
------------------------------------------------------------------------
                                                Examples of Affected
                 Category                             Entities
------------------------------------------------------------------------
Industry                                    Electroindustry
                                             manufacturers, end-users of
                                             electricity and general
                                             contractors
 
------------------------------------------------------------------------
Utilities and rural electric cooperatives   Electric power and light
                                             companies
 
------------------------------------------------------------------------
Individuals, Federal, State, and Municipal  Individuals and agencies
 Governments                                 which own, use, process and
                                             distribute PCBs in commerce
------------------------------------------------------------------------

This table is not exhaustive, but lists the types of entities that 
could potentially be affected by this action. Other types of entities 
may also be interested in this action. To determine whether your entity 
is affected by this action, carefully examine the applicability 
criteria in Title 40 of the Code of Federal Regulations (CFR), part 
761. If you have any questions regarding the applicability of this 
action to a particular entity, you should consult the applicable 
regulations, or the technical contact listed in ``FOR FURTHER 
INFORMATION CONTACT'' for the referenced final rule.

II. How Can I Get Additional Information, Copies of this Document, 
and Support Documents?

    1. Electronically. You may obtain electronic copies of this 
document on the Internet from the EPA Home Page at http://www.epa.gov. 
An electronic copy of this document can be found under the ``Federal 
Register-Environmental Documents'' listing and the date of the 
publication of this document in the Federal Register (http://
www.epa.gov/fedrgstr/EPA-TOX/1999/).
    2. In person. The official record for this action, including the 
public version, has been established under docket control number OPPTS-
66009F. The official record also includes all material and submissions 
filed under docket control number OPPTS-66009C, the record for the 
referenced final rule. The public version of the record, including 
printed, paper versions of any electronic comments, which does not 
include any information claimed as confidential business information 
(CBI), is available for inspection in the TSCA Nonconfidential 
Information Center, Northeast Mall Rm. NE-B607, 401 M St., SW., 
Washington, DC. The Center is open from noon to 4 p.m., Monday through 
Friday, excluding legal holidays. The telephone number of the Center is 
(202) 260-7099.

III. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is

[[Page 69359]]

imperative that you identify docket control number OPPTS-66009F in the 
subject line on the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in the East Tower Rm. G-099, Waterside Mall, 401 M 
St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is 202-260-7093.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected],'' or mail your computer disk to the 
address identified above. Do not submit any information electronically 
that you consider to be CBI. Electronic comments must be submitted as 
an ASCII file avoiding the use of special characters and any form of 
encryption. Comments will also be accepted on standard computer disks 
in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by the docket control number OPPTS-66009F. 
Electronic comments may also be filed online at many Federal Depository 
Libraries.

IV. How Should I Handle CBI Information That I Want to Submit to 
the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the technical person identified in the ``FOR FURTHER 
INFORMATION CONTACT'' section.

V. What Does this Action Do?

    This action announces the availability of data that were submitted 
to EPA after the comment period closed for the December 6, 1994 
proposed rule (59 FR 62788) (FRL-4167-1). These data, as described 
below, are available for review and comment. This action also solicits 
additional information and comment on the potential risks of exposure 
to PCBs, and the use and concentration of PCBs found in the non-liquid 
PCB (NLPCB) applications that are the subject of this action. EPA 
proposed to amend its rules under the Toxic Substances Control Act 
(TSCA) to authorize the use of NLPCBs and their distribution in 
commerce, and to impose related information collection requirements. 
These issues had also been discussed in the Advanced Notice of Proposed 
Rulemaking (ANPR) of June 10, 1991 (56 FR 26740).
    In advocating the removal of the conditions that were included in 
the December 6, 1994 proposal (e.g., notification, marking, air 
monitoring and standard wipe tests, remediation, repair and/or removal, 
reporting and recordkeeping requirements), some commenters submitted 
supplemental data that they claim showed that these NLPCB uses ``do not 
pose a risk above acceptable measures.'' However, EPA did not include 
this use authorization in the final rule which was published on June 
29, 1998 (63 FR 35384) (FRL-5726-1) because insufficient data were 
available to enable the Agency to make the no unreasonable risk finding 
for many of the NLPCB uses. These data submissions, as well as an 
assessment of those data are available for inspection (see the listing 
of reference documents at Unit VIII. of this action) in the TSCA Public 
Docket Office. In the absence of data which could be used to determine 
whether a correlation exists between PCB bulk sample results and PCB 
surface contamination, several conservative assumptions were used in 
the draft risk document (see Ref. 23 ``Revised Draft, Assessment of 
Risks Associated with Proposed PCB Use Authorizations''). The Agency 
solicits public comment on these materials, and in particular, would 
appreciate comments, which are supported by data, regarding the draft 
risk analysis.

VI. What Non-liquid PCB Uses Are of Interest to EPA?

    In the ANPR (June 10, 1991), EPA solicited information on 
unauthorized uses of NLPCBs in existing applications, and in the NPRM 
of December 6, 1994 (59 FR 62788), EPA solicited comments regarding a 
provision which would authorize the use of these NLPCBs. Items not 
authorized by the regulations but currently in use and identified as 
containing PCBs include, but are not limited to, some wool felt 
insulating materials, plastics, paint formulations, small rubber parts, 
adhesive tape, insulating materials used in electrical cabling, 
fluorescent light ballast potting materials, gaskets in heating, 
ventilation and air conditioning and other duct systems, caulking, 
coatings for ceiling tiles, flooring and floor wax/sealants, roofing 
and siding materials, adhesives, waterproofing compounds, anti-fouling 
compounds, fire retardant coatings, coal-tar enamel coatings for steel 
water pipe and underground storage tanks (i.e., American Water Works 
Association (AWWA) Standard C203 coal tar enamel), and any number of 
other chemical uses such as additives and plasticizers. The PCB 
contamination in these various products was reported to range from <1 
to 688,498 parts per million (ppm). EPA is interested in data for those 
NLPCBs that do not satisfy the criteria for excluded PCB products, 
recycled PCBs, or inadvertently generated PCBs (i.e., generally 
historic uses of PCBs at concentrations of <50 ppm PCB) which are 
authorized by the current regulations. (For a detailed discussion, see 
40 CFR 761.3 for the definitions of ``excluded PCB products'' and 
``recycled PCBs.'' Also see the definition for ``excluded manufacturing 
processes'' at 40 CFR 761.3, the regulatory requirements for excluded 
manufacturing processes at 40 CFR 761.185 and 761.187, and the 
requirements for inadvertently generated PCBs at 40 CFR 761.193.)
    A brief description of the non-liquid PCB uses which have been 
reported to EPA follows. Limited information regarding many of these 
products is contained in the NPRM (see 59 FR 62809-62811, December 6, 
1994), as well as the comments and data that were submitted to EPA in 
response to the ANPR and NPRM (OPPTS-66009/66009A) and are summarized 
below. The following descriptions also reflect information gained by 
EPA over the course of implementing the PCB program. Additional non-
liquid PCB products, when discovered, may also be covered by this use 
authorization. Therefore, information concerning unauthorized NLPCB 
uses which have not been identified above are also of interest and may 
be submitted to the Agency.
     Insulation (e.g., wool felt, foam rubber and fiberglass) 
and sound-dampening materials. These materials have been found to 
contain PCBs at concentrations which exceed 50 ppm. Wool felt and foam 
rubber insulation, as well as sound-dampening materials have been 
discovered in naval vessels and may include ships of all types, as well 
as nuclear submarine reactor

[[Page 69360]]

compartments. PCB concentrations were reported to range from <1 ppm to 
a high of 688,498 ppm (Ref. 15). Fiberglass insulation containing PCBs 
has been found in federally owned buildings at various concentrations. 
Bulk PCB concentrations were reported to range between <1 to 39,158 
ppm, and surface contamination was reported to range between 7.5 to 188 
micrograms per 100 square centimeters. All air samples were reported by 
the submitter as being below the analytical detection limit which was 
generally reported as 0.97 micrograms per cubic meter (Ref. 3). The use 
of PCB-contaminated fiberglass insulation may be widespread throughout 
the United States.
     Plastics, small foam rubber and rubber parts, adhesive 
tape, and insulating materials used in electrical cabling. PCBs may be 
in many of the components of electric cable at concentrations ranging 
from <1 ppm PCBs to 280,000 ppm PCBs (Refs. 15 and 16). In addition to 
electrical applications, these components may be in widespread use in 
marine and industrial applications. It is not clear whether PCB-
containing cables would be found in residential settings.
     Paint formulations. During the 1950-1960 time frame, PCBs 
were added to paint formulations as drying oils (resins) and 
plasticizers or softening agents (liquids) in concentrations that range 
from 10-12% PCBs (100,000-120,000 ppm) to 20-30% PCBs (200,000-300,000 
ppm). Concrete surfaces and equipment, as well as marine or 
waterproofing applications, used at Federal installations and in the 
manufacturing and industrial sectors may have painted surfaces 
contaminated with PCBs. Data provided to EPA indicate that PCBs have 
been found in dried paint at concentrations that range from <1 ppm to 
97,000 ppm (Refs. 9 and 13).
     Fluorescent light ballast potting materials. Older 
fluorescent lamps (i.e., manufactured prior to 1978) may contain a 
small PCB Capacitor with 100% PCBs (i.e., 1,000,000 ppm) and/or 
petroleum-asphalt insulating material contaminated with PCBs (Ref. 6).
     Gaskets in heating, ventilation and air conditioning 
(HVAC) and other duct systems. It is not known whether this particular 
PCB application represents a widespread use. PCBs were discovered in 
older government buildings at concentrations of 18,900 ppm (Ref. 16); 
however, given the generic nature of the specifications for this 
material, these gaskets also may have been installed in commercial and 
industrial buildings. Additionally, ventilation system gasket materials 
made from processed cork that have been contaminated with PCBs at 
concentrations up to 6,400 ppm PCB have been found on naval vessels 
(Ref. 15).
     Coatings for ceiling tiles. Ceiling tiles contaminated 
with PCBs have been found at educational institutions with surface 
level PCB concentrations at a maximum of 53 ppm. However, the 
availability and dissemination in the marketplace of this material is 
not known.
     Flooring and floor wax/sealants. A commenter indicated 
that these materials have been found to contain PCBs; however, little 
else is known about specific PCB concentrations, application(s) or its 
availability and dissemination in the marketplace (Ref. 2).
     Roofing and siding materials. This material was 
manufactured and marketed worldwide as Robertson Protected Metal (RPM) 
and Galbestos to airlines, railroads, chemical plants, steel mills, 
mines, industrial/manufacturing facilities, and military facilities. 
PCB concentrations have been found to range from <2 ppm to 30,000 ppm 
(59 FR 62809).
     Caulking and grout. Very little is known about 
contaminated caulking and grout, their specific applications and 
dissemination in the marketplace. Samples of caulking that have been 
contaminated with PCBs have been found in a setting previously used as 
a school at a maximum concentration of 310,000 ppm PCBs (Ref. 12). 
Likewise, grout has been found in the joints and cracks of a water 
reservoir at 2,700 ppm PCB and on marine vessels at concentrations 
which range from <1 to 9,100 ppm PCB (Ref. 15) in the mess room and 
other onboard locations.
     Waterproofing compounds, anti-fouling compounds, and fire 
retardant coatings. These non-liquid uses of PCBs have been found in 
military, marine and other applications; PCB concentrations have been 
found as high as 59,000 ppm PCB.
     Coal-tar enamel coatings for steel water pipe and 
underground storage tanks (i.e., AWWA C203 coal tar enamel). This 
coating was previously approved for use by EPA pursuant to the Safe 
Drinking Water Act and has been used in some older Army, municipal and 
other water supply systems. The PCB concentration in this enamel may 
range from non-detect to 1,264 ppm (Refs. 11 and 26). EPA withdrew and 
thereby invalidated its list of acceptable drinking water products on 
April 7, 1990, and since that time, individual States have had the 
authority to regulate the sale and/or use of specific products. The 
Agency has never used its authority under TSCA to control the use of 
this indirect additive to a drinking water system.

VII. What Data Are Currently Available to EPA?

    The following table provides information on the maximum PCB 
concentrations found in sample data that have been submitted to EPA. A 
review of this table, along with the criteria discussions that follow, 
will give you some indication of the NLPCBs that EPA could possibly 
authorize under the TSCA PCB regulations and the data that would be 
useful in order to evaluate the risks of exposure to PCBs associated 
with specific NLPCB uses. Unit VI. of this action provides additional 
guidance on the type of data that EPA needs to finalize a NLPCB use 
authorization.

                              Table 1.--Maximum PCB Concentrations From Sample Data
----------------------------------------------------------------------------------------------------------------
                                        Bulk Sample (mg/kg or     Standard Wipe Sample   Air Sample (g/
               Material                          ppm)             (g/100 cm2)             cm3)
----------------------------------------------------------------------------------------------------------------
Adhesive tape                          1,400                    No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Anti-fouling compounds                 No data available        No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Caulking                               310,000                  No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Ceiling tiles                          53                       1.3                      No data available
 
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[[Page 69361]]

 
Cloth/paper insulating material        12,000                   No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Coal-tar enamel coatings               1,264                    No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Dried paint                            63,3001                  2,5601                   No data available
                                       97,0002                  402                      No data available
 
----------------------------------------------------------------------------------------------------------------
Fiberglass insulation3                 39,158                   188                      <0.97
 
----------------------------------------------------------------------------------------------------------------
Fire retardant coatings                No data available        No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Flooring and floor wax/sealant         No data available        No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Fluorescent light ballast potting      No data available        No data available        No data available
 material
 
----------------------------------------------------------------------------------------------------------------
Foam rubber insulation                 13,100                   No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Foam rubber parts                      1,092                    No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Grout                                  9,100                    No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Insulating materials in electric       280,000                  No data available        No data available
 cable
 
----------------------------------------------------------------------------------------------------------------
Plastics/plasticizers                  13,000                   304                      No data available
 
----------------------------------------------------------------------------------------------------------------
Processed cork ventilation system      6,400                    No data available        No data available
 gasket material
 
----------------------------------------------------------------------------------------------------------------
Roofing/siding material                22,000                   No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Rubber parts                           84,000                   No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Sound-dampening material               No data available        No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Thermal insulation                     73,000                   No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Waterproofing compounds                No data available        No data available        No data available
 
----------------------------------------------------------------------------------------------------------------
Wool felt gaskets                      688,498                  No data available        No data available
----------------------------------------------------------------------------------------------------------------
1 Non-degraded gray chlorinated rubber-based paint, Federal specification TT-P-912; PCBs added presumably to
  prevent brittleness.
2 Semi-gloss paint; white and light blue, Amercoat 33HB with red Amercoat 86 primer.
3 Athough sampling results for this material are available from the docket, these data were not available at the
  time the draft risk analysis was completed.
4 Surface PCB concentration taken from wipe samples of plastic cable.

    EPA's criteria for authorizing a NLPCB use. EPA will apply certain 
criteria to test data results when determining whether a material that 
is suspected of containing PCBs should be authorized for use. For 
instance, EPA has received some data that would not satisfy the 
criteria stated below. These data showed positive wipe sample results 
from contamination of the surface by PCBs. However, the bulk sample did 
not contain PCBs. This type of information is not useful for 
authorizing a NLPCB application. EPA believes these results indicate 
contamination due to a PCB spill rather than contamination associated 
with the manufacture of a product containing PCBs. EPA will not 
authorize the use of spilled PCBs. If you own items that have been 
contaminated as a result of a spill, you should either decontaminate or 
dispose of the item(s). The objective of the use authorization is to 
allow the continued use of those PCB-containing materials that do not 
pose an unreasonable risk. The use of these materials is currently 
unauthorized. Since some items currently being considered for the NLPCB 
use authorization may be contaminated with PCBs due to their proximity 
to PCB liquids, as opposed to being a PCB containing item, EPA intends 
to use the following criteria for determining whether materials 
suspected of containing PCBs should actually be considered for the 
NLPCB use authorization.
     If the bulk sample contains PCBs, but the wipe sample does 
not contain detectable levels of PCBs, then the PCBs have not 
significantly migrated from the material onto the surface. If there are 
no PCBs present on the surface, then it is assumed that no significant 
releases of PCBs to air are occurring. Therefore, air sampling would 
not be necessary. In

[[Page 69362]]

this situation, there would most likely be a low risk of exposure to 
PCBs, since PCBs are being released from the material at a low or non-
existent rate. EPA could most likely authorize this use without some or 
all of the conditions listed in the proposal (see 59 FR 62857).
     If the bulk sample contains PCBs that are migrating out 
onto the surface, then the wipe sample will be expected to contain 
PCBs. Likewise, if the PCBs are being released from the surface into 
the air, then the air sample will be expected to contain PCBs. Note 
that the air sample will most likely contain PCBs at more dilute 
concentrations than those in the surface levels. EPA may or may not 
authorize this use, depending on the risk of exposure to PCBs.
     If neither the bulk nor the wipe sample contains PCBs, but 
the air sample does contain PCBs, then the PCBs are most likely from a 
source other than the material being tested. EPA cannot use these data 
to support a use authorization.
     If there are no PCBs in the bulk sample, but the wipe 
sample contains PCBs, then the PCBs are most likely from a spill rather 
than from the material being tested. EPA cannot use these data to 
support a use authorization.
    The following chart provides a summary of the criteria that EPA 
will use to authorize the use of certain non-liquid PCBs.

                              Table 2.--Criteria for Authorizing the Use of NLPCBs
----------------------------------------------------------------------------------------------------------------
             Bulk Sample                     Wipe Sample               Air Sample            Possible Result
----------------------------------------------------------------------------------------------------------------
Contains PCBs                          No PCBs                  No PCBs or data are not  PCBs not being
                                                                 available                released; possible
                                                                                          authorization for use
----------------------------------------------------------------------------------------------------------------
Contains PCBs                          Contains PCBs            Contains PCBs            PCBs are being released
                                                                                          from the material; use
                                                                                          authorization depends
                                                                                          on risk levels
----------------------------------------------------------------------------------------------------------------
No PCBs                                No PCBs                  Contains PCBs            PCB contamination from
                                                                                          another source
----------------------------------------------------------------------------------------------------------------
No PCBs                                Contains PCBs            May or may not contain   PCBs due to a spill
                                                                 PCBs
----------------------------------------------------------------------------------------------------------------

    In addition to the risk of developing cancer, PCBs also have 
significant non-carcinogenic effects, including neurotoxicity, 
reproductive and developmental toxicity, immune system suppression, 
liver damage, skin irritation, and endocrine disruption. These toxic 
effects should also be considered when assessing risk (Ref. 27). 
Therefore, in addition to evaluating the cancer risks associated with 
these NLPCB uses, the Agency intends to consider the potential non-
cancer effects. It should be noted, however, that the Agency is 
currently conducting a reassessment of the non-carcinogenic effects of 
PCBs in order to determine whether the reference dose (RfD) factors for 
PCBs currently in the Agency's Integrated Risk Information System 
(IRIS) can be updated. It is possible, therefore, that the current RfDs 
may not be retained. Therefore, detection limits that are estimated 
using the current RfDs may not be low enough after the Agency's re-
evaluation is complete. Thus, achieving the lowest possible detection 
limits is the recommended course of action in order to avoid 
reanalyzing samples if these RfDs are lowered.

VIII. What Data Does EPA Need?

    EPA received some very useful data, but much of these data do not 
address the Agency's objective of assessing the risk of exposure due to 
the use of PCBs in a particular product. For example, wipe samples from 
the wall of a ship's engine room or air samples from living quarters 
cannot be used to evaluate the risk from air handling system gaskets 
when other potential sources of PCBs may be present on the ship or when 
no gaskets containing PCBs are present in the ship's handling system. 
It would be useful to have both surface results and bulk sampling 
results so that possible relationships between bulk and surface 
concentrations could be better defined. EPA also needs a better 
understanding of the individual sampling results including summary 
statistics such as range, median mean, standard deviation, and 
geometric mean in order to better determine if the results are 
representative of the sample population. Likewise, it is necessary to 
know the population characteristics with respect to PCB concentration, 
number of data points collected within a population, and how those data 
points represent the overall population of the items in use.
    EPA would like to use the data to assess exposure via dermal 
contact and inhalation for most materials, as well as via incidental 
ingestion, as appropriate (e.g., paint chips). Surface samples are 
preferable for estimating dermal exposures because they reflect the PCB 
concentrations that individuals actually contact. EPA has data on a 
limited number of uses for which there are both bulk PCB concentrations 
and surface concentrations for the same material. Therefore, 
information on both bulk sample concentrations and wipe sample 
concentrations would be useful for defining the relationship between 
bulk and surface samples for use in dermal exposure assessments. Bulk 
sample data are also needed to assess incidental ingestion for some 
materials. EPA has no data on the volatilization or entrainment of PCBs 
from individual uses. This information would greatly facilitate the 
estimation of inhalation risk. Preliminary estimates were based on 
theoretical calculations, often employing very conservative approaches 
(Refs. 23 and 24). Also, the data EPA is currently using to assess 
dermal and inhalation risk for most uses is relatively old. Newer data 
would be useful in providing updated estimates.
    As suggested earlier, EPA is interested in being able to detect 
cancer risks at or below 1 x 10-6 and non-carcinogenic 
hazards at or below a hazard index of 1. Because traditional sampling 
techniques may not have sufficiently low practical limits of 
quantitation (PQL) for EPA to determine that these NLPCB uses do not 
pose unreasonable risks, the approach to sampling may require much 
larger surface areas, much larger air volumes, or much more sensitive 
chemical analysis procedures than previously used. Consideration should 
also be given to achieving the lowest possible detection limits because 
of potential changes to the current RfDs.
    Prior to finalizing a rule that would authorize the conditional use 
of these materials, the Agency is soliciting public review of and 
comment on the data that were submitted subsequent to

[[Page 69363]]

the official comment period for the December 6, 1994 NPRM. Data 
supporting a non-conditional use authorization for NLPCBs (i.e., a 
provision which would eliminate or minimize notification, marking, air 
monitoring and standard wipe test, remediation, repair and/or removal, 
reporting and recordkeeping requirements) may be submitted for the use 
of PCBs in any of the various applications identified above. A listing 
of the data elements that are required for this analysis is provided 
below. Please note that due to the uncertainty associated with updating 
the reference dose (RfD) for PCBs, the following discussions focus 
solely on the risk of developing cancer. In the absence of an updated 
RfD, the Agency is inclined to continue to use conservative risk 
assumptions for issues associated with the use of PCBs.
    1. Wipe sample data for each of the products (or classes of 
products, i.e., paint) for which use would be authorized. Data should 
be collected from products that are known to contain PCBs (i.e., based 
on bulk sample results or from historic knowledge). Also, the detection 
limits for these materials should be sufficiently low to ensure that 
the cancer risks and non-carcinogenic hazards can be calculated down to 
less than 1 x 10-6 and below 1, respectively (note that the 
current RfDs for PCBs are likely to change), in order for the NLPCB use 
to be authorized. EPA recommends using the lowest achievable detection 
limit possible.
    2. Transfer data. Information on the transfer of PCBs to human skin 
from the non-liquid PCBs listed in Table 1 of Unit V.
    3. Air monitoring data for each of the products (or classes of 
products, i.e., paint) for which use would be authorized. Data should 
be collected from products that are known to contain PCBs (i.e., based 
on bulk sample results or from historic knowledge). Also, the detection 
limits for these materials should be sufficiently low to ensure that 
the cancer risks and non-carcinogenic hazards can be calculated down to 
less than 1 x 10-6 and below 1, respectively. EPA recommends 
using the lowest achievable detection limit possible.
    Each product (or class of products, i.e., paint) sampled must 
contain high enough concentrations of PCBs in their bulk sample to be 
representative of the highest concentrations of PCBs in the product (or 
class of products, i.e., paint). For example, commenters provided 
information that paint formulations with 10-12% PCBs were recommended 
in the commercial formulation manuals. Therefore, EPA is especially 
interested in wipe sample and air monitoring data for products such as 
paints with bulk sample levels of 10-12% PCBs. In addition to the 
collected data, EPA requests the sampling plan that was used in 
collecting the data and a description of the quality assurance/quality 
control procedures that were applied to the data set.
    In order to facilitate EPA's review of the data (i.e., bulk, 
standard wipe, and air sample results) on NLPCB containing materials, 
you should consider the following in order to judge the adequacy of 
your data submissions:
     Are the bulk and wipe samples of specific materials (i.e., 
uses) rather than of areas (e.g., engine room, mess deck/galley, 
berthing, pilot house, etc.)?
     Do you have corresponding samples (i.e., both bulk and 
wipe samples) for the specific materials?
     Did you collect air samples using procedures for chamber 
testing in order to differentiate PCBs that offgas from specific 
materials rather than from PCBs that are in ambient air?
    EPA recommends using the lowest achievable detection limit possible 
so that cancer risks of 1 x 10-6 or non-cancer hazards of 1 
may be detected. The detection limits at these risk levels may be 
estimated using cancer slope factors or reference doses for PCBs 
developed by EPA. The lower of the detection limits based on either 
cancer or non-cancer endpoints should be used to ensure that both types 
of effects could be detected.
    If commenters and/or data submitters would like to submit comments 
or data anonymously, EPA will accept anonymous comments and data 
submissions (e.g., via a third party). However, it is important that 
EPA be able to contact someone should questions arise concerning the 
collection methodology, analytical procedures or other technical 
issues, even if through a third party.

IX. List of Reference Documents

    The following documents are available in the combined docket for 
OPPTS-66009 (OPPTS-66009A, OPPTS-66009B and OPPTS-66009C). Documents 
identified with an asterisk were submitted to EPA after the official 
comment period for the proposed rule had closed. Since these data will 
be used in the Agency's decision making process, this listing is 
intended to ensure ample opportunity for public review and comment on 
pertinent documents.
    1. Aluminum Company of America. Comments from Connie Glover Ritzert 
to the TSCA Nonconfidential Information Center, USEPA. Subject: 
Comments on Proposed Amendments to the TSCA PCB Regulations (59 FR 
62788) - OPPS[sic]-66009A; FRL-4167-1 (May 3, 1995) (see C1-239, Table 
3).
    2. Consumers Power. Comments from William L. Beckman to the TSCA 
Nonconfidential Information Center, USEPA. Subject: Document Control 
Number OPPTS-66009A; FRL-4167-1, U.S. Environmental Protection Agency, 
December 6, 1994, Proposed Amendment to 40 CFR Part 761, Disposal of 
Polychlorinated Biphenyls (PCBs) (May 4, 1995) (see C1-179).
    3. General Services Administration. Letter from David Spannbauer to 
Barry Breen, Federal Facilities Enforcement, USEPA, Subject: PCBs in 
Fiberglass Insulation in Federally Owned Buildings (1994) With 
Enclosures (see B3-032).*
    4. General Services Administration. Letter from Casey Jones to 
Robert Harding, Section Chief, Toxic Substance Branch, USEPA, Subject: 
PCB Contamination at the Wallace F. Bennett Federal Building (date not 
discernible) With Enclosure (see B3-033).*
    5. General Services Administration. Letter from Casey Jones to Kim 
Le, USEPA, Subject: Update on PCB Contaminated Insulation at the 
Wallace F. Bennett Federal Building (February 2, 1994) With Enclosure 
(see B3-034).*
    6. Kominsky, John, NIOSH et al. ``Polychlorinated Biphenyl 
Contamination Resulting from Fluorescent Light Ballast Burnout 
(Draft).'' (April 14, 1986) (see C3-010).
    7. Larcom, B.J.; Cline, J.M.; Merrill, E.A.; Jederberg, W.W.; 
Still, W.R. ``Risk Assessment of Polychlorinated Biphenyls On-board 
Navy Ships.'' A report prepared for the U.S. Navy. AL/OE-TR-1996-0153. 
WRAIR-TR-NMRI-96-72 (1996) (see C3-001).*
    8. Parsons Engineering Science, Inc. ``Risk Review Paper, 
Evaluation of Existing Data for PCBs in Non-liquid Material (NLPCBs).'' 
A report prepared for Environmental Management Directorate, Robins Air 
Force Base, GA and Air Force Material Command Under USAF Contract No. 
F41624-94-D-8136, Delivery Order No. 0069 (1997) (see C3-002).*
    9. Ropes Gray. Letter from Mark A. Greenwood to Mr. John H. Smith, 
USEPA. Subject: Response to Data Request on PCBs in Paint (July 21, 
1998) (see C3-017).*
    10. Ross, M.; Mangum, S.; Adema, C. ``Sampling and Analysis of 
Polychlorinated Biphenyls (PCBs) in Navy Ship Cables.'' A report 
prepared by the Naval Sea Systems Command, Code 05V, Report No. 9510, 
Ser. 6110/121 (1993) (see C1-107, Enclosure 11).

[[Page 69364]]

    11. U.S. Army. Comments from Lewis D. Walker to Joseph S. Carra, 
USEPA. Subject: Comments on Proposed Polychlorinated Biphenyl Rule (May 
2, 1995) (see C1-260).
    12. U.S. Army Corps of Engineers, New England Division. ``Final 
Site Investigation Report for Campbell, Lyle, Stone and Otis Memorial 
Schools, Bourne, MA.'' A report prepared by Stone and Webster 
Environmental Technology and Services under Delivery Order 17, Contract 
No. DACW33-94-D-007 (1996) (see B3-001).*
    13. U.S. Department of Energy. Letter from Thomas T. Traceski to 
Mr. John Melone, USEPA. Subject: Results of Testing at the Savannah 
River Site (October 29, 1988) (see C3-018).*
    14. U.S. Department of Energy, Schenactady Naval Reactors Office. 
Letter from A.R. Seepo to Kim Tisa, USEPA Region 1. Subject: 
Documentation of Research Regarding Historical Uses of PCBs in Paint 
(April 19, 1995) (see C3-004).
    15. U.S. Department of the Navy. Electronic submission; CD-ROM 
containing spreadsheets of PCB sample results, Excel for Office 97. 
Samples taken from various naval vessels; Files: PCBEPA01.XLS (see 
Sheet 1) and PCBEPA02.XLS (see Sheet 1) (see C3-019).*
    16. U.S. Department of Transportation, Maritime Administration. 
Appendices from Report No. MA-ENV-820-96003; Appendix D, Sampling and 
Analysis (January 1997) and Appendix E, Survey of Ships and Materials 
(July 1997) (see B3-030).*
    17. U.S. Department of Transportation, U.S. Coast Guard. Memorandum 
from Alan M. Steinman, Chief, Office of Health and Safety to Chief, 
Office of Engineering, Logistics and Development. Subject: Health Risk 
Evaluation of 65' WYTL and 82' WPB Class Cutters (January 18, 1996) 
With Enclosure: ``PCB Health Risk Evaluation of 65' WYTL and 82' WPB 
Class Cutters, Office of Health and Safety, Safety and Environmental 
Health Division, January 1996.'' (see B3-031).*
    18. Versar Inc. Memo from Linda Phillips to Tony Baney, USEPA. 
Subject: Review of PCB Data for DOE Savannah River Site (November 13, 
1998) (see B3-038).*
    19. Versar Inc. Memo from Linda Phillips to Tony Baney, USEPA. 
Subject: Review of Ropes Gray Sampling Data (October 12, 1998) (see B3-
037).*
    20. Versar Inc. Memo from Linda Phillips to Peggy Reynolds, USEPA. 
Subject: Data Submissions for Risk Analysis for Authorized Uses of PCBs 
(December 8, 1998) (see B3-039).*
    21. Versar Inc. Memo from Linda Phillips to John Smith, USEPA. 
Subject: Review of Air Force Risk Assessment (November 10, 1997) (see 
B3-035).*
    22. Versar Inc. Memo from Linda Phillips to John Smith, USEPA. 
Subject: Review of U.S. Coast Guard PCB Risk Assessment (March 13, 
1998) (see B3-036).*
    23. Versar, Inc. ``Revised Draft, Assessment of Risks Associated 
with Proposed PCB Use Authorizations.'' A report prepared for the U.S. 
Environmental Protection Agency under Contract No. 68-W6-0023, Work 
Assignment No. III-3 (March 12, 1999) (see B3-040).*
    24. Versar, Inc. ``Revised Preliminary Draft, Assessment of Risks 
Associated with Proposed PCB Use Authorizations.'' A report prepared 
for the U.S. Environmental Protection Agency under Contract No. 68-W6-
0023, Work Assignment No. II-9 (October 14, 1997) (see E3-021).*
    25. Westinghouse Savannah River Company. Letter from Nancy Lowry to 
David K. Hannemann, USEPA. Subject: Detailed Information on PCB 
Analyses of Painted Surfaces (May 28, 1997) (see C3-005).*
    26. U.S. Army Corps of Engineers. Comments from Daniel R. Burns to 
the TSCA Nonconfidential Information Center, USEPA. Subject: Comments 
on the Proposed Rule on the Disposal of Polychlorinated Biphenyls 
(April 20, 1995) (see C1-139).
    27. U.S. Environmental Protection Agency. PCBs: Cancer Dose-
Response Assessment and Application to Environmental Mixtures, EPA/600/
P-96/001 (September 1996) (See B3-026).*
    28. Midwest Research Institute. ``Polychlorinated Biphenyl Analysis 
of Cable Samples from U.S. Navy Ships.'' A report prepared for the U.S. 
Environmental Protection Agency under Contract No. 68-DO-0137, Work 
Assignment No. 30 (August 14, 1992) (See B3-043)*.

List of Subjects in 40 CFR Part 761

    Environmental protection, Hazardous substances, Polychlorinated 
biphenyls, Reporting and recordkeeping requirements.

    Dated: November 29, 1999.
Susan H. Wayland,
Deputy Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 99-32079 Filed 12-9-99; 8:45 am]
BILLING CODE 6569-50-F