[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18818-18822]
[FR Doc No: 2014-07556]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0143; FRL-9909-02]

Thiram; Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of thiram in or on banana. Taminco US, Inc. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The
tolerances expire on March 31, 2015.

DATES: This regulation is effective April 4, 2014. Objections and
requests for hearings must be received on or before June 3, 2014, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0143, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0143 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 3, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0143, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of February 25, 2014 (79 FR 10458) (FRL-
9906-77), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4E8243) by Taminco US, Inc., Two Windsor Plaza, Suite 411, Allentown,
PA 18195. The petition requested that 40 CFR 180.132 be amended by
extending the expiration date on the tolerance for residues of the
fungicide thiram in or on banana at 0.8 parts per million (ppm) from
March 31, 2014, to March 31, 2015. That document referenced a summary
of the petition prepared by Taminco US, Inc., the registrant, which is
available to the public in the docket, http://www.regulations.gov.
There were no comments received in response to the notice of filing.
These tolerances expire on March 31, 2015.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the

pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C) of
FFDCA requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for thiram including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with thiram follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Thiram is a dimethyl dithiocarbamate fungicide. Thiram has been
shown to cause neurotoxicity following acute and subchronic exposures.
In the acute and subchronic neurotoxicity studies submitted,
neurotoxicity is characterized as lethargy, reduced and/or tail pinch
response, changes in the functional-observation battery (FOB)
parameters, increased hyperactivity, changes in motor activity, and
increased occurrences of rearing events. No treatment-related changes
were observed in brain weights or in the histopathology of the nervous
system. In a non-guideline study published in the open literature,
chronic feeding of thiram to rats caused neurotoxicity, with onset of
ataxia in some animals 5-19 months after beginning of treatment.
However, no evidence of neurotoxicity was seen following chronic
exposures in mice or rats in guideline studies submitted to the Agency.
The chronic toxicity profile for thiram indicates that the liver,
blood, and urinary system are the target organs for this chemical in
mice, rats, and dogs. There is no evidence for increased susceptibility
following in utero exposures to rats or rabbits and following pre- and
post-natal exposures to rats for 2 generations. There is evidence of
quantitative susceptibility in the developmental neurotoxicity (DNT)
study. However, there is low concern for the increased susceptibility
seen in the DNT study since the dose response is well defined with a
clear NOAEL and this endpoint is used for assessing the acute dietary
risk for the most sensitive population. Thiram is classified as ``not
likely to be carcinogenic to humans'' based on lack of evidence for
carcinogenicity in mice or rats. There are no mutagenic/genotoxic
concerns with thiram. The available toxicological database for thiram
suggests that this chemical has a low to moderate acute-toxicity
profile.
    Specific information on the studies received and the nature of the
toxic effects caused by thiram as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Thiram. Update to the Aggregate Risk
Assessment to Support the Requested PHI Reduction and Increased
Tolerance Request on Strawberry,'' p. 9 in docket ID number EPA-HQ-OPP-
2012- 0925.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for thiram used for human
risk assessment is discussed in Unit III.B. of the final rule published
in the Federal Register of February 12, 2014 (79 FR 8295) (FRL-9904-
22).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiram, EPA considered exposure from the petitioned-for
tolerances as well as all existing thiram tolerances in 40 CFR 180.132.
EPA assessed dietary exposures from thiram in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    A partially refined probabilistic acute dietary-exposure assessment
was performed using 100 percent crop treated (PCT), tolerance, the
highest residue found during field-trials, distributions of field trial
residues, and empirical processing factors.
    ii. Chronic exposure. Tolerances level residues for banana and
average field trial residues for apples, peaches and strawberries along
with 100 PCT were used for the chronic dietary exposure analysis for
all crops. Empirical processing factors were also used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
classified thiram as ``Not Likely to be Carcinogenic to Humans,''
therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is not needed.
    iv. Anticipated residue information. EPA did not use PCT
information in the dietary assessment for thiram. The acute used field
trial residues for the majority of commodities. The chronic dietary
used average field trial residues along with tolerance level residues.
In addition, 100 PCT were assumed for all food commodities. Section
408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data

call-ins as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Data will be required to be submitted no
later than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for thiram in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of thiram. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
thiram for acute exposures are 0.0478 parts per billion (ppb) and
0.0025 ppb for chronic exposures (for non-cancer assessments) for
surface water. Ground water sources were not included (for acute or
chronic exposures), as the EDWCs for ground water are minimal in
comparison to those for surface water. Surface water EDWCs were
incorporated in DEEM-FCID into the food categories ``water, direct, all
sources'' and ``water, indirect, all sources'' for the dietary
assessments.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Thiram is not
available for sale or use by homeowner applicators; therefore, there
are no residential handler exposure scenarios. However, there is
potential for residential post-application dermal exposure from treated
golf course greens and tees. Residential exposures resulting from
dermal contact with thiram-treated turf were assessed for children 6 to
<11 years old, children 11 to <16 years old, and adults as described in
document ``Thiram. Update to the Aggregate Risk Assessment to Support
the Requested PHI Reduction and Increased Tolerance Request on
Strawberry,'' p. 8299 in docket ID number EPA-HQ-OPP-2012-0925.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike the N-methyl carbamate pesticides, EPA has not found thiram
(a dithiocarbamate) to share a common mechanism of toxicity with any
other substances, and thiram does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that thiram does not have
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility following in utero exposure to rats or rabbits
or following pre-and post natal exposures to rats. There is evidence of
quantitative susceptibility in the DNT study. Offspring effects
(increased locomotor activity in females on PND 17) occurred at a lower
dose than maternal effects (increased number of rearing events and
elevated incidences of hyperactivity in females at weeks 8 and 13).
There is low concern for the enhanced susceptibility seen in the DNT
study because:
    i. Clear NOAELs/LOAELs were established for the offspring effects.
    ii. The dose-response is well defined.
    iii. The behavioral effect of concern were observed only in females
on one evaluation time period. and
    iv. The dose/endpoint is used for acute dietary risk for the most
sensitive population subgroup (females 13-49 years old). Consequently,
there are no residual uncertainties for pre- and post-natal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for thiram is complete with acceptable
neurotoxicity, developmental, and reproductive toxicity studies.
    ii. As explained in this unit, there are no residual uncertainties
for pre- and post-natal toxicity.
    iii. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to thiram in
drinking water. In addition, the acute dietary exposure analysis used
FDA apple monitoring data and field trial data along with the maximum
PCT. The chronic dietary exposure analysis used tolerance level
residues except for apple along with the average PCT. In addition,
washing studies were incorporated into the dietary analyses since
thiram is not a systemic pesticide and will wash off during normal
washing procedures. These assessments will not underestimate the
exposure and risks posed by thiram. These assessments will not
underestimate the exposure and risks posed by thiram.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using DEEM-FCID, acute dietary exposure at the 95th
exposure percentile is estimated at 0.012053 mg/kg bw/day for the
general U.S. population (1.9% of the aPAD) and 0.008637 mg/kg bw/day
(62% of the aPAD) for females 13-49 years old, the population subgroup
with the highest % aPAD dietary exposure to thiram.
    2. Chronic risk. The chronic aggregate risk assessment takes into
account exposure estimates from dietary consumption of thiram (food and
drinking water). Dietary risk estimates

were determined considering exposures from food and drinking water
using EDWCs for surface water sources. Using the DEEM-FCID software,
dietary exposure is estimated at 0.002257 mg/kg bw/day for the general
U.S. population (15% of the cPAD) and 0.011943 mg/kg bw/day (80% of the
cPAD) for children 1-2 years old, the population subgroup with the
highest estimated chronic dietary exposure to thiram.
    3. Short-term and intermediate-term risk. Short-term aggregate
exposure takes into account short-term residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level). Intermediate-term aggregate exposure takes into
account intermediate-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level).
    In aggregating short- and intermediate-term risk, the Agency
routinely combines background chronic dietary exposure (food + water)
with short/intermediate-term residential exposure (dermal only). The
combined exposure may then be used to calculate an MOE for aggregate
risk. Using the golfer scenario for adult males, adult females, and
children >6 years old, combined with the applicable subpopulation with
the greatest dietary exposure, the total short/intermediate-term food
and residential aggregate MOEs are 600, 600, and 370, respectively. As
these MOEs are greater than 100, the short- and intermediate-term
aggregate risks do not exceed the Agency's LOC.
    4. Aggregate cancer risk for U.S. population. Thiram is classified
as ``Not Likely to be Carcinogenic to Humans'' based on lack of
evidence for carcinogenicity in mice or rats; therefore, thiram is not
expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to thiram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (colorimetric analytical method)
is available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for thiram in or on banana.

V. Conclusion

    Therefore, the expiration date on time-limited tolerance for
residues of thiram in or on banana at 0.8 ppm is being extended until
March 31, 2015. An extension of the time limited tolerance has been
imposed to allow the Agency time to review additional residue data
submitted in consideration of a permanent tolerance for banana.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 28, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.132, in the table in paragraph (a), in the entry for
``Banana'', revise the Expiration/revocation date, ``3/31/14'' to read
``3/31/15'' to read as follows:

Sec.  180.132  Thiram; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Expiration/
              Commodity                Parts  per  million   revocation
                                                                date
------------------------------------------------------------------------

                                * * * * *
Banana \1\...........................  * * *                     3/31/15

                               * * * * *
------------------------------------------------------------------------
\1\ No U.S. registrations as of September 23, 2009.

* * * * *
[FR Doc. 2014-07556 Filed 4-3-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 222 (Tuesday, November 18, 2014)]
[Notices]
[Pages 68750-68751]
[FR Doc No: 2014-27219]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2014-0114]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    In accordance with Part 235 of Title 49 Code of Federal Regulations
and 49 U.S.C. 20502(a), this document provides the public notice that
by a document dated October 20, 2014, Union Pacific Railroad (UP)
petitioned the Federal Railroad Administration (FRA) seeking approval
for the discontinuance or modification of a signal system. FRA assigned
the petition Docket Number FRA-2014-0114.
    Applicant: Union Pacific Railroad, Mr. Neal Hathaway, AVP
Engineering-Signal, 1400 Douglas Street, MS 0910, Omaha, NE 68179.
    UP seeks approval of the discontinuance of Control Point K905 at
Milepost 4.9, Armourdale, KS, on the Kansas City Metro Kansas
Subdivision. All signals will be discontinued and all power-operated
switches will be converted to hand operation. The purpose of the
discontinuance is to reestablish remote control locomotive operations
through this area.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200

New Jersey Avenue SE., W12-140, Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays. Communications received by January 2, 2015
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on November 12, 2014.
Ron Hynes,
Director of Technical Oversight.
[FR Doc. 2014-27219 Filed 11-17-14; 8:45 am]
BILLING CODE 4910-06-P


DRAFT: Appendix G Case Studies G 1 Appendix G Case Studies INTRODUCTION This Appendix presents seven hypothetical case studies to illustrate how to report information on Form U. EPA designed the case studies to cover a variety of reporting scenarios. These case studies are not based on actual data, but are hypothetical situations generated to assist submitters. None of these hypothetical situations are binding. EPA will assess each situation in a case by case basis. Each case study is divided into the following sections:

° Scenario  This section presents a sample manufacturing scenario for a single chemical including processing and use information. For some cases, a figure is included to clarify the manufacture, process, and use information;

° EPA Approach  This section discusses the rationale for each of the three criteria presented in Chapter 2 and identifies which parts of Form U must be completed;

° Key Points  This section highlights important information which is helpful for completing Form U;

° Completing the Form  This section discusses the responses which should be entered on Form U for each manufacturing scenario. This section explains the basis and rationale for the reported information; and ° Sample Form U  A completed Form U for each scenario is included. Part I of Form U was completed for Case Study A only. Parts II and III of Form U were completed for all cases, as necessary.

EPA created these case studies to cover the following frequently asked questions:

1. How do I know if my chemical is site limited? A chemical is site limited if it is manufactured at your plant site and you do not distribute the substance or any mixture containing the substance outside the plant site for commercial purposes. See Section 4.6.3 and Case Study A for additional guidance. DRAFT: Appendix G Case Studies G 2 2. What if my site only imports a chemical? Manufacturers and importers are required to report under the IURA. Importers should check the " import" box in Block 2. B. 4. Sections <IP_ADDRESS> and 4.6.4 and Case Study B of this document provide additional guidance for reporting this information.

3. What if my site exports the entire volume of the manufactured chemical? If you manufacture an IUR reportable chemical substance solely for export, you are required to report and otherwise comply with all IUR requirements for Parts I and II of Form U. Case Study C illustrates how to complete Form U for a chemical that is exported.

4. What if my site both manufactures and imports the same chemical? Sites both manufacturing and importing a chemical substance should check both boxes in Block 2. B. 4. The total volume of chemical ( both manufactured and imported) should be reported in Parts II and III of Form U. See Sections <IP_ADDRESS> and 4.6.4 and Case Study G for additional guidance.

5. How do I report the number of workers at my site and at downstream sites? Estimates for the number of workers reasonably likely to be exposed are required for both the manufacturing and industrial processing sections of Form U. Sections 4.6.7 and <IP_ADDRESS> of this document describe how to report these codes and give examples of worker activities that could potentially result in exposure. All case studies provide examples of how to report the number of potentially exposed workers along with the basis and rationale for selecting the reported code.

6. How do I report the maximum concentration of my chemical? You are required to report the maximum concentration, by weight, of your chemical at the time it sent off site from each site. If a chemical is site limited, report the maximum concentration before it is reacted on site to produce a different chemical substance. Section 4.6.8 of this document provides guidance for reporting this information. Case Study A illustrates how to complete Block 2. B. 8.

7. What if I manufacture my chemical in more than one physical form? You are required to report all physical forms of the chemical substance at the time it leaves your site and the percent of production volume for each form. The percentage must be rounded off to the nearest 10%; the sum of the percentages for each form must not add up to more than 100%. Section 4.6.9 of this document provides guidance for reporting the physical form and the percent production volume in each physical form. Case Study F provides a scenario and illustrates how to complete Blocks 2. B. 9 though 2. B. 14. DRAFT: Appendix G Case Studies G 3 8. What if there are multiple NAICS, IFC, and " Types of Process or Use" code combinations for my chemical? You are required to report up to ten unique combinations of codes. If more than 10 unique combinations apply, you need only report the ten combinations that represent the largest percentage of production volume. Section 4.7.1 and Case Studies F and G provide additional guidance.

9. What if my percent production volume is less than 5% for a process/ use, NAICS, and IFC code combination and the total production volume is less than 300,000 pounds? As discussed in Section <IP_ADDRESS> of this document, if a particular combination accounts for less than 5% of the percent production volume and is less than 300,000 pounds, then you may report the percent production volume as 0%. Case Study G illustrates how to report this information.

10. What if my percent production volume is less than 5% for a process/ use, NAICS, and IFC code combination but the total production volume is greater than 300,000 pounds? As discussed in Section <IP_ADDRESS> of this document, if a particular combination accounts for less than 5% of the percent production volume and is 300,000 pounds or greater, then you must report the percent production volume to the nearest 1% of production volume. Case Study G illustrates how to report this information.

11. What if the values I report for percent production volume for each end use add up to more than 100%? As discussed in Section <IP_ADDRESS>, the total percent production volumes may add up to more than 100% since you are reporting on the distribution of the chemical to downstream sites. The values may add up to less than 100% if the information on production volume is not readily obtainable. Case Studies F and G illustrate how to report this information.

12. What if my chemical has multiple commercial and consumer uses? You must report up to 10 commercial and consumer product categories for which your chemical is used. Section <IP_ADDRESS> and Case Studies F and G provide additional guidance for completing Column " a" in Part III, Section B.

13. What if my substance is used in children's products? You must determine, within each commercial and consumer product category reported, whether any amount of each reportable chemical substance is present in consumer products intended for use by children age 14 or younger. Section <IP_ADDRESS> of this document provides guidance for completing Column " b" in Part III, Section B of Form U. Case Study F presents a scenario to illustrate how to complete this part of Form U. DRAFT: Appendix G Case Studies G 4 14. How do I report chemicals that are intermediates? Definitions for " intermediate" and " non isolated intermediate" are provided in Appendix B. Section 2.2.3 of this document states that impurities, byproducts, and non isolated intermediates are exempt from reporting. However, reporting the manufacture of an isolated intermediate is required. Case Study A provides a possible scenario for reporting an isolated intermediate. Additional examples are available in section 2.2.3 of this document.

15. How do I report hydrates of a chemical substance? You are required to complete Form U for the corresponding anhydrous form. Section <IP_ADDRESS> of this document specifically addresses how to report a hydrate of a chemical substance and provides an example. Furthermore, Case Study D presents another example of how to report a hydrate of a chemical substance.

16. How do I report inorganic chemical substances? Inorganic chemical substances are partially exempt from reporting for the 2006 reporting period and will not be exempt for subsequent reporting periods. For the 2006 reporting period, you only need to complete Parts I and II of Form U. Section <IP_ADDRESS> of this document provides additional guidance on this subject. Case Study D illustrates how to report an inorganic chemical substance for the 2006 reporting period.

17. What if my chemical is listed on the " specific exempted chemical substances" list? EPA generates a list of chemicals for which manufacturers are exempt from reporting Part III of Form U. Additional information about these chemicals can be found in section <IP_ADDRESS> of this document. Case Study E illustrates how to report a chemical that is listed as a " partially exempt chemical substance." DRAFT: Appendix G Case Studies G 5 CASE STUDY A This example illustrates how to report:

Site limited chemicals; and

Intermediates.

Scenario: Company A manufactures 1,100,000 lbs/ yr of an intermediate called Monomer # 1 ( Accession # 99999) at the Big Lot site. Monomer # 1 is used for the manufacture of a polyamide and is sitelimited meaning it is only used at the Big Lot site. Monomer # 1 is produced as part of a liquid solution at 89.6% concentration and transferred to an on site storage tank for future use. Monomer # 1 is subsequently consumed during the reaction to produce the polyamide. Twelve workers are potentially exposed during the manufacture of Monomer# 1 during sampling and equipment cleaning. Two additional workers transfer Monomer # 1 from the storage tank to the reactor that produces the polyamide. Four administrative workers are on site but not directly involved with the manufacture of any chemicals.

John Doe is the plant manager for the Company A's Big Lot site. The mailing address for this site is 100 John Doe Highway, Richmond, VA 23222. The Dun & Bradstreet number for the site is 099999999. The mailing address for Company A's headquarters is 100 First Street, Suite 100, New York, NY 10001. The Dun & Bradstreet number for this office is 999999999.

EPA Approach: Criterion I: Monomer # 1 is on the TSCA Inventory and in not subject to a special regulatory action under TSCA. Monomer # 1 is used to produce a polyamide. The polyamide is excluded from reporting under the polymer exemption, but Monomer # 1 does not qualify for this exemption.

Criterion II: Company A manufactures 25,000 pounds or more of Monomer # 1 and does not qualify as a small manufacturer. Monomer # 1 is considered to be site limited because it is not imported to the site and does not leave the site. Monomer # 1 is defined as isolated because the transfer operation from the reactor to the storage tank isolates Monomer # 1; therefore, Monomer # 1 does not qualify for the nonisolated intermediate exemption.

Criterion III: Company A manufactures 300,000 pounds for more of Monomer # 1 and Monomer # 1 does not qualify for any partial exemptions. Therefore, Company A must complete Parts I, II, and III.

Key Points:

Company A estimates 12 exposed workers from sampling and equipment cleaning DRAFT: Appendix G Case Studies G 6 during manufacture of Monomer # 1. The administrative workers are not included in this total because they are not likely to be exposed to this chemical. The 2 workers responsible for transferring Monomer # 1 from the storage tank to the reactor are reported in Part III. DRAFT: Appendix G Case Studies G 7 Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 2. A. 1 Chemical ID Number 99999 Accession number.

2. A. 2 ID Code A IUR code for accession number.

2. A. 3 Chemical Name Monomer # 1 Chemical Abstracts Index/ Preferred name. Note: if this were a real chemical, the chemical name should be reported.

2. B. 3 Site limited Y Monomer # 1 is site limited because it is not imported and it never leaves the site because it is destroyed during the reaction to produce polyamide.

2. B. 4 Activity Manufacture Monomer # 1 is manufactured by Company A and not imported.

2. B. 5 Production Volume ( lbs) 1,100,000 Amount manufactured.

2. B. 7 Number of Workers W2 At least 10 but fewer than 25. Company A estimates 12 exposed workers from sampling and equipment cleaning during manufacture of Monomer # 1. The administrative workers are not included in this total because they are not likely to be exposed to this chemical.

2. B. 8 Maximum Concentration M4 From 61% to 90% by weight. The maximum concentration is 89.6%.

2. B. 14 Physical Form Percent of PV a. Liquid; b. 100 100% of the product is produced as a liquid.

Part III  Section I. Industrial Processing and Use Information Block Block Title Report Basis/ Rationale 3. A. 1 Type of Process or Use PC Processing as a reactant.

NAICS 32619 Other plastics product manufacturing.

IFC U16 Intermediate.

Percent PV 100 100% of the PV is used as an intermediate.

Number of Sites S1 Fewer than 10. Only one site uses this chemical.

Number of Workers W1 Fewer than 10. Company A estimates 2 workers are exposed during transfer operations during the reaction that produces polyamide.

Part III  Section II. Commercial and Consumer End Use Exposure Related Data DRAFT: Appendix G Case Studies G 8 Check the " N/ A" box in the upper right hand corner. The intermediate is destroyed during the production of polyamide and therefore never leaves this site for further processing or use. DRAFT: Appendix A Forms G 9 FOR EPA USE ONLY Report Number Mark " X" here if this is a revision to the previous report Previous Report Number Form U  Case Study A PAGE 1 of _ 2_ ( IMPORTANT: Type only, read instructions before completing form)

U. S. Environmental Protection Agency Washington, DC 20460 Partial Updating of TSCA Inventory Data Base Production and Site Report ( Section 8( a) Toxic Substances Control Act, 15 U. S. C. 2607)

PART I. SITE IDENTIFICATION INFORMATION SECTION A. CERTIFICATION Certification Statement: I hereby certify that I have reviewed the attached documents and that, to the best of my knowledge and belief, the submitted information is true and complete and that the amounts and values in this report are accurate based on reasonable estimates using data available to the preparers of this report.

1. A. 1 Signature 1. A. 2 Date signed 1. A. 3 Name John Doe 1. A. 4 Official Title Plant Manager SECTION B. PARENT COMPANY AND TECHNICAL CONTACT INFORMATION 1. B. 1 Parent Company Name Company A, Inc.

1. B. 2 Parent Company Dun & Bradstreet Number 999999999 1. B. 3 Technical Contact Name John Doe 1. B. 4 Technical Contact Telephone ( w/ Area Code) 555 555 5555 1. B. 5 Technical Contact Email Address john. doe@ companya. com Technical Contact Mailing Address 1. B. 6 Technical Contact Address ( Line1) 100 First Street 1. B. 7 Technical Contact Address ( Line 2) Suite 100 1. B. 8 City New York 1. B. 9 State NY 1. B. 10 Zip Code 10001 SECTION C. PLANT SITE IDENTIFICATION 1. C. 1 Plant Site Name Company A, Inc.

1. C. 2 Plant Site Dun & Bradstreet Number 099999999 EPA Facility Identification Number ( for Agency Use Only) LEAVE BLANK 1. C. 3 Street Address ( Line 1) 100 Joe Doe Highway 1. C. 4 Street Address ( Line 2)

1. C. 5 City Richmond 1. C. 6 County/ Parish Chesterfield 1. C. 7 State VA 1. C. 8 Zip Code 23222 FORM U 2006 DRAFT: Appendix A Forms G 10 EPA Form Number < XXXX X> ( Rev 8/ 22/ 03)  Previous editions are obsolete Form Approved OMG Number : XX/ X XXXX DRAFT: Appendix A Forms G 11 Form U  Case Study A ( continued) Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION A. CHEMICAL IDENTIFICATION CBI*

2. A. 1 Chemical Identifying Number 99999 2. A. 2 ID Code A 2. A. 3 Chemical Name Monomer # 1 SECTION B. MANUFACTURING INFORMATION 2. B. 1 Company Information CBI 2. B. 2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2. B. 3 Site Limited ( Y/ N) Y CBI 2. B. 9 Dry Powder 2. B. 4 Activity ( Check all that apply)

Manufacture G Import CBI 2. B. 10 Pellets or Large Crystals 2. B. 5 Production Volume ( LB) 1,100,000 CBI 2. B. 11 Water or Solvent Wet Solid 2. B. 6 Production Volume Range LEAVE BLANK CBI 2. B. 12 Other Solid 2. B. 7 Number of Workers ( code) W2 CBI 2. B. 13 Gas or Vapor 2. B. 8 Maximum Concentration ( code) M4 CBI 2. B. 14 Liquid

100 PART III. PROCESSING AND USE INFORMATION Complete Part III, Sections A and B only if the production volume noted in Block 2. B. 5 is greater than or equal to 300,000 lb/ year.

SECTION A. INDUSTRIAL PROCESSING AND USE DATA N/ A a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 3. A. 1 PC 32619 U16 100 S1 W1 3. A. 2 3. A. 3 3. A. 4 3. A. 5 3. A. 6 3. A. 7 3. A. 8 3. A. 9 3. A. 10 SECTION B. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A

a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 3. B. 1 3. B. 2 3. B. 3 3. B. 4 3. B. 5 3. B. 6 3. B. 7 3. B. 8 3. B. 9 3. B. 10 * Substantiation required for CBI claims on chemical identity and plant site identity. FOR EPA USE ONLY DRAFT: Appendix G Case Studies G 12 CASE STUDY B This example illustrates how to report:

A chemical substance that is imported only;

TSCA exempt uses ( cosmetic lotions).

Scenario: Company B imports 400,000 pounds of 2 propanol ( IPA) ( CAS# 67 63 0) to its only site during a reporting year as part of a liquid solution at 95% concentration. Company B employs 5 workers per shift for 3 shifts ( 15 total workers) to incorporate the IPA into mixtures and formulations ranging from 10% to 50% in concentration. Half the production volume ( 200,000 pounds) is incorporated into industrial solvents and cleaners and is sold to hundreds of sites. Company B estimates 3 workers are exposed at each of these sites. 100,000 pounds of IPA is used in commercially used soaps and cleaners. The remaining 100,000 pounds is incorporated into cosmetic lotions for consumer use. The soap and lotion products are used at thousands of sites.

EPA Approach: Criterion I: IPA is on the TSCA Inventory and is not a substance excluded from reporting.

Criterion II: Company B imported 25,000 pounds or more of IPA and does not qualify as a small manufacturer. Company B does not qualify for any additional reporting exemptions for IPA.

Criterion III: Company B imported 300,000 pounds or more of IPA and the IPA is not listed as a partial exemption; therefore, Company B must report Parts I, II, and III for IPA.

Key Points: Since IPA is imported, no exposed workers are reported for the manufacturing section in Part II. Use of cosmetic lotions is exempt from TSCA reporting because it is regulated by the Food and Drug Administration ( FDA), but the manufacture and processing of IPA into these products is not exempt. Therefore, the consumer use of cosmetic lotions is not required in Part III of Form U and does not need to be reported. DRAFT: Appendix G Case Studies G 13 Company B incorporates the IPA into liquid formulations and solutions at concentrations of 10  50% ( Block 3. A. 1) 400,000 lbs. of IPA is imported to Company B at 95% concentrations 200,000 lbs. IPA sold as industrial solvents and cleaners ( Block 3. A. 2)

100,000 lbs. IPA sold as soaps and cleaners ( Block 3. B. 1) 100,000 lbs. IPA sold as cosmetic lotions ( Exempt because regulated by FDA) INDUSTRIAL PROCESSING AND USE COMMERCIAL AND CONSUMER END USE CASE STUDY B  Flow Diagram DRAFT: Appendix G Case Studies G 14 Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 2. A. 1 Chemical ID Number 67 63 0 CAS Number.

2. A. 2 ID Code C Code for CAS Number.

2. A. 3 Chemical Name 2 propanol Chemical Abstracts Index/ Preferred name.

2. B. 3 Site limited N Imported chemicals cannot be claimed as site limited and IPA leaves the site of manufacture.

2. B. 4 Activity Import IPA is imported only ( not domestically manufactured).

2. B. 5 Production Volume ( lbs) 400,000 Amount of IPA imported.

2. B. 7 Number of Workers W1 Fewer than 10. Since the product is imported, no workers are exposed during the manufacture of IPA.

2. B. 8 Maximum Concentration M3 From 31% to 60% by weight. The maximum concentration leaving the site is 50%. The imported concentration of 95% is not pertinent to this assessment.

2. B. 14 Physical Form Percent of PV a. Liquid; b. 100 100% of the product is produced as liquid formulations and mixtures.

Part III  Section I. Industrial Processing and Use Information Block Block Title Report Basis/ Rationale 3. A. 1 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32519 Other basic organic chemical manufacturing.

IFC U28 Solvent ( which becomes part of product formulation or mixture).

Percent PV 100 All of the production volume is formulated into a mixture.

Number of Sites S1 Less than 10 sites. Company B imports IPA to a single site.

Number of Workers W2 At least 10 but fewer than 25. Company B employs 15 workers to formulate the IPA. DRAFT: Appendix G Case Studies Block Block Title Report Basis/ Rationale G 15 3. A. 2 Type of Process or Use U Use as an industrial solvent and cleaner.

NAICS 32519 Other basic organic chemical manufacturing.

IFC U27 Solvents for cleaning and degreasing.

Percent PV 50 Half of the production volume ( 200,000 lbs.) is used in industrial solvents.

Number of Sites S5 From 251 to 1,000. Company B estimates hundreds of sites.

Number of Workers W7 At least 1,000 but fewer than 10,000. Company B estimates 3 exposed workers for each industrial processing site during transfer and use operations. 3 workers per site x 1,000 sites = 3,000 workers.

Part III  Section II. Commercial and Consumer End Use Related Data Block Block Title Report Basis/ Rationale 3. B. 1 Commercial and Consumer Product Category C16 Soaps and detergents.

Use in Children's Product Y Some soaps and detergents may be used by children.

Percent PV 30 Of the 400,000 lbs imported, 100,000 lbs ( 25%) is used in soaps and detergents. Round up to 30% based on standard rounding convention.

Maximum Concentration M3 From 31% to 60% by weight. The maximum concentration used in formulations is 50%. DRAFT: Appendix G Case Studies G 16 Form U  CASE STUDY B Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION A. CHEMICAL IDENTIFICATION CBI*

2. A. 1 Chemical Identifying Number 67 63 0 2. A. 2 ID Code C 2. A. 3 Chemical Name 2 Propanol SECTION B. MANUFACTURING INFORMATION 2. B. 1 Company Information CBI 2. B. 2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2. B. 3 Site Limited ( Y/ N) N CBI 2. B. 9 Dry Powder 2. B. 4 Activity ( Check all that apply) G Manufacture

Import CBI 2. B. 10 Pellets or Large Crystals 2. B. 5 Production Volume ( LB) 400,000 CBI 2. B. 11 Water or Solvent Wet Solid 2. B. 6 Production Volume Range LEAVE BLANK CBI 2. B. 12 Other Solid 2. B. 7 Number of Workers ( code) W1 CBI 2. B. 13 Gas or Vapor 2. B. 8 Maximum Concentration ( code) M3 CBI 2. B. 14 Liquid

100 PART III. PROCESSING AND USE INFORMATION Complete Part III, Sections A and B only if the production volume noted in Block 2. B. 5 is greater than or equal to 300,000 lb/ year.

SECTION A. INDUSTRIAL PROCESSING AND USE DATA N/ A a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 3. A. 1 PF 32519 U28 100 S1 W2 3. A. 2 U 32519 U27 50 S5 W7 3. A. 3 3. A. 4 3. A. 5 3. A. 6 3. A. 7 3. A. 8 3. A. 9 3. A. 10 SECTION B. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 3. B. 1 C16 Y 30 M3 3. B. 2 3. B. 3 3. B. 4 3. B. 5 3. B. 6 3. B. 7 3. B. 8 3. B. 9 3. B. 10 * Substantiation required for CBI claims on chemical identity and plant site identity. FOR EPA USE ONLY DRAFT: Appendix G Case Studies G 17 CASE STUDY C This example illustrates how to report:

$ A chemical substance that is exported only ( production volume is 300,000 lbs/ yr or more).

Scenario: Company C manufactures 400,000 pounds of liquid cyclohexane ( CAS# 110 82 7) in solution at 90% concentration during a reporting year. The manufacturer exports the entire production volume outside the United States. Since cyclohexane is extremely volatile, all manufacturing operations occur in closed systems with engineering controls to minimize releases and worker exposures. However, Company C estimates 4 workers will perform transfer and drumming operations and 4 workers will perform maintenance and equipment cleaning activities.

EPA Approach: Criterion I: Cyclohexane is on the TSCA Inventory and is not excluded from reporting.

Criterion II: Company C manufactures 25,000 pounds or more of cyclohexane and does not qualify as a small manufacturer. Company C does not qualify for any additional reporting exemptions.

Criterion III: Company C manufactures 300,000 pounds or more of cyclohexane and cyclohexane does not qualify for any partial exemptions. Therefore, Company C must complete Parts I, II, and III of Form U for cyclohexane.

Key Points:

Company C should report 8 workers potentially exposed during manufacturing operations despite the use of engineering controls and personal protection equipment.

Reporting the industrial, commercial, and processing use information of this chemical is not required for activities outside the United States.

Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 2. A. 1 Chemical ID Number 110 82 7 CAS Number 2. A. 2 ID Code C Code for CAS Number 2. A. 3 Chemical Name Cyclohexane Chemical Abstracts Index/ Preferred name 2. B. 3 Site limited N Cyclohexane is distributed off site for commercial purposes.

2. B. 4 Activity Manufacture Cyclohexane is manufactured and not imported. DRAFT: Appendix G Case Studies Block Block Title Report Basis/ Rationale G 18 2. B. 5 Production Volume ( lbs) 400,000 Amount manufactured.

2. B. 7 Number of Workers W1 Fewer than 10. Company C estimates 8 workers exposed during the manufacturing process.

2. B. 8 Maximum Concentration M4 From 61% to 90% by weight. The maximum concentration leaving the site is 90%.

2. B. 14 Physical Form Percent of PV a. Liquid; b. 100 100% of the product is produced as liquid formulations and mixtures.

Part III  Section I. Industrial Processing and Use Information Check the " N/ A" box in the upper right hand corner.

Part III  Section II. Commercial and Consumer End Use Exposure Related Data Check the " N/ A" box in the upper right hand corner. DRAFT: Appendix G Case Studies G 19 Form U  CASE STUDY C Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION A. CHEMICAL IDENTIFICATION CBI*

2. A. 1 Chemical Identifying Number 110 82 7 2. A. 2 ID Code C 2. A. 3 Chemical Name Cyclohexane SECTION B. MANUFACTURING INFORMATION 2. B. 1 Company Information CBI 2. B. 2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2. B. 3 Site Limited ( Y/ N) N CBI 2. B. 9 Dry Powder 2. B. 4 Activity ( Check all that apply)

Manufacture G Import CBI 2. B. 10 Pellets or Large Crystals 2. B. 5 Production Volume ( LB) 400,000 CBI 2. B. 11 Water or Solvent Wet Solid 2. B. 6 Production Volume Range LEAVE BLANK CBI 2. B. 12 Other Solid 2. B. 7 Number of Workers ( code) W1 CBI 2. B. 13 Gas or Vapor 2. B. 8 Maximum Concentration ( code) M4 CBI 2. B. 14 Liquid

100 PART III. PROCESSING AND USE INFORMATION Complete Part III, Sections A and B only if the production volume noted in Block 2. B. 5 is greater than or equal to 300,000 lb/ year.

SECTION A. INDUSTRIAL PROCESSING AND USE DATA N/ A

a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 3. A. 1 3. A. 2 3. A. 3 3. A. 4 3. A. 5 3. A. 6 3. A. 7 3. A. 8 3. A. 9 3. A. 10 SECTION B. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A

a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 3. B. 1 3. B. 2 3. B. 3 3. B. 4 3. B. 5 3. B. 6 3. B. 7 3. B. 8 3. B. 9 3. B. 10 * Substantiation required for CBI claims on chemical identity and plant site identity. FOR EPA USE ONLY DRAFT: Appendix G Case Studies G 20 CASE STUDY D This example illustrates how to report:

A hydrate of a chemical substance;

Inorganic chemical substances ( partial exemption for 2006 reporting year); and

TSCA exempt use ( as a pesticide).

Scenario: Company D produces 800,000 lbs/ yr of copper sulfate pentahydrate ( CuSO 4 · 5H 2 O) crystals at 93% purity. 70% of the production volume is used for metal electroplating and 30% is used as pesticides. This site employs 60 workers in the manufacturing area.

EPA Approach: Criterion I: Copper sulfate pentahydrate is a hydrate and not listed on the TSCA Inventory. However, copper sulfate is on the TSCA Inventory and is required to be reported under IUR. Copper sulfate does not qualify as a substance excluded from reporting.

Criterion II: Company D manufacturers 25,000 pounds or more of copper sulfate ( not copper sulfate pentahydrate) and does not qualify as a small manufacturer. Company D does not qualify for any additional reporting exemptions.

Criterion III: Company D manufactures 300,000 pounds or more of copper sulfate ( not copper sulfate pentahydrate). Copper sulfate is an inorganic substance and is partially exempted for the 2006 reporting period. Therefore, Company D must complete Parts I and II of Form U for copper sulfate.

Key Points:

This material is a hydrate, therefore only the weight fraction of the non hydrated form of copper sulfate ( CuSO 4) ( CAS# 7758 98 7) should be reported. To determine the weight fraction, multiply the production volume of the copper sulfate pentahydrate by the molecular weight of copper sulfate ( CuSO 4) divided by the molecular weight of the copper sulfate pentrahydrate ( CuSO 4 · 5H 2 O). The molecular weight of CuSO 4 is 159.6 lbs/ lb · mole and the molecular weight of CuSO 4 · 5H 2 O is 249.7 lbs/ lb · mole. Calculation:

800,000 lbs CuSO 4 5H 2 O yr 159.6 lbs / lb mole CuSO 4 249.7 lbs / lb mole CuSO 4 5H 2 O 511,386 lbs CuSO 4 / yr   ×

    =

The manufacture and use of pesticides is regulated by Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and is exempt from TSCA regulations; therefore, the portion of the production volume used in pesticides does not need to DRAFT: Appendix G Case Studies G 21 Company D produces 800,000 lbs. of copper sulfate pentahydrate crystals ( 511,386 lbs. CuSO4) at 93% purity 560,000 lbs. of copper sulfate pentahydrate ( 357,970 lbs. CuSO4) is used for metal electroplating INDUSTRIAL PROCESSING AND USE 240,000 lbs. of copper sulfate pentahydrate ( 153,416 lbs. CuSO 4) is used as a pesticide ( Exempt because regulated by FIFRA) be reported for Part III.

Copper sulfate is an inorganic substance. For the 2006 reporting year, inorganic substances are partially exempt, so only Parts I and II need to be reported.

Company D should report 60 workers potentially exposed because they work in the manufacturing area.

CASE STUDY D  Flow Diagram DRAFT: Appendix G Case Studies G 22 Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 2. A. 1 Chemical ID Number 7758 98 7 CAS Number 2. A. 2 ID Code C Code for CAS Number 2. A. 3 Chemical Name Copper ( II) sulfate Chemical Abstracts Index/ Preferred name 2. B. 3 Site limited N Copper sulfate is distributed off site for commercial purposes.

2. B. 4 Activity Manufacture Copper sulfate is manufactured and not imported.

2. B. 5 Production Volume ( lbs) 357,970 Calculated amount of anhydrous copper sulfate produced for non pesticidal uses. 511,386 lbs x 70% PV = 357,970 lbs.

2. B. 7 Number of Workers W4 At least 50 but fewer than 100. Company D estimates 60 workers exposed during the manufacturing process, mostly due to cleaning, sampling, handling, and transfer operations.

2. B. 8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 93%.

2. B. 10 Physical Form Percent of PV a. Large crystals; b. 100 100% of the product is produced as large crystals.

Part III  Section I. Industrial Processing and Use Information Check the " N/ A" box in the upper right hand corner.

Part III  Section II. Commercial and Consumer End Use Exposure Related Data Check the " N/ A" box in the upper right hand corner. DRAFT: Appendix G Case Studies G 23 Form U  CASE STUDY D Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION A. CHEMICAL IDENTIFICATION CBI*

2. A. 1 Chemical Identifying Number 7758 98 7 2. A. 2 ID Code C 2. A. 3 Chemical Name Copper ( II) Sulfate SECTION B. MANUFACTURING INFORMATION 2. B. 1 Company Information CBI 2. B. 2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2. B. 3 Site Limited ( Y/ N) N CBI 2. B. 9 Dry Powder 2. B. 4 Activity ( Check all that apply)

Manufacture G Import CBI 2. B. 10 Pellets or Large Crystals

100 2. B. 5 Production Volume ( LB) 357,970 CBI 2. B. 11 Water or Solvent Wet Solid 2. B. 6 Production Volume Range LEAVE BLANK CBI 2. B. 12 Other Solid 2. B. 7 Number of Workers ( code) W4 CBI 2. B. 13 Gas or Vapor 2. B. 8 Maximum Concentration ( code) M5 CBI 2. B. 14 Liquid PART III. PROCESSING AND USE INFORMATION Complete Part III, Sections A and B only if the production volume noted in Block 2. B. 5 is greater than or equal to 300,000 lb/ year.

SECTION A. INDUSTRIAL PROCESSING AND USE DATA N/ A

a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 3. A. 1 3. A. 2 3. A. 3 3. A. 4 3. A. 5 3. A. 6 3. A. 7 3. A. 8 3. A. 9 3. A. 10 SECTION B. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A

a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 3. B. 1 3. B. 2 3. B. 3 3. B. 4 3. B. 5 3. B. 6 3. B. 7 3. B. 8 3. B. 9 3. B. 10 * Substantiation required for CBI claims on chemical identity and plant site identity. FOR EPA USE ONLY DRAFT: Appendix G Case Studies G 24 CASE STUDY E This example illustrates how to report:

A chemical listed on the " partially exempt chemical substances" list.

Scenario: Company E produces 500,000 lbs/ yr of a benzene, mono C14 16 alkyl derivs. ( CAS # 129813 60 1) liquid solution at concentrations up to 95%. Company E distributes the entire amount produced ( 500,000 lbs) to twelve companies for formulation into laundry detergents. These detergents are intended for use by approximately 200 commercial companies.

Company E has two production lines on this site that produce benzene, mono C14 16 alkyl derivs. Each line employs 20 workers ( covering 3 shifts) to operate and maintain equipment during manufacturing operations, including sampling, handling, and equipment cleaning.

EPA Approach: Criterion I: Benzene, mono C14 16 alkyl derivs. is listed on the TSCA Inventory and is not a substance excluded from reporting.

Criterion II: Company E manufactures 25,000 pounds or more of benzene, mono C14 16 alkyl derivs. and does not qualify as a small manufacturer. Company E does not qualify for any additional reporting exemptions.

Criterion III: Company E manufactures 300,000 pounds or more of benzene, mono C14 16 alkyl derivs. Benzene, mono C14 16 alkyl derivs. is listed as a partially exempted substance in Appendix E; therefore, Company E must complete Parts I and II of Form U. Company E does not need to complete Part III because it is partially exempted.

Key Points:

Benzene, mono C14 16 alkyl derivs. is partially exempt from reporting ( see 40 CFR 710.46( b)( 2)( iv) and Appendix E), therefore only Parts I and II need to be completed. DRAFT: Appendix G Case Studies G 25 Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 2. A. 1 Chemical ID Number 129813 60 1 CAS Number 2. A. 2 ID Code C Code for CAS Number 2. A. 3 Chemical Name Benzene, mono C14 16 alkyl derivs. Chemical Abstracts Index/ Preferred name 2. B. 3 Site limited N Benzene, mono C14 16 alkyl derivs. is distributed off site.

2. B. 4 Activity Manufacture Benzene, mono C14 16 alkyl derivs. is manufactured and not imported.

2. B. 5 Production Volume ( lbs) 500,000 Reported to amount reasonably obtainable.

2. B. 7 Number of Workers W2 At least 25 but fewer than 50. Company E estimates 40 workers exposed ( 20 workers per line x 2 lines = 40 workers).

2. B. 8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 95%.

2. B. 14 Physical Form Percent of PV a. Liquid; b. 100 100% of the product is produced as liquid formulations and mixtures.

Part III  Section I. Industrial Processing and Use Information Check the " N/ A" box in the upper right hand corner.

Part III  Section II. Commercial and Consumer End Use Exposure Related Data Check the " N/ A" box in the upper right hand corner. DRAFT: Appendix G Case Studies G 26 Form U  CASE STUDY E Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION A. CHEMICAL IDENTIFICATION CBI*

2. A. 1 Chemical Identifying Number 129813 60 1 2. A. 2 ID Code C 2. A. 3 Chemical Name Benzene, Mono C14 16 Alkyl Derivs.

SECTION B. MANUFACTURING INFORMATION 2. B. 1 Company Information CBI 2. B. 2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2. B. 3 Site Limited ( Y/ N) N CBI 2. B. 9 Dry Powder 2. B. 4 Activity ( Check all that apply)

Manufacture G Import CBI 2. B. 10 Pellets or Large Crystals 2. B. 5 Production Volume ( LB) 500,000 CBI 2. B. 11 Water or Solvent Wet Solid 2. B. 6 Production Volume Range LEAVE BLANK CBI 2. B. 12 Other Solid 2. B. 7 Number of Workers ( code) W2 CBI 2. B. 13 Gas or Vapor 2. B. 8 Maximum Concentration ( code) M5 CBI 2. B. 14 Liquid

100 PART III. PROCESSING AND USE INFORMATION Complete Part III, Sections A and B only if the production volume noted in Block 2. B. 5 is greater than or equal to 300,000 lb/ year.

SECTION A. INDUSTRIAL PROCESSING AND USE DATA N/ A

a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 3. A. 1 3. A. 2 3. A. 3 3. A. 4 3. A. 5 3. A. 6 3. A. 7 3. A. 8 3. A. 9 3. A. 10 SECTION B. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A

a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 3. B. 1 3. B. 2 3. B. 3 3. B. 4 3. B. 5 3. B. 6 3. B. 7 3. B. 8 3. B. 9 3. B. 10 * Substantiation required for CBI claims on chemical identity and plant site identity. FOR EPA USE ONLY DRAFT: Appendix G Case Studies G 27 CASE STUDY F This example illustrates how to report:

When two different physical forms are manufactured;

The use in a children's product; and

Children's Product Use as " not readily obtainable"; when the sum of the percent production volume is greater than 100%.

Scenario: At one site, Company F manufacturers a total of 800,000 lb/ yr of C. I. Pigment Yellow 100 ( CAS# 12225 21 7) in both powdered and liquid forms. Company F manufactures and sells 300,000 lb/ yr of powdered C. I. Pigment Yellow 100 ( 100% concentration) to 6 sites that incorporate it into plastic pellets at less than 1% concentration. These pellets are then molded into plastic articles which are sold to consumers. The remaining 500,000 pounds of C. I. Pigment Yellow 100 is sold as a liquid at concentrations between 1% and 30% as a coloring agent to approximately 50 paint manufacturers. The paint manufacturers then sell 60% of this paint ( 300,000 lbs.) directly to the consumer and the other 40% to about 10 toy manufacturers that paint wooden toys ( 200,000 lbs.). The toys are then sold to consumers, including children.

Company F employs 25 workers to manufacture C. I. Pigment Yellow 100 as a powder and an additional 20 workers to manufacture the liquid formulations. Company F estimates that 5 workers are exposed to C. I. Pigment Yellow 100 at each plastic manufacturing site and 5 workers are exposed at each paint manufacturing site. Company F estimates 5 workers are exposed at to C. I. Pigment Yellow 100 at each wooden toy manufacturer site.

EPA Approach: Criterion I: C. I. Pigment Yellow 100 is listed on the TSCA Inventory and does not qualify as an excluded substance for IUR reporting.

Criterion II: Company F manufactures 25,000 pounds or more of C. I. Pigment Yellow 100 and does not qualify as a small manufacturer. Company F does not qualify for any additional reporting exemptions.

Criterion III: Company F manufactures 300,000 pounds or more of C. I. Pigment Yellow 100, which does not qualify as a partial exemption.

Key Points:

Company F should report 45 workers potentially exposed during manufacturing operations.

Company F based its estimates for Part III on its understanding of how its customers process and use C. I. Pigment Yellow 100. DRAFT: Appendix G Case Studies G 28 Company F produces 300,000 lbs. of powdered CI Pigment Yellow 100 at 100% concentration INDUSTRIAL PROCESSING AND USE 500,000 lbs. of CI Pigment Yellow 100 is sold to 50 paint manufacturers as a coloring agent and is blended into paint formulations at concentrations of 1  30% ( Block 3. A. 2) Company F produces 500,000 lbs. of powdered CI Pigment Yellow in liquid solution at 1  30%

300,000 lbs. of CI Pigment Yellow 100 sold to 6 sites that incorporate it into plastic pellets ( Block 3. A. 1)

Plastic pellets containing CI Pigment Yellow 100 are molded into articles ( Block 3. B. 1) 300,000 lbs. is sold directly to the consumer as a component in paint ( Block 3. B. 2) 200,000 lbs. is sold to 10 toy manufacturers for painting wooden toys ( Block 3. B. 3)

COMMERCIAL AND CONSUMER END USE CASE STUDY F  Flow Diagram DRAFT: Appendix G Case Studies G 29 Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 2. A. 1 Chemical ID Number 12225 21 7 CAS Number 2. A. 2 ID Code C Code for CAS Number 2. A. 3 Chemical Name C. I. Pigment Yellow 100 Chemical Abstracts Index/ Preferred name 2. B. 3 Site limited N C. I. Pigment Yellow 100 is distributed off site for commercial purposes.

2. B. 4 Activity Manufacture C. I. Pigment Yellow 100 is manufactured and not imported.

2. B. 5 Production Volume ( lbs) 800,000 Reported to amount reasonably obtainable.

2. B. 7 Number of Workers W3 At least 25 but fewer than 50. Company F employs 45 workers to produce C. I. Pigment Yellow 100 ( 25 for powder form and 20 for liquid form).

2. B. 8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 100%.

2. B. 9 Physical Form Percent of PV a. Powder; b. 40 300,000 of the total 800,000 pounds ( 37.5%) of product is produced as a powder. Round up to 40%.

2. B. 14 Physical Form Percent of PV a. Liquid; b. 60 500,000 of the total 800,000 pounds ( 62.5%) of product is produced as a liquid. Round down to 60%. DRAFT: Appendix G Case Studies G 30 Part III  Section I. Industrial Processing and Use Information Block Block Title Report Basis/ Rationale 3. A. 1 Type of Process or Use PA Incorporation into an article. This accounts for the powder form being incorporated into plastic pellets.

NAICS 32619 Other plastics product manufacturing.

IFC U08 Coloring agents, pigments.

Percent PV 40 37.5% of the production volume is used for this use. Round up to 40%.

Number of Sites S1 Less than 10. Company F has 6 customer sites.

Number of Workers W3 At least 25 but fewer than 50. Company B estimates 5 exposed workers for each of 6 processing sites. 5 workers per site x 6 sites = 30 workers.

3. A. 2 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32551 Paint and coating manufacturing.

IFC U08 Coloring agents, pigments.

Percent PV 60 62.5% of the production volume is used for this use. Round down to 60%.

Number of Sites S3 From 26 to 100. Company F estimates 50 paint manufacturers use their product.

Number of Workers W5 At least 100 but fewer than 500. Company F estimates 5 exposed workers per site for 50 processing sites = 250 of workers. DRAFT: Appendix G Case Studies G 31 Part III  Section II. Commercial and Consumer End Use Exposure Related Data Block Block Title Report Basis/ Rationale 3. B. 1 Commercial and Consumer Product Category C15 Rubber and plastics products.

Use in Children's Product ? Information not readily obtainable.

Percent PV 40 40% of C. I. Pigment Yellow 100 manufactured by Company F is used in polymers/ plastics.

Maximum Concentration M1 Less than 1% by weight.

3. B. 2 Commercial and Consumer Product Category C12 Paints and coatings.

Use in Children's Product N Paints sold directly to consumer are not expected to be used by children.

Percent PV 40 37.5% of C. I. Pigment Yellow 100 manufactured by Company F is used in paint. Round up to 40%.

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 30%.

3. B. 3 Commercial and Consumer Product Category C18 Wood and wood furniture.

Use in Children's Product Y Wooden toys are expected to be used by children.

Percent PV 30 25% of PV ( 200,000 lbs.) is used in paint for wooden toys. Round up to 30%.

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 30%. DRAFT: Appendix G Case Studies G 32 Form U  CASE STUDY F Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION A. CHEMICAL IDENTIFICATION CBI*

2. A. 1 Chemical Identifying Number 12225 21 7 2. A. 2 ID Code C 2. A. 3 Chemical Name C. I. Pigment Yellow 100 SECTION B. MANUFACTURING INFORMATION 2. B. 1 Company Information CBI 2. B. 2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2. B. 3 Site Limited ( Y/ N) N CBI 2. B. 9 Dry Powder

40 2. B. 4 Activity ( Check all that apply)

Manufacture G Import CBI 2. B. 10 Pellets or Large Crystals 2. B. 5 Production Volume ( LB) 800,000 CBI 2. B. 11 Water or Solvent Wet Solid 2. B. 6 Production Volume Range LEAVE BLANK CBI 2. B. 12 Other Solid 2. B. 7 Number of Workers ( code) W3 CBI 2. B. 13 Gas or Vapor 2. B. 8 Maximum Concentration ( code) M5 CBI 2. B. 14 Liquid

60 PART III. PROCESSING AND USE INFORMATION Complete Part III, Sections A and B only if the production volume noted in Block 2. B. 5 is greater than or equal to 300,000 lb/ year.

SECTION A. INDUSTRIAL PROCESSING AND USE DATA N/ A a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 3. A. 1 PA 32619 U08 40 51 W3 3. A. 2 PF 32551 U08 60 53 W5 3. A. 3 3. A. 4 3. A. 5 3. A. 6 3. A. 7 3. A. 8 3. A. 9 3. A. 10 SECTION B. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 3. B. 1 C15 ? 40 M1 3. B. 2 C12 N 40 M2 3. B. 3 C18 Y 30 M2 3. B. 4 3. B. 5 3. B. 6 3. B. 7 3. B. 8 3. B. 9 3. B. 10 * Substantiation required for CBI claims on chemical identity and plant site identity. FOR EPA USE ONLY DRAFT: Appendix G Case Studies G 33 CASE STUDY G This example illustrates how to report:

A chemical substance that is both manufactured and imported at the same site;

Multiple Types of Process or Use codes;

Multiple NAICS codes

Multiple IFC codes;

When the sum of the percent production volume for Industrial Processing is greater than 100%; and

TSCA exempt use ( as a pesticide)

Scenario: Company G produced 19,000,000 pounds of xylene, mixed isomers ( CAS# 1330 20 7) ( referred to as xylene throughout this case study) and imported an additional 1,000,000 pounds during the same reporting year to the same site. The xylene is manufactured at 100% concentration. Company G estimates 8 exposed workers during the manufacture of xylene for sampling and maintenance, in addition to 6 exposed workers during the drumming of product.

Company G distributes 4,000,000 pounds of xylene directly to 3 chemical manufacturing facilities at 100% concentration to be used as a chemical reactant. Company G estimates 4 workers are potentially exposed at each manufacturing facility to transfer the xylene from shipping containers to the reactor.

The remaining 16,000,000 pounds of xylene is shipped to 15 different distributors for formulation of products. Company G estimates 6 workers are potentially exposed at each distribution site. The distributors formulate 4,000,000 pounds of xylene and sell it as a metal degreaser at 95% concentration to 200 hardware manufacturers; and Company G estimates 3 workers are potentially exposed to xylene per hardware manufacturer. The formulator dilutes the remaining 12,000,000 pounds such that xylene is present at a concentration ranging between 0.5% and 95% and places the final product into smaller containers. Of the 12,000,000 pounds of xylene that is processed, 6,000,000 pounds is used in automotive care products ( 35% max. conc.) used both commercially and by consumers. 3,200,000 pounds will be used in paint formulations ( 15% max. conc.) which are then sold for commercial and consumer applications. 2,200,000 pounds is formulated into pesticides ( 10% max conc.) which is then sold for commercial use. 400,000 pounds is sold for formulation of a wood preservative ( 20% conc.) to be used on furniture for residential use. 200,000 pounds is sold as a component of solvents on the consumer market ( 95% max conc.).

EPA Approach: Pesticides are regulated by the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and are exempt from TSCA regulations. Therefore, the portion of xylene used in pesticides does not need to be reported under IUR.

Criterion I: Xylene is listed on the TSCA Inventory and is not a substance excluded from DRAFT: Appendix G Case Studies G 34 reporting.

Criterion II: Company G manufactures 25,000 pounds or more of xylene and does not qualify as a small manufacturer. Company G does not qualify for any additional reporting exemptions.

Criterion III: Company G manufactures 300,000 pounds or more of xylene and does not qualify for any partial exemptions. Therefore, Company G must complete Parts I, II, and III of Form U for xylene.

Key Points:

Pesticides are exempt from regulation under TSCA, therefore the use of xylene for the preparation of a commercial pesticide formulation does not need to be included in Form U.

The 200,000 lbs. of xylene used as a component of solvents sold to consumers should not be reported in Part III because it is less than 5% of the total production volume and less than the 300,000 pounds threshold.

The percent production volumes for use as wood preservatives and paint used by consumers should be reported to the nearest percentage point because it is less than 5% of the production volume and totals 300,000 lbs. or more.

The furniture that contains xylene may be used by children.

Company G based its estimates for Part III on information readily obtainable from its knowledge of how its customers use the xylene. Some information about how its customers processed and used xylene for paint formulations and wood preservatives were left blank because it was not readily obtainable. DRAFT: Appendix G Case Studies G 35 19,000,000 lbs. xylene produced by Company A at 100% concentration INDUSTRIAL PROCESSING AND USE Paint sold for commerical and consumer applications ( Block 3. B. 2)

COMMERCIAL AND CONSUMER END USE 1,000,000 lbs. xylene imported by Company A at 100% concentration Company A manufactures 20,000,000 lbs. of xylene at 100% concentration 16,000,000 lbs. shipped to 15 different forulators for formulation and packaging at 0.5%  95% ( Block 3. A. 2)

4,000,000 lbs. used at 95% concentration as a metal degreaser at 200 hardware manufacturers ( Block 3. A. 3) 4,000,000 lbs. shipped directly to 3 chemical manufactures at 100% concentration for use as a chemical reactant ( Block 3. A. 1)

2,200,000 lbs. reformulated into pesticides at 10% concentration ( Exempt because regulated by FIFRA)

3,200,000 lbs. reformulated into paint at 15% maximum concentration ( Block 3. A. 4) 400,000 lbs. sold as a component in wood preservatives at 20% maximum concentration ( Block 3. A. 5)

Pesticides sold for commerical and consumer applications ( Exempt because regulated by FIFRA) Applied to residential furniture ( Block 3. B. 3)

6,000,000 lbs. used as a component in automotive care products at 35% maximum concentration ( Block 3. B. 1) 200,000 lbs. used as a component of solvents sold to consumers at 95% maximum concentration ( Exempt: Less than 300,000 lbs. and 5% PV) CASE STUDY G  Flow Diagram DRAFT: Appendix G Case Studies G 36 Completing the Form: Part II  Manufacturing Information Block Block Title Report Basis/ Rationale 2. A. 1 Chemical ID Number 1330 20 7 CAS Number 2. A. 2 ID Code C Code for CAS Number 2. A. 3 Chemical Name Xylene, mixed isomer Chemical Abstracts Index/ Preferred name 2. B. 3 Site limited N Xylene is distributed off site for commercial purposes.

2. B. 4 Activity Manufacture and import Xylene is both manufactured and imported.

2. B. 5 Production Volume ( lbs) 17,800,000 Combined manufacture and import volumes, but not including the 2,200,000 lbs used in pesticide formulations.

2. B. 7 Number of Workers W2 At least 10 but fewer than 25. Company G reports 14 workers are exposed during the manufacture of xylene.

2. B. 8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 100%.

2. B. 14 Physical Form Percent of PV a. Liquid; b. 100 100% of the product is manufactured in liquid form. DRAFT: Appendix G Case Studies G 37 Part III  Section I. Industrial Processing and Use Information.

Block Block Title Report Basis/ Rationale 3. A. 1 Type of Process or Use PC Processing as a reactant.

NAICS 32519 Other basic organic chemical manufacturing.

IFC U16 Intermediates.

Percent PV 20 20% PV ( 4,000,000 lbs) is distributed directly to 3 chemical manufacturers. 4,000,000 lbs. / 20,000,000 lbs. total = 20%.

Number of Sites S1 Less than 10 sites.

Number of Workers W2 At least 10 but fewer than 25. Company B estimates 4 exposed workers for each of 3 industrial sites. 4 workers per site x 3 sites = 12 workers.

3. A. 2 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32519 Other basic organic chemical manufacturing.

IFC U27 Solvents ( for cleaning or degreasing).

Percent PV 80 80% PV ( 16,000,000 lbs.) is repackaged.

Number of Sites S2 From 10 to 25. Company G distributes xylene to 15 distributor/ repackaging centers.

Number of Workers W4 At least 50 but fewer than 100. Company F estimates 6 exposed workers per site x 15 sites = 90 workers.

3. A. 3 Type of Process or Use U Industrial grade solvent. Used as a metal degreaser.

NAICS 33251 Hardware manufacturing.

IFC U27 Solvents ( for cleaning or degreasing).

Percent PV 20 20% PV ( 4,000,000 lbs) is distributed from distribution/ repackaging centers to 200 hardware manufacturers for use as a metal degreaser.

Number of Sites S4 From 101 to 250. 200 hardware manufacturers use xylene as a metal degreaser.

Number of Workers W6 At least 500 but fewer than 1000. Company B estimates 3 exposed workers for each of 200 sites. 3 workers per site x 200 sites = 600 workers. DRAFT: Appendix G Case Studies Block Block Title Report Basis/ Rationale G 38 3. A. 4 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32551 Paint and coating manufacturing.

IFC U28 Solvents ( which become part of product formulation or mixture).

Percent PV 20 16% PV of xylene ( 3,200,000 lbs.) is used in paint formulations. Round to 20%.

Number of Sites Company G has determined that this information is not readily obtainable.

Number of Workers Company G has determined that this information is not readily obtainable.

3. A. 5 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32111 Sawmills and wood preservation.

IFC U28 Solvents ( which become part of product formulation or mixture).

Percent PV 2 2% PV ( 400,000 lbs.) of xylene is used as a component in wood preservatives. This percentage is rounded to the nearest percentage point because it is less than 5% and volume is 300,000 lbs. or greater.

Number of Sites Company G has determined that this information is not readily obtainable.

Number of Workers Company G has determined that this information is not readily obtainable. DRAFT: Appendix G Case Studies G 39 Part III  Section II. Commercial and Consumer End Use Exposure Related Data Block Block Title Report Basis/ Rationale 3. B. 1 Commercial and Consumer Product Category C03 Automotive care products.

Use in Children's Product N Not expected to be used by children.

Percent PV 30 30% PV ( 6,000,000 lbs.) is used in the formulation of automotive care products.

Maximum Concentration M3 From 31% to 60% by weight. The maximum concentration used in formulations is 35%.

3. B. 2 Commercial and Consumer Product Category C12 Paints and coatings ( commercial use).

Use in Children's Product N Not expected to be used by children.

Percent PV 20 16% PV ( 3,200,000 lbs.) is used in paints for commercial use. Round up to 20%.

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 15%.

3. B. 3 Commercial and Consumer Product Category C18 Wood and wood furniture.

Use in Children's Product Y Not expected to be used by children.

Percent PV 2 2%

PV ( 400,000 lbs. ) of xylene is used as a component in wood preservatives. Since this percentage is less than 5% and totals 300,000 pounds or greater, round to the nearest percentage point ( 2%).

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 20%. DRAFT: Appendix G Case Studies G 40 Form U  CASE STUDY G Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION A. CHEMICAL IDENTIFICATION CBI*

2. A. 1 Chemical Identifying Number 12225 21 7 2. A. 2 ID Code C 2. A. 3 Chemical Name C. I. Pigment Yellow 100 SECTION B. MANUFACTURING INFORMATION 2. B. 1 Company Information CBI 2. B. 2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2. B. 3 Site Limited ( Y/ N) N CBI 2. B. 9 Dry Powder 2. B. 4 Activity ( Check all that apply)

Manufacture

Import CBI 2. B. 10 Pellets or Large Crystals 2. B. 5 Production Volume ( LB) 17,800,000 CBI 2. B. 11 Water or Solvent Wet Solid 2. B. 6 Production Volume Range LEAVE BLANK CBI 2. B. 12 Other Solid 2. B. 7 Number of Workers ( code) W2 CBI 2. B. 13 Gas or Vapor 2. B. 8 Maximum Concentration ( code) M5 CBI 2. B. 14 Liquid

100 PART III. PROCESSING AND USE INFORMATION Complete Part III, Sections A and B only if the production volume noted in Block 2. B. 5 is greater than or equal to 300,000 lb/ year.

SECTION A. INDUSTRIAL PROCESSING AND USE DATA N/ A a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 3. A. 1 PC 32519 U16 20 S1 W2 3. A. 2 PF 32519 U27 80 S2 W4 3. A. 3 U 33251 U27 20 S4 W6 3. A. 4 PF 32551 U28 20 3. A. 5 PF 32111 U28 2 3. A. 6 3. A. 7 3. A. 8 3. A. 9 3. A. 10 SECTION B. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 3. B. 1 C03 N 30 M3 3. B. 2 C12 N 20 M2 3. B. 3 C18 Y 2 M2 3. B. 4 3. B. 5 3. B. 6 3. B. 7 3. B. 8 3. B. 9 3. B. 10 * Substantiation required for CBI claims on chemical identity and plant site identity. FOR EPA USE ONLY