[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Rules and Regulations]
[Pages 8301-8308]
[FR Doc No: 2014-03077]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0791; FRL-9905-22]

Linuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of linuron
in or on multiple commodities which are identified and discussed later
in this document. This regulation additionally removes a tolerance with
regional registrations in or on parsley leaves, as it will be
superseded by a tolerance without regional registrations. IR-4
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective February 12, 2014. Objections and
requests for hearings must be received on or before April 14, 2014, and
must be filed in accordance with 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-2012-0791, 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 EPA's
tolerance regulations at 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-2012-0791 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
April 14, 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-2012-0791, 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.htm.

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 Tolerance

    In the Federal Register of November 7, 2012 (77 FR 66781) (FRL-
9367-5), 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
2E8083) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.184 be amended by
establishing tolerances for residues of the herbicide linuron, 3-(3,4-
dichlorophenyl)-1-methoxy-1-methylurea), and its metabolites, in or on
cilantro, dried leaves at 27 parts per million (ppm); cilantro, fresh
leaves at 3 ppm; dillweed, dried leaves at 7.1 ppm; dillweed, fresh
leaves at 1.5 ppm; dill oil at 4.8 ppm; dill seed at 0.3 ppm;
horseradish at 0.050 ppm; parsley, dried leaves at 8.3 ppm; parsley
leaves at 3 ppm; and pea, dry, seed at 0.08 ppm. The petition
additionally requested to delete the regional tolerance in 40 CFR
180.184(c) for residues of linuron in or on parsley, leaves at 0.25 ppm
upon approval of the requested tolerances for parsley leaves. That
document referenced a summary of the petition prepared on behalf of IR-
4 by Syngenta Crop Protection, LLC, the registrant, which is available
in the docket, http://www.regulations.gov. Comments were received on
the notice of filing. EPA's response to these comments is discussed in
Unit IV.C.
    Subsequent to the publication of the November 7, 2012 Federal
Register notice, the petitioner submitted a second petition, in which
it requested again the same tolerances noticed in the November 7, 2012
Federal Register document and added a new request for a tolerance for
residues of linuron and its metabolites in or on coriander seed at 0.01
ppm. So, in the Federal Register of July 19, 2013 (78 FR 43115) (FRL-
9392-9), EPA issued another document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 2E8083) by IR-4, seeking tolerances for commodities as
noted in the November 7, 2012 document as well as a tolerance for
coriander seed at 0.01 ppm. That document referenced a summary of the
petition prepared on behalf of IR-4 by Syngenta Crop Protection, LLC,
the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the tolerances for several proposed commodities. The Agency has
also determined that the tolerance expression should be revised for all
commodities. The reasons for these changes are explained in Unit IV.D.

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 linuron including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with linuron 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.
    With repeated dosing in test animals, linuron produces two primary
effects: (1) Changes in the hematopoetic system in rats, mice, and dogs
and; (2) changes in the male reproductive system in developing rats.
Lowest observed adverse effect levels (LOAELs) for hematological
effects produced by linuron were substantially lower than LOAELs for
reproductive effects. Dogs were shown to be most sensitive to the
hematological effects, including hemolytic anemia characterized by
slightly reduced hemoglobin, hematocrit, and erythrocyte counts
accompanied by hemosiderin deposition in liver Kupffer cells. Secondary
erythropogenic activity (erythroid hyperplasia of bone marrow) was also
found. Systemic toxicity observed in mice included increased
methemoglobin formation, vacuolation and hemosiderosis of the spleen,
and decreased erythrocyte counts. In the chronic rat study, microscopic
observations consistent with hemolysis (hemosiderin in Kupffer cells
and increased hemosiderosis in bone marrow, spleen, and/or mesenteric
lymph nodes) were found.
    The rat developmental study showed increased post-implantation
loss, fetal resorptions, decreased litter size, and decreased fetal
body weight. In the rabbit developmental toxicity study, an increased
incidence of fetuses with skeletal skull variations was found. In the
2-generation reproductive toxicity study, rats exposed to linuron
during both development and adulthood had gross lesions of the testes
(including reduction in size); abnormally soft and small epididymides,
deformities of the epididymides, decreased pup survival, decreased
weanling body weights, decreased liver and kidney weights; and
increased incidence of offspring liver atrophy.

    The developmental effects on the reproductive system seen in the
guideline studies are consistent with those reported in the published
literature, though it should be noted that most of the literature
studies employed dose levels of 100 milligrams/kilogram (mg/kg) or
greater. The available data indicate that linuron inhibits
transcriptional activity of dihydrotestosterone (DHT), human androgen
receptor (hAR) in vitro, and steroidogenic enzymes. Additional findings
indicate that linuron exposure decreases anogenital distance; may
increase retention of areole/nipples in male rat offspring following in
utero exposure; increases luteinizing hormone (LH) levels in F0 and F1
male rats; reduces the size of androgen dependent tissues such as
seminal vesicles, epididymis, and ventral prostate; and demonstrates a
weak affinity for androgen receptors, which may decrease fetal
testosterone synthesis (Refs 1, 2, 3, and 4). At this time, linuron has
not been demonstrated to be an estrogen receptor antagonist (Ref 5). It
should be emphasized that the toxicity endpoints based on the
hematological effects for chronic exposures were derived from the
chronic oral toxicity study in dogs. The point of departure (POD) for
hematological effects was approximately 40X lower than the LOAEL that
caused the testicular effects seen in the rat reproduction toxicity
study.
    In rat and mouse carcinogenicity studies, linuron induced
interstitial cell adenomas in the testes of rats and hepatocellular
adenomas in mice. In a special study with aged rats, linuron induced
hyperplasia and adenomas of the testes within 6 to 12 months. However,
EPA has concluded that quantification of cancer risk is not necessary
because both interstitial cell adenomas and hepatocellular adenomas
were benign and show no progression towards malignancy. In addition,
linuron was not mutagenic in bacteria or in cultured mammalian cells.
There was also no indication of a clastogenic effect up to toxic doses
in vivo. Finally, the cRFD is a NOAEL of 0.77 mg/kg/day, which would be
protective of any tumors caused by linuron in the rat and mouse
carcinogenicity study at higher doses.
    At the highest dose tested, the acute neurotoxicity study
demonstrated that linuron produced changes in the parameters of the
field observation battery (FOB). These changes included rats holding
their heads low, crusty deposits on the nose, impaired mobility,
ataxia, low arousal, decreased rearing, no reaction to tail pinch or
startle, decreased righting reflex, reduced or no hindlimb extensor
strength, decreased grip strength in both hindlimbs and forelimbs,
reduced rotarod performance, decreased hindlimb footsplay, and
increased catalepsy. At the lowest-observed-adverse-effect-level
(LOAEL), linuron produced decreases in motor activity and rearing. No
compound-related changes in neurohistopathology were observed at any of
the tested dose levels. In addition, linuron did not show any signs of
immunotoxicity in the submitted immunotoxicity study up to the highest
dose tested.
    Specific information on the studies received and the nature of the
adverse effects caused by linuron as well as the no-observed-adverse-
effect-level (NOAEL) and the LOAEL from the toxicity studies can be
found at http://www.regulations.gov in document: ``Linuron: Section 3
Human Health Risk Assessment for Proposed Use on Coriander, Dill,
Horseradish, Parsley, Celeriac, Rhubarb, and Pea (Dry).'' at pages 33-
38 in docket ID number EPA-HQ-OPP-2012-0791. References for the
published toxicity studies cited in this section may be found Unit VI.

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 linuron used for human risk assessment is shown in Table
1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Linuron for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-49       NOAEL = 12 mg/kg/day  Acute RfD = 0.12 mg/ Rat Developmental Toxicity.
 years of age).                    UFA = 10X...........   kg/day              LOAEL = 50 mg/kg/day based on
                                   UFH = 10X...........  aPAD = 0.12 mg/kg/    increased post-implantation loss
                                   FQPA SF = 1X........   day.                 and fetal/litter resorptions.
Acute dietary (General population  NOAEL = 20 mg/kg/day  Acute RfD = 0.2 mg/  Acute Neurotoxicity Study (Rat).
 including infants and children).  UFA = 10X...........   kg/day.             LOAEL = 100 mg/kg based on
                                   UFH = 10X...........  aPAD = 0.2 mg/kg/     decreases in rearing and in motor
                                   FQPA SF = 1X........   day.                 activity.
Chronic dietary (All populations)  NOAEL= 0.77 mg/kg/    Chronic RfD =        Chronic Oral Dog Study.
                                    day.                  0.0077 mg/kg/day.   LOAEL = 3.5 mg/kg/day based on
                                   UFA = 10X...........  cPAD = 0.0077 mg/kg/  hematological effects (increased
                                   UFH = 10X...........   day.                 met- and sulf-hemoglobin levels).
                                   FQPA SF = 1X........

Cancer (Oral, dermal, inhalation)    Quantification of human cancer risk is not necessary for reasons stated in
                                                                     Unit III.A.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligrams/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to linuron, EPA considered exposure under the petitioned-for
tolerances as well as all existing linuron tolerances in 40 CFR
180.184. EPA assessed dietary exposures from linuron 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. Such effects were identified
for linuron. In estimating acute dietary exposure, EPA used Dietary
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID) Version 3.16, which uses food consumption data
from the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, ``What We Eat in America'' (NHANES/WWEIA)
from 2003 through 2008. As to residue levels in food, EPA utilized
tolerance-level residues, DEEM (Ver. 7.81) default processing factors
as necessary, and 100 percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment. EPA used the food consumption data from the USDA's 2003-
2008 NHANES/WWEIA. As to residue levels in food, EPA used tolerance-
level residues for all commodities, and DEEM default processing
factors. The Agency utilized average PCT estimates, when available, and
100 PCT for all other commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a cancer exposure assessment is not necessary.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of
food treated for assessing chronic dietary risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the average PCT for existing uses for use in
the chronic dietary assessment as follows:
    Asparagus, 25%; carrots, 85%; celery, 25%; corn, 1.0%; cotton,
1.0%; potatoes, 5.0%; sorghum, 1.0%; soybeans, 1.0%; sweet corn, 1.0%;
and wheat, 1.0%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which linuron may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for linuron in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of linuron. 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 Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of linuron for
surface water are estimated to be 89.05 parts per billion (ppb) for
acute exposures and 48.69 ppb for chronic exposures for non-cancer
assessments. The EDWCs of linuron for groundwater are estimated to be
48.8 ppb for acute

and chronic exposures for non-cancer assessments.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 89.05 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 48.8 ppb was used to
assess the contribution to drinking water.
    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). Linuron is not
registered for any specific use patterns that would result in
residential exposure.
    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.'' EPA has not found linuron
to share a common mechanism of toxicity with any other substances, and
linuron does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that linuron 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. The following acceptable
studies are available to assess the prenatal and postnatal sensitivity
to linuron: rat and rabbit developmental toxicity studies, a 2-
generation rat reproductive toxicity study, and a 3-generation rat
reproductive toxicity study. There is no qualitative or quantitative
evidence of increased susceptibility of rabbits in the developmental
study; developmental effects were seen at a dose higher than those
causing maternal toxicity. In the rat developmental study, increases in
post-implantation losses and increases in fetal resorptions/litter were
seen at a dose that caused decreases in maternal body weight and food
consumption. Since increases in resorptions were marginal and there was
no change in the number of live fetuses to corroborate the increases in
post-implantation losses, these effects were not indicative of
qualitative evidence of susceptibility.
    There was no quantitative evidence of susceptibility in either the
2-generation or the 3-generation reproduction studies. In the 2-
generation study, reduced body weight gains of pups were seen at the
same dose that caused decreases in parental body weights. In the 3-
generation study, offspring effects including deceased pup survival and
pup body weight were seen a dose (44 mg/kg/day) higher than the dose
that caused decreases in body weight gain in the parental animals (9
mg/kg/day). However, when reproductive effects were examined,
testicular atrophy was seen at the same dose (45 mg/kg/day) in both
studies. In both studies, while the F0 males were not affected,
testicular lesions and reduced fertility were seen in the F1 males.
This effect in the F1 males is an indication of qualitative evidence of
susceptibility.
    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 linuron is complete.
    ii. In an acute neurotoxicity study, FOB findings of impaired
mobility, alterations in gait, lack of coordination, lowered body
temperature, no reaction to stimuli, low arousal, and decreases in
motor activity were seen at the time of peak effect (7 hours post
dosing) on study day 0. These observations were mostly seen in the 500
mg/kg group and no pathological changes were found in nervous system
tissues. A clear NOAEL (20 mg/kg/day) was established, and this NOAEL
was approximately 2-26X greater than most PODs selected for risk
assessment. The nervous system was not a target organ for linuron. The
requirement of a subchronic neurotoxicity study was waived by the
Agency because the target systems for linuron toxicity are the
hematopoietic and endocrine systems and not the nervous system as shown
by all available/required toxicity studies. There is no need for a
developmental neurotoxicity study because linuron affects testes and
hematological parameters but did not produce an increased
susceptibility in young rats. Therefore, the concern for neurotoxicity
is low, and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that linuron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies. While increased qualitative susceptibility was
identified from the reproductive findings in the 2-generation and 3-
generation rat toxicity studies, clear NOAELs were established for the
effects on the reproductive system. Furthermore, the point of departure
(POD) selected for assessment of chronic effects, is approximately 40X
lower than the LOAEL that caused the testicular effects seen in the rat
reproduction toxicity study; therefore, EPA considers the PODs for risk
assessment to be protective of the effects seen on the male
reproductive system and an additional safety factor to account for this
qualitative susceptibility is not necessary.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on tolerance-level residues, 100 PCT for the acute assessment and
average PCT for available commodities in the chronic dietary
assessment. EPA made conservative (protective) assumptions in the
ground-water and surface water modeling used to assess exposure to
linuron in drinking water. These assessments will not underestimate the
exposure and risks posed by linuron.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to linuron will occupy 10% of the aPAD for all infants less than 1 year
old, the most highly exposed U.S. population subgroup; and 5.7% of the
aPAD for females 13-49 years old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
linuron from food and water will utilize 60% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for linuron.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, linuron is
not registered for any use patterns that would result in short- or
intermediate-term residential exposure. Short- and intermediate-term
risk is assessed based on short- and intermediate-term residential
exposure plus chronic dietary exposure. Because there are no short- or
intermediate-term residential exposures and chronic dietary exposure
has already been assessed under the appropriately protective cPAD
(which is at least as protective as the POD used to assess short- or
intermediate-term risks), no further assessments of short- or
intermediate-term risk are necessary, and EPA relies on the chronic
dietary risk assessment for evaluating the short- and intermediate-term
risks for linuron.
    4. Aggregate cancer risk for U.S. population. Based on the
discussion of carcinogenicity for linuron in Unit III.A., EPA has
concluded that the cPAD is protective of possible cancer effects. Given
the results of the chronic risk assessment, EPA has concluded that
linuron does not 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 linuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, Method ABC-68406-M, is available
to enforce the tolerance expression. This method involves reflux of
crop samples in strong base to hydrolyze residues of linuron and its
metabolites to 3,4-DCA, which is analyzed using gas chromatography/mass
spectrometry (GC/MS).
    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 linuron.

C. Response to Comments

    EPA received one comment to the notice of filing from November 7,
2012 which opposed the use of linuron on any food. The commenter
expressed a general opposition to the use of ``toxic chemicals'' on
food and further noted that ``red blood cells are harmed in animals
from this toxic chemical.'' The Agency understands the commenter's
concerns and recognizes that some individuals believe that certain
pesticide chemicals should not be permitted in our food. However, the
existing legal framework provided by section 408 of the FFDCA states
that tolerances may be set when the pesticide meets the safety standard
imposed by that statute. The Agency is required by Section 408 of the
FFDCA to estimate the risk of the potential exposure to these residues.
EPA has concluded, based on data submitted in support of the petition
and other reliable data, that there is a reasonable certainty that no
harm will result from aggregate human exposure to linuron residues from
these uses. The points of departure selected for risk assessment are
protective of any effects on the hematopoietic system, including red
blood cells. Additionally, testing requirements for pesticide
tolerances have been specified by rulemaking after allowing for notice
and comment by the public and peer review by appropriate scientific
bodies. See 40 CFR part 158 for further information.

D. Revisions to Petitioned-for Tolerances

    Based on the data supporting the petition, EPA has revised the
proposed tolerances for several commodities, as follows: Cilantro,
dried leaves from 27 ppm to 10 ppm; dillweed, dried leaves from 7.1 ppm
to 5.0 ppm; dill, seed from 0.3 ppm to 0.5 ppm; dill, oil from 4.8 ppm
to 2.0 ppm; parsley, leaves from 3.0 ppm to 4.0 ppm; parsley, dried
leaves from 8.3 ppm to 9.0 ppm; and pea, dry, seed from 0.08 ppm to
0.09 ppm. The Agency revised the cilantro, fresh leaves; dillweed,
fresh leaves, and pea, dry seed tolerance levels based on analysis of
the residue field trial data using the Organization for Economic
Cooperation and Development (OECD) tolerance calculation procedures.
Due to a limited number of field trials, EPA used the formula of 5X the
mean in order to establish tolerance levels for coriander, seed; dill,
seed; and parsley, leaves. Finally, for the dried herbs (cilantro,
dillweed, and parsley) and dill oil, the formula of the highest average
field trial (HAFT), multiplied by the concentration factor was used to
calculate the recommended tolerance levels for these commodities. These
concentration factors were derived from dividing the average dried or
oil commodity residue by the average fresh commodity residue. Based on
this calculation method, all four tolerance levels were decreased.
    Finally, the Agency has revised the tolerance expression to clarify
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of linuron not specifically mentioned; and
(2) that compliance with the specified tolerance levels is to be
determined by measuring only residues of linuron convertible to 3,4-
dichloroaniline.

 V. Conclusion

    Therefore, tolerances are established for residues of linuron, 3-
(3,4-dichlorophenyl)-1-methoxy-1-methylurea), and its metabolites, in
or on cilantro, fresh leaves at 3.0 ppm; cilantro, dried leaves at 10
ppm; coriander, seed at 0.01 ppm; dillweed, fresh leaves at 1.5 ppm;
dillweed, dried

leaves at 5.0 ppm; dill, seed at 0.5 ppm; dill, oil at 2.0 ppm;
horseradish at 0.05 ppm; parsley, leaves at 4.0 ppm; parsley, dried
leaves at 9.0 ppm; and pea, dry, seed at 0.09 ppm. The regulation
additionally removes the tolerance in or on parsley, leaves at 0.25 ppm
from 40 CFR 180.184(c).

VI. References

    The following literature was referenced in the preamble of this
document.

1. Gray, L; Wolf, C; Lambright, C; Mann, P; Price, M; Cooper, R;
Ostby, J. 1999. Administration of potentially antiandrogenic
pesticides (procymidone, linuron, iprodione, chlozolinate, p,p'-DDE,
and ketoconazole) and toxic substances (dibutyl- and diethylhexyl
phthalate, PCB 169, and ethane dimethane sulphonate) during sexual
differentiation produces diverse profiles of reproductive
malformations in the male rat. Toxicol Ind Health, 15 (1-2):94-118.
2. Hotchkiss, A; Parks-Saldutti, L; Ostby, J; Lambright, C; Furr, J;
Vandenbergh, J; & Gray, L. 2004. A mixture of the ``antiandrogens''
linuron and butyl benzyl phthalate alters sexual differentiation of
the male rats in a cumulative fashion. Biol.of Reprod 71:1852-1861.
3. Lambright, C; Ostby, J; Bobseine, K; Wilson, V; Hotchkiss, A;
Mann, PC; Gray, L. 2000. Cellular and molecular mechanisms of action
of linuron: an antiandrogenic herbicide that produces reproductive
malformations in male rats. Toxicol Sci. 56(2):389-99.
4. McIntyre, B; Barlow, N; Wallace, D; Maness, S; Gaido, K; Foster,
P. 2000. Effects of in utero exposure to linuron on androgen-
dependent reproductive development in the male Crl:CD(SD)BR rat.
Toxicol Appl Pharmacol. 167(2):87-9.
5. Vinggaard, A., Breinholt, V., and Larsen, J. 1999. Screening of
selected pesticides for oestrogen receptor activation in vitro. Food
Addit Contam. 16(12):533-542.

VII. 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 tolerances 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).

VIII. 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: January 24, 2014.
Daniel J. Rosenblatt,
Acting 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.  180.184:
0
a. Revise the introductory text in paragraph (a).
0
b. Add ``Cilantro, dried leaves'', Cilantro, fresh leaves'',
``Coriander, seed'', ``Dill, oil'', ``Dill, seed'', ``Dillweed, dried
leaves'', Dillweed, fresh leaves'', Horseradish'', ``Parsley, dried
leaves'', ``Parsley, leaves'', and ``Pea, dry, seed'' to the table in
paragraph (a).
0
c. Revise the introductory text in paragraph (b).
0
d. Revise the introductory text in paragraph (c).
0
e. Remove ``Parsley, leaves'' from the table in paragraph (c).
    The amendments read as follows:

Sec.  180.184  Linuron; tolerance for residues.

    (a) General. Tolerances are established for residues of the
herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea),
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only those linuron residues
convertible to 3,4-dichloroaniline, calculated as the stoichiometric
equivalent of linuron, in or on the commodity:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Cilantro, dried leaves..................................           10
Cilantro, fresh leaves..................................            3.0
Coriander, seed.........................................            0.01

                                * * * * *
Dill, oil...............................................            2.0
Dill, seed..............................................            0.5
Dillweed, dried leaves..................................            5.0
Dillweed, fresh leaves..................................            1.5

                                * * * * *
Horseradish.............................................            0.05

                                * * * * *
Parsley, dried leaves...................................            9.0
Parsley, leaves.........................................            4.0

                                * * * * *
Pea, dry, seed..........................................            0.09

                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide linuron [3-(3,4-
dichlorophenyl)-1-methoxy-1-methylurea], including its metabolites and
degradates, in or on the commodities in the table below, resulting from
use of the pesticide pursuant to FIFRA section 18 emergency exemptions.
Compliance with the tolerance levels specified below is to be
determined by measuring only those linuron residues convertible to 3.4-
dichloroaniline, calculated as the stoichiometric equivalent of
linuron, in or on the commodity. The tolerance expires and is revoked
on the date specified in the table.
* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in Sec.  180.1(l), are established
for residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-
methoxy-1-methylurea), including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only those
linuron residues convertible to 3,4-dichloroaniline, calculated as the
stoichiometric equivalent of linuron, in or on the commodity.
* * * * *
[FR Doc. 2014-03077 Filed 2-11-14; 8:45 am]
BILLING CODE 6560-50-P


SUPPORTING STATEMENT

	ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Iron and Steel Foundry Area Sources (40 CFR Part 63, Subpart
ZZZZZ) (Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Iron and Steel Foundry Area Sources (40 CFR Part 63, Subpart
ZZZZZ) (Renewal), EPA ICR Number 2267.03, OMB Control Number 2060-0605

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP)
for Iron and Steel Foundry Area Sources (40 CFR Part 63, Subpart ZZZZZ)
with the final rule published on January 2, 2008 (73 FR 225).  Potential
respondents are owners or operators of any existing or new iron or steel
foundry that is an area source of hazardous air pollutants (HAP)
emissions.  Research and development facilities are not covered by the
rule.  Foundries covered by the rule would not be required to obtain a
Title V operating permit.

There are different requirements for foundries based on size.  Small
iron and steel foundries are required to comply with pollution
prevention management practices for scrap materials, the removal of
mercury switches, and binder formulations.  Large iron and steel
foundries are required to comply with the same pollution prevention
management practices as small foundries in addition to emissions
limitations for melting furnaces and foundry operations.  Existing
foundries with an annual metal melt production greater than 20,000 tons
and new foundries with an annual metal melt capacity greater than 10,000
tons are classified as large foundries.  Existing foundries with an
annual metal melt production of 20,000 tons or less and new foundries
with an annual metal melt capacity of 10,000 tons or less are
classified.

For metallic scrap, the pollution prevention management practices
require foundries to purchase (or otherwise obtain) the motor vehicle
scrap only from scrap providers participating in an EPA-approved program
for the removal of mercury switches or to comply with alternative
provisions.  The requirements for binder formulations require foundries
to use on one type of production line chemical formulations that do not
contain methanol as a specific ingredient of the catalyst formulation.
The management practices also include a pollution prevention initiative
to encourage foundries to investigate and switch to non-HAP binders and
coating materials by requiring records of the annual quantity and
composition of each HAP-containing chemical binder or coating material
used to make molds and cores.  The NESHAP allows foundries 2 years after
promulgation to comply with the management practices for mercury, 1 year
to comply with the opacity limit for melt shops, and 6 months for other
requirements.

Small foundries would submit two types of one-time notifications
required by the NESHAP general provisions and keep records of specific
information to demonstrate compliance with the rule requirements.  The
final rule also requires small foundries to calculate for each calendar
month their 12-month rolling average production rate to ensure that the
facility continues to meet the size criteria that defines a small iron
and steel foundry.  Records of the monthly production rate and monthly
rolling average calculations are required.  A small foundry must report
any deviation from these requirements within 30 days.

	Large area source foundries are required to comply with the pollution
prevention management practices in addition to emissions standards for
metal melting furnaces and foundry operations.  The owner or operator
may elect to comply with emissions limits for particulate matter (PM) or
total metal HAP.  The final rule contains provisions for demonstrating
compliance with the limits using emissions averaging.  The owner or
operator of an existing affected source is required to conduct initial
and periodic visual inspections of PM control devices (baghouses, wet
scrubbers, electrostatic precipitators).  Foundries using a baghouse to
comply with the PM emission limit may choose to install and operate a
bag leak detection system instead of conducting the initial and periodic
inspections.  Bag leak detection systems are required at new foundries.
New source foundries must use a  continuous parameter monitoring system
(CPMS) to measure and record pressure drop and scrubber water flow rate
for a wet scrubber and/or a CPMS to measure and record the hourly
average voltage and secondary current (or total power input) to an
electrostatic precipitator.  Monthly inspections of capture systems are
also be required.  An operation and maintenance plan for control devices
also is required.  Foundries also must conduct an opacity test at least
every 6 months to demonstrate compliance with an opacity limit for
fugitive emissions from buildings or structures housing foundry
operations.  Alternatively, foundries may conduct semiannual visible
emissions observations by Method 22.  The Method 22 test is considered
successful if no visible emissions are observed for 90 percent of a
1-hour test.  A Method 9 opacity test is required if the Method 22 test
is not successful.

Large foundries will demonstrate initial compliance with emissions
limits through performance tests.  The owner or operator of an existing
area source may certify initial compliance based on the results of a
previous performance test that meets the rule requirements.  Subsequent
performance tests for furnaces are to be performed every 5 years.
Provisions also are included for demonstrating compliance through
emissions averaging.  A facility that uses emissions averaging must
conduct monthly compliance determinations by calculating the weighted
average emissions for furnaces in the emissions averaging group.
Consistent with the NESHAP General Provisions, large foundries are
required to submit one-time notifications; comply with requirements for
startup, shutdown, and malfunction (SSM) plans and reports;  submit
semiannual excess emissions and monitoring system performance reports;
and maintain records of specific information to ensure that the rule
requirements are being achieved and maintained.

Any owner or operator subject to the provisions of this part will
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance reports,
and records.  All reports are sent to the delegated state or local
authority.  In the event that there is no such delegated authority, the
reports are sent directly to the United States Environmental Protection
Agency (EPA) regional office.

Approximately 427 respondents are currently subject to the regulation,
and it is estimated that no additional respondents per year will become
subject to the regulation in the next three years.  Therefore, the
average number of total respondents per year is 142.33.

In the United States, there are approximately 427 iron and steel
foundries that are owned and operated by the iron and steel foundry
industry.  None of these 427 facilities are owned by state, local,
tribal, or the Federal government.  They are owned and operated by
privately owned for-profit businesses.  You can find the burden to the
“Affected Public” listed below in Table 1: Annual Respondent Burden
and Cost - NESHAP for Iron and Steel Foundry (40 CFR Part 63, Subpart
ZZZZZ).  The Federal government burden does not include work performed
by Federal employees.  The burden refers only to work performed by
contractors, which could be found listed below in Table 2: Average
Annual EPA Burden - NESHAP for Iron and Steel Foundry (40 CFR Part 63,
Subpart ZZZZZ).

The Office of Management and Budget (OMB) approved the currently active
Information Collection Request (ICR) without any “Terms of Clearance
(TOC).”

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended,
to establish standards of performance for each category or subcategory
of major sources and area sources of hazardous air pollutants (HAP).
These standards are applicable to new or existing sources of HAP and
shall require the maximum degree of emission reduction.  In addition,
section 114(a) states that the Administrator may require any owner or
operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3); and (G) provide such other information as the
Administrator may reasonably require.

In the Administrator's judgment, HAP emissions from cellulose products
manufacturing cause or contribute to air pollution that may reasonably
be anticipated to endanger public health or welfare.  Therefore, the
NESHAP for this source category was promulgated at 40 CFR part 63,
subpart ZZZZZ.

2(b)  Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard ensure
compliance with the applicable regulations which where promulgated in
accordance with the Clean Air Act.  The collected information is also
used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected
facility’s initial capability to comply with the emission standard.
Continuous emission monitors are used to ensure compliance with the
standard at all times.  During the performance tests, a record of the
operating parameters under which compliance was achieved may be recorded
and used to determine compliance in place of a continuous emission
monitor.

The notifications required in the standard are used to inform the Agency
or delegated authority when a source becomes subject to the requirements
of the regulations.  The reviewing authority may then inspect the source
to ensure that the pollution control devices are properly installed and
operated, that leaks are being detected and repaired, and that the
standards are being met.  The performance test may also be observed.

The information generated by the monitoring, recordkeeping, and
reporting requirements described in this ICR is used by the Agency to
ensure that facilities affected by the NESHAP continue to operate the
control equipment in compliance with the regulation.

3.  Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
63, subpart ZZZZZ.

3(a)  Nonduplication

If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state or local agency.  If
a state or local agency has adopted their own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

3(b)  Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register (76 FR 26900) on May 9, 2011.  No
comments were received on the burden published in the Federal Register.

3(c)  Consultations

The Agency’s industry experts have been consulted, and the Agency’s
internal data sources and projections of industry growth over the next
three years have been considered.  The primary source of information as
reported by industry, in compliance with the recordkeeping and reporting
provisions in the standard, is the Online Tracking Information System
(OTIS) which is operated and maintained by the EPA Office of Compliance.
 OTIS is the EPA database for the collection, maintenance, and retrieval
of all compliance data.  The growth rate for the industry is based on
our consultations with the Agency’s internal industry experts.

Industry trade associations and other interested parties were provided
an opportunity to comment on the burden associated with the standard as
it was being developed.

After a thorough review of comments, it is our policy to respond to
those received since the last ICR renewal, as well as to those submitted
in response to the First Federal Register Notice.

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards.
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and that emission limitations are met.  If the information
required by these standards was collected less frequently, the proper
operation and maintenance of control equipment and the possibility of
detecting violations would be less likely.

3(e)  General Guidelines

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require the respondents to maintain all records,
including reports and notification for at least five years.  This is
consistent with the General Provisions as applied to the standards.  EPA
believes that the five-year records retention requirement is consistent
with the Part 70 permit program and the five-year statute of limitations
on which the permit program is based.  The retention of records for five
years allows EPA to establish the compliance history of a source, any
pattern of non-compliance and to determine the appropriate level of
enforcement action.  EPA has found that the most flagrant violators have
violations extending beyond the five years.  In addition, EPA would be
prevented from pursuing the violators due to the destruction or
nonexistence of essential records.

3(f)  Confidentiality

Any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in title 40, chapter 1, part 2, subpart B -
Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902,
September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR
42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are iron
foundries and steel foundries.  The North American Industry
Classification System (NAICS) codes for the respondents affected by the
standards are 331511, 331512, and 331513.

4(b)  Information Requested

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

(i)  Data Items

In this ICR, all the data recorded or reported is required by National
Emission Standards for Hazardous Air Pollutants for Iron and Steel
Foundry Area Sources (40 CFR Part 63, Subpart ZZZZZ).

Source Data and Information Requirements, summarize the data items,
including recordkeeping and reporting requirements are found in
Attachment 1.

Electronic Reporting

Some of the respondents are using monitoring equipment that
automatically records parameter data.  Although personnel at the
affected facility must evaluate the data, internal automation has
significantly reduced the burden associated with monitoring and
recordkeeping at a plant site.

Regulatory agencies, in cooperation with the respondents, continue to
create reporting systems to transmit data electronically.  However,
electronic reporting systems are still not widely used.  At this time,
it is estimated that approximately zero percent of the respondents use
electronic reporting.

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate CEMS for opacity, or for
pressure drop and liquid supply pressure for control device.

Perform initial performance test, and repeat performance tests if
necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable
instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

	Currently, sources are using monitoring equipment that provides
parameter data in an automated way, e.g., continuous parameter
monitoring system.  Although personnel at the source still need to
evaluate the data, this type of monitoring equipment has significantly
reduced the burden associated with monitoring and recordkeeping.

5.  The Information Collected: Agency Activities, Collection
Methodology, and Information Management

5(a)  Agency Activities

EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information.

Agency Activities

Observe initial performance tests and repeat performance tests if
necessary.

Review notifications and reports, including performance test reports,
and excess emissions reports required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Online Tracking Information
System (OTIS).

5(b)  Collection Methodology and Management

Following notification of startup, the reviewing authority might inspect
the source to determine whether the pollution control devices are
properly installed and operational.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard, and note the operating conditions under which
compliance was achieved.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.

Information contained in the reports is entered into OTIS which is
operated and maintained by the EPA Office of Compliance.  OTIS is the
EPA database for the collection, maintenance, and retrieval of
compliance data for approximately 125,000 industrial and
government-owned facilities.  EPA uses OTIS for tracking air pollution
compliance and enforcement by local and state regulatory agencies, EPA
regional offices, and EPA headquarters.  EPA delegated Authorities can
edit, store, retrieve, and analyze the data.

The records required by this regulation must be retained by the owner or
operator for five years.

5(c)  Small Entity Flexibility

	A small entity for this industry is defined by the Small Business
Administration as a firm having no more than 500 employees.  A total of
319 of the 427 iron and steel foundries are small entities.
Approximately 45 percent (37 of 83) of the large iron and steel
foundries (annual metal melt production greater than 20,000 tons) are
owned by small entities while 85 percent (292 of 344) of the small iron
and steel iron and steel foundries are owned by small entities.  The
final  rule includes a specific compliance option for small foundries
that provides a maximum degree of operational flexibility, and the ICR
requirements are the minimum necessary to demonstrate compliance.  Since
proposal, we have further reduced the impacts on small entities by
increasing the threshold definition for a small foundry from an annual
melt production of 10,000 tons to 20,000 tons.  Our analyses show that
the final NESHAP will not result in a significant economic impact on a
substantial number of small entities.  No small entities are expected to
incur an economic impact that is greater than 3 percent of its revenue.
The number of foundries that may incur an economic impact greater than 1
percent of their revenues ranges from an average of 9 to a maximum (at
the 98th percentile) of 13.

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown in Table 2A and 2B: Annual Respondent Burden and
Cost, NESHAP for Iron and Steel Foundry Area Sources (40 CFR Part 63,
Subpart ZZZZZ) (Renewal).

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Wherever appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB Control Number.

6(a)  Estimating Respondent Burden

The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated to be 6,024
(Total Labor Hours from Table 2A, and 2B).  These hours are based on
Agency studies and background documents from the development of the
regulation, Agency knowledge and experience with the NESHAP program, the
previously approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

This ICR uses the following labor rates:

Managerial	$97.99 ($46.66 + 110%)

Technical	$72.09 ($34.33 + 110%)

Clerical	$33.16 ($15.79 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, May 2006, "Table 2. Civilian Workers, by Occupational
and Industry group."  The rates are from column 1, "Total Compensation."
 The rates have been increased by 110 percent to account for the benefit
packages available to those employed by private industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

As shown in Table 2B, the estimate of capital costs for large foundries
is $59,620 with no O&M costs.  This cost does not include the cost of
any monitoring equipment because the final rule requires visual
inspections instead of automated monitoring equipment at existing
affected sources. This cost does include the cost of a file cabinet for
data storage.

	 	(iii)  Capital/Startup vs. Operating and Maintenance (O&M) Costs

The estimate of capital/startup costs versus O&M costs is shown in Table
2B.  No O&M costs would occur over the 3-year period of this ICR.

		(iv)  Annualizing Capital Costs

Table 2B shows an estimate of the annualized cost of capital to be
$8,490 per year.

6(c)  Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of
the reported information.  The EPA compliance and enforcement program
includes activities such as: the examination of records maintained by
the respondents; periodic inspection of sources of emissions, and the
publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is
estimated to be $32,917.

This cost is based on the average hourly labor rate as follows:

		Managerial	$58.18 (GS-13, Step 5, $36.36 + 60%)

		Technical	$47.97 (GS-12, Step 1, $26.98 + 60%)

		Clerical	$22.66 (GS-6, Step 3, $14.60 + 60%)

These rates are from the Office of Personnel Management (OPM) “2007
General Schedule” which excludes locality rates of pay.  The rates
have been increased by 60 percent to account for the benefit packages
available to government employees.  Details upon which this estimate is
based appear in Table 2: Average Annual EPA Burden, NESHAP for Iron and
Steel Foundry Area Sources (40 CFR Part 63, Subpart ZZZZZ) (Renewal).

6(d)  Estimating the Respondent Universe and Total Burden and Costs

There are 427 existing iron and steel foundries.  No new sources are
expected during the next 3 years.  Consequently, the average annual
number of respondents during the 3 year period of this ICR is 142.33.  A
total of 344 of the 427 facilities are foundries with a metal melting
rate of 20,000 tpy or less and 83 have metal melting rates greater than
20,000 tpy.  Consequently, the average annual number of small foundries
during the 3-year period of this ICR is 114.67 and the average annual
number of large foundries is 27.67.

The only components of the total annual responses for small foundries
attributable to this ICR are two one-time initial notifications for each
facility.  Large foundries are required to submit two one-time initial
notifications; prepare an operation and maintenance plan and a startup,
shutdown, and malfunction plan, and submit semiannual compliance
reports.  The number of total annual responses for Subpart ZZZZZ is
estimated as:  (114.67 annual average respondents × 1 notification) +
(114.67 annual average respondents × 1 notification) + (27.67 annual
average respondents x 1 deviations report) + (27.67 annual average
respondents × 2 written plans) + (27.67 annual average respondents x 2
semiannual reports).   Therefore, the number of total annual responses
for Subpart ZZZZZ is 367.7.

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the
respondents and the Agency are shown in Tables 2A, 2B, and 3,
respectively, and summarized below.

(i)  Respondent Tally

The bottom line respondent burden hours and costs, presented in Table 2
are calculated by adding person-hours per year down each column for
technical, managerial, and clerical staff, and by adding down the cost
column.

The average annual burden for the monitoring, recordkeeping, and
reporting requirements in Subpart ZZZZZ for small foundries is 3,555
person hours with an annual average cost of $248,288 with no capital and
O&M costs.  The average annual burden for the monitoring, recordkeeping,
and reporting requirements in Subpart ZZZZZ for large foundries is 2,469
person hours with an annual average cost of $172,430; the annualized
capital cost is $8,490 with no operation and maintenance costs.  The
average annual burden for the monitoring, recordkeeping, and reporting
requirements in Subpart ZZZZZ for all iron and steel foundry area
sources is 6,024 person hours with an annual average cost of $420,718
with annualized capital costs of $8,490 and no O&M costs.

(ii)  The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 712 labor hours at a cost of $32,917.  See Table 3.
Annual Agency Burden and Cost: NESHAP for Iron and Steel Foundry Area
Sources (40 CFR Part 63, Subpart ZZZZZ) (Renewal).

6(f)  Reasons for Change in Burden

There is no change in the labor hours or cost to the respondents in this
ICR compared to the previous ICR.  This is due to two considerations: 1)
the regulations have not changed over the past three years and are not
anticipated to change over the next three years; and 2) the growth rate
according to the industry sources is very low, negative or non-existent,
so there is no significant change in the overall burden.  There are no
new facilities expected to be constructed over the next three years of
this ICR.  Therefore, the labor hours and cost figures in the previous
ICR reflect the current burden on the respondents and are reiterated in
this ICR.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 16 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid OMB
Control Number.  The OMB Control Numbers for the EPA regulations are
listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2011-0229.  An electronic version of the public docket is
available at   HYPERLINK "http://www.regulations.gov/"
http://www.regulations.gov/  which may be used to obtain a copy of the
draft collection of information, submit or view public comments, access
the index listing of the content of the docket, and to access those
documents in the public docket that are available electronically.  When
in the system, select “search” than key in the docket ID number
identified in this document.  The documents are also available for
public viewing at the Enforcement and Compliance Docket and Information
Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Avenue, N.W., Washington, D.C.  The EPA Docket Center
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 Reading
Room is<PHONE_NUMBER>, and the telephone number for the Enforcement and
Compliance Docket and Information Center Docket is<PHONE_NUMBER>.
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, N.W.,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ-OECA-2011-0229 and OMB Control Number
2060-0605 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in
collecting this information.

ATTACHMENT 1.  INFORMATION REQUIREMENTS

 Requirement for new and existing sources 	Citation for small
foundries	Citation for large foundries	Citation for NESHAP general
provisions

Initial and periodic inspections for baghouses, wet scrubber, and
electrostatic precipitator at existing source;  	NA	§63.10897(a)	NA

CPMS for wet scrubber at new source	NA	§63.10897(b)	NA

CPMS for electrostatic precipitator at new source	NA	§63.10897(c)	NA

BLDS or inspections for baghouse at existing source; BLDS for baghouse
at new source.	NA	§63.10897(d)	NA

Monthly capture system inspections	NA	§63.10897(e)	NA

Semiannual opacity tests	NA	§63.10898(i)	NA

CMS performance evaluation	NA	NA

	Metal melting furnaces and fugitive emissions 	NA	§63.10898	40 CFR
63.7

CMS performance evaluation	NA	NA	40 CFR 63.8(e)(3)

Notification of applicability	§63.10890(b)	§63.10900(a), Table 3	40
CFR 63.9(b)(2)

Notification of construction/ reconstruction 1	§63.10890(f)
§63.10900(a), Table 3	40 CFR 63.9(b)(5)

Notification of special compliance requirements  1	§63.10890(f)
§63.10900(a), Table 3	40 CFR 63.9(d)

Notification of performance test	NA	§63.10900(a), Table 3	40 CFR
63.9(c)

Notification of opacity/VE observations	NA	§63.10900(a), Table 3	40 CFR
63.9(f)

Additional CMS notifications	NA	NA	40 CFR 63.9(g)

Notification of compliance status	§63.10890(c)	§63.10900(a), Table 3
40 CFR 63.9(h)(1)

Notification of changes in information  1	§63.10890(f)	§63.10900(a),
Table 3	40 CFR 63.9(j)

Scrap management material specifications 	§63.10885(b),(c)

NA

Operation and maintenance plan	NA	§63.10896(a)	NA

Startup, shutdown, and malfunction plan	NA	§63.10900(a), Table 3	40 CFR
63.6(e)(3)

Performance test plan	NA	§63.10900(a), Table 3	40 CFR 63.7(c)(2)

CMS quality control plan	NA	§63.10900(a), Table 3	40 CFR 63.8(d)

CMS performance evaluation test plan	NA	NA	40 CFR 63.8(e)(3)

Information to support notifications	§63.10890(e)(1)	§63.10900(a),
Table 3	40 CFR 63.10(b)(2)

Material specifications	§63.10890(e)(2)	§63.10899(b)(1)	NA

Mercury	§63.10890(e)(3)-(4)	§63.10899(b)(2)-(3)	NA

Nonmethanol binder chemical formulations	§63.10890(e)(5)
§63.10899(b)(4)	NA

Annual quantity and composition of each HAP-containing chemical binder
or coating material 	§63.10890(e)(6)	§63.10899(b)(5)	NA

Metal melt production	§63.10890(e)(7)	§63.10899(b)(6)

	Operation and maintenance plan	NA	§63.10899(b)(7)	NA

If applicable, emissions averaging plan	NA	§63.10899(b)(8)	NA

Bag leak detection system (new sources)	NA	§63.10899(b)(9)	NA

Capture system inspections	NA	§63.10899(b)(10)	NA

CPMS specifications	NA	§63.10899(b)(11)	NA

Corrective action	NA	§63.10899(b)(12)	NA

PM control device log of inspections/maintenance	NA	§63.10899(b)(13)	NA

Semiannual excess emissions/deviation reports	§63.10890(f)
§63.10899(c), Table 3	40 CFR 63.10(e)(3)

Initial performance test report	NA	§63.10900(a), Table 3	40 CFR
63.7(e)(1)

CMS performance evaluation report	NA	NA	40 CFR 63.8(e)(5)

SSM reports	NA	§63.10900(a), Table 3	40 CFR 63.6(e)(3)

1 Requirement is not expected to occur during the 3-year term of this
ICR

Table 2A:  Annual Respondent Burden and Cost for Small Foundries –
NESHAP for Iron and Steel Foundry Area Sources (40 CFR Part 63, Subpart
ZZZZZ) (Renewal)

Burden item	(A)

Person-hours per occurrence	(B)

No. of occurrences per respondent	(C)

 Person-hours per respondent (C=A*B)	(D) Respondents per yeara	(E)

Technical person-hours per year (E=C*D)	(F)

Management person-hours per year

 (E*0.05)	(G)

Clerical person-hours per year (E*0.1)	(H)

Costb, $

1.  Applications	N/A

2.  Surveys and Studies	N/A

3.  Acquisition, Installation, and Utilization of Technology and Systems
N/A

4.  Reporting Requirements

A.  Read instructions	4	1	4	114.67	458.68	22.934	45.868	 $36,836

B.  Required activities

     Scrap specifications	4	1	4	114.67	458.68	22.934	45.868	 $36,836

Monthly rolling average calculation	0.25	12	3	114.67	344.01	17.2005
34.401	 $27,627

     No methanol binder formulation c 	0	0	0	0	0	0	0	 $-

C.  Create information	See 4B

D.  Gather existing information	See 4B

E.  Write report	See 4B

     Initial notification of applicability	2	1	2	101	202	10.1	20.2
$16,222

     Notification of compliance status	4	1	4	114.67	458.68	22.934	45.868
 $36,836

Deviations report	1	1	1	57.34	57.34	2.867	5.734	 $4,605

     Notification of construction/reconstruction	N/A

     Notification of anticipated startup	N/A

     Notification of actual startup	N/A

     Notification of special compliance requirements	N/A

     Request for compliance extension	N/A

     Notification of performance test	N/A

     Site specific test plan	N/A

     Notification of performance evaluation	N/A

     Quality assurance plan for CEMS/COMS	N/A

     NESHAP waiver request	N/A

     Startup, shutdown, and malfunction plan/reports	N/A

     Semiannual excess emissions reports	N/A

Subtotal for Reporting Requirements

2,276.4185

5.  Recordkeeping Requirements

A.  Read instructions	See 4A

B.  Plan activities	See 4A

C.  Implement activities	See 4A

D   Develop record system 	2	1	2	114.67	229.34	11.467	22.934	 $18,418

E.  Time to enter information d	0.1	52	5.2	114.67	596.284	29.8142
59.6284	 $47,886

F.  Time to transmit or disclose information	0.25	2	0.5	114.67	57.335
2.86675	5.7335	 $4,604

G.  Time to adjust existing ways	2	1	2	114.67	229.34	11.467	22.934
$18,418

F.  Time to train personnel e	N/A

G.  Time for audits	N/A

Subtotal for Recordkeeping Requirements

1,279.14385

TOTAL LABOR BURDEN AND COST

	 3,555 	 $248,288

     Annualized cost of capital

$0

     Operation and maintenance (O&M)

$0

     Total (capital recovery plus O&M)

$0

N/A = not applicable.

a We have assumed that there are 427 existing iron and steel foundries
that area sources.  No new sources are projected during the 3-year term
of this ICR.  Therefore, the average number of total respondents per
year is 142.33.  A total of 344 of the 427 facilities are small
foundries and 83 are large foundries.  Consequently, the average number
of small foundries during the 3-year period of this ICR is 114.67 and
the average number of large foundries is 27.67.   No new sources are
expected during the next 3 years.  For the purposed of deviation
reports, 1 report per year is estimated for one-half (50.5) of the
114.67 respondents per year.

b  This ICR uses the following labor rates: The fully-burdened hourly
wage rates used to represent respondent labor costs are:  technical at
$72.09, management at $97.99, and clerical at $33.16.  Technical,
management, and clerical average hourly rates for private industry
workers in the foundry industry (NAICS 331500) were taken from the
United States Department of Labor, Bureau of Labor Statistics, May 2006
available at http://www.bls.gov. The rates have been increased by 110%
to account for the benefit packages available to those employed by
private industry.

c We have assumed that no burden would be incurred for this requirement
because all small area source foundries are already meeting the no
methanol requirement.

d  We have assumed that small foundries must record information to
demonstrate compliance with pollution prevention management practices
for metallic scrap and binder formulations.

e  We have assumed that no cost would be incurred to train personnel.

TABLE 2B.  Annual Respondent Burden and Cost for Large Foundries –
NESHAP for Iron and Steel Foundry Area Sources (40 CFR Part 63, Subpart
ZZZZZ) (Renewal)

Burden item	(A)

Person-hours per occurrence	(B)

No. of occurrences per respondent	(C)

Person-hours per respondent (C=A*B)	(D) Respondents per yeara	(E)

Technical person-hours per year (E=C*D)	(F) Management person-hours per
year (E*0.05)	(G)

Clerical person-hours per year (E*0.1)	(H) Costb, $

1.  Applications	N/A

	2.  Surveys and Studies	N/A

	3.  Acquisition, Installation, and Utilization of Technology and
Systems 	N/A

	4.  Reporting Requirements

	A.  Read instructions	8	1	8	27.67	221.4	11.1	22.1	$17,777

B.  Required activities

     Scrap material specifications	4	1	4	27.67	110.7	5.5	11.1	$8,889

     Prepare operation & maintenance plan	8	1	8	27.67	221.4	11.1	22.1
$17,777

     No methanol binder formulation c 	4	1	4	0.67	2.68	0.134	0.268	$215

Initial/subsequent performance tests d	0	0	0	0	0.0	0.0	0.0	$0

Initial and periodic inspections of PM control devices, monthly
inspection of capture systems d	0	0	0	0	0.0	0.0	0.0	$0

 Monthly emissions averaging calculations d	0	0	0	0	0.0	0.0	0.0	$0

C.  Create information	See 4B

	D.  Gather existing information	See 4B

	E.  Write report	See 4B

	     Initial notification of applicability	4	1	4	27.67	110.7	5.5	11.1
$8,889

     Notification of compliance status	8	1	8	27.67	221.4	11.1	22.1
$17,777

     Notification of construction/reconstruction	N/A

	     Notification of anticipated startup	N/A

	     Notification of actual startup	N/A

	     Notification of special compliance requirements	N/A

	     Request for compliance extension	N/A

	     Notification of performance test d	1	1	1	27.67	27.7	1.4	2.8	$2,222

     Site specific test plan d	0	0	0	0	0.0	0.0	0.0	$0

     Notification of performance evaluation	N/A

	     Quality assurance plan for CEMS/COMS	N/A

	     NESHAP waiver request	N/A

	     Startup, shutdown, and malfunction plan/reports	4	1	4	27.67	110.7
5.5	11.1	$8,889

     Semiannual excess emissions reports d	2	2	4	27.67	110.7	5.5	11.1
$8,889

Subtotal for Reporting Requirements

1,307.982

5.  Recordkeeping Requirements

	A.  Read instructions	See 4A

	B.  Plan activities	See 4A

	C.  Implement activities	See 4A

	D   Develop record system 	4	1	4	27.67	110.7	5.5	11.1	$8,889

E.  Time to enter information e	0.5	52	26	27.67	719.4	36.0	71.9	$57,775

F.  Time to transmit or disclose information	0.25	2	1	27.67	13.8	0.7	1.4
$1,111

G.  Time to adjust existing ways	2	1	2	27.67	55.3	2.8	5.5	$4,444

F.  Time to train personnel f	4	1	4	27.67	110.7	5.5	11.1	$8,889

G.  Time for audits	N/A

	Subtotal for Recordkeeping Requirements

1,161.4

TOTAL LABOR BURDEN AND COST

	  2,469 	$172,430

     Annualized cost of capital g

	$8,490

     Operation and maintenance (O&M) h

$0

     Total (capital recovery plus O&M) g

$8,490

N/A = not applicable.

a We have assumed that there are 427 existing iron and steel foundries
that area sources.  No new sources are projected during the 3-year term
of this ICR.  Therefore, the average number of respondents per year is
142.33.  A total of 344 of the 427 facilities are small foundries and 83
are large foundries.  Consequently, the average number of small
foundries during the 3-year period of this ICR is 114.67 and the average
number of large foundries is 27.67

 b  This ICR uses the following labor rates: The fully-burdened hourly
wage rates used to represent respondent labor costs are:  technical at
$72.09, management at $97.99, and clerical at $33.16.  Technical,
management, and clerical average hourly rates for private industry
workers in the foundry industry (NAICS 331500) were taken from the
United States Department of Labor, Bureau of Labor Statistics, May 2006
available at http://www.bls.gov. The rates have been increased by 110%
to account for the benefit packages available to those employed by
private industry.

c We assumed that two large area source foundries (2 foundries over 3
years = 0.67 foundries per year) are expected to have to change
formulations to meet the no methanol requirement.

d  We have assumed that these activities are not expected to occur
during the first 3 years of this ICR.

e   We have assumed that large foundries must record information to
demonstrate compliance with pollution prevention management practices
for metallic scrap and binder formulations and information to
demonstrate compliance with monitoring; inspection; operation and
maintenance; startups, shutdowns, and malfunctions; and other
requirements of the General Provisions (40 CFR part 63, subpart A).

f   We have assumed that large foundries are expected to monitor visible
emissions using a trained employee.

g  Based on capital cost of $59,620 for file storage cabinets, 7 percent
interest, and 20-year equipment life (capital recovery factor = 0.142).
No costs for monitoring equipment are estimated because no monitoring
equipment is required for existing foundries.

Total Burden Hours, Costs and Annualized Cost of Capital From 2A and 2B:

Tables	Burden Hours	Burden Cost	Annualized Cost of Capital

2A	3,555	$248,288	$0

2B	2,469	$172,430	$8,490

	Totals	6,024	$420,718	$8,490

Table 3:  Average Annual EPA Burden - NESHAP for Iron and Steel Foundry
Area Sources (40 CFR Part 63, Subpart ZZZZZ) (Renewal)

Burden Item	(A)

Person hours per occurrence	(B)

Occurrences per respondent	(C)

Plants per year a	(D)

Technical

hours/year (D=A*B*C)	(E)

Management

  hours/year (E=0.05*D)	(F)

Clerical

  hours/year   (F=0.1*D)	(G)

Costb, $

Report Review:

	  Initial notification of applicability 	1	1	142.33	142.3	7.1	14.2
$7,564

Deviation reports	1	1	50.1	50.1	2.5	5.0	$2,662

  Startup, shutdown, malfunction plan/report	2	1	142.33	142.3	7.1	14.2
$7,564

  Notification of compliance status	2	1	142.33	142.3	7.1	14.2	$7,564

  Semiannual excess emissions report	2	1	142.33	142.3	7.1	14.2	$7,564

TOTAL BURDEN AND COST

	712.3	$32,917

 a There are 427 existing iron and steel foundries that are area
sources.  No new sources are projected during the 3-year term of this
ICR.  Therefore, the average number of respondents per year is 142.33.
.

b  This ICR uses the following average hourly labor rates: 58.18 for
managerial (GS-13, Step 5, $36.36 x 1.6), $43.14 (GS-12, Step 1, $29.98
x 1.6) for technical and $22.66 (GS-6, Step 3, $14.16 x 1.6) for
clerical.  These rates are from the Office of Personnel Management (OPM)
(2007 General Schedule( which excludes locality rates of pay.

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