[Federal Register: July 28, 2006 (Volume 71, Number 145)]
[Notices]
[Page 42889]
[DOCID:fr28jy06-114]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

Federal Register Citation of Previous Announcement: [71 FR 41484, July
21, 2006].

Status: Closed Meeting.

Place: 100 F Street, NE., Washington, DC

Date and Time of Previously Announced Meeting: Thursday, July 27, 2006
at 2 p.m.

Change in the Meeting: Time Change.
    The closed meeting scheduled for Thursday, July 27, 2006 at 2 p.m.
has been changed to Thursday, July 27, 2006 at 3 p.m.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: July 25, 2006.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-6571 Filed 7-25-06; 4:48 pm]

BILLING CODE 8010-01-M


     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

                             OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
MEMORANDUM FOR THE RECORD

RE:  	Meeting with NYCO on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)
List of Contents
 Meeting Summary
 Attendees

Meeting Summary

On July 19, 2022, representatives from EPA met with NYCO to discuss comments submitted in docket EPA-HQ-OPPT-2021-0598 on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Compliance Date Extension, published March 8, 2022. During the meeting, NYCO presented on their use of PIP (3:1) in aviation hydraulic fluids and lubricants and greases, providing information on current worker protection measures. NYCO discussed their efforts to identify an alternative chemistry to PIP (3:1) in their products, and the long timelines for product replacement. EPA gave an overview of the TSCA section 6(h) rulemaking activities to date. NYCO indicated they would continue engaging with the EPA rulemaking process, in particular with respect to PIP (3:1) in lubricants and greases.

Attendees
EPA:
Niva Kramek
Cindy Wheeler
Gabriela Rossner

NYCO:
James Mustacchio
Jonathan Gledhill
Roman Gulesk
James Votaw
Deborah Morefield


[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Rules and Regulations]
[Pages 38976-38980]
[FR Doc No: 2015-16419]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0346; FRL-9927-25]

Prohexadione Calcium; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
prohexadione calcium in or on strawberry and watercress. Inter-Regional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 8, 2015. Objections and
requests for hearings must be received on or before September 8, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0346, 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), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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-2014-0346 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
September 8, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0346, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), 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
4E8264) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08450. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the fungicide
prohexadione calcium, calcium 3-oxido-5-oxo-4-propionylcyclohex-3-
enecarboxylate, in or on strawberry at 0.3 parts per million (ppm) and
watercress at 2.0 ppm. That document referenced a summary of the
petition prepared by BASF Corporation, the registrant, which is
available in the docket, http://www.regulations.gov. A comment was
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
amended the tolerance for watercress from what the petitioner
requested. The reason for this change is 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 prohexadione calcium including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with prohexadione
calcium 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.
    The most sensitive effect in the prohexadione toxicity database by
oral exposure is kidney toxicity in dogs both for subchronic and
chronic durations. Minor hematological changes (decreased white blood
cell counts in males), and fore-stomach hyperplasia were seen only at
very high doses in rodents. No dermal toxicity was observed up to the
limit dose of 1,000 milligram/kilogram/day (mg/kg/day). There was no
evidence of neurotoxicity in either of the neurotoxicity screening
batteries up to or exceeding the limit dose.
    In rats and rabbits, no increased quantitative or qualitative pre-
or postnatal susceptibility was observed. In rats, no maternal or
developmental toxicity was observed up to the limit dose (1,000 mg/kg/
day). Three developmental studies in rabbits are available in the
toxicological database for prohexadione calcium. In one study, late
abortions occurred during GD 24-29 at 200 mg/kg/day, with increased
mortality in maternal animals (GD 15-24) also noted at this dose. In
another rabbit developmental study, two premature deliveries (on GD 24
and 26) were noted at the highest dose tested (350 mg/kg/day) with no
developmental effects observed. No maternal or developmental effects
were seen in a third rabbit developmental study up to 150 mg/kg/day. In
the 2-generation reproductive toxicity study with rats, parental
toxicity (minimal mortality) occurred at a dose well below the dose
that caused decreases in offspring body weight (3, 850 mg/kg/day).
    Prohexadione calcium is classified as not likely to be carcinogenic
to humans based on lack of evidence of carcinogenicity in rats and
mice.
    Specific information on the studies received and the nature of the
adverse effects caused by prohexadione calcium as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Prohexadione Calcium. Section 3
Registration for Use on Strawberry and Watercress. Human Health Risk
Assessment on pages 11-14 in docket ID number EPA-HQ-OPP-2014-0346.

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 (U/SF) 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 prohexadione calcium
used for human risk assessment is shown in the Table of this unit.
Since the assessment in 2011, (November 18, 2011) (76 FR 71459) (FRL-
9326-4), the Agency has reevaluated the endpoints and determined that
the previously identified dermal endpoints are no longer appropriate.

    Table--Summary of Toxicological Doses and Endpoints for Prohexadione Calcium for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)....     No endpoint attributable to a single dose and appropriate for the U.S.
                                         general population was seen in the prohexadione calcium toxicological
                                       database; therefore, an acute dietary point of departure for the general
                                                         U.S. population was not established.
                                    ----------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL = 20 mg/kg/day..  Chronic RfD = cPAD =    Chronic toxicity--Dog.
                                     UFA = 10x.............   0.20 mg/kg/day.         LOAEL = 200 mg/kg/day
                                     UFH = 10x.............                           based on histopathological
                                     FQPA SF = 1x..........                           changes in the kidneys
                                                                                (dilated basophilic
                                                                                tubules) and increased
                                                                                urinary volume and sodium
                                                                                concentration.
Incidental oral short-term (1 to 30  NOAEL= 80 mg/kg/day...  LOC for MOE = 100.....  90-Day oral toxicity--Dog.
 days) and intermediate-term.        UFA = 10x.............                           LOAEL = 400 mg/kg/day
(1 to 6 months)....................  UFH = 10x.............                           based on moderate cortical
                                     FQPA SF = 1x..........                           areas of dilated
                                                                                basophilic tubules in the
                                                                                kidneys and decreased
                                                                                potassium levels.
                                    ----------------------------------------------------------------------------

Dermal short-term (1 to 30 days)      Short-term and intermediate-term dermal endpoints were not selected since
 and intermediate-term (1 to 6          there were no adverse dermal or systemic effects observed in the 28-day
 months).                             dermal study in rats. There was also no evidence of increased quantitative
                                       or qualitative pre- or postnatal sensitivity in the prohexadione calcium
                                       database. Therefore no concern for any duration of dermal exposure and no
                                                             dermal endpoints are required
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30       NOAEL= 40 mg/kg/day...  LOC for MOE = 100.....  Prenatal Developmental
 days) and intermediate-term (1 to   UFA = 10x.............                           Toxicity--Rabbit. Maternal
 6 months).                          UFH = 10x.............                           LOAEL = 200 mg/kg/day
                                     FQPA SF = 1x..........                           based on increased
                                     Inhalation assumed                               mortality, and abortions.
                                      equivalent to oral.
                                    ----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..   ``Not likely to be carcinogenic to humans'' based upon lack of evidence of
                                       carcinogenicity in rats and mice. No evidence of carcinogenic potential,
                                                  therefore, cancer risk assessment is not required.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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 prohexadione calcium, EPA considered exposure under the
petitioned-for tolerances as well as all existing prohexadione calcium
tolerances in 40 CFR 180.547. EPA assessed dietary exposures from
prohexadione calcium 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.
    No such effects were identified in the toxicological studies for
prohexadione calcium; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA Nationwide
Health and Nutrition Examination Survey, What We Eat In America
(NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food,
the chronic dietary analysis assumed Dietary Exposure Evaluation Model
(DEEM) (ver. 7.81) default processing factors, 100 percent crop treated
(PCT) and tolerance-level residues for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that prohexadione calcium does not pose a cancer risk to
humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for prohexadione calcium. Tolerance-level residues and/or
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for prohexadione calcium in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of prohexadione calcium. 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 Tier 1 Rice Model and Screening Concentration in
Ground Water (SCI-GROW) model, the estimated drinking water
concentrations (EDWCs) of prohexadione calcium for chronic exposures
for non-cancer assessments are estimated to be 170 parts per billion
(ppb) for surface water and 0.137 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 170 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).
    Prohexadione calcium is currently registered for the following uses
that could result in residential exposures: Residential lawns,
ornamentals, athletic fields, parks, and golf courses. EPA assessed
residential exposure using the following assumptions: Short-term
residential handler exposures may result from adults applying
prohexadione calcium to residential lawns and ornamentals. The Agency
assessed inhalation exposures for adult handlers applying manually-
pressurized handwand applications to bedding plants. Short-term
exposure is also possible for post-application incidental oral
exposures of children 1-<2 years old. The Agency assessed hand-to-mouth
exposures and incidental soil ingestions from applications to turf for
children. Intermediate- and long-term exposures are not expected since
there are no registered or proposed uses of prohexadione calcium that
result in intermediate- or long-term residential exposures. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 prohexadione calcium to share a common mechanism

of toxicity with any other substances, and prohexadione calcium does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that prohexadione calcium 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 Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data are available to EPA support the
choice of a different factor.
    2. Prenatal and postnatal sensitivity. There are no residual
uncertainties for prenatal and postnatal toxicity and there is no
evidence of increased qualitative or quantitative susceptibility of any
kind for fetuses and offspring in both rats and rabbits.
    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 prohexadione calcium is complete.
    ii. There is no indication that prohexadione calcium is a
neurotoxic chemical and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that prohexadione calcium results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT, tolerance-level residues, and DEEM (Ver 7.81) default
processing factors. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
prohexadione calcium in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by prohexadione calcium.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
prohexadione calcium is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
prohexadione calcium from food and water will utilize 19% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
prohexadione calcium is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Prohexadione calcium is currently registered for uses that could
result in short-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to prohexadione
calcium.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 14,000 for adults
and 2,100 for children. Because EPA's level of concern for prohexadione
calcium is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
prohexadione calcium is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure 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 intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for prohexadione calcium.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, prohexadione calcium is not expected to pose a cancer risk to
humans.
    6. 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 prohexadione calcium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (BASF Analytical Method D9601 and
564/0) is available to enforce the tolerance expression for residues of
prohexadione calcium in watercress and strawberry samples.
    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 prohexadione calcium in/on
strawberries and watercress.

C. Response to Comments

    One comment was received in response to the notice of filing of IR-
4's petition. The commenter stated this use should be denied due to
toxicity to bees and that all use of chemicals should be stopped. The
comment primarily appears directed to the registration of the pesticide
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
but to the extent the comment is directed at the present tolerance
action, the Agency understands the commenter's concerns and recognizes
that some individuals believe that pesticides should be banned on
agricultural crops. However, the existing legal framework provided by
section 408 of FFDCA states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework. As to bees the
EPA will consider impacts to the environment and non-target species
under the authority of FIFRA.

D. Revisions to Petitioned-For Tolerances

    The tolerance on watercress has been revised from what was proposed
in the initial petition. EPA is increasing the proposed tolerance for
residues in/on watercress from 2 ppm to 4.0 ppm based on the available
watercress field trial data and the OECD tolerance calculation
procedure.

 V. Conclusion

    Therefore, tolerances are established for residues of prohexadione
calcium, calcium 3-oxido-5-oxo-4-propionylcyclohex-3-enecarboxylate, in
or on strawberry at 0.30 ppm and watercress at 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been
exempted from review under Executive Order 12866, this action 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 action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 22, 2015.
Daniel J. Rosenblatt,
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.  180.547, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:

Sec.  180.547  Prohexadione calcium; tolerances for residues.

    (a) * * *

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

                                * * * * *
Strawberry.................................................         0.30
Watercress.................................................          4.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-16419 Filed 7-7-15; 8:45 am]
 BILLING CODE 6560-50-P


1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

	1650 Arch Street

	    Philadelphia ,   Pennsylvania     19103

DATE:	December 7, 2010

SUBJECT:	Technical Support Document for Maryland’s Adoption of Control Techniques Guidelines (CTG) for Flat Wood Paneling Coatings

FROM:	Gregory Becoat, Environmental Scientist /s/

Office of Air Program Planning

TO:		File

THRU: 	Marilyn Powers, Acting Associate Director /s/

Office of Air Program Planning

A.  BACKGROUND

What is the flat wood paneling coating CTG?

Section 172(c)(1) of the Clean Air Act (CAA) provides that state implementation plans (SIPs) for nonattainment areas must include reasonably available control measures (RACM), including reasonably available control technology (RACT), for sources of emissions.  Section 182(b)(2)(A) provides that for certain nonattainment areas, States must revise their SIPs to include RACT for sources of volatile organic compound (VOC) emissions covered by a CTG document issued after November 15, 1990 and prior to the area’s date of attainment.

The United States Environmental Protection Agency (EPA) defines RACT as “the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.” (44 FR 53761, Sept. 17, 1979).  In subsequent Federal Register notices, EPA has addressed how states can meet the RACT requirements of the CAA.

The CTG for flat wood paneling coatings is intended to provide state and local air pollution control authorities information that should assist them in determining RACT for VOCs from flat wood paneling coating. In developing this CTG, EPA, among other things, evaluated the sources of VOC emissions from the flat wood paneling coating industry and the available control approaches for addressing these emissions, including the costs of such approaches. Based on available information and data, EPA provides recommendations for RACT for flat wood paneling coating.

In June 1978, EPA published a final CTG for flat wood paneling coatings, entitled “Control of Volatile Organic Emissions from Existing Stationary Sources, Volume VII, Factory Surface Coating of Flat Wood Paneling,” EPA-450/2-78-034 (June 1978). Control of Volatile Organic Emissions from Existing Sources - Volume VII: Factory Surface Coating of Flat Wood Paneling. Publication No. EPA-450/2-78-032. U. S. Environmental Protection Agency, Research Triangle Park, NC. June 1978.

  In September 1979, EPA published guidance to provide assistance to State and local air pollution control agencies in preparing RACT regulations for a variety of categories, including flat wood paneling.  In 2003, EPA promulgated national emission standards for hazardous air pollutants (NESHAP) covering surface coating of wood building products (including flat wood paneling).  See 68 FR 31746 (May 28, 2003).

What is flat wood paneling coatings?

Flat wood paneling products are used in construction and can be classified as three main product types: decorative interior panels, exterior siding, and tileboard.  Flat wood paneling, like most wood products, are vulnerable to light, moisture and insects. Coatings are used for three principal purposes: protection, appearance, and surface modification. Surface coatings are applied to reduce potential damage from environmental elements such as moisture and temperature extremes and other climate-related hazards and from insect infestation. Coatings are also applied to enhance surfaces to make other coatings more effective.  Finally, coatings are applied to improve the appearance of the wood product.  Releases of VOC occur during the coating process as the coatings are mixed or thinned, as they are applied to the substrate, and as they dry and the VOC within the coating evaporate into the air.

A typical flat wood coating facility applies stains and varnishes to natural plywood panels used for wall coverings.  Other plants print wood grain patterns on particle board panels that were first undercoated with an opaque coating to mask the original surface.  Coatings applied to flat wood paneling include fillers, sealers, “groove” coats, primers, stains, basecoats, inks and topcoats. Most coatings are applied by direct roll coating.  Filler is usually applied by reverse roll coating.  The offset rotogravure process is used where the coating and printing operation requires precision printing techniques.  Other coating methods include spray techniques, brush coating and curtain coating.  A typical flat wood paneling coating line includes a succession of coating operations.  Each individual operation consists of the application of one or more coatings followed by a heated oven to cure the coatings.  A typical production line begins with mechanical alterations of the substrate (filling of holes, cutting of grooves, sanding, etc.), followed by the coating operations, and packaging/stacking for shipment.

This CTG applies to facilities that apply flat wood paneling coatings that emit at least 6.8 kg/day (15 lb/day) of VOC before consideration of controls.  Flat wood paneling coatings means wood paneling products that are any interior, exterior or tileboard (class I hardboard) panel to which a protective, decorative, or functional material or layer has been applied.

There are several approaches to reducing VOC emissions from flat wood coating facilities: (1) the use of low-VOC, waterborne coatings, (2) the use of ultraviolet cure and electron beam cure coatings, (3) adding/improving add-on controls, and (4) the implementation of work practice standards.

EPA’s Recommended Emissions and Control Options for Flat wood Paneling Coatings

EPA issued a CTG for Flat wood Paneling Coatings on June 1978 (EPA-450/2-78-034).  EPA recommended emission limits for the inks, coatings and adhesives used by the flat wood paneling coating facilities and work practices for cleaning materials used.  The recommended emission limits for inks, coatings, and adhesives can be achieved either by using materials with VOC contents low enough to achieve the limits during application, or by reducing the amount of VOC emitted through the use of add-on controls.  There are two alternative limits recommended for the use of low VOC inks, coatings and adhesives.  Table 1 summarizes the VOC emission limits recommended in this CTG.

A. Emissions Limit based on Low-VOC Coatings for Inks, Coatings and Adhesives

The low-VOC materials recommendation for inks, coatings and adhesives include an emissions limit of 250 g VOC/liter (2.1 lb VOC/gal) of material (minus water and exempt compounds).  An equivalent limit, expressed as units of weight of VOC per volume of solids in all coatings is 350 grams of VOC per liter solids (2.9 lb of VOC per gal of solids).

B. Optional Add-On Controls for Inks, Coatings and Adhesives

Should product performance requirements or other needs dictate the use of higher-VOC coatings than specified in Table 1, a facility could choose to use add-on control equipment to meet an overall control efficiency of 90 percent.

C. Work Practices

The recommended work practice plan include steps to ensure that VOC emissions are minimized from mixing operations, storage tanks and other containers, and handling operations for coatings, thinners, cleaning materials, and waste materials. Examples of work practice standards include: storing all VOC coatings, thinners, and cleaning materials in closed containers, minimizing spills of VOC containing coatings, thinners, cleaning up spills immediately, conveying any coatings, thinners, and cleaning materials in closed containers or pipes, closing mixing vessels which contain VOC coatings and other materials except when specifically in use, and minimizing emissions of VOC during cleaning of storage, mixing, and conveying equipment.

Table 1. Recommended Emission Limits for Flat Wood Paneling Coating Operations

Surface Coatings, Inks, or Adhesives Applied to the Following Flat Wood Paneling Categories

Should Meet One of These Emission Limits:lb VOC per

gallon material

(grams VOC per

liter material)

[excluding water and exempt compounds ]lb VOC per

gallon solids

(grams VOC per

liter solids)Overall Control Efficiency Using an Add-On Control Device:

Printed interior panels made of hardwood, plywood, or thin particleboard 2.1 (250) 2.9 (350)

90%

Natural finish hardwood plywood panels 2.1 (250)

2.9 (350)

90%

Class II finishes on hardboard panels 2.1 (250)

2.9 (350)

90%

Tileboard 2.1 (250)

2.9 (350)

90%

Exterior siding

2.1 (250) 2.9 (350) 90%

B.  STATE SUBMITTAL

On April 23, 2010, Maryland Department of the Environment (MDE) submitted to EPA a SIP revision concerning the adoption of the EPA CTG for flat wood paneling coatings.  EPA develops CTGs to provide States with guidance on control requirements for source categories.  States can follow the CTGs or adopt more restrictive standards.  MDE is adopting EPA’s CTG standards for flat wood paneling coatings (see EPA-450/2-78-034, June 1978).  This SIP revision includes new regulation .33 under COMAR 26.11.19, Volatile Organic Compounds from Specific Processes.  This action affects facilities that apply stains and varnishes to natural plywood panels used for wall coverings.  This SIP revision also includes amendments to regulation .32 under COMAR 26.11.19; however, on November 12, 2010, MDE submitted a letter to withdraw this portion because Maryland had not previously submitted COMAR <IP_ADDRESS> to be approved as part of the SIP.

COMAR <IP_ADDRESS> – Control of Volatile Organic Compounds (VOCs) Emissions from Flat Wood Paneling Coatings is being added:

Section .33(A):  Includes definitions for the following terms pertaining to flat wood paneling coatings: (1) “Class II finishes on hardboard panels,” “Exterior siding,” “Flat wood paneling,” “Hardwood plywood,” “Natural finish hardwood plywood panels,” “Printed interior panels,” “Thin particleboard,” and “Tileboard.”

Section .33(B):  Incorporates by reference ANSI A135.5-2004, Prefinished Hardwood Paneling and ANSI A135.4-2004, Basic Hardboard.

Section .33(C):  Describes the applicability of this regulation.

Section .33(D):  Includes the requirements for flat wood paneling coating.  Any person who applies flat wood paneling coatings, including inks and adhesives, where total precontrol VOC emissions from all flat wood paneling coating operations at a premises is 15 pounds or more per day (6.8 kg/day) shall meet the coating standards or overall control efficiency specified in Table 1.

C.  EPA EVALUATION

The State of Maryland has adopted the standards and requirements of the CTG for flat wood paneling coating and is revising its SIP to reflect these amendments.  The maximum benefit from these amendments will be provided during the ozone season when VOCs readily combine with nitrogen oxide to form ground-level ozone.  Therefore, this revision will help Maryland attain and maintain the national ambient air quality standard for ozone.

D.  CONCLUSIONS AND RECOMMENDED AGENCY ACTION

The adoption of the EPA CTG requirements for flat wood paneling coating by the State of Maryland will result in the reduction of VOC emissions from flat wood coating facilities.  EPA approval of the SIP revision is recommended.


[Federal Register: October 9, 2007 (Volume 72, Number 194)]
[Notices]
[Page 57330-57331]
[DOCID:fr09oc07-77]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12788-000]

Mountain Property Resources, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

October 1, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12788-000.
    c. Date filed: March 22, 2007.
    d. Applicant: Mountain Property Resources, LLC.
    e. Name of Project: Grace Project.
    f. Location: The project would be located on Fall Creek in Eagle
County, Colorado. The project will occupy approximately 3.8 acres of
federal land within the White River National Forest.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Steven R. Coley, Mountain Property
Resources, LLC, 1857 County Road 109, Glenwood Springs, CO 81601,
phone:<PHONE_NUMBER>.
    i. FERC Contact: Henry Woo,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of:
(1) An existing water diversion structure, (2) a proposed 3,000-foot-
long steel penstock, (3) an existing powerhouse containing a proposed
generating unit with an installed capacity of 140 kilowatts, (4) a
proposed 25 kilovolt transmission line; and (5) appurtenant facilities.
The applicant estimates the average annual generation would be 1.209
gigawatt-hours and would be sold to a local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to

the Commission on or before the specified comment date for the
particular application (see 18 CFR 4.36). Submission of a timely notice
of intent allows an interested person to file the competing preliminary
permit application no later than 30 days after the specified comment
date for the particular application. A competing preliminary permit
application must conform with 18 CFR 4.30 and 4.36.
    o. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'',``COMPETING APPLICATION'' or
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-19788 Filed 10-5-07; 8:45 am]

BILLING CODE 6717-01-P