[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Rules and Regulations]
[Pages 20545-20550]
[FR Doc No: 2016-08138]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0197; FRL-9942-99]

Fluazinam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluazinam in or on cabbage, mayhaw, the cucurbit vegetable crop group
9, and the tuberous and corm vegetable subgroup 1C and amends the
existing tolerance for ``vegetable, Brassica leafy, group 5'' to read
``vegetable, Brassica leafy, group 5, except cabbage.'' Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 8, 2016. Objections and
requests for hearings must be received on or before June 7, 2016, 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-2015-0197, 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-2015-0197 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 7, 2016. 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-2015-0197, 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 May 20, 2015 (80 FR 28925) (FRL-9927-
39), 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
5E8349) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide fluazinam (3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), including its metabolites and
degradates in or on mayhaw at 2.0 parts per million (ppm); cabbage at
3.0 ppm; the squash/cucumber subgroup 9B at 0.05 ppm; and vegetable,
tuberous and corm, subgroup 1C at 0.02 ppm. The petition also requested
to amend the tolerances in 40 CFR 180.574 in or on the vegetable,
Brassica leafy, group 5 at 0.01 by changing it to read ``vegetable,
Brassica leafy, group 5, except cabbage'' at 0.01 ppm and by removing
the existing tolerance on potato at 0.02 ppm upon approval of the
requested tolerance on the tuberous and corm subgroup 1C. That document
referenced a summary of the petition prepared by ISK Biosciences, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    EPA is combining the existing tolerance for the melon subgroup 9A
tolerance with the proposed squash/cucumber subgroup 9B tolerance and
establishing a tolerance for the entire cucurbit vegetable crop group
9, rather than just subgroup 9B. The reason for these changes is
explained in Unit IV.C.

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 fluazinam including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with fluazinam 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 liver is a primary target organ for fluazinam and numerous
liver effects were observed in rats, mice, and dogs after oral and
dermal exposure. After inhalation exposure, portal of entry effects
(increased lung/bronchial weights, alveolar macrophages and
peribronchiolar proliferation) were seen.
    Clinical signs were observed in an acute oral neurotoxicity study
in rats; decreases in motor activity and soft stools were seen on the
day of dosing at the limit dose. These effects were attributed to
systemic toxicity and were not considered to be evidence of frank
neurotoxicity. In two subchronic neurotoxicity studies (evaluated
together) in rats, no evidence of neurotoxicity was observed. A
neurotoxic lesion was observed initially in long-term studies in mice
and dogs; however, the lesion is reversible and was later attributed to
the presence of an impurity (Impurity-5) in the technical material. A
NOAEL for the impurity was determined (based on the maximum
concentration of Impurity-5 in technical grade fluazinam), equivalent
to a NOAEL for central nervous system (CNS) effects of 20 mg/kg/day for
technical grade fluazinam. The current acute and chronic reference
doses selected for risk assessment are lower than the determined NOAEL
and thus, protective of any possible neurotoxic effects resulting from
exposure to Impurity-5.
    In an immunotoxicity study in mice, significant suppressions of
anti-SRBC AFC assay response were demonstrated at the highest dose
tested indicating potential immunotoxicity. However, clear NOAELs and
LOAELs were identified for the effects seen in the study and the points
of departure (PODs) and endpoints selected for risk assessment are
protective of immunotoxic effects.
    There was no evidence of increased quantitative or qualitative
susceptibility in the rabbit developmental or rat reproduction studies.
However, quantitative susceptibility was seen in rat developmental and
developmental neurotoxicity (DNT) studies where fetal/offspring effects
were observed in the absence of maternal toxicity. The concern is low
for the increased susceptibility noted in the studies since clear
NOAELs are established, and the most sensitive endpoints/PODs are used
for risk assessment and are protective of the observed susceptibility.
Therefore, the Food Quality Protection Act (FQPA) safety factor (SF)
has been reduced to 1x.
    Fluazinam is classified as having ``Suggestive evidence of
carcinogenicity, but not sufficient to assess human carcinogenic
potential,'' based on increases in thyroid gland follicular cell tumors
in male rats and increases in hepatocellular tumors in male mice.
Although there is evidence of thyroid tumors in male rats and liver
tumors in male mice, the NOAEL used (1.12 mg/kg/day) for establishing
the chronic reference dose (cRfD) is approximately 3-fold lower than
the lowest dose that induced tumors (3.8 mg/kg/day). The Agency has
determined that quantification of cancer risk using a non-linear
approach (cRfD) would adequately account for all chronic toxicity,
including carcinogenicity, which could result from exposure to
fluazinam.
    Specific information on the studies received and the nature of the
adverse effects caused by fluazinam 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 the document titled ``Fluazinam. Human Health
Risk Assessment to Support Section 3 Registration for New Uses on
Tuberous and Corm, Subgroup 1C, Mayhaw, Squash/Cucumber Subgroup 9B;
Amended Uses on Cabbage'' on page 44 in docket ID number EPA-HQ-OPP-
2015-0197.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for fluazinam used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of November 7, 2012 (77 FR 66723)
(FRL-9366-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazinam, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluazinam tolerances in 40 CFR
180.574. EPA assessed dietary exposures from fluazinam 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 fluazinam. In estimating acute dietary exposure, EPA used food
consumption information from the 2003-2008 United States Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, the acute analysis is based on tolerance-level residues for all
commodities and uses high-end residue estimates for the metabolite AMGT
((3-[[4-amino-3-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]amino]-2-
nitro-6-(trifluoromethyl) phenyl]thio]-2-(beta-D-glucopyranosyloxy)
propionic acid)). In addition, the acute assessment assumes 100 percent
crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, the chronic

analysis is based on tolerance-level residues for all commodities
except apples. For apples, the average field trial value was used. As
with the acute assessment, it incorporates high-end estimates for AMGT,
100 PCT assumptions, default processing factors for all relevant
processed commodities without a separate tolerance.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to fluazinam. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluazinam and its transformation products, including
DCPA (6-(4-carboxy-3-chloro-2,6-dinitroanilino)-5-chloronicotinic
acid), CAPA (3-chloro-6-(3-chloro-2,6-dinitro-4-trifluoromethyl
anilino)nicotinic acid), DAPA (3-chloro-N\4\-(3-chloro-5-
trifluoromethyl-2-pyridyl)-[alpha],[alpha],[alpha]-trifluorotoluene-
3,5,5-triamine; 3-chloro-2(2,6-diamino-3-chloro-
[alpha],[alpha],[alpha]-trifluoro-p-toluidino)-5-(trifluoromethyl)
pyridine), HYPA (5-[[3-chloro-5-(trifluoromethyl-2-pyridyl]amino]-
[alpha],[alpha],[alpha]-trifluoro-4,6-dinitro-o-cresol), and AMPA (2-
(6-amino-3-chloro-[alpha],[alpha],[alpha]-trifluoro-2-nitro-p-
toluidino)-3-chloro-5-(trifluoromethyl)pyridine).
    These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of fluazinam and its
transformation products. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and the
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated
drinking water concentrations (EDWCs) for total residues of fluazinam
and its transformation products for acute exposures are estimated to be
226 parts per billion (ppb) for surface water and 137 ppb for ground
water and for chronic exposures are estimated to be 37.8 ppb for
surface water and 119 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 226 ppb was used to assess
the contribution to drinking water, and for the chronic dietary risk
assessment, the water concentration of value 119 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).
    Fluazinam is currently registered for the following uses that could
result in residential exposures: golf course turf. EPA assessed
residential exposure using the following assumptions: Only short-term
dermal exposure is expected for residential post-application scenarios
for children, teens, and adults who could potentially be exposed when
they play golf on treated turf. No other residential exposures are
expected. Further information regarding EPA standard assumptions and
generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 fluazinam to share a common mechanism of toxicity
with any other substances, and fluazinam does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluazinam 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 SF. In
applying this provision, EPA either retains the default value of 10x,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased quantitative or qualitative susceptibility in the rabbit
developmental or rat reproduction studies. However, quantitative
susceptibility was seen in rat developmental and DNT studies where
fetal/offspring effects were observed in the absence of maternal
toxicity. The concern is low for the increased susceptibility noted in
the studies since clear NOAELs are established, and the most sensitive
endpoints/PODs are used for risk assessment and are protective of the
observed 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 fluazinam is complete.
    ii. Although indications of neurotoxicity and immunotoxicity were
observed in the database for fluazinam, there were clear NOAELs for
these effects, and the endpoints and doses for risk assessment are
protective of the potential effects.
    iii. There is no evidence that fluazinam results in increased
susceptibility in the rabbit developmental or rat reproduction studies.
However, quantitative susceptibility was seen in rat developmental and
DNT studies where fetal/offspring effects were observed in

the absence of maternal toxicity. The concern is low for the increased
susceptibility noted in the studies since clear NOAELs are established,
and the most sensitive endpoints/PODs are used for risk assessment.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues for all commodities except
apples, where anticipated residues were used in the chronic assessment.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to fluazinam and its
transformation products in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children. These assessments will not underestimate the exposure and
risks posed by fluazinam.

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 fluazinam will occupy 32% of the aPAD for females 13-49 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluazinam from food and water will utilize 92% of the cPAD for all
infants, 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 fluazinam 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). Fluazinam 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 fluazinam.
    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 690 for children
6 to <11 years old, 820 for youth 11 to <16 years old and 890 for
adults. Because EPA's level of concern for fluazinam 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,
fluazinam 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
fluazinam.
    5. Aggregate cancer risk for U.S. population. EPA assessed cancer
risk using a non-linear approach (i.e., RfD) since it adequately
accounts for all chronic toxicity, including carcinogenicity, that
could result from exposure to fluazinam. As the chronic dietary
endpoint and dose are protective of potential cancer effects, fluazinam
is not expected to pose an aggregate cancer risk.
    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 fluazinam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate Gas Chromatography with Electron Capture Detector (GC/
ECD) method is available for enforcing fluazinam tolerances on plant
commodities.
    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 MRLs for fluazinam for any of the
commodities covered by this action.

C. Revisions to Petitioned-For Tolerances

    Because the tolerance level for the existing melon subgroup 9A is
the same as the squash/cucumber subgroup 9B tolerance the Agency is
establishing, the Agency is combining the tolerances for the two
subgroups and establishing a tolerance for the entire cucurbit
vegetable crop group 9.

V. Conclusion

    Therefore, tolerances are established for residues of fluazinam (3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), including its metabolites and
degradates in or on mayhaw at 2.0 ppm; cabbage at 3.0 ppm; cucurbit
vegetables crop group 9 at 0.07 ppm; and vegetable, tuberous and corm,
subgroup 1C at 0.02 ppm. In addition, the existing tolerance on the
vegetable, Brassica leafy, group 5 at 0.01 is modified to read
``vegetable, Brassica leafy, group 5, except cabbage'' at 0.01 ppm and
the existing tolerance on potato at 0.02 ppm is removed as unnecessary
since it is covered by the tolerance on the tuberous and corm subgroup
1C, and the melon subgroup 9A tolerance is removed since it is now
replaced by the cucurbit vegetables crop group 9 tolerance.

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 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 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: March 31, 2016.
G. Jeffrey Herndon,
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.  180.574, amend the table in paragraph (a)(1) as follows:
0
a. Alphabetically add the entries ``Cabbage'' and ``Mayhaw''.
0
b. Remove the entries ``Melon subgroup 9A'' and ``Potato''.
0
c. Remove the entry for ``Vegetable, Brassica leafy, group 5'' and
alphabetically add entries for ``Vegetable, Brassica leafy, group 5,
except cabbage'' and ``Vegetable, tuberous and corm, subgroup 1C``.
    The additions read as follows:

Sec.  180.574  Fluazinam; tolerances for residues.

    (a) * * * (1) * * *

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

                                * * * * *
Cabbage...................................................          3.0

                                * * * * *
Mayhaw....................................................          2.0

                                * * * * *
Vegetable, Brassica leafy, group 5, except cabbage........          0.01
Vegetable, cucurbit, group 9..............................          0.07

                                * * * * *
Vegetable, tuberous and corm, subgroup 1C.................          0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-08138 Filed 4-7-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54626-54627]
[FR Doc No: 2023-17262]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1954]

Classification Categories for Certain Supplements Under the
Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Classification Categories for Certain Supplements Under BsUFA III.''
This draft guidance provides recommendations for applicants and FDA
review staff on classification categories A, B, C, D, E, and F for
original and resubmitted prior approval supplements submitted to
approved applications under the Public Health Service Act (PHS Act).
The commitment letter associated with the Biosimilar User Fee
Amendments of 2022 (BsUFA III) sets forth these supplement
classification categories and their associated review performance
goals. This draft guidance is intended to help applicants identify the
appropriate classification category and review goal date of the
supplement being submitted.

DATES: Submit either electronic or written comments on the draft
guidance by October 10, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-1954 for ``Classification Categories for Certain Supplements
Under BsUFA III.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, 301-796-
1042, [email protected]; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Classification Categories for Certain Supplements Under
BsUFA III.'' This draft guidance provides recommendations for
applicants and FDA review staff on classification categories A, B, C,
D, E, and F for original and resubmitted prior approval supplements
(hereafter ``supplements'') submitted to approved applications under
section 351(k) of the PHS Act (42 U.S.C. 262(k)).
    These classification categories pertain to supplements for
biosimilar and interchangeable biosimilar products seeking the
following:

 To update prescribing information and, if applicable, FDA-
approved patient labeling (e.g., Patient Package Insert, Medication
Guide, Instructions for Use) with safety information that has been
updated in the reference product labeling and is applicable to one or
more indications for which the biosimilar or interchangeable biosimilar
product is licensed
 To receive licensure for an additional indication
 To remove an approved indication
 To receive an initial determination of interchangeability

    This draft guidance is intended to help applicants identify the
appropriate classification category and review goal date of the
supplement being submitted. Section I.A. of the commitment letter
associated with the BsUFA III sets forth these supplement
classification categories and their associated review performance
goals. The full text of the proposed BsUFA III Commitment Letter can be
found on the Agency's web page ``BsUFA III: Fiscal Years 2023-2027,''
available at https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Classification Categories for Certain Supplements Under BsUFA III.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information pertaining to the Biosimilar User Fee Program and for
the submission of biologics license applications under section 351(k)
of the PHS Act regarding biosimilar product applications,
interchangeable biosimilar product applications, and supplemental
applications have been approved under OMB control number 0910-0718. The
collections of information in 21 CFR 201.56 and 201.57 for the
submission of labeling have been approved under OMB control number
0910-0572. The collections of information pertaining to Medication
Guides for prescription human drug and biological products have been
approved under OMB control number 0910-0393. The collections of
information in 21 CFR part 601 for the submission of biologics license
applications, supplemental applications, and Form FDA 356h have been
approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17262 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P


Reader’s Guide for Tebupirimphos

CRM: Wilhelmena Livingston

EPA/OPPTS/OPP/SRRD

Reader’s Guide to Tebupirimphos (Phostebupirim)

Docket # EPA-HQ-OPP-2008-0940

Publication Date: June 24, 2009

	EPA has created this document to provide an organizational structure to
the Registration Review Tebupirimphos Docket for Public Comments.  The
docket index groups related documents.  The first group contains the
Federal Register and Docket Organizational Documents, the second group
contains the Human Health Assessment, the third group contains the
Environmental Risk Assessment documents, and the fourth group contains
use/usage information pertaining to the tebupirimphos registration
review.   The Agency is providing the “Reader’s Guide” to allow
the reader to more easily access and navigate the various items
contained in the tebupirimphos docket.

Federal Register and Docket Organizational Documents:

Docket Item 1.	Federal Register Notice:  Tebupirimphos Registration
Review

Docket Item 2.	Reader’s Guide to the Tebupirimphos Docket # EPA-
					HQ-OPP-2008-0940

Docket Item 3.	Tebupirimphos Summary Document

			(June 11, 2009)

Human Health Documents for Registration Review

Docket Item 4.	Tebupirimphos.  Human Health Assessment Scoping Document
in Support of Registration Review

			(April 8, 2009)

This document evaluates the status of the human health assessment to
determine the scope of work necessary to support the registration review
of the insecticide tebupirimphos.

Environmental Fate and Effects Documents for Registration Review

Docket Item 5.	Registration Review - Problem Formulation for the
Ecological Risk and Drinking Water Exposure Assessments for
Tebupirimphos (PC Code 129086); D360013

			(April 22, 2009)

This document provides a better understanding of the environmental fate
and ecological effects of the registered uses of tebupirimphos.

Use and Usage Information for Registration Review

Docket Item 6.	Phostebupirim (129086) Screening Level Usage Analysis
(SLUA)

	(September 26, 2008)

This document provides available estimates of Pesticide usage data for
tebupirimphos that is used on agricultural crops in the United States.

Docket Item 7.	SRRD Appendix A Food/Feed & Non-Food/Non Feed Uses
Considered in Registration Review Work Planning

(August 11, 2008)

This table lists the food/feed and non-food/non- feed uses for
tebupirimphos.

Incident Report for Phostebupirim

Docket Item 8.	Updated Review of Phostebupirim (Aztec) Incident Reports

			(January 30, 2009)

This report represents incidents occurring in the United States from
2002 to the present for the single active ingredient (tebupirimphos)
only.


Table 3 also illustrates the incremental costs under a Uniform Marketable Permit System ( UMPS), when trading occurs across sectors and the permit price is assumed to be the marginal cost for the last user switching to methyl bromide alternatives in order to sell the permit. The permit price was $ 14.49, which corresponds to the economic loss per kilogram of methyl bromide measured for the representative user in the forest seedling sector. This marketable permit system is most cost effective, at $ 35.5 million, when methyl bromide users are allowed to trade freely across sectors. The total adjustment cost of the UMPS is less than one third that of a fixed allocation system based on proportional reductions among methyl bromide users ( average cost scenario in Table 3). The potential cost savings of 60 This may also lead to an overstatement of benefits because the total 2005 requested amount may be greater than the current methyl bromide use. *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 183  marketable permit systems could range from 36 percent to 80 percent, depending on the trading system and initial allocation of CUEs Payment and receipt of marketable permits among methyl bromide users would affect individual income. Buyers of permits would incur additional costs to purchase permits, but this would be more than offset by avoiding costs of adjusting to alternatives, so they would realize a net gain from trade. Users who sell marketable permits would enjoy more income because their cost of adjusting to alternatives would be less than that value of the permit they sold. The total costs of meeting a required reduction of methyl bromide to the economy as a whole may be minimized using a marketable permit system, but it is also important to bear in mind that the initial distribution of permits can affect the distribution of gains and losses, and these equity considerations may be an important factor in designing a trading system.

The potential cost savings estimated in this study were based on the assumption that the price of methyl bromide remains at the 2001 price, which was $ 8.8 to $ 11 per kilogram. However, It is unlikely that the price of methyl bromide in 2005 will be the same as that in 2001. The price of methyl bromide in United States has increased approximately 300 percent over the seven year period from 1995 to 2001 ( US EPA, 2003a). The price of methyl bromide has increased due to the decreased production levels and the price policies of suppliers. The potential cost savings associated with marketable permit systems will be smaller if the price of methyl bromide increases and more growers switch to the alternatives, so the price assumption may lead to overestimates of savings from trading. The cost effectiveness of a marketable permit design also depends on the total amount of the critical use exemption allowed.

Smaller amounts of total methyl bromide in CUEs leads to lower savings and a narrower market, while greater amounts of CUEs lead to a broader market and more trading. Similarly, trading across sectors leads to broader markets and greater impetus to trade. One factor that may lead to underestimating the gains from a trading system include our assumption that the point estimate of costs for a portion of a sector is representative of all methyl bromide users in the sector, whereas there may be greater heterogeneity among users. Another factor is heterogeneity in implicit costs of adopting methyl bromide alternatives ( e. g., transaction costs, R& D) that would lead to gains from trading.

Theoretically, the different initial allocation of the permits to use methyl bromide should not affect the efficient outcome of the permit system. No one would be worse off when permit trading is allowed.

Permits could correct inefficiency in initial allocation because trading would tend to allocate methyl bromide to users with the highest costs of adoption alternatives. Initial allocation can, however, affect how much each user gains or losses from the CUE allocation process, as well as the transaction costs of the program. Below we briefly introduce and discuss four possible options for allocating initial permits.

Each option varies widely in the method and amount of information required to distribute the initial allocation of permits. *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 184  Allocation to CUE Applicants In this option, the permits could be allocated to the individuals or organizations submitting CUE applications to the U. S. government, based on the U. S. nomination affirmed by the International Parties to the Montreal Protocol. CUE applicants who incurred significant costs in applying for a CUE would probably favor this option, which implicitly confers to them a property right to the initial distribution of permits. Methyl bromide users not represented among those applicants would have to buy permits to be able to use methyl bromide. Because most of the CUE applicants are not individual users, but consortia representing many users, this option requires a process to distribute the permits to individual users in each consortium. Permits could be distributed to consortia that completed CUE applications, and the consortia might distribute permits to their members. However, there are many ways consortia could use to make distributions to members, with many potential equity issues. The U. S. nomination was based on users with a critical need for methyl bromide, which for many sectors was less than applicants' request.

The challenge for consortia under this allocation scheme, therefore, is to distribute permits to members with a critical need for methyl bromide use, recognizing heterogeneity among members in a consortium,

with respect to costs of adopting alternatives.

Allocation by Grandfathering Permits could be distributed in proportion to historical use, for the types of uses and regions granted a CUE. This option could be satisfactory to current methyl bromide users, but would reward those who have used the most methyl bromide in the past. Those who have already switched to methyl bromide alternatives could receive fewer permits under this system. This option would provide an incentive to use as much methyl bromide as possible now in order to get the most permits.

Output based Allocation In this option, permits would be distributed in proportion to the acres grown by each grower of a crop in a region. For post harvest uses, allocation could be based on the volume of commodity treated or by the area treated ( for structural uses). This option treats all users equally according to output, but not necessarily according to patterns of production costs. Users who already switched to alternatives would be rewarded by being able to sell their permits. However, this option might not be viewed as fair by others who attempt to buy permits to supplement their initial allocation.

Allocation Auction Permits could also be distributed to the highest bidder among those uses covered by the CUE.

This option would probably lead to minimal permit trading, if any. Some users may object to bidding for *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 185  permits after incurring the cost of applying for the CUE. A small portion of auction proceeds could be to applicants to offset part of the costs of applying for the CUE, or a portion of the CUE could be allocated for applicants, again to offset costs.

CONCLUSION Marketable permit trading for methyl bromide critical use exemptions could significantly reduce economic losses to current methyl bromide users, when they are faced with adopting less effective pesticide alternatives. The effectiveness of marketable permit trading largely depends on the four factors;

1) heterogeneity in the incremental costs associated with alternatives, 2) the initial allocation of the critical use exemptions, 3) price of methyl bromide, and 4) total amount of the critical use exemption allowed.

This study shows that there are considerable variations of the incremental costs among the methyl bromide uses, and that this could lead to gains from trade in CUEs. The allocation system affects the distribution of gains from trade ( but not overall efficiency), and we explored several different options for allocation. The total amounts of the critical use exemptions influence the total size of potential efficiency gains. The potential savings of marketable permit trading to methyl bromide critical use exemptions are likely to be significant, compared to a fixed allocation system. However, the size of the savings cannot be measured accurately until the allocation and the total amounts of the critical use exemptions are determined and price of methyl bromide in 2005 can be reasonably forecasted. This also forms the basis for the continued research in this area. *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 186  REFERENCES Allen, J. and et al., ( 1993), " Using Coupon Incentives in Recycling Aluminum: A Market Approach to Energy Conservation Policy," Journal of Consumer Affairs 27( 2): 300 318.

Atkinson, S. E. and D. H. Lewis ( 1974), ` A Cost Effective Analysis of Alternative Air Quality Control Strategies', Journal of Environmental Economics and Management 1, 237 250.

Atkinson, S. E. and T. H. Tietenberg ( 1982), ` The Empirical Properties of Two Classes of Designs for Transferable Discharge Permit Markets', Journal of Environmental Economics and Management 9, 101 121.

Austin, S. ( 2001), " Designing a Nonpoint Source Selenium Load Trading Program," The Harvard Environmental Law Review 25( 2): 339 403.

Berry, D. ( 2002), " The Market for Tradable Renewable Energy Credits," Ecological Economics 42( 3): 369 379.

Boots, M. ( 2003), " Green Certificates and Carbon Trading in the Netherlands," Energy Policy 31( 1): 43 50.

Dinan, T. M. ( 1992), " Implementation Issues for Marketable Permits: A Case Study of Newsprint," Journal of Regulatory Economics 4( 1): 71 87.

Kraemer, A. and K. M. Banholzer ( 1999), Ch. IV   Tradable Permits in Water Resource Management and Water Pollution Control, Implementing Domestic Tradable Permits for Environmental Protection, OECD, Organization for Economic Co Operation and Development.

Morgan, C. L. and et al., ( 2001), " Tradable Permits for Controlling Nitrates in Groundwater at the Farm Level: A Conceptual Model," Journal of Agricultural and Applied Economics 32( 2).

Nielsen, L. and T. Jeppesen ( 2003), " Tradable Green Certificates in Selected European Countries   Overview and Assessment," Energy Policy 31( 1): 3 14.

Oates, W. E., P. R. Portney and A. M. McGartland ( 1989), ` The Net Behavior of Incentive based Regulation: A Case study of Environmental Standard Setting', American Economic Review 79, 1233 1242.

Schmalensee, R. and P. L. Joskow , A. D. Ellerman, J. P. Montero, and E. M. Bailey ( 1998), " An Interim Evaluation of Sulfur Dioxide Emissions Trading," Journal of Economic Perspectives 12( 3), 53 68 Sprenger, R.   U. ( 1999), " Designing a scheme for trading non returnable beverage containers in Germany," UK, Edward Elgar Publishing Limited: 231 254.

Stephenson, K. and Shabman, L. ( 2001), " The Trouble with Implementing TMDLs," Regulation 24( 1): 28 32.

Tietenberg, T. H. ( 1995), " Tradable Permits for Pollution Control when Emission Location Matters: What have we Learned?"' Environmental and Resource Economics 5, 95 113. *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 187  United States Environmental Protection Agency ( 2003a), methyl bromide phase out website,

http:// www. epa. gov/ spdpublic/ mbr.

United States Environmental Protection Agency ( 2003b), methyl bromide dockets and documents,

http:// cascade. epa. gov/ RightSite/ dk_ public_ home. htm.

Table 1. Total Methyl Bromide Request and U. S. Nomination for each sector in 2005 Sector Total Request by Sector ( kilograms) U. S. Sector Nomination ( kilograms)

Fresh Market Tomatoes 5,233,521 2,865,262 Strawberries 2,893,763 2,468,873 Cucurbits1 1,187,773 1,187,773 Peppers 2,003,793 1,085,265 Orchard Replant2 1,256,223 706,176 Food Processing3 612,576 536,328 Turfgrass 791,427 352,194 Sweet Potatoes 224,528 224,528 Forest Seedlings4 454,289 192,515 Commodity Uses5 135,828 87,753 Eggplant 163,173 73,565 Strawberry Nursery 380,948 54,988 Orchard Seedlings6 290,088 45,789 Ornamental Nurseries7 267,461 29,412 Ginger 18,336 9,221 Tobacco 4,612 1,323 Total 15,918,339 9,920,968 Percentage of 1991 Baseline ( 25,527,550) 62% 39%

1Cucurbits represents a crop group that includes cucumbers, melons, cantaloupes, honeydews, watermelons, and various squash varieties. 2Orchard replant represents stone fruit ( including cherry, peach, nectarine, plum, and prune), almonds, walnuts, and grapes. 3Food Processing represents rice milling, flour milling, pet food manufacturing, and bakeries. 4Forest Seedlings represent seedlings of conifers and hardwoods. 5Commodity Uses represent dried fruits, nuts, beans, and meat warehouses. 6Orchard Seedlings represent fruit tree nurseries that include citrus, peaches, prunes, nectarines, cherries, plums, apples, avocados, pears, ornamental fruit trees, and raspberry nurseries. 7Ornamental Nurseries represent chrysanthemum propagative material and nursery roses. *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 188  Table 2. The Technically Feasible Alternatives and Economic Losses per Kilogram Sector Technically Feasible Alternatives Economic Losses per Kilogram of Methyl Bromide Fresh Market Tomatoes Chloropicrin; 1,3 D + Chloropicrin1; 1,3 D + Chloropicrin + Pebulate; Metam sodium $ 6.14   $ 95.96 Strawberries 1,3 D + Chloropicrin; 1,3 D + Metam sodium $ 17.28   $ 46.72 Cucurbits Metam sodium $ 6.72  $ 37.42 Peppers 1,3 D + Chloropicrin $ 4.15   $ 20.02 Orchard Replant 1,3 D; 1,3 D + Metam sodium; 1,3 D + Chloropicrin $ 10.98  $ 43.91 Food Processing Heat treatment $ 71  $ 602 Turfgrass No technically feasible alternatives available Not available Sweet Potatoes Fallow/ crop rotation $ 9.02 Forest Seedlings Dazomet w/ tarp; Metam sodium; 1,3 D + Chloropicrin + Pebulate; $ 7.71  $ 45.32 Commodity Uses Phosphine $ 80  $ 607 Eggplant No technically feasible alternatives available Not available Strawberry Nursery No technically feasible alternatives available Not available Orchard Seedlings 1,3 D + Metam sodium; 1,3 D + Chloropicrin; $ 12.92   $ 18.60 Ornamental Nurseries Steam sterilization; 1,3, D + hoeing $ 8.68  $ 21.72 Ginger Metam sodium; Fallow $ 20.19 Tobacco No technically feasible alternatives available Not available 11,3 D is also known as 1,3 Dichloropropene and is also sold under the trade name Telone ® . *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 189

Table 3. Cost Savings of Marketable Permit Systems Command and Control System Sectoral Marketable Permit System ( SMPS) 4 Uniform Marketable Permit System ( UMPS) 5 Incremental Cost to the Sector in 1,000 $

Sector 2005 Request in 1,000 kg Reduction in Methyl Bromide use in 1,000 kg High Cost Scenario1 Average Cost Scenario2 Low Cost Scenario3 Reduction in Methyl Bromide use in 1,000 kg Incremental Cost to the Sector in 1,000 $ Reduction in Methyl Bromide use in 1,000 kg Incremental Cost to the Sector in 1,000 $

Commodity 135 47 $ 14,745 $ 7,531 $ 3,752 47 $ 3,752 0 $ 680 Food Processing 606 75 $ 41,937 $ 31,551 $ 5,353 75 $ 5,353 0 $ 1,093 Forest Seedling 443 262 $ 4,353 $ 3,671 $ 2,549 262 $ 2,549 364 $ 2,344 Ginger 18 9 $ 184 $ 184 $ 184 9 $ 184 0 $ 132 Orchard Replant 1,091 384 $ 16,883 $ 12,539 $ 4,560 384 $ 4,560 374 $ 4,258 Orchard Seedling 290 244 $ 3,424 $ 3,382 $ 3,164 244 $ 3,164 244 $ 3,161 Ornamental Nurseries 267 238 $ 5,142 $ 4,804 $ 4,758 238 $ 4,758 32 $ 3,266 Pepper 2,004 919 $ 18,389 $ 14,315 $ 9,502 919 $ 9,502 632 $ 7,918 Strawberry 2,894 425 $ 19,851 $ 10,592 $ 7,342 425 $ 7,342 0 $ 6,157 Tomatoes 5,234 2,368 $ 52,272 $ 31,615 $ 14,541 2,368 $ 14,541 3,327 $ 6,539 Total 12,98 1 4,972 $ 177,180 $ 120,193 $ 55,706 4,972 $ 55,706 4,972 $ 35,546 1 High cost scenario represents the case when all the permits are initially allocated to the applicants with lower costs in each sector.

2 Average cost scenario represents the case when all the applicants in each sector are required to have the same percentage reduction in their uses of methyl bromide to meet the U. S. nominations in each sector.

3 Low cost scenario represents the case when all the permits are initially allocated to the applicants with higher costs in each sector.

4 Sectoral Marketable Permit System ( SMPS) allows one to one permit trading only for the CUE applicants in the same sector.

5 Uniform Marketable Permit System ( UMPS) allows all the CUE applicants freely trade their methyl bromide permits to use by one to one basis. *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

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Attachment 1. The Technically Feasible Alternatives and Economic Losses for each CUE Application in 2005 Sector CUE Application Technically Feasible Alternatives 2005 Applicant Requested ( in kilograms) Economic Losses per Kilogram of Methyl Bromide Tomato # 1 Chloropicrin 52,348 $ 95.96 Tomato # 2 1,3 D + Chloropicrin + Metam sodium 136,078 $ 24.77 Tomato # 2 1,3 D + Herbicide 453,592 $ 29.59 Tomato # 3 1,3 D + Chloropicrin + Pebulate 902,603 $ 23.34 Tomato # 4 1,3 D + Chloropicrin 3,326,644 $ 6.14 Tomato # 5 1,3 D + Chloropicrin + Pebulate 362, 257 $ 18.10 Fresh Market Tomatoes Total kilograms requested : 5,233,521 Straw # 1 1,3 D + Chloropicrin 2,041,164 $ 17.28 Straw # 2 1,3 D + Chloropicrin 272,908 $ 35.83 Straw # 3 1,3 D + Chloropicrin 579,691 $ 46.72 Strawberries Total kilograms requested : 2,893,763 Cuke # 1 Metam sodium 28,187 $ 37.42 Cuke # 2 No Technically Feasible Alternative 753,688 N/ A Cuke # 3 Metam sodium 92,874 $ 6.71 Cuke # 4 No Technically Feasible Alternative 67,224 N/ A Cucurbits Cuke # 5 Metam sodium 245,800 $ 6.92 Total kilograms requested : 1,187,773 Pepper # 1 1,3 D + Chloropicrin 181,437 $ 4.15 Pepper # 2 1,3 D + Chloropicrin 112,445 $ 6.69 Pepper # 3 1,3 D + Chloropicrin 338,248 $ 6.69 Pepper # 4 1,3 D + Chloropicrin 1,371,662 $ 20.02 Peppers Total kilograms requested : 2,003,793 *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

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Sector CUE Application Technically Feasible Alternatives 2005 Applicant Requested ( in kilograms) Economic Losses per Kilogram of Methyl Bromide OrchSeed # 1 1,3 D + Chloropicrin 46,510 $ 18.60 OrchSeed # 2 1,3 D + Chloropicrin 224,528 $ 12.92 OrchSeed # 3 1,3 D + Chloropicrin 19,051 $ 13.12 Orchard Seedlings Total kilograms requested : 290,088 Food # 1 Heat Treatment 202,756 $ 71 Food # 2 Heat Treatment 14,742 $ 433 Food # 3 Heat Treatment 48,081 $ 582 Food # 4 Heat Treatment 340,194 $ 602 Food Processing Total kilograms requested : 612,576 Turf # 1 No Technically Feasible Alternatives 680,388 N/ A Turfgrass Turf # 2 No Technically Feasible Alternatives 111,039 N/ A Total kilograms requested : 791,427 Sweet Potato SweetPot # 1 Crop rotation 224, 528 $ 9.02 Forest # 1 Dazomet with tarping 246,032 $ 10.15 Forest # 2 Dazomet with tarping 41,730 $ 8.76 Forest # 3 Dazomet with tarping 20,412 $ 7.71 Forest # 4 Dazomet with tarping 52,390 $ 14.49 Forest # 5 Dazomet with tarping 4,264 $ 28.89 Forest # 6 Dazomet with tarping 22,453 $ 24.62 Forest # 7 Dazomet with tarping 24,752 $ 14.34 Forest Seedling Forest # 8 Dazomet with tarping 33,112 $ 34.61 *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

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Forest # 9 Dazomet with tarping 9,144 $ 45.32 Total kilograms requested : 454,289 Sector CUE Application Technically Feasible Alternatives 2005 Applicant Requested ( in kilograms) Economic Losses per Kilogram of Methyl Bromide Commodity # 1 No Technically Feasible Alternative 181 N/ A Commodity # 2 Phosphine 12,088 $ 218 Commodity # 3 Phosphine 20,412 $ 414 Commodity # 4 Phosphine 4,536 $ 607 Commodity # 5 Phosphine 97,704 $ 80 Commodity # 6 No Technically Feasible Alternative 907 N/ A Commodity Uses Total kilograms requested : 135,828 Eggplant # 1 No Technically Feasible Alternative 48,868 N/ A Eggplant # 2 No Technically Feasible Alternative 114,305 N/ A Eggplant Total kilograms requested : 163,173 StrawNurs # 1 No Technically Feasible Alternative 358,338 N/ A Strawberry Nursery StrawNurs # 2 No Technically Feasible Alternative 22,611 N/ A Total kilograms requested : 380,948 OrchRep # 1 1,3 D + Chloropicrin 716,449 $ 43.91 OrchRep # 2 No Technically Feasible Alternative 165,561 N/ A OrchRep # 3 1,3 D + Chloropicrin 226,796 $ 10.98 OrchRep # 4 1,3 D + Chloropicrin 147,417 $ 10.98 Orchard Replant Total kilograms requested : 1,256,223 Ornamental Ornament # 1 Steam sterilization 31,593 $ 8.68 *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

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Ornament # 2 1,3 D + hoeing 235,868 $ 21.72 Nurseries Total kilograms requested : 267,461 Ginger Ginger Fallow 18,336 $ 20.19 Tobacco Tobacco No Technically Feasible Alternative 4,612 N/ A *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 194  Appendix D: Number of Entities that Applied for CUE Applications for Critical Use Exemption in 2002 were submitted by groups consisting of multiple entities ( e. g., groups of crop growers or commodity producers). These groups, termed " consortia,"

typically represented many individual entities that grew similar crops or produced similar commodities. As an example of the diverse nature of consortia ( as opposed to individuals) that applied for CUE in 2002, in the southeastern United States alone, applications were submitted by the Southeastern Strawberry Consortium, the Southeastern Tomato Consortium, the Southeastern Cucurbit Consortium, the Florida Fruit and Vegetable Association, the Auburn University Southern Forest Nursery Management Cooperative, and the Georgia Fruit and Vegetable Growers Association. The number of individual entities that were represented in each 2002 CUE application was estimated and is provided in Exhibit 1 below.

The number of end users represented by each group or consortia application was estimated.

These estimates were made as follows:

1) 56 CUE applications were submitted to EPA and analyzed.

2) Worksheet 5 of each CUE application that was nominated for receipt of methyl bromide for CUE was consulted. Worksheet 5 contained a section for consortia to indicate the number of users represented by the application, and the range of acres farmed by the users. The number of end users indicated in this section was tallied.

3) For consortia and other groups that did not indicate the number of users in Worksheet 5, an estimate of the number of entities represented in the application was made based on Worksheet 1. Worksheet 1 contained a section that requested information on the area that methyl bromide would be applied to,

and the size of the operation of a " representative user" within the application. The area requested for methyl bromide application was then divided by the area of the operation of a typical user to estimate the number of entities represented in the application.

4) Numbers of entities represented in the CUE applications ( determined by Worksheets 1 or 5) were tallied.

Exhibit 1 provides estimates of the number of entities in each sector that applied for methyl bromide for CUE in 2002. Only those entities that applied and were nominated to receive methyl bromide for CUE are included in the exhibit. *** DRAFT ( 8/ 20/ 2004) DO NOT CITE, QUOTE OR ATTRIBUTE***

 195  Exhibit 1. Approximate Number of Entities Applying for Methyl Bromide CUE in 2002 Sector Applicants Number of Entities Almond Almond Hullers and Processors Association 10 Bean California Bean Shippers Association 6 Bell Pepper California Pepper Commission, Florida Fruit and Vegetable Association Solanaceous Application, Georgia Fruit and Vegetable Growers Association, Southeastern Pepper Consortium 8161 Citrus and Avocado California Association of Nurserymen Citrus and Avocado Growers 3 Cucumber Georgia Fruit and Vegetable Growers Association 7961 Cucurbits Michigan Cucurbit Growers, Southeastern Cucurbit Consortium 375 Deciduous Fruit & Nut Trees California Association of Nurserymen Deciduous Fruit and Nut Tree 6 Dried Plum California Dried Plum Board 60 Eggplant Georgia Fruit and Vegetable Growers Association 7961 Forest Seedling Auburn University Southern Forest Nursery Management Cooperative, Illinois Department of Natural Resources, International Paper, Michigan Seedling Association, Nursery Technology Cooperative, Western Forest and Conservation Public Nursery Association, Weyerhaeuser Company 120 Ginger Hawaii Farm Bureau Federation 7 Meat Gwaltney of Smithfield 1 Melon Georgia Fruit and Vegetable Growers Association 7961 Milling Kraft Foods North America, Inc.; North American Millers' Association; Rice Millers' Association 3662 Pet Food Pet Food Institute 78 Pistachio California Pistachio Processors 3 Raspberry Western Raspberry Nursery Consortium 7 Rose Garden Rose Council 9 Squash Georgia Fruit and Vegetable Growers Association 7961 Stone Fruit California Grape and Tree Fruit League) 90 Strawberry California Strawberry Commission, Florida Fruit and Vegetable Association, Southeastern Strawberry Consortium 1,494 Strawberry Nursery California Strawberry Nursery Association, Southeastern Strawberry Consortium 19 Sweet Potato Sweet Potato Council of California 78 Table and Raisin Grape California Grape and Tree Fruit League 5 Tobacco Seedling Tobacco Growers Association of North Carolina  63 Tomato Florida Fruit and Vegetable Association, Georgia Fruit and Vegetable Growers Association, Southeastern Tomato Consortium, Michigan Solanaceous Crops, Virginia Tomato Growers 349 Walnut   preharvest California Walnut Commission and Walnut Processing Board 38 Walnut   post harvest California Walnut Commission and Walnut Processing Board 51 TOTAL 3,218 61 Georgia squash, eggplant, cucurbit, and melon farm numbers ( 79 in each application) were not counted in the total because they were a repeat of the number of Georgia tomato farms represented.

62 Does not include the number of entities represented by the North American Millers Association because insufficient information was available to determine this value. Only the Rice Millers' Association and Kraft Foods North America, Inc. are included in this estimate.

63 The farm numbers provided in the application ( 7,730) were unreasonably high for the amount of methyl bromide requested and were therefore not included in the total estimate.