Mancozeb; Pesticide Tolerances, 44444-44455 [2013-17869]
Download as PDF
<![CDATA[
44444
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
ehiers on DSK2VPTVN1PROD with RULES
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
Dated: July 17, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Therefore, 40 CFR chapter I is
Public Reading Room is open from 8:30
amended as follows:
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
PART 180—[AMENDED]
telephone number for the Public
■ 1. The authority citation for part 180
Reading Room is (202) 566–1744, and
continues to read as follows:
the telephone number for the OPP
Docket is (703) 305–5805. Please review
Authority: 21 U.S.C. 321(q), 346a and 371.
the visitor instructions and additional
■ 2. In § 180.651, in paragraph (a), add
information about the docket available
alphabetically the following
at https://www.epa.gov/dockets.
commodities to the table to read as
FOR FURTHER INFORMATION CONTACT: Lois
follows:
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
§ 180.651 Imazosulfuron; tolerances for
residues.
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
(a) * * *
DC 20460–0001; telephone number:
Parts per (703) 305–7090; email address:
Commodity
million
RDFRNotices@epa.gov.
Melon subgroup 9A ......................
0.02 SUPPLEMENTARY INFORMATION:
I. General Information
*
*
*
*
*
Vegetable, tuberous and corm,
subgroup 1C .............................
*
*
*
*
0.02
*
[FR Doc. 2013–17823 Filed 7–23–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0628; FRL–9393–2]
Mancozeb; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of mancozeb in
or on walnuts and tangerines. United
Phosphorus requested the tolerance for
walnuts and Dow AgroSciences
requested the tolerance for tangerines
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July
24, 2013. Objections and requests for
hearings must be received on or before
September 23, 2013, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0628, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
ADDRESSES:
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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 eCFR
site at https://www.ecfr.gov/cgi-bin/textidx?&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–
E:\FR\FM\24JYR1.SGM
24JYR1
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
ehiers on DSK2VPTVN1PROD with RULES
OPP–2012–0628 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 23, 2013. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2012–0628, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of May 2, 2012
(77 FR 25954) (FRL–9346–1), 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 1F7935) by United
Phosphorus, Inc., 630 Freedom Business
Center, King of Prussia, PA 19406. The
petition requested that 40 CFR 180.176
be amended by establishing tolerances
for residues of the fungicide mancozeb
in or on walnuts at 0.75 parts per
million (ppm). That document
referenced a summary of the petition
prepared by United Phosphorus, the
registrant, which is available in the
docket (EPA–HQ–OPP–2012–0044),
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
In the Federal Register of September
28, 2012 (77 FR 59578) (FRL–9364–6),
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
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 2E8062) by Dow
AgroSciences LLC, 9330 Zionsville
Road, Indianapolis, IN 46268. The
petition requested that 40 CFR 180.176
be amended by establishing tolerances
for residues of the fungicide mancozeb
in or on tangerine at 10 ppm. The
proposed tolerance supports imports of
mandarins, tangerines, and clementines.
That document referenced a summary of
the petition prepared by Dow
AgroSciences, the registrant, which is
available in the docket (EPA–HQ–OPP–
2012–0628) https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has
modified the level at which the
tolerance is being established for
walnut. The reason for this change 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 mancozeb
including exposure resulting from the
tolerances established by this action.
Mancozeb is a member of the ethylene
bisdithiocarbamate (EBDC) group of
fungicides that also includes the related
active ingredient metiram, the only
other registered EBDC. A third EBDC,
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
44445
maneb, is no longer registered for use.
Mancozeb and metiram are metabolized
to ethylenethiourea (ETU) in the body
and both degrade to ETU in the
environment. Therefore, EPA has
considered the aggregate or combined
risks from food, water and nonoccupational exposure resulting from
mancozeb alone and ETU from all
sources (i.e., the other EBDC fungicides)
for this action. EPA’s assessment of
exposures and risks associated with
mancozeb and ETU 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. In addition to
evaluating mancozeb, EPA also
evaluated the risks of ETU, a
contaminant, metabolite and
degradation product of mancozeb and
the other EBDC group of fungicides,
which includes the related active
ingredient metiram.
1. Mancozeb. Mancozeb is not acutely
toxic via the oral, dermal or inhalation
routes of exposure. Further, mancozeb is
not a skin irritant nor is it a skin
sensitizer, although it does cause mild
eye irritation. The findings in multiple
studies demonstrate that the thyroid is
a target organ for mancozeb. Thyroid
toxicity is manifested as alternations in
thyroid hormones, increased thyroid
weight, and microscopic thyroid lesions
(mainly thyroid follicular cell
hyperplasia). These effects are due to
the ETU metabolite.
In a subchronic study in the rat,
neuropathology was seen
microscopically (injury to peripheral
nerves) with associated clinical signs
(abnormal gait and limited use of rear
legs) and loss of muscle mass. Decreased
motor activity occurred in the acute
neurotoxicity study. In the
developmental neurotoxicity study,
there was no maternal toxicity and pup
effects were limited to decreased body
weight. Other toxicity included
increases in bilateral retinopathy in the
chronic rat study. Elevated cholesterol
and a mild, regenerative, anemia
occurred in subchronic and chronic dog
studies.
Mancozeb is rapidly absorbed and
eliminated in the urine. In oral rat
metabolism studies with radiolabeled
mancozeb and other EBDCs, an average
7.5% in vivo metabolic conversion of
EBDC to ETU occurred, on a weight-to-
E:\FR\FM\24JYR1.SGM
24JYR1
44446
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
weight basis. Metabolism data indicate
mancozeb does not bio-accumulate.
Mancozeb has been tested in a series of
in vitro and in vivo genotoxicity assays,
which have shown that it exhibits weak
genotoxic potential.
Thyroid follicular cell adenomas and
carcinomas were increased in high-dose
males and females in the combined rat
toxicity/carcinogenicity study with
mancozeb. Doses in a mouse study were
too low to assess carcinogenicity, and
there were no treatment-related changes
in tumor rates. Historically, mancozeb’s
potential for carcinogenicity has been
based on its metabolite ETU, which is
classified as a probable human
carcinogen. However, since ETU is
known to be the chemical causing the
thyroid tumors observed, the cancer
assessment has been done only for ETU
rather than the parent compound.
Developmental defects in the rat
developmental toxicity study included
hydrocephaly, skeletal system defects,
and other gross defects which occurred
at a dose causing maternal mortality and
did not indicate increased susceptibility
of offspring. Abortions occurred in the
rabbit developmental toxicity study at
the high dose which also caused
maternal mortality, and there was no
indication of enhanced susceptibility of
offspring in the rabbit. There was no
evidence of reproductive toxicity in the
2-generation reproduction study in rats.
There was evidence of sensitivity in the
developmental neurotoxicity study with
mancozeb with decreased pup body
weight observed in the absence of
maternal toxicity; the selected
endpoints are protective for these pup
effects.
An immunotoxicity study has been
reviewed and mancozeb did not show
any immunotoxicity potential.
2. ETU. The thyroid is a target organ
for ETU; thyroid toxicity in subchronic
and chronic rat, mouse, and dog studies
included decreased levels of thyroxine
(T4), increases or decreases in
triiodothyronine (T3), compensatory
increases in levels of thyroid
stimulating hormone (TSH), increased
thyroid weight, and microscopic thyroid
changes, chiefly hyperplasia. Overt liver
toxicity was observed in one chronic
dog study. ETU is classified as a
probable human carcinogen based on
liver tumors in female mice.
Developmental defects in the rat
developmental study were similar to
those seen with mancozeb, and
included hydrocephaly and related
lesions, skeletal system defects, and
other gross defects. These defects
showed increased susceptibility to
fetuses because they occurred at a dose
which only caused decreased maternal
food consumption and body weight
gain.
An immunotoxicity study on ETU did
not show any immunotoxicity potential.
Specific information on the studies
received and the nature of the adverse
effects caused by mancozeb as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
titled ‘‘Mancozeb: Human Health Risk
Assessment to Support Proposed New
Section 3 Uses on Walnuts and
Tolerances for Imported Tangerines’’ on
pages 70–75 in docket ID number EPA–
HQ–OPP–2012–0628.
Additionally, specific information on
the studies received and the nature of
the toxic effects caused by ETU as well
as the NOAEL and the LOAEL from the
toxicity studies can be found at
www.regulations.gov in the document
titled ‘‘Ethylene Thiourea (ETU);
Aggregate Human Health Risk
Assessment of the Common Metabolite/
Degradate Ethylene Thiourea (ETU) to
Support Proposed New Section 3 Use on
Walnuts and Tolerance for Imported
Tangerines’’ on pages 30–33 in docket
ID number EPA–HQ–OPP–2012–0628.
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for mancozeb and ETU used
for human risk assessment is shown in
Tables 1 and 2 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MANCOZEB FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and
uncertainty/safety
factors
RfD, PAD, LOC for risk assessment
ehiers on DSK2VPTVN1PROD with RULES
Acute dietary (Adult Males, Females > 49, and Children ≥ 6
years).
NOAEL = 500 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 5 mg/kg/day ............................................................
aPAD = 5 mg/kg/day
Acute dietary (Children < 6
years).
NOAEL = 500 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF UFDB =
10x
Acute RfD = 5 mg/kg/day ............................................................
aPAD = 0.5 mg/kg/day
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
E:\FR\FM\24JYR1.SGM
24JYR1
Study and
toxicological
effects
Acute neurotoxicity
study in the rat.
LOAEL 1,000 mg/kg/
day based on decreased motor activity.
Acute neurotoxicity
study in the rat.
LOAEL 1,000 mg/kg/
day based on decreased motor activity.
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
44447
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MANCOZEB FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Acute Dietary (Females 13–49
years).
Point of departure
and
uncertainty/safety
factors
RfD, PAD, LOC for risk assessment
NOAEL = 1.28 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF UFDB =
10x
Acute RfD = 1.3 mg/kg/day .........................................................
aPAD = 0.13 mg/kg/day
NOAEL = 4.83 mg/
kg/day.
UFA = 3x
UFH = 10x
FQPA SF = 1x
Chronic dietary (Females 13–49 NOAEL = 4.83 mg/
years and Children < 6 years).
kg/day.
UFA = 3x
UFH = 10x
FQPA SF UFDB =
10x
Inhalation all durations (Adult
Inhalation study
Males, Females > 49 years,
NOAEL = 0.079
and Children ≥ 6 years).
mg/L (21 mg/kg/
day).
UFA = 3x
UFH = 10x
FQPA SF = 1x
Inhalation all durations (FeInhalation study
males 13–49 years and ChilNOAEL= 0.079
dren < 6 years).
mg/L (21 mg/kg/
day).
UFA = 3x
UFH = 10x
FQPA SF UFDB =
10x
Chronic RfD = 0.16 mg/kg/day ....................................................
cPAD = 0.16 mg/kg/day
Chronic dietary (Adult Males,
Females > 49, and Children
≥ 6 years).
Cancer (Oral, dermal, inhalation).
Chronic RfD = 0.16 mg/kg/day ....................................................
cPAD = 0.016 mg/kg/day
Study and
toxicological
effects
Developmental toxicity study in the
rat.
LOAEL = 512 mg/kg/
day based on
hydrocephaly and
other malformations.
Toxicity/Carcinogenicity in the rat.
LOAEL = 30.9 mg/
kg/day based on
thyroid toxicity.
Toxicity/Carcinogenicity in the rat.
LOAEL = 30.9 mg/
kg/day based on
thyroid toxicity.
LOC for MOE = 30 ......................................................................
Subchronic Inhalation in the rat.
LOAEL = 0.326 mg/L
based on thyroid
toxicity.
LOC for MOE = 300 ....................................................................
Subchronic Inhalation in the rat.
LOAEL = 0.326 mg/L
based on thyroid
toxicity.
Mancozeb’s potential for carcinogenicity is due to the formation of the metabolite, ETU, which is classified as a
probable human carcinogen. Mancozeb’s cancer risk is calculated by estimating exposure to mancozeb-derived ETU and using the ETU cancer potency factor (Q1*) of 6.01 × 10¥2 (mg/kg/day)¥1 to quantitate risk.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligrams/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). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies).
TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETU FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
NOAEL = 5 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF UFDB =
10x
Study and toxicological effects
A study with acute
toxicity applicable
to the general population was not
identified.
Acute Dietary (Females 13–49
years).
ehiers on DSK2VPTVN1PROD with RULES
Acute dietary (General population including infants and
children).
RfD, PAD, LOC for
risk assessment
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
PO 00000
Acute RfD = 0.05
mg/kg/day.
aPAD = 0.005 mg/
kg/day
Frm 00029
Fmt 4700
Sfmt 4700
Developmental Rat Toxicity.
LOAEL = 10 mg/kg/day, based on hydrocephaly and other malformations.
E:\FR\FM\24JYR1.SGM
24JYR1
44448
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETU FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Point of departure
and uncertainty/
safety factors
Chronic dietary (Adult Males,
Females > 49, and Children
≥ 6 years).
NOAEL = 0.18 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic dietary (Females 13–49 NOAEL = 0.18 mg/
years and Children < 6 years).
kg/day.
UFA = 10x
UFH = 10x
FQPA SF UFDB =
10x
Dermal short and intermediateOral study ................
term (Children < 6 years old). NOAEL = 7 mg/kg/
day (dermal absorption rate =
26%)
UFA = 10x
UFH = 10x
FQPA SF = 10x
Dermal short and intermediateOral study ................
term (Adult Males, Females.
NOAEL = 7 mg/kg/
> 49 years, Children ≥ 6
day (dermal abyears).
sorption rate =
26%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
Dermal short- and intermediate- Oral study ................
term (Females 13–49 years
NOAEL = 5 mg/kg/
old).
day (dermal absorption rate =
26%)
UFA = 10x
UFH = 10x
FQPA SF = 10x
Inhalation short- and interOral study ................
mediate-Term (Children < 6
NOAEL = 7 mg/kg/
years of age).
day
UFA = 10x
UFH = 10x
FQPA SF UFDB =
10x
Inhalation short- and interOral study ................
mediate-term (adult males,
NOAEL= 7 mg/kg/
females > 49 years, children
day
≥ 6 years).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Inhalation short- and interOral study ................
mediate-term (Females 13–
NOAEL = 5 mg/kg/
49 years old).
day
UFA = 10x
UFH = 10x
FQPA SF = 10x
Cancer (Oral, dermal, inhalation).
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Chronic RfD =
0.0018 mg/kg/day.
cPAD = 0.0018 mg/
kg/day
Dog Chronic Oral Toxicity.
LOAEL = 1.99 mg/kg/day based on thyroid toxicity.
Chronic RfD =
0.0018 mg/kg/day.
cPAD = 0.00018 mg/
kg/day
Dog Chronic Oral Toxicity.
LOAEL = 1.99 mg/kg/day based on thyroid toxicity.
LOC for MOE =
1,000.
4-Week Range-Finding Dog Study.
LOAEL = 34 mg/kg/day based on thyroid toxicity.
LOC for MOE = 100
4-Week Range-Finding Dog Study.
LOAEL = 34 mg/kg/day based on thyroid toxicity.
LOC for MOE =
1,000.
Developmental Rat Toxicity.
LOAEL = 10 mg/kg/day, based on hydrocephaly and other malformations.
LOC for MOE =
1,000.
4-Week Range-Finding Dog Study.
LOAEL = 34 mg/kg/day based thyroid toxicity.
LOC for MOE = 100
4-Week Range-Finding Dog Study.
LOAEL = 34 mg/kg/day based thyroid toxicity.
LOC for MOE =
1,000.
Developmental Rat Toxicity.
LOAEL = 10 mg/kg/day, based on hydrocephaly and other malformations.
ETU is classified as a probable human carcinogen. ETU’s cancer potency factor
(Q1*) is 6.01 × 10¥2 (mg/kg/day)¥1.
ehiers on DSK2VPTVN1PROD with RULES
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligrams/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). UFDB = to account for the absence of data or other data deficiency. 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 mancozeb, EPA considered
VerDate Mar<15>2010
18:27 Jul 23, 2013
Jkt 229001
exposure under the petitioned-for
tolerances as well as all existing
mancozeb tolerances in 40 CFR 180.176.
In evaluating dietary exposure to ETU,
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
EPA considered exposure under the
petitioned-for tolerances discussed in
this document as well as all existing
uses of the EBDC group of fungicides
E:\FR\FM\24JYR1.SGM
24JYR1
ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
(mancozeb and metiram). EPA assessed
dietary exposures from mancozeb and
ETU 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 mancozeb and ETU. In estimating
acute dietary exposure for both
mancozeb and ETU, EPA used food
consumption information from the
2003–2008 food consumption data from
the U.S. Department of Agriculture’s
(USDA’s) National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA).
a. Mancozeb. The Agency conducted
a highly refined, probabilistic acute
dietary assessment incorporating field
trial or monitoring data from the EBDC/
ETU Market Basket Survey, percent crop
treated (PCT) information, and
processing study results to assess the
established uses of mancozeb. The
monitoring data were used for several
commodities (corn, cucumber, onion,
pumpkin, potato, squash, starfruit,
tomato, meat, and milk). For evaluation
of the proposed new uses and
tolerances, field trial data, processing
factors, PCT data based on section 18
usage for walnuts, and percent imported
commodity in domestic consumption
data on tangerines for mancozeb were
used to refine residue estimates. The
entire distributions of residue data from
field trials or monitoring data were used
to generate residue distribution files
(RDFs) for commodities that are
considered to be not blended or
partially blended. For commodities
considered to be blended, the average
residues incorporating the likely
maximum estimated PCT was used as a
point estimate.
b. ETU. The Agency conducted a
highly refined, probabilistic acute
dietary assessment incorporating field
trial or monitoring data from the EBDC/
ETU Market Basket Survey, PCT
information, and processing study
results to assess exposures to ETU from
the established uses of mancozeb and
metiram. The monitoring data were
used for several commodities (corn,
cucumber, onion, pumpkin, potato,
squash, starfruit, tomato, meat, and
milk). For evaluation of the proposed
new uses and tolerances, field trial data,
processing factors, PCT data based on
section 18 usage for walnuts, and
percent imported commodity in
domestic consumption data on
tangerines for mancozeb were used to
refine residue estimates. The entire
distributions of residue data from field
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
trials or monitoring data were used to
generate residue distribution files
(RDFs) for commodities that are
considered to be not blended or
partially blended. For commodities
considered to be blended, the average
residues incorporating the likely
maximum estimated PCT was used as a
point estimate.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
for both mancozeb and ETU, EPA used
food consumption information from the
2003–2008 food consumption data from
the USDA NHANES/WWEIA.
a. Mancozeb. The chronic dietary
exposure and risk assessment for
mancozeb (non-cancer and cancer)
incorporated average values based either
on field trial data or monitoring data
and average PCT data for new and
existing uses, as well as processing and
cooking factors. Averages of the field
trials were used for the walnuts and
tangerines, while field trial and market
basket survey data were used for
established uses.
b. ETU. Chronic anticipated residues
were calculated using average values
based either on field trial data or
monitoring data and average PCT data
or average projected PCT as well as
processing and cooking factors.
Averages of the field trials were used for
the walnuts and tangerines, while field
trial and market basket survey data were
used for established uses.
iii. Cancer. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse pesticide based on the weight of the
evidence from cancer studies and other
relevant data. If quantitative cancer risk
assessment is appropriate, cancer risk
may be quantified using a linear or
nonlinear approach. If sufficient
information on the carcinogenic mode
of action is available, a threshold or
nonlinear approach is used and a cancer
RfD is calculated based on an earlier
noncancer key event. If carcinogenic
mode of action data are not available, or
if the mode of action data determines a
mutagenic mode of action, a default
linear cancer slope factor approach is
utilized.
The cancer risks were aggregated
using the food and drinking water doses
for the general population and the food,
water and recreational doses for home
gardeners (considered protective of
other residential scenarios). The average
daily dose was used for food and water
exposures and the lifetime average daily
dose was used for the recreational
exposures. The aggregate doses were
multiplied times the potency factor for
ETU, 0.0601 (mg/kg/day) ¥1 to
determine the cancer risks.
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
44449
Mancozeb degrades and/or
metabolizes to ETU which causes
thyroid tumors; therefore, EPA has
historically attributed mancozeb’s
carcinogenicity to the formation of ETU,
which is classified as a probable human
carcinogen. The Agency has used the
cancer potency factor (Q1*) of 0.0601
(mg/kg/day) ¥1 for ETU (based on liver
tumors in female mice) for risk
assessment. Therefore, cancer risk from
exposure to mancozeb has been
calculated by estimating exposure to
mancozeb-derived ETU and using the
Q1* for ETU. The same approach has
been taken for the other EBDCs. EPA’s
estimated exposure to mancozebderived ETU included ETU residues
found in food as well as ETU formed by
metabolic conversion on parent
mancozeb in the body (conversion rate
of 0.075).
iv. Anticipated residue and percent
crop treated (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.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
For mancozeb and ETU derived from
mancozeb, the following maximum PCT
E:\FR\FM\24JYR1.SGM
24JYR1
ehiers on DSK2VPTVN1PROD with RULES
44450
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
estimates were used in the acute dietary
risk assessment for the following crops:
Apples: 45%; asparagus: 30%; barley:
2.5%; cantaloupes: 15%; carrots: 2.5%;
celery: 2.5%; corn: 2.5%; cranberries:
20%; cucumbers: 50%; grapes: 20%;
oats: 1%; onions: 70%; peanuts: 2.5%;
pears: 50%; potatoes: 65%; pumpkins:
15%; rice: 2.5%; spinach: 2.5%; squash:
30%; sugar beets: 2.5%; sweet corn:
15%; tomatoes: 50%; watermelons:
50%; and wheat: 2.5%. A percent
import value of 99% was used for
banana.
For mancozeb and ETU derived from
mancozeb, the following average PCT
estimates were used in the chronic and
cancer dietary risk assessments for the
following crops: Apples: 40%;
asparagus: 15%; barley: 1%;
cantaloupes: 5%; carrots: 1%; celery:
1%; cherries: 1%; corn: 1%; cranberries:
20%; cucumbers: 25%; grapes: 10%;
oats: 1%; onions: 60%; peanuts: 2.5%;
pears: 40%; potatoes: 55%; pumpkins:
10%; rice: 1%; spinach: 1%; squash:
20%; sugar beets: 1%; sweet corn: 5%;
tomatoes: 25%; watermelons: 40%; and
wheat: 1%. A percent import value of
99% was used for banana.
As a further refinement, the
commodity having the highest PCT
results with livestock feed uses had
these values applied to meat and milk
(potato; 65% CT maximum for acute
and 55% CT average for chronic).
For ETU derived from metiram, the
following maximum PCT estimates were
used in the acute dietary risk
assessment: apples: 15%; potatoes: 10%.
A 31% imported commodity in
domestic consumption was used for
wine grapes.
For ETU derived from metiram, the
following average PCT estimates were
used in the chronic and cancer dietary
risk assessment: Apples: 10%; potatoes:
5%. A 31% imported commodity in
domestic consumption was used for
wine grapes.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
Also, for the acute risk assessment for
mancozeb and ETU derived from
mancozeb, the Agency estimated PCT
for the following uses for mancozeb,
which were recently approved in 2011:
Almond, 25%; broccoli, 6%; cabbage,
47%; cabbage, Chinese, 47%; head
lettuce 75%; leaf lettuce 66%; pepper,
bell, 48%; pepper, non-bell, 48%. For
the chronic risk assessment for
mancozeb and ETU derived from
mancozeb, the Agency estimated PCT as
follows: Almond, 18%; broccoli, 5%;
cabbage, 42%; cabbage, Chinese, 42%;
head lettuce 67%; leaf lettuce 62%;
pepper, bell, 44%; pepper, non-bell,
44%. Since metiram is not registered for
use on these crops, all potential ETU
exposure on these crops will result from
use of mancozeb.
EPA developed these refined PCT
values based on a detailed chemicalspecific analysis. EPA has considered
all available relevant information and
concludes that it is unlikely that the
PCT values for these uses will be
exceeded during the next 5 years.
Further discussion of how these PCT
values were derived can be found at
www.regulations.gov in the document
titled ‘‘Percent Crop Treated for new
Uses (PCTn) of Mancozeb on Almonds,
Broccoli, Cabbage, Pepper, Pumpkin,
and Winder Squash, PC Code: 014504;
DP Barcode: 360397; Lettuce, both head
and Other; PC Code: 014504; DP
Barcode: 364745, NON PRIA, Parent DP:
635267; and Percent Crop Treated with
Maneb for Collards, Mustard Greens,
Turnip Greens, and Kale’’ in docket ID
number EPA–HQ–OPP–2012–0628.
For mancozeb and ETU derived from
mancozeb, a maximum PCT projected
estimate of 50% for walnuts and a
maximum percent import consumption
value of 35% for tangerines were used
in the acute dietary risk assessment. An
average PCT estimate of 40% for
walnuts as well as an average percent
imported commodity in domestic
consumption value of 29% for
tangerines were used in the chronic and
cancer dietary risk assessments.
The walnut information is an
amalgamation of the USDA/NASS and
private pesticide market research data.
The PCT values for walnuts are derived
from survey data reported in 2006, 2010,
and 2011. Only the state of California is
represented in the survey data as 99%
of the walnuts grown in the United
States are grown in that state. The
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
percent of imported fresh mandarin
oranges in domestic consumption was
calculated with data for the reporting
period of 2008–2013 obtained from the
Foreign Agricultural Service (FAS)
USDA/Office of Global Analysis (FAS,
2013).
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition a, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certain
that the percentage of the food treated
is not likely to be an underestimation.
As to Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which mancozeb may be applied in a
particular area.
2. Dietary exposure from drinking
water—i. Mancozeb. The Agency has
determined that mancozeb is very shortlived in soil and water, and would not
reach water used for human
consumption whether from surface
water or ground water.
ii. ETU. ETU is highly water soluble,
and may reach both surface water and
ground water under some conditions.
The ETU surface water Estimated
Drinking Water Concentrations (EDWCs)
were generated using a combined
monitoring/modeling approach. Results
of a surface water monitoring study
conducted by the ETU Task Force were
used to refine the outputs of the
Pesticide Root Zone Model/Exposure
Analysis Modeling System (PRZM–
EXAMS) models; the site/scenario
modeled was application of an EBDC
fungicide on peppers in Florida, and
was chosen to produce the highest
EDWC acute values. The ground water
EDWC was detected in a Florida
community water system intake in a
targeted ground water monitoring study
conducted by the EBDC task force from
1999 to 2003. Both these surface water
and ground water values represent
E:\FR\FM\24JYR1.SGM
24JYR1
ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
upper-bound conservative estimates of
the total ETU residual concentrations
that might be found in surface water and
ground water due to the use of the EBDC
fungicides.
Based on the PRZM/EXAMS and
monitoring studies, the EDWCs of ETU
acute and chronic exposures are
estimated to be 25.2 parts per billion
(ppb), and 0.1 ppb, respectively for
surface water. The EDWC for acute and
chronic exposure is estimated to be 0.21
ppb for ground water.
Estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 25.2 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment of ETU, the water
concentration of value 0.21 ppb was
used to assess the contribution to
drinking water. For cancer dietary risk
assessment of ETU, the water
concentration of value 0.21 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
1. Mancozeb. Mancozeb is currently
registered for use on the following
residential sites: Home gardens, golf
courses, and sod farms (where treated
sod could be transplanted to a
residential setting). The Agency has
determined that it is appropriate to
aggregate chronic exposure through food
with short-term residential exposures to
mancozeb.
The exposure scenario that was
evaluated for mancozeb was the
residential handler home garden use
which considers residential handler
exposures (inhalation) to adult
applicators combined with average food
exposures. Dermal exposure was not
evaluated because no effects were
observed in a mancozeb 28-day dermal
toxicity study.
For post-application, dermal exposure
to home gardeners (adults and youth)
harvesting vegetables from treated
gardens and golfers (adults and youth)
contacting mancozeb-treated turf after
application is possible. However, as no
dermal hazard was identified for
mancozeb, a quantitative dermal postapplication assessment (non-cancer/
short-term and cancer) for the dermal
exposure to home gardeners and golfers
(adults and youth) was only performed
for its metabolite, ETU.
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
The previous mancozeb risk
assessment had evaluated the short/
intermediate-term exposure of toddlers
to treated turf from the sod farm use. In
the most recent risk assessment, the
Agency considered post-application
exposure resulting from this scenario to
be negligible for the following reasons:
(1) Mancozeb has a post-harvest interval
(PHI) of 5 days for sod; (2) it is unlikely
that sod treated with mancozeb would
be installed more than once per year; (3)
transplanted sod requires constant and
significant watering which will result in
decreased mancozeb residues on the
transplanted sod; and (4) it is unlikely
that adults or children will spend any
significant amount of time on recently
transplanted sod until it is rooted which
typically occurs around 2 weeks after
transplanting. Therefore, dermal and
incidental oral post-application
scenarios were not quantitatively
assessed for the sod farm use of
mancozeb. There are no postapplication exposure risks of concern
anticipated from the use of mancozeb on
sod farms.
ii. ETU. ETU non-dietary exposure is
expected as a result of the registered
uses of mancozeb, which is currently
registered for use on the following
residential sites: home gardens, golf
courses, and sod farms (where treated
sod could be transplanted to a
residential setting). There are no uses of
metiram that will result in exposure in
residential settings. The Agency has
determined that it is appropriate to
aggregate chronic exposure through food
with short-term residential exposures to
ETU.
The scenario that was evaluated for
ETU was the residential home garden
use, which considered handler garden
exposures (inhalation and dermal) plus
average daily food and drinking water
exposure for adults and post-application
garden exposures (dermal) plus average
daily food and drinking water exposure
for females 13–49 years old and youths.
The previous risk assessment also
considered treated turf (sod farm) postapplication exposures to toddlers
(incidental oral and dermal). This more
recent risk assessment did not evaluate
the sod farm use for the reasons
outlined above in the mancozeb nondietary exposure section.
The previous risk assessment also
calculated risks for adult and youth
golfers from golfing on treated turf. The
more recent assessment concluded that
for residential post-application, the
gardening scenarios represent the most
conservative exposure estimates and are
used in the aggregate assessment. The
gardening scenarios result in higher
estimated exposure than the golfing
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
44451
scenarios and are therefore protective of
any golfer risk.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
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.’’
As previously mentioned, the risk
estimates summarized in this document
are those that result only from the use
of mancozeb, and ETU derived from
mancozeb and metiram, the other
registered EBDC chemical, both of
which are dithiocarbamates. For the
purposes of this action, EPA has
concluded that mancozeb does not share
a common mechanism of toxicity with
other substances. The Agency reached
this conclusion after a thorough internal
review and external peer review of the
data on a potential common mechanism
of toxicity.
EPA concluded that the available
evidence does not support grouping the
dithiocarbamates based on a common
toxic effect (neuropathology) occurring
by a common mechanism of toxicity
(related to metabolism to carbon
disulfide). After a thorough internal and
external peer review of the existing data
bearing on a common mechanism of
toxicity, EPA concluded that the
available evidence shows that
neuropathology cannot be linked with
carbon disulfide formation. For more
information, please see the December
19, 2001 memo, ‘‘The Determination of
Whether Dithiocarbamate Pesticides
Share a Common Mechanism of
Toxicity’’ on the internet at https://
www.epa.gov/oppsrrd1/cumulative/
dithiocarb.pdf.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
E:\FR\FM\24JYR1.SGM
24JYR1
ehiers on DSK2VPTVN1PROD with RULES
44452
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
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—
i. Mancozeb. In the rat developmental
study, developmental effects were
observed in the presence of severe
maternal effects, including maternal
mortality and clinical signs. In the
rabbit developmental study,
developmental effects (spontaneous
abortions) were observed at the same
dose (80 mg/kg/day) at which maternal
effects included mortality and clinical
signs. In the rat reproduction study, no
effects were observed in offspring, while
thyroid effects and body weight gain
decrements occurred in adults. There
was evidence of sensitivity in the
developmental neurotoxicity study with
mancozeb with decreased pup body
weight occurring in the absence of
maternal toxicity; risk assessment
endpoints are protective for these pup
effects.
ii. ETU. There is evidence of
increased susceptibility of fetuses to
ETU. Fetal malformations occurred
mainly in rats, although hydrocephaly
and domed head were observed in a
rabbit developmental study with ETU.
The malformations in rats occurred
throughout the body. Hydrocephaly
occurred in the absence of maternal
toxicity after treatment with a single
dose of ETU. There was a steep doseresponse for the malformations in rats.
An acceptable reproductive toxicity
study was not available for ETU. As a
result, the Agency evaluated the level of
concern for the effects observed when
considered in the context of all available
toxicity data. In addition, the Agency
evaluated the database to determine if
there were residual uncertainties after
establishing toxicity endpoints and
traditional uncertainty factors to be used
in the ETU risk assessment.
3. Conclusion for mancozeb. EPA is
retaining the 10X FQPA safety factor for
women of childbearing age and for
children less than 6 years old but has
determined that reliable data show the
safety of children greater than 6 years of
age would be adequately protected if the
FQPA safety factor were reduced to 1X.
That decision is based on the following
findings:
i. The toxicology database for
mancozeb is complete, except that it
lacks adequate data on the developing
thyroid. Brain development is very
sensitive to perturbations in thyroid
hormones and it is possible that the
developmental thyroid study (being
conducted with ETU) could result in
lower NOAELs for women of
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
childbearing age (i.e., fetuses) and for
children less than 6 years old. Results
from the developmental thyroid study
will not affect endpoints for children
over 6 years of age (for whom the
thyroid system is more developed) or
adults as thyroid data for those
populations are already available.
Therefore, the FQPA safety factor is
reduced to 1X for these populations.
ii. There was some evidence of
neurotoxicity for mancozeb as seen in
the acute and subchronic neurotoxicity
studies; however, no neurotoxicity
occurred in the DNT. Additionally,
there are clear NOAELs identified for
the effects observed in the toxicity
studies. The doses and endpoints
selected for risk assessment are
protective of all neurotoxicological
effects observed in the database.
iii. As noted above in Unit III.D.2.,
there was some evidence of increased
susceptibility of rat pups to mancozeb
exposure. Aside from the uncertainty
resulting from the lack of adequate
thyroid data (for which EPA is retaining
the 10X FQPA safety factor), there are
clear NOAELs for the offspring effects,
and regulatory doses were selected to be
protective of these effects.
iv. There are no residual uncertainties
identified in the exposure databases.
The acute, chronic, and cancer dietary
exposure assessments were refined and
used PCT estimates and monitoring
residue values for several commodities,
including some major contributors to
the dietary risk such as milk and corn
commodities. Monitoring or modeling
data were used to derive estimated
drinking water concentrations. The
drinking water concentrations that were
derived from monitoring data reflect the
highest value found in a community
well monitoring program. The drinking
water concentrations from modeling
used conservative, health-protective,
high-end estimates and are unlikely to
be exceeded. The residential exposure
assessment used residential SOPs,
which are based on conservative highend assumptions such as maximum
application rates and day 0 exposures.
Given the overall conservative nature of
the exposure assumptions, the aggregate
(food, water, and residential) exposure
and risk estimates presented in this
assessment are not expected to
underestimate actual exposure and risk
expected based on the current and
proposed use patterns.
4. Conclusion for ETU. EPA is
retaining the 10X FQPA safety factor for
women of childbearing age and for
children less than 6 years old but has
determined that reliable data show the
safety of children 6 years of age or older
would be adequately protected if the
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
FQPA safety factor were reduced to 1X.
That decision is based on the following
findings:
i. The toxicology database for ETU is
missing a developmental thyroid study,
a reproduction study, and a
developmental neurotoxicity (DNT)
study. These data gaps are being
addressed by an ongoing extended onegeneration reproductive toxicity study.
Because the developing brain is very
sensitive to perturbations in thyroid
hormones, it is possible that these
studies could result in lower NOAELs
for women of childbearing age (i.e.,
fetuses) and for children less than 6
years old; however, results from the
developmental thyroid study will not
affect points of departure for children
greater than 6 years of age, who have a
thyroid system similar to adults, adult
females greater than 49 years of age
(assumed to be beyond typical childbearing age), or adult males since
thyroid data for those populations are
already available. Additionally,
endpoints from the other segments of
the extended one-generation study will
not affect these latter populations, and
the FQPA safety factor is being reduced
to 1X for these populations.
ii. Although the ETU studies were
inadequate in evaluating signs of
neurotoxicity, there was no evidence of
neurotoxicity seen in any study in the
database. In any event, the Agency has
determined that the selected endpoints
would be protective of potential
neurotoxicity. The basis for this is that
the principal toxic effects occur in the
thyroid; thyroid effects provide the most
sensitive endpoint, which the Agency is
regulating on. Although the extended 1gen study being performed on ETU is
evaluating the potential for effects on
the developing brain, the Agency does
not believe that a 10X FQPA safety
factor is necessary to protect children 6
years old or older because: (1) The
weight-of-evidence of the available data
indicates that thyroid effects are the
most sensitive effect of this chemical;
(2) the Agency is regulating on the more
sensitive thyroid effect; and (3) the
Agency is retaining a 10X FQPA safety
factor for the population most likely
affected by the thyroid effects.
iii. As noted in Unit III.D.2., there is
evidence of increased quantitative and
qualitative susceptibility following
increased in utero exposure to ETU. The
developmental study with the lowest
NOAEL was selected for the acute
endpoint for women of childbearing age
and is therefore protective of the
developmental malformations. The only
remaining developmental uncertainties
are related to effects on the developing
fetus caused by perturbations in the
E:\FR\FM\24JYR1.SGM
24JYR1
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
ehiers on DSK2VPTVN1PROD with RULES
still-not-completely-developed thyroid
in children younger than 6 years old.
Brain development being very sensitive
to perturbations in thyroid hormones, it
is possible that the extended 1generation reproductive toxicity test, in
which developmental thyroid effects
will be evaluated, will result in lower
NOAELs for these populations than are
presently being used to assess risk;
therefore, the Agency is retaining the
10X FQPA safety factor for females 13–
49 years of age and for children less
than 6 years of age.
iv. There are no residual uncertainties
identified in the EBDC’s (mancozeb or
metiram) exposure databases for ETU
assessment. The acute, chronic, and
cancer dietary exposure assessments
were refined and used PCT estimates
and monitoring residue values for
several commodities including some
major contributors to the dietary risk
such as milk and corn commodities.
Monitoring or modeling data were used
to derive estimated drinking water
concentrations. The drinking water
concentrations that were derived from
monitoring data reflect the highest value
found in a community well monitoring
program. The drinking water
concentrations from modeling used
conservative, health-protective, highend estimates and are unlikely to be
exceeded. The residential exposure
assessment used residential SOPs,
which are based on conservative highend assumptions such as maximum
application rates and day 0 exposures.
Given the overall conservative nature of
the exposure assumptions, the aggregate
(food, water, and residential) exposure
and risk estimates presented in this
assessment are not expected to
underestimate actual exposure and risk
expected based on the current and
proposed use patterns.
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. (mancozeb). The
mancozeb acute aggregate assessment
considers acute exposure to mancozeb
only and not ETU. Further, this
assessment is based on residues of
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
mancozeb in food only since residues of
mancozeb are not expected in drinking
water. Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food to mancozeb will occupy
9.9% of the aPAD for children 1–2 years
old, the population subgroup receiving
the greatest exposure.
2. Acute risk (ETU). Using the
exposure assumptions discussed in this
unit for acute exposure, the acute
dietary exposure from food and water to
ETU (from mancozeb and metiram) will
occupy 60% of the aPAD for females
13–49 years of age, the only population
group of concern.
3. Chronic risk (mancozeb). There are
no long-term residential exposure
scenarios for mancozeb and there is not
likely to be residues of mancozeb in
drinking water. Therefore, the long-term
or chronic (non-cancer) aggregate risk
for mancozeb includes contribution
from food alone. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to mancozeb from
food will utilize 2.3% of the cPAD for
children 1–2 years of age, the
population group receiving the greatest
exposure.
4. Chronic risk (ETU). There are no
long-term residential exposure scenarios
for ETU; the aggregate chronic risks
were calculated using food and water
exposure only. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to ETU (from
mancozeb and metiram) from food and
water will utilize 58% of the cPAD for
children (1 to 2 years old), the
population group receiving the greatest
exposure.
5. Short-term risk (mancozeb). Shortterm aggregate exposure takes into
account short-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Mancozeb 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
with short-term residential exposures to
mancozeb. The scenario that was
evaluated for mancozeb was the
residential handler home garden use.
The aggregate short-term home garden
MOEs for adult males and females
greater than 49 years old is 99,000 and
the MOE for adult females 13–49 years
old is 94,000. Because for mancozeb
EPA is concerned only with MOEs that
are below 30 (adult males and females
greater than 49 years old) and 300 (adult
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
44453
females 13–49 years old), these MOEs
do not raise a risk concern.
6. Short-term risk (ETU). 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).
Mancozeb is currently registered for
uses that could result in short-term
residential exposure to ETU. There are
no residential uses for metiram. The
Agency determined that it was
appropriate to aggregate chronic
exposure through food with short-term
residential exposures to ETU. The ETU
short-term handler home garden
aggregate MOE for adult females 13–49
years old is 27,000 and for adult males
(and females older than 49 years old) is
42,000. The ETU short-term postapplication home garden aggregate MOE
for adult females 13–49 years old is
2,600 and for youths 11–16 years old is
3,100. Because for ETU EPA is
concerned only with MOEs that are
below 1,000 (adult females 13–49 years
old) and 100 (adult males, females >49
years old and youth 11–16 years old),
these MOEs do not raise a risk concern.
7. 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, mancozeb is
not registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm 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
mancozeb.
8. Aggregate cancer risk for U.S.
population. As noted earlier in this
document, mancozeb degrades and/or
metabolizes to ETU which causes the
same types of thyroid tumors as those
seen when animals are dosed with
mancozeb; therefore, EPA has
historically attributed mancozeb’s
carcinogenicity to the formation of ETU,
which is classified as a probable human
carcinogen.
The cancer aggregate risk estimates
(home garden handler and postapplication scenarios) for the U.S.
E:\FR\FM\24JYR1.SGM
24JYR1
44454
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
population are 2 × 10¥6 and 3 × 10¥6,
respectively.
EPA generally considers cancer risks
(expressed as the probability of an
increased cancer case) in the range of 1
in 1 million (or 1 × 10¥6) or less to be
negligible. The precision which can be
assumed for cancer risk estimates is best
described by rounding to the nearest
integral order of magnitude on the
logarithmic scale; for example, risks
falling between 3 × 10¥7 and 3 × 10¥6
are expressed as risks in the range of
10¥6. Considering the precision with
which cancer hazard can be estimated,
the conservativeness of low-dose linear
extrapolation, and the rounding
procedure described above, cancer risk
should generally not be assumed to
exceed the benchmark level of concern
of the range of 10¥6 until the calculated
risk exceeds approximately 3 × 10¥6.
This is particularly the case where some
conservatism is maintained in the
exposure assessment. Although the
mancozeb risk assessment is highly
refined, the Agency believes there is
some conservatism for the following
reasons: (1) The linear low-dose
extrapolation approach is conservative
because it does not take into account
certain human biological processes such
as reversibility and repair; (2) the
residential SOPs are based on
conservative high-end assumptions such
as maximum application rates and day
0 exposures; and (3) some food
exposures are estimated based on
tolerance-level residues. Accordingly,
EPA has concluded the cancer risk for
all existing mancozeb uses and the uses
associated with the tolerances
established in this action fall within the
range of 1 × 10¥6 and are thus
negligible.
9. 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 mancozeb
and/or ETU residues.
ehiers on DSK2VPTVN1PROD with RULES
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methods are available for
the enforcement of tolerances for the
plant commodities which are the subject
of this request. The Pesticide Analytical
Method (PAM) Vol. II lists Methods I, II,
III, IV, and A for the determination of
dithiocarbamate residues in/on plant
commodities. The Keppel colorimetric
method (Method III) is the preferred
method for tolerance enforcement. The
Keppel method determines EBDCs as a
group by degradation to CS2. The
analytical methodology for ETU is based
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
on the original method published by
Olney and Yip (JAOAC 54:165–169).
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address:
residuemethods@epa.gov.
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.
There is no Codex MRL established
for mancozeb on walnuts.
There is a MRL of 10 ppm established
by Codex for the use of EBDC
compounds on mandarins which is
consistent with the 10 ppm tolerance on
tangerine being established by this
document.
C. Revisions to Petitioned-For
Tolerances
Based on the evaluation of the residue
data, the Agency is modified the
tolerance for walnuts from the proposed
level of 0.75 ppm to 0.70 ppm. EPA
revised the tolerance levels based on
analysis of the residue field trial data
using the Organization for Economic
Cooperation and Development (OECD)
tolerance calculation procedures.
V. Conclusion
Therefore, tolerances are established
for residues of mancozeb, in or on
walnut at 0.70 ppm and tangerine at 10
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
E:\FR\FM\24JYR1.SGM
24JYR1
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
ENVIRONMENTAL PROTECTION
AGENCY
VII. Congressional Review Act
40 CFR Part 300
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).
[EPA–HQ–SFUND–1990–0010; FRL 9836–9]
List of Subjects in 40 CFR Part 180
SUMMARY:
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 16, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.176, add alphabetically the
following commodities and the footnote
to the table in paragraph (a) to read as
follows:
■
§ 180.176 Mancozeb; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
*
Walnut .........................................
*
0.70
*
*
*
*
10
*
are no U.S. registrations for use of
mancozeb on tangerine.
*
*
*
*
*
ehiers on DSK2VPTVN1PROD with RULES
[FR Doc. 2013–17869 Filed 7–23–13; 8:45 am]
BILLING CODE 6560–50–P
VerDate Mar<15>2010
15:33 Jul 23, 2013
Jkt 229001
Environmental Protection
Agency.
ACTION: Direct final rule.
AGENCY:
The Environmental Protection
Agency (EPA) Region 9 is publishing a
direct final Notice of Deletion of the
Sola Optical U.S.A., Inc. Superfund Site
(Site), located in Petaluma, California,
from the National Priorities List (NPL).
The NPL, promulgated pursuant to
section 105 of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an
appendix of the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP). This direct
final deletion is being published by EPA
with the concurrence of the State of
California, through the California
Regional Water Quality Control Board—
San Francisco Bay Region, because EPA
has determined that all appropriate
response actions under CERCLA have
been completed. However, this deletion
does not preclude future actions under
Superfund.
DATES: This direct final deletion is
effective September 23, 2013, unless
EPA receives adverse comments by
August 23, 2013. If adverse comments
are received, EPA will publish a timely
withdrawal of the direct final deletion
in the Federal Register informing the
public that the deletion will not take
effect.
Submit your comments,
identified by Docket ID no. EPA–HQ–
SFUND–1990–0010, by one of the
following methods:
• https://www.regulations.gov. Follow
on-line instructions for submitting
comments.
• Email: rodriguez.dante@epa.gov.
• Fax: (415)947–3528.
• Mail: Dante Rodriguez, U.S. EPA
Region 9, mail code SFD–8–2, 75
Hawthorne Street, San Francisco, CA
94105.
• Hand delivery: U.S. EPA Region 9,
75 Hawthorne Street, mail code SFD–8–
2, San Francisco, CA 94105.
Such deliveries are only accepted
during the Docket’s normal hours of
operation, and special arrangements
ADDRESSES:
*
*
*
*
Tangerine1 ..................................
1 There
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List: Deletion
of the Sola Optical U.S.A., Inc.
Superfund Site
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
44455
should be made for deliveries of boxed
information.
Instructions: Direct your comments to
Docket ID no. EPA–HQ–SFUND–1900–
0010. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or email. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through https://
www.regulations.gov, your email
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket
All documents in the docket are listed
in the https://www.regulations.gov index.
Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statue. Certain
other material, such as copyrighted
material, will be publicly available only
in the hard copy. Publicly available
docket materials are available either
electronically in https://
www.regulations.gov or in hard copy at:
Superfund Records Center, 95
Hawthorne St., Room 403, Mail Stop
SFD–7C, San Francisco, CA 94105,
(415) 536–2000, Mon–Fri: 8:00 a.m. to
5:00 p.m.;
or the Site Repository at
Petaluma Public Library, 100
Fairgrounds Drive, Petaluma, CA
94952, (707) 763–9801, Mon, Thurs,
Fri, Sat: 10:00 a.m. to 6:00 p.m., Tues,
Wed: 10:00 a.m. to 9:00 p.m.
E:\FR\FM\24JYR1.SGM
24JYR1
]]>Agencies
[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Rules and Regulations]
[Pages 44444-44455]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17869]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0628; FRL-9393-2]
Mancozeb; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
mancozeb in or on walnuts and tangerines. United Phosphorus requested
the tolerance for walnuts and Dow AgroSciences requested the tolerance
for tangerines under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 24, 2013. Objections and
requests for hearings must be received on or before September 23, 2013,
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-2012-0628, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
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 eCFR site at https://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-
[[Page 44445]]
OPP-2012-0628 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 23, 2013.
Addresses for mail and hand delivery of objections and hearing requests
are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0628, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1),
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 1F7935)
by United Phosphorus, Inc., 630 Freedom Business Center, King of
Prussia, PA 19406. The petition requested that 40 CFR 180.176 be
amended by establishing tolerances for residues of the fungicide
mancozeb in or on walnuts at 0.75 parts per million (ppm). That
document referenced a summary of the petition prepared by United
Phosphorus, the registrant, which is available in the docket (EPA-HQ-
OPP-2012-0044), https://www.regulations.gov. There were no comments
received in response to the notice of filing.
In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), 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
2E8062) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN
46268. The petition requested that 40 CFR 180.176 be amended by
establishing tolerances for residues of the fungicide mancozeb in or on
tangerine at 10 ppm. The proposed tolerance supports imports of
mandarins, tangerines, and clementines. That document referenced a
summary of the petition prepared by Dow AgroSciences, the registrant,
which is available in the docket (EPA-HQ-OPP-2012-0628) https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the level at which the tolerance is being established for
walnut. The reason for this change 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 mancozeb including exposure
resulting from the tolerances established by this action.
Mancozeb is a member of the ethylene bisdithiocarbamate (EBDC)
group of fungicides that also includes the related active ingredient
metiram, the only other registered EBDC. A third EBDC, maneb, is no
longer registered for use. Mancozeb and metiram are metabolized to
ethylenethiourea (ETU) in the body and both degrade to ETU in the
environment. Therefore, EPA has considered the aggregate or combined
risks from food, water and non-occupational exposure resulting from
mancozeb alone and ETU from all sources (i.e., the other EBDC
fungicides) for this action. EPA's assessment of exposures and risks
associated with mancozeb and ETU 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. In addition to evaluating mancozeb, EPA also evaluated the
risks of ETU, a contaminant, metabolite and degradation product of
mancozeb and the other EBDC group of fungicides, which includes the
related active ingredient metiram.
1. Mancozeb. Mancozeb is not acutely toxic via the oral, dermal or
inhalation routes of exposure. Further, mancozeb is not a skin irritant
nor is it a skin sensitizer, although it does cause mild eye
irritation. The findings in multiple studies demonstrate that the
thyroid is a target organ for mancozeb. Thyroid toxicity is manifested
as alternations in thyroid hormones, increased thyroid weight, and
microscopic thyroid lesions (mainly thyroid follicular cell
hyperplasia). These effects are due to the ETU metabolite.
In a subchronic study in the rat, neuropathology was seen
microscopically (injury to peripheral nerves) with associated clinical
signs (abnormal gait and limited use of rear legs) and loss of muscle
mass. Decreased motor activity occurred in the acute neurotoxicity
study. In the developmental neurotoxicity study, there was no maternal
toxicity and pup effects were limited to decreased body weight. Other
toxicity included increases in bilateral retinopathy in the chronic rat
study. Elevated cholesterol and a mild, regenerative, anemia occurred
in subchronic and chronic dog studies.
Mancozeb is rapidly absorbed and eliminated in the urine. In oral
rat metabolism studies with radiolabeled mancozeb and other EBDCs, an
average 7.5% in vivo metabolic conversion of EBDC to ETU occurred, on a
weight-to-
[[Page 44446]]
weight basis. Metabolism data indicate mancozeb does not bio-
accumulate. Mancozeb has been tested in a series of in vitro and in
vivo genotoxicity assays, which have shown that it exhibits weak
genotoxic potential.
Thyroid follicular cell adenomas and carcinomas were increased in
high-dose males and females in the combined rat toxicity/
carcinogenicity study with mancozeb. Doses in a mouse study were too
low to assess carcinogenicity, and there were no treatment-related
changes in tumor rates. Historically, mancozeb's potential for
carcinogenicity has been based on its metabolite ETU, which is
classified as a probable human carcinogen. However, since ETU is known
to be the chemical causing the thyroid tumors observed, the cancer
assessment has been done only for ETU rather than the parent compound.
Developmental defects in the rat developmental toxicity study
included hydrocephaly, skeletal system defects, and other gross defects
which occurred at a dose causing maternal mortality and did not
indicate increased susceptibility of offspring. Abortions occurred in
the rabbit developmental toxicity study at the high dose which also
caused maternal mortality, and there was no indication of enhanced
susceptibility of offspring in the rabbit. There was no evidence of
reproductive toxicity in the 2-generation reproduction study in rats.
There was evidence of sensitivity in the developmental neurotoxicity
study with mancozeb with decreased pup body weight observed in the
absence of maternal toxicity; the selected endpoints are protective for
these pup effects.
An immunotoxicity study has been reviewed and mancozeb did not show
any immunotoxicity potential.
2. ETU. The thyroid is a target organ for ETU; thyroid toxicity in
subchronic and chronic rat, mouse, and dog studies included decreased
levels of thyroxine (T4), increases or decreases in
triiodothyronine (T3), compensatory increases in levels of
thyroid stimulating hormone (TSH), increased thyroid weight, and
microscopic thyroid changes, chiefly hyperplasia. Overt liver toxicity
was observed in one chronic dog study. ETU is classified as a probable
human carcinogen based on liver tumors in female mice.
Developmental defects in the rat developmental study were similar
to those seen with mancozeb, and included hydrocephaly and related
lesions, skeletal system defects, and other gross defects. These
defects showed increased susceptibility to fetuses because they
occurred at a dose which only caused decreased maternal food
consumption and body weight gain.
An immunotoxicity study on ETU did not show any immunotoxicity
potential.
Specific information on the studies received and the nature of the
adverse effects caused by mancozeb 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 https://www.regulations.gov in the document titled ``Mancozeb: Human Health
Risk Assessment to Support Proposed New Section 3 Uses on Walnuts and
Tolerances for Imported Tangerines'' on pages 70-75 in docket ID number
EPA-HQ-OPP-2012-0628.
Additionally, specific information on the studies received and the
nature of the toxic effects caused by ETU as well as the NOAEL and the
LOAEL from the toxicity studies can be found at www.regulations.gov in
the document titled ``Ethylene Thiourea (ETU); Aggregate Human Health
Risk Assessment of the Common Metabolite/Degradate Ethylene Thiourea
(ETU) to Support Proposed New Section 3 Use on Walnuts and Tolerance
for Imported Tangerines'' on pages 30-33 in docket ID number EPA-HQ-
OPP-2012-0628.
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for mancozeb and ETU used
for human risk assessment is shown in Tables 1 and 2 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Mancozeb for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure Study and
Exposure/scenario and uncertainty/ RfD, PAD, LOC for risk assessment toxicological
safety factors effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Adult Males, NOAEL = 500 mg/kg/ Acute RfD = 5 mg/kg/day........... Acute neurotoxicity
Females > 49, and Children >= 6 day. aPAD = 5 mg/kg/day................ study in the rat.
years). UFA = 10x........... LOAEL 1,000 mg/kg/
UFH = 10x........... day based on
FQPA SF = 1x........ decreased motor
activity.
Acute dietary (Children < 6 NOAEL = 500 mg/kg/ Acute RfD = 5 mg/kg/day........... Acute neurotoxicity
years). day. aPAD = 0.5 mg/kg/day.............. study in the rat.
UFA = 10x........... LOAEL 1,000 mg/kg/
UFH = 10x........... day based on
FQPA SF UFDB = 10x.. decreased motor
activity.
[[Page 44447]]
Acute Dietary (Females 13-49 NOAEL = 1.28 mg/kg/ Acute RfD = 1.3 mg/kg/day......... Developmental
years). day. aPAD = 0.13 mg/kg/day............. toxicity study in
UFA = 10x........... the rat.
UFH = 10x........... LOAEL = 512 mg/kg/
FQPA SF UFDB = 10x.. day based on
hydrocephaly and
other
malformations.
Chronic dietary (Adult Males, NOAEL = 4.83 mg/kg/ Chronic RfD = 0.16 mg/kg/day...... Toxicity/
Females > 49, and Children >= 6 day. cPAD = 0.16 mg/kg/day............. Carcinogenicity in
years). UFA = 3x............ the rat.
UFH = 10x........... LOAEL = 30.9 mg/kg/
FQPA SF = 1x........ day based on
thyroid toxicity.
Chronic dietary (Females 13-49 NOAEL = 4.83 mg/kg/ Chronic RfD = 0.16 mg/kg/day...... Toxicity/
years and Children < 6 years). day. cPAD = 0.016 mg/kg/day............ Carcinogenicity in
UFA = 3x............ the rat.
UFH = 10x........... LOAEL = 30.9 mg/kg/
FQPA SF UFDB = 10x.. day based on
thyroid toxicity.
Inhalation all durations (Adult Inhalation study LOC for MOE = 30.................. Subchronic
Males, Females > 49 years, and NOAEL = 0.079 mg/L Inhalation in the
Children >= 6 years). (21 mg/kg/day). rat.
UFA = 3x............ LOAEL = 0.326 mg/L
UFH = 10x........... based on thyroid
FQPA SF = 1x........ toxicity.
Inhalation all durations (Females Inhalation study LOC for MOE = 300................. Subchronic
13-49 years and Children < 6 NOAEL= 0.079 mg/L Inhalation in the
years). (21 mg/kg/day). rat.
UFA = 3x............ LOAEL = 0.326 mg/L
UFH = 10x........... based on thyroid
FQPA SF UFDB = 10x.. toxicity.
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Mancozeb's potential for carcinogenicity is due to the formation of the
metabolite, ETU, which is classified as a probable human carcinogen.
Mancozeb's cancer risk is calculated by estimating exposure to mancozeb-
derived ETU and using the ETU cancer potency factor (Q1\*\) of 6.01 x 10-2
(mg/kg/day)-1 to quantitate risk.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligrams/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). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population
(intraspecies).
Table 2--Summary of Toxicological Doses and Endpoints for ETU for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population A study with acute
including infants and children). toxicity applicable
to the general
population was not
identified.
------------------------------------------------------------------------------
Acute Dietary (Females 13-49 NOAEL = 5 mg/kg/day. Acute RfD = 0.05 mg/ Developmental Rat Toxicity.
years). UFA = 10x........... kg/day. LOAEL = 10 mg/kg/day, based on
UFH = 10x........... aPAD = 0.005 mg/kg/ hydrocephaly and other
FQPA SF UFDB = 10x.. day. malformations.
[[Page 44448]]
Chronic dietary (Adult Males, NOAEL = 0.18 mg/kg/ Chronic RfD = Dog Chronic Oral Toxicity.
Females > 49, and Children >= 6 day. 0.0018 mg/kg/day. LOAEL = 1.99 mg/kg/day based on
years). UFA = 10x........... cPAD = 0.0018 mg/kg/ thyroid toxicity.
UFH = 10x........... day.
FQPA SF = 1x........
Chronic dietary (Females 13-49 NOAEL = 0.18 mg/kg/ Chronic RfD = Dog Chronic Oral Toxicity.
years and Children < 6 years). day. 0.0018 mg/kg/day. LOAEL = 1.99 mg/kg/day based on
UFA = 10x........... cPAD = 0.00018 mg/ thyroid toxicity.
UFH = 10x........... kg/day.
FQPA SF UFDB = 10x..
Dermal short and intermediate- Oral study.......... LOC for MOE = 1,000 4-Week Range-Finding Dog Study.
term (Children < 6 years old). NOAEL = 7 mg/kg/day LOAEL = 34 mg/kg/day based on
(dermal absorption thyroid toxicity.
rate = 26%).
UFA = 10x...........
UFH = 10x...........
FQPA SF = 10x.......
Dermal short and intermediate- Oral study.......... LOC for MOE = 100.. 4-Week Range-Finding Dog Study.
term (Adult Males, Females. NOAEL = 7 mg/kg/day LOAEL = 34 mg/kg/day based on
> 49 years, Children >= 6 years) (dermal absorption thyroid toxicity.
rate = 26%).
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
Dermal short- and intermediate- Oral study.......... LOC for MOE = 1,000 Developmental Rat Toxicity.
term (Females 13-49 years old). NOAEL = 5 mg/kg/day LOAEL = 10 mg/kg/day, based on
(dermal absorption hydrocephaly and other
rate = 26%). malformations.
UFA = 10x...........
UFH = 10x...........
FQPA SF = 10x.......
Inhalation short- and Oral study.......... LOC for MOE = 1,000 4-Week Range-Finding Dog Study.
intermediate-Term (Children < 6 NOAEL = 7 mg/kg/day. LOAEL = 34 mg/kg/day based thyroid
years of age). UFA = 10x........... toxicity.
UFH = 10x...........
FQPA SF UFDB = 10x..
Inhalation short- and Oral study.......... LOC for MOE = 100.. 4-Week Range-Finding Dog Study.
intermediate-term (adult males, NOAEL= 7 mg/kg/day.. LOAEL = 34 mg/kg/day based thyroid
females > 49 years, children >= UFA = 10x........... toxicity.
6 years). UFH = 10x...........
FQPA SF = 1x........
Inhalation short- and Oral study.......... LOC for MOE = 1,000 Developmental Rat Toxicity.
intermediate-term (Females 13-49 NOAEL = 5 mg/kg/day. LOAEL = 10 mg/kg/day, based on
years old). UFA = 10x........... hydrocephaly and other
UFH = 10x........... malformations.
FQPA SF = 10x.......
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) ETU is classified as a probable human carcinogen. ETU's cancer potency factor
(Q1\*\) is 6.01 x 10-2 (mg/kg/day)-1.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligrams/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). UFDB = to account for the absence of data or other
data deficiency. 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 mancozeb, EPA considered exposure under the petitioned-for
tolerances as well as all existing mancozeb tolerances in 40 CFR
180.176. In evaluating dietary exposure to ETU, EPA considered exposure
under the petitioned-for tolerances discussed in this document as well
as all existing uses of the EBDC group of fungicides
[[Page 44449]]
(mancozeb and metiram). EPA assessed dietary exposures from mancozeb
and ETU 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 mancozeb and ETU. In estimating acute dietary exposure for both
mancozeb and ETU, EPA used food consumption information from the 2003-
2008 food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA).
a. Mancozeb. The Agency conducted a highly refined, probabilistic
acute dietary assessment incorporating field trial or monitoring data
from the EBDC/ETU Market Basket Survey, percent crop treated (PCT)
information, and processing study results to assess the established
uses of mancozeb. The monitoring data were used for several commodities
(corn, cucumber, onion, pumpkin, potato, squash, starfruit, tomato,
meat, and milk). For evaluation of the proposed new uses and
tolerances, field trial data, processing factors, PCT data based on
section 18 usage for walnuts, and percent imported commodity in
domestic consumption data on tangerines for mancozeb were used to
refine residue estimates. The entire distributions of residue data from
field trials or monitoring data were used to generate residue
distribution files (RDFs) for commodities that are considered to be not
blended or partially blended. For commodities considered to be blended,
the average residues incorporating the likely maximum estimated PCT was
used as a point estimate.
b. ETU. The Agency conducted a highly refined, probabilistic acute
dietary assessment incorporating field trial or monitoring data from
the EBDC/ETU Market Basket Survey, PCT information, and processing
study results to assess exposures to ETU from the established uses of
mancozeb and metiram. The monitoring data were used for several
commodities (corn, cucumber, onion, pumpkin, potato, squash, starfruit,
tomato, meat, and milk). For evaluation of the proposed new uses and
tolerances, field trial data, processing factors, PCT data based on
section 18 usage for walnuts, and percent imported commodity in
domestic consumption data on tangerines for mancozeb were used to
refine residue estimates. The entire distributions of residue data from
field trials or monitoring data were used to generate residue
distribution files (RDFs) for commodities that are considered to be not
blended or partially blended. For commodities considered to be blended,
the average residues incorporating the likely maximum estimated PCT was
used as a point estimate.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment for both mancozeb and ETU, EPA used food consumption
information from the 2003-2008 food consumption data from the USDA
NHANES/WWEIA.
a. Mancozeb. The chronic dietary exposure and risk assessment for
mancozeb (non-cancer and cancer) incorporated average values based
either on field trial data or monitoring data and average PCT data for
new and existing uses, as well as processing and cooking factors.
Averages of the field trials were used for the walnuts and tangerines,
while field trial and market basket survey data were used for
established uses.
b. ETU. Chronic anticipated residues were calculated using average
values based either on field trial data or monitoring data and average
PCT data or average projected PCT as well as processing and cooking
factors. Averages of the field trials were used for the walnuts and
tangerines, while field trial and market basket survey data were used
for established uses.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or nonlinear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized.
The cancer risks were aggregated using the food and drinking water
doses for the general population and the food, water and recreational
doses for home gardeners (considered protective of other residential
scenarios). The average daily dose was used for food and water
exposures and the lifetime average daily dose was used for the
recreational exposures. The aggregate doses were multiplied times the
potency factor for ETU, 0.0601 (mg/kg/day) -1 to determine
the cancer risks.
Mancozeb degrades and/or metabolizes to ETU which causes thyroid
tumors; therefore, EPA has historically attributed mancozeb's
carcinogenicity to the formation of ETU, which is classified as a
probable human carcinogen. The Agency has used the cancer potency
factor (Q1*) of 0.0601 (mg/kg/day) -1 for ETU
(based on liver tumors in female mice) for risk assessment. Therefore,
cancer risk from exposure to mancozeb has been calculated by estimating
exposure to mancozeb-derived ETU and using the Q1* for ETU.
The same approach has been taken for the other EBDCs. EPA's estimated
exposure to mancozeb-derived ETU included ETU residues found in food as
well as ETU formed by metabolic conversion on parent mancozeb in the
body (conversion rate of 0.075).
iv. Anticipated residue and percent crop treated (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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
For mancozeb and ETU derived from mancozeb, the following maximum
PCT
[[Page 44450]]
estimates were used in the acute dietary risk assessment for the
following crops: Apples: 45%; asparagus: 30%; barley: 2.5%;
cantaloupes: 15%; carrots: 2.5%; celery: 2.5%; corn: 2.5%; cranberries:
20%; cucumbers: 50%; grapes: 20%; oats: 1%; onions: 70%; peanuts: 2.5%;
pears: 50%; potatoes: 65%; pumpkins: 15%; rice: 2.5%; spinach: 2.5%;
squash: 30%; sugar beets: 2.5%; sweet corn: 15%; tomatoes: 50%;
watermelons: 50%; and wheat: 2.5%. A percent import value of 99% was
used for banana.
For mancozeb and ETU derived from mancozeb, the following average
PCT estimates were used in the chronic and cancer dietary risk
assessments for the following crops: Apples: 40%; asparagus: 15%;
barley: 1%; cantaloupes: 5%; carrots: 1%; celery: 1%; cherries: 1%;
corn: 1%; cranberries: 20%; cucumbers: 25%; grapes: 10%; oats: 1%;
onions: 60%; peanuts: 2.5%; pears: 40%; potatoes: 55%; pumpkins: 10%;
rice: 1%; spinach: 1%; squash: 20%; sugar beets: 1%; sweet corn: 5%;
tomatoes: 25%; watermelons: 40%; and wheat: 1%. A percent import value
of 99% was used for banana.
As a further refinement, the commodity having the highest PCT
results with livestock feed uses had these values applied to meat and
milk (potato; 65% CT maximum for acute and 55% CT average for chronic).
For ETU derived from metiram, the following maximum PCT estimates
were used in the acute dietary risk assessment: apples: 15%; potatoes:
10%. A 31% imported commodity in domestic consumption was used for wine
grapes.
For ETU derived from metiram, the following average PCT estimates
were used in the chronic and cancer dietary risk assessment: Apples:
10%; potatoes: 5%. A 31% imported commodity in domestic consumption was
used for wine grapes.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
Also, for the acute risk assessment for mancozeb and ETU derived
from mancozeb, the Agency estimated PCT for the following uses for
mancozeb, which were recently approved in 2011: Almond, 25%; broccoli,
6%; cabbage, 47%; cabbage, Chinese, 47%; head lettuce 75%; leaf lettuce
66%; pepper, bell, 48%; pepper, non-bell, 48%. For the chronic risk
assessment for mancozeb and ETU derived from mancozeb, the Agency
estimated PCT as follows: Almond, 18%; broccoli, 5%; cabbage, 42%;
cabbage, Chinese, 42%; head lettuce 67%; leaf lettuce 62%; pepper,
bell, 44%; pepper, non-bell, 44%. Since metiram is not registered for
use on these crops, all potential ETU exposure on these crops will
result from use of mancozeb.
EPA developed these refined PCT values based on a detailed
chemical-specific analysis. EPA has considered all available relevant
information and concludes that it is unlikely that the PCT values for
these uses will be exceeded during the next 5 years. Further discussion
of how these PCT values were derived can be found at
www.regulations.gov in the document titled ``Percent Crop Treated for
new Uses (PCTn) of Mancozeb on Almonds, Broccoli, Cabbage, Pepper,
Pumpkin, and Winder Squash, PC Code: 014504; DP Barcode: 360397;
Lettuce, both head and Other; PC Code: 014504; DP Barcode: 364745, NON
PRIA, Parent DP: 635267; and Percent Crop Treated with Maneb for
Collards, Mustard Greens, Turnip Greens, and Kale'' in docket ID number
EPA-HQ-OPP-2012-0628.
For mancozeb and ETU derived from mancozeb, a maximum PCT projected
estimate of 50% for walnuts and a maximum percent import consumption
value of 35% for tangerines were used in the acute dietary risk
assessment. An average PCT estimate of 40% for walnuts as well as an
average percent imported commodity in domestic consumption value of 29%
for tangerines were used in the chronic and cancer dietary risk
assessments.
The walnut information is an amalgamation of the USDA/NASS and
private pesticide market research data. The PCT values for walnuts are
derived from survey data reported in 2006, 2010, and 2011. Only the
state of California is represented in the survey data as 99% of the
walnuts grown in the United States are grown in that state. The percent
of imported fresh mandarin oranges in domestic consumption was
calculated with data for the reporting period of 2008-2013 obtained
from the Foreign Agricultural Service (FAS) USDA/Office of Global
Analysis (FAS, 2013).
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which mancozeb may be applied in a particular area.
2. Dietary exposure from drinking water--i. Mancozeb. The Agency
has determined that mancozeb is very short-lived in soil and water, and
would not reach water used for human consumption whether from surface
water or ground water.
ii. ETU. ETU is highly water soluble, and may reach both surface
water and ground water under some conditions. The ETU surface water
Estimated Drinking Water Concentrations (EDWCs) were generated using a
combined monitoring/modeling approach. Results of a surface water
monitoring study conducted by the ETU Task Force were used to refine
the outputs of the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM-EXAMS) models; the site/scenario modeled was application
of an EBDC fungicide on peppers in Florida, and was chosen to produce
the highest EDWC acute values. The ground water EDWC was detected in a
Florida community water system intake in a targeted ground water
monitoring study conducted by the EBDC task force from 1999 to 2003.
Both these surface water and ground water values represent
[[Page 44451]]
upper-bound conservative estimates of the total ETU residual
concentrations that might be found in surface water and ground water
due to the use of the EBDC fungicides.
Based on the PRZM/EXAMS and monitoring studies, the EDWCs of ETU
acute and chronic exposures are estimated to be 25.2 parts per billion
(ppb), and 0.1 ppb, respectively for surface water. The EDWC for acute
and chronic exposure is estimated to be 0.21 ppb for ground water.
Estimates of drinking water concentrations were directly entered
into the dietary exposure model. For acute dietary risk assessment, the
water concentration value of 25.2 ppb was used to assess the
contribution to drinking water. For chronic dietary risk assessment of
ETU, the water concentration of value 0.21 ppb was used to assess the
contribution to drinking water. For cancer dietary risk assessment of
ETU, the water concentration of value 0.21 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).
1. Mancozeb. Mancozeb is currently registered for use on the
following residential sites: Home gardens, golf courses, and sod farms
(where treated sod could be transplanted to a residential setting). The
Agency has determined that it is appropriate to aggregate chronic
exposure through food with short-term residential exposures to
mancozeb.
The exposure scenario that was evaluated for mancozeb was the
residential handler home garden use which considers residential handler
exposures (inhalation) to adult applicators combined with average food
exposures. Dermal exposure was not evaluated because no effects were
observed in a mancozeb 28-day dermal toxicity study.
For post-application, dermal exposure to home gardeners (adults and
youth) harvesting vegetables from treated gardens and golfers (adults
and youth) contacting mancozeb-treated turf after application is
possible. However, as no dermal hazard was identified for mancozeb, a
quantitative dermal post-application assessment (non-cancer/short-term
and cancer) for the dermal exposure to home gardeners and golfers
(adults and youth) was only performed for its metabolite, ETU.
The previous mancozeb risk assessment had evaluated the short/
intermediate-term exposure of toddlers to treated turf from the sod
farm use. In the most recent risk assessment, the Agency considered
post-application exposure resulting from this scenario to be negligible
for the following reasons: (1) Mancozeb has a post-harvest interval
(PHI) of 5 days for sod; (2) it is unlikely that sod treated with
mancozeb would be installed more than once per year; (3) transplanted
sod requires constant and significant watering which will result in
decreased mancozeb residues on the transplanted sod; and (4) it is
unlikely that adults or children will spend any significant amount of
time on recently transplanted sod until it is rooted which typically
occurs around 2 weeks after transplanting. Therefore, dermal and
incidental oral post-application scenarios were not quantitatively
assessed for the sod farm use of mancozeb. There are no post-
application exposure risks of concern anticipated from the use of
mancozeb on sod farms.
ii. ETU. ETU non-dietary exposure is expected as a result of the
registered uses of mancozeb, which is currently registered for use on
the following residential sites: home gardens, golf courses, and sod
farms (where treated sod could be transplanted to a residential
setting). There are no uses of metiram that will result in exposure in
residential settings. The Agency has determined that it is appropriate
to aggregate chronic exposure through food with short-term residential
exposures to ETU.
The scenario that was evaluated for ETU was the residential home
garden use, which considered handler garden exposures (inhalation and
dermal) plus average daily food and drinking water exposure for adults
and post-application garden exposures (dermal) plus average daily food
and drinking water exposure for females 13-49 years old and youths.
The previous risk assessment also considered treated turf (sod
farm) post-application exposures to toddlers (incidental oral and
dermal). This more recent risk assessment did not evaluate the sod farm
use for the reasons outlined above in the mancozeb non-dietary exposure
section.
The previous risk assessment also calculated risks for adult and
youth golfers from golfing on treated turf. The more recent assessment
concluded that for residential post-application, the gardening
scenarios represent the most conservative exposure estimates and are
used in the aggregate assessment. The gardening scenarios result in
higher estimated exposure than the golfing scenarios and are therefore
protective of any golfer risk.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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.''
As previously mentioned, the risk estimates summarized in this
document are those that result only from the use of mancozeb, and ETU
derived from mancozeb and metiram, the other registered EBDC chemical,
both of which are dithiocarbamates. For the purposes of this action,
EPA has concluded that mancozeb does not share a common mechanism of
toxicity with other substances. The Agency reached this conclusion
after a thorough internal review and external peer review of the data
on a potential common mechanism of toxicity.
EPA concluded that the available evidence does not support grouping
the dithiocarbamates based on a common toxic effect (neuropathology)
occurring by a common mechanism of toxicity (related to metabolism to
carbon disulfide). After a thorough internal and external peer review
of the existing data bearing on a common mechanism of toxicity, EPA
concluded that the available evidence shows that neuropathology cannot
be linked with carbon disulfide formation. For more information, please
see the December 19, 2001 memo, ``The Determination of Whether
Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity'' on
the internet at https://www.epa.gov/oppsrrd1/cumulative/dithiocarb.pdf.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying
[[Page 44452]]
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--i. Mancozeb. In the rat
developmental study, developmental effects were observed in the
presence of severe maternal effects, including maternal mortality and
clinical signs. In the rabbit developmental study, developmental
effects (spontaneous abortions) were observed at the same dose (80 mg/
kg/day) at which maternal effects included mortality and clinical
signs. In the rat reproduction study, no effects were observed in
offspring, while thyroid effects and body weight gain decrements
occurred in adults. There was evidence of sensitivity in the
developmental neurotoxicity study with mancozeb with decreased pup body
weight occurring in the absence of maternal toxicity; risk assessment
endpoints are protective for these pup effects.
ii. ETU. There is evidence of increased susceptibility of fetuses
to ETU. Fetal malformations occurred mainly in rats, although
hydrocephaly and domed head were observed in a rabbit developmental
study with ETU. The malformations in rats occurred throughout the body.
Hydrocephaly occurred in the absence of maternal toxicity after
treatment with a single dose of ETU. There was a steep dose-response
for the malformations in rats. An acceptable reproductive toxicity
study was not available for ETU. As a result, the Agency evaluated the
level of concern for the effects observed when considered in the
context of all available toxicity data. In addition, the Agency
evaluated the database to determine if there were residual
uncertainties after establishing toxicity endpoints and traditional
uncertainty factors to be used in the ETU risk assessment.
3. Conclusion for mancozeb. EPA is retaining the 10X FQPA safety
factor for women of childbearing age and for children less than 6 years
old but has determined that reliable data show the safety of children
greater than 6 years of age would be adequately protected if the FQPA
safety factor were reduced to 1X. That decision is based on the
following findings:
i. The toxicology database for mancozeb is complete, except that it
lacks adequate data on the developing thyroid. Brain development is
very sensitive to perturbations in thyroid hormones and it is possible
that the developmental thyroid study (being conducted with ETU) could
result in lower NOAELs for women of childbearing age (i.e., fetuses)
and for children less than 6 years old. Results from the developmental
thyroid study will not affect endpoints for children over 6 years of
age (for whom the thyroid system is more developed) or adults as
thyroid data for those populations are already available. Therefore,
the FQPA safety factor is reduced to 1X for these populations.
ii. There was some evidence of neurotoxicity for mancozeb as seen
in the acute and subchronic neurotoxicity studies; however, no
neurotoxicity occurred in the DNT. Additionally, there are clear NOAELs
identified for the effects observed in the toxicity studies. The doses
and endpoints selected for risk assessment are protective of all
neurotoxicological effects observed in the database.
iii. As noted above in Unit III.D.2., there was some evidence of
increased susceptibility of rat pups to mancozeb exposure. Aside from
the uncertainty resulting from the lack of adequate thyroid data (for
which EPA is retaining the 10X FQPA safety factor), there are clear
NOAELs for the offspring effects, and regulatory doses were selected to
be protective of these effects.
iv. There are no residual uncertainties identified in the exposure
databases. The acute, chronic, and cancer dietary exposure assessments
were refined and used PCT estimates and monitoring residue values for
several commodities, including some major contributors to the dietary
risk such as milk and corn commodities. Monitoring or modeling data
were used to derive estimated drinking water concentrations. The
drinking water concentrations that were derived from monitoring data
reflect the highest value found in a community well monitoring program.
The drinking water concentrations from modeling used conservative,
health-protective, high-end estimates and are unlikely to be exceeded.
The residential exposure assessment used residential SOPs, which are
based on conservative high-end assumptions such as maximum application
rates and day 0 exposures. Given the overall conservative nature of the
exposure assumptions, the aggregate (food, water, and residential)
exposure and risk estimates presented in this assessment are not
expected to underestimate actual exposure and risk expected based on
the current and proposed use patterns.
4. Conclusion for ETU. EPA is retaining the 10X FQPA safety factor
for women of childbearing age and for children less than 6 years old
but has determined that reliable data show the safety of children 6
years of age or older would be adequately protected if the FQPA safety
factor were reduced to 1X. That decision is based on the following
findings:
i. The toxicology database for ETU is missing a developmental
thyroid study, a reproduction study, and a developmental neurotoxicity
(DNT) study. These data gaps are being addressed by an ongoing extended
one-generation reproductive toxicity study. Because the developing
brain is very sensitive to perturbations in thyroid hormones, it is
possible that these studies could result in lower NOAELs for women of
childbearing age (i.e., fetuses) and for children less than 6 years
old; however, results from the developmental thyroid study will not
affect points of departure for children greater than 6 years of age,
who have a thyroid system similar to adults, adult females greater than
49 years of age (assumed to be beyond typical child-bearing age), or
adult males since thyroid data for those populations are already
available. Additionally, endpoints from the other segments of the
extended one-generation study will not affect these latter populations,
and the FQPA safety factor is being reduced to 1X for these
populations.
ii. Although the ETU studies were inadequate in evaluating signs of
neurotoxicity, there was no evidence of neurotoxicity seen in any study
in the database. In any event, the Agency has determined that the
selected endpoints would be protective of potential neurotoxicity. The
basis for this is that the principal toxic effects occur in the
thyroid; thyroid effects provide the most sensitive endpoint, which the
Agency is regulating on. Although the extended 1-gen study being
performed on ETU is evaluating the potential for effects on the
developing brain, the Agency does not believe that a 10X FQPA safety
factor is necessary to protect children 6 years old or older because:
(1) The weight-of-evidence of the available data indicates that thyroid
effects are the most sensitive effect of this chemical; (2) the Agency
is regulating on the more sensitive thyroid effect; and (3) the Agency
is retaining a 10X FQPA safety factor for the population most likely
affected by the thyroid effects.
iii. As noted in Unit III.D.2., there is evidence of increased
quantitative and qualitative susceptibility following increased in
utero exposure to ETU. The developmental study with the lowest NOAEL
was selected for the acute endpoint for women of childbearing age and
is therefore protective of the developmental malformations. The only
remaining developmental uncertainties are related to effects on the
developing fetus caused by perturbations in the
[[Page 44453]]
still-not-completely-developed thyroid in children younger than 6 years
old. Brain development being very sensitive to perturbations in thyroid
hormones, it is possible that the extended 1-generation reproductive
toxicity test, in which developmental thyroid effects will be
evaluated, will result in lower NOAELs for these populations than are
presently being used to assess risk; therefore, the Agency is retaining
the 10X FQPA safety factor for females 13-49 years of age and for
children less than 6 years of age.
iv. There are no residual uncertainties identified in the EBDC's
(mancozeb or metiram) exposure databases for ETU assessment. The acute,
chronic, and cancer dietary exposure assessments were refined and used
PCT estimates and monitoring residue values for several commodities
including some major contributors to the dietary risk such as milk and
corn commodities. Monitoring or modeling data were used to derive
estimated drinking water concentrations. The drinking water
concentrations that were derived from monitoring data reflect the
highest value found in a community well monitoring program. The
drinking water concentrations from modeling used conservative, health-
protective, high-end estimates and are unlikely to be exceeded. The
residential exposure assessment used residential SOPs, which are based
on conservative high-end assumptions such as maximum application rates
and day 0 exposures. Given the overall conservative nature of the
exposure assumptions, the aggregate (food, water, and residential)
exposure and risk estimates presented in this assessment are not
expected to underestimate actual exposure and risk expected based on
the current and proposed use patterns.
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. (mancozeb). The mancozeb acute aggregate assessment
considers acute exposure to mancozeb only and not ETU. Further, this
assessment is based on residues of mancozeb in food only since residues
of mancozeb are not expected in drinking water. Using the exposure
assumptions discussed in this unit for acute exposure, the acute
dietary exposure from food to mancozeb will occupy 9.9% of the aPAD for
children 1-2 years old, the population subgroup receiving the greatest
exposure.
2. Acute risk (ETU). Using the exposure assumptions discussed in
this unit for acute exposure, the acute dietary exposure from food and
water to ETU (from mancozeb and metiram) will occupy 60% of the aPAD
for females 13-49 years of age, the only population group of concern.
3. Chronic risk (mancozeb). There are no long-term residential
exposure scenarios for mancozeb and there is not likely to be residues
of mancozeb in drinking water. Therefore, the long-term or chronic
(non-cancer) aggregate risk for mancozeb includes contribution from
food alone. Using the exposure assumptions described in this unit for
chronic exposure, EPA has concluded that chronic exposure to mancozeb
from food will utilize 2.3% of the cPAD for children 1-2 years of age,
the population group receiving the greatest exposure.
4. Chronic risk (ETU). There are no long-term residential exposure
scenarios for ETU; the aggregate chronic risks were calculated using
food and water exposure only. Using the exposure assumptions described
in this unit for chronic exposure, EPA has concluded that chronic
exposure to ETU (from mancozeb and metiram) from food and water will
utilize 58% of the cPAD for children (1 to 2 years old), the population
group receiving the greatest exposure.
5. Short-term risk (mancozeb). 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).
Mancozeb 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 with short-
term residential exposures to mancozeb. The scenario that was evaluated
for mancozeb was the residential handler home garden use. The aggregate
short-term home garden MOEs for adult males and females greater than 49
years old is 99,000 and the MOE for adult females 13-49 years old is
94,000. Because for mancozeb EPA is concerned only with MOEs that are
below 30 (adult males and females greater than 49 years old) and 300
(adult females 13-49 years old), these MOEs do not raise a risk
concern.
6. Short-term risk (ETU). 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).
Mancozeb is currently registered for uses that could result in
short-term residential exposure to ETU. There are no residential uses
for metiram. The Agency determined that it was appropriate to aggregate
chronic exposure through food with short-term residential exposures to
ETU. The ETU short-term handler home garden aggregate MOE for adult
females 13-49 years old is 27,000 and for adult males (and females
older than 49 years old) is 42,000. The ETU short-term post-application
home garden aggregate MOE for adult females 13-49 years old is 2,600
and for youths 11-16 years old is 3,100. Because for ETU EPA is
concerned only with MOEs that are below 1,000 (adult females 13-49
years old) and 100 (adult males, females >49 years old and youth 11-16
years old), these MOEs do not raise a risk concern.
7. 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,
mancozeb 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
mancozeb.
8. Aggregate cancer risk for U.S. population. As noted earlier in
this document, mancozeb degrades and/or metabolizes to ETU which causes
the same types of thyroid tumors as those seen when animals are dosed
with mancozeb; therefore, EPA has historically attributed mancozeb's
carcinogenicity to the formation of ETU, which is classified as a
probable human carcinogen.
The cancer aggregate risk estimates (home garden handler and post-
application scenarios) for the U.S.
[[Page 44454]]
population are 2 x 10-6 and 3 x 10-6,
respectively.
EPA generally considers cancer risks (expressed as the probability
of an increased cancer case) in the range of 1 in 1 million (or 1 x
10-6) or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the logarithmic scale; for
example, risks falling between 3 x 10-7 and 3 x
10-6 are expressed as risks in the range of 10-6.
Considering the precision with which cancer hazard can be estimated,
the conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment. Although the mancozeb risk
assessment is highly refined, the Agency believes there is some
conservatism for the following reasons: (1) The linear low-dose
extrapolation approach is conservative because it does not take into
account certain human biological processes such as reversibility and
repair; (2) the residential SOPs are based on conservative high-end
assumptions such as maximum application rates and day 0 exposures; and
(3) some food exposures are estimated based on tolerance-level
residues. Accordingly, EPA has concluded the cancer risk for all
existing mancozeb uses and the uses associated with the tolerances
established in this action fall within the range of 1 x 10-6
and are thus negligible.
9. 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 mancozeb and/or ETU residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methods are available for the enforcement of tolerances
for the plant commodities which are the subject of this request. The
Pesticide Analytical Method (PAM) Vol. II lists Methods I, II, III, IV,
and A for the determination of dithiocarbamate residues in/on plant
commodities. The Keppel colorimetric method (Method III) is the
preferred method for tolerance enforcement. The Keppel method
determines EBDCs as a group by degradation to CS2. The
analytical methodology for ETU is based on the original method
published by Olney and Yip (JAOAC 54:165-169).
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
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.
There is no Codex MRL established for mancozeb on walnuts.
There is a MRL of 10 ppm established by Codex for the use of EBDC
compounds on mandarins which is consistent with the 10 ppm tolerance on
tangerine being established by this document.
C. Revisions to Petitioned-For Tolerances
Based on the evaluation of the residue data, the Agency is modified
the tolerance for walnuts from the proposed level of 0.75 ppm to 0.70
ppm. EPA revised the tolerance levels based on analysis of the residue
field trial data using the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures.
V. Conclusion
Therefore, tolerances are established for residues of mancozeb, in
or on walnut at 0.70 ppm and tangerine at 10 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology
[[Page 44455]]
Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 16, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.176, add alphabetically the following commodities and
the footnote to the table in paragraph (a) to read as follows:
Sec. 180.176 Mancozeb; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Tangerine\1\................................................ 10
* * * * *
Walnut...................................................... 0.70
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of mancozeb on tangerine.
* * * * *
[FR Doc. 2013-17869 Filed 7-23-13; 8:45 am]
BILLING CODE 6560-50-P
