[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Rules and Regulations]
[Page 16553-16559]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr08-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0145; FRL-8354-4]
Boscalid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
boscalid in or on caneberry subgroup 13A at 6.0 parts per million
(ppm); bushberry subgroup 13B at 13 ppm; cotton, undelinted seed at 1.0
ppm; cotton, gin by-products at 55 ppm; avocado at 1.5 ppm; sapote,
black at 1.5 ppm; canistel at 1.5 ppm; sapote, mamey at 1.5 ppm; mango
at 1.5 ppm; papaya at 1.5 ppm; sapodilla at 1.5 ppm; and star apple at
1.5 ppm. It revokes the existing berries, group 13 tolerance at 3.5 ppm
because the two new caneberry and bushberry tolerances cover all
commodities in the berries, group 13. Tolerances are being increased
for cucumber from 0.20 ppm to 0.5 ppm, and vegetable, root, subgroup
1A, except sugarbeet, garden beet, radish, and turnip from 0.7 ppm to
1.0 ppm. BASF, Inc requested these tolerance actions under the Federal
Food, Drug, and Cosmetic Act (FFDCA). In addition, this action
establishes a time-limited tolerance for residues of boscalid in or on
Endive, Belgian, in response to the approval of a crisis exemption
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing the post harvest use of the fungicide on
Endive, Belgian to control the fungal pathogen, scelerotinia
sclerotiorum. This regulation establishes a maximum permissible level
of residues of boscalid in this food commodity. The time-limited
tolerance expires and is revoked on December 31, 2009.
DATES: This regulation is effective March 28, 2008. Objections and
requests for hearings must be received on or before May 27, 2008, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0145. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-
[[Page 16554]]
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Bryant Crowe, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-0025; e-mail address: crowe.bryant@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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2005-0145 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before May 27, 2008.
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2005-0145, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of February 15, 2006 (71 FR 7951) (FRL-
7759-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F6986) by BASF, 26 Davis Drive, P.O. Box 13528, Research Triangle
Park, NC 27709. The petition requested that 40 CFR 180.589 be amended
by increasing the tolerance for residues of the fungicide boscalid in
or on berries, crop group 13 from 3.5 to 8.0 ppm; and increasing the
tolerance for strawberries from 1.2 ppm to 4.0 ppm. That notice
referenced a summary of the petition prepared by BASF, the registrant,
which is available to the public in the docket, http://
www.regulations.gov.
On April 4, 2007, in the Federal Register (72 FR 16352) (FRL-8119-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E7164) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540, proposes to establish a
tolerance for residues of the fungicide boscalid in or on food
commodities avocado at 1.5 ppm; sapote, black at 1.5 ppm; canistel at
1.5 ppm; sapote, mamey at 1.5 ppm; mango at 1.5 ppm; papaya at 1.5 ppm;
sapodilla at 1.5 ppm; star apple at 1.5 ppm; and herbs, fresh, subgroup
19A at 60.0 ppm. Fresh herbs, subgroup 19A, tolerances were
subsequently withdrawn from this petition, on February 6, 2008, by IR-
4, in accordance with 40 CFR 180.8. The docket ID number EPA-HQ-OPP-
2007-0115, identifies this petition.
On June 27, 2007, EPA issued a notice pertaining to boscalid
announcing the filing of a pesticide petition (PP 7F7169), (72 FR)
(FRL-8133-4), by BASF, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709. The petition, identified by the docket ID
number EPA-HQ-OPP-2007-0377, requested that 40 CFR 180.589 amended by
increasing the tolerance for residues of the fungicide boscalid in or
on cotton, undelinted seed at 1.0 ppm and cotton, gin byproducts at
55.0 ppm. In the Federal Register of February 13, 2008 (73 FR 7951)
(FRL-7759-3), EPA issued a notice pertaining to boscalid announcing the
filing of a pesticide petition (PP 5F6986) by BASF. The petition
requested that 40 CFR 180.589 be amended by increasing the tolerance
for residues of the fungicide boscalid in or on caneberry, crop group
13A at 6.0 ppm; bushberry, crop group 13B at 10.0 ppm; cucumber at 0.5
ppm; and vegetable, root, subgroup 1A, except sugar beet, garden beet,
radish and turnip at 1.0 ppm.
Each petition's notice referenced a summary of the petition
prepared by the registrant BASF, which is available to the public in
the docket, http://www.regulations.gov. For the foregoing petitions,
there were no comments in response to their notice of filing
[[Page 16555]]
Based upon review of the data supporting the petition, an increased
strawberry tolerance to 4.5 ppm is not needed because EPA previously
increased the strawberry tolerance to 4.5 ppm via the rule published
May 3, 2006 (71 FR 25956) (FRL-8064-4). Furthermore, whereas the
registrant requested the tolerance for the entire berry group 13 be
increased from 3.5 ppm to 8.0 ppm, the Agency has established a
separate tolerance for each of the two berry group 13 sub groups. Thus,
where there was one tolerance for the entire group, there are now two
separate tolerances covering all crops in the entire berry crop group
13. Thus, the existing berries, group 13 tolerance is being revoked
because it is not needed.
BASF submitted field trial data on cucumbers, mustard greens, and
sunflower. These field trials were required as a condition for the
registration of boscalid on these crops. BASF has also submitted
supplemental field trials on fruiting vegetables, spearmint and
peppermint, radishes, stone fruits, and grapes, which were conducted to
support the use of boscalid on these crops in Canada. Review of these
new data is the basis for the need to increase the existing tolerances
in or on cucumber from 0.2 to 0.5 ppm, and vegetable, root, subgroup
1A, except sugarbeet, garden beet, radish, and turnip from 0.7 to 1.0
ppm.
EPA is also establishing a time-limited tolerance for residues of
the fungicide boscalid in or on Endive, Belgian at 16 ppm. This
tolerance expires and is revoked on December 31, 2009. The Agency is
establishing this time-limited tolerance in response to a crisis
exemption request under FIFRA section 18 on behalf of the California
Environmental Protection Agency, Department of Pesticide Regulation for
emergency use of boscalid as a post harvest treatment on chicory roots
to control fungal growth of scelerotinia sclerotiorum.
According to the applicant, the dormant chicory roots are taken out
of cold storage and propagated in sheds within a controlled environment
to stimulate bud development. These edible buds are known as belgian
endive, and are marketed in grocery stores throughout the year. Based
on information provided in the submission, an emergency situation
exists because the pathogen, scelerotinia sclerotiorum, resides in
field soils and can grow on the chicory root during cold storage, which
makes the produce unmarketable. Vinclozolin had been registered for
control of this pest until it was cancelled in 2001. Existing stocks of
vinclozolin were used until 2003, and there are currently no other
fungicides registered for the post harvest treatment of chicory root to
control fungal growth. Further, the State claims that good agricultural
practices are not sufficient to control this fungal pathogen.
As part of its assessment of the emergency exemption request, EPA
assessed the potential risks presented by the residues of boscalid in
or on endive, belgian, as discussed below. In doing so, EPA considered
the safety standard in section 408 (b) (2) of the FFDCA, and EPA
decided that the necessary time-limited tolerance under section 408 (l)
(6) of the FFDCA would be consistent with the safety standard and with
FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address the urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this time-limited tolerance without notice and opportunity
for public comment as provided in section 408 (l) (6) of the FFDCA.
Although, this time-limited tolerance expires and is revoked on
December 31, 2009, under section 408 (l) (5) of the FFDCA, residues of
the pesticide not in excess of the amount specified in the tolerance
remaining in or on endive, belgian after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this time-limited tolerance at the time of application. EPA will
take action to revoke this time-limited tolerance earlier if any
experience with, scientific data, or other relevant information on this
pesticide indicates that the residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
boscalid meets EPA's registration requirements for use on endive,
belgian or whether a permanent tolerance for this use would be
appropriate. Under this circumstance, EPA does not believe that the
time-limited tolerance serves as a basis for registration of boscalid
by a State for special local needs under FIFRA section 24(c). Nor does
the time-limited tolerance serve as the basis for any State other than
California to use this pesticide on this crop under section 18 of FIFRA
without following all provisions of EPA's regulations implementing
FIFRA section 18 as identified in 40 CFR part 166.
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. * *
* '' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
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 the petitioned-for
tolerances for residues of boscalid on caneberry subgroup 13A, and
bushberry subgroup 13B, respectively at 6.0 and 13 ppm; cotton,
undelinted seed at 1.0 ppm; cotton, gin byproducts at 55 ppm; avocado
at 1.5 ppm; sapote, black at 1.5 ppm; canistel at 1.5 ppm; sapote,
mamey at 1.5 ppm; mango at 1.5 ppm; papaya at 1.5 ppm; sapodilla at 1.5
ppm; star apple at 1.5 ppm; cucumber at 0.5 ppm; and vegetable, root,
subgroup 1A, except sugar beet, garden beet, radish and turnip at 1.0
ppm, as well as the time-limited tolerance for residues of boscalid in
or on endive, belgian at 16 ppm. EPA's assessment of exposures and
risks associated with establishing these tolerances 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.
Animal studies indicate that repeat dosing with boscalid results in
effects in the liver and/or thyroid in various species. Mechanistic
studies indicated
[[Page 16556]]
that the thyroid effects were derivative of enzymatic effects on the
liver. The boscalid database shows no effects that were attributable to
a single dose, and thus boscalid is deemed not to pose an acute risk.
Testing involving in utero and/or post-natal exposure of animals shows
no developmental or reproductive effects; however, this testing
resulted in some findings of qualitative or quantitative sensitivity
with regard to body weight effects in the young.
The Agency determined that boscalid shows suggestive evidence of
carcinogenicity. This finding is based on the following weight of
evidence considerations. First, in male wistar rats, there was a
significant trend (but not pairwise comparison) for the combined
thyroid adenomas and carcinomas. This trend is driven by the increase
in adenomas. Second, in the female rats, there was only a borderline
significant trend for thyroid adenomas (there were no carcinomas).
Third, the mouse study was negative as were all of the mutagenic tests.
Consistent with this weak evidence of carcinogenic effects, the Agency
concluded that a quantitative risk and exposure assessment for cancer
(either linear low-dose extrapolation or margin of exposure
calculation) was not appropriate.
Specific information on the studies received and the nature of the
adverse effects caused by boscalid as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov. The referenced documents are available in the
docket established by this action, which are described under ADDRESSES,
and are identified as follows:
Boscalid: Human Health Risk Assessment for Section 3
Tolerance on Endive, an Amendment to the Tolerances for Strawberries
and Berries, Crop Group 13, and an Increase in Tolerances in/on
Cucumber and Vegetable, Root, Subgroup 1A, except Sugar Beet, Garden
Beet, Radish, and Turnip, dated 7-10-07.
Boscalid: Addendum to the July 10, 2007 Human Risk
Assessment to Support a Section 3 Use on Endive, an Amendment to the
Tolerances for Strawberries and Berries, Crop Group 13, and an Increase
in Tolerances in/on Cucumber and Vegetable, Root, Subgroup 1A, except
Sugar Beet, Garden Beet, Radish, and Turnip.PC Code: 128008, Petition
Nos: 5E7013, 5F6986, DP Barcode: 34857, dated 2-13-08.
Boscalid: Human Health Risk Assessment to Support Proposed
New Uses on Fresh Herbs (Herbs Subgroup 19A), Avocado, Black Sapote,
Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, Star Apple and
Cotton. PC Code: 128008; Petition Nos: 6E7164, 7F7169; DP Barcodes:
336182, 337369, dated 2-13-08.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-term, intermediate-term, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see:
http://www.epa.gov/oppfead1/trac/science
http://www.epa.gov/pesticides/factsheets/riskassess.htm
http://www.epa.gov/pesticides/trac/science/ aggregate.pdf
A summary of the toxicological endpoints for boscalid used for
human risk assessment is discussed in Unit III.B of the final boscalid
rule published in the Federal Register of July 30, 2003 (68 FR 44640)
(FRL-7319-6).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to boscalid tolerances in (40 CFR 180.589), EPA assessed
dietary exposures from boscalid in food as follows:
i. Acute exposure. There are no toxic effects attributable to a
single (acute) exposure to boscalid; therefore an acute reference dose
was not established for boscalid and an acute dietary exposure
assessment is not needed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) Continuing Survey of Food Intake by
Individuals (CSFII) 1994-1996 and 1998. As to residue levels in food,
EPA assumed all foods for which there are tolerances were treated and
contain tolerance-level residues. The Agency did not use anticipated
residue estimates or percent crop treated (PCT) information.
iii. Cancer. For the reasons described in Unit III.A, the Agency
concluded that a quantitative risk and exposure assessment for cancer
(either linear low-dose extrapolation or margin of exposure
calculation) was not appropriate.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for boscalid in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
boscalid. Further information regarding EPA drinking water models used
in pesticide exposure assessment can be found at http://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the maximum
estimated surface and ground drinking water concentrations (EDWCs) of
boscalid for chronic exposures are 29.6 parts per billion (PPB) for
surface water and 0.63 ppb for ground water. Modeled estimates of
drinking water concentrations were directly entered into the dietary
exposure model. The chronic dietary risk assessment used the surface
water concentration value of 29.6 ppb 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,
[[Page 16557]]
indoor pest control, termiticides, and flea and tick control on pets).
Boscalid is registered for use on sites that would result in
residential exposure. From boscalid, residential exposure is only
possible on golf courses and at ``U-Pick'' farms and orchards. A non-
occupational dermal post-application exposure/risk assessment for these
exposures was conducted in the previous occupational and residential
exposure assessment and is described in the final rule in the Federal
Register of July 30, 2003 (68 FR 44640) (FRL-7319-6).
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to boscalid and any other
substances and boscalid does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that boscalid has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. In the 2-generation
reproduction study in rats, body weight effects were seen in the mid
and high doses in the second generation male pups. However, the degree
of concern is low for the quantitative evidence of susceptibility seen
in this study, since the body weight effects were seen in only one sex
and only after dosing for two generations. There is a clear NOAEL for
the body weight effects seen in the rat 2-generation reproduction study
and EPA is regulating based on a point of departure below where these
effects are seen.
In the developmental neurotoxicity study, transient body weight
effects were seen in one sex at post-natal days 1-4 with the animals
recovering by post-natal day 11. Body weight effects were also seen in
the high dose, which was the limit dose. The degree of concern for
these effects are low since the effects are either transient in nature
or occurred at the limit dose and EPA is regulating based on a point of
departure below where these effects are seen.
While qualitative sensitivity was seen in the rabbit developmental
study, the fetal effects were seen only at the limit dose in the
presence of maternal toxicity. Further, since EPA is regulating based
on a point of departure which is an order of magnitude below where
these effects are seen in the rabbit developmental study, EPA concludes
that the qualitative sensitivity evidenced in the fetuses in the rabbit
developmental study does not require retention of the 10X children's
safety factor.
3. Conclusion. The FQPA safety factor has been reduced to 1X for
boscalid for the following reasons. First, EPA has a complete toxicity
database for boscalid. The toxicity studies for boscalid show it
generally to have low mammalian toxicity. Further, while data involving
the testing of young animals did show increased quantitative
sensitivity in the young with regard to body weight effects and
qualitative sensitivity in one developmental study, clear NOAELs were
identified for all of these effects. Moreover, the body weight effects
at the LOAELs in these studies were either transient or inconsistent
and qualitative sensitivity occurred at the limit dose in the presence
of maternal toxicity. EPA concludes that there are no residual
uncertainties for pre-natal and/or post-natal toxicity. The NOAEL used
for various risk assessments would address the body weight effects seen
at higher doses in the developmental and reproductive studies. Finally,
EPA has conservatively estimated human exposure to boscalid, relying on
worst case exposures in food (assuming all registered crops contain
residues at the tolerance level), and conservative models as well as
pesticide-specific data in estimating exposure from residues in
drinking water and from residential uses.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
1. Acute risk. There were no toxic effects attributable to a single
exposure to boscalid, therefore, neither an acute reference dose (aRfD)
nor aPAD were established and acute dietary risk assessment and acute
aggregate risk assessment are not required for boscalid.
2. Chronic risk. The unrefined chronic dietary risk assessment for
boscalid was made using tolerance level residues, default and empirical
processing factors and 100% CT assumptions. Results of this analysis
indicate that chronic risk from the dietary (food + drinking water)
exposure from boscalid will not exceed EPA's level of concern for the
general U.S. population, and all population subgroups. The chronic
dietary risk estimate for the highest reported exposed population
subgroup, children 1-2 years old, is 33% of the cPAD. Chronic
residential exposure from residues of boscalid is not expected;
therefore the aggregate chronic risk is equivalent to the chronic
dietary risk described above.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus average exposure to food and water
(considered to be a background exposure level).
Boscalid is currently registered for uses that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate average food and water exposures with
short-term non-occupational exposures for boscalid. Using the exposure
assumptions described in this unit for short-term exposures, EPA has
concluded that food, water, and residential exposures aggregated result
in aggregate MOEs, which are below the Agency's level of
[[Page 16558]]
concern. MOEs for the U.S. population, and all subpopulations of
concern exceed 1,000. The level of concern for this assessment is for
MOEs below 100.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because no
intermediate term, non-occupational exposures are anticipated from the
use of boscalid, an intermediate-term aggregate risk assessment is not
required for boscalid.
5. Aggregate cancer risk for U.S. population. Given the data
showing no more than weak evidence of carcinogenic effects for
boscalid, EPA concludes that boscalid poses no greater than a
negligible risk of cancer.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to boscalid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatographic with mass
spectrometric detection) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no Codex Maximum Residue Limits (MRLs) for
boscalid. Canada has established MRLs for boscalid, but not for the
crops that are in this rule.
V. Conclusion
Therefore, this regulation establishes tolerances for residues of
boscalid,3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-
yl), in or on caneberry subgroup 13A, and bushberry subgroup 13B,
respectively at 6.0 and 13 ppm; cotton, undelinted seed at 1.0 ppm;
cotton, gin byproducts at 55 ppm; avocado at 1.5 ppm; sapote, black at
1.5 ppm; canistel at 1.5 ppm; sapote, mamey at 1.5 ppm; mango at 1.5
ppm; papaya at 1.5 ppm; sapodilla at 1.5 ppm; star apple at 1.5 ppm;
cucumber at 0.5 ppm; and vegetable, root, subgroup 1A, except sugar
beet, garden beet, radish and turnip at 1.0 ppm. In addition, this
regulation establishes a time-limited tolerance for residues of
boscalid in or on endive, belgian at 16 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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
section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This
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) (Public Law 104-4). 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), Public Law
104-113, section 12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 18, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. Section 180.589 is amended by removing the entry for berry group 13,
and alphabetically adding the following commodities to the table in
paragraph (a)(1), and by revising paragraph (b) to read as follows:
Sec. 180.589 Boscalid; tolerance for residues.
(a) * * *
(1) * * *
[[Page 16559]]
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
* * * * *
Avocado.......................................................... 1.5
Bushberry, subgroup 13B.......................................... 13.0
Caneberry, subgroup13A........................................... 6.0
Canistel......................................................... 1.5
* * * * *
Cotton, gin byproducts........................................... 55.0
Cotton, undelinted seed.......................................... 1.0
Cucumber......................................................... 0.5
* * * * *
Mango............................................................ 1.5
* * * * *
Papya............................................................ 1.5
Sapodilla........................................................ 1.5
Sapote, black.................................................... 1.5
Sapote, mamey.................................................... 1.5
Star Apple....................................................... 1.5
* * * * *
Vegetable, root, subgroup 1A, except sugarbeet, garden beet, 1.0
radish, and turnip
* * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for the residues of the fungicide boscalid, 2-chloro-N-(4'-
chloro [1, 1'-biphenyl]-2-yl)-3-pyridinecarboxamide in connection with
use of the pesticide under a section 18 emergency exemption granted by
EPA. This tolerance will expire and is revoked on the date specified in
the following table.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/Revocation Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endive, Belgian 16 12/31/09
Tangerine 2.0 12/31/08
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. E8-6264 Filed 3-27-08; 8:45 am]
BILLING CODE 6560-50-S