Document ID: EPA-HQ-OPP-2005-0145-0045
Agency: epa
Document Type: Rule
Title: Boscalid; Pesticide Tolerance
Posted Date: 2008-03-28T04:00Z

[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