[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Rules and Regulations]
[Page 55293-55300]
[DOCID:fr22se06-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0053; FRL-8093-9]

Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-
(1H-1,2,4-triazole)-1-propanenitrile, and its metabolites RH-9129, cis-
5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, in or on almond; almond,
hulls; apple; apple wet pomace; banana; beet, sugar, dried pulp; beet,
sugar, molasses; beet, sugar, roots; beet, sugar, tops; bushberry
subgroup 13B; cattle, meat byproducts; citrus, dried pulp; citrus, oil;
cranberry; fruit, citrus, group 10; fruit, stone, group 12; goat, meat
byproducts; grain, aspirated fractions; grape; horse, meat byproducts;
peanut; pecan; sheep, meat byproducts; wheat, forage; wheat, grain;
wheat, hay; and wheat, straw. EPA is also deleting several existing
tolerances that are no longer needed as a result of this action. Dow
AgroSciences requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
of 1996 (FQPA).

DATES: This regulation is effective September 22, 2006. Objections and
requests for hearings must be received on or before November 21, 2006,
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-2005-0053. All documents in the
docket are listed in the index for the docket. 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-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 provides
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 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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2005-0053 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 on or
before November 21, 2006.
    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 your copies, identified by docket ID
number EPA-HQ-OPP-2005-0053, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of July 20, 2005, 70 FR 41718 (FRL-7702-7),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of pesticide petitions (PP 0E6208, PP
1E6252, PP 1F3989, PP 1F3995, PP 2F4127, PP 2F4135, PP 2F4154, PP
3F4914, PP 4F6879, PP 7F4887, PP 9E5041, and PP 9F6024) by Dow
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, Indiana 46268-
1054. The petition requested that 40 CFR 180.480 be amended by
establishing tolerances for combined residues of the fungicide
fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile, and its metabolites cis-5-(4-
chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-
furanone and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone, in or on almond at 0.05 parts per
million (ppm) (PP 3F4194); almond, hulls at 3.0 ppm (PP 3F4194); apple
at 0.4 ppm (PP 2F4135); apple, wet pomace at 1.0 ppm (PP 2F4135);
banana at 0.3 ppm (PP 2F4154); blueberry at 0.3 ppm (PP 9E5041);
cranberry at 1.0 ppm (PP 1E6252); fruit, citrus, group 10 at 1.0 ppm
(PPs 7F4900 and 4F6879); fruit, stone, group 12 (except plum, prune) at
2.0 ppm (PP 1F3989); grape at 1.0 ppm (PP 0E6208); pecan at 0.1 ppm (PP
1F3995); plum at 2.0 ppm (PP 1F3989); plum, prune, dried at 7.0 ppm (PP
1F3989); sugar beet, dried pulp at 1.0 ppm (PP 7F4887); sugar beet,
molasses at 0.4 ppm (PP 7F4887); sugar beet, roots at 0.2 ppm (PP
7F4887); sugar beet, tops at 9.0 ppm (PP 7F4887); wheat, grain at 0.05
ppm (PP 2F4127); and wheat, straw (PP 2F4127) at 10.0 ppm; establishing
tolerances for combined residues of the fungicide fenbuconazole,
[alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-1,2,4-
triazole)-1-propanenitrile, and its metabolite [alpha]-(2-(4-chloro-3-
(D-glucopyranosyloxy)-phenyl)ethyl)-[alpha]-phenyl-1H-1,2,4-triazole-1-
propanenitrile, in or on peanut at 0.1 ppm (PP 9F6024) and peanut, hay
at 20 ppm (PP 9F6024); by establishing tolerances for combined residues
of the fungicide fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-
[alpha]-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile, and its
metabolites cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone, trans-5-(4-chlorophenyl)-dihydro-3-
phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, and 4-chloro-
[alpha]-hydroxymethyl-[alpha]-phenyl-benzenebutanenitrile in or on fat
of cattle, goats, hogs, horses, and sheep at 0.05 ppm (PP 2F4127), and
liver of cattle, goats, hogs, horses, and sheep at 0.3 ppm (PP 2F4127).
That notice included a summary of the petition prepared by Dow
AgroSciences LLC, the registrant. There were no comments received in
response to the notice of filing.
    EPA is also deleting several established time-limited tolerances in
Sec.  180.480(b) that are no longer needed. These revisions are as
follows:
    i. Delete the cattle, goat, horse, and sheep meat byproducts
tolerances, each for 0.01 ppm and expiring on December 31, 2008. These
tolerances are replaced by permanent tolerances of 0.05 ppm for cattle,
goat, horse, and sheep meat byproducts, respectively.
    ii. Delete the grapefruit tolerance of 0.5 ppm that expires on
December 31, 2008. It is replaced by a permanent tolerance of 1.0 ppm
for fruit, citrus, group 10.
    iii. Delete the grapefruit, dried pulp tolerance of 4.0 ppm that
expires on December 31, 2008. It is replaced by a permanent tolerance
of 5.0 ppm for citrus, dried pulp.
    iv. Delete the grapefruit, oil tolerance of 35 ppm that expires on
December 31, 2008. It is replaced by a permanent tolerance of 40.0 ppm
for citrus, oil.
    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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the

FFDCA and a complete description of the risk assessment process, see
http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm,

http://www.epa.gov/oppfead1/trac/science, http://www.epa.gov/pesticides/factsheets/riskassess.htm, and http://www.epa.gov/
d http://www.epa.gov/pesticides/trac/science/aggregate.pdf
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of
fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile), and its metabolites RH-9129, cis-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, in or on almond at 0.05
ppm; almond, hulls at 1.0 ppm; apple at 0.4 ppm; apple, wet pomace at
1.0 ppm; banana at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet,
sugar, molasses at 0.4 ppm; beet, sugar, roots at 0.3 ppm; beet, sugar,
tops at 9.0 ppm; bushberry subgroup 13B at 0.3 ppm; cattle, meat
byproducts at 0.05 ppm; citrus, dried pulp at 5.0 ppm; citrus, oil at
40.0 ppm; cranberry at 0.5 ppm; goat, meat byproducts at 0.05 ppm;
fruit, citrus, group 10 at 1.0 ppm; fruit, stone, group 12 at 1.0 ppm;
grain, aspirated fractions at 6.0 ppm; grape at 1.0 ppm; horse, meat
byproducts at 0.05 ppm; peanut at 0.1 ppm; pecan at 0.05 ppm; sheep,
meat byproducts at 0.05 ppm; wheat, forage at 4.0 ppm; wheat, grain at
0.1 ppm; wheat, hay at 8.0 ppm; and wheat, straw at 8.0 ppm. EPA's
assessment of exposures and risks associated with establishing the
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. Specific information on the studies received and the nature
of the toxic effects caused by fenbuconazole 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
, Docket Identification (ID) Number EPA-HQ-OPP-2005-

0053.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect 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.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for fenbuconazole used for
human risk assessment is shown below in Table 1 of this document.

    Table 1.--Summary of Toxicological Dose and Endpoints for Fenbuconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment;          Special FQPA Safety
          Exposure Scenario                Interspecies and      Factor (SF); Level of     Study; Endpoint and
                                         Intraspecies and any       Concern for Risk      Toxicological Effects
                                            Traditional UF             Assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of  NOAEL = 30 mg/kg/day;    Special FQPA SF = 1;     Rat developmental
 age)                                  UF = 100; Acute RfD\1\   aPAD = acute RfD\1\ /     study;
                                        = 0.3 mg/kg/day.         Special FQPA SF = 0.3   Developmental LOAEL =
                                                                 mg/kg/day.               75 mg/kg/day based on
                                                                                increased resorptions
                                                                                and decreased live
                                                                                fetuses per dam
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      No NOAEL was             Special FQPA SF is not   No study was selected
 including infants and children)        identified; UF is not    applicable; no aPAD\2\   because no appropriate
                                        applicable; no Acute     was calculated.          dose and endpoint
                                        RfD\1\ was calculated.                            could be identified
                                                                                for this population
                                                                                group
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 3 mg/kg/day; UF   Special FQPA SF = 1;     Rat combined chronic
                                        = 100; Chronic RfD\1\    cPAD\3\ = chronic        toxicity/
                                        = 0.03 mg/kg/day.        RfD\1\ / Special FQPA    carcinogenicity study;
                                                                 SF = 0.03 mg/kg/day.    LOAEL = 30.6 mg/kg/day
                                                                                for males and 43.1 mg/
                                                                                kg/day for females
                                                                                based on decreased
                                                                                body weight gain,
                                                                                increased thyroid
                                                                                weight, and
                                                                                histopathological
                                                                                lesions in the liver
                                                                                and thyroid gland
----------------------------------------------------------------------------------------------------------------
Incidental Oral (all durations)        No NOAEL was             Special FQPA SF is not   No study was selected
                                        identified; UF is not    applicable; no LOC was   because no registered
                                        applicable; no RfD\1\    determined.              uses would result in
                                        was calculated.                                   residential exposure
----------------------------------------------------------------------------------------------------------------

Long-Term Dermal (several months to    Oral study NOAEL= 3 mg/  Residential LOC for      Rat combined chronic
 lifetime)                              kg/day (dermal           MOE\4\ = not             toxicity/
                                        absorption rate =        applicable;.             carcinogenicity study;
                                        4.25%).                 Occupational LOC for     LOAEL = 30.6 mg/kg/day
                                                                 MOE = 100.               for males and 43.1 mg/
                                                                                kg/day for females
                                                                                based on decreased
                                                                                body weight gain,
                                                                                increased thyroid
                                                                                weight, and
                                                                                histopathological
                                                                                lesions in the liver
                                                                                and thyroid gland
----------------------------------------------------------------------------------------------------------------
Inhalation (all durations)             Oral study NOAEL= 3 mg/  Residential LOC for      Rat combined chronic
                                        kg/day; Absorption       MOE\4\ = not             toxicity/
                                        factor = 100%).          applicable;.             carcinogenicity study;
                                                                Occupational LOC for     LOAEL = 30.6 mg/kg/day
                                                                 MOE = 100.               for males and 43.1 mg/
                                                                                kg/day for females
                                                                                based on decreased
                                                                                body weight gain,
                                                                                increased thyroid
                                                                                weight, and
                                                                                histopathological
                                                                                lesions in the liver
                                                                                and thyroid gland
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)             Classification: Under the 1986 cancer classification scheme,
                                          fenbuconazole was classified as a Group C - Possible Human Carcinogen
                                         with a low dose extrapolation model applied to the animal data for the
                                             quantification of human risk (Q1*). This was based on increased
                                         incidence of hepatocellular adenomas and carcinomas in male and female
                                        mice and of thyroid follicular adenomas and combined adenomas/carcinomas
                                           in male rats. Based on mechanistic data, quantification of risk was
                                           derived using combined hepatocellular adenomas/carcinomas in female
                                          mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)-\1\, is
                                                           3.59 x 10-\3\ in human equivalents.
----------------------------------------------------------------------------------------------------------------
\1\RfD means ``Reference Dose''; \2\aPAD means ``acute Population Adjusted Dose''; \3\cPAD means ``chronic
  Population Adjusted Dose; \4\MOE means ``Margin of Exposure''

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have
previously been established (40 CFR 180.480) for the combined residues
of fenbuconazole and its metabolites RH-9129 and RH-9130, in or on a
variety of raw agricultural commodities. These raw agricultural
commodities include fat, meat, and meat byproducts of cattle, goat,
hog, horse, and sheep. Risk assessments were conducted by EPA to assess
dietary exposures from fenbuconazole 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 one-day or single exposure.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated
the individual food consumption as reported by respondents in the USDA
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute exposure
assessments: The acute dietary (food plus water) assessment was very
conservative -- a screening level, Tier 1 assessment. It was based on
tolerance-level residues and assumed that 100% of each crop was treated
with fenbuconazole. For water exposure the assessment used the
estimated maximum peak concentration of fenbuconazole in surface water
that was calculated from the requested use pattern for cherries, a
worst-case estimate. The only population subgroup that is relevant for
this acute assessment is females (13-49 years old).
    ii. Chronic (non-cancer) exposure. In conducting this chronic
dietary risk assessment the Dietary Exposure Evaluation Model
(DEEM\TM\) analysis evaluated the individual food consumption as
reported by respondents in the USDA 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: The chronic
(non-cancer) dietary assessment included contributions from both food
and water. This analysis is more refined than the acute dietary
assessment in that it uses average residues from field trials. Due to
the manner in which these data were submitted and reviewed, multiple
averages were calculated for many of the crops. For these crops the
highest average was used in the analysis. The non-cancer chronic
dietary analysis assumed 100% crop treated and the annual average
estimated surface water concentration from the cherry use.
    iii. Cancer. The cancer dietary assessment used the same food
residue inputs as those of the non-cancer assessment--average residues
from field trials and 100% crop treated for all crops. The water
component of this assessment used the estimated 30-year average surface
water concentration from the cherry use.
    iv. Anticipated residue information. Section 408(b)(2)(E) of the
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 chemicals that have been measured in food. If EPA
relies on such information, EPA must, pursuant to section 408(f)(1),
require 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. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. For the present

action, EPA will issue such data call-ins for information relating to
anticipated residues as are required by FFDCA section 408(b)(2)(E) and
authorized under FFDCA section 408(f)(1). Such data call-ins will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances. Anticipated residue data were used in the
chronic (non-cancer) and cancer dietary risk analyses but not in the
acute dietary risk analysis. The anticipated residues used were the
highest per-study-volume average residue from the field trial studies
for each crop that were submitted by the registrant.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fenbuconazole 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 physical
characteristics of fenbuconazole. 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 PRZM/EXAMS and SCI-GROW models, the estimated
environmental concentrations (EECs) of fenbuconazole for acute
exposures are estimated to be 20.3 parts per billion (ppb) for surface
water and 0.031 ppb for ground water. The EECs for chronic (non-cancer)
and for cancer exposures are estimated to be 16.5 ppb for surface water
and 0.031 ppb for ground water.
    3. From non-dietary exposure. Where the term ``residential
exposure'' is used in this document, it refers 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).
However, fenbuconazole is not registered for any use that will result
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Fenbuconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative
.

    Fenbuconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazole alanine and triazole acetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including fenbuconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazole alanine, and triazole acetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, Docket

Identification (ID) Number EPA-HQ-OPP-2005-0497.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. 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 safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The data provided no
indication of increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to fenbuconazole. In the prenatal
developmental study in rats and rabbits and the 2-generation study in
rats, effects in the offspring were observed only at or above those
treatment levels which resulted in maternal toxicity.
    The degree of concern for infants and children exposed to
fenbuconazole in utero and/or postnatally is low; there are no residual
uncertainties. The toxicology database for fenbuconazole is complete
and adequate for risk assessment purposes. Acceptable developmental
studies in rats and rabbits and the 2-generation reproduction study in
rats did not show evidence of increased susceptibility in offspring
exposed to fenbuconazole in utero and/or postnatally. A NOAEL for acute
effects has been selected for the subpopulation females (13-49 years
old) based on developmental effects (increased resorptions and
decreased live fetuses per dam) seen at the LOAEL in the developmental
rat study. By regulating on the effect of concern for this
subpopulation, the risk assessment is protective of potential effects
to infants and children. No acute effects of fenbuconazole were
identified in any of the other studies.
    3. Conclusion. There is a complete toxicity data base for
fenbuconazole and exposure data are complete or are estimated based on
data that reasonably account for potential exposures. The

FQPA safety factor was therefore removed (i.e., reduced to 1x) in
assessing the risk posed by fenbuconazole, based on the following
considerations:
    i. There are no toxicology data gaps for the assessment of the
effects of fenbuconazole; a developmental neurotoxicity study is not
required.
    ii. There is no indication of quantitative or qualitative
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to fenbuconazole.
    iii. The dietary exposure assessment is based on models and input
parameters designed to be protective of human health.
    iv. At this time, there are no registered residential uses for
fenbuconazole, so this type of exposure to infants and children is not
expected.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute exposure to fenbuconazole from
dietary (food plus water) consumption was calculated only for the
population subgroup females (13-49 years old). It will occupy 3% of the
aPAD for this subgroup based on a 95\th\ percentile acute dietary
exposure of 0.009014 mg/kg/day. The surface water concentration that
was used in this analysis was 20.3 ppb. Because of the toxicology of
fenbuconazole, an acute risk analysis is not relevant for the general
U.S. population or any other population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has calculated that chronic dietary
exposure to fenbuconazole from food plus water will utilize 2% of the
cPAD for the general U.S. population, 7% of the cPAD for all infants
(less than 1 year old), and 6% of the cPAD for children (1-2 years
old). There are no residential uses for fenbuconazole that result in
chronic residential exposure to fenbuconazole. The surface water
concentration of fenbuconazole that was used for the general U.S.
population and each population subgroup in this analysis was 16.5 ppb.
EPA does not expect the aggregate exposure to exceed 100% of the cPAD
for the general U.S. population or any subgroup of it, as shown below,
in Table 2 of this document.

Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to
                              Fenbuconazole
------------------------------------------------------------------------
                                                  Exposure
              Population/Subgroup               (mg/kg/day)     % cPAD
------------------------------------------------------------------------
General U.S. Population                            0.000666            2
------------------------------------------------------------------------
All Infants (>1 Year Old)                          0.002016            7
------------------------------------------------------------------------
Children (1-2 Years Old)                           0.001795            6
------------------------------------------------------------------------
Children (3-5 Years Old)                           0.001408            5
------------------------------------------------------------------------
Children (6-12 Years Old)                          0.000783            3
------------------------------------------------------------------------
Youth (13-19 Years Old)                            0.000419            1
------------------------------------------------------------------------
Adults (20-49 Years Old)                           0.000525            2
------------------------------------------------------------------------
Adults (50+ Years Old)                             0.000612            2
------------------------------------------------------------------------
Females (13-49 Years Old)                          0.000539            2
------------------------------------------------------------------------

    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures take into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Fenbuconazole is not registered for use on any site(s) that
would result in residential exposure. Therefore, the aggregate risks
are the sums of the risks from food and water, which do not exceed the
Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Dietary exposure
(food plus water) is the only source of exposure to fenbuconazole that
is expected to be chronic (cancer exposure is considered to be life-
time exposure). The chronic (cancer) aggregate exposure and risk
estimates are based on those for the general U.S. population group. In
this case the risk is based on a cancer potency (Q1*) value
of 3.59 x 10-\3\ and a dietary exposure to fenbuconazole of
0.000666 mg/kg/day. The dietary exposure is the same as that used for
the chronic (non-cancer) assessment. The estimated cancer risk that
resulted from this assessment is 2.4 x 10-\6\. In general,
the precision which can be assumed for cancer risk estimates is best
described by rounding to the nearest integral order of magnitude on the
log scale, e.g., 3.16 x 10-\7\ to 3.16 x 10-\6\,
expressed as 10-\6\. Risks are generally reported to two
significant figures in Agency risk assessments to allow better
characterization of changes in risk which might result from potential
risk mitigation. This rounding procedure indicates that risks should
generally not be assumed to exceed the benchmark level of concern of 1
x 10-\6\ until the calculated risks exceed approximately 3 x
10-\6\. Therefore, the Agency considers this risk estimate
to be negligible because it falls within the range of 1 in 1 million.
In addition, the cancer risk estimate for fenbuconazole is over-stated
due to very conservative exposure assumptions. The exposure estimate
used in the cancer risk assessment assumes that 100 percent of crops
covered by tolerances are treated and that all crops contain residues
at the highest per-study-volume average residue found in crop field
trials using maximum, or greater than maximum, permitted application
amounts.
    5. Determination of safety. Based on these risk assessments, EPA
therefore concludes that there is a reasonable certainty that no harm
will result to the general population, infants, or children from
aggregate exposure to fenbuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen-
phosphorus 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:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    Codex MRL's are established on bananas and pecans at 0.05 ppm,
wheat grain at 0.1 ppm, peach at 0.5 ppm, cherries at 1.0 ppm, and
wheat straw at 3.0 ppm. Although the residue definitions differ (i.e.,
Codex does not include the metabolites), the U.S. tolerances for pecans
and wheat grain match the Codex limits numerically. The U.S. stone
fruit crop group tolerance of 1.0 ppm is consistent with the highest
Codex MRL on an individual member (cherries) of that crop group. In the
cases of bananas and wheat straw, the levels of total residues in the
U.S. tolerance expression (which includes fenbuconazole metabolites)
are higher than the Codex MRL (which excludes these metabolites).
Therefore, EPA has not harmonized these values.

V. Conclusion

    Therefore, tolerances are established for combined residues of
fenbuconazole,

[alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-1,2,4-
triazole)-1-propanenitrile and its metabolites cis-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone and
trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-
ylmethyl)-2-3H-furanone, expressed as fenbuconazole, in or on almond at
0.05 ppm; almond, hulls at 1.0 ppm; apple at 0.4 ppm; apple, wet pomace
at 1.0 ppm; banana at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm;
beet, sugar, molasses at 0.4 ppm; beet, sugar, roots at 0.3 ppm; beet,
sugar, tops at 9.0 ppm; bushberry subgroup 13B at 0.3 ppm; cattle, meat
byproducts at 0.05 ppm; citrus, dried pulp at 5.0 ppm; citrus, oil at
40.0 ppm; cranberry at 0.5 ppm; fruit, citrus, group 10 at 1.0 ppm;
fruit, stone, group 12 at 1.0 ppm; goat, meat byproducts at 0.05 ppm;
grain, aspirated fractions at 6.0 ppm; grape at 1.0 ppm; horse, meat
byproducts at 0.05 ppm; peanut at 0.1 ppm; pecan at 0.05 ppm; sheep,
meat byproducts at 0.05 ppm; wheat, forage at 4.0 ppm; wheat, grain at
0.1 ppm; wheat, hay at 8.0 ppm; and wheat, straw at 8.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 due to its lack of
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerances in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: September 13, 2006.
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 180.480 is amended in paragraph (a)(1) by revising the table
and in paragraph (b), in the table, by removing the commodities cattle,
meat byproducts; goat, meat byproducts; grapefruit; grapefruit, dried
pulp; grapefruit, oil; horse, meat by products; and sheep, meat
byproducts.
    The amendment reads as follows:

Sec.  180.480   Fenbuconazole; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond...............................................               0.05
Almond, hulls........................................                1.0
Apple................................................                0.4
Apple, wet pomace....................................                1.0

Banana...............................................                0.3
Beet, sugar, dried pulp..............................                1.0
Beet, sugar, molasses................................                0.4
Beet, sugar, roots...................................                0.3
Beet, sugar, tops....................................                9.0
Bushberry subgroup 13B...............................                0.3
Cattle, meat byproducts..............................               0.05
Citrus, dried pulp...................................                5.0
Citrus, oil..........................................               40.0
Cranberry............................................                0.5
Fruit, citrus, group 10..............................                1.0
Fruit, stone, group 12...............................                1.0
Goat, meat byproducts................................               0.05
Grain, aspirated fractions...........................                6.0
Grape\1\.............................................                1.0
Horse, meat byproducts...............................               0.05
Peanut...............................................                0.1
Pecan................................................               0.05
Sheep, meat byproducts...............................               0.05
Wheat, forage........................................                4.0
Wheat, grain.........................................                0.1
Wheat, hay...........................................                8.0
Wheat, straw.........................................                8.0
------------------------------------------------------------------------
\1\There are no United States registrations for grape as of August 2006.

* * * * *
[FR Doc. 06-7957 Filed 9-21-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27614-27616]
[FR Doc No: 2018-12633]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0223]

Humanitarian Device Exemption Program; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Humanitarian Device
Exemption (HDE) Program.'' This draft guidance concerns the HDE program
as a whole and, among other topics, it explains the criteria FDA
considers to determine if ``probable benefit'' has been demonstrated as
part of the Agency's decision-making process regarding marketing
authorization for a humanitarian use device (HUD). The draft guidance
also incorporates recent amendments to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) that affect the HDE program and answers other
common questions that we receive about the program. This draft guidance
is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by August 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0223 for ``Humanitarian Device Exemption (HDE) Program.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Humanitarian Device Exemption (HDE) Program'' to the Office of the
Center Director, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA developed this draft guidance to clarify to industry and FDA
staff the current review practices for the HDE program. This draft
guidance answers common questions about the HDE program and responds to
a requirement in the 21st Century Cures Act (Cures Act, Pub. L. 114-
255) to define the criteria for establishing ``probable benefit'' as
that term is used in section 520(m)(2)(C) of the FD&C Act (21 U.S.C.
360j(m)(2)(C)).
    This draft guidance incorporates recent amendments to the FD&C Act
that affect the HDE program. Specifically, section 3052 of the Cures
Act modified the eligibility for an HDE by increasing the threshold
number of patients affected by the disease or condition that a HUD is
designed to treat or diagnose to ``not more than 8,000 individuals in
the United States.'' Further, section 3056 the Cures Act removed the
requirement that institutional review committees, i.e., institutional
review boards (IRBs), that supervise the clinical testing of HUDs or
approve the use of HUDs in clinical care be local.
    Additionally, the FDA Reauthorization Act of 2017 (Pub. L. 115-52)
amended section 520(m) of the FD&C Act to provide that the use of a
device under an HDE at a facility to treat or diagnose patients may be
approved by an IRB or an appropriate local committee. Previously,
section 520(m)(4) of the FD&C Act only allowed an IRB to perform this
function. FDA is providing an interpretation of the term ``appropriate
local committee'' in this draft guidance, and we welcome comment on the
characteristics that should define an appropriate local committee for
purposes of the HDE program.
    This draft guidance supplants the draft guidance, ``Humanitarian
Device Exemption (HDE): Questions and Answers--Draft Guidance for HDE
Holders, IRBs, Clinical Investigators, and Food and Drug Administration
Staff,'' issued on March 18, 2014. When final, this guidance will
supersede the guidance, ``Guidance for HDE holders, IRBs, Clinical
Investigators, and Food and Drug Administration Staff, HDE Regulation:
Questions and Answers,'' issued on July 8, 2010, available online at:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM110203.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
Humanitarian Device Exemption Program. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by

downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Humanitarian Device Exemption (HDE) Program''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number 17040
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 10 have been
approved under OMB control number 0910-0191; the collections of
information in 21 CFR parts 50 and 56 have been approved under OMB
control numbers 0910-0755 and 0910-0130; the collections of information
in 21 CFR part 54 have been approved under OMB control number 0910-
0396; the collections of information in 21 CFR part 803 have been
approved under OMB control number 0910-0437; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 814,
subparts A through E, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 814, subpart H,
have been approved under OMB control number 0910-0332; the collections
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information regarding Information
to Accompany HDE Applications and Annual Distribution Number Reporting
Requirements have been approved under OMB control number 0910-0661; and
the collections of information in the guidance document ``De Novo
Classification Process (Evaluation of Automatic Class III
Designation)'' have been approved under OMB control number 0910-0844.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12633 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Rules and Regulations]
[Pages 48018-48020]
[FR Doc No: 2021-18422]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0075; Airspace Docket No. 21-ASO-2]
RIN 2120-AA66

Amendment of Class E Airspace; Muscle Shoals, AL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace extending upward from 700
feet above the surface in Muscle Shoals, AL, due to the decommissioning
of the Muscle Shoals Very High Frequency Omni-Directional Radio Range
Tactical Air Navigation Aid (VORTAC), and cancellation of the
associated approach at Northwest Alabama Regional Airport. This action
also updates the airport name under the Class E surface airspace and
makes an editorial change replacing the term Airport/Facility Directory
with the term Chart Supplement in the legal descriptions of associated
Class E airspace. Controlled airspace is necessary for the safety and
management of instrument flight rules (IFR) operations in the area.

DATES: Effective 0901 UTC, December 2, 2021. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave., College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rule regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106,
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace at Northwest Alabama Regional Airport,
Muscle Shoals, AL.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (86 FR 27329, May 20, 2021) for Docket No. FAA-2021-0075 to
amend Class E airspace extending upward from 700 feet above the surface
at Northwest Alabama Regional Airport, Muscle Shoals, AL. Also, the FAA
proposed to update the airport name and replace the outdated term
Airport/Facility Directory with the term Chart Supplement in the
associated Class E airspace legal description for this airport.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. One
comment was received supporting the airspace change.
    Class E airspace designations are published in Paragraphs 6002 and
6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and
effective September 15, 2020, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic routes, and reporting
points.

The Rule

    The FAA is amending 14 CFR part 71 by amending Class E airspace
extending upward from 700 feet above the surface at Northwest Alabama
Regional Airport, Muscle Shoals, AL, as the Muscle Shoals VORTAC has
been decommissioned, and associated approaches cancelled. The radius of
the airport is decreased from 7 miles to 6.8 miles, adding a 12.5-mile
extension to the east and an 8.1-mile extension to the south. Also, the
FAA updates the airport name to Northwest Alabama Regional Airport,
(formerly Muscle Shoals Regional Airport) in both the Class E surface
airspace and Class E airspace extending upward from 700 feet above the
surface. In addition, the FAA is replacing the outdated term Airport/
Facility Directory with the term Chart Supplement in the associated
Class E airspace legal description for this airport.
    These changes are necessary for continued safety and management of
IFR operations in the area.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is minimal. Since this is a routine matter that only
affects air traffic procedures an air navigation, it is certified that
this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6002 Class E Surface Airspace.

* * * * *

ASO AL E2 Muscle Shoals, AL [Amended]

Northwest Alabama Regional Airport, AL
    (Lat. 34[deg]44'43'' N, long. 87[deg]36'37'' W)

    That airspace extending upward from the surface within a 4.2-
mile radius of Northwest Alabama Regional Airport. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Chart
Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO AL E5 Muscle Shoals, AL [Amended]

Northwest Alabama Regional Airport, AL
    (Lat. 34[deg]44'43'' N, long. 87[deg]36'37'' W)

    That airspace extending upward from 700 feet or more above the
surface within a 6.8-mile radius of Northwest Alabama Regional
Airport, and within 3.7-miles each side of the 114[deg] bearing from
the airport, extending from the 6.8-mile radius to 12.5-miles east
of the airport, and within 1.2-miles each side of the 181[deg]
bearing from the airport, extending from the 6.8-mile radius to 8.1-
miles south of the airport.

    Issued in College Park, Georgia, on August 23, 2021.
Matthew N. Cathcart,
Manager, Airspace & Procedures Team North, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2021-18422 Filed 8-26-21; 8:45 am]
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