[Federal Register Volume 60, Number 12 (Thursday, January 19, 1995)]
[Proposed Rules]
[Pages 3797-3798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1320]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4349/P599; FRL-4932-9]
RIN 2070-AC18
Pesticide Tolerance for Amitraz
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to establish a tolerance for residues of the
insecticide/miticide amitraz and its metabolites in or on imported
dried hops at 60 parts per million (ppm). AgrEvo (formerly Nor Am)
Chemical Co. requested this regulation to establish the maximum
permissible level of residues of the insecticide/miticide in or on the
commodity.
DATE: Comments, identified by the document control number [PP 4E4349/
P599], must be received on or before February 21, 1995.
ADDRESSES: Comments may be submitted to: Public Docket and Freedom of
Information Section, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person,
bring comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice. All
written comments will be available for public inspection in Rm. 1132 at
the address given above, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 207, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)-305-6386.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of December 13, 1991 (56 FR 65080), which announced
that Nor-Am Chemical Co., Little Falls Centre One, 2711 Centerville
Rd., Wilmington, DE 19808, had submitted a food additive petition (FAP
2H5618) to EPA requesting that the Administrator, pursuant to sections
408(d) and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d) and 348, establish a tolerance for the insecticide/
miticide amitraz (N'-[2,4-dimethylphenyl]-N-[[(2,4-
dimethylphenyl)imino]methyl]]-N-methylmethanimidamide) and its
metabolites N-(2,4-dimethylphenyl)-N-methyl formamide and N-(2,4-
dimethylphenyl)-N-methylmethanimidamide (both calculated as the parent
compound) in or on imported dried hops at 75 parts per million. There
were no comments received in response to the initial notice of filing.
In the Federal Register of May 17, 1994 (59 FR 25586), the Agency
issued a proposal to establish the amitraz hops tolerance at 75 ppm. No
comments were received in response to this proposal; however, a concern
was raised regarding the potential acute dietary risk of amitraz posed
by its registered uses during reregistration under the Federal
Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq., and
therefore the final rule was not published. To address this concern,
the company provided a voluntary human study and additional residue
data and proposed a lower tolerance of 50 ppm for hops. An Agency
review of the data concluded that a tolerance of 60 ppm is needed given
the existing application rates.
EPA had not proposed to establish a tolerance for amitraz on hops
in the past because dried hops have been considered a processed food
requiring a section 409 tolerance and EPA was concerned that a section
409 tolerance for amitraz might be prohibited by the section 409
Delaney anti-cancer clause. Recently, EPA reclassified dried hops as a
raw agricultural commodity (see proposed rule at 59 FR 25586; May 17,
1994).
The data submitted in the petition and all other relevant material
have been evaluated. The toxicology data considered in support of the
tolerance was described in the May 17, 1994 proposed rule. In June
1994, a voluntary human study was submitted. This study indicated
changes in systolic blood pressure, body temperature, ECG rate, and
psychomotor performance observed from a single oral dose at the 0.125
mg/kg (the NOEL) level to be minimal and transient.
As directed by FIFRA section 4(g)(2)(A), the database for amitraz
has undergone a reevaluation and reassessment as part of the
reregistration process. It was determined that a combined
developmental, neurological, and reproduction toxicity study in rats is
needed to provide confirmatory data. The amitraz Reregistration
Eligibility Document (RED), which is expected to be released shortly,
will require this study.
The nature of the residue in plants and livestock is adequately
understood. The residues of concern are amitraz and its metabolites
containing the 2,4-dimethylaniline moiety. The residue analytical
method is a common moiety method which converts amitraz and its two
metabolites to 2,4-dimethylaniline with determination of the residues
by gas chromatography using 63Ni electron detection. The method has
been published in FDA's PAM II. Magnitude of the residue data show that
total amitraz residues on dried hops are not expected to exceed the
proposed tolerance when amitraz is used as directed. There are
currently no actions pending against continued registration of this
chemical.
The Agency has prepared a dietary risk assessment for the amitraz
RED, which is expected to be released shortly. Amitraz is a possible
human carcinogen based on a 2-year mouse carcinogenicity study. The
current dietary risk determined during preparation of the RED was
calculated to be 1.4 X 10-6 (for the cottonseed/eggs/poultry use,
plus pears, cattle, swine, and honey/beeswax). The addition of the use
on hops will add 1.2 X 10-6 to this risk, assuming exposure over a
lifetime of 70 years for a total lifetime dietary cancer risk from
exposure to amitraz residues of 2.6 X 10-6. The use of amitraz on
imported hops is expected to still keep the overall lifetime dietary
cancer risk within the negligible range.
The anticipated residue contribution (ARC) for this chemical from
published tolerances utilizes 1 percent of the reference dose (RfD).
The proposed tolerance will contribute 0.000025 mg/kg/bwt/day utilizing
an additional 1 percent of the RfD. This results in a total utilization
of 2 percent of the RfD.
[[Page 3798]]
As stated previously, the May 17, 1994 proposed rule to establish a
tolerance for amitraz in/on imported hops was not finalized because the
amitraz reregistration activities indicated the potential for an acute
risk of concern. Using the voluntary human study submitted by the
company, a revised dietary exposure analysis was performed assessing
the acute risk from the proposed use of amitraz on dried hops. Acute
exposure from beer was calculated by multiplying individual, single day
consumption estimates taken from the USDA's 1977-1978 Nationwide Food
Consumption Survey by a residue of 0.22 ppm to derive a distribution of
acute exposures for the two subgroups previously identified as being
most highly exposed to amitraz through beer, ``Males 13 years and
older'' and ``Females 13 years and older.'' Because hops are mixed as
part of the brewing process, a residue value in beer reflecting the
average residue in hops was deemed more appropriate than using a
residue value in beer based on the tolerance on hops.
The Margin of Exposure (MOE) is a measure of how closely exposure
comes to the NOEL (the highest dose at which no effects were observed
in the study), and is calculated as the ratio of the NOEL to the
exposure (NOEL/exposure = MOE). The Agency normally considers an MOE of
10 or greater acceptable when the NOEL is based on a human study. MOEs
at the 99th percentile from amitraz in beer were 10 for ``Males, 13 +''
and 15 for ``Females, 13 +''. Only those consumers within both
subgroups having consumption greater than the 99th percentile consumer
would have MOEs for beer which are below 10. Additionally, the acute
risk assessment assumed that 100 percent of all imported beer and 100
percent of all imported hops used in domestic beer production would
contain amitraz. The Agency considers this to be extremely unlikely.
The Agency expects a brewing study providing additional residue
data to be submitted which may enable further refinement and
reevaluation of the risk. At this time, no residue data supporting
domestic use have been submitted for the U.S., and there are no U.S.
registrations for the use of amitraz on hops. The Agency will not
consider any applications for registration of amitraz to be used on
hops in the U.S., nor will EPA consider any Special Local Needs
Registrations (FIFRA section 24(c)) until acceptable U.S. residue data
are submitted and reviewed and a risk/benefit analysis is performed.
Based on the above information considered by the Agency, the
tolerance established by amending 40 CFR part 180 would protect the
public health. Therefore, it is proposed that the tolerance be
established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide under FIFRA, as amended, which contains any
of the ingredients listed herein may request within 30 days after
publication of this document in the Federal Register that this
rulemaking proposal be referred to an Advisory Committee in accordance
with FFDCA section 408(e).
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [PP 4E4349/P599]. All written comments filed
in response to this petition will be available in the Public Docket and
Freedom of Information Section, at the address given above from 8 a.m.
to 4 p.m., Monday through Friday, except legal holidays.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Recording and recordkeeping requirements.
Dated: January 12, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that part 180 be amended as follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.287, by amending the table therein by adding and
alphabetically inserting the raw agricultural commodity dried hops, to
read as follows:
Sec. 180.287 Amitraz; tolerances for residues.
* * * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Hops, dried................................................ 60
* * * * *
------------------------------------------------------------------------
[FR Doc. 95-1320 Filed 1-18-95; 8:45 am]
BILLING CODE 6560-50-F
