[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]



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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.

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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<SUP>-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<SUP>-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<SUP>-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.

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                                                              Parts per 
                         Commodity                             million  
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                  *        *        *        *        *                 
Hops, dried................................................           60
                                                                        
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[FR Doc. 95-1320 Filed 1-18-95; 8:45 am]
BILLING CODE 6560-50-F