metalaxyl (Apron, Ridomil, Subdue) Pesticide Tolerance 3/93
Pesticide Tolerances for Metalaxyl
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This document establishes a tolerance for combined
residues of the fungicide metalaxyl and its metabolites in or
on the raw agricultural commodity ginseng. This regulation to
establish a maximum permissible level for residues of the fungicide
in or on the commodity was requested in a petition submitted
by the Interregional Research Project No. 4 (IR-4).
EFFECTIVE DATE: This regulation becomes effective March 24,
ADDRESSES: Written objections, identified by the document control
number, [PP 1E3926/R1133], may be submitted to: Hearing Clerk
(A-110), Environmental Protection Agency, rm. M3708, 401 M St.,
SW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Emergency
Response and Minor Use Section (H-7505W), Registration Division,
Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: No. 1, 6th Floor,
CS #1, 2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-
SUPPLEMENTARY INFORMATION: In the Federal Register of August
28, 1991 (56 FR 42577), EPA issued a proposed rule that gave
notice that the Interregional Research Project No. 4 (IR-4),
New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers
University, New Brunswick, NJ 08903, had submitted pesticide
petition 1E3926 to EPA on behalf of the Agricultural Experiment
Stations of North Carolina and Virginia.
The petition requested that the Administrator, pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
(21 U.S.C. 346a(e)), propose the establishment of a tolerance
for residues of the fungicide metalaxyl, [N-(2,6-dimethylphenyl)-
N-(methoxyacetyl) alanine methyl ester] and its metabolites
containing the 2,6-dimethylaniline moiety, and N-[2-hydroxy
methyl-6-methyl)-N-(methoxyacetyl)-alanine methyl ester, in
or on the raw agricultural commodity ginseng at 3.0 parts per
There were no requests for referral to an advisory committee
received in response to the proposed rule.
However, one comment was received opposing the proposed establishment
of the tolerance in or on ginseng. The commenter, generally,
asserts that EPA has failed to conclude that the tolerance would
be protective of the public health. EPA disagrees. The proposed
rule states, and supports by analysis, that the tolerance would
result in a negligible increase in dietary exposure to resiudes
of metalaxyl. The tolerance process is highly protective in
that it is based on the most sensitive animal test results available
and a combination of highly conservative assumptions and risk
Specifically, the commenter asserts that EPA has not concluded
that metalaxyl is useful for the purpose for which the tolerance
is sought and that the tolerance is unnecessary since there
is "no actual demonstrated need" for the proposed use of metalaxyl
in order to produce an adequate or safe food supply and no emergency
condition which is uncontrollable with fungicides for which
tolerances already exist. The commenter implies that EPA should
not allow the tolerance or use of metalaxyl on ginseng unless
EPA can "conclusively and effectively" demonstrate that other
fungicides, already registered and with tolerances for ginseng,
are inadequate to provide for a safe and reliable supply of
that food commodity.
EPA believes that the commenter has incorrectly interpreted
the standard for approval of tolerances under FFDCA sec. 408.
EPA construes the requirement in sec. 408 to consider the "necessity
for the production of an adequate, wholesome and economical
food supply" to prevent the Agency from denying a tolerance
solely on the basis of a calculation of the risks posed by pesticide
residues on agricultural products. Instead, the Agency must
balance these risks against the benefits of the pesticide for
food production. The commenter's reading of the FFDCA would
negate this balancing by preventing issuance of a tolerance
solely on the basis of failure of the pesticide to meet one
possible aspect of the benefits consideration, i.e., essentiality.
Although essential pesticides would clearly provide large benefits
for food production, the statute in no way suggests that only
essential pesticides provide benefits worthy of consideration
in the risk/benefit weighing mandated by section 408.
This construction of FFDCA sec. 408 is supported by sec.
3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). EPA must consider the provisions of the FFDCA and
the FIFRA together and construed in a manner that is harmonious,
if possible, given EPA's overlapping responsibilities under
the two statutes-to regulate the use of pesticides under FIFRA
and to regulate pesticide residues in food under FFDCA. FIFRA
sec. 3(c)(5) provides in part the following:
The Administrator shall not make any lack of essentiality
a criterion for denying registration of any pesticide. Where
two pesticides meet the requirements of this paragraph, one
should not be registered in preference to the other. * * *
If EPA were to deny a pesticide tolerance under FFDCA solely
because there are other adequate pesticides for the affected
crop, EPA's registration decisions under FIFRA would be negated
by the tolerance determination. Thus, the FIFRA language on
essentiality would become a nullity.
The commenter is also concerned that the tolrance would allow
the unnecessary introduction of metalaxyl residues into the
environment and ground and surface waters of the U.S.
The Agency points out that the Federal Food, Drug, and Cosmetic
Act (FFDCA) is not the mechanism through which EPA considers
pesticide effects on public health that occur through other
than dietary routes. FFDCA section 408 only refers to tolerances
on raw agricultural commodities. Other pesticidal effects are
appropriately considered under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) when a pesticide is registered.
Under sec. 3(c)(5) of FIFRA, the Agency registers a pesticide,
generally, if it will not cause "unreasonable adverse effects
on the environment." FIFRA sec. 2(j) defines "environment" to
include "water, air, land, and all plants and man and other
animals living therein, and the interrelationships which exist
The commenter is further concerned, in the case of metalaxyl
on ginseng, that EPA's conclusion concerning utilization of
RfD for the overall population and resulting negligible nature
of the dietary population exposure "fails to take into account
of the unusual consumptive patterns connected with the use of
ginseng in certain portions of the population."
Before making tolerance decisions on a pesticide, EPA uses
a Dietary Risk Evaluation System (DRES) to calculate the theoretical
maximum residue contribution and risk estimates for the general
population and a number of subgroups. If the DRES analysis indicates
that exposure, and thus estimated risk, to a subgroup is so
high that adverse effects are likely to occur, the Agency will
not approve a tolerance even if the estimated risks to the average
population are acceptable. None of the population subgroups
examined in EPA's DRES analysis had consumption patterns that
raised risk concerns from metalaxyl on ginseng assumed that
metalaxyl would be present on all ginseng consumed at the tolerance
level. This is a very conservative assumption. Metalaxyl is
unlikely to be used on all ginseng, and studies have shown that
the level of residues on foods, when they reach the consumer,
is typically well below the established tolerance level. Accordingly,
EPA believes that the tolerance is protective of public health.
It also appears that the commenter is asserting that a certification
of usefulness under section 408(l) is required before EPA may
issue a tolerance regulation for metalaxyl on ginseng. This
is incorrect. The metalaxyl tolerance is issued in response
to a petition pursuant to section 408(e) of the FFDCA on behalf
of the Agricultural Experiment Stations of North Carolina and
Virginia. Tolerances issued in response to section 408(e) petitions,
from persons other than registrants of the pesticides, do not
require certifications of usefulness. Moreover, EPA believes
the tolerance is protective of public health in view of the
negligible increase in dietary exposure even assuming metalaxyl
is present on all ginseng consumed.
The data submitted in the petition and other relevant material
have been evaluated and discussed in the proposed rule. Based
on the data and information considered, the Agency concludes
that the tolerance will protect the public health. Therefore,
the tolerance is established as set forth below.
Any person adversely affected by this regulation may, within
30 days after publication of this document in the Federal Register,
file written objections with the Hearing Clerk, at the address
given above. 40 CFR 178.20. The objections submitted must specify
the provisions of the regulation deemed objectionable and the
grounds for the objections. 40 CFR 178.25. Each objection must
be accompanied by the fee prescribed by 40 CFR 180.33(i). If
a hearing is requested, the objections must include a statement
of the factual issue(s) on which a hearing is requested and
the requestor's contentions on each such issue. 40 CFR 178.27.
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following:
There is a genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of
such issues in favor of the requestor, taking into account uncontested
claims or facts to the contrary; and resolution of the factual
issue(s) in the manner sought by the requestor would be adequate
to justify the action requested. 40 CFR 178.32.
The Office of Management and Budget has exempted this rule
from the requirements of section 3 of Executive Order 12291.
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
List of Subjects in 40 CFR Part 180
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: March 15, 1993.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
2. Section 180.408(a) is amended in the table therein by
adding and alphabetically inserting the raw agricultural commodity
ginseng, to read as follows:
180.408 Metalaxyl; tolerances for residues.
(a) * * *
Commodity Parts per
* * * * *
* * * * *
[FR Doc. 93-6730 Filed 3-23-93; 8:45 am]
BILLING CODE 6560-50-F