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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 
assessment practices.
   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 
among these." 
   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 
as follows:

   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   
               *              *              *              *              *  
Ginseng........................................................          3.0  
               *              *              *              *              *  

[FR Doc. 93-6730 Filed 3-23-93; 8:45 am]