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dichlobenil (Casoron) Proposed Tolerance Revocations 9/98


[Federal Register: October 16, 1998 (Volume 63, Number 200)]
[Proposed Rules]               
[Page 55565-55571]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc98-33]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 185

[OPP-300734; FRL-6035-7]
RIN 2070-AB78

 
Pesticides Tolerance Reassessment Actions; 4-Amino-6-(1,1-
dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one [Metribuzin], 
Dichlobenil, Diphenylamine, O-Ethyl O-[4-(methylthio) phenyl] S-propyl 
phosphorodithioate [Sulprofos], Pendimethalin, and Terbacil

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document announces the proposed revocation of tolerances 
for the herbicides 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-
triazin-5(4H)-one [Metribuzin], dichlobenil, pendimethalin, and 
terbacil; and the insecticide O-ethyl O-[4-(methylthio) phenyl] S-
propyl phosphorodithioate [Sulprofos]. EPA expects to determine whether 
any individuals or groups want to support these tolerances. Also, this 
document is proposing the establishment and revision of tolerances for 
4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one 
(metribuzin), dichlobenil, pendimethalin, terbacil, and the plant 
growth regulator diphenylamine. In addition, EPA is also proposing to 
revise commodity terminology for 4-amino-6-(1,1-dimethylethyl)-3-
(methylthio)-1,2,4-triazin-5(4H)-one [Metribuzin], diphenylamine, and 
pendimethalin to conform to current practice. The regulatory actions in 
this notice are part of the Agency's reregistration program under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the 
tolerance reassessment requirements of the Federal Food, Drug, and 
Cosmetic Act (FFDCA). By law, EPA is required to reassess 33% of the 
tolerances in existence on August 2, 1996, by August 1999, or about 
3,200 tolerances.

DATES: Comments must be received on or before December 15, 1998.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit IV of the ``SUPPLEMENTARY INFORMATION'' section of 
this document. Be sure to identify the appropriate docket number [OPP-
300734].

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Joseph Nevola, Special Review Branch, (7508C), Special Review and 
Reregistration Division, Office of Pesticide Programs, U.S. 
Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460. 
Office location: Special Review Branch, Crystal Mall #2, 6th floor, 
1921 Jefferson Davis Hwy., Arlington, VA. Telephone: (703) 308-8037; e-
mail: nevola.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

I. What is the progress of tolerance reassessment?

    By law, EPA is required to reassess 33% of the tolerances in 
existence on August 2, 1996, by August 1999, or about 3,200 tolerances. 
The regulatory actions proposed in this document pertain to the 
provosed revocation of 29 tolerances and/or exemptions, which count 
toward the August, 1999 review deadline of FIFRA, as amended by the 
Food Quality Protection Act (FQPA) of 1996.

II. Does this notice apply to me?

    You may be affected by this notice if you sell, distribute, 
manufacture, or use pesticides for agricultural applications, process 
food, distribute or sell food, or implement governmental pesticide 
regulations. Pesticide reregistration and other actions [see FIFRA 
section 4(g)(2)] include tolerance and exemption reassessment under 
FFDCA section 408. In this notice, the tolerance actions are proposed 
in coordination with the cancellation of associated registrations. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                               Examples of Potentially
                 Category                         Affected Entities
------------------------------------------------------------------------
Agricultural Stakeholders.................  Growers/Agricultural Workers
                                            Contractors [Certified/
                                             Commercial Applicators,
                                             Handlers, Advisors, etc.]
                                            Commercial Processors
                                            Pesticide Manufacturers
                                            User Groups
                                            Food Consumers
Food Distributors.........................  Wholesale Contractors
                                            Retail Vendors
                                            Commercial Traders/Importers
Intergovernmental Stakeholders............  State, Local, and/or Tribal
                                             Government Agencies
Foreign Entities..........................  Governments, Growers, Trade
                                             Groups
------------------------------------------------------------------------

    This table 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 table could also be 
affected. If you have any questions regarding the applicability of this 
action to a particular entity, you can consult with the technical 
person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.

III. How can I get additional information or copies of this or 
other support documents?

A. Electronically

    You may obtain electronic copies of this document and various 
support documents from the EPA Internet Home Page at http://
www.epa.gov/. On the Home Page select ``Laws and Regulations'' and then 
look up the entry for this document under ``Federal Register - 
Environmental Documents.'' You can also go directly to the ``Federal 
Register'' listings at http://www.epa.gov/homepage/fedrgstr/.

B. In Person or by Phone

    If you have any questions or need additional information about this 
action, please contact the technical person identified in the ``FOR 
FURTHER INFORMATION CONTACT'' section. In addition, the official record 
for this notice, including the public version, has been established 
under docket control number [OPP-300734], (including comments and data 
submitted electronically as described below). A public version of this 
record, including printed, paper versions of any electronic comments, 
which does not include any information claimed as Confidential Business 
Information (CBI), is available for inspection in Room 119, Crystal 
Mall

[[Page 55566]]

#2, 1921 Jefferson Davis Hwy., Arlington VA, from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Public Information 
and Records Integrity Branch telephone number is 703-305-5805.

IV. How can I respond to this notice?

A. How and to whom do I submit comments to?

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropriate docket control 
number (i.e., [OPP-300734]) in your correspondence.
    1. By mail. Submit written comments, identified by the docket 
control number [OPP-300734], to: Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 
M St., S.W., Washington, DC 20460.
    2. In person or by courier. Deliver written comments, identified by 
the docket control number [OPP-300734], to: Public Information and 
Records Integrity Branch, Office of Pesticide Programs, U.S. 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    3. Electronically. Submit your comments and/or data electronically 
by E-mail to: oppt.ncic@epa.gov. Do not submit any information 
electronically that you consider to be CBI. Submit electronic comments 
in ASCII file format avoiding the use of special characters and any 
form of encryption. Comment and data will also be accepted on standard 
computer disks in WordPerfect 5.1/6.1 or ASCII file format. All 
comments and data in electronic form must be identified by the 
appropriate docket control number [OPP-300734]. You may also file 
electronic comments and data online at many Federal Depository 
Libraries.

B. How should I handle CBI information in my comments?

    You may claim information that you submit in response to this 
document as CBI by marking any part or all of that information as 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 will be included in the public 
docket by EPA without prior notice. If you have any questions about CBI 
or the procedures for claiming CBI, please consult with the technical 
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.

V. What is a `tolerance''?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals in or on raw agricultural commodities and processed 
foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the 
FQPA of 1996, Pub.L. 104-170, authorizes the establishment of 
tolerances (maximum residue levels), exemptions from the requirement of 
a tolerance, modifications in tolerances, and revocation of tolerances 
for residues of pesticide chemicals in or on raw agricultural 
commodities and processed foods. 21 U.S.C. 346(a). Without a tolerance 
or exemption, food containing pesticide residues is considered to be 
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. 
If food containing pesticide residues is considered to be 
``adulterated,'' you can not distribute the product in interstate 
commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be 
sold and distributed, the pesticide must not only have appropriate 
tolerances under the FFDCA, but also must be registered under section 3 
of FIFRA (7 U.S.C. et seq.).

VI. Why is EPA proposing the tolerance actions discussed below?

    EPA has issued a Reregistration Eligibility Decision (RED) for each 
of the pesticides subject to this notice, except for sulprofos, which 
during the RED process was voluntarily canceled by the registrant. The 
RED contains the Agency's evaluation of the database for a pesticide, 
including requirements for additional data on the active ingredients to 
confirm the potential human health and environmental risk assessments 
associated with current product uses, and the Agency's decisions and 
conditions under which these uses and products will be eligible for 
reregistration. The safety findings for pesticide tolerances can be 
found in those RED documents. Printed copies of the RED may be obtained 
from EPA's National Center for Environmental Publications and 
Information (EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-2419, 
telephone 1-800-490-9198; fax 513-489-8695 and from the National 
Technical Information Service (NTIS), 5285 Port Royal Road, 
Springfield, VA 22161, telephone 703-487-4650. Electronic copies of the 
RED are available on the internet at http://www.epa.gov/REDs.
    It is EPA's general practice to propose revocation of tolerances 
for residues of pesticide active ingredients for which FIFRA 
registrations no longer exist. EPA has historically expressed a concern 
that retention of tolerances that are not necessary to cover residues 
in or on legally treated foods has the potential to encourage misuse of 
pesticides within the United States. However, in accordance with FFDCA 
section 408, EPA will not revoke any tolerance or exemption proposed 
for revocation if any person demonstrates a need for the retention of 
the tolerance, and if retention of the tolerance will meet the 
tolerance standard established under FQPA. Generally, interested 
parties support the retention of such tolerances in order to permit 
treated commodities to be legally imported into the United States, 
since raw agricultural commodities or processed food or feed 
commodities containing pesticide residues not covered by a tolerance or 
exemption are considered to be adulterated.
    Tolerances and exemptions established for pesticide chemicals with 
FIFRA registrations cover residues in or on both domestic and imported 
commodities. To retain these tolerances and exemptions, EPA must make a 
finding that the tolerances and exemptions are safe. To make this 
safety finding, EPA needs data and information indicating that there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide residues covered by the tolerances and exemptions.
    For tolerances without U.S. registrations, EPA has the same 
toxicology and residue chemistry data requirements as are needed to 
support U.S. food-use registrations. For import tolerances, EPA applies 
these data requirements on a case-by-case basis to account for specific 
growing conditions in foreign countries. (See 40 CFR part 158 for EPA's 
data requirements to support domestic use of a pesticide and the 
establishment and maintenance of a tolerance. EPA is developing a 
guidance concerning submissions for import tolerance support. This 
guidance will be made available to interested stakeholders.) In most 
cases, EPA also requires residue chemistry data (crop field trials) 
that are representative of growing conditions in exporting countries in 
the same manner that EPA requires representative residue chemistry data 
from different U.S. regions to support domestic use of a pesticide and 
any resulting tolerance(s) or exemption(s). Good Laboratory Practice 
(GLP) requirements for studies submitted in support of tolerances and 
exemptions for import purposes only are the same as for domestic 
purposes; i.e., the studies are required to either

[[Page 55567]]

fully meet GLP standards, or have sufficient justification presented to 
show that deviations from GLP requirements do not significantly affect 
the results of the studies.
    Monitoring and enforcement of pesticide tolerances and exemptions 
are carried out by the U.S. Food and Drug Administration (FDA) and the 
U.S. Department of Agriculture (USDA). This includes monitoring for 
pesticide residues in or on commodities imported into the United 
States.

VII. Which pesticides are covered by this action?

    4-Amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-
one [Metribuzin, trade name Sencor] is an herbicide used on a wide 
range of crop and non-crop sites, including alfalfa, asparagus, barley, 
carrots, field corn, garbanzo beans, lentils, peas, potatoes, soybean, 
sugarcane, tomatoes, wheat, fallow land and turfgrasses, to selectively 
control broadleaf and grassy weed species. It is manufactured by Bayer 
Corporation.
    Dichlobenil (trade names Casoron, Norosac) is a selective herbicide 
registered for use on cranberry bogs, dichondra, ornamentals; 
blackberry, raspberry, and blueberry fields; apple, pear, filbert, and 
cherry orchards; vineyards, and hybrid poplar-cottonwood plantations. 
It is manufactured by Uniroyal Chemical.
    Diphenylamine is a plant growth regulator used post-harvest on 
apples to control storage scald. Elf Atochem and Pace International are 
the manufacturers of the chemical.
    O-Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate 
[Sulprofos] is an insecticide once used on cotton. It was manufactured 
by Bayer Corporation.
    Pendimethalin (trade names Prowl, Squadron) is a selective 
herbicide used to control broadleaf weeds and grassy weed species on a 
number of crop and noncrop areas and on residential lawns and 
ornamentals. It is manufactured by American Cyanamid Corporation.
    Terbacil (3-tert-butyl-5-chloro-6-methyluracil, trade name Sinbar) 
is an herbicide used to control barnyardgrass, broadleaf weeds, 
chickweed, clover, crabgrass, dandelion, foxtail, peppergrass, pigweed, 
quackgrass, ragweed, and ryegrass. It is manufactured by E. I. Du Pont 
de Nemours and Co., Incorporated.

VIII. What action is being taken?

    This notice proposes revocation of FFDCA tolerances for residues of 
the herbicides 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-
triazin-5(4H)-one [Metribuzin], dichlobenil, pendimethalin, and 
terbacil; and the insecticide O-Ethyl O-[4-(methylthio) phenyl] S-
propyl phosphorodithioate [Sulprofos] in or on commodities listed in 
the regulatory text because these pesticides are not registered under 
FIFRA for uses on the commodities. The registrations for these 
pesticide chemicals were canceled because the registrant failed to pay 
the required maintenance fee and/or the registrant voluntarily canceled 
one or more registered uses of the pesticide. It is EPA's general 
practice to propose revocation of those tolerances for residues of 
pesticide chemicals for which there are no active registrations under 
FIFRA, unless any person in comments on the proposal demonstrates a 
need for the tolerance to cover residues in or on imported commodities 
or domestic commodities legally treated.
    Changes in the commodity terminology and definitions are proposed 
in accordance with the revised Crop Group Regulation (40 CFR 180.41) 
and the updated Table I ``Raw Agricultural and Processed Commodities 
and Feedstuffs Derived from Crops' (August, 1996) in the Residue 
Chemistry Test Guidelines: OPPTS 860.1000 (EPA 721-C-96-169). Table I 
contains data on both crops and livestock diets, and lists feed 
commodities considered significant in livestock diets. Significant 
feedstuffs account for more than 99% of the available annual tonnage 
(on-a dry-matter basis) of feedstuffs used in the domestic production 
of more than 95 percent of beef and dairy cattle, poultry, swine, milk, 
and eggs. EPA has devised criteria to include or exclude feedstuffs 
from Table I and sets tolerances for significant feedstuffs. Tolerances 
are not set for feedstuffs which are neither significant nor a human 
food. Pesticide residues on such feedstuffs are governed by tolerances 
on the commodity from which they are derived (December 17, 1997, 62 FR 
66020) (FRL-5753-1). These changes are technical in nature and have no 
effect on the scope of the tolerance.
    This notice also proposes to establish and revise tolerances as 
given in the regulatory text. A determination of safety by EPA includes 
consideration of (a) potential cumulative effects with pesticides that 
have a common mode of toxicity, (b) aggregate risks resulting from 
exposure to residues in food and drinking water and exposure occuring 
due to pesticide application in residential settings, and (c) special 
sensitivity to children. FFDCA section 408(b)(2)(C) requires that when 
determining appropriate tolerances EPA apply an additional ten-fold 
safety factor for infants and children to take into account potential 
pre- and post-natal toxicity and the completeness of data on toxicity 
and exposure unless a different margin of safety, on the basis of 
reliable data, will be safe for infants and children. Retention, 
reduction, or removal of the ten-fold safety factor is based on a 
weight-of-evidence evaluation of all applicable data. Through the 
Reregistration Eligibility Decision (RED) process, EPA has determined 
that each of the amended tolerances meet the safety standards under 
FQPA for each of the following active ingredients. This safety finding 
determination is found in detail in the RED for the active ingredient. 
Each RED concerning an active ingredient is publically available as 
described in Unit VI of this proposed rule and by contacting the 
Pesticide Docket, Public Information and Records Integrity Branch, 
Information Resources and Services (7502C), Office of Pesticide 
Programs (OPP), U.S. EPA, Washington, DC 20460, telephone 703-305-5805.

4-Amino-6(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one 
[Metribuzin]

    The tolerance for lentils, vine hay in 40 CFR 180.332 is being 
proposed for revocation. Lentils, vine hay is no longer considered a 
significant livestock feed commodity. Contrary to the RED, a registered 
use now exists for sweet corn, as conveyed by EPA in a letter to the 
Bayer Corporation as of August, 1997. Therefore, the tolerance for 
corn, fresh (inc. sweet K + CWHR) will not be revoked. Tolerances for 
both barley, hay and wheat, hay are proposed to be established at 7 
ppm. Tolerances for both asparagus and soybeans should be increased 
from 0.05 to 0.1 and from 0.1 to 0.3 ppm, respectively. The tolerance 
for peas, vine hay is proposed to be increased from 0.05 to 4 ppm 
(along with a proposed terminology revision to peas, field, hay); and 
the tolerance for sugarcane molasses was listed incorrectly as 0.3 ppm, 
it should be revised to reflect the correct tolerance of 2 ppm (August 
24, 1978, 43 FR 35915), along with a proposed terminology revision to 
sugarcane, molasses. Other terminology changes are given in the 
regulatory text.

Dichlobenil

    The tolerances listed under 40 CFR 180.231 are for the combined 
negligible residues of the herbicide dichlobenil (2,6-
dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzoic acid (2,6-
DCBA). The Agency has determined that the metabolite 2,6-

[[Page 55568]]

Dichlorobenzamide (BAM) should be added to the tolerance expression and 
the metabolite 2,6-DCBA should be deleted from the tolerance 
expression. Tolerances for almond hulls; avocados; citrus; figs; and 
mangoes in 40 CFR 180.231 are being proposed for revocation because no 
registered uses exist. The tolerance for nuts in 40 CFR 180.231 is 
proposed for revocation and a tolerance for filberts is being proposed 
to be established at 0.1 parts per million, since the use of 
dichlobenil on all other nuts has been canceled. Based upon the 
available residue data and to reflect the combined residues of 
dichlobenil and BAM, tolerances for apples and pears should be 
increased from 0.15 to 0.5 ppm, and tolerances for blackberries, 
cranberries, and raspberries should be decreased from 0.15 to 0.10 ppm.

Diphenylamine

    This notice proposes to establish tolerances of 0.01 ppm for 
residues in milk and meat, fat, and mbyp (excluding liver) of cattle, 
goats, horses, and sheep. Separate tolerances are proposed to be 
established at 0.1 ppm for residues of diphenylamine in liver of 
cattle, goats, horses, and sheep. A tolerance of 30 ppm is proposed to 
be established for diphenylamine residues in wet apple pomace. Also, 
this notice proposes to increase milk and meat tolerances for 
diphenylamine residues from 0 to 0.01 ppm based on adequate ruminant 
data. Terminology changes are given in the regulatory text.

O-Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate 
[Sulprofos]

    The tolerance for cottonseed oil in 40 CFR 185.3000 is being 
proposed for revocation because the registrant voluntarily canceled its 
registered use.

Pendimethalin

    The tolerance for peanut, forage in 40 CFR 180.361(a) is being 
proposed for revocation because it is no longer considered a 
significant livestock feed commodity; therefore, a tolerance is not 
necessary. This notice proposes to establish a tolerance of 0.1 ppm for 
residues in or on rice, straw; and to raise the tolerance on rice grain 
from 0.05 to 0.1 ppm based on available field trial data and to reflect 
the analytical method's limit of quantitation for the combined residues 
of pendimethalin and its regulated metabolite. EPA also proposes to 
combine the tolerance for garlic, listed under 180.361(c) Tolerances 
with regional registrations, with tolerances 180.361(a), which lists 
tolerances for registrations without regional restriction, since EPA 
has data that supports a national registration and tolerance for garlic 
at the same level (0.1 ppm). Terminology changes are given in the 
regulatory text.

Terbacil

    Tolerances for pears; pecans; sainfoin, forage; and sainfoin hay in 
40 CFR 180.209(a) are being proposed for revocation because no 
registered uses exist. Tolerances for cattle, fat; cattle, mybp; 
cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, 
mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; milk, fat; 
sheep, fat; sheep, mbyp; and sheep, meat in 40 CFR 180.209(a) are being 
proposed for revocation because there is no reasonable expectation of 
finite terbacil residues in animal commodities since available data 
support the establishment of lower alfalfa tolerances [40 CFR 
180.6(a)(3)]. For further information, consult the RED for Terbacil. 
EPA is proposing that the tolerance expressions be unified to include 
terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its metabolites [3-
tert-butyl-5-chloro-6-hydroxymethyl-uracil], [6-chloro-2,3-dihydro-7-
hydroxymethyl 3,3-dimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one], and [6-
chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one], 
calculated as terbacil. In accordance, 40 CFR 180.209 sections (a)(1) 
and (a)(2) should be combined. To reflect the combined limit of 
detection for terbacil and its three regulated metabolites, this 
document proposes to raise the tolerances for terbacil residues in or 
on peaches from 0.1 to 0.2 ppm, blueberries from 0.1 to 0.2 ppm, and 
caneberries from 0.1 to 0.2 ppm. Based upon available residue data, 
tolerances should be increased for apples from 0.1 to 0.3 ppm, 
asparagus from 0.2 to 0.4 ppm, and sugarcane from 0.1 to 0.4 ppm; 
however, tolerances should be decreased for alfalfa, forage; from 5.0 
to 1.0 ppm, and alfalfa, hay; from 5.0 to 2.0 ppm.

IX. When do these actions become effective?

    EPA proposes that these actions become effective 90 days following 
publication of a final rule in the Federal Register. EPA has delayed 
the effectiveness of these revocations for 90 days following 
publication of a final rule to ensure that all affected parties receive 
notice of EPA's action. For this particular proposed rule, the actions 
will affect uses which have been canceled for more than a year. This 
should ensure that commodities have cleared the channels of trade. If 
you have comments regarding existing stocks, please submit comments as 
described in Unit IV of this preamble.
    Any commodities listed in the regulatory text of this notice that 
are treated with the pesticides subject to this notice, and that are in 
the channels of trade following the tolerance revocations, shall be 
subject to FFDCA section 408(1)(5), as established by FQPA. Under this 
section, any residue of these pesticides in or on such food shall not 
render the food adulterated so long as it is shown to the satisfaction 
of FDA that, (1) the residue is present as the result of an application 
or use of the pesticide at a time and in a manner that was lawful under 
FIFRA, and (2) the residue does not exceed the level that was 
authorized at the time of the application or use to be present on the 
food under a tolerance or exemption from tolerance. Evidence to show 
that food was lawfully treated may include records that verify the 
dates that the pesticide was applied to such food.

X. What can I do if I wish the Agency to maintain a tolerance that 
the Agency proposes to revoke?

    In addition to submitting comments in response to this notice, you 
may also submit an objection. EPA subsequently issues a final rule 
after considering the comments that are submitted in response to this 
notice. If you fail to file an objection to the final rule within the 
time period specified, you will have waived the right to raise any 
issues resolved in the final rule. After the specified time, the issues 
resolved in the final rule cannot be raised again in any subsequent 
proceedings.
    This proposal provides 60 days for any interested person to 
demonstrate a need for retaining a tolerance, if retention of the 
tolerance will meet the tolerance standard established under FQPA. If 
EPA receives a comment to that effect, EPA will not proceed to revoke 
the tolerance immediately. However, EPA will take steps to ensure the 
submission of any needed supporting data and will issue an order in the 
Federal Register under FFDCA section 408(f) if needed. The order would 
specify the data needed, the time frames for its submission, and would 
require that within 90 days some person or persons notify EPA that they 
will submit the data. If the data are not submitted as required in the 
order, EPA will take appropriate action under FIFRA or FFDCA.

[[Page 55569]]

XI. How do the regulatory assessment requirements apply to this 
action?

A. Is this a ``significant regulatory action''?

    No. Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this action is not a 
``significant regulatory action.'' The Office of Management and Budget 
(OMB) has determined that tolerance actions, in general, are not 
``significant'' unless the action involves the revocation of a 
tolerance that may result in a substantial adverse and material affect 
on the economy. In addition, this action is not subject to Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997), because this 
action is not an economically significant regulatory action as defined 
by Executive Order 12866. Nonetheless, environmental health and safety 
risks to children are considered by the Agency when determining 
appropriate tolerances. Under FQPA, EPA is required to apply an 
additional 10-fold safety factor to risk assessments in order to ensure 
the protection of infants and children unless reliable data supports a 
different safety factor.

B. Does this action contain any reporting or recordkeeping 
requirements?

    No. This action does not impose any information collection 
requirements subject to OMB review or approval pursuant to the 
Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

C. Does this action involve any ``unfunded mandates''?

    No. This action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4).

D. Do Executive Orders 12875 and 13084 require EPA to consult with 
States and Indian Tribal Governments prior to taking the action in this 
notice?

    No. Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to the Office of Management and Budget (OMB) a description 
of the extent of EPA's prior consultation with representatives of 
affected State, local and tribal governments, the nature of their 
concerns, copies of any written communications from the governments, 
and a statement supporting the need to issue the regulation. In 
addition, Executive Order 12875 requires EPA to develop an effective 
process permitting elected officials and other representatives of 
State, local and tribal governments ``to provide meaningful and timely 
input in the development of regulatory proposals containing significant 
unfunded mandates.''
    Today's proposed rule does not create an unfunded federal mandate 
on State, local or tribal governments. The rule does not impose any 
enforceable duties on these entities. Accordingly, the requirements of 
section 1(a) of Executive Order 12875 do not apply to this proposed 
rule.
    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governmen (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's proposed rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this proposed rule.

E. Does this action involve any environmental justice issues?

    No. This action is not expected to have any potential impacts on 
minorities and low income communities. Special consideration of 
environmental justice issues is not required under Executive Order 
12898, entitled Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994).

F. Does this action have a potentially significant impact on a 
substantial number of small entities?

    No. Pursuant to section 605(b) of the Regulatory Flexibility Act (5 
U.S.C. 601 et seq.), the Agency hereby certifies that tolerance 
actions, including these specific tolerance actions, will not result in 
a significant economic impact on a substantial number of small 
entities. Because similar tolerance actions are expected to have the 
same general impact from chemical to chemical, this certification is 
applicable to all tolerance actions. Unless a particular tolerance 
action is expected to have impacts different than those used for the 
analysis, this determination will also serve as a ``generic'' 
certification for the promulgation of any pesticide tolerance action, 
and EPA will incorporate it by reference in future individual tolerance 
actions. This ``generic'' certification (46 FR 24950, May 4, 1981) and 
the rationale presented below has been provided to the Chief Counsel 
for Advocacy of the Small Business Administration. Technical changes 
such as changing the individual commodity name or crop group definition 
will have no impact on the crop itself or residue requirements. 
Therefore, I certify that these types of administrative changes will 
not have an economic impact or cause significant adverse effects on a 
substantial number of small entities.
    EPA has determined that the revocation of a tolerance after the use 
of the pesticide becomes illegal in this country, will not have a 
significant impact on a substantial number of small entities, because 
such revocations do not have a significant impact on affected entities 
in general, regardless of the size of the entity. Since small entities 
are not disproportionally impacted, EPA considered the impacts on 
domestic growers and domestic importers of food products that could be 
affected by the revocation of the tolerance.
    In the case of domestically grown food, the tolerances revoked by 
this notice will have no economic impact. Since the uses are no longer 
registered, uses have already been deleted from the pesticide product 
labels. U.S. growers may no longer purchase the pesticides in question 
for use on such crops and EPA believes that no existing stocks

[[Page 55570]]

remain of the pesticides in question labeled for the deleted uses. In 
these circumstances, revoking the tolerances after deletion of the uses 
should have no impact on food grown in the United States. However, food 
legally treated under FIFRA before the use deletions occurred will not 
be considered adulterated if the residue level complies with the 
tolerance in effect at the time of treatment [see FFDCA section 
408(l)(5)].
    Revocation may have an effect on domestic importers of foreign-
grown food to the extent their foreign suppliers use pesticides in ways 
that result in residues no longer allowed in the United States. If 
foreign growers use a pesticide on crops for which there is no 
tolerance or exemption from the requirement of a tolerance, the food 
they grow will be considered adulterated and subject to detention and 
regulatory action if residues of the pesticide are found in or on the 
food when offered for import or imported into the United States. 
Nevertheless, the effect on U.S. importers is expected to be minimal 
regardless of their size.
    In the absence of extraordinary circumstances, the revocation of a 
particular tolerance is unlikely to have a significant impact on the 
price of a commodity on the international market. Transaction costs may 
occur as a result of having to find alternative suppliers of food 
untreated with pesticides for which tolerances were revoked. Affected 
importers, however, would have the options of finding other suppliers 
in the same country or in other countries, or inducing the same 
supplier to switch to alternative pest controls. Given the existence of 
these options, EPA expects any price increases or transaction costs 
resulting from revocations to be minor. Given the overall minimal 
impact anticipated, revocations are not expected to have a significant 
impact on those affected, including small entities.
    As to the pesticide uses involved in this action, EPA has reviewed 
its available data on imported food and foreign pesticide usage and 
concludes that there is a reasonable international supply of food not 
treated with the pesticides having tolerances that are proposed for 
revocation, generally within the same countries from which the relevant 
commodities are currently imported.

G. Does this action involve technical standards?

    No. This tolerance 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), Pub. L. 104-113, Section 12(d) (15 
U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus 
standards in its regulatory activities unless to do so would be 
inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. The NTTAA requires EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards. EPA invites public comment on 
this conclusion.

H. Are there any international trade issues raised by this action?

    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a 
tolerance that is different from a Codex MRL, however FFDCA section 
408(b)(4) requires that EPA explain in a Federal Register notice the 
reasons for departing from the Codex level. EPA's effort to harmonize 
with Codex MRLs is summarized in the tolerance reassessment section of 
individual REDs. The U.S. EPA is developing a guidance concerning 
submissions for import tolerance support. This guidance will be made 
available to interested stakeholders.

I. Is this action subject to review under the Congressional Review Act?

    No. This action is not a final rule. Under 5 U.S.C. 801(a)(1)(A) of 
the Administrative Procedure Act (APA) as amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-
121, 110 Stat. 847), only final rules must be submitted to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication in the Federal Register.

List of Subjects

40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and record 
keeping requirements.

40 CFR Part 185

    Environmental protection, Food additives, Pesticides and pests.

    Dated: September 28, 1998.

Marcia E. Mulkey,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR parts 180 and 185 be amended 
to read as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

    b. Section 180.190 is revised to read as follows:


Sec. 180.190  Diphenylamine; tolerances for residues.

    (a) General. Tolerances for residues of the plant regulator 
diphenylamine are established in or on the following commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Apple, pomace, wet........................  30
Apples from preharvest or postharvest use   10
 (including use of impregnated wraps).
Cattle, fat...............................  0.01
Cattle, liver.............................  0.1
Cattle, mbyp (excluding liver)............  0.01
Cattle, meat..............................  0.01
Goat, fat.................................  0.01
Goat, liver...............................  0.1
Goat, mbyp (excluding liver)..............  0.01
Goat, meat................................  0.01
Horse, fat................................  0.01
Horse, liver..............................  0.1
Horse, mbyp (excluding liver).............  0.01
Horse, meat...............................  0.01
Milk......................................  0.01
Sheep, fat................................  0.01
Sheep, liver..............................  0.1
Sheep, mbyp (excluding liver).............  0.01
Sheep, meat...............................  0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[[Page 55571]]

    c. In Sec. 180.209, by alphabeticaly adding the entries in the 
table in paragraph (a)(1) to the table in paragraph (a)(2), by removing 
paragraph (a)(1), by redesignating paragraph (a)(2) as paragraph (a), 
and revising newly designated paragraph (a) to read as follows:


Sec. 180.209  Terbacil; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
the herbicide terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its 
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo (3,2-a) pyrimidin-
5-one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a) 
pyrimidin-5-one], calculated as terbacil, in or on raw agricultural 
commodities as follows:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage...........................  1.0
Alfalfa, hay..............................  2.0
Apple.....................................  0.3
Asparagus.................................  0.4
Blueberry.................................  0.2
Caneberry (blackberry, boysenberry,         0.2
 dewberry, loganberry, raspberry, and
 youngberry, and varieties and/or hybrids
 of these).
Citrus fruits.............................  0.1
Mint hay (peppermint and spearmint).......  2.0
Peach.....................................  0.2
Strawberry................................  0.1
Sugarcane.................................  0.4
------------------------------------------------------------------------

* * * * *
    d. Section 180.231 is revised to read as follows:


Sec. 180.231  Dichlobenil; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of the herbicide dichlobenil (2,6-dichlorobenzonitrile) and its 
metabolite 2,6-dichlorobenzamide in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Apple.....................................  0.5
Blackberry................................  0.1
Blueberry.................................  0.15
Cranberry.................................  0.1
Filbert...................................  0.1
Grape.....................................  0.15
Pear......................................  0.5
Raspberry.................................  0.1
Stone fruits group........................  0.15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
    e. In Sec. 180.332, paragraph (a) the table is revised to read as 
follows:


Sec. 180.332  4-Amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-
triazin-5(4H)-one; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, green............................  2
Alfalfa, hay..............................  7
Asparagus.................................  0.1
Barley, grain.............................  0.75
Barley, hay...............................  7
Barley, milled fractions (exceept flour)..  3
Barley, straw.............................  1
Carrots...................................  0.3
Cattle, fat...............................  0.7
Cattle, mbyp..............................  0.7
Cattle, meat..............................  0.7
Corn, field, stover.......................  0.1
Corn, field, forage.......................  0.1
Corn, fresh (inc. sweet K+CWHR)...........  0.05
Corn, grain (inc. popcorn)................  0.05
Eggs......................................  0.01
Goats, fat................................  0.7
Goats, mbyp...............................  0.7
Goats, meat...............................  0.7
Grass, forage.............................  2
Grass, hay................................  7
Hogs, fat.................................  0.7
Hogs, mbyp................................  0.7
Hogs, meat................................  0.7
Horses, fat...............................  0.7
Horses, mbyp..............................  0.7
Horses, meat..............................  0.7
Lentil....................................  0.5
Milk......................................  0.05
Peas, field, hay..........................  4
Pea, field, vine..........................  0.5
Pea, seed.................................  0.05
Pea, succulent............................  0.1
Potato, processed potato waste............  3
Potatoes..................................  0.6
Poultry, fat..............................  0.7
Poultry, mbyp.............................  0.7
Poultry, meat.............................  0.7
Sainfoin, forage..........................  2
Sainfoin, hay.............................  7
Sheep, fat................................  0.7
Sheep, mbyp...............................  0.7
Sheep, meat...............................  0.7
Soybean, seed.............................  0.3
Soybeans, forage..........................  4
Soybeans, hay.............................  4
Sugarcane.................................  0.1
Sugarcane, molasses.......................  2
Tomatoes..................................  0.1
Wheat, forage.............................  2
Wheat, hay................................  7
Wheat, grain..............................  0.75
Wheat, milled fractions (except flour)....  3
Wheat, straw..............................  1
------------------------------------------------------------------------

 * * * * *
    f. In Sec. 180.361, paragraph (a), the table is revised to read as 
follows:


Sec. 180.361  Pendimethalin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Bean, succulent and bean, seed............  0.1
Beans, forage.............................  0.1
Beans, hay................................  0.1
Corn, field, stover.......................  0.1
Corn, forage..............................  0.1
Corn, sweet (K+CWHR)......................  0.1
Corn, field, grain........................  0.1
Corn, pop, grain..........................  0.1
Cotton, undelinted seed...................  0.1
Onions, dry bulb..........................  0.1
Peanuts...................................  0.1
Peanut, hay...............................  0.1
Peas (except field peas)..................  0.1
Potatoes..................................  0.1
Rice, grain...............................  0.1
Rice, straw...............................  0.1
Sorghum, stover...........................  0.1
Sorghum, forage...........................  0.1
Sorghum, grain............................  0.1
Soybeans..................................  0.1
Soybeans, forage..........................  0.1
Soybeans, hay.............................  0.1
Sugarcane.................................  0.1
Sunflower, seeds..........................  0.1
------------------------------------------------------------------------

* * * * *
    g. In Sec. 180.361, paragraph (c), the entry for ``garlic'' is 
alphabetically added to the table in paragraph (a).

PART 185-- [AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:
    Authority: 21 U.S.C. 348.

Sec. 185.3000  [Removed]

    b. By removing Sec. 185.3000.

[FR Doc. 98-27707 Filed 10-15-98; 8:45 am]
BILLING CODE 6560-50-F