[Federal Register Volume 68, Number 153 (Friday, August 8, 2003)]
[Rules and Regulations]
[Pages 47246-47253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20307]



[[Page 47246]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0127; FRL-7321-6]


2,6-Diisopropylnaphthalene; Temporary Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary tolerance of 0.5 parts 
per million (ppm) for 2,6-Diisopropylnaphthalene (2,6-DIPN) in or on 
potatoes, and 3 ppm in or on potato peels. Platte Chemical Company 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). 
The temporary tolerance will expire on May 31, 2006.

DATES: This regulation is effective August 8, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0127, 
must be received on or before October 7, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing 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 unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0127. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml__00/ Title----40/40cfr180--
00.html, a beta site currently under development. To access the OPPTS 
Harmonized Guidelines referenced in this document, go directly to the 
guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    In the Federal Register of September 21, 2001 (66 FR 48677) (FRL-
6798-3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PF-1043) by Platte Chemical Company, 
7251 4th Street, Greely, CO 80632. This notice included a summary of 
the petition prepared by the petitioner Platte Chemical Company.
    The petition requested that 40 CFR 180.1208 be amended by 
establishing a temporary tolerance for residues of the plant growth 
regulator 2,6-DIPN, in or on potatoes at 3 parts per million (ppm) for 
the peels, 0.5 ppm for potato (whole). The tolerance will expire on May 
31, 2006. EPA received comments on this petition submitted by John 
Forsythe, General Manager, on behalf of D-I-1-4, Inc. (Meridian, ID). 
The issues raised by Mr. Forsythe related to the following: (1) The 
classification of 2,6-DIPN as a biochemical pesticide; (2) the lack of 
chronic toxicity data; and (3) the public's exposure to this chemical 
through its use as an industrial chemical. Mr. Forsythe's comments are 
discussed individually below, along with EPA's response.
    Comment 1. Mr. Forsythe requested that the Agency re-evaluate the 
biochemical classification determination for 2,6-DIPN and provide any 
publicly available information regarding the natural occurrence of 2,6-
DIPN in any food source.
    EPA Response. A biochemical pesticide, by definition, is a 
naturally occurring substance which controls target pests by a non-
toxic mode of

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action. However, there are products that are not naturally occurring, 
yet they are registered by the Agency as ``biochemical-like,'' insofar 
as data requirements are concerned. Thus, while 2, 6-DIPN, is synthetic 
and does not occur naturally in any food or non-food plants, it is 
structurally similar to three compounds (1-isopropyl- 4,6-
dimethylnaphthalene, 1-methyl-7-isopropylnaphthalene, and 4-isopropyl-
1,6-dimethylnaphthalene) that occur naturally in potatoes, and 2,6-DIPN 
is functionally identical to the naturally occurring plant growth 
regulator in potatoes.
    Comment 2. Mr. Forsythe expressed concern that the Agency had not 
presented any public documentation demonstrating that the mode of 
action of 2,6-DIPN is non-toxic.
    EPA Response. The new active ingredient, 2,6-DIPN, is a plant 
growth regulator (PGR) intended to inhibit sprouting in stored 
potatoes. PGRs may stimulate or retard ripening, maturity of whole 
plants and/or fruits, enhance growth, yield, enhance or counteract the 
activities of other PGRs, and/or change plant architecture (amongst 
other processes). PGRs are not toxic to the target plant, especially at 
the application rate. Tests conducted during the experimental use 
permit showed no toxicity to potatoes. None of these actions are 
directly lethal to the plants upon which they are applied, which 
supports a determination that 2, 6-DIPN operates through a non-toxic 
mode of action. Diisopropylnapthalene is similar in molecular 
structure, and functions as three sprout inhibiting compounds naturally 
occurring in potatoes (1-isopropyl-4,6-dimethylnaphthalene, 1-methyl-7-
isopropylnaphthalene, and 4-isopropyl-1,6-dimethylnaphthalene). The 
three compounds found in potatoes and 2,6 DIPN are all isopropyl 
napthalene, a sprout inhibitor in a manner comparable to natural PGRs 
found in potato plants (as described above). In addition, acute 
toxicity studies conducted on animals indicated Toxicity Category IV 
for all routes of exposure and chronic studies were not triggered 
following the data requirements for biochemical pesticides as given in 
40 CFR 158.690(c). EPA therefore has concluded that its mode of action 
can be classified as ``non-toxic.''
    Comment 3. Mr. Forsythe expressed concerns regarding dietary intake 
of 2,6-DIPN, due to: (1) The synthetic nature of the compound; and (2) 
the lack of toxicity information to support an assessment of dietary 
exposure to 2,6-DIPN.
    EPA Response. As discussed in the previous response, the data 
support the classification of 2,6-DIPN as a biochemical, based on its 
structural similarity to naturally occuring PGRs. In addition, the 
registrant has conducted a series of toxicity tests according to the 
requirements listed in 40 CFR 158.690, in support of experimental use 
permits (EUPs) and for product registration. Dietary exposure estimates 
were based on the assumption that 100% of the crop will be treated, and 
other worst-case assumptions were applied to overestimate the typical 
dietary exposure likely under normal conditions of use.
    A 90-day oral toxicity study (MRID 450493-01) demonstrated that 
rats did not exhibit immune system effects, demonstrated by no changes 
in spleen or thymus weights and absence of lesions in spleen, thymus, 
and lymph nodes. The 90-day oral no observable adverse effects level 
(NOAEL) was 100 milligrams/kilogram/day (mg/kg/day), and the lowest 
observable adverse effects level (LOAEL) was 200 mg/kg/day, based on 
decreased body weight gain and food consumption. In a developmental 
toxicity study (MRID 4500010-01) in rats, the test animals did not 
exhibit increased fetal susceptibility to 2,6-DIPN when compared to 
untreated animals. The prenatal developmental toxicity NOAEL was 150 
mg/kg/day and the LOAEL was 500 mg/kg/day, based on decreased fetal 
body weight and a possible treatment-related cartilage anomaly.
    The toxicity data on 2,6-DIPN does not indicate extra sensitivity 
of offspring when compared with that of adult animals, but the data 
base does not represent a complete assessment of potential age-related 
sensitivity or acute effects other than lethality. The absence of a 
developmental toxicity study in a second species, a multigeneration 
reproduction toxicity study, or a range of doses adequate to induce a 
full range of toxic responses, especially potential acute effects in 
any of the available studies, required that the FQPA 10-fold safety 
factor be retained in defining EPA's level of concern.
    Studies submitted to test the potential genotoxicity or 
mutagenicity of 2,6-DIPN included a reverse mutation (Ames) assay (MRID 
446141-11), an unscheduled DNA synthesis assay in rat primary 
hepatocytes (MRID 446141-10), and a mouse micronucleus assay (MRID 
446141-12); all of these were negative. A mouse lymphoma assay (MRID 
454388-01) was positive at higher concentrations for mutagenicity, but 
since 2,6-DIPN was cytotoxic (killed the test cells) at the those 
concentrations where the positive results occurred (with and without 
metabolic activation), the test results are considered as being 
equivocal, or falsely positive. As a group, these four studies 
demonstrated that 2,6-DIPN is not a mutagen.
    Information supplied by the commenter (Ref. 5) noted that ``Di-
Isopropylnaphthalene(s) contained no chemical groups that would be 
structurally alerting for potential mutagenicity.'' Additionally, in 
spite of the equivocal study (MRID 454388-01), ``there was no evidence 
for a mutagenic effect in other in-vitro mutagenicity tests or in an 
adequately performed in vivo micronucleus assay in mice. The Committee 
agreed that no further mutagenicity testing was required.''
    Based on the absence of effects on the immune system in the 90-day 
subchronic study, no effects on developing rats at doses below those 
causing maternal effects, and no genetic toxicity, Tier II and Tier III 
toxicity data requirements were not triggered. The Agency does not 
require any additional toxicity studies at this time although a 
livestock feeding study must be conducted as a condition of 
registration (see EPA Response to Comment 4).
    Comment 4. Mr. Forsythe stated that, in the absence of any chronic 
toxicity data, ``it would be inappropriate to disregard the safety 
factor'' (referring to the FQPA 10-fold margin of safety to account for 
effects on sensitive populations, such as infants and children), and 
that ``threshold effects cannot be fully determined, and a safety 
factor would seem appropriate to address this lack of a complete data 
set regarding dietary exposure and chronic toxicity.''
    EPA Response. As stated above, the Agency has retained the FQPA 
safety factor in its assessment of the dietary exposure to 2,6-DIPN.
    Comment 5: Mr. Forsythe stated that the Agency should consider non-
dietary and non-occupational sources of human exposure to 2,6-DIPN. The 
commenter submitted an EPA document (Ref. 5), in which 2,6-DIPN is 
described as an ``emerging pollutant'' in Lake Michigan. The document 
also states that polychlorinated biphenyl (PCB) substitute compounds 
(which include 2,6-DIPN), are ``detected in effluent, sediment, and 
fish in the basin; bioaccumulative and toxic.''
    Additionally, the commenter provided information that European 
governments have expressed concerns regarding public exposure to DIPNs 
via the paper industry. In studies conducted by the United Kingdom 
Joint Food Safety and Standards Group (JFSSG), it was determined that 
DIPNs could be present in recycled food packaging and in packaged food 
(Ref. 5). DIPNs were

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detected in 30 of 34 samples of retail packaging at up to 44 mg/kg, and 
in 6 of 10 food samples at 0.04-0.89 mg/kg.
    EPA Response. Section 408(b)(2)(A)(ii) explicitly requires the 
Agency to find that ``there is a reasonable certainty that no harm will 
result from aggregate exposures, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' (emphasis added). As discussed below, EPA has considered 
all available information on non-dietary and non-occupational exposures 
in establishing this temporary tolerance.
    EPA reviewed the LaMP study (Ref. 5), and found that these 
``emerging pollutants'' were only included in a list of chemical 
stressors in the lake ``as a precautionary measure, either because of 
their widespread use in the basin, the fact that these chemicals are 
beginning to show up in monitoring data, or both.'' The list of 
emerging pollutants listed includes: Mineral and silicone oils, di(2-
ethylhexyl)phathalate (DEHP), isopropylbiphenyls, diphenylmethanes, 
butylbiphenyls, dichlorobenzyldichlorotoluene, phenylxylyl ethane, and 
diisopropylnaphthalene. The article does list PCB substitute compounds 
as being ``detected in effluent, sediment, and fish in the basin; 
bioaccumulative and toxic'' (Ref. 5). According to the Michigan LaMP 
(Ref. 5), ``Following the 1979 restrictions on PCB use, [these] 
compounds began being used in dielectric fluids, hydraulic system 
lubricants, and in solvents and carriers in the carbonless paper 
industry. Little was known about the potential impact of these (PCB) 
substitutes on the basin; therefore (they) were designated an emerging 
pollutant needing further evaluation.'' With the exception of DHEP, the 
Michigan LaMP goes on to state that ``other PCB substitutes (such as 
DIPN) have not been extensively studied; therefore, information on 
releases to the environment are limited.'' The article further states 
that information regarding the actual loading of PCB substitutes into 
Lake Michigan and their impact on the lake ecosystem were unknown (Ref. 
5).
    An environmental sampling study (Ref. 5), indicated that DIPNs and 
three other PCB substitutes were identified in effluent from: A de-
inking/recycling paper plant and a wastewater treatment facility that 
received waste water from a carbonless paper manufacturing plant; fish 
collected near discharge points; and sediments, all of these samples 
were collected from the Fox River in Wisconsin. However, it is unknown 
whether all four PCB substitutes were found nor what concentrations 
were measured in each, and the study lacked environmental fate and 
transport data for DIPNs. Based on the statements in the LaMP study, 
EPA concluded that although DIPNs have been detected in a few 
environmental matrices, it has not been associated with any adverse 
effects to human health or the environment.
    EPA also reviewed the JFSSG Food Surveillance Information Sheet, 
No. 169, January 1999. The conclusion reached by the JFSSG was that 
although varying amounts of DIPNs can be carried through the 
papermaking process to the finished product, there was no correlation 
between DIPN levels in food and that found in the food packaging 
materials.
    Data was reviewed that demonstrated that 2,6-DIPN does not pose any 
significant bioaccumulation risk. A summary of metabolism studies/data 
in support of a temporary tolerance exemption on stored potatoes (PP 
8G05008; Ref. 3; MRIDs 451632-01 and 451632-02) was submitted by the 
registrant, Platte Chemical Co., that demonstrated orally administered 
DIPNs were rapidly metabolized and excreted by experimental animals, 
and exhibited little potential for bioaccumulation (Ref. 5). 
Additionally, experimental animals exposed to DIPNs via inhalation did 
not exhibit any clinical signs of toxicity or mortality (Ref. 5). 
Necropsies were negative in experimental animals dosed with DIPNs in 
all of the aforementioned studies.

III. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997; FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for residues of 2,6-DIPN on 
potatoes at 3 ppm for the peels and 0.5 ppm for potato (whole) ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The classification of 2,6-DIPN as a biopesticide was based on its 
structural and functional similarity to 1-isopropyl-4,6-
dimethylnaphthalene, 1-methyl-7-isopropylnaphthalene, and 4-isopropyl-
1,6-dimethylnaphthalene which are naturally occurring plant growth 
regulators found in plant tissues. In addition, 2,6-DIPN is a sprout 
inhibitor, with a non-toxic mode of action. Therefore, the toxicity 
data reviewed include acute oral, dermal and inhalation toxicity 
studies, eye and skin irritation studies, a dermal sensitization study, 
subchronic feeding and developmental toxicity studies and genetic 
toxicity studies.
    2,6-DIPN is classified in Toxicity Category IV for mammalian acute 
oral toxicity (lethal dose (LD)50 > 5,000 mg/kg; OPPTS 
Harmonized Guideline 870.1100; 152-10; MRID 446141-04), acute dermal 
toxicity (LD50 > 5,000 mg/kg; OPPTS Harmonized Guideline 
870.1200; 152-11; MRID 446141-05), and acute inhalation toxicity 
(lethal concentration (LC)50 >2.60 mg/L; OPPTS Harmonized 
Guideline 870.1300; 152-12; MRID 446141-06), eye irritation (OPPTS 
Harmonized Guideline 870.2400; 152-13; MRID 446141-07) and dermal 
irritant (OPPTS Harmonized Guideline 870.2500; 152-14; MRID 446141-08). 
The active ingredient was not allergenic on skin (not a dermal 
sensitizer; OPPTS Harmonized Guideline 870.2600; 152-15; MRID 446141-
09).
    The subchronic toxicity study in rats (OPPTS Harmonized Guideline 
870.3100; 152-20; MRID 450493-01) suggests a no observed effect level 
(NOEL) of 104 mg/kg/day (104 or 121 mg/kg/day for males and females, 
respectively). The lowest observed adverse effect level (LOAEL) is 208 
mg/kg/day (208 and 245 mg/kg/day for males and females, respectively), 
based on minimal decreases in body weight gains, food consumption, 
adrenal effects (including increased absolute and relative organ 
weights and adrenal cortical hypertrophy) and kidney toxicity (evidence 
of tubular nephrosis in male rats).
    In the rat developmental toxicity study (OPPTS Harmonized Guideline

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870.3700; 152-23; MRID 450001-01), the maternal toxicity LOAEL is 150 
mg/kg/day based on reduced body weight gains and food consumption. The 
maternal toxicity NOAEL is 50 mg/kg/day. The developmental toxicity 
LOAEL is 500 mg/kg/day based on reduced fetal body weights and a 
slightly increased incidence of a skeletal alteration (fusion of 
cartilaginous bands in the cervical centra). The developmental toxicity 
NOAEL is 150 mg/kg/day.
    A mouse lymphoma gene mutation assay (OPPTS Harmonized Guideline 
870.5300; 152-17; MRID 454388-01) showed that 2,6-DIPN might be 
mutagenic without metabolic activation at doses between 10-30 [mu]g/mL. 
With metabolic activation, the results were equivocal at doses between 
25-90 [mu]g/mL. Cytotoxicity was observed in tests using the 
aforementioned doses, with and without metabolic activation. No 
genotoxicity was observed in other acceptable studies including a 
reverse mutation (Ames) assay (OPPTS 870.5100; 152-17; MRID 446141-11), 
in vivo/in vitro unscheduled DNA synthesis (UDS) assays in rat primary 
hepatocytes (OPPTS 870.5550; 152-17; MRID 446141-10), and a mouse 
micronucleus assay (OPPTS 870.5395; 152-17; MRID 446141-12). The 
collective data from the four-study mutagenicity battery demonstrates 
that 2,6-DIPN is not likely to be mutagenic.

B. Toxicological Endpoints

    1. Acute toxicity. The acute toxicity studies were acceptable in 
accordance with the guidelines as discussed in Unit III.A. All studies 
were performed at a single limit dose with no observable (non-lethal) 
toxic endpoints.
    2. Short-term and intermediate-term toxicity. Although the rat 
developmental toxicity study indicates a lower maternal NOEL (50 mg/kg/
day) for similar toxicity than the subchronic toxicity study (reduced 
body weight, weight gain and food consumption), the maternal LOAEL of 
150 mg/kg/day falls between the subchronic NOEL of 104-121 mg/kg/day 
and the subchronic LOAEL of 208-245 mg/kg/day. The maternal NOEL of 50 
mg/kg/day from the developmental toxicity study may be appropriate for 
use in characterization of risks for the subpopulation of women 13-49 
years of (child-bearing) age. However, the 104 mg/kg/day NOEL in the 
subchronic study was selected as the endpoint for short-term and 
intermediate-term dietary assessments since the effects observed at the 
subchronic LOAEL (208-245 mg/kg/day) were more thoroughly defined than 
the developmental effects observed at the LOAEL (500 mg/kg/day) in the 
developmental toxicity study, which were minimal.
    A reference dose (RfD) of 1 mg/kg/day is established by dividing 
the 104 mg/kg/day NOEL by a 100-fold uncertainty factor (10X for 
interspecies extrapolation and 10X for intraspecies variability). 
Available developmental toxicity data on 2,6-DIPN does not indicate 
extra sensitivity of offspring when compared with that of adult 
animals, but a developmental toxicity study in a second species and a 
multigeneration reproduction toxicity study are needed to fully 
determine age-related differences in response. In addition, residues 
have been detected in treated potatoes under laboratory and field 
conditions. Therefore, the default safety factor of 10X is retained, 
and acute and chronic population adjusted doses (aPAD and cPAD) for 
dietary risk characterizations are established by dividing the RfD by 
10X (accounting for age-related sensitivity for the subpopulations of 
infants and children). Therefore, the aPAD and cPAD are 0.1 mg/kg/day.
    3. Chronic toxicity. An extra 10-fold uncertainty factor for the 
absence of chronic toxicity data were not applied to determine a RfD 
because 2,6-DIPN has been classified as a biochemical pesticide having 
a non-toxic mode of action with biological activity more specific to 
plants than animals. Acute toxicity studies on animals indicated 
Toxicity Category IV for all routes of exposure. Chronic studies are 
not required to support registration of biochemical pesticides unless 
all of the following are true:
    i. Has subchronic toxicity.
    ii. Its use pattern involves a significant rate, frequency or site 
of application.
    iii. The frequency and level of human exposure are significant (40 
CFR 158.690(c)).
These criteria were evaluated in the Agency's risk assessment (Refs. 1 
and 2) which compared the cPAD to worst-case estimates of dietary 
exposure. The use pattern and exposure associated with 2,6-DIPN on 
potatoes in storage does not trigger chronic studies. Since the 
conservative exposure estimates did not result in risk 
characterizations exceeding the defined level of concern (exposure 
>100% of the cPAD).
    4. Carcinogenicity. Based on the 90-day oral toxicity study and the 
genotoxicity/mutagencity studies, there were no results to indicate 
potential neoplastic changes, and the genetic toxicity studies did not 
suggest carcinogenic potential in mammalian cells.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. There is a potential 
for dietary exposure to 2,6-DIPN, which can occur following its 
application to stored potatoes. According to the label, the plant 
growth regulator is to be applied at a rate of 16.6 ppm (weight/
weight), and as many as three applications can be used in a storage 
period with a minimum interval between application and use of the 
treated potatoes of 30 days.
    Residue profile. The submitted residue chemistry data for the use 
of 2,6-DIPN on potatoes is limited, and important factors in this 
assessment depend on default assumptions or hypothetical calculations 
having a low level of confidence.
    For purposes of this rule, the regulated residue is considered to 
be 2,6-DIPN, and a potential for some accumulation of 2,6-DIPN residues 
in body and subcutaneous fat was observed. These results and the 
possible use of peels with residues from treated potatoes as livestock 
feed (processed potato wastes are used for this purpose) suggest that 
residues of 2,6-DIPN may occur in meat and milk; however, this has not 
been evaluated in a livestock metabolism study.
    Limited field and laboratory residue data suggested tolerance 
levels as high as 0.5 ppm in/on whole potatoes, 3 ppm on potato peels, 
1.35 ppm in meat and meat by-products, and 0.7 ppm in milk.
    The analytical method for 2,6-DIPN has a level of quantification 
(LOQ) of 0.02 ppm and field and laboratory studies suggests that 20 ppm 
is a likely maximum commercial application rate for 2,6-DIPN. Residue 
levels expressed as 2,6-DIPN were reported at 3 ppm in potato peels and 
0.5 ppm in whole potatoes.
    In a published report (MRID 451632-01), the investigators noted 
that DIPNs could accumulate in the fat of treated rats suggesting a 
potential for secondary residues in meat and milk from livestock fed 
treated potatoes, but a livestock metabolism study was not submitted. 
Worst-case estimates of secondary residues were calculated for meat 
(1.35 ppm) and milk (0.7 ppm) of beef/dairy cattle fed waste from 2,6-
DIPN-treated processed potatoes.
    Supplementary metabolism information was submitted on 2,6-DIPN in 
rats from two published articles (MRID 451632-01). In one study, rats 
were given either a single dose or 30 daily oral doses, at 100 mg 2,6-
DIPN per kg body weight. Residues of 2,6-DIPN were detected in all 
tissues 2 hours after receiving the test dose. With the

[[Page 47250]]

exception of body and subcutaneous fat, DIPN was not detected 48 hours 
after the single (100 mg/kg) dose. Peak levels in body and subcutaneous 
fat were found 24 hours after dosing at 75 and 85 [mu]g/g of tissue, 
respectively; these levels declined to approximately 60 [mu]g/g by 48 
hours following the single dose. Results were similar in rats given the 
repeated doses with the peak levels in body and subcutaneous fat 
reported to be 150 and 90 [mu]g/g, respectively, at 2 hours following 
administration of the last dose. By 30 days after this last dose was 
given, the 2,6-DIPN levels in fat had declined to 5 [mu]g/g. The 
estimated half-life for 2,6-DIPN in fat was approximately 7 days, and 
the investigators noted that DIPNs had a small potential for 
accumulation in fat (levels increased from 2 to 7% over those found 
after a single dose in subcutaneous and body fat, respectively). Worst-
case estimates of secondary residues were calculated for meat (1.35 
ppm) and milk (0.7 ppm) of beef/dairy cattle fed waste from 2,6-DIPN-
treated processed potatoes. These tolerance provide a reasonable 
certainty of no harm and livestock feeding studies will allow further 
refinement of these estimates.
    In the second article, it was noted that 2,6-DIPN was metabolized 
in rats primarily by way of an oxidative pathway involving the 
isopropyl groups. Five metabolites were identified in urine from rats 
given an oral dose of 240 mg 2,6-DIPN per kg body weight, and the 
majority of the DIPN residues recovered in the urine (23% of the dose 
at 24 hours) was represented by 2-[6(1-hydroxy-1-
methyl)ethylnaphthalen-2-yl]-2-hydroxypionic acid (17.5% of the dose). 
This study did not explain the fate of the remaining 77% of the 
administered dose. The livestock feeding study should determine the 
fate of the administered dose, but because worst-case estimates were 
used to establish the tolerances, there is a reasonable certainty of no 
harm.
    Acute and chronic dietary exposure assessments were conducted using 
the Dietary Exposure Evaluation Model software (DEEM\TM\ version 1.30) 
which incorporates consumption data from USDA's Continuing Surveys of 
Food Intakes by Individuals (CSFII, 1994-1996/1998).
    For acute exposure assessments, individual 1-day food consumption 
data define an exposure distribution which is expressed as a percentage 
of the aPAD (aPAD is 0.1 mg/kg). For chronic exposure and risk 
assessment, an estimate of the residue level in each food or food-form 
on the commodity residue list is multiplied by the average daily 
consumption estimate for the food/food-form. The resulting residue 
consumption estimate for each food/food-form is summed with the residue 
consumption estimate for all other food/food-forms on the commodity 
residue list to arrive at the total estimated exposure. Exposure 
estimates are expressed as mg/kg body weight/day and as a percent of 
the cPAD (0.1 mg/kg/day). It is just as likely that the exposure 
estimates are appropriate, given that it is not uncommon for the peels 
to be eaten. These procedures were performed for each population 
subgroup.
    As a condition of registration, the registrant will be required to 
submit livestock feeding studies and enforcement analytical methods for 
livestock and potatoes; however, EPA believes that its analyses, which 
rely on the available data, supplemented with conservative assumptions, 
are sufficient to support a tolerance for the short period during which 
these studies are conducted.
    2. Dietary exposure from drinking water. Pesticide residues in 
drinking water are not expected to result from this use. The use is 
restricted to application in a commercial warehouse to stored potatoes. 
In addition, the label will restrict users from contaminating water 
supplies when cleaning equipment or disposing of equipment wash waters.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    2,6-DIPN is not registered for use on any sites that would result 
in residential exposure, but is restricted to use in commercial 
warehouses.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether 2,6-DIPN has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 2,6-
DIPN does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that 2,6-DIPN has a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the final rule for Bifenthrin 
Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional ten-fold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The toxicity data on 2,6-
DIPN does not indicate extra sensitivity of offspring when compared 
with that of adult animals, but the data base does not represent a 
complete assessment of potential age-related sensitivity or acute 
effects other than lethality. The following data would be necessary to 
allow for a complete assessment: A developmental toxicity study in a 
second species, a multigeneration reproduction toxicity study, or a 
range of doses adequate to induce a full range of toxic responses, 
especially potential acute effects in any of the available studies.
    3. Conclusion. In light of the absence of a developmental toxicity 
study in a second species, a multigeneration reproduction toxicity 
study, or a range of doses adequate to induce a full range of toxic 
responses, especially potential acute effects in any of the available 
studies, EPA has retained the default 10-fold safety factor

IV. Aggregate Risks and Determination of Safety for U.S. Population, 
Infants and Children

    1. Acute risk. Acute dietary exposure estimates were based on the 
available residue data and worst-case assumptions (Refs. 1 and 2). For 
the U.S. population, acute dietary exposure was estimated to be 
0.023113 mg/kg. These

[[Page 47251]]

values represented 23.11% of the aPAD. The subpopulation with the 
highest acute dietary exposure estimate was children 1 to 6 years of 
age (0.053492 mg/kg; 53.49% of the aPAD). The acute dietary exposures 
to all the subpopulations in the analysis did not exceed EPA's level of 
concern (> 100% of the aPAD).
    2. Chronic risk. Using the exposure assumptions described 
previously for chronic exposure, EPA has concluded that the chronic 
dietary exposure for the general population was estimated to be 
0.006939 mg/kg/day, 6.9% of the cPAD. The subpopulation with the 
highest chronic dietary exposure estimate was children 1 to 6 years of 
age, with estimated exposures of 0.023247 mg/kg/day, which constitutes 
23.25% of the cPAD.
    3. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to 2,6-DIPN residues. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.

V. Other Considerations

A. Analytical Enforcement Methodology

    A liquid chromatography (HPLC) method was used to measure the 
levels of 2,6-DIPN in the residue study.
    Adequate enforcement methodology (for example, gas chromatography) 
is available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no Codex Alimentarius Commission (Codex) maximum residue 
levels for residues of 2,6-DIPN.

VI. Conclusion

    Based upon the risk assessment, residue data and use pattern 
described above, a temporary tolerance is established for residues of 
2,6-DIPN in raw potatoes and potato peel at 0.5 ppm and 3 ppm 
respectively.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0127, in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before October 
7, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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 
information 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.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0127, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

[[Page 47252]]

B. When Will the Agency Grant a Request for a Hearing?

    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 issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. References

    1. EPA Memorandum. Roger Gardner to Manying Xue. ``Addendum to a 
previous review of a petition for an exemption from the requirement of 
a tolerance (PP 1F06338) for 2,6-DIPN (PC 055803) in/on stored 
potatoes (EPA File Symbol No. 34704-IUE; DP Barcodes D276743 and 
D276753; Submission Nos. S601233 and S601234).'' March 7, 2003.
    2. EPA Memorandum. Roger Gardner to Driss Benmhend. ``Petition for 
an exemption from the requirement of a tolerance (PP 1F06338) 
for 2,6-DIPN (PC 055803) in/on stored potatoes (EPA File Symbol No. 
34704-IUE; DP Barcodes D276743 and D276753; Submission Nos. S601233 and 
S601234).'' December 10, 2002.
    3. EPA Memorandum. Russell S. Jones to Driss Benmhend. ``Renewal 
Request for an Experimental Use Permit for Amplify[reg] Sprout 
Inhibitor (EPA Symbol No. 034704-EUP-13), containing 99.7% 2,6-
Diisopropyl-napthlalene [2,6-DIPN; (Chemical No. 055803)] as its Active 
Ingredient; and a Petition to Extend the Temporary Exemption from the 
Requirement of a Tolerance on Stored Potatoes (PP 8G05008). 
Review of Toxicity, Metabolism, and Residue Chemistry Studies. DP 
Barcodes D267369 and D267587; Case Nos. 062532 and 290334; Submission 
Nos. S581969 and S582755; MRIDs 451632-01 and -02.'' August 3, 2000.
    4. EPA Memorandum. Russell S. Jones to Driss Benmhend. 
``Amplify[reg] Sprout Inhibitor (EPA Symbol No. 034704-EUP-13), 
containing 99.7% 2,6-Diisopropyl-napthlalene [2,6-DIPN; (Chemical No. 
055803)] A New Active Ingredient; and a Petition For Exemption from the 
Requirement of Tolerances for 2,6-DIPN on Food Commodities (PP 
1F06338). Response to Comments Received Following Publication of an FR 
Notice Regarding a Request for a Tolerance Exemption for 2,6-DIPN. DP 
Barcode D278840; Case No. 070700; Submission No. S601234; No MRID 
Nos.'' August 7, 2000.
    5. Lake Michigan Lakewide Management Plan (LaMP Study). United 
States Environmental Protection Agency, Office of Water, Chapter 5 pp 
5-125. April 2000.

IX. Statutory and Executive Order Reviews

    This final rule establishes a temporary tolerance under section 
408(d) of the FFDCA in response to a petition submitted to the Agency. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). Because this rule 
has been exempted from review under Executive Order 12866 due to its 
lack of significance, this rule is not subject to Executive Order 
13211, Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final 
rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This 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), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under section 408(d) of the 
FFDCA, such as the temporary tolerance in this final rule, do not 
require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General

[[Page 47253]]

of the United States. EPA will submit a report containing this rule and 
other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: July 31,2003.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.590 is added to subpart C to read as follows:


Sec.  180.590  2,6-Diisopropylnaphthalene (2,6-DIPN); tolerances for 
residues.

    (a) General. Tolerances are established for residues of 2,6-
Diisopropylnaphthalene (2,6-DIPN) in or on the following commodities:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Meat                                                   1.35      5/31/06
Meat byproducts                                        1.35      5/31/06
Milk                                                    0.7      5/31/06
Potatoes (peel)                                           3      5/31/06
Potatoes (whole)                                        0.5      5/31/06
------------------------------------------------------------------------

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

Sec.  180.1208 [Removed]

0
3. Section 180.1208 is removed.
[FR Doc. 03-20307 Filed 8-7-03; 8:45 am]
BILLING CODE 6560-50-S