[Federal Register Volume 68, Number 185 (Wednesday, September 24, 2003)]
[Rules and Regulations]
[Pages 55261-55269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24012]



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  Federal Register / Vol. 68, No. 185 / Wednesday, September 24, 2003 / 
Rules and Regulations  

[[Page 55261]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0269; FRL-7326-5]


Cyromazine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
cyromazine in or on leek; onion, green; onion, potato; onion, tree; 
onion, welsh; shallot, fresh leaves; garlic, bulb; garlic, great-
headed, bulb; onion, dry bulb; rakkyo, bulb; shallot, bulb; vegetable, 
brassica, leafy, group 5, except broccoli; broccoli; turnip, greens; 
cabbage, abyssinian; cabbage, seakale; hanover salad, leaves; kidney of 
cattle, goat, hog, horse, and sheep; and meat byproducts, except 
kidney, of cattle, goat, hog, horse, and sheep. The petitioner has 
requested that existing tolerances for residues of cyromazine in/on dry 
bulb onion at 2.0 ppm, green onion at 0.1 ppm, and mustard greens and 
cabbage, Chinese at 3.0 ppm be deleted. Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 24, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0269, 
must be received on or before November 24, 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 VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-3194; 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 an are 
agricultural producer, food manufacturer, and pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Industry (NAICS 111), e.g., Crop production.
    [sbull] Industry (NAICS 112), e.g., Animal production.
    [sbull] Industry (NAICS 311), e.g., Food manufacturing.
    [sbull] Industry (NAICS 32532), e.g., Pesticide manufacturing.
    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-2003-0269. 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

    In the Federal Register of August 6, 2003 (68 FR 46616) (FRL-7319-
3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP 2E6507 and 2E6510) by IR-4, 681 US Highway 
1 South, New Brunswick, NJ 08902-3390. That notice included a 
summary of the petitions prepared by Syngenta Crop Protection 
Incorporated, the registrant.
    The petitions requested that 40 CFR 180.414 be amended by 
establishing tolerances for residues of the insecticide, cyromazine, 
(N-cyclopropyl-1,3,5-triazine-2,4,6-triamine), in or on the following 
commodities: leek; onion, green; onion, potato; onion, tree; onion, 
welsh; and shallot, fresh leaves at 3.0 parts per million (ppm) 
(2E6507), garlic, bulb; garlic, great-headed, bulb; onion, dry bulb; 
rakkyo, bulb; and shallot, bulb at 0.2 ppm (2E6507), vegetable, 
brassica,

[[Page 55262]]

leafy, group 5, except broccoli at 10.0 ppm (2E6510), broccoli at 1.0 
ppm, turnip, greens; cabbage, abyssinian; cabbage, seakale; and hanover 
salad, leaves at 10.0 ppm, and kidney of cattle, goat, hog, horse, and 
sheep at 0.2 ppm, and meat byproducts, except kidney, of cattle, goat, 
hog, horse, and sheep at 0.05 ppm (2E6510).
    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....''
    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).

III. Aggregate Risk Assessment and Determination of Safety

    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 tolerances for residues of cyromazine on 
leek; onion, green; onion, potato; onion, tree; onion, welsh; and 
shallot, fresh leaves at 3.0 ppm, garlic, bulb; garlic, great-headed, 
bulb; onion, dry bulb; rakkyo, bulb; and shallot, bulb at 0.2 ppm, 
vegetable, brassica, leafy, group 5, except broccoli at 10.0 ppm, 
broccoli at 1.0 ppm, turnip, greens; cabbage, abyssinian; cabbage, 
seakale; and hanover salad, leaves at 10.0 ppm, and kidney of cattle, 
goat, hog, horse, and sheep at 0.2 ppm, and meat byproducts, except 
kidney, of cattle, goat, hog, horse, and sheepat 0.05 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances follow.

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 nature of the toxic effects caused by cyromazine are 
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 Subchronic oral-Dog         The systemic toxicity LOAEL is 1,000 ppm
                                                                      (25 mg/kg/day) based on alteration in
                                                                      liver weight in males.
                                                                     The systemic toxicity NOAEL is 300 ppm (7.5
                                                                      mg/kg/day).
----------------------------------------------------------------------------------------------------------------
870.3100                                 Subchronic oral-Rat         The systemic toxicity LOAEL is 300 ppm (30
                                                                      mg/kg/day), based on alteration in the
                                                                      liver weight changes in males.
                                                                     The systemic toxicity NOAEL is 30 ppm (3 mg/
                                                                      kg/day).
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-day dermal toxicity-     No treatment related systemic toxicity was
                                          Rabbit                      noted. The systemic toxicity NOAEL > 2,000
                                                                      mg/kg/day.
                                                                     The systemic toxicity LOAEL > 2,000 mg/kg/
                                                                      day.
                                                                     No dermal irritation was noted. The dermal
                                                                      toxicity NOAEL > 2,000 mg/kg/day.
                                                                     The dermal toxicity LOAEL > 2,000 mg/kg/
                                                                      day.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-day dermal toxicity-     No treatment related systemic toxicity was
                                          Rabbit                      noted. The systemic toxicity NOAEL > 2,010
                                                                      mg/kg/day.
                                                                     The systemic toxicity LOAEL > 2,010 mg/kg/
                                                                      day.
                                                                     No dermal irritation was noted. The dermal
                                                                      toxicity NOAEL > 2,010 mg/kg/day.
                                                                     The dermal toxicity LOAEL > 2,010 mg/kg/
                                                                      day.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic oral (6-months)-    The systemic toxicity LOAEL is 3,000 ppm
                                          Dog                         (75 mg/kg/day) based on alteration in
                                                                      hematological parameters (hemoglobin, and
                                                                      hematocrit).
                                                                     The systemic toxicity NOAEL is 300 ppm (7.5
                                                                      mg/kg/day).
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combine Chronic/            The systemic toxicity LOAEL is 300 ppm (15
                                          Carcinogenicity-Rat         mg/kg/day) based on decreased body weight.
                                                                     The systemic toxicity NOAEL is 30 ppm. (1.5
                                                                      mg/kg/day). There is no evidence of
                                                                      carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity-Mouse       The systemic toxicity LOAEL is 1,000 ppm
                                                                      (150 mg/kg/day) based on decreased body
                                                                      weight.
                                                                     The systemic toxicity NOAEL is 50 ppm. (7.5
                                                                      mg/kg/day). There is no evidence of
                                                                      carcinogenicity.
----------------------------------------------------------------------------------------------------------------

[[Page 55263]]

 
870.3700                                 Developmental toxicity-     The maternal toxicity LOAEL is 30 mg/kg/
                                          Rabbit                      day, based on reduced body weight gain and
                                                                      food consumption.
                                                                     The maternal toxicity NOAEL is 10 mg/kg/
                                                                      day.
                                                                     The developmental toxicity LOAEL was not
                                                                      established.
                                                                     The developmental toxicity NOAEL > 60 mg/kg/
                                                                      day (HDT).
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental toxicity-Rat  The maternal toxicity LOAEL is 300 mg/kg/
                                                                      day, based on clinical signs (red or clear
                                                                      nasal discharge) and decreased body
                                                                      weights.
                                                                     The maternal toxicity NOAEL = 100 mg/kg/
                                                                      day.
                                                                     The developmental toxicity LOAEL is 600 mg/
                                                                      kg/day (HDT), based on increased incidence
                                                                      of minor skeletal variations.
                                                                     The developmental toxicity NOAEL is 300 mg/
                                                                      kg/day.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Two-generation              The parental systemic toxicity LOAEL is
                                          reproduction-Rat            3,000 ppm (150 mg/kg/day) based on
                                                                      decreased body weights that were
                                                                      associated with decreased food efficiency.
                                                                     The parental systemic toxicity NOAEL is
                                                                      1,000 ppm (50 mg/kg/day).
                                                                     The offspring systemic/developmental
                                                                      toxicity LOAEL is 3,000 ppm (150 mg/kg/
                                                                      day), based on decreased body weights at
                                                                      birth and through weaning.
                                                                     The systemic/developmental toxicity NOAEL
                                                                      is 1,000 ppm (50 mg/kg/day).
                                                                     No effects were noted on reproductive
                                                                      parameters and no reproductive toxicity
                                                                      LOAEL was determined.
                                                                     The reproductive toxicity NOAEL is >= 3,000
                                                                      ppm (150 mg/kg/day).
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism-Rat              Cyromazine was well absorbed after oral
                                                                      administration. Excretion was rapid at the
                                                                      dose (3 mg/kg), but an apparent delay in
                                                                      excretion occurred at the high dose (300
                                                                      mg/kg). Fecal elimination was equivalent
                                                                      among dose groups except the high dose
                                                                      males, where a greater percentage was
                                                                      eliminated by this route. The origin of
                                                                      fecal radioactivity was via biliary
                                                                      elimination. Residual radioactivity in
                                                                      tissues was minimal in all dose groups.
                                                                      Urinary and fecal metabolites of \14\C-
                                                                      cyromazine were isolated and identified by
                                                                      TLC, HPLC, and GC/MS. The major compounds
                                                                      were the N-dealkylated product melamine,
                                                                      hydroxycyromazine, and unmetabolized
                                                                      cyromazine identified.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal Absorption-Rat       Absorption at 10 hrs = 13 %. Cyromazine
                                                                      apparently rapidly absorbed into the skin
                                                                      in an inverse dose related manner. The
                                                                      absorption into the skin is followed by a
                                                                      slower release into the body. The main
                                                                      route of excretion is apparently by the
                                                                      urine. There is no evidence that the
                                                                      compound is sequestered in the skin.
                                                                     Mean absorption based on blood, urinary/
                                                                      fecal excretion, and carcass, ranged from
                                                                      0.6 to 7% for animals sacrificed at the
                                                                      end of the exposure periods. For animals
                                                                      exposed for 10 and 24 hours and followed
                                                                      for 48 hours post-exposure, mean
                                                                      absorption ranged from 8 to 14.5%. Total
                                                                      radioactivity absorbed generally decreased
                                                                      as dose increased indicating saturation of
                                                                      absorption with increasing dose. Amounts
                                                                      remaining in/on the skin at termination
                                                                      ranged from 4.5% (10 mg dose/2 h exposure)
                                                                      to 24% ( 0.1 mg dose/24 hour exposure).
                                                                      The majority of the absorbed radioactivity
                                                                      was found in the urine and carcass. Most
                                                                      of the unabsorbed radioactivity was found
                                                                      in the skin washes from each dose/
                                                                      duration.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal Absorption-Rat       Absorption at 10 hrs = 10%. Mean total
                                                                      recoveries of applied radioactivity from
                                                                      all dose groups ranged from 85 to 101%.
                                                                     Mean absorption based on blood, urinary/
                                                                      fecal excretion, and carcass, ranged from
                                                                      2% to 11%. Total radioactivity absorbed
                                                                      generally increased with increasing
                                                                      exposure time but decreased with
                                                                      increasing dose indicating saturation of
                                                                      penetration with increasing dose. The
                                                                      majority of the absorbed radioactivity was
                                                                      found in the urine and carcass. Most of
                                                                      the unabsorbed radioactivity was found in
                                                                      the skin washes from each dose/duration
                                                                      (35-90%). However, based on measurements
                                                                      of skin absorption, a significant amount
                                                                      of radioactive dose was also found in the
                                                                      skin itself (9-40%). Mean absorption with
                                                                      inclusion of radioactivity in dissolved
                                                                      skin ranged from 10 to 45%. The ratio of
                                                                      the amount of radioactive dose in the skin
                                                                      wash to the radioactivity in the skin
                                                                      itself decreased with time indicating
                                                                      penetration into the subsurface of the
                                                                      skin with time after treatment.
----------------------------------------------------------------------------------------------------------------
870.5395                                 Gene mutation in Hamster    Negative mutagen.
                                          (Chinese)-Mutagenic-
                                          Nucleus Anomaly
----------------------------------------------------------------------------------------------------------------
870.5100                                 Mutagenic-Point Mutation    Negative results for point mutations in
                                          Salmonella typhimurium      TA1537, TA1537, TA98, and TA100 with and
                                                                      without activation.
----------------------------------------------------------------------------------------------------------------
870.5450                                 Mutagenic-Dominant lethal   Negative mutagen.
                                          test species: Mouse
----------------------------------------------------------------------------------------------------------------


[[Page 55264]]

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors 
(SF) is retained due to concerns unique to the FQPA, this additional 
factor is applied to the RfD by dividing the RfD by such additional 
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is 
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for cyromazine used for human risk assessment is shown is 
shown in Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Cyromazine for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (All populations)         NA                       NA                      An appropriate endpoint
                                                                                          attributable to a
                                                                                          single dose (exposure)
                                                                                          of cyromazine was not
                                                                                          observed in oral
                                                                                          toxicity studies.
                                                                                          Thus, an acute dietary
                                                                                          endpoint was not
                                                                                          chosen.
-----------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 7.5 mg/kg/day      FQPA SF = 1x             Chronic Oral Toxicity
                                       UF = 100...............  cPAD = chronic RfD /      in Dogs.
                                       Chronic RfD = NOAEL/UF    FQPA SF = 0.075 mg/kg/  LOAEL = 75 mg/kg/day
                                        = 0.075 mg/kg/day.       day.                     based on alterations
                                                                                          in hematological
                                                                                          parameters [hematocrit
                                                                                          and hemoglobin
                                                                                          (males)], decreased
                                                                                          body weight/body
                                                                                          weight gain and
                                                                                          increases in several
                                                                                          organ weights.
-----------------------------------------------------------------------------------------
Short-Term Incidental Oral (1-30        NOAEL = 10 mg/kg/day     Residential LOC for      Developmental Toxicity
 days)                                                           MOE = 100                study in rabbits.
                                                                                         LOAEL = 30 mg/kg/day
                                                                                          based on decreases in
                                                                                          body weight gain and
                                                                                          food consumption.
-----------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1-  NOAEL = 7.5 mg/kg/day    Residential LOC for MOE   Chronic Oral Toxicity
 6 months)                                                       = 100                    in Dogs.
                                                                                         LOAEL = 75 mg/kg/day
                                                                                          based on alterations
                                                                                          in hematological
                                                                                          parameters [hematocrit
                                                                                          and hemoglobin
                                                                                          (males)], decreased
                                                                                          body weight/body
                                                                                          weight gain and
                                                                                          increases in several
                                                                                          organ weights.
-----------------------------------------------------------------------------------------
Short-, Intermediate- and Long-Term    NA                       NA                       No hazard was
 Dermal                                                                                   identified via the
                                                                                          dermal route of
                                                                                          exposure.
-----------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   Inhalation (oral) study  Residential LOC for MOE  Chronic Oral Toxicity
                                        NOAEL = 10 mg/kg/day     = 100                    in Dogs.
                                        (inhalation absorption                           LOAEL = 75 mg/kg/day
                                        rate = 100%)                                      based on alterations
                                                                                          in hematological
                                                                                          parameters [hematocrit
                                                                                          and hemoglobin
                                                                                          (males)], decreased
                                                                                          body weight/body
                                                                                          weight gain and
                                                                                          increases in several
                                                                                          organ weights.
-----------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 to 6   Inhalation (or oral)     Residential LOC for MOE  Chronic Oral Toxicity
 months)                                study NOAEL = 7.5 mg/    = 100                    in Dogs.
                                        kg/day (inhalation                               LOAEL = 75 mg/kg/day
                                        absorption rate =                                 based on alterations
                                        100%)                                             in hematological
                                                                                          parameters [hematocrit
                                                                                          and hemoglobin
                                                                                          (males)], decreased
                                                                                          body weight/body
                                                                                          weight gain and
                                                                                          increases in several
                                                                                          organ weights.
-----------------------------------------------------------------------------------------

[[Page 55265]]

 
Long-Term Inhalation (> 6 months)      Inhalation (or oral)      Occupational LOC for     Chronic Oral Toxicity
                                        study NOAEL = 7.5 mg/    MOE = 100                in Dogs.
                                        kg/day (inhalation      Residential LOC for MOE  LOAEL = 75 mg/kg/day
                                        absorption rate =        = 100.                   based on alterations
                                        100%)                                             in hematological
                                                                                          parameters [hematocrit
                                                                                          and hemoglobin
                                                                                          (males)], decreased
                                                                                          body weight/body
                                                                                          weight gain and
                                                                                          increases in several
                                                                                          organ weights.
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NA                       NA                       Group E carcinogen -
                                                                                          evidence of non-
                                                                                          carcinogenicity for
                                                                                          humans.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.414) for the residues of cyromazine, in or on 
the following raw agricultural commodities: dry bean, except cowpea, 
cabbage, chinese; mustard greens, mango, potato, leafy vegetables 
(except Brassica) group, cucurbit vegetables group, tomato, onions, 
mushroom, lima beans and pepper. Cyromazine tolerances are established 
for milk and tissues of cattle, goat, hog, horse, and sheep as a result 
of feeding cyromazine treated feed items. Rotational crop tolerances 
are established for sweet corn, radishes, and cotton. Additionally, 
cyromazine is registered for use as a feed through treatment for 
poultry for the control of flies and maggots in poultry manure. As a 
result of the feed-through use, tolerances are established for residues 
of cyromazine in egg and poultry tissues. Risk assessments were 
conducted by EPA to assess dietary exposures from cyromazine in food as 
follows:
    i. Acute exposure. Quantitative acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. For this assessment, an appropriate 
endpoint attributable to a single dose (exposure) of cyromazine was not 
observed in oral toxicity studies.
    ii. Chronic exposure. In conducting this acute dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\) which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessment: An unrefined chronic exposure analysis (Tier 1) was 
conducted for cyromazine using the DEEM software. The assumptions of 
the chronic dietary exposure assessment are tolerance-level residues 
and one hundred percent crop-treated.
    iii. Cancer. Cyromazine is classified as a Group E carcinogen 
(evidence of non-carcinogenicity for humans), and was shown not to be 
carcinogenic in mice or rats following long-term dietary 
administration. The available mutagenicity data suggest that cyromazine 
does not have genotoxic activity.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for cyromazine in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of cyromazine.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow groundwater. For a screening-level assessment 
for surface water EPA will use FIRST (a tier 1 model) before using 
PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for 
pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to cyromazine they are further 
discussed in the aggregate risk sections in Unit III.E.
    In soil, cyromazine is stable to hydrolysis and photolysis and is 
rather persistent in aerobic soil (half-life value of 150 days). The 
field studies confirmed this half-life value, where average half-lives 
varied from 75 days to more than 250 days. Soil adsorption coefficients 
are generally low. This would indicate that cyromazine has the 
potential to leach through soils, especially sand and silt loam soils.
    The EECs for cyromazine reflect six applications of cyromazine at 
0.125 lbs ai/A. For surface water, the annual average of 15.5 [mu]g/L 
(or ppb) is based on use of the FIRST model. The groundwater EEC of 5.3 
[mu]g/L has been estimated by the SCI-GROW2 program. Both of these 
surface and groundwater values represent upper-bound conservative 
estimates for concentrations that might be found in

[[Page 55266]]

surface water and groundwater due to the use of cyromazine.
    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).
    Cyromazine is not registered for use on any sites that would result 
in residential exposure. There are no currently existing or proposed 
uses for cyromazine in residential or public sites and therefore no 
residential risk assessment was performed.
    4. Cumulative effects from 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 cyromazine has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to cyromazine 
and any other substances and cyromazine does not appear to produce a 
toxic metabolite produced by other substances. EPA has determined, 
however, that there is no known mechanism of toxicity that would 
support grouping cyromazine by a common mechanism with atrazine, 
simazine, and cyanazine. For the purposes of this tolerance action, 
therefore, EPA has not assumed that cyromazine 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 policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold 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. There is no evidence of 
susceptibility and no residual uncertainties for pre- and post-natal 
toxicity resulting from exposure to cyromazine.
    3. Conclusion. There is a complete toxicity data base for 
cyromazine and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X Safety factor to protect infants and children should be 
reduced to 1X because:
    [sbull] There is no evidence of increased susceptibility 
(quantitative or qualitative) to rats or rabbits following in utero 
exposure or post-natal exposure to rats. In the prenatal developmental 
toxicity study in rats, the NOAEL for developmental toxicity was higher 
than the maternal NOAEL. In the developmental toxicity study in 
rabbits, no evidence of developmental toxicity was noted. For 
developmental toxicity, the NOAEL was > 60 mg/kg/day highest dose 
tested (HDT). In the two-generation reproduction study in rats no 
reproductive effects were observed. In this study, the reproductive 
NOAEL is >= 150 mg/kg/day (HDT). No neurotoxic effects were observed in 
the available data, and there is no requirement for a developmental 
neurotoxicity study. Further, exposure assessments have been conducted 
in a manner unlikely to underestimate exposure.
    [sbull] The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
    [sbull] The dietary food exposure assessment is based on current 
and proposed registrations and is completely unrefined (i.e. tolerance 
level residues and 100% crop treated). The dietary exposure analysis 
will not underestimate exposure/risk.
    [sbull] No residual uncertainties were identified in the exposure 
database.
    [sbull] There are no residential uses for cyromazine.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An appropriate endpoint attributable to a single 
dose (exposure) of cyromazine was not observed in oral toxicity 
studies. Thus, an acute dietary endpoint was not chosen, and cyromazine 
is not expected to pose an acute risk.

[[Page 55267]]

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
cyromazine from food will utilize 8.3% of the cPAD for the U.S. 
population, 5.0% of the cPAD for all infants (< 1 year old), 13% of the 
cPAD for children 1-2 years old, and 7.5% of the cPAD for females 13-49 
years old. Based on the use pattern, chronic residential exposure to 
residues of cyromazine is not expected. In addition, there is potential 
for chronic dietary exposure to cyromazine in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 3 of this unit:

               Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyromazine
----------------------------------------------------------------------------------------------------------------
                                                                              Ground      Surface
              Population Subgroup                cPAD (mg/kg/    % cPAD     Water EEC    Water EEC     Chronic
                                                     day)        (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                0.075          8.3          5.3         15.5  2.4 x 10\3\
---------------------------------------------------------------------------
All Infants (< 1 year old)                             0.075          5.0          5.3         15.5  7.1 x 10\2\
---------------------------------------------------------------------------
Children 1-2 years old                                 0.075           13          5.3         15.5  6.5 x 10\2\
---------------------------------------------------------------------------
Females 13-49 years old                                0.075          7.5          5.3         15.5  2.1 x 10\3\
----------------------------------------------------------------------------------------------------------------

    3. Aggregate cancer risk for U.S. population. Cyromazine is not 
expected to pose a cancer risk to humans.
    4. 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 cyromazine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Methods AG-408 (HPLC,/UV) and AG-417A (GLC/NPD) are the tolerance 
enforcement methods for cyromazine as published in the Pesticide 
Analytical Manual (PAM), Vol. II. These methods combined and with minor 
modifications comprise Method AG-621. The residue data submitted in 
support of these petitions were generated using Methods AG-408 and AG-
621. Method AG-621 has been adequately validated for use for the 
determination of residues of cyromazine in/on bulb vegetables, leafy 
Brassica vegetables, and turnip greens. Method AG-408 is adequate for 
enforcement of the proposed tolerance for residues of cyromazine.
    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

    Codex, Canadian or Mexican Maximum Residue Limits (MRLs) are not 
established for cyromazine in/on leafy Brassica vegetables, bulb 
vegetables, and turnip greens. Therefore, no compatability problems 
exist for the tolerances established by this rule.

V. Conclusion

    Therefore, the tolerances are established for residues of 
cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) in or on 
leek; onion, green; onion, potato; onion, tree; onion, welsh; and 
shallot, fresh leaves at 3.0 ppm, garlic, bulb; garlic, great-headed, 
bulb; onion, dry bulb; rakkyo, bulb; and shallot, bulb at 0.2 ppm, 
vegetable, brassica, leafy, group 5, except broccoli at 10.0 ppm, 
broccoli at 1.0 ppm, turnip, greens; cabbage, abyssinian; cabbage, 
seakale; and hanover salad, leaves at 10.0 ppm, and kidney of cattle, 
goat, hog, horse, and sheep at 0.2 ppm, and meat byproducts, except 
kidney, of cattle, goat, hog, horse, and sheep at 0.05 ppm.

VI. 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 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-2003-0269 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 November 
24, 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

[[Page 55268]]

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-2003-0269, 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.

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).

VII. Statutory and Executive Order Reviews

    This final rule establishes a 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 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.

[[Page 55269]]

VIII. 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 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: September 10, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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 180.414 is amended as follows:
0
a. By revising the commodities cattle, goat, hog, horse, and sheep meat 
byproducts in the table in paragraph (a).
0
b. By revising the commodities onion, dry bulb and onion, green in the 
table in paragraph (a).
0
c. By alphabetically adding commodities in the table in paragraph (a).
0
d. By removing and reserving paragraph (c).


Sec.  180.414  Cyromazine; tolerances for residues.

    (a) * * *


------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Broccoli...................................................          1.0
Cabbage, abyssinian........................................         10.0
Cabbage, seakale...........................................         10.0
                                * * * * *
Cattle, kidney.............................................          0.2
                                * * * * *
Cattle, meat byproducts, except kidney.....................         0.05
                                * * * * *
Garlic, bulb...............................................          0.2
Garlic, great-headed, bulb.................................          0.2
                                * * * * *
Goat, kidney...............................................          0.2
                                * * * * *
Goat, meat byproducts, except kidney.......................         0.05
Hanover salad, leaves......................................         10.0
                                * * * * *
Hog, kidney................................................          0.2
                                * * * * *
Hog, meat byproducts, except kidney........................         0.05
                                * * * * *
Horse, kidney..............................................          0.2
                                * * * * *
Horse, meat byproducts, except kidney......................         0.05
                                * * * * *
Leek.......................................................          3.0
                                * * * * *
Onion, dry bulb............................................          0.2
Onion, green...............................................          3.0
Onion, potato..............................................          3.0
Onion, tree................................................          3.0
Onion, welsh...............................................          3.0
                                * * * * *
Rakkyo, bulb...............................................          0.2
Shallot, bulb..............................................          0.2
Shallot, fresh leaves......................................          3.0
                                * * * * *
Sheep, kidney..............................................          0.2
                                * * * * *
Sheep, meat byproducts, except kidney......................         0.05
                                * * * * *
Turnip, greens.............................................         10.0
Vegetable, brassica, leafy, group 5, except broccoli.......         10.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. [Reserved]
* * * * *

[FR Doc. 03-24012 Filed 9-23-03; 8:45 am]
BILLING CODE 6560-50-S