[Federal Register Volume 61, Number 21 (Wednesday, January 31, 1996)]
[Rules and Regulations]
[Pages 3328-3330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1905]



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


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 4E4288 and 4E4289/R2198; FRL-4995-1]
RIN 2070-AC18


Chlorpyrifos; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This rule revises tolerances for residues of the insecticide 
chlorpyrifos in or on the raw agricultural commodities peaches, pears, 
plums, and nectarines by establishing the current time-limited 
tolerances as permanent tolerances. The regulations to establish 
maximum permissible levels of residues of the insecticide were 
requested in petitions submitted by DowElanco and are needed to cover 
maximum expected residues in or on imported commodities.

EFFECTIVE DATE: This regulation became effective January 24, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [PP 4E4288 and 4E4289/R2198], may be submitted 
to: Hearing Clerk (A-110), Environmental Protection Agency, Rm. M3708, 
401 M St., SW., Washington, DC 20460. A copy of any objections and 
hearing requests filed with the Hearing Clerk should be identified by 
the docket control number and submitted to: Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring copy of objections and hearing 
requests to Rm. 1132, CM 1B2, 1921 Jefferson Davis Highway, Arlington, 
VA. Fees accompanying objections shall be labeled ``Tolerance Petition 
Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, 
OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
    An electronic copy of objections and hearing requests filed with 
the Hearing Clerk may be submitted to OPP by sending electronic mail 
(e-mail) to:
    [email protected]
    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding 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 5.1 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [PP 4E4288 and 4E4289/
R2198]. No Confidential Business Information (CBI) should be submitted 
through e-mail. Copies of electronic objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found below in 
this document.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr., 
Product Manager (PM) 19, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 207, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, 
(703) 305-6386; e-mail:[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a proposed rule, published in the 
Federal Register of September 28, 1993 (58 FR 68621) which announced 
that DowElanco had submitted pesticide petitions (PP 4E4288 and PP 
4E4289) to the Administrator, pursuant to section 408(e) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), to amend 40 
CFR 180.342 by revising the tolerances for residues of the insecticide 
chlorpyrifos [O,O-diethyl O-(3,5,6-trichloro-2-pyridyl) 

[[Page 3329]]
phosphorothioate] in or on the raw agricultural commodity pears from 
0.01 to 0.05 part per million (ppm) and peaches, nectarines, and plums 
from 0.01 ppm to 0.05 ppm. These revisions in the tolerances were 
needed because of differing use patterns of chlorpyrifos in other parts 
of the world as compared to the U.S.
    The Agency reviewed preliminary residue data and concluded that 
residues should not exceed the proposed tolerances, but determined that 
additional residue data for imported pears, peaches (data for peaches 
suffices for nectarines), plums and prunes (the processed commodity of 
plums) were required.
    Pending submission and review of the data, the Agency issued a 
final rule, published in the Federal Register of February 25, 1994 (59 
FR 9095), which announced that the Agency had revised the tolerances 
for a 2-year period. The expiration date is January 28, 1996, at which 
time the tolerances would revert to the previous 0.01 ppm for the named 
commodities.
    Additional residue data for pears, peaches, and plums were 
submitted. (It was determined that chlorpyrifos residues do not 
concentrate in the processing of plums to prunes, and no data were 
submitted or required.) The data were reviewed and were determined to 
be sufficient to justify removing the time limitation from the existing 
tolerances. The available data do not support a change in the U.S. use 
pattern for the crops listed above. If such a change is desired, 
additional residue data generated in the U.S. must be submitted.
    The scientific data submitted in the petitions and other relevant 
material have been evaluated. The toxicological data considered in 
support of the tolerance include:
    1. A 2-year dog feeding study with a no-observed-effect level 
(NOEL) for systemic effects of 1.0 milligram (mg)/kilogram (kg)/day and 
lowest effect level (LEL) (increased liver weight) of 3.0 mg/kg/day. 
The NOELs for cholinesterase (ChE) inhibition were as follows: 0.01 mg/
kg/day for plasma, 0.1 mg/kg/day for red blood cells, and 1.0 mg/kg/day 
for brain cells. Levels tested were 0, 0.01, 0.03, 0.1, 1.0, and 3 mg/
kg/day.
    2. A voluntary human study with chronic ChE NOEL of 0.03 mg/kg/day 
(based on 20 days of exposure at this level).
    3. A 2-year mouse chronic toxicity/carcinogenicity study with a 
NOEL of 15 ppm for systemic effects (equivalent to 2.25 mg/kg/day) and 
no carcinogenic effects observed under the conditions of the study at 
all levels tested (0, 0.5, 5, and 15 ppm, equivalent to 0.075, 0.75, 
and 2.25 mg/kg/day).
    4. A voluntary human study with acute ChE NOEL of 0.10 mg/kg/day 
(based on daily single-dose exposures of 0, 0.014, 0.03, or 0.10 mg/kg/
day) determined at 1, 3, 6, and 9 days of treatment.
    5. A 2-year rat feeding/carcinogenicity study with ChE NOEL of 0.1 
and LEL of 1.0 mg/kg/day (based on decreased plasma and brain ChE 
activity), and a systemic NOEL of 1.0 mg/kg/day and LEL of 10 mg/kg/day 
(based on decreased erythrocyte and hemoglobin values and increased 
platelet count during the first year). There were no observed 
carcinogenic effects at the levels tested (0.05, 0.1, 1.0, and 10 mg/
kg/day) under the conditions of the study. Chlorpyrifos is classified 
as a Group E chemical (no evidence of carcinogenicity).
    6. A three-generation reproduction study in rats with no 
reproductive effects observed at the dietary levels tested (0, 0.1, 
0.3, and 1.0 mg/kg/day).
    7. Two rat developmental toxicity studies: one negative for 
developmental toxicity at all dose levels (levels tested were 0.1, 3.0, 
and 15.0 mg/kg/day); and one with maternal NOEL of 15 mg/kg/day and 
developmental NOEL of 2.5 mg/kg/day (levels tested, by gavage, were 0, 
0.5, 2.5, and 15 mg/kg/day).
    8. A mouse developmental toxicity study with a teratogenic NOEL 
greater than 25 mg/kg/day (highest dose tested) and a developmental 
fetotoxic NOEL of 10 mg/kg/day and LEL of 25 mg/kg/day (decreased fetal 
length and increased skeletal variants).
    9. A developmental toxicity study in rabbits with maternal and 
developmental NOELs of 81 mg/kg/day, and maternal and developmental 
LELs of 140 mg/kg/day (based on maternal decreased food consumption on 
gestation day 15 to 19, and body weight loss during the dosing period 
followed by a compensatory weight gain; and based on a slight reduction 
in fetal weights and crown-rump lengths, and fetal increased incidence 
of unossified fifth sternebrae and/or xiphisternum). Levels tested were 
0, 1, 9, 81, and 140 mg/kg/day.
    10. An acute delayed neurotoxicity study in the hen that was 
negative at 50 and 100 mg/kg/day.
    11. Several mutagenicity studies which were all negative. These 
include an Ames assay, two Chinese hamster ovary cell mutation assays, 
a micronucleus assay for chromosomal aberration, an in vitro 
chromosomal aberration assay with and without enzymatic activation, and 
an unscheduled DNA synthesis assay.
    12. A general metabolism study in rats shows that the major 
metabolite of chlorpyrifos is 3,5,6-trichloro-2-pyridinol (TCP). The 
studies listed below were conducted to demonstrate that TCP is less 
toxic than chlorpyrifos and is not a ChE inhibitor.
    a. A 90-day rat feeding study with a systemic NOEL of 30 mg/kg/day. 
Levels tested were 0, 10, 30, and 100 mg/kg/day.
    b. A rat developmental toxicity study with no developmental 
toxicity observed at the dosages tested (0, 50, 100, and 150 mg/kg/
day).
    c. Mutagenicity studies (including an Ames assay and an unscheduled 
DNA synthesis assay) were negative for mutagenic effects.
    Based on the above studies, the Agency has concluded that the TCP 
metabolite is not of toxicological concern.
    For the assessment of chronic dietary risk, the reference dose 
(RfD) based on the human voluntary ChE study (ChE NOEL of 0.03 mg/kg/
day) and using a 10-fold uncertainty factor is calculated to be 0.003 
mg/kg of body weight/day. Tolerances for food uses appear in 40 CFR 
180.342 and 40 CFR 185.1000. The Dietary Risk Exposure Section (DRES) 
used, when justified and appropriate, anticipated residues rather than 
published tolerance values, and data regarding percent crop treated 
(when less than 100%). The anticipated residue contribution (ARC) from 
published uses of chlorpyrifos is 0.000860 mg/kg of body weight/day for 
the overall U.S. population. This represents 28.7% of the RfD. None of 
the DRES subgroups has an exposure that exceeds the RfD. The population 
subgroup most highly exposed is non-nursing infants, less than 1 year 
old, with an ARC from published uses of 0.002147 mg/kg of body weight/
day, 71.6% of the RfD. The next most highly exposed population subgroup 
is children, 1-6 years old, with an ARC from published uses of 0.001914 
mg/kg of body weight/day, 63.8% of the RfD. It should be noted that 
these values include contributions from pears, nectarines, peaches, and 
plums with tolerances of 0.05 ppm; the tolerances are already in place 
as temporary tolerances. This rule converts existing, temporary 
tolerances to permanent tolerances and does not raise the ARC as a 
percentage of the RfD.
    The DRES detailed acute analysis estimates the distribution of 
single-day exposures for the overall U.S. population and certain 
subgroups. The analysis evaluates individual food consumption as 
reported by respondents in the USDA 1977-78 

[[Page 3330]]
Nationwide Food Consumption Survey (NFCS) and accumulates exposure to 
the chemical for each commodity. Each analysis assumes uniform 
distribution of chlorpyrifos in the commodity. Since the toxicological 
endpoint to which exposure is being compared in this analysis is 
neurotoxicity, four human population subgroups (infants, less than 1 
year old; children, 1-12 years old; females, 13 years old and older; 
males, 13 years old and older), as well as the overall population, are 
of interest.
    The Margin of Exposure (MOE) is the ratio of the NOEL to the 
exposure (NOEL/exposure = MOE). For neurotoxicity, the Agency is 
generally not concerned unless the MOE is below 10 when the NOEL is 
based on human data. Using refined exposure estimates generated in the 
preparation of the Reregistration Eligibility Document (RED) for 
chlorpyrifos, MOEs are greater than 10 for all population subgroups 
evaluated except for children 1 through 6 years. Although the Agency 
has concerns when low MOEs are calculated, this tolerance action does 
not raise risk concerns. The MOEs are not affected by the rule because 
any incremental change in exposure resulting from the tolerances for 
pears, nectarines, peaches, and plums is negligible. Thus MOEs are not 
changed by the tolerances for these commodities, much less by the 
raising of the tolerance from 0.01 ppm to 0.05 ppm. It should also be 
noted that the Agency will reassess chlorpyrifos tolerances in general 
as part of the reregistration process. The RED is scheduled to be 
issued in 1996.
    A record has been established for this rulemaking under docket 
number [PP 4E4288 and 4E4289/R2198] (including any objections and 
hearing requests submitted electronically as described below). A public 
version of this record, including printed, paper versions of electronic 
comments, which does not include any information claimed as CBI, is 
available for inspection from 8 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The public record is located in Room 
1132 of the Public Response and Program Resources Branch, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines ``a significant regulatory action'' as an action that 
is likely to result in a rule: (1) Having an annual effect on the 
economy of $100 million or more, or adversely and materially affecting 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities (also referred to as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs or the rights and obligations thereof; or (4) 
raising novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in this Executive 
Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

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

    Dated: January 24, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 346a and 371.

    2. In Sec. 180.342, by revising paragraph (e), to read as follows:


Sec. 180.342   Chlorpyrifos; tolerances for residues.

*      *      *      *      *
    (e) Tolerances are established as follows for residues of the 
insecticide chlorpyrifos [O,O-diethyl O-(3,5,6-trichloro-2-pyridyl) 
phosphorothioate] in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
Nectarines.................................................         0.05
Peaches....................................................         0.05
Pears......................................................         0.05
Plums......................................................         0.05
                                                                        
------------------------------------------------------------------------

*      *      *      *      *

[FR Doc. 96-1905 Filed 1-26-96; 2:55 pm]
BILLING CODE 6560-50-F