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pronamide (Kerb) Proposed Tolerance 11/95

[Federal Register: November 15, 1995 (Volume 60, Number 220)]
[Notices]               
[Page 57422-57423]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300402; FRL-4985-6] RIN 2070-AC18
3,5-Dichloro-N-(1,1-Dimethyl-2- Propynyl)Benzamide; Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA has completed the reregistration process and issued a 
Reregistration Eligibility Decision (RED) document for the pesticide 
3,5-dichloro-N- (1,1-dimethyl-2-propynyl)benzamide, also known as 
pronamide. In the reregistration process, all information to support a 
pesticide's continued registration is reviewed for adequacy and, when 
needed, supplemented with new scientific studies. Based on the RED 
tolerance assessments for the pesticide chemical subject to this 
proposed rule, EPA is proposing the following tolerance actions: to 
delete individual tolerances and establish crop-grouping tolerances, 
raise some tolerances and lower others, amend an incorrectly listed 
tolerance, and modify the statement under 40 CFR 180.317 for the 
pesticide pronamide.
DATES: Written comments, identified by the OPP document control number 
[OPP-300402], must be received on or before January 16, 1996.
ADDRESSES: By mail, submit comments to Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person, 
deliver comments to Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis 
Hwy., Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [OPP-300402]. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
proposed 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: The contact for the chemical listed 
above is: Philip Poli, (703)-308-8038; e-mail: 
              poli.philip@epamail.epa.gov. 
By mail: Special Review and Reregistration Division (7508W), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office location: 
Special Review Branch, Crystal Station #1, 3rd Floor, 2800 Crystal Drive, 
Arlington, VA 22202.
SUPPLEMENTARY INFORMATION:
I. Legal Authorization
    The Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.) 
authorizes the establishment of tolerances (maximum legal residue 
levels) and exemptions from the requirement of a tolerance for residues 
of pesticide chemicals in or on raw agricultural commodities pursuant 
to section 408 (21 U.S.C. 346(a)). Without such tolerances or 
exemptions, a food containing pesticide residues is considered to be 
"adulterated" under section 402 of the FFDCA, and hence may not 
legally be moved in interstate commerce (21 U.S.C. 342). To establish a 
tolerance or an exemption under section 408 of the FFDCA, EPA must make 
a finding that the promulgation of the rule would "protect the public 
health" (21 U.S.C. 346a(b)). For a pesticide to be sold and 
distributed the pesticide must not only have appropriate tolerances 
under the FFDCA, but also must be registered under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et 
seq.).
    In 1988, Congress amended FIFRA and required EPA to review and 
reassess the potential hazards arising from currently registered uses 
of pesticides registered prior to November 1, 1984. As part of this 
process, the Agency must determine whether a pesticide is eligible for 
reregistration and if any subsequent actions are required to fully 
attain reregistration status. EPA has chosen to include in the 
reregistration process a reassessment of existing tolerances or 
exemptions from the need for a tolerance. Through this reassessment 
process, EPA can determine whether a tolerance must be amended, 
revoked, or established, or whether an exemption from the requirement 
of one or more tolerances must be amended or is necessary.
    The procedure for establishing, amending, or repealing tolerances 
or exemptions from the requirement of tolerances is set forth in the 
Code of Federal Regulations, 40 CFR parts 177 through 180. The 
Administrator of EPA or any person may initiate an action proposing to 
establish, amend, revoke, or exempt a tolerance for a pesticide 
registered for food uses. The proposal must explain the grounds for 
such a proposed action and must be published as a public notice. Each 
petition or request for a new tolerance, an amendment to an existing 
tolerance, or a new exemption from the requirement of a tolerance must 
be accompanied by a fee or a request for a waiver of such fee. Current 
Agency policy on tolerance actions identified during the reregistration 
process is to administratively process without requiring payment of a 
fee tolerance actions for revision or revocation of an established 
tolerance. Comments submitted in response to the Agency's published 
proposals are reviewed; the Agency then publishes its final 
determination regarding the specific tolerance actions.
II. Chemical-Specific Information and Proposed Actions
Pronamide: Amendment to 40 CFR 180.317
    1. Regulatory background. Pronamide was registered in the United 
States in 1972 for use as a herbicide to control grassy and broadleaf 
weeds on field, vegetable, and orchard crops, forage and fodder, fallow 
land, woody ornamentals, nursery stock, and Christmas tree plantations.
    A Registration Standard for pronamide was issued in April 1986. 
Under this standard, registrants were required to generate data, supply 
missing data, and replace unacceptable data. A Data Call-In was issued 
in 1990 for pronamide requiring additional data. The Reregistration 
Eligibility Decision (RED) document of May 1994 reflects a reassessment 
of all data which were submitted in response to the Registration 
Standard and the Data Call-In.
    2. Proposed action--Modification of tolerance expression. The 
Agency is proposing to modify the 40 CFR 180.317(a) and (b) tolerance 
expressions to state that tolerances "* * * are established for the 
combined residues of the herbicide 3,5-dichloro-N-(1,1- dimethyl-2-
propynyl)benzamide and its metabolites (containing the 3,5-
dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-(1,1-dimethyl-
2-propynyl)benzamide) * * *" to clarify which metabolites of pronamide 
are determined by the enforcement methods and are included in the 
tolerance expression.
Tolerances Under 40 CFR 180.317(a)
    It is the Agency's policy to set a crop group tolerance when there 
is an established or proposed tolerance for all of the representative 
commodities for a specific group or related commodities. This reduces 
the number of tolerances in 40 CFR part 180 and allows the pesticide to 
be used on all the commodities in the crop group. The procedures and 
data requirements for establishing a group tolerance are described in 
40 CFR 180.34(f).
    A crop group tolerance of 10 parts per million (ppm) is proposed 
for residues of pronamide in/on the forage and hay of the nongrass 
animal feeds group. The available data satisfy the requirements for 
crop group tolerance establishment. Concomitant with this tolerance 
proposal, the established tolerances for "alfalfa, fresh", "alfalfa, 
forage", "alfalfa, hay", "clover", "crown vetch", "sainfoin", 
and "trefoil" will be deleted.
    A crop group tolerance of 0.1 ppm is proposed for residues of 
pronamide in/on the stone fruits group. Adequate data are available to 
support the established tolerances for the representative commodities 
cherries, nectarines, peaches, and plums/fresh prunes, all at 0.1 ppm. 
Concomitant with this tolerance proposal, the established tolerances 
for "cherries", "nectarines", "peaches", and "plums" will be 
deleted.
    The available residue data support a proposal to reduce the 
tolerance for residues in/on endive from 2.0 ppm to 1.0 ppm.
    As a result of the improvement in the enforcement method for animal 
commodities, the Agency is proposing to amend the tolerances for the 
kidney and liver of cattle, goats, hogs, horses, and sheep from 0.2 ppm 
to 0.4 ppm. The improved enforcement method measured a higher 
percentage of the residues of concern in the kidney and liver, plus the 
residue data reflected an inadequate established tolerance. The Agency 
has examined the added dietary exposure as a result of this tolerance 
increase. Since exposure to kidney and liver amounts to approximately 5 
percent of the total dietary intake, the additional risk is 
insignificant. In addition, the tolerance for sheep meat was 
incorrectly listed in 40 CFR 180.317(a) as 0.2 ppm and will be changed 
to the correct tolerance of 0.02 ppm.
    Confirmatory residue data are required for alfalfa seed; once these 
data are received the Agency will reassess the tolerance for this 
commodity. In the interim, the existing tolerance for alfalfa forage 
will support the alfalfa seed use.
Tolerances Under 40 CFR 180.317(b)
    Confirmatory residue data are required for dried winter peas; once 
these data are received the Agency will reassess the tolerance for this 
commodity. In the interim, alternate data from Europe are available to 
support the present tolerance on dried winter peas.
III. Public Comment Procedures
    Interested persons are invited to submit written comments, 
information, or data in response to this proposed rule. Comments must 
be submitted by January 16, 1996. Comments must bear a notation 
indicating the document control number. Three copies of the comments 
should be submitted to either location listed under ADDRESSES above in this 
document. Information submitted as a comment concerning this document may be 
claimed confidential by marking any or all of that information as 
"Confidential Business Information" (CBI).
    Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of a comment 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.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, which contains any of the 
ingredients listed herein, may request within 60 days after publication 
of this notice in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the FFDCA.
    Documents considered and relied upon by EPA pertaining to this 
action, and all written comments filed pursuant to this proposed rule, 
will be available for public inspection in Rm. 1132, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA, between 8 a.m. and 4:30 
p.m., Monday through Friday, except legal holidays. Any person who has 
registered, or who has submitted an application for registration under 
FIFRA of any of the pesticide chemicals listed in this proposed rule, 
may request that this proposal be referred to an advisory committee. 
Such a request must be made within 60 days of the publication of this 
proposal. To satisfy requirements for analysis specified by Executive 
Order 12866 and the Regulatory Flexibility Act, EPA has considered the 
impacts of this proposal.
     A record has been established for this rulemaking under docket 
number [OPP-300402] (including comments and data 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.
    Electronic comments can be sent directly to EPA at:
                      opp-Docket@epamail.epa.gov
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    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 all comments 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.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
    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 entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
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, 
it has been determined that this rule is not a "significant regulatory 
action," because it does not meet any of the regulatory-significance 
criteria listed above.
B. Regulatory Flexibility Act
    This proposed rule has been reviewed under the Regulatory 
Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et 
seq.), and EPA has determined that it will not have a significant 
economic impact on any small businesses, governments, or organizations. 
Accordingly, I certify that this proposed rule does not require a 
separate regulatory flexibility analysis under the Regulatory 
Flexibility Act.
C. Paperwork Reduction Act
    This proposed regulatory action does not contain any information 
collection requirements subject to review by OMB under the Paperwork 
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
D. Unfunded Mandates
    This proposed rule contains no Federal mandates under Title II of 
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State, 
local, or tribal governments or the private sector because it would not 
impose enforceable duties on them.
List of Subjects in 40 CFR Part 180
    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.
    Dated: November 1, 1995.
Jack E. Housenger,
Chief, Special Review Branch, Special Review and Reregistration 
Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR part 180 be 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. By revising Sec. 180.317 to read as follows:
Sec. 180.317   3,5-Dichloro-N-(1,1-dimethyl-2-propynyl)benzamide; tolerances 
for residues.
    (a) Tolerances are established for the combined residues of the 
herbicide 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide and its 
metabolites (containing the 3,5-dichlorobenzoyl moiety and calculated 
as 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide) in or on the 
following raw agricultural commodities:
------------------------------------------------------------------------
                                     Parts per 
Commodity                             million  
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Apples................................ 0.1
Artichokes............................ 0.1
Blackberries.......................... 0.05
Blueberries........................... 0.05
Boysenberries......................... 0.05
Cattle, fat........................... 0.02
Cattle, kidney........................ 0.4
Cattle, liver......................... 0.4
Cattle, mbyp (except kidney, liver)... 0.02
Cattle, meat.......................... 0.02
Eggs.................................. 0.02
Endive (escarole)......................1.0
Goats, fat.............................0.02
Goats, kidney..........................0.4
Goats, liver...........................0.4
Goats, mbyp (except kidney, liver).....0.02
Goats, meat............................0.02
Grapes.................................0.1
Hogs, fat..............................0.02
Hogs, kidney...........................0.4
Hogs, liver............................0.4
Hogs, mbyp (except kidney, liver)......0.02
Hogs, meat.............................0.02
Horses, fat............................0.02
Horses, kidney.........................0.4
Horses, liver..........................0.4
Horses, mbyp (except kidney, liver)....0.02
Horses, meat...........................0.02
Lettuce................................1.0
Milk...................................0.02
Nongrass animal feeds.................10.0
Pears................................. 0.1
Poultry, fat...........................0.02
Poultry, kidney....................... 0.2
Poultry, liver........................ 0.2
Poultry, mbyp (except kidney, liver)...0.02
Poultry, meat..........................0.02
Raspberries............................0.05
Sheep, fat.............................0.02
Sheep, kidney......................... 0.4
Sheep, liver.......................... 0.4
Sheep, mbyp (except kidney, liver).....0.02
Sheep, meat............................0.02
Stone fruits...........................0.1
------------------------------------------------------------------------
    (b) Tolerances with regional registrations are established for the 
combined residues of the herbicide 3,5-dichloro-N-(1,1-dimethyl-2 
propynyl)benzamide and its metabolites (containing the 3,5 
dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-(1,1-dimethyl-
2- propynyl)benzamide) in or on the following raw agricultural 
commodities:
------------------------------------------------------------------------
                                     Parts per 
Commodity                             million  
------------------------------------------------------------------------
Peas, dried (winter)................. 0.05
Rhubarb.............................. 0.1
------------------------------------------------------------------------