[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Rules and Regulations]
[Pages 33019-33023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15964]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300486B; FRL-5724-9]
RIN 2070-AB78
Bromoxynil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes the following time-limited
tolerances, to expire on January 1, 1998, for the residues of the
herbicide bromoxynil (3,5-dibromo-4-hydroxybenzonitrile) and its
metabolite DBHA (3,5-dibromo-4-hydroxybenzoic acid) resulting from the
application of octanoic and heptanoic acid esters of bromoxynil to
cotton: undelinted cottonseed at 7 parts per million (ppm), cotton gin
byproducts at 50 ppm, and cotton hulls at 21 ppm. (Active ingredient
codes are 35302 for the octanoic acid ester, and 128920 for the
heptanoic acid ester. CAS Reg. Nos. are 1689-99-2 for the octanoic acid
ester, and 56634-95-8 for the heptanoic acid ester.) In addition, this
document revises tolerances for the residues of bromoxynil, resulting
from the application of octanoic and heptanoic acid esters of
bromoxynil to cotton, in or on cattle, hogs, horses, goats, and sheep
to 0.5 ppm in meat, 3.0 ppm in meat by-products, and 1.0 ppm in fat.
Further, this document establishes tolerances for residues of
bromoxynil, resulting from the application of octanoic and heptanoic
acid esters of bromoxynil to cotton, at 0.1 ppm in milk; at 0.05 ppm in
eggs; and at 0.05 ppm in poultry meat, meat by-products, and fat. The
tolerances for the cotton commodities will expire and are revoked on
January 1, 1998. After January 1, 1998, EPA will publish a document in
the Federal Register to remove the revoked tolerances from the Code of
Federal Regulations. Rhone-Poulenc AG Company submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act as amended by the
Food Quality Protection Act of 1996 requesting a tolerance on
cottonseed.
EFFECTIVE DATE: This rule becomes effective June 18, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300486B], may be submitted to: Hearing
Clerk (1900), 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 Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. In person, bring a copy of objections
and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA. Fees accompanying objections and hearing requests shall
be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of objections and hearing
requests filed with the Hearing Clerk may also be submitted
electronically by sending electronic mail (e-mail) to : docket@epamail.epa.gov. Copies of objections and hearing requests must
be submitted as an ASCII file avoiding the use of special characters
and any form of encryption. Copies of objections and hearing requests
will also be accepted on disks in WordPerfect in 5.1 file format or
ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300486B]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of 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: Jim Tompkins, Product Manager
(PM) 25, 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. 241, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6027, e-mail:
tompkins.jim@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 24, 1995 (60
FR 27414), EPA established a time-limited tolerance under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a,
for residues of the herbicide bromoxynil, (3,5-dibromo-4-
hydroxybenzonitrile) on cottonseed. This tolerance expired on April 1,
1997. The tolerance was established in response to a petition filed by
the Rhone-Poulenc AG Company, P.O. Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709.
In the Federal Register of December 24, 1996 (61 FR 67807) (FRL-
5576-8), EPA issued a notice of filing that stated that the Rhone-
Poulenc AG Company had submitted a pesticide petition to EPA proposing
to extend the time-limited tolerance on cottonseed. Comments in
response to the notice of filing were received from the Union of
Concerned Scientists, the Pesticide Action Network, the Edmonds
Institute, Friends of the Earth, the Environmental Defense Fund, and
many individuals.
In the Federal Register of May 2, 1997 (62 FR 24065) (FRL-5617-5),
EPA issued a proposed rule for establishment of tolerances on cotton
commodities and poultry, and revision of tolerances on animal
commodities. The Agency issued this proposed rule because, after review
of the petition, the Agency determined that as a result of bromoxynil
use on cotton: (1) A higher tolerance will be needed for cottonseed;
(2) existing tolerances for bromoxynil on animal commodities (meat,
meat byproducts, and fat) need to be raised; and (3) additional
tolerances will be needed for other cotton commodities (undelinted
cottonseed and cotton gin byproducts) and other animal commodities
(poultry meat, meat by-products, fat; eggs; and milk).
Written comments on the proposed rule were to be received within 17
days of issuance of the Federal Register notice. Under section 408 of
the FFDCA, the Agency is required to provide a 60-day comment period on
proposed rules unless EPA finds for good cause that it would be in the
public interest to provide a shorter period. The Agency shortened the
comment period on the bromoxynil tolerances to 17 days because notice
had been provided on the intention of establishing a tolerance
permitting use of bromoxynil on cotton, and cotton growers faced a
potential hardship if a decision was not made expeditiously.
Following publication of the May 2 proposed rule, several
environmental and public interest groups requested that EPA extend this
comment period from 17 to 60 days. In their request for an extension,
these groups cited a number of health issues and questions regarding
interpretation of the FFDCA safety standard. EPA was not convinced that
the comment period was inadequate to address the issues raised by these
groups. Nonetheless, in a
[[Page 33020]]
Federal Register notice published on May 16, 1997 (62 FR 27002) (FRL-
5719-2), EPA agreed to extend the comment period for an additional 7
days. In recognition of the cotton growers' situation, the comment
period was extended to a total of 24 days rather than 60 days.
Comments in response to the proposed rule were received from public
interest groups, individual concerned citizens, agricultural extension
agents, representatives of state agencies, individual growers, industry
groups, and Rhone Poulenc Ag Company. Responses to several of the most
significant comments are presented in Unit III. of this document. Other
significant comments and the Agency's responses are provided in a
Response to Comments document that has been included in the docket for
this action.
I. Statutory Background
Section 408 of the FFDCA, 21 U.S.C. 301 et seq., as amended by the
Food Quality Protection Act of 1996, (Pub. L. 104-170) authorizes the
establishment of tolerances (maximum residue levels), exemptions from
the requirement of a tolerance, modifications in tolerances, and
revocation of tolerances for residues of pesticide chemicals in or on
raw agricultural commodities and processed foods. Without a tolerance
or exemption, food containing pesticide residues is considered to be
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA,
and hence may not legally be moved in interstate commerce. 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 section 3 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA, 7 U.S.C. 136 et seq.).
Section 408 was substantially amended by FQPA. Among other things,
the FQPA amends the FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. New section 408(b)(2)(A)(i) 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) 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 food, drinking water, and from pesticide use
in gardens, lawns, or buildings (residential and other indoor uses) but
does not include occupational exposure. Section 408(b)(2)(C) 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. . . .''
II. Final Action
The proposed rule summarizes EPA's risk assessment process, the
scientific data bearing on the risk presented by bromoxynil, and EPA's
assessment of the aggregate risk posed by bromoxynil. In that document,
EPA concluded that there is a reasonable certainty that no harm will
result to the general population and major identifiable population
subgroups from aggregate exposure to bromoxynil. After reviewing all
comments that were received, EPA reaffirms that conclusion today for
substantially the same reasons. EPA has expanded on its basis for its
conclusion in addressing significant comments.
In finalizing this rulemaking, EPA reconsidered its estimation of
exposure through drinking water. Since the publication of the proposed
rule, the Agency has completed a more refined (tier 2) assessment of
the estimated concentration of bromoxynil residues in surface water,
which can be used as an estimate of residues in surface water source
drinking water. Bromoxynil residues in ground water source drinking
water are expected to be negligible because bromoxynil and bromoxynil
phenol degrade quickly in the environment. EPA estimated exposure in
the proposal based on a modeling of potential exposure taking into
account the chemical characteristics of bromoxynil octanoate. For the
revised (tier 2) modeling, EPA used the chemical characteristics of
bromoxynil phenol. EPA believes it is more appropriate to use the
phenol because bromoxynil octanoate degrades rapidly to bromoxynil
phenol, and, although both bromoxynil octanoate and bromoxynil phenol
degrade rapidly, bromoxynil phenol is more persistent than bromoxynil
octanoate.
The tier 2 analysis is based on the PRZM-EXAMS model (Pesticide
Root Zone Model Version 2.3 plus Exposure Analysis Modeling System
Version 2.94) instead of the GENEEC model (GENeric Expected
Environmental Concentration) used for the tier 1 preliminary screen.
PRZM-EXAMS uses data on the physical-chemical properties of the
pesticide plus soil and topographic characteristics, weather data, and
water quality parameters for the modeled site. PRZM-EXAMS uses this
information to estimate runoff from a 10 hectare agricultural field
into an immediately adjacent 1 hectare by 2 meter deep pond. PRZM-EXAMS
considers reduction in dissolved pesticide concentration due to
adsorption of pesticide to soil or sediment, incorporation, degradation
in soil before wash off to a water body, direct deposition of spray
drift into the water body, and degradation of the pesticide within the
water body. PRZM-EXAMS, which was designed to estimate exposure for
ecological risk assessments, tends to substantially overestimate
pesticide residues in drinking water for several reasons. First,
surface water source drinking water generally comes from bodies of
water that are substantially larger than a 1 hectare pond. PRZM-EXAMS
assumes that essentially the whole basin receives an application of the
pesticide. Yet, in virtually all cases, basins large enough to support
a drinking water facility will contain a substantial fraction of the
area which does not receive the pesticide. Additionally, there is often
at least some flow (in a river) or turn over (in a reservoir or lake)
of the water so the persistence of the pesticide near the drinking
water facility is usually overestimated. Second, even assuming a
reservoir is directly adjacent to an agricultural field, the
agricultural field may not be used to grow a crop on which the
pesticide in question is registered for use. Further, the PRZM-EXAMS
model does not take into account reductions in residue-loading due to
applications of less than the maximum application rate or no treatment
of the crop at all (percent crop treated data).
EPA has obtained sampling data from surface water that support
EPA's conclusion that the 0.2 ppb (parts per billion) estimate for
chronic exposure is a substantial overestimate for drinking water
exposure. These data showed that approximately one percent of the
samples were positive for bromoxynil with levels ranging from 0.035 ppb
(level of quantification) to 6.1 ppb with the majority of samples
closer to the lower end of this range. When it is considered that this
sampling was conducted predominantly in locations not representative of
drinking water intakes, that only a small percentage of the samples had
detectable levels of bromoxynil, and that most of the samples showing
bromoxynil were at levels close to or below 0.2 ppb, EPA believes that
assuming 0.2 ppb for all
[[Page 33021]]
drinking water in the United States is a substantial overestimate.
The estimated chronic exposure level for bromoxynil in drinking
water is 0.2 ppb based on the PRZM-EXAMS model; this value had
previously been estimated as 0.3 ppb. In addition, the Agency has since
put in place an interim policy for selection of water consumption
values to be used in calculations of dietary risk; this was done in
order to improve the consistency of these calculations for all Agency
dietary risk analyses. Based on the estimated chronic level in drinking
water of 0.2 ppb and estimated drinking water consumption of 2L by a 70
kilogram (kg) adult, carcinogenic risk is 6 x 10-7. If the
carcinogenic risk were calculated using the same water consumption
value as in the proposed rule (20.9 grams/kilograms/day (g/kg/day) for
the southern U.S.) and the revised chronic exposure level of 0.2 ppb,
the resulting carcinogenic risk would be 4 x 10-7.
Finally, EPA notes two corrections to the preamble of the proposed
rule. First, EPA proposed to set a tolerance of 0.1 ppm for bromoxynil
residues in milk. In the preamble to the proposal, EPA stated that it
was proposing to increase the tolerance for bromoxynil in milk. The
statement was incorrect because no milk tolerance was then in
existence. The tolerance value that was proposed was accurate. Second,
the preamble stated that the bromoxynil registration limits use to 3
percent of the cotton crop, or 400,000 acres. Rhone Poulenc Ag Company
has applied to amend its registration to allow treatment of 400,000
acres; however, presently the application is limited to 200,000 acres.
EPA plans to make a decision on that application shortly.
III. Response to Public Comments
Comments in response to the December 26, 1996 notice of filing and
the May 2, 1997 proposed rule were received from several public
interest groups, individual concerned citizens, agricultural extension
agents, state agencies, industry groups, individual growers, and Rhone
Poulenc Ag Company.
Public interest groups and individual citizens made the following
comments. The commenters requested that the Agency not extend
tolerances for bromoxynil on BXN cotton because: (1) Bromoxynil is a
possible human carcinogen; (2) bromoxynil has caused birth defects in
laboratory mammals; (3) bromoxynil is toxic to broadleaf plants and
fish; (4) there are no data on bromoxynil residues on cotton fibers
processed from bromoxynil-tolerant cotton; (5) expanding use of
bromoxynil with a bromoxynil-tolerant crop violates the FQPA's safety
standard of ``reasonable certainty of no harm from aggregate
exposure''; (6) the carcinogenic risk of bromoxynil exceeds the one in
a million standard of the FQPA; (7) the Agency does not have sufficient
data to assess the toxicity of the metabolite DBHA.
Agricultural extension agents, representatives of state agencies,
industry groups, Rhone Poulenc Ag Company, and cotton growers have
requested that the Agency approve the tolerance because bromoxynil is
useful to control weeds in BXN cotton. Several individuals associated
with state agricultural regulatory agencies and universities have
requested that the expiration date for the bromoxynil tolerance on
cotton be changed from the proposed date of January 1, 1998, to January
1, 1999. The reason for this request is that commenters believe that
the Agency cannot receive and analyze the results of required residue
trials before January of 1999, and that having the tolerance expire
before a new analysis can be conducted causes hardship for cotton
growers and BXN cottonseed producers.
In this document, EPA responds to the comments concerning the level
of carcinogenic risk, the available data on DBHA, and the 1 year time
limitation.
1. Cancer risk. Various commenters argued that EPA could not make
the reasonable certainty of no harm finding required by the FQPA
because the aggregate cancer risk for bromoxynil exceeds 1 in 1
million. The commenters relied on legislative history from the House
Commerce Committee that states that ``reasonable certainty of no harm''
for cancer risk means a risk no greater than ``negligible.'' H. Rep.
104-669, 104th Cong., 2d Sess. 44 (1996). The Committee further stated
that it understood current EPA practice to be that a negligible risk is
interpreted as a ``one-in-a-million lifetime risk.''
EPA believes the aggregate risk from bromoxynil meets the
reasonable certainty of no harm standard. Additionally, EPA believes
that the bromoxynil risk is ``negligible'' as EPA has used that term
and complies with a one-in-a-million risk standard.
The lifetime dietary cancer risk (food only) for bromoxynil is 1.5
in 1 million. The lifetime cancer risk from bromoxynil residues in
water is 0.6 in 1 million. Adding these risk estimates together yields
an aggregate dietary risk of 2.1 in 1 million. EPA believes this risk
estimate is consistent with EPA's past practice in applying a
negligible risk approach. See 60 FR 3797 (2.6 x 10-6 is
within negligible risk range), 59 FR 13654, 13657 (2.2 x 10-6
is within negligible risk range). EPA does not apply the negligible
risk standard as a bright line test because of the lack of precision in
quantitative cancer risk assessment. There are a significant number of
uncertainties in both the toxicology data used to derive the cancer
potency of a substance and in the data used to measure and calculate
exposure. Extrapolation of results at high doses in animal studies to
much lower doses in humans and from limited numbers of animals to large
human populations also adds to the imprecision. Thus, with cancer risk
estimates, EPA generally does not attach great significance to
numerical estimates that differ by approximately a factor of 2.
In evaluating quantitative risk estimates it is also important to
consider the qualitative evidence supporting the cancer assessment.
EPA's Proposed Guidelines for Cancer Risk Assessment, 61 FR 17960,
17983 (April 23, 1996) (FRL-5460-3), list a series of factors to be
considered in making a cancer assessment. Factors supporting a cancer
classification include: (1) More than one study with consistent
results; (2) same tumor site across species; (3) multiple observations
across species, sites, and sexes; and (4) severity and progression of
lesions including dose response relationships and rarity of tumor type.
Here, bromoxynil was shown to induce liver tumors in the male mouse in
two studies. Liver tumors in the female mouse was shown in one study.
Bromoxynil was not shown to induce cancer in more than one species
(negative in the rat) but, as indicated, did show positive results in
male and female mouse in the liver. As to the severity and progression
of tumors, bromoxynil appeared to have a dose response relationship in
the male mouse but only induced tumors at one dose in the female. Liver
tumors are common in male mice but less so in females. Finally, in the
cancer studies, there was no effect from bromoxynil on survival rates,
body weights, or food consumption. Bromoxynil's carcinogenicity was
also supported by positive findings in three mutagenicity studies and
its structural similarity to another chemical which has tested positive
for carcinogenicity. While these data fully support EPA's decision to
perform a quantitative cancer risk assessment, EPA would have a greater
concern for the cancer risk posed by bromoxynil if, for example, a
cancer response was seen in two species, the tumor involved was less
common, and/
[[Page 33022]]
or a more severe effect was seen in treated animals.
Taking into account the quantitative cancer risk estimate, the lack
of precision in quantitative cancer risk assessment, and the
qualitative cancer evidence on bromoxynil, EPA concludes that there is
a reasonable certainty of no harm from aggregate exposure to
bromoxynil. Further, EPA is in the process of evaluating all of the
bromoxynil uses this year as part of FIFRA reregistration. This will
permit EPA to better evaluate the total bromoxynil cancer risk and take
steps to reduce any cancer risks of concern.
2. Data on DBHA. Several commenters argued that the tolerance
should not be granted because the Agency does not have sufficient data
to assess the toxicity of the metabolite DBHA. They argued that the
Agency's assumption that DBHA is equal in toxicity to bromoxynil could
be wrong, that it is possible that DBHA is more toxic than bromoxynil.
EPA believes that there is little chance that DBHA would exhibit
significant toxicity over that of the parent bromoxynil. Bromoxynil and
DBHA are extremely similar in structure, varying only in that
bromoxynil has a cyano (-CN) group that has been converted to a
carboxyl (-COOH) group in the DBHA metabolite. Conversion to a carboxyl
group is generally considered to decrease the toxicity of a molecule.
The conversion to the carboxyl group should cause the DBHA to be more
polar and therefore more soluble in water and less in fats.
Additionally, the presence of the carboxyl group will allow DBHA to
combine (conjugate) with certain water soluble molecules (e.g.
glucuronic acid) which should further increase DBHA's water solubility
and further decrease its solubility in fats. This increased water
solubility as well as the decreased fat solubility means that DBHA
should be eliminated faster from the organism than bromoxynil, and thus
DBHA is less likely than bromoxynil to remain in the cell and engage in
the formation of additional, possibly toxic metabolites.
For these reasons, EPA believes that specific toxicity data on DBHA
are not needed for the safety determination on the bromoxynil
tolerances.
3. Length of tolerance. Various growers and cottonseed producers
requested that the expiration date for the bromoxynil tolerance on
cotton be changed from the proposed date of January 1, 1998, to January
1, 1999. These commenters argued that the Agency cannot receive and
analyze the results of required residue trials before January of 1999,
and having the tolerance expire before a new analysis can be conducted
causes hardship for cotton growers and BXN cottonseed producers.
The Agency proposed the January 1, 1998 expiration date because it
was anticipated that the risk assessment for bromoxynil reregistration
would be completed late in 1997 after this final rule was issued. EPA's
reregistration decision, however, will probably not be made in time to
incorporate it into a decision on a permanent tolerance if that must
occur by January 1, 1998. Required residue data also will not be
available for review this year. Nonetheless, EPA proposed that the
tolerance only run through January 1, 1998, and this proposal had a
shortened period for public comment.
EPA is willing to consider a request for an additional time
extension of the bromoxynil tolerance; however, appropriate procedures
must be followed. Prior to consideration of extension of the tolerance,
EPA must receive a petition to request such an extension. This petition
must be published, and the public given a chance to comment, before EPA
can make a decision concerning the extension of this tolerance after
January 1, 1998.
IV. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
the new section 408(e) and (1)(6) as was provided in the old section
408 and section 409. However, the period for filing objections is 60
days rather than 30 days. EPA currently has procedural regulations
which governs the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by August 18, 1997, file written objections to any
aspect of this regulation and may also request a hearing with the
Hearing Clerk, at the address given below (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issue(s) on which a hearing is requested, the
requestor's contentions on each such issue, and a summary of any
evidence relied upon by the objector, 40 CFR 178.27. 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 issue(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as ``Confidential Business Information'' (CBI).
Information marked as CBI 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.
V. Public Docket
A record has been established for this rulemaking under docket
number [PP 6F4641/OPP-300486B]. 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 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA.
Electronic comments may 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 any 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.
[[Page 33023]]
The official rulemaking record is a paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.
VI. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and since this action
does not impose any information collection requirements subject to
approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it
is not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty, or contain
any ``unfunded mandates'' as described in Title II of the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior
consultation as specified by Executive Order 12875 (58 FR 58093,
October 28, 1993), or special considerations as required by Executive
Order 12898 (59 FR 7629, February 16, 1994).
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 explaining the factual basis
for this determination was published in the Federal Register of May 4,
1981 (46 FR 24950).
VII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's Federal Register. This 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, Food additive, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: June 13, 1997.
Stephen L. Johnson,
Acting 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. Section 180.324 is revised to read as follows:
Sec. 180.324 Bromoxynil; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
herbicide bromoxynil (3,5-dibromo-4-hydroxybenzonitrile) resulting from
application of its octanoic and/or heptanoic acid ester in or on the
following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, seeding 0.1 ppm
Barley, forage, green 0.1 ppm
Barley, grain 0.1 ppm
Barley, straw 0.1 ppm
Cattle, fat 1 ppm
Cattle, meat 0.5 ppm
Cattle, meat by-products 3 ppm
Corn, fodder (dry) 0.1 ppm
Corn, fodder (green) 0.1 ppm
Corn, fodder, field (dry) 0.1 ppm
Corn, fodder, field (green) 0.1 ppm
Corn, grain 0.1 ppm
Corn, grain, field 0.1 ppm
Eggs 0.05 ppm
Flaxseed 0.1 ppm
Flax straw 0.1 ppm
Garlic 0.1 ppm
Goats, fat 1 ppm
Goats, meat 0.5 ppm
Goats, meat by-products 3 ppm
Grass, canary, annual, seed 0.1 ppm
Grass, canary, annual, straw 0.1 ppm
Hogs, fat 1 ppm
Hogs, meat 0.5 ppm
Hogs, meat by-products 3 ppm
Horses, fat 1 ppm
Horses, meat 0.5 ppm
Horses, meat by-products 3 ppm
Milk 0.1 ppm
Mint hay 0.1 ppm
Oats, forage, green 0.1 ppm
Oats, grain 0.1 ppm
Oats, straw 0.1 ppm
Onions (dry bulb) 0.1 ppm
Poultry, fat 0.05 ppm
Poultry, meat 0.05 ppm
Poultry, meat by-products 0.05 ppm
Rye, forage, green 0.1 ppm
Rye, grain 0.1 ppm
Rye, straw 0.1 ppm
Sheep, fat 1 ppm
Sheep, meat 0.5 ppm
Sheep, meat by-products 3 ppm
Sorghum, fodder 0.1 ppm
Sorghum, forage 0.1 ppm
Sorghum, grain 0.1 ppm
Wheat, forage, green 0.1 ppm
Wheat, grain 0.1 ppm
Wheat, straw 0.1 ppm
------------------------------------------------------------------------
(2) Tolerances are established for residues of the herbicide
bromoxynil (3,5-dibromo-4-hydroxybenzonitrile) and its metabolite 3,5-
dibromo-4-hydroxybenzoic acid resulting from application of its
octanoic and/or heptanoic acid ester in or on the following
commodities:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Cotton gin byproducts 50 ppm 1/1/1998
Cotton, hulls 21 ppm 1/1/1998
Cotton, undelinted seed 7 ppm 1/1/1998
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-15964 Filed 6-17-97; 8:45 am]
BILLING CODE 6560-50-F
