[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]


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

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.

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

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 : opp-
[email protected]. 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: 
[email protected].

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:
    [email protected]
    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