Document ID: EPA-HQ-OPP-2005-0280-0002
Agency: epa
Document Type: Rule
Title: 2-Bromo-2-Nitro-1,3-Propanediol (Bronopol); Exemptions from the Requirement of a Tolerance
Posted Date: 2005-11-09T05:00Z

[Federal Register: November 9, 2005 (Volume 70, Number 216)]
[Rules and Regulations]               
[Page 67906-67910]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no05-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0280; FRL-7743-5]

 
2-Bromo-2-Nitro-1,3-Propanediol (Bronopol); Exemptions from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of 2-bromo-2-nitro-1,3-propanediol, which is 
also known as bronopol (Chemical Abstracts Service (CAS) Registry 
Number (Reg. No.) 52-51-7; 1,3-propanediol, 2-bromo-2-nitro- (9CI)), 
when used as an inert ingredient in-can preservative at 0.04% or less 
by weight of the total pesticide formulation when applied to growing 
crops or to raw agricultural commodities after harvest under 40 CFR 
180.910, and when applied to animals under 40 CFR 180.930. BASF 
Corporation submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA), requesting the exemptions from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of 2-bromo-2-nitro-1,3-propanediol.

DATES: This regulation is effective November 9, 2005. Objections and 
requests for hearings must be received on or before January 9, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0280. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 

listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; e-mail address: angulo.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180 

is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of December 24, 2002 (67 FR 78459) (FRL-
7277-5), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 2E6475) by BASF Corporation, 3000 Continental 
Drive - North, Mount Olive, NJ 07828-1234. The petition requested that 
exemptions from the requirement of a tolerance be established for 
residues of 2-bromo-2-nitro-1,3-propanediol under 40 CFR 180.910 
(growing crops or to raw agricultural commodities after harvest) and 
under 40 CFR 180.930 (animals) when it is used as an inert ingredient 
in-can preservative at 0.04% or less by weight of the total pesticide 
formulation. This notice included a summary of the petition prepared by 
the petitioner BASF.
    For ease of reading in this document, 2-bromo-2-nitro-1,3-
propanediol will be referred to as bronopol. The CAS Reg. No. of 
bronopol is 52-51-7 and the CAS name is 1,3-propanediol, 2-bromo-2-
nitro- (9CI).
    Comments were received from the United States Food and Drug 
Administration (FDA) in response to the notice of filing. FDA's 
comments pertained to the possible formation of n-

[[Page 67907]]

nitrosoamines, which are potentially carcinogenic compounds, when 
pesticide formulations containing bronopol also contain a nitrosatable 
amine. Rebuttals to FDA's comments were submitted from two companies. 
EPA acknowledges the concerns of FDA. The Agency evaluated the 
carcinogenic potential of bronopol and found there to be evidence of 
non-carcinogenicity for humans based on a lack of cancer effects in 
acceptable studies with two animal species, the rat and mouse. It 
should be noted that n-nitrosamines are also possibly formed by the 
action of bronopol with naturally occurring nitrosatable amines that 
are present in the diet of humans or are present as bodily 
constituents. In addition, Agency policy requires that pesticidal 
formulations be analyzed for nitrosamine content, and limits the 
allowable amount to 1 part per million (ppm). Pesticide formulations 
containing bronopol will be subject to this requirement.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for 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(c)(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 
drinking water and in residential settings, but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which requires EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
bronopol are discussed in this unit.
    A Reregistration Eligibility Decision (RED) was completed in 1995 
for bronopol. The RED is available on the Agency's website at 
http://www.epa.gov/pesticides/reregistration/status.htm. The Agency is not 

aware of any more recent information that changes the risk findings of 
the RED, therefore, the toxicity findings of the RED are being used 
here for the evaluation of the petition. The following briefly 
summarizes the toxicity findings of the RED.
    Bronopol is moderately toxic in acute oral toxicity studies with 
rats, with a lethal dose (LD)50 of 307 milligrams/kilogram 
(mg/kg) for males and 342 mg/kg for females (Toxicity Category II) 
(Toxicity Category I has the highest toxicity and Category IV the 
lowest). In an acute inhalation study on the rat, bronopol was found to 
be slightly toxic with an lethal concentration (LC)50 of > 5 
mg/liter (L) (Toxicity Category III).
    Results from an acute dermal toxicity study (rat) suggest that 
bronopol is highly toxic by the dermal route (Toxicity Category I), 
with an LC50 of 64 to 160 mg/kg. Slight to moderate erythema 
and slight to severe edema was noted, and the results of this study 
determined that bronopol was a slight to severe irritant (Toxicity 
Category II). In a study to determine dermal sensitization potential 
(ai >98.8%, guinea pigs), bronopol was determined not to be a skin 
sensitizer. In addition, bronopol has been shown to be a corrosive eye 
irritation (Toxicity Category I).
    A 90-day oral toxicity study using rats indicated that bronopol is 
a severe gastrointestinal irritant. The no observed adverse effect 
level (NOAEL) and the lowest observed adverse effect level (LOAEL) for 
systemic toxicity, for both sexes, are 20 mg/kg/day and 80 mg/kg/day, 
respectively. A similar study in beagle dogs indicated only treatment-
related effects of increased liver and spleen weights in the high dose 
group. In a 90-day dermal toxicity study in rabbits, a NOAEL of 2 mg/
kg/day and a LOAEL of 5 mg/kg/day were determined based on dermal 
irritation.
    A chronic feeding/carcinogenicity study with rats resulted in high 
mortality, stomach lesions, and severe reduction in body weight gain. 
The unpalatability of bronopol reduced the water intake and urine 
output in a dose-related manner in all treated groups, which may have 
affected the results of the study. Based on the above findings, the 
systemic NOAEL and LOAEL for both sexes are 10 mg/kg/day and 40 mg/kg/
day, respectively. In a chronic dermal/carcinogenicity study, male mice 
exhibited moderate reduction in body weight gain in the high dose 
group. Bronopol was not determined to be carcinogenic in either study. 
The EPA Office of Pesticide Program's Reference Dose (RfD)/Peer Review 
Committee evaluated the carcinogenic potential of bronopol and found 
there to be evidence of non-carcinogenicity for humans based on a lack 
of evidence of cancer effects in acceptable studies. In addition, 
bronopol was not mutagenic in four mutagenicity studies.
    Developmental toxicity studies were conducted using rats and 
rabbits. The results showed marginal to no effects in the rat study and 
effects only at the high dose level in the rabbit study. In the study 
on rats, no developmental effects could be attributed to the 
administration of bronopol, and the highest dose of >80 mg/kg/day is 
considered to be the NOAEL for both maternal and developmental 
toxicity. In the study on rabbits, the maternal and developmental NOAEL 
and LOAEL are 40 mg/kg/day and 80 mg/kg/day (the highest dose group), 
respectively. The effects observed only in the 80 mg/kg/day group 
include decreased fetal body weight in both sexes (10%), and an 
increase in fetuses with major external/visceral and skeletal 
abnormalities (6.9% - 29.5%).
    A reproductive toxicity study using rats reported effects at the 
mid- to high-dose levels, including increases in kidney, thyroid, and 
adrenal weights, decreases in liver and body weights. The NOAEL and 
LOAEL for systemic toxicity are 25 mg/kg/day and 70 mg/kg/day, 
respectively. Reproductive toxicity was observed only in the high-dose 
group as evidenced by a slight decrease in the female fertility index 
during the F1 mating. The NOAEL and LOAEL for reproductive 
toxicity are 70 mg/kg/day and 200 mg/kg/day, respectively.
    For metabolism, the results from four studies show that bronopol 
administered orally was rapidly absorbed and rapidly excreted by the 
rats of both sexes, with urine being the major route of excretion.

[[Page 67908]]

    For ecological risks, bronopol is practically nontoxic to slightly 
toxic to birds; slightly to moderately toxic to freshwater fish and 
terrestrial invertebrates; moderately to highly toxic to estuarine/
marine invertebrates; and slightly toxic to estuarine/marine fish. 
Based on bronopol's low octanol/water ratio and high solubility in 
water, it is not expected to bioaccumulate. Accumulation reportedly 
does not occur in tested mammals and metabolism is also reported to be 
rapid and complete.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    1. Food. A dietary exposure analysis for the inert ingredient use 
of bronopol was conducted using the generic screening model for 
estimating inert ingredient dietary exposure. The dietary assessment is 
unrefined and extremely conservative in nature because the screening 
model assumes that the inert ingredient is used on all commodities, and 
that 100 percent of crops are treated with the inert ingredient. 
Further, the screening model assumes residues will be present for every 
consumed commodity (including meat, milk, poultry and eggs) that is 
included in the Dietary Exposure Evaluation Model (DEEM\TM\). The 
screening model does not specifically include an application rate 
input, rather it is based on tolerances for pesticide active 
ingredients that are typically found in agricultural food use products 
at concentrations greater than 50%. Therefore, to more accurately 
estimate residues resulting from bronopol's lower application rate 
limitation of 0.04% (the tolerance exemption limitation proposed by the 
petitioner), the results from the screening model were adjusted by a 
factor of 1250 (50% / 0.04%).
    The results for acute and chronic dietary exposure for all 
population subgroups are considered to be not of concern. The highest 
dietary exposure estimate was for children (1-2 years), where the acute 
dietary risk was estimated to be 0.0007512 mg/kg/day and 0.19% of the 
acute Population Adjusted Dose (aPAD), and where the chronic dietary 
risk was estimated to be 0.0003376 mg/kg/day and 0.34% of the chronic 
Population Adjusted Dose (cPAD). These are well-below any dose level at 
which an adverse effect is expected from exposure to bronopol when it 
is used as an inert ingredient in-can preservative at 0.04% or less by 
weight of the total pesticide formulation.
    2. Drinking water exposure. Bronopol is expected to have a 
relatively short half-life upon release into the environment. Bronopol 
is not anticipated to be present in drinking waterwhen used as an inert 
ingredient in-can preservative at 0.04% or less by weight of the total 
pesticide formulation.

B. Other Non-Occupational Exposure

    Pesticide products containing bronopol as an in-can preservative 
may be used in residential settings. Considering the small amount of 
bronopol that will be used in pesticide formulations (no more than 
0.04% by weight), inhalation and dermal exposures of concern are not 
anticipated from residential uses.

V. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.'' Unlike other 
pesticide chemicals for which EPA has followed a cumulative risk 
approach based on a common mechanism of toxicity, EPA has not made a 
common mechanism of toxicity finding as to bronopol. For the purposes 
of this tolerance action, therefore, EPA has not assumed that bronopol 
has a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

VI. Determination of Safety for U.S. Population, Infants and Children

    Based on the information in this preamble and on the modeled 
exposure levels that are well-below any dose level where adverse 
effects are expected, EPA concludes that there is a reasonable 
certainty of no harm to any population subgroup from aggregate exposure 
to residues of bronopol. Accordingly, EPA finds that exempting bronopol 
from the requirement of a tolerance will be safe for the general 
population including infants and children.

VII. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect . . . .'' EPA has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
bronopol for endocrine effects may be required.

B. Analytical Method(s)

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Tolerances

    There are no existing tolerances or tolerance exemptions for 
bronopol.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
bronopol, nor have any CODEX maximum residue levels been established 
for any food crops at this time.

VIII. Conclusions

    There is sufficient information on bronopol to conduct this 
assessment. Bronopol has been shown to have significant dermal acute 
toxicity, and eye and gastrointestinal irritation, but it is not a skin 
sensitizer. Study results indicate that bronopol has moderate acute and 
chronic oral toxicity, and slight acute inhalation toxicity. It is not 
considered to be carcinogenic. For developmental effects, marginal to 
no effects were reported in the rat study and effects were observed 
only at the high dose level in the rabbit study. Reproductive toxicity 
was observed only in the high-dose group as evidenced by a slight 
decrease in the female fertility index during the F1 mating.
    Although, bronopol does have toxicity, the small amount that will 
be permitted for use in pesticide

[[Page 67909]]

formulations (0.04% or less by weight) is expected to result in no 
effects of concern for all endpoints, including residential exposures. 
The results from a conservative dietary screening model show that acute 
and chronic dietary exposure for all population subgroups are 
considered to be not of concern. The highest dietary exposure estimates 
from the conservative screening model are well-below any dose level at 
which an adverse effect is expected. Bronopol is expected to have a 
relatively short half-life upon release into the environment, 
therefore, its contribution to drinking water is not expected.
    Considering the information above, there is a reasonable certainty 
that no harm to any population subgroup will result from aggregate 
exposure to the pesticide chemical (bronopol) residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. Exemptions from the requirement of a tolerance 
are established for 2-bromo-2-nitro-1,3-propanediol; (CAS Reg. No. 52-
51-7;) when used as an inert ingredient in-can preservative at 0.04% or 
less by weight of the total pesticide formulation when applied to 
growing crops or to raw agricultural commodities after harvest under 40 
CFR 180.910, and when applied to animals under 40 CFR 180.930.

IX. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0280 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before January 
9, 2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2005-0280, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in ADDRESSES. You may also send an electronic copy of your 
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

X. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are

[[Page 67910]]

established on the basis of a petition under FFDCA section 408(d), such 
as the exemptions in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4). 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: October 28, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910 the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

------------------------------------------------------------------------
        Inert Ingredient                Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
2-Bromo-2-nitro-1,3-propanediol   0.04% or less by    In-can
 (CAS Reg. No. 52-51-7)            weight of the       preservative
                                   total pesticide
                                   formulation
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
0
3. In Sec.  180.930 the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

------------------------------------------------------------------------
        Inert Ingredient                Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
2-Bromo-2-nitro-1,3-propanediol   0.04% or less by    In-can
 (CAS Reg. No. 52-51-7)            weight of the       preservative
                                   total pesticide
                                   formulation
                              * * * * * * *
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[FR Doc. 05-22255 Filed 11-8-05; 8:45 am]

BILLING CODE 6560-50-S