[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Rules and Regulations]
[Pages 31846-31848]
[FR Doc No: 2011-13689]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0167]
RIN 1625-AA00

Safety Zone; 28th Annual Humboldt Bay Festival, Fireworks
Display, Eureka, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in
support of the 28th Annual Humboldt Bay Festival Fireworks Display on
the specified waters off the South end of Woodley Island in Eureka,
California. This safety zone is established to ensure the safety of
participants and spectators from the dangers associated with the
pyrotechnics. Unauthorized persons or vessels are prohibited from
entering into, transiting through, or remaining in the safety zone
without permission of the Captain of the Port or her designated
representative.

DATES: This rule is effective from 11:45 a.m. on July 3, 2011 until
10:45 p.m. on July 4, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0167 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0167 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call ENS Liz Ellerson at<PHONE_NUMBER>, or e-mail<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
because it would be impracticable to delay this rule because the event
would occur before the rulemaking process would be completed. Because
of the dangers posed by the pyrotechnics used in these fireworks
displays, the immediate action is necessary to provide for the safety
of event participants, spectators, spectator craft, and other vessels
transiting the event area. For the safety concerns noted, it is in the
public interest to have these regulations in effect during the event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Any delay in the effective date of
this rule would expose mariners to the dangers posed by the
pyrotechnics used in the fireworks display.

Basis and Purpose

    The City of Eureka will sponsor the 28th Annual Humboldt Bay
Festival Fireworks Display. The fireworks display is for entertainment
purposes. This safety zone establishes a temporary restricted area on
the waters 100 feet surrounding the fireworks loading, transit and
launch sites, and extends the safety zone to 1,000 feet of the launch
site during the fireworks display. This safety zone is necessary to
protect spectators, vessels, and other property from the hazards
associated with pyrotechnics on the fireworks barges. The Coast Guard
has granted the event sponsor a marine event permit for the fireworks
displays.

Discussion of Rule

    The City of Eureka will sponsor the 28th Annual Humboldt Bay
Festival Fireworks Display from 11:45 a.m. on July 3, 2011 until 10:45
p.m. on July 4, 2011, on the navigable waters of Humboldt Bay located
200 yards off the South end of Woodley Island in Eureka, California.
From 12 p.m. until 8 p.m. on July 3, 2011, pyrotechnics will be loaded
onto a barge at Schneider Pier. From 3 p.m. until 4 p.m. on July 4,
2011 the loaded barge will be transiting from Schneider Dock to the
launch site located at position 40[deg]48'35.30'' N, 124[deg]09'56.47''
W (NAD 83). The temporary safety zone will extend 100 feet from the
nearest point of the barge during the loading, transit, and arrival of
the pyrotechnics from Schneider Pier to position 40[deg]48'35.30'' N,
124[deg]09'56.47'' W (NAD 83). The fireworks display will occur from 10
p.m. on July 4, 2011 until 10:25 p.m., during which the safety zone
will extend 1,000 feet from the nearest point of the barge at position
40[deg]48'35.30'' N, 124[deg]09'56.47'' W (NAD 83). At 11 p.m. on July
4, 2011 the safety zone shall terminate.
    The effect of the temporary safety zones will be to restrict
navigation in the vicinity of the fireworks sites while the fireworks
are set up, and until the conclusion of the scheduled displays. Except
for persons or vessels authorized by the Coast Guard Patrol Commander,
no person or vessel may enter or remain in the restricted area. These
regulations are needed to keep spectators and vessels a safe distance
away from the fireworks barges to ensure the safety of

participants, spectators, and transiting vessels.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although this rule restricts access to the waters encompassed by
the safety zones, the effect of this rule will not be significant
because: (1) The entities most likely to be affected are pleasure craft
engaged in recreational activities; (2) the rule will only restrict
access for a limited time; and (3) the Public Broadcast Notice to
Mariners will notify the users of local waterway to ensure that the
safety zone will result in minimum impact.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: the owners and operators of pleasure craft
engaged in recreational activities and sightseeing intending to transit
the designated area of Humboldt Bay between 11:45 a.m. on July 3, 2011
and 10:45 p.m. July 4, 2011.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for several reasons: (i) This rule
will encompass only a small portion of the waterway for a limited
period of time; (ii) vessel traffic can pass safely around the area;
(iii) vessels engaged in recreational activities and sightseeing have
ample space outside of the affected areas of San Francisco, CA to
engage in these activities; and (iv) the maritime public will be
advised in advance of this safety zone via Broadcast Notice to
Mariners.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have Tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian Tribes, 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling

procedures; and related management systems practices) that are
developed or adopted by voluntary consensus standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 0023.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves establishing a safety
zone. An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add temporary Sec.  165.T11-409 to read as follows:

Sec.  165.T11-409  Safety Zone; 28th Annual Humboldt Bay Festival,
Fireworks Display, Eureka, CA

    (a) Location. (1) This temporary safety zone is established for the
waters located 200 yards off the South end of Woodley Island in Eureka,
CA. The fireworks launch site will be located in position:
40[deg]48'35.30'' N, 124[deg]09'56.47'' W (NAD 83).
    (2) During the loading of the fireworks, on July 3, 2011 at 12 p.m.
at Schneider Dock in Eureka, CA, and until the start of the fireworks
displays at 10 p.m. on July 4, 2011 the temporary safety zone shall
extend 100 feet from the loaded pyrotechnics barge at Schneider Dock,
during transit and arrival to position: 40[deg]48'35.30'' N,
124[deg]09'56.47'' W (NAD 83).
    (3) From 9:45 p.m. until 10:45 p.m. on July 4, 2011, the area to
which the temporary safety zones apply will increase in size to 1,000
feet at position 40[deg]48'35.30'' N, 124[deg]09'56.47'' W (NAD 83). At
10:45 p.m. on July 4, 2011, this safety zone shall terminate.
    (b) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel and a Federal, State, and local officer designated by or
assisting the Captain of the Port San Francisco (COTP) in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general regulations in Sec.  165.23,
entry into, transiting, or anchoring within this safety zone is
prohibited unless authorized by the COTP or the COTP's designated
representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or a designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or a designated representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP or the designated representative. Persons and vessels
may request permission to enter the safety zones on VHF-16 or through
the 24-hour Command Center at telephone<PHONE_NUMBER>.
    (d) Effective period. This section is effective from 11:45 a.m. on
July 3, 2011 until 10:45 p.m. on July 4, 2011.

    Dated: May 1, 2011.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2011-13689 Filed 6-1-11; 8:45 am]
BILLING CODE 4910-15-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [PV Shah, Branch Chief Inert Assessment Branch (IAB)<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "BASF Corporation," with the information specific to your action.

TEMPLATE:

BASF Corporation

[TBD]

	EPA has received a pesticide petition ([TBD]) from [Spring Trading Company, LLC on behalf of BASF Corporation, 100 Campus Drive, Florham Park, NJ 07932, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.910 and 930.

The addition of an exemption from the requirement of a tolerance for Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) as a solvent/co-solvent in or on the raw agricultural commodity [growing crops or in products to treat animals] at [under 40 CFR 180.910, and 930].  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d) (2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A.    Residue Chemistry

[The petitioner has provided EPA with sufficient toxicity data to support the issuance of this tolerance exemption for an inert ingredient.   The data submitted will allow EPA to determine the sensitivities of major identifiable subgroups of consumers, including infants and children.]

	       1. Analytical method. [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.]

	2. Magnitude of residues. [BASF Corporation is petitioning the agency to establish an exemption from the requirement of a tolerance for a class of chemistry that is well known and similar to an existing tolerance exemption.  Therefore information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required.]

B. Toxicological Profile

      1. Acute toxicity.  Oral: [Two groups, each of three female HanRcc: WIST (SPF) rats, were treated with Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) by oral gavage administration at a dos of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) to a concentration of 0.5 g/mL and administered at a dosing volume of 4 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.  Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The oral LD50 in the rat was greater than 2000 mg/kg body weight (Toxicity Category III).]

Dermal: Five male and five female HanRcc: WIST (SPF) rats were treated with Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) at 2000 mg/kg by dermal application.  The OECD testing guideline 402. The test item was diluted in vehicle (purified water) at a concentration of 0.5 g/mL and administered at a volume dosage of 4 mL/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.  Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs of systemic toxicity were observed during the course of the study. Local findings were noted at the application site of all animals except one female. These comprised slight erythema, slight scaling and slight to moderate scab formation. At the end of the two-week observation period, local findings were still present in one male and four female animals. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The dermal LD50 was >2000 mg/kg (Toxicity Category III).

Inhalation:  HanRCC:WIST (SPF) (5/sex) were exposed by nose only to Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) at a mean chemically determined concentration of 5.005 mg/L for a period of four hours.  The gravimetrically determined concentration was 5.226 mg/L.  The study was conducted according to OECD test guideline 403 and OPPTS test guideline 870.1300.  The rats were examined at 1, 2, 3 and 4 hours after the start of exposure, approximately 1 and 2.5 hours after exposure on day 1 and at least twice daily during the 14-day observation period. Clinical signs were recorded at approximately 1, 2, 3 and 4 hours after the start of exposure, at approximately 1 hour at the end of exposure and then daily to study termination.  Body weights were recorded on study days 1, 4, 8 and 15.  A complete necropsy was conducted at the end of exposure.  There were no deaths, clinical signs of toxicity or gross necropsy findings.  A body weight loss was noted in some of the rats.  Particle size was determined twice and was 2.52 and 2.32 um with a GSD of 1.93 and 2.15, respectively.  The acute inhalation LC50 was determined to be >5.005 mg/L (Toxicity Category IV).

Eye Irritation:  Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) was tested for eye irritation potential in the eyes of three young adult New Zealand white rabbits according to OECD test guideline 405.  One tenth of an mL of the test substance was to the left eye of one male and two females. The right eye served as the control.  The eyes of each animal were examined 1, 24, 48, and 72 after administering the test material. No corneal opacity or iritis was observed.  Redness (3 rabbit; score = 2) and chemises (2 rabbits; score = 2) of the conjunctiva was observed at 1 hour.  The eyes were clear at 72 hours. No clinical signs of systemic toxicity were observed during the study and no mortality occurred. This product is considered to be "mildly irritating" to the rabbit eye (Toxicity Category III).  The study authors concluded that the test material was "not irritating" to the rabbit eye.

Dermal Irritation:  Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) was tested for dermal irritation according to OECD test guideline 404.   The test material (0.5 mL0 was applied to a gauze patch and placed on the clipped intact skin of the left flank of one male and two female New Zealand white rabbits.  The patch was covered with a semi-occlusive dressing.  The dressing was wrapped around the abdomen and secured with tape.  Animals were observed for mortality and clinical signs daily during acclimation and throughout the test.  Body weights were recorded at the start of acclimation, on the day of application and study termination.  The test sites were scored for dermal irritation at 1, 24, 48 and 72 hours after removal of the dressing and gauze patch.  No mortality or clinical signs of toxicity occurred.  The only irritation observed occurred in one female rabbit at 1 hour after exposure.  This animal had erythema with a score of 1.  It had cleared by 24 hours.  The test material was considered to be "not irritating" to rabbit skin (Toxicity Category IV).

Dermal Sensitization:  Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) was tested for possible skin sensitization potential using the local lymph node assay in mice. Three groups of four females CBA/CaOlaHd mice were treated daily with the test item at concentrations of 25, 50, and 100% (w/v) for three consecutive days, and a separate control group of four female mice were treated with the vehicle only. The application volume, 25 ul, was spread over the entire dorsal surface ( ̴ 8mm) of each ear lobe once daily for three consecutive days.  Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine).  The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.  A positive response was considered to be a Stimulation Index of >3.  No mortality or clinical signs of toxicity was observed. The Stimulation Indices were 1.6, 1.8 and 2.4 at concentrations of 25, 50 and 100%, respectively. This product was found not to be a skin sensitizer under the conditions of this study.

	2. Genotoxicty. [Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) does not react with DNA or protein, and bacterial mutagenicity studies do not indicate a concern for mutagenicity. Based on the lack of genotoxicity and lack of specific organ toxicity in the repeated dose studies, carcinogenic effects are unknown. Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) shows no evidence of mutagenicity, (AMES).]

	3. Reproductive and developmental toxicity. Several developmental toxicity studies were located on Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) and its effects on the prenatal development in Wistar rats. Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) was tested for developmental toxicity in Wistar rats. The test substance was administered as an aqueous solution to groups of 25 time-mated female Wistar rats by gavage at doses of 100, 200, and 500 mg/kg body weight/day (mg/kg bw/d) on gestation days (GD) 6 through 19. A standard dose volume of 10 mL/kg body weight was used for each test group.

The NOAELs for maternal and developmental toxicity were as follows:    * Propanamide, 2-hydroxy-N, N-dimethyl- (9CI):      * 500 mg/kg/day (highest dose tested; HDT) for maternal and developmental toxicity in female rats    * 200 mg/kg/day (HDT) for maternal and developmental toxicity in female rats    * 100 mg/kg/day (HDT) for maternal and developmental toxicity in female rats

	4. Subchronic toxicity. [Wistar rats (10/sex/group) were administered Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) by gavage at dose levels of 0, 100, 200, 500 and 1000 mg/kg/day for 90 days. The study was conducted according to OECD test guideline 408.  The animals were observed for mortality twice daily and for clinical signs of toxicity daily and within 2 to 5 hours of dose administration.  Detailed clinical examinations were conducted weekly.  Body weights and food consumption were recorded weekly.  A functional observation battery was performed on all animals at the end of the exposure period. Motor activity was measured the same day as the FOB was conducted.  Ophthalmology was performed prior to dose administration and on study day 91 for males and study day 89 for females.  Vaginal smears were taken daily for three weeks to determine estrus cycling.  Blood was taken from fasted animals for hematology and clinical chemistry evaluations.  Urinalysis parameters were examined at study termination.  The following sperm parameters were evaluated:  sperm motility, sperm morphology and sperm head count (cauda epididymis and testis.  A complete necropsy was performed and a full set of organs were weighed and examined microscopically.

There were no deaths during the study.  Food consumption, FOB observations, motor activity, urinalysis parameters, ophthalmology, sperm parameters and estrous cyclicity were unaffected by treatment. Body weight gain was statistically decreased in males at 1000 mg/kg/day. Platelet counts and relative eosinophil counts were statistically decreased at the high dose in females.  Cholesterol levels were statistically increased in males and females at the high dose and in males at 500 mg/kg/day.  Creatinine levels were statistically decreased in both sexes at 500 and 1000 mg/kg/day.  Triglyceride levels were statistically increased in males at 500 and 1000 mg/kg/day.  Absolute and relative liver weights were statistically increased in males at 500 and 1000 mg/kg/day and relative liver weights in females at 1000 mg/kg/day which were accompanied with an increase in centrilobular hypertrophy.  Relative liver weights were also, but statistically increased at 200 mg/kg/day. Absolute kidney weights were statistically increased in females at 200, 500 and 1000 mg/kg/day and relative kidney weights at 1000 mg/kg/day.  Relative kidney weights were statistically increased in males at 500 and 1000 mg/kg/day.  Grade 3 eosinophilic droplets were observed in the kidneys of the males at 500 and 1000 mg/kg/day.  The kidney effects in males were considered to be related to alpha-2u-globulin and were therefore considered treatment related but not adverse.  The effect on kidney weight in females was not considered adverse because it was not accompanied with any histopathological findings.  The liver effects observed at 100 and 200 mg/kg/day were considered to be adaptive. The NOAEL was therefore considered to be 200 mg/kg/day and the LOAEL 500 mg/kg/day.

	5. Endocrine disruption. [There is no available evidence that Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) is an endocrine disruptor.  The literature was searched for any information on the endocrine disruption of the solvent/ co-solvent. No information was located indicating any potential for endocrine disruption nor was any evidence observed in the studies supporting this petition.]

C. Aggregate Exposure

	1. Dietary exposure. [In examining aggregate exposure, section 408 of the FFDCA 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).

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) as a food ingredient that is consumed and result in intermediate-term residential exposure and BASF has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to this solvent/ co-solvent.

D. Cumulative Effects

	[Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity.  BASF Corporation has not found that Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) share a common mechanism of toxicity with any other substances, and Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, BASF Corporation has assumed that Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) does not have a common mechanism of toxicity with other substances.]

E. Safety Determination

	1. U.S. population. [Based on these risk assessments, BASF concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of Propanamide, 2-hydroxy-N, N-dimethyl- (9CI).]

	2. Infants and children. [Based on these risk assessments, BASF concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of the lower weight of Propanamide, 2-hydroxy-N, N-dimethyl- (9CI).]

F. International Tolerances

	[BASF Corporation is not aware of any country requiring a tolerance for the Propanamide, 2-hydroxy-N, N-dimethyl- (9CI) nor have any CODEX Maximum Residue Levels been established for any food crops at this time.