[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Proposed Rules]
[Pages 53669-53670]
[FR Doc No: 2014-21582]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0014; Airspace Docket No. 13-ASO-27]

Proposed Establishment of Class D Airspace and Amendment of Class
E Airspace; Dallas, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class D airspace and amend
Class E airspace at Dallas, GA, to accommodate the proposed temporary
air traffic control tower at Paulding Northwest Atlanta Airport.
Controlled airspace is necessary for the safety and management of
instrument flight rules (IFR) operations at the airport. This action
also would recognize the airport's name change.

DATES: 0901 UTC. Comments must be received on or before October 27,
2014. The Director of the Federal Register approves this incorporation
by reference action under title 1, Code of Federal Regulations, part
51, subject to the annual revision of FAA, Order 7400.9 and publication
of conforming amendments.

ADDRESSES: Send comments on this rulemaking to: U. S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2014-0014; Airspace Docket No. 13-ASO-27, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: John Fornito, Airspace Specialist,
Operations Support Group, Eastern Service Center, Air Traffic
Organization, Federal Aviation Administration, P.O. Box 20636, Atlanta,
Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rulemaking by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal. Communications should identify
both docket numbers (FAA docket number. FAA-2014-0014; Airspace Docket
No. 13-ASO-27) and be submitted in triplicate to the Docket Management
System (see ADDRESSES section for address and phone number). You may
also submit comments through the Internet at http://www.regulations.gov. Those wishing the FAA to acknowledge receipt of
their comments on this rulemaking must submit with those comments a
self-addressed, stamped postcard on which the following statement is
made: ``Comments to Docket No. The postcard will be date/time stamped
and returned to the commenter. All communications received before the
specified closing date for comments will be considered before taking
action on the proposed rule. The proposal contained in this document
may be changed in light of the comments received. A report summarizing
each substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airtraffic/publications/
airspaceamendments/. Additionally, any person may obtain a
copy of this document by submitting a request to the Federal Aviation
Administration (FAA), Office of Air Traffic Airspace Management, ATA-
400, 800 Independence Avenue SW., Washington, DC 20591, or by calling
(202) 267-8783. Communications must identify both docket numbers for
this document. Persons interested in being placed on a mailing list for
future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-
9677, to request a copy of Advisory Circular No. 11-2A, Notice of
Proposed Rulemaking Distribution System, which describes the
application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class D airspace within a
4.2-mile radius of Paulding Northwest Atlanta Airport, Dallas, GA,
formerly Paulding County Regional Airport; and amend existing Class E
airspace extending upward from 700 feet above the surface to within a
6.7-mile radius of the airport. Controlled airspace is necessary to
support the operation of the proposed temporary air traffic control
tower, and would enhance the safety and management of IFR operations.
    Class D and E airspace designations are published in Paragraphs
5000 and

6005 respectively, of FAA Order 7400.9X, dated August 7, 2013, and
effective September 15, 2013, which is incorporated by reference in 14
CFR 71.1. The Class D and E airspace designations listed in this
document will be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would establish Class D and amend existing
Class E airspace at Paulding Northwest Atlanta Airport, Dallas, GA.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action. It is
anticipated that this environmental analysis will be incorporated into
the environmental document described in more detail at 79 FR 22177 (May
21, 2014).

Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 will continue to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, and effective September 15, 2013, is
amended as follows:

Paragraph 5000 Class D Airspace

* * * * *

ASO GA D Dallas, GA [New]

Paulding Northwest Atlanta Airport, GA
    (Lat. 33[deg]54[min]43[sec] N., long. 84[deg]56[min]26[sec] W.)

    That airspace extending upward from the surface up to and
including 2,500 feet MSL within a 4.2-mile radius of Paulding
Northwest Atlanta Airport. This Class D airspace area is effective
during specific dates and times established in advance by a Notice
to Airmen. The effective date and time will thereafter be
continuously published in the Airport/Facility Directory.

Paragraph 6005. Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO GA E5 Dallas, GA [Amended]

Paulding Northwest Atlanta Airport, GA
    (Lat. 33[deg]54[min]43[sec] N., long. 84[deg]56[min]26[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of. Paulding Northwest Atlanta Airport.

    Issued in College Park, Georgia, on September 2, 2014.
Myron A. Jenkins,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2014-21582 Filed 9-9-14; 8:45 am]
BILLING CODE 4910-13-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Cynthia Giles-Parker – Branch Chief,

Fungicide Branch

July 30, 2009

[9E7606]

EPA has received a pesticide petition ([9E7606]) from [Syngenta

Crop Protection, Inc], [410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-

8300] 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.

(Options (pick one)

1. by establishing a tolerance for residues of

“NA Remove”

[isopyrazam (SYN520453)] in or on the raw agricultural commodity [banana] at

[0.05] parts per million (ppm). 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

1. Plant metabolism. [SYN520453 has been studied on wheat, grapes, and

lettuce. The metabolic routes of SYN520453 in all three crops were the same and

the parent molecule was the primary constituent of the total radioactive residue

(TRR) in all three matrices. The most significant metabolite identified in plant was

the primary alcohol, the metabolites CSCD459488 and CSCD459489 (syn and anti

2

forms respectively).

Based on the results of the metabolism studies conducted, it was concluded that the

definition of the residue for tolerance enforcement purposes should be parent

isopyrazam only (SYN534968 plus SYN534969); however the residue-of-concern for

risk assessment purposes includes parent isopyrazam (SYN534968 plus SYN534969)

plus the metabolite CSCD459488.]

2. Analytical method. [An adequate, validated method (GRM006.01B) is

available for enforcement purposes for the determination of residues of isopyrazam,

analyzed as the isomers SYN534968 and SYN534969, in crop samples. The limit of

quantification has been set at 0.005 mg/kg for each isomer (0.01mg/kg for

SYN520453 in total). Samples are extracted by homogenization with

acetonitrile:water (80:20 v/v for most crops and 50:50 v/v for straw). Extracts are

centrifuged and aliquots (equivalent to 0.2 g) are diluted with methanol:water

(50:50 v/v). Final determination is by LC-MS/MS. An analytical method suitable

for the determination of residues of the metabolites CSCD459488 and CSCD459489

(syn and anti forms respectively) in crop samples using an external standardization

procedure is also available (GRM006.03A). The limit of quantification (LOQ) has

been set at 0.005 mg/kg for both analytes. Samples are extracted by homogenization

with acetonitrile:water (80:20 v/v). Extracts are centrifuged and aliquots (equivalent

to 0.09 g) are hydrolyzed with 0.1 M HCl at 60°C for 3 hours. Aliquots are then

diluted with acetonitrile and ultra pure water. Final determination is by LCMS/

MS. ]

3. Magnitude of residues. [Twelve residue trials were conducted in Latin

America to determine the magnitude of the residue of SYN520453 in or on bananas.

The targeted treatment regime consisted of five applications at a rate of 75 grams

a.i./hectare with a 10-day retreatment interval. Bananas were harvested after the

last application was made (0-day PHI).

Banana peel, pulp and whole fruits were analyzed for residues of parent SYN520453

[analyzed as SYN534968 (anti) and SYN534969 (syn)], and for residues of its

metabolite [analyzed as CSCD459489 (anti) and CSCD459488 (syn)]. The limit of

quantitation for each analyte was 0.005 ppm. Mean procedural recoveries of all

analytes on all matrices were between the acceptable range of 70-110%.

The maximum residue levels of SYN520453 (summed SYN534968 and SYN534969)

were 0.084, 0.046 and 0.048 ppm in banana bagged peel, unbagged fruit and

unbagged peel, respectively. The highest residue levels of CSCD459488 were 0.010,

0.014 and 0.016 ppm in banana bagged peel, unbagged fruit and unbagged peel,

respectively.]

B. Toxicological Profile

1. Acute toxicity. [SYN520453 is of low acute oral toxicity. Three (of the five)

acute oral studies conducted focused on the isomeric proportions of SYN520453.

3

The LD50 for isomeric mixtures containing more than 50% of the syn isomer of

isopyrazam was >2000 mg/kg.]

2. Genotoxicty. [In vitro, both specifications of SYN520453 (Tox Reserve and

70:30) were negative for bacterial reverse mutation, in vitro cytogenetics, and

mammalian cells gene mutation (L5178Y TK+/- mouse lymphoma). The L5178 TK+/-

assay, which is also able to detect chromosomal damage, was negative for

clastogenicity. In the in vitro cytogenetic assay using primary human lymphocyte

cultures, neither specification of SYN520453 induced chromosomal aberrations. In

vivo, SYN520453 (Tox Reserve specification) was found to be non-clastogenic in the

rat bone marrow micronucleus assay and there was also no evidence for any

indication of DNA damage or repair in the rat liver UDS (unscheduled DNA

synthesis) assay.]

3. Reproductive and developmental toxicity. [SYN520453 was assessed for

reproductive toxicity in a multi-generation reproduction study in the rat at dietary

inclusion levels of 0, 100, 500 or 3000 ppm SYN520453. The parental toxicity

NOAEL was 100 ppm based on decreased body weight and food consumption in

females at 500 ppm, and increased liver weight and hepatocyte hypertrophy in F0

and F1 animals at 500 ppm. The offspring NOAEL was 100 ppm based on

increased liver weights in F1 and F2 pups at 500 ppm. No treatment related

reproductive parameters were affected due to treatment with SYN520453; thus the

reproductive NOAEL was the top dose 3000 ppm, and a LOAEL was not

established. There is no indication of increased sensitivity of offspring to

SYN520453 in a multi-generation reproduction study in rats.

Two developmental toxicity studies were conducted in the rat: one with Tox Reserve

material and the other with 70:30 material. In the study with Tox Reserve, rats

were given oral doses of SYN520453 at 0, 20, 75 or 250 mg/kg/day on gestation days

5 to 21. The maternal NOAEL was 75 mg/kg/day based on mortality, decreased

body weight gain and food consumption and clinical signs of toxicity at 250

mg/kg/day. The fetal NOAEL was 75 mg/kg/day based on increased postimplantation

loss, a reduced number of live fetuses, decreased fetal weight and

reduced ossification at 250 mg/kg/day. The fetal effects were considered to be

secondary to maternal toxicity.

In the rat developmental toxicity study with 70:30 material, rats were given oral

doses of SYN520453 at 0, 20, 75 or 200 mg/kg/day. The fetal and maternal NOAEL

was 20 mg/kg/day based on decreased fetal body weight and delayed ossification;

and decreases in maternal body weight gain at 75 and 200 mg/kg/day. The fetal

effects were considered to be secondary to maternal toxicity.

In rabbits, two preliminary developmental toxicity studies were conducted in the

Himalayan rabbit and a preliminary and regulatory study were conducted in the

New Zealand White (NZW) rabbit. All studies were conducted using the Tox

Reserve material.

4

In the first preliminary study, Himalayan rabbits were given oral doses of 0, 100,

200 or 400 mg/kg/day. Mean maternal food consumption was decreased throughout

treatment at 400 mg/kg/day. The only fetal effect possibly related to treatment was

the observation of 2 fetuses at 400 mg/kg/day with the variation of “eyes small,

slight.”

In the second preliminary study, Himalayan rabbits were given oral doses of 0, 600,

800 or 1000 mg/kg/day. Maternal food consumption was slightly decreased at 1000

mg/kg/day. There was a small effect on male fetal body weights and a higher

incidence of flexed or malrotated limbs at 1000 mg/kg/day. The main treatment

related fetal finding was the observation, eyes of smaller than expected size, which

occurred either as an abnormality or variation. The combined incidence of small

eyes (abnormality and variation) was increased in all dose groups, but not in a doserelated

manner. It was concluded that administration of SYN520453 at 600-1000

mg/kg/day was associated with effects in the eye consistent with microphthalmia.

A preliminary rabbit developmental toxicity study was conducted in NZW rabbits

at doses of 0, 400, 700 or 1000 mg/kg/day. Maternal toxicity was noted at all dose

levels tested, evident as decreased food consumption and decreased maternal weight

gain throughout the treatment period. The effects were sufficient to produce

moribundity and/or abortion in animals from each dose group. Maternal liver

weight was increased at all doses and hypertrophy and vacuolation were observed

histopathologically. At 1000 mg/kg/day, there was an increase in the incidence of

microphthalmia which was associated with the variations hemorrhagic ring around

the iris and/or reddened or red areas around the eyes.

In the regulatory developmental toxicity study, NZW rabbits were dosed at 0, 30,

150 or 500 mg/kg/day. The maternal NOAEL was 30 mg/kg/day based on clinical

signs of toxicity (days 13-19), decreased food consumption, increased liver weights,

and hepatocellular hypertrophy and vacuolation at 150 and 500 mg/kg/day. The

fetal NOAEL was 150 mg/kg/day based only on the single incidence of

microphthalmia observed at 500 mg/kg/day. The single incidence of

microphthalmia at 500 mg/kg/day was within the historical control range for the

laboratory. However, based on the data from the NZW range-finding study, which

was conducted in the same laboratory, an association between treatment and the

single incidence of microphthalmia at 500 mg/kg/day cannot be excluded.]

4. Subchronic toxicity. [Subchronic testing was conducted in the mouse, rat,

and dog via the oral route of exposure, including evaluation of the effect of isomer

content of SYN520453. Three 28-day studies conducted in rats showed similar

findings and confirmed that the liver was the systemic target organ for SYN520453.

Liver effects were evident at doses of 500 ppm and above, with no liver effects

observed at 300 ppm (approximately 28.1 mg/kg/day). The only other evidence of

systemic toxicity was the observed decrease in body weight gain compared to

controls, which tended to occur at dose levels of 2000 ppm and above, and which

were observed in conjunction with decreased food utilization. The study conducted

with pure syn and anti-isomers demonstrated equivalent toxicological properties

5

from both a qualitative and quantitative perspective.

Two 90-day dietary studies in rats demonstrated similar toxicological findings to the

28-day studies. The NOAELs from the two 90-day studies were similar: a NOAEL

of 300 ppm (21.3 mg/kg/day) in the Tox Reserve study, and a NOAEL of 250 ppm

for both Tox Reserve and 70:30 specification materials in the comparative study,

based on decreased body weight/weight gain, clinical chemistry changes, increased

liver weight, and hepatocellular hypertrophy and vacuolation at 1500 and 2000 ppm

respectively.

The 90-day dietary study in mice was conducted with Tox Reserve material at 0,

500, 2500 or 7000 ppm. The systemic toxicity findings in this study were decreased

body weight/weight gain observed at 2500 and 7000 ppm. Increased liver weight

was seen at all dose levels and hepatocyte hypertrophy was seen in both sexes at

2500 and 7000 ppm. Minimal hypertrophy was seen in males at 500 ppm.

Two 90-day oral toxicity studies were conducted in dogs; one was conducted using

Tox Reserve and the other with 70:30 material. In the first 90-day study with Tox

Reserve material, dogs were dosed orally at 0, 30, 100 or 300 mg/kg/day. In the

second 90-day study with 70:30 material, dogs were dosed orally at 0, 10, 30 or 250

mg/kg/day. The findings were similar. An overall NOAEL of 30 mg/kg/day was

based on initial body weight loss and/or decreased weight gain and decreased food

consumption, and increased liver weights (males only) at 100 and 250 mg/kg/day.

One male dog at the mid-dose of 100 mg/kg/day also displayed abnormal clinical

signs/behavior, some of which were evident throughout the study.]

5. Chronic toxicity. [SYN520453 was evaluated for chronic toxicity in the dog

and rat, and for carcinogenic potential in the rat and the mouse.

In the 1 year dog study with Tox Reserve, dogs were dosed orally by capsule at 0, 25,

100 or 250 mg/kg/day. The NOAEL was 25 mg/kg/day based on decreased body

weight gain and minor changes in clinical chemistry, and increased liver weight

(males only) at 100 and 250 mg/kg/day. No clinical signs of toxicity were observed in

the 1 year dog study up to a dose level of 250 mg/kg/day.

In a 2 year rat combined chronic toxicity/carcinogenicity study conducted at dietary

inclusion levels of 0, 100, 500 or 3000 ppm, there were no treatment related effects

on survival. The NOAEL for the chronic toxicity phase of the study was 100 ppm

and the NOAEL for neoplastic findings was 500 ppm (27.6 and 34.9 mg/kg/day in

males and females respectively) based on increased incidence of hepatocellular

adenoma and uterine carcinoma observed as a consequence of excessive dosing in

females at 3000 ppm. The overall NOAEL was 100 ppm (5.5 and 6.9 mg/kg/day in

males and females respectively) based on decreased body weight/weight gain in

females at 500 ppm, and minor changes in clinical chemistry and non-neoplastic

findings in the liver at 500.

In a carcinogenicity study in the mouse, mice were fed diets containing 0, 70, 500 or

6

3500 ppm SYN520453 for a period of up to 80 weeks. There were no treatment

related effects on survival. Apart from an increased incidence of „discharge from

‟ in males at 3500 ppm, there were no effects on the clinical condition of the

animals. There were no treatment-related neoplastic micropathology findings. The

NOAEL for this study was 70 ppm (7.8 mg/kg/day in males and 9.9 mg/kg/day in

females) based on reduced food utilization in females at 500 ppm, and

hepatocellular hypertrophy and increased liver weight at 500 ppm.]

6. Animal metabolism. [SYN520453 was extensively metabolized by rats via

oxidation to give a range of hydroxy, dihydroxy, acid and hydroxy acid metabolites.

Oxidation of the N-desmethyl metabolite of SYN520453 produced an equivalent

range of N-desmethyl metabolites. Incubation of SYN534969 (pure syn) with rat

liver microsomes resulted in oxidative biotransformation to the tertiary alcohol

CSCD459488; quantities decreased with increased incubation time, demonstrating

that the metabolite CSCD459488 is a short-liver metabolite. The major routes of

biotransformation appeared to be independent of dose level and sex and also

appeared to be the same for both syn and anti isomers of the parent molecule. All

metabolites accounting for >5% of the dose and the majority of minor metabolites

were identified. Therefore in total, greater than 90% of the administered dose was

accounted for by identified metabolites.]

7. Metabolite toxicology. [Acute oral toxicity testing was performed with two

metabolites, resulting in LD50 >2000 mg/kg for both CSCD465008 and

CSCD459488. Genotoxicity testing (bacterial reverse mutation, in vitro cytogenetics,

and mammalian cell gene mutation (mouse lymphoma) with metabolites

CSCD465008 and CSCD459488 indicated no genotoxicity. Subchronic toxicity

studies (28 day dietary in the rat) were conducted with metabolites CSCD465008

and CSCD459488. CSCD465008 is toxicologically benign and is of lower toxicity

than parent SYN520453. The metabolite CSCD459488 is considered to have

equivalent toxicity to parent SYN520453, with both compounds having a NOAEL of

300 ppm (equivalent to approximately 27-28 mg/kg/day), and both compounds

having a primary effect upon xenobiotic metabolizing enzymes in the liver with

accompanying liver enlargement and centrilobular hypertrophy.]

8. Endocrine disruption.

The endocrine system includes the reproductive hormones estrogen and androgens

as well as the thyroid hormone system. There is no evidence of any consistent

treatment related effects with SYN520453 that could be considered as perturbation

of endocrine homeostasis. There were no adverse affects related to female

reproductive function or on reproduction in the multi-generation reproductive

toxicity study, and there were no micropathology changes in the organs that had

altered weight effects. Overall, the database does not suggest that SYN520453 is an

endocrine disruptor.

C. Aggregate Exposure

1. Dietary exposure. [Tier I acute and chronic dietary exposure assessments

7

were performed for isopyrazam (a mixture of 3-(difluoromethyl)-1-methyl-N-

[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-

yl]pyrazole-4-carboxamide (syn-isomer, also called SYN534968) and 3-

(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropy l-1,4-

methanonaphthalen-5-yl]pyrazole-4-carboxamide (anti-isomer, also called

SYN534969)) using the Dietary Exposure Evaluation Model (DEEM-FCIDTM),

version 2.16 from Exponent for a proposed use on imported bananas. There are no

current or pending uses for isopyrazam. The definition of the residue for tolerance

enforcement purposes is parent isopyrazam only (SYN534968 plus SYN534969);

however the residue-of-concern for risk assessment purposes includes parent

isopyrazam (SYN534968 plus SYN534969) plus the metabolite CSCD459488. An

import tolerance for bananas of 0.05 ppm is proposed using the EPA/PMRA

tolerance tool (PRO2008-02, ”Guidance for Setting Pesticide Maximum Residue

Limits Based on Field Trial Data - Revised,” PMRA, April 4, 2008), based upon

residue field trial data on unbagged bananas treated at the maximum labeled

application rate and harvested at the minimum pre-harvest interval (PHI) of 0-days.

In these risk assessments, the EPA/PMRA tolerance tool was used to develop an

upper-bound residue-of-concern estimate of 0.07 ppm from the same 0-day PHI

unbagged bananas to account for residues of both parent isopyrazam plus the

metabolite CSCD459488. Default DEEM processing factors were assumed for dried

bananas (3.9X). Percent of crop treated (%CT) was conservatively assumed to be

100%. Since the proposed use on imported bananas will not result in transfer of

residues to livestock via consumption of treated feedstuffs, residues of isopyrazam in

meat, milk, or egg commodities were not anticipated. Additionally, since there are

no registered uses for isopyrazam in the United States, dietary exposures via

drinking water (surface water and/or ground water) were also not considered. All

consumption data for these assessments were taken from the USDA‟s Continuing

Survey of Food Intake by individuals (CSFII) with the 1994-96 consumption

database and the Supplemental CSFII children‟s survey (1998) consumption

database.]

i. Food. [Acute dietary (food only) risk assessments for parent isopyrazam

plus metabolite CSCD459488 were performed for all population sub-groups using

an acute reference dose (aRfD) of 0.30 mg/kg-bw/day, based upon a 90-day study in

dogs with a no observed adverse effect level (NOAEL) of 30 mg/kg-bw/day and an

uncertainty factor of 100X. The 100X safety factor includes intra- and inter-species

variations; no additional FQPA safety factor was applied. For the purpose of

aggregate risk assessment, the exposure values were expressed in terms of margin of

exposure (MOE), which was calculated by dividing the NOAEL by the exposure for

each population subgroup. In addition, exposure was expressed as a percent of the

acute reference dose (%aRfD). At the 95th percentile, acute (food only) exposure to

the U.S. population resulted in a MOE of 210,328 (0.1% of the RfD of 0.30 mg/kgbw/

day). The most exposed sub-population was all infants <1 year old, with a MOE

of 43,765 (0.2% of the RfD of 0.30 mg/kg-bw/day). Since the benchmark MOE for

this assessment was 100 and since the EPA generally has no concern for exposures

above the benchmark or below 100% of the reference dose, Syngenta believes that

8

there is a reasonable certainty that no harm will result from dietary (food only)

exposure to residues arising from the proposed use on imported bananas.

Chronic dietary (food only) risk assessments for parent isopyrazam plus metabolite

CSCD459488 were performed for all population sub-groups using a chronic

reference dose of 0.055 mg/kg-bw/day, based upon a 2-year study in rats with a no

observed adverse effect level (NOAEL) of 5.5 mg/kg-bw/day and an uncertainty

factor of 100X. The 100X safety factor includes intra- and inter-species variations;

no additional FQPA safety factor was applied. For the purpose of aggregate risk

assessment, the exposure values were expressed in terms of margin of exposure

(MOE), which was calculated by dividing the NOAEL by the exposure for each

population subgroup. In addition, exposure was expressed as a percent of the

chronic reference dose (%cRfD). Chronic (food only) exposure to the U.S.

population resulted in a MOE of 218,995 (0.0% of the cRfD of 0.055 mg/kg-bw/day).

The most exposed sub-population was children (1-2 years old) with a MOE of 42,933

(0.2% of the cRfD of 0.055 mg/kg-bw/day). Since the benchmark MOE for this

assessment was 100 and since the EPA generally has no concern for exposures above

the benchmark or below 100% of the reference dose, Syngenta believes that there is

a reasonable certainty that no harm will result from dietary (food only) exposure to

residues arising from the proposed use on imported bananas.

A cancer dietary assessment was not conducted.]

ii. Drinking water. [Since the proposed use on imported bananas will not

result in contributions of SYN520453 or its metabolite(s) to surface or ground water

in the United States, a drinking water exposure assessment was not conducted.]

2. Non-dietary exposure. [There are no currently registered residential uses

for SYN520453, so a non-dietary residential exposure assessment was not

conducted.]

D. Cumulative Effects

[Cumulative Exposure to Substances with a Common Mechanism of

Toxicity, Section 408(b)(2)(D)(v), requires that when considering whether to

establish, modify, or revoke a tolerance, the Agency consider “available

‟s residues

and “other substances that have a common mechanism of toxicity”. Syngenta did

not perform a cumulative risk assessment as part of this tolerance action for

isopyrazam because HED has not yet determined that there are any other chemical

substances that have a mechanism of toxicity common with that of isopyrazam.]

E. Safety Determination

1. U.S. population. [Using the conservative assumptions described above, and

based on the completeness and reliability of the toxicity data, the acute aggregate

9

(food only) exposure calculation for the proposed use of isopyrazam on imported

bananas resulted in a MOE of 210,328 for the U.S. population. The chronic

aggregate (food only) exposure analysis showed that exposure from the proposed

use of isopyrazam on imported bananas resulted in a MOE of 218,995 for the U.S.

population. Since the worst case aggregate MOE of 210,328 (acute aggregate

exposure) exceeds the benchmark MOE of 100, Syngenta believes that there is a

reasonable certainty that no harm will occur to the U.S. Population from acute and

chronic aggregate exposures arising from the proposed use of isopyrazam on

imported bananas.]

2. Infants and children. [Using the conservative assumptions described above,

B*

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and based on the completeness and reliability of the toxicity data, the acute

aggregate (food only) exposure calculation for the proposed use of isopyrazam on

imported bananas resulted in a MOE of 43,765 for infants <1 year old. The chronic

aggregate (food only) exposure analysis showed that exposure from the proposed

use of isopyrazam on imported bananas resulted in a MOE of 42,933 for children 1-

2 years old. Since the worst case aggregate MOE of 42,933 (chronic aggregate

exposure) exceeds the benchmark MOE of 100, Syngenta believes that there is a

reasonable certainty that no harm will occur to infants and children from acute and

chronic aggregate exposures arising from the proposed use of isopyrazam on

imported bananas.]

F. International Tolerances

[There are no Codex Alimentarius MRLs set for isopyrazam.]


22 MS. RIORDAN: Mr. Chairman, I think there's 23 a side bar which is not necessarily in the body of this but 24 is extremely important, and I don't believe it is. And I 25 don't recall each and every word, but that was the 285 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 testimony that we've really seriously got to undertake an 2 effort to clean diesel fuel, and it really isn't just 3 California that needs to do this. This needs to be 4 something that's done nationwide, and I think that's one of 5 the compelling things that this Board, constituted as we 6 are today or another Board in years to come, just really 7 needs to concentrate on.

8 I believe that very strongly because I know 9 as we watch the movement of freight through our state, much 10 of the fuel that's put into those big rigs that come across 11 our state, it's often bought outside of the state and they 12 can run it through and out again before we have an 13 opportunity to really benefit from our requirements versus 14 the requirements of other areas. It really needs to be a 15 nationwide effort, and I think that was something I keyed 16 in on and something that has been of concern to me and we 17 really need to work on this.

18 MS. EDGERTON: Mr. Chairman, I would like to 19 make another comment about the .2

20 CHAIRMAN DUNLAP: One second. Does the 21 court reporter need a minute to change the paper?

22 ( Interruption in the proceedings.)

23 CHAIRMAN DUNLAP: What other new issues are 24 left? What about it, Joe?

25 MR. CALHOUN: Mr. Chairman and members of 286 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 the Board and audience, my big concern is the testimony 2 we've heard from industry and the staff today about the 3 truck, and particularly the truck between 6,000 and 8,500.

4 Now, California has been in this emission 5 game since 1966, and I believe the first truck standards 6 that were required started with 1970 with the ' 70 model 7 year, and since that time to this day the trucks have 8 always had different standards from passenger cars, and the 9 reason for it is because the duty cycle is different, and I 10 don't think that has changed.

11 Now, admitted people use them for other 12 reasons other than they were intended, but the 13 manufacturers have to certify the vehicle with this  I'll 14 call it adverse equipment on  the manufacturers have to 15 meet the vehicle and test protocol is somewhat different, 16 and they have to  these trucks have to work harder in 17 order to meet the standard, so it's difficult for me,

18 knowing what I know about it and knowing all these years it 19 hasn't been changed, my preference would have been that if 20 we want to get more emissions, tighten up on the car 21 standard, but that's not the issue before this Board today.

22 So I have trouble supporting the staff proposal for light 23 duty trucks or these trucks, and I would propose we 24 substitute the industry proposal for it.

25 CHAIRMAN DUNLAP: Okay. All right. Is 287 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 there anybody on the Board that we ought to bump from the 4 2 percent to the 15, that that resonates with them other than 3 Mr. Calhoun?

4 MR. PARNELL: John, I don't want to elongate 5 this meeting, but it is somewhat concerning to me, although 6 I heard the staff briefing. They were very articulate. I 7 heard what we heard from General Motors and Ford, and for 8 me there is a total disconnect in the information that you 9 say that we have off the shelf technology that was aged 10 that put on the cars and we can meet the standards, and 11 they said they can't meet the standards. I understand 12 headroom and I understand their concerns, but I also 13 understand that the appearance here is the total disconnect 14 between what you're saying.

15 Normally we get closer on these issues, but 16 having said that, I have to say that I'm compelled by the 17 argument that if we do biannual reviews, that the industry 18 has time to come in and make  if in fact what they're 19 saying is absolutely true, that they can't meet these 20 emission standards  that they'll have an opportunity to 21 talk to some other Board some other day and to the staff to 22 make that point. You know, I've never been as probably 23 confused in the past as I am today just because of that one 24 serious, serious disconnect, and I don't know if anyone can 25 shed any light on it. Perhaps there is no light to be 288 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 shed.

2 CHAIRMAN DUNLAP: That's the troubling part 3 of this. I think we kind of crossed a threshold a few 4 years ago with that issue relative to the industry. We 5 worked with them. We have a process whereby with this MOA 6 we're working with them, and I know that staff's done that 7 well and I know the relationship has been good, but I would 8 agree with Mr. Parnell.

9 In the four years I've been here, I've not 10 seen this effort going into finding a common ground and 11 people still not being there. I've told the industry and 12 I'll say again, the staff, while not perfect, has been 13 right more often than not, and when I have the staff 14 telling me that this can be done, they're showing the data 15 and they're willing to go toe to toe on some of these 16 arguments, it's difficult for me to say no, I'm going to 17 disregard all that and I'm going to go with some industry 18 points of view, because that leaves me nowhere, and so I'm 19 troubled by that too. I am comforted by the two year 20 review. Okay. 21 Why don't we get down to the business of 22 moving this item. Has it been fair thus far that we've got 23 the most support things out there?

24 So the primary, there seems to be consensus 25 on all issues save the diesel issue, and what else am I 289 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 missing?

2 MS. EDGERTON: The .2 partial credit.

3 CHAIRMAN DUNLAP: Again the hybrid issue.

4 What do we call it?

5 MR. CACKETTE: Partial ZEV credit for 6 gasoline.

7 MS. EDGERTON: I wanted to again articulate 8 my concern.

9 CHAIRMAN DUNLAP: I want to find out if 10 there's anybody else on the Board that feels that way so we 11 can get a flavor for it. Anybody else concerned about the 12 partial ZEV credit?

13 SUPERVISOR ROBERTS: You're talking about 14 the gasoline, .2 or whatever?

15 CHAIRMAN DUNLAP: Yes.

16 SUPERVISOR ROBERTS: Yes. Both of those.

17 CHAIRMAN DUNLAP: So we have a couple other 18 members concerned about that. Okay. Why don't we  well,

19 I think I'm willing to put that to a vote, so what I'm 20 going to try to do, Kathleen, if I can is isolate that 21 component and see if the Board wants to not give the 22 partial ZEV credit on gasoline vehicles. Can we do that?

23 MS. WALSH: What you might want to do is ask 24 if you have a motion for the revised resolution, second.

25 You can then take amendments, proposed amendments to the 290 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 resolution.

2 CHAIRMAN DUNLAP: Fine. Okay. I'm going to 3 take a motion on the resolution, so I'm going to look to 4 Mrs. Rakow who has clear thinking on this thing and put it 5 on your shoulders to capture as much of this as you can.

6 She's been keeping a list.

7 MRS. RAKOW: I was going to make it very 8 simple and say that I move that the Board accept the staff 9 proposal on California's Low Emission Vehicle program and 10 include the eight pages of the revised proposed amendments.

11 CHAIRMAN DUNLAP: Resolution.

12 MRS. RAKOW: Resolution.

13 CHAIRMAN DUNLAP: Okay.

14 MS. RIORDAN: I'll second the motion.

15 CHAIRMAN DUNLAP: We have a motion and a 16 second. Now, there

17 MS. WALSH: Might I just inquire?

18 So we don't have any confusion, there are 19 two proposed resolutions out. The one that includes the 20 language that Mrs. Rakow proposed earlier, that is the 21 resolution the motion refers to, says revised proposed 22 resolution?

23 MRS. RAKOW: Right.

24 CHAIRMAN DUNLAP: The second would agree?

25 MS. RIORDAN: I would agree. 291 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 CHAIRMAN DUNLAP: Now, amendments to that 2 motion, Ms. Edgerton, would be what?

3 MS. EDGERTON: Yes. I would like to do the 4 seriatim. I would like to first propose that the .2 5 partial ZEV credit for gasoline vehicles be deleted from 6 the partial ZEV credit.

7 CHAIRMAN DUNLAP: There's a motion to that 8 amendment. Is there a second?

9 SUPERVISOR ROBERTS: I'll second that, John.

10 CHAIRMAN DUNLAP: Any discussion we need to 11 have on that?

12 MS. EDGERTON: Yes. I would like to discuss 13 it as the maker of the motion.

14 CHAIRMAN DUNLAP: Okay.

15 MS. EDGERTON: I think what we've seen, and 16 this whole hearing began with the presentation from 17 Ballard. I think what we've seen are enormous advances in 18 the fuel cell area, and we've also seen tremendous advances 19 with battery powered electric vehicles that we've all been 20 driving.

21 I think that those advances are very 22 exciting and we don't know whether in this next time frame 23 of 2004 to 2010 whether it might not be possible for that 24 10 percent to be filled up with hybrid vehicles, hybrid 25 electric vehicles and more ZEVs if there are breakthroughs 292 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 in that technology. So my argument here is that are we 2 shooting ourselves in the foot? I do certainly respond 3 enthusiastically to Honda's and others' super ULEVs. I 4 think that's great.

5 However, I think we want to be sure that we 6 keep this category open to further those technologies that 7 are making so much progress and which are the silver bullet 8 or silver bullets for southern California, for your 9 children, my children and our grandchildren, and so with 10 respect, though I think  and the second thing I think 11 that it is not clear. I believe the gasoline vehicles do 12 not belong here because part of the reason, I distinctly 13 recall the major part of the reason was to try to provide 14 for the upstream emissions measures, so I think that also 15 it torments the category.

16 CHAIRMAN DUNLAP: Mrs. Rakow, you're welcome 17 to say something.

18 MRS. RAKOW: Thank you. I'm very 19 understanding of your viewpoint because I'm very,

20 extremely, completely supportive of fuel cells and electric 21 vehicles. However, I looked on this as the ZEV credit,

22 where I normally would have been completely  I look on it 23 as a building block to get to where we ultimately want to 24 be with electric vehicles in California, and so I think 25 this is part of building the support to get there, so  293 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 CHAIRMAN DUNLAP: One of the things that 2 Lynne not so much surprised me about your position is this.

3 I just remember you being very enthusiastic about hybrid 4 technology, about finding some way to get them into the 5 program, about getting them some credit. I remember you 6 encouraging me early in my tenure to come clean with what 7 was going on, and I remember us having some conversations 8 with staff about some exciting technology developments that 9 use the best of both kinds of elements of clean gasoline 10 engines and electric powered zero emission, so  I think 11 we've put this issue off for a long time.

12 Tom, you and I have talked about this for 13 about two and a half, three years, so I don't see this so 14 much as a give away or a bad thing on ZEVs, but I view it,

15 as Mrs. Rakow does, as kind of a step to recognize people 16 for coming up with a cleaner car and giving proportional 17 credit.

18 Now, I'll say  and I think I've said it 19 before  I support zero emission vehicles. I want them to 20 be successful. I want Sam to move that EV 1. I want 21 harmony. I want all these things out there, but we can 22 want it all day long, but if they're not getting out there,

23 A, the only benefits we're going to see is only going to be 24 on paper and expectation. So I think what we want to do is 25 nurture and support some things getting out there that 294 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 maybe don't do everything we like, but are certainly making 2 progress and are attractive to consumers, and if people are 3 perceiving it as a walk away from the gold standard of 4 ZEVs, I think that's a false assumption, and I think we've 5 got a ways to go to get the consumers there. There's 6 pricing issues, there's performance issues, there's 7 technology barriers, so I'm not afraid either of the 8 symbolism or kind of where that leaves us consistently.

9 I'm just not worried about it that much yet. I think we 10 need this technology.

11 Supervisor Patrick, you're welcome to say 12 anything if you like.

13 SUPERVISOR PATRICK: Thank you,

14 Mr. Chairman. I would like to just say how much I agree 15 with your position on this. I think that the environmental 16 community has made some very compelling arguments for why 17 they want us to go in another direction, and we have heard 18 them and I think they are very compelling.

19 On the other hand, I think the industry 20 needs more flexibility, and I think this helps to encourage 21 the kind of commitment that we need to move towards 22 complete zero emission vehicles in the future, and I think 23 that we need to support that flexibility for industry. It 24 helps us get there, I think.

25 CHAIRMAN DUNLAP: Thank you. Ron, did you 295 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 want to  and Ron, I know you've been a big booster of 2 this technology from the get go.

3 SUPERVISOR ROBERTS: Yeah. And I guess I'm 4 not as convinced as you are

5 CHAIRMAN DUNLAP: Right. 6 SUPERVISOR ROBERTS:  that this is moving 7 in a direction that  I think we just have a strong 8 difference of opinion, John, and I was also persuaded by 9 the comments that I heard about looking at this as a 10 system, and it's not just the car and it's not just what's 11 coming out of the tailpipe, but it's a whole system of 12 things contributing to a problem. That by allowing this 13 option we're losing sight of a good portion of this, and I 14 just  I don't feel comfortable, and I think it's 15 inappropriate and I don't see it as helping in the way that 16 you feel confident.

17 CHAIRMAN DUNLAP: Okay. All right. If 18 there's no other discussion, we'll vote on the amendment.

19 Lynne, would you restate it?

20 MS. EDGERTON: To delete from the partial 21 ZEV credit measure only the credit provision for gasoline 22 vehicles, which is the credit of .2.

23 CHAIRMAN DUNLAP: Okay.

24 MR. CACKETTE: I would like to clarify that 25 gasoline only vehicles, because there are credits in there 296 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 for gasoline hybrid electric vehicles, for example.

2 MS. EDGERTON: I think gasoline only, that 3 they only have gasoline, not for hybrids that have gasoline 4 and

5 SUPERVISOR ROBERTS: That's the .2?

6 MS. EDGERTON: Yes.

7 CHAIRMAN DUNLAP: All right. We'll proceed 8 with a voice vote, and we have a motion and second relative 9 to this amendment as it relates to gasoline only hybrids 10 and SULEVs. All those in favor of the motion say " aye."

11 okay. Raise your hand. We have one, two, three, four.

12 Opposed? Raise your hand. Okay.

13 It appears that that motion, that amendment 14 is not made. Okay. What's the other amendment we have?

15 MS. EDGERTON: Mr. Roberts, do you want to 16 make it or do you want me to make it?

17 SUPERVISOR ROBERTS: Well, this would be 18 that as it pertains to the diesel

19 CHAIRMAN DUNLAP: Okay.

20 SUPERVISOR ROBERTS:  exemption.

21 CHAIRMAN DUNLAP: Okay.

22 SUPERVISOR ROBERTS: I would move that we 23 would delete that.

24 DR. FRIEDMAN: Second.

25 CHAIRMAN DUNLAP: Okay. 297 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 MS. EDGERTON: Second. Who's the second?

2 CHAIRMAN DUNLAP: Okay. There's a motion by 3 Supervisor Roberts

4 MS. EDGERTON: I second.

5 CHAIRMAN DUNLAP:  and a second by 6 Dr. Friedman. All right. Let's

7 MR. KENNY: Actually, I want  for 8 clarification purposes, I think we need to make sure we 9 understand what the motion is.

10 CHAIRMAN DUNLAP: Okay. Very good. Ron, 11 restate it, and Tom, you're welcome to assist him to make 12 sure we cover what the intent is.

13 MR. KENNY: Is the motion to delete the TLEV 14 standard and the alt TLEV standard as proposed by staff?

15 And that is essentially the on trade we discussed for 16 diesels.

17 SUPERVISOR ROBERTS: That's correct.

18 CHAIRMAN DUNLAP: Okay. We have a motion 19 and a second.

20 MR. CACKETTE: There was also a nuance item.

21 I'm not sure this came out, but we have a standard in 2004 22 which is a TLEV standard available to gasoline or diesel.

23 There's an optional standard as well for that, and in 2007 24 the staff proposed to tighten the standard down, so I just 25 want to point out there's a couple of time windows and 298 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 obviously the motion could be to eliminate all 2 TLEVs from day one in the LEV II program or only after 3 2007. There's various

4 MS. EDGERTON: My motion is to eliminate all 5 TLEVs

6 MR. CACKETTE: From the LEV II program.

7 MS. EDGERTON:  from 2004 on.

8 CHAIRMAN DUNLAP: Okay. Is that okay with 9  Ron, you made that motion?

10 SUPERVISOR ROBERTS: Yes.

11 MS. EDGERTON: Oh, wait.

12 CHAIRMAN DUNLAP: Is that okay with the 13 second from Dr. Friedman? 14 DR. FRIEDMAN: Yes.

15 CHAIRMAN DUNLAP: Okay.

16 MS. EDGERTON: Is that wrong?

17 MR. KENNY: That's correct.

18 There are two TLEVs in 2004. There's the 19 standard TLEV which is essentially the carryover from LEV 20 I. There is an alt TLEV which is the proposal by the 21 staff, and there's an alternative to the LEV I, TLEV 22 proposal, and then there is a 2007 TLEV proposal. So as I 23 understand what the motion is, you're proposing to 24 eliminate TLEVs from 2004 on, so what would happen is that 25 there would not be any TLEVs in either 2004, there would 299 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 not be any alt TLEVs in 2004, and there would not be any 2 TLEVs in 2007, so all the TLEV references would be deleted.

3 CHAIRMAN DUNLAP: Okay.

4 MR. SCHONING: Mr. Chairman, if you look at 5 page 2 of the 15 day handout, you can see the standard 6 table and the four places where there are TLEV standards.

7 CHAIRMAN DUNLAP: Okay. Page 2? Okay.

8 We have a motion and a second to delete the 9 TLEV elements as outlined by our executive officer.

10 MS. EDGERTON: Point of information, I'd 11 like to ask the staff. Alternatively we could keep the 12 TLEV but at the lower level which you indicated to me it 13 could be made to gasoline and so it wouldn't be especially 14 for diesel; right?

15 MR. KENNY: It's not especially for diesel. 16 The TLEV standard as part of LEV I is the original TLEV 17 standard that is being utilized by both gasoline and 18 diesel. It does have a NOx standard which is more lenient,

19 diesel is able to take advantage of, so that TLEV standard 20 as part of LEV I would essentially on its own disappear by 21 2007 as part of LEV I.

22 What we're really talking about here is do 23 we have the original TLEV standard which the Board adopted 24 back in 1990 as part of LEV I continue out and run its 25 course or do we take that TLEV standard out beginning in 300 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 2004, then what the staff has proposed as part of LEV II as 2 an alternative to the TLEV standard in 2004, and then the 3 tighter TLEV standard in 2007.

4 MR. CACKETTE: If I could, maybe this might 5 help a little bit. I don't want to add confusion here.

6 CHAIRMAN DUNLAP: I forbid you to confuse 7 anyone.

8 ( Laughter.)

9 MR. CACKETTE: Let me just say that the TLEV 10 standard was there for two purposes. It's been in there 11 LEV I and LEV II because we thought having a menu of 12 different standards from dirtier to super clean was a way 13 of providing flexibility to the auto industry. They make 14 some TLEVs, some super ULEVs, mostly LEVs and ULEVs.

15 That's kind of the way it's gone. Where the diesel aspect 16 comes in is it happens to be that the only standard is the 17 TLEV standard, so that's why you're focusing on TLEV. But 18 it was there for another purpose which is to provide some 19 flexibility for even gasoline powered cars, and obviously 20 we called it transitional because we had a vision of it 21 going away eventually. And the way it goes away is we have 22 this fleet average standard and it just cranks down and you 23 just can't make measure of these dirtier vehicles, gas or 24 diesel, so that's what its two purposes were. I just 25 wanted to tell you. 301 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 CHAIRMAN DUNLAP: Okay.

2 MS. EDGERTON: My understanding is that

3 CHAIRMAN DUNLAP: I want to call the 4 question. We think we know what we want here. How is it 5  the only clarification I think at this point is how is 6 it going to disadvantage or impact gasoline powered 7 vehicles, Tom?

8 MR. CACKETTE: The TLEV I, the current 9 standard, can be used to a limited extent to the year 2006,

10 then that program goes away in 2007. It's not available.

11 If you make this motion, it's not available to anybody. I 12 don't think it creates an impossible situation anywhere,

13 but it clearly takes away flexibility and it does in our 14 mind prevent any diesel vehicle we are aware of or can see 15 in the future from complying with the LEV standards.

16 MS. EDGERTON: So we'll just stay with 17 taking it out.

18 CHAIRMAN DUNLAP: Well, we have a motion and 19 a second. Any discussion we need to have?

20 I'm going to do a voice vote. Okay? So, 21 Ms. Shelby, why don't you call the question.

22 MS. SHELBY: Calhoun.

23 MR. CALHOUN: No.

24 MS. SHELBY: DeSaulnier.

25 SUPERVISOR DE SAULNIER: Aye. 302 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 MS. SHELBY: Is that yes?

2 SUPERVISOR DE SAULNIER: Yes.

3 MS. SHELBY: Edgerton.

4 MS. EDGERTON: Yes.

5 MS. SHELBY: Friedman.

6 DR. FRIEDMAN: Yes.

7 MS. SHELBY: Parnell.

8 MR. PARNELL: No.

9 MS. SHELBY: Patrick.

10 SUPERVISOR PATRICK: Yes.

11 MS. SHELBY: Rakow.

12 MRS. RAKOW: Yes.

13 MS. SHELBY: Riordan.

14 MS. RIORDAN: No.

15 MS. SHELBY: Roberts.

16 SUPERVISOR ROBERTS: Yes.

17 MS. SHELBY: Silva.

18 SUPERVISOR SILVA: Yes.

19 MS. SHELBY: Chairman Dunlap.

20 ( Laughter.)

21 CHAIRMAN DUNLAP: Do I really have any power 22 to effect that one? I'll abstain on that one. I don't see 23 any purpose. 24 All right. That motion carries. TLEVs are 25 gone. 303 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 MS. SHELBY: Seven to three with the 2 Chairman abstaining.

3 CHAIRMAN DUNLAP: Okay. Now the whole 4 motion. What else do we have? We have the rest  well,

5 unless I have an amendment, Joe. Do we have somebody that 6 wants to offer an amendment other than the one we just 7 voted on?

8 MR. CALHOUN: Yes.

9 CHAIRMAN DUNLAP: Okay. What's your 10 amendment?

11 MR. CALHOUN: Mr. Chairman of the Board, I 12 propose that we amend the resolution so far as it pertains 13 to the LEV II exhaust emission standards for new 2004 and 14 subsequent model years, LEVs, ULEVs and sub ULEVs, and 15 passenger car, light duty truck and medium duty vehicles

16 we've already eliminated TLEVs  amended to accept the 17 industry proposal in lieu of the

18 CHAIRMAN DUNLAP: Okay. We kind of talked 19 about it. I was looking for consensus to that, Joe, and I 20 couldn't find any. Does anybody want to second that 21 motion? Okay. Joe, the motion dies. I appreciate the 22 effort.

23 Let's go to the main motion which we have 24 before us which proved the resolution, the revised 25 resolution with exception of the TLEV elements that have 304 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 been stripped out. Do we need to have any discussion on 2 that? Okay.

3 We'll proceed with a voice vote. All those 4 in favor say " aye".

5 ARB BOARD: Aye.

6 CHAIRMAN DUNLAP: Any opposed? Very good.

7 Thank you. It looks like we're done with LEV II.

8 What we're going to do  first of all, I 9 want to thank everybody who participated and testified 10 today. It was a long day.

11 We have an open comment period. I'm going 12 to ask Supervisor Riordan to open up the open comment 13 period. We have five witnesses who have signed up. I'm 14 going to ask Supervisor Riordan to proceed to do that.

15 MS. RIORDAN: Thank you, Mr. Chairman.

16 Mr. Parnell, did you want to make a comment?

17 MR. PARNELL: I only wanted to take the 18 opportunity to say this, and I've worked at the highest 19 levels of federal government, the highest levels of state 20 government, and I have never in my whole experience ever 21 had the opportunity to work with a brighter, more diligent 22 young man that has probably one of the great futures ahead 23 of him.

24 I've never worked with anyone with more 25 integrity, anyone with more strength of character, anyone 305 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 with more singleness of purpose. This clean air is his 2 agenda and has been, so I just wanted to say publicly in 3 all of my experience across the board in government, this 4 man has meant an awful lot to me and will continue to meet 5 an awful lot to me because I think he is the absolute 6 epitome of leadership in America today, so thank you, John.

7 ( Applause.)

8 CHAIRMAN DUNLAP: You guys have been hearing 9 from me all day, so I'll make it brief.

10 Jack, it's very kind. I've really, really 11 enjoyed my time with the Air Resources Board. It was a 12 great honor for the Governor to ask me to serve in this 13 way. I not only come to enjoy the work, which I kind of 14 was trained to do earlier in my career because I knew air 15 pollution, but I've really come to have great fondness and 16 affection not only of the members of this Board, but to the 17 staff.

18 Mike Kenny has just been terrific and the 19 staff is supremely competent and committed, and any way 20 that it looked favorably upon me or us is because of them 21 and you, and so I'll be always grateful for that and also 22 the stakeholders. You guys have kept everybody honest, and 23 I think that's important in the process, so thank you. I'm 24 embarrassed by the attention and we'll proceed with the 25 open comment period. Thank you. 306 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 MS. RIORDAN: And thank you, Mr. Chairman.

2 And we'll have another opportunity to honor our Chairman 3 and we look forward to that a little bit later in this 4 month.

5 This is an open comment period. Although 6 the Board can't take formal action, we are open to hearing 7 items that are in our jurisdiction, and so let me call on 8 Bob Warden from Western States Petroleum Association.

9 MR. WARDEN: Pass.

10 MS. RIORDAN: Pardon me?

11 MR. WARDEN: I'll pass.

12 MS. RIORDAN: You'll pass.

13 Don Gilson from Western States Petroleum 14 Association.

15 MR. GILSON: I'll pass, too.

16 MS. RIORDAN: You know we have a lot of work 17 to do, gentlemen, so we're delighted you're here, and I 18 think you heard the comments about partnership and working 19 with cleaner fuels.

20 Wolfgang Groth from Volkswagen of America.

21 Mr. Groth?

22 MR. GROTH: Pass.

23 MS. RIORDAN: Passing? You're saying 24 goodbye. Patrick Kudell from the American Lung 25 Association, are you still here? Mike McCormach from EEC, 307 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 pardon me, CEC, California Energy Commission. I guess they 2 left.

3 And so with that in mind, I am going to 4 adjourn the meeting and thank you all very much for coming.

5 * * *

6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 308 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900 1 STATE OF CALIFORNIA )

2 ) ss.

3 COUNTY OF SAN BERNARDINO )

4 5 I, Terri L. Emery, CSR 11598, a Certified 6 Shorthand Reporter in and for the State of California, do 7 hereby certify:

8 That the foregoing proceeding was taken down 9 by me in shorthand at the time and place named therein and 10 was thereafter reduced to typewriting under my supervision;

11 that this transcript is a true record of the testimony 12 given by the witnesses and contains a full, true and 13 correct record of the proceedings which took place at the 14 time and place set forth in the caption hereto as shown by 15 my original stenographic notes.

16 I further certify that I have no interest in 17 the event of the action.

18 EXECUTED this 20th day of November, 1998.

19 20 21 22 ______________________________

23 Terri L. Emery, CSR # 11598 24 25 309 BARNEY, UNGERMANN & ASSOCIATES 1 888 326 5900


[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Notices]
[Pages 79461-79465]
[FR Doc No: 2013-31215]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1155]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling
Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
29, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0381.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105 (OMB
Control Number 0910-0381)--Revision to Include Collections Previously
Approved By OMB, But Currently in Use Without Approval

    Our food labeling regulations require food producers to disclose to
consumers and others specific information about themselves or their
products on the label or labeling of their products. Related
regulations require that food producers retain records establishing the
basis for the information contained in the label or labeling of their
products and provide those records to regulatory officials. Finally,
certain regulations provide for the submission of food labeling
petitions to us. We issued our food labeling regulations under parts
101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) under the
authority of sections 4, 5, and 6 of the Fair Packaging and Labeling
Act (FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402,
403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e).
Most of these regulations derive from section 403 of the FD&C Act,
which provides that a food product shall be deemed to be misbranded if,
among other things, its label or labeling fails to bear certain
required information concerning the food product, is false or
misleading in any particular, or bears certain types of unauthorized
claims. The disclosure requirements and other collections of
information in the regulations in parts 101, 102, 104, and 105 are
necessary to ensure that food products produced or sold in the United
States are in compliance with the labeling provisions of the FD&C Act
and FPLA.
    Upon review of the information collection requests supporting these
food labeling regulations, FDA found that the third-party disclosure
burdens associated with the requirements found in Sec. Sec.
101.9(c)(2)(ii) and 101.36(b)(2) to

declare the amount of trans fatty acids present in a food, and with the
voluntary declaration of the quantitative amount and the percent of
Daily Value of a dietary ingredient on a ``per day'' basis in addition
to the required ``per serving'' basis are in use without current OMB
approval. These collections of information were previously approved by
OMB under control numbers 0910-0595 and 0910-0395 respectively;
however, the approval period for these collections has expired. To
remedy this oversight, to most appropriately streamline these
information collections, and to eliminate redundancy in its information
collection requests, we seek to revise the instant collection to
include these third-party disclosure elements and have included them in
the burden estimates and discussion in this document in support of our
approval request for OMB control number 0910-0381.
    Section 101.3 of our food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity
(i.e., the name of the product), including, as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form. Section 101.5 requires that
the label of a food product in packaged form specify the name and place
of business of the manufacturer, packer, or distributor and, if the
food producer is not the manufacturer of the food product, its
connection with the food product. Section 101.9 requires that nutrition
information be provided for all food products intended for human
consumption and offered for sale, unless an exemption in Sec.  101.9(j)
applies to the product. In particular, Sec.  101.9(c)(2)(ii) requires
that the amount of trans fatty acids present in a food must be declared
on the nutrition label on a separate line immediately under the line
for the declaration of saturated fat. Section 101.9(g)(9) provides that
interested parties may submit to us requests for alternative approaches
to nutrition labeling requirements. Finally, Sec.  101.9(j)(18)
provides that firms claiming the small business exemption from
nutrition labeling must submit notice to us supporting their claim
exemption. We developed Form FDA 3570 to assist small businesses in
claiming the small business exemption from nutrition labeling. The form
contains all the elements required by Sec.  101.9(j)(18).
    Section 101.10 requires that restaurants provide nutrition
information, upon request, for any food or meal for which a nutrient
content claim or health claim is made. Section 101.12(b) provides the
reference amount that is used for determining the serving sizes for
specific products, including baking powder, baking soda, and pectin.
Section 101.12(e) provides that a manufacturer that adjusts the
reference amount customarily consumed (RACC) of an aerated food for the
difference in density of the aerated food relative to the density of
the appropriate non-aerated reference food must be prepared to show us
detailed protocols and records of all data that were used to determine
the density-adjusted RACC. Section 101.12(g) requires that the label or
labeling of a food product disclose the serving size that is the basis
for a claim made for the product if the serving size on which the claim
is based differs from the RACC. Section 101.12(h) provides for the
submission of petitions requesting that we change the reference amounts
defined by regulation.
    Section 101.13 requires that nutrition information be provided in
accordance with Sec.  101.9 for any food product for which a nutrient
content claim is made. Under some circumstances, Sec.  101.13 also
requires the disclosure of other types of information as a condition
for the use of a nutrient content claim. For example, under Sec.
101.13(j), if the claim compares the level of a nutrient in the food
with the level of the same nutrient in another ``reference'' food, the
claim must also disclose the identity of the reference food, the amount
of the nutrient in each food, and the percentage or fractional amount
by which the amount of the nutrient in the labeled food differs from
the amount of the nutrient in the reference food. It also requires that
when this comparison is based on an average of food products, this
information must be provided to consumers or regulatory officials upon
request. Section 101.13(q)(5) requires that restaurants document and
provide to appropriate regulatory officials, upon request, the basis
for any nutrient content claims they have made for the foods they sell.
    Section 101.14(d)(2) and (d)(3) provides for the disclosure of
nutrition information in accordance with Sec.  101.9 and, under some
circumstances, certain other information as a condition for making a
health claim for a food product. Section 101.15 provides that, if the
label of a food product contains any representation in a foreign
language, all words, statements, and other information required by or
under authority of the FD&C Act to appear on the label must appear in
both the foreign language and in English. Section 101.22 contains
labeling requirements for the disclosure of spices, flavorings,
colorings, and chemical preservatives in food products. Section
101.22(i)(4) sets forth disclosure and recordkeeping requirements
pertaining to certifications for flavors designated as containing no
artificial flavors. Section 101.30 specifies the conditions under which
a beverage that purports to contain any fruit or vegetable juice must
declare the percentage of juice present in the beverage and the manner
in which the declaration is to be made.
    Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in Sec.
101.36(h) applies. In particular, Sec.  101.36(b)(2) requires that the
amount of trans fatty acids present in dietary supplements must be
declared on the nutrition label on a separate line immediately under
the line for the declaration of saturated fat. Section 101.36(e)
permits the voluntary declaration of the quantitative amount and the
percent of Daily Value of a dietary ingredient on a ``per day'' basis
in addition to the required ``per serving'' basis, if a dietary
supplement label recommends that the dietary supplement be consumed
more than once per day. Section 101.36(f)(2) cross-references the
provisions in Sec.  101.9(g)(9) for the submission to us of requests
for alternative approaches to nutrition labeling requirements. Also,
Sec.  101.36(h)(2) cross-references the provisions in Sec.
101.9(j)(18) for the submission of small business exemption notices. As
noted previously, we developed Form FDA 3570 to assist small businesses
in claiming the small business exemption from nutrition labeling. The
form contains all the elements required by Sec.  101.36(h)(2).
    Section 101.42 requests that food retailers voluntarily provide
nutrition information for raw fruit, vegetables, and fish at the point
of purchase and Sec.  101.45 contains guidelines for providing such
information. Also, Sec.  101.45(c) provides for the submission to us of
nutrient databases and proposed nutrition labeling values for raw
fruit, vegetables, and fish for review and approval.
    Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify
information that must be disclosed as a condition for making particular
nutrient content claims. Section 101.67 provides for the use of
nutrient content claims for butter, and cross-references requirements
in other regulations for information declaration (Sec.  101.4) and
disclosure of information concerning performance characteristics (Sec.
101.13(d)). Section 101.69 provides for the submission of a

petition requesting that we authorize a particular nutrient content
claim by regulation. Section 101.70 provides for the submission of a
petition requesting that we authorize a particular health claim by
regulation. Section 101.77(c)(2)(ii)(D) requires the disclosure of
soluble fiber per serving in the nutrition labeling of a food bearing a
health claim about the relationship between soluble fiber and a reduced
risk of coronary heart disease. Section 101.79(c)(2)(iv) requires the
disclosure of the amount of folate in the nutrition label of a food
bearing a health claim about the relationship between folate and a
reduced risk of neural tube defects.
    Section 101.100(d) provides that any agreement that forms the basis
for an exemption from the labeling requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the FD&C Act be in writing and that a
copy of the agreement be made available to us upon request. Section
101.100 also contains reporting and disclosure requirements as
conditions for claiming certain labeling exemptions (e.g., 101.100(h)).
    Section 101.105 specifies requirements for the declaration of the
net quantity of contents on the label of a food in packaged form and
prescribes conditions under which a food whose label does not
accurately reflect the actual quantity of contents may be sold, with
appropriate disclosures, to an institution operated by a Federal, State
or local government. Section 101.108 provides for the submission to us
of a written proposal requesting a temporary exemption from certain
requirements of Sec. Sec.  101.9 and 105.66 for the purpose of
conducting food labeling experiments with our authorization.
    Regulations in part 102 define the information that must be
included as part of the statement of identity for particular foods and
prescribe related labeling requirements for some of these foods. For
example, Sec.  102.22 requires that the name of a protein hydrolysate
will include the identity of the food source from which the protein was
derived.
    Part 104, which pertains to nutritional quality guidelines for
foods, cross-references several labeling provisions in part 101 but
contains no separate information collection requirements.
    Part 105 contains special labeling requirements for hypoallergenic
foods, infant foods, and certain foods represented as useful in
reducing or maintaining body weight.
    The purpose of our food labeling requirements is to allow consumers
to be knowledgeable about the foods they purchase. Nutrition labeling
provides information for use by consumers in selecting a nutritious
diet. Other information enables a consumer to comparison shop.
Ingredient information also enables consumers to avoid substances to
which they may be sensitive. Petitions or other requests submitted to
us provide the basis for us to permit new labeling statements or to
grant exemptions from certain labeling requirements. Recordkeeping
requirements enable us to monitor the basis upon which certain label
statements are made for food products and whether those statements are
in compliance with the requirements of the FD&C Act or FPLA.
    Description of Respondents: Respondents to this information
collection are manufacturers, packers, and distributors of food
products. Because of the existence of exemptions and exceptions, not
all of the requirements apply to all food producers or to all of their
products. Some of the regulations affect food retailers, such as
supermarkets and restaurants.
    In the Federal Register of November 1, 2013 (78 FR 65663), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Several comments were received in response
to the notice. Many were generally supportive of the necessity of our
food labeling regulations. Other comments were beyond the scope of the
four collections of information topics on which the notice solicits
comments and will therefore not be discussed in this document.
    A number of comments referenced our Federal Register notice
published on November 8, 2013 (78 FR 67169) (``the November 8, 2013,
notice''), announcing the tentative determination that partially
hydrogenated oils (PHOs) are no longer ``generally recognized as safe''
(GRAS). Some comments supported this determination while others opposed
it. Supportive comments suggested that labels should be placed on food
packaging warning consumers of the negative health effects of the trans
fatty acid component of PHOs. FDA notes that it does not require
warning labels on food containing trans fatty acid, but we agree that
trans fatty acid content should be provided in the nutrition labeling
of food. In the Federal Register of July 11, 2003 (68 FR 41434), we
issued a final rule (``the July 2003 final rule'') amending our
nutrition labeling regulations to require declaration of the trans
fatty acid content of food in the nutrition label of conventional foods
and dietary supplements (Sec.  101.9(c)(2)(ii)). This requirement was
effective January 1, 2006. The November 8, 2013, notice seeks comments
on our preliminary determination that PHOs are not GRAS and we have
submitted comments relevant to this topic to that docket as well. If
FDA makes a final determination that PHOs are not GRAS, the food
industry would be required to phase out the use of PHOs in food over
time, not place warning labels on their food products.
    FDA estimates the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
101.3, 101.22, 102, and 104;              25,000            1.03          25,750           0.5            12,875
 statement of identity labeling
 requirements...................
101.4, 101.22, 101.100, 102,              25,000            1.03          25,750           1              25,750
 104, and 105; ingredient
 labeling requirements..........
101.5; requirement to specify             25,000            1.03          25,750           0.25            6,438
 the name and place of business
 of the manufacturer, packer, or
 distributor and, if the food
 producer is not the
 manufacturer of the food
 product, its connection with
 the food product...............
101.9, 101.13(n), 101.14(d)(3),           25,000            1.03          25,750           4             103,000
 101.62, and 104; labeling
 requirements for disclosure of
 nutrition information..........
101.9(g)(9) and 101.36(f)(2);                 12            1                 12           4                  48
 alternative means of compliance
 permitted......................

101.10; requirements for                 300,000            1.5          450,000           0.25          112,500
 nutrition labeling of
 restaurant foods...............
101.12(b); RACC for baking                    29            2.3               67           1                  67
 powder, baking soda, and pectin
101.12(e); adjustment to the                  25            1                 25           1                  25
 RACC of an aerated food
 permitted......................
101.12(g); requirement to                  5,000            1              5,000           1               5,000
 disclose the serving size that
 is the basis for a claim made
 for the product if the serving
 size on which the claim is
 based differs from the RACC....
101.13(d)(1) and 101.67;                     200            1                200           1                 200
 requirements to disclose
 nutrition information for any
 food product for which a
 nutrient content claim is made.
101.13(j)(2), 101.13(k), 101.54,           5,000            1              5,000           1               5,000
 101.56, 101.60, 101.61, and
 101.62; additional disclosure
 required if the nutrient
 content claim compares the
 level of a nutrient in one food
 with the level of the same
 nutrient in another food.......
101.13(q)(5); requirement that           300,000            1.5          450,000           0.75          337,500
 restaurants disclose the basis
 for nutrient content claims
 made for their food............
101.14(d)(2); general                    300,000            1.5          450,000           0.75          337,500
 requirements for disclosure of
 nutrition information related
 to health claims for food
 products.......................
101.15; requirements pertaining              160           10              1,600           8              12,800
 to prominence of required
 statements and use of foreign
 language.......................
101.22(i)(4); supplier                        25            1                 25           1                  25
 certifications for flavors
 designated as containing no
 artificial flavors.............
101.30 and 102.33; labeling                1,500            5              7,500           1               7,500
 requirements for fruit or
 vegetable juice beverages......
101.36; nutrition labeling of                300           40             12,000           4.025          48,300
 dietary supplements............
101.42 and 101.45; nutrition               1,000            1              1,000           0.5               500
 labeling of raw fruits,
 vegetables, and fish...........
101.45(c); databases of nutrient               5            4                 20           4                  80
 values for raw fruits,
 vegetables, and fish...........
101.79(c)(2)(i)(D); disclosure             1,000            1              1,000           0.25              250
 requirements for food labels
 that contain a folate/neural
 tube defect health claim.......
101.79(c)(2)(iv); disclosure of              100            1                100           0.25               25
 amount of folate for food
 labels that contain a folate/
 neural tube defect health claim
101.100(d); disclosure of                  1,000            1              1,000           1               1,000
 agreements that form the basis
 for exemption from the labeling
 requirements of section 403(c),
 (e), (g), (h), (i), (k), and
 (q) of the FD&C Act............
101.105 and 101.100(h);                   25,000            1.03          25,750           0.5            12,875
 disclosure requirements for
 food not accurately labeled for
 quantity of contents and for
 claiming certain labeling
 exemptions.....................
    Total.......................                                                                       1,029,258
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
         21 CFR section             Number of      records per     Total annual         per         Total hours
                                  recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
101.12(e); recordkeeping to                  25              1                25            1                 25
 document the basis for density-
 adjusted RACC.................
101.13(q)(5); recordkeeping to          300,000              1.5         450,000            0.75         337,500
 document the basis for
 nutrient content claims.......
101.14(d)(2); recordkeeping to          300,000              1.5         450,000            0.75         337,500
 document nutrition information
 related to health claims for
 food products.................
101.22(i)(4); recordkeeping to               25              1                25            1                 25
 document supplier
 certifications for flavors
 designated as containing no
 artificial flavors............
101.100(d)(2); recordkeeping              1,000              1             1,000            1              1,000
 pertaining to agreements that
 form the basis for an
 exemption from the labeling
 requirements of section
 403(c), (e), (g), (h), (i),
 (k), and (q) of the FD&C Act..

101.105(t); recordkeeping                   100              1               100            1                100
 pertaining to disclosure
 requirements for food not
 accurately labeled for
 quantity of contents..........
    Total......................                                                                          676,150
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     21 CFR Section/Form No.         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
101.9(j)(18) and 101.36(h)(2);            10,000               1          10,000               8          80,000
 procedure for small business
 nutrition labeling exemption
 notice using Form FDA 3570.....
101.12(h); petitions to                        5               1               5              80             400
 establish or amend a RACC......
101.69; petitions for nutrient                 3               1               3              25              75
 content claims.................
101.70; petitions for health                   5               1               5              80             400
 claims.........................
101.108; written proposal for                  1               1               1              40              40
 requesting temporary exemptions
 from certain regulations for
 the purpose of conducting food
 labeling experiments...........
                                 -------------------------------------------------------------------------------
    Total.......................                                                                          80,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated annual third-party disclosure, recordkeeping, and
reporting burdens are based on our communications with industry and our
knowledge of and experience with food labeling and the submission of
petitions and requests to us.
    As noted, we are revising this collection to include previously
approved third-party disclosure burdens associated with the requirement
to declare the amount of trans fatty acids present in a food, including
dietary supplements. The third-party disclosure burden hours formerly
associated with OMB control number 0910-0515 (collection entitled,
``Food Labeling: Trans Fatty Acids in Nutrition Labeling'') are
represented by the citation to Sec.  101.9 on line 4 of table 1 and the
citation to Sec.  101.36 on line 17 of table 1. For this revision, we
have not added burden hours to line 4 or line 17 of table 1 because,
based on our experience with food labeling, the 4 hours estimated for
meeting the labeling requirements of Sec.  101.9 and the 4 hours
estimated for meeting the labeling requirements of Sec.  101.36 are
appropriate estimates of the total time it takes a respondent to meet
our requirements for nutrition labeling in Sec. Sec.  101.9 and 101.36.
    We are also revising this collection to include previously approved
third-party disclosure burdens associated with the voluntary
declaration of the quantitative amount and the percent of Daily Value
of a dietary ingredient on a ``per day'' basis in addition to the
required ``per serving'' basis. The third-party disclosure burden hours
formerly associated with OMB control number 0910-0395 (collection
entitled, ``Food Labeling: Nutrition Labeling of Dietary Supplements on
a `Per Day' Basis'') are represented by the citation to Sec.  101.36 on
line 17 of Table 1 and the addition of 300 hours to our previous
estimate of 48,000 hours. For this revision, we added 300 burden hours
to line 17 of table 1 because voluntary labeling on a ``per day'' basis
is in addition to the required ``per serving'' basis. We estimate that
``per day'' information would generally be placed on, at most, 10
percent of the estimated 12,000 disclosures, for a total of 1,200
annual disclosures, and that a respondent will spend 15 minutes (0.25
hours) per disclosure, for a total of 300 hours. Thus, the total
estimated burden on line 17 of table 1 is 48,300 hours and average
burden per disclosure on line 17 of table 1 has been increased from 4.0
to 4.025 hours, to represent an averaging of the burden hours across
all of the estimated 12,000 disclosures.
    We expect that the burden hours for submissions under Sec.  101.108
will be insignificant. Section 101.108 was originally issued to provide
a procedure whereby we could grant exemptions from certain food
labeling requirements. Exemption petitions have infrequently been
submitted in the recent past; none have been submitted since
publication on January 6, 1993, of the final regulations implementing
section 403(q) and (r) of the FD&C Act. Thus, in order to maintain OMB
approval of Sec.  101.108 to accommodate the possibility that a food
producer may propose to conduct a labeling experiment on its own
initiative, we estimate that we will receive one or fewer submissions
under Sec.  101.108 in the next 3 years.

    Dated: December 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31215 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 170 (Friday, August 31, 2018)]
[Notices]
[Page 44615]
[FR Doc No: 2018-18945]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER18-2308-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization; K&K Wind
Enterprises, LLC

    This is a supplemental notice in the above-referenced proceeding
K&K Wind Enterprises, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 17, 2018.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
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    Dated: August 27, 2018..
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-18945 Filed 8-30-18; 8:45 am]
 BILLING CODE 6717-01-P