[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36349-36356]
[FR Doc No: 2011-15266]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0474; FRL-8877-1]

Diethylene Glycol MonoEthyl Ether (DEGEE); Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Diethylene Glycol MonoEthyl Ether
(DEGEE) when used as an inert ingredient as a solvent, stabilizer and/
or antifreeze within pesticide formulations/products, for preharvest
use on growing crops and raw agricultural commodities, without
limitation. Huntsman, Dow AgroSciences L.L.C., Nufarm Americas Inc.,
BASF, Stepan Company, Loveland Products Inc., and Rhodia Inc. submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of DEGEE on growing crops and
raw agricultural commodities.

DATES: This regulation is effective June 22, 2011. Objections and
requests for hearings must be received on or before August 22, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0474. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Lisa Austin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0474 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 22, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2008-0474, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Exemption

    In the Federal Register of July 9, 2008 (73 FR 39291) (FRL-8371-2),
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 8E7355) by Huntsman,
10003 Woodloch Forest Drive, The Woodlands, TX 77380; Dow AgroSciences
L.L.C., 9330 Zionsville Road, Indianapolis, Indiana 46268; Nufarm
Americas Inc., 150 Harvester Drive, Suite 220, Burr Ridge, Illinois,
60527; BASF, 26 Davis Drive, Research Triangle Park, NC 27709; Stepan
Company, 22 W. Frontage Road, Northfield, IL 60093; Loveland Products
Inc., PO Box 1286, Greeley, CO 80632; and Rhodia Inc., CN 1500,
Cranbury, New Jersey, 08512. The petition requested that 40 CFR 180.920
be amended by establishing an exemption from the requirement of a
tolerance for residues of DEGEE (CAS Reg. No. 111-90-0) when used as an
inert ingredient, as a solvent, stabilizer and/or antifreeze

in pesticide formulations applied to growing crops and raw agricultural
commodities pre-harvest without limitation. That notice referenced a
summary of the petition prepared by Huntsman, Dow AgroSciences L.L.C.,
Nufarm Americas Inc., BASF, Stepan Company, Loveland Products Inc., and
Rhodia Inc., the petitioners, which is available in the docket, http://www.regulations.gov. The Agency received one comment in response to the
notice of filing.
    Currently, there is a tolerance exemption for DEGEE under 40 CFR
180.920 when it is used as a deactivator for formulations used before
the crops emerge from the soil and stabilizer. This document provides
an assessment of the risk to human health and the environment for DEGEE
when used as a pesticide inert ingredient as a solvent, stabilizer and/
or antifreeze within pesticide formulations/products without
limitation.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. * * * ''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for DEGEE including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with DEGEE follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by DEGEE as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
    The following toxicity data on DEGEE were summarized from these
sources, the World Health Organization (WHO), National Toxicology
Program (NTP), Hazardous Substances Data Base (HSDB) and BIBRA
Toxicology Advisory and Consulting (1976, 2003, respectively). DEGEE
has low acute toxicity via oral and dermal routes. It is moderately
irritating to the skin and is mildly irritating to the eye. It is not a
skin sensitizer.
    Several subchronic studies with DEGEE were available in rodents,
ferrets and pigs. In rodents, toxicity was primarily manifested in the
kidneys and liver. Increased kidney weights, tubular dilatation and
centrilobular hepatocyte enlargement were seen at doses > 2,500
milligrams/kilogram/day (mg/kg/day). In ferrets, effects in the kidney
were also observed. The concentrating power of the kidney was decreased
and water intake was decreased at > 2.0 milliliter (mL)/kg/day (2,240
mg/kg/day). Kidney and liver effects were also observed in pigs. Kidney
weights were increased, tubular hydropic degeneration and enlarged
centrilobular and midzonal hepatocytes with pyknotic nuclei and fatty
infiltration were observed at > 500 mg/kg/day.
    A subchronic inhalation study with DEGEE in the rat was also
available. No effects were observed at doses up to 1.1 milligrams/liter
(mg/L) (approximately 314 mg/kg/day).
    Several chronic carcinogenicity studies with DEGEE were available
in rodents. However, these studies were conducted with a limited number
of animals and doses and a complete histopathological examination was
not performed. Due to these deficiencies, a definitive conclusion
regarding carcinogenicity of DEGEE cannot be made on the basis of these
studies. However, there were no obvious tumors detected in mice and
rats.
    Developmental studies with DEGEE in rodents were available for
review. Fetal susceptibility was not observed in these studies.
Parental (mortality and reduced body weight) and offspring (reduced
mean pup birth weight) toxicity were observed in mice at the high dose
(2,500 mg/kg/day). In a developmental toxicity study in rats via the
dermal route of exposure, maternal toxicity was manifested as decreased
body weight at 6,615 mg/kg/day. Developmental toxicity was not observed
at this dose. In an inhalation developmental toxicity study in rats,
maternal and developmental toxicity were not observed up to 100 parts
per million (ppm) (approximately 31 mg/kg/day).
    Two reproduction toxicity studies were available for review with
DEGEE in rodents. One study in rats reported that increased urinary
protein, bladder calculi, epithelial necrosis of the renal

tubules and cloudy swelling of hepatic tissue were observed in all
animals at 920 mg/kg/day of DEGEE with less than 0.2% of ethylene
glycol. The NOAEL in this study was 200 mg/kg/day. In another study in
mice, offspring toxicity (decreased live pup weights, decreased
absolute brain and liver weights) and parental toxicity (increase water
intake and decreased body weight in males) occurred at 2,500 mg/kg/day.
There were no effects on reproductive parameters in either study.
    Several mutagenicity studies (Ames test, micronucleus assay and
unscheduled DNA synthesis) with DEGEE were available for review. One
Ames test reported ambiguous results, another reported positive results
at high doses. However, in vivo assays (micronucleus and unscheduled
DNA synthesis) reported negative results. Therefore, based on the
weight of evidence, DEGEE is not considered mutagenic.
    As noted, available long-term carcinogenicity studies were
considered inadequate to fully assess DEGEE's potential to cause
cancer; however, these studies in mice and rats do not report any
tumors. DEGEE belongs to the glycol ether class of chemicals which
include structurally similar chemicals ethylene glycol (EG) and
diethylene glycol (DEG). EG and DEG have toxicities similar to DEGEE.
Target organs of toxicity are the kidney and liver. There was no
evidence of carcinogenicity in rats and mice when treated with EG
(NTP). Bladder tumors were observed in rats treated with DEG at >1,500
mg/kg/day, however, these tumors were secondary to irritation from
bladder stones. The resulting classification for EG and DEG was that
they are not expected to pose a carcinogenic risk in humans. Therefore,
the carcinogenicity data on EG and DEG were used to assess the cancer
potential of DEGEE. Based on the lack of evidence of carcinogenicity
potential for EG and DEG, lack of tumors in mice and rats with DEGEE,
and the fact that DEGEE is not mutagenic, DEGEE is not expected to be
carcinogenic to humans. Also, the established chronic reference dose/
chronic population adjusted dose (cRfD/cPAD) (2.0 mg/kg/day) for DEGEE
will be protective of effects leading to kidney damage and tumor
formation seen at >1,500 mg/kg/day following DEG exposures.
    Immunotoxicity studies for DEGEE were not available for review.
However, DEGEE belongs to the glycol ethers class of chemicals.
Immunotoxicity studies were available for ethylene glycol mono butyl
ether (DEGBE), also a glycol ether differing in only one ethyl and
butyl group from DEGEE. These data were used to assess the immunotoxic
potential of DEGEE. Signs of potential immunotoxicity were not observed
in any of the available studies for the surrogate chemical. Nor was
there evidence of immunotoxicity potential in any of the studies
submitted for DEGEE. Therefore, DEGEE is not expected to be
immunotoxic.
    Dermal absorption studies were available with DEGEE. In a study
using human epidermal membranes, the absorption rate of DEGEE was 0.206
mg/cm\2\/hr.
    The available metabolism data in an adult human revealed that 68%
of the administered dose of DEGEE was excreted in the urine as (2-
ethoxy) acetic acid. In a metabolism study in the rabbit, oral or
subcutaneous exposure to DEGEE resulted in the excretion of glucuronic
acid in the urine; the major part of the dose was oxidized.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for DEGEE used for human
risk assessment is shown in the following table.

         Table--Summary of Toxicological Doses and Endpoints for DEGEE for Use in Human Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary general population                 An acute endpoint was not identified in the database.
 including Females 13-50 years of age.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 200 mg/kg/day..  Chronic RfD = 2.0 mg/kg/ Reproduction Toxicity
                                       UFA = 10x..............   day cPAD = 2.0 mg/kg/    Study with chronic/
                                       UFH = 10 x.............   day.                     carcinogenicity
                                       FQPA SF = 1x...........                            measurements--rat
                                                                                LOAEL = 920 mg/kg bw/
                                                                                day, based on
                                                                                decreased growth,
                                                                                epithelial necrosis of
                                                                                renal tubules and
                                                                                cloudy swelling of
                                                                                hepatic tissue.

Incidental oral short-term (1 to 30    NOAEL= 200 mg/kg/day...  LOC for MOE = 100......  Reproduction Toxicity
 days).                                UFA = 10x..............                            Study with chronic/
                                       UFH = 10 x.............                            carcinogenicity
                                       FQPA SF = 1x...........                            measurements--rat
                                                                                LOAEL = 920 mg/kg bw/
                                                                                day, based on
                                                                                decreased growth,
                                                                                epithelial necrosis of
                                                                                renal tubules and
                                                                                cloudy swelling of
                                                                                hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term (1   NOAEL= 200 mg/kg/day...  LOC for MOE = 100......  Reproduction Toxicity
 to 6 months).                         UFA = 10x..............                            Study with chronic/
                                       UFH = 10 x.............                            carcinogenicity
                                       FQPA SF = 1x...........                            measurements--rat
                                                                                LOAEL = 920 mg/kg bw/
                                                                                day, based on
                                                                                decreased growth,
                                                                                epithelial necrosis of
                                                                                renal tubules and
                                                                                cloudy swelling of
                                                                                hepatic tissue.
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Dermal short-term (1 to 30 days).....  NOAEL= 200 mg/kg/day     LOC for MOE = 100......  Reproduction Toxicity
                                        (dermal absorption                                Study with chronic/
                                        rate = 25%).                                      carcinogenicity
                                       UFA = 10x..............                            measurements--rat
                                       UFH = 10x..............                            LOAEL = 920 mg/kg bw/
                                       FQPA SF = 1x...........                            day, based on
                                                                                decreased growth,
                                                                                epithelial necrosis of
                                                                                renal tubules and
                                                                                cloudy swelling of
                                                                                hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (1 to 6       NOAEL= 200 mg/kg/day     LOC for MOE = 100......  Reproduction Toxicity
 months).                               (dermal absorption                                Study with chronic/
                                        rate = 25% when                                   carcinogenicity
                                        appropriate).                                     measurements--rat
                                       UFA = 10x..............                            LOAEL = 920 mg/kg bw/
                                       UFH = 10x..............                            day, based on
                                       FQPA SF = 1x...........                            decreased growth,
                                                                                epithelial necrosis of
                                                                                renal tubules and
                                                                                cloudy swelling of
                                                                                hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 days).  Inhalation (or oral)     LOC for MOE = 100......  Reproduction Toxicity
                                        study NOAEL= 200 mg/kg/                           Study with chronic/
                                        day (inhalation                                   carcinogenicity
                                        absorption rate =                                 measurements--rat
                                        100%).                                            LOAEL = 920 mg/kg bw/
                                       UFA = 10x..............                            day, based on
                                       UFH = 10x..............                            decreased growth,
                                       FQPA SF = 1x...........                            epithelial necrosis of
                                                                                renal tubules and
                                                                                cloudy swelling of
                                                                                hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Inhalation (1 to 6 months)...........  Inhalation (or oral)     LOC for MOE = 100......  Reproduction Toxicity
                                        study NOAEL = 200 mg/                             Study with chronic/
                                        kg/day (inhalation                                carcinogenicity
                                        absorption rate =                                 measurements--rat
                                        100%).                                            LOAEL = 920 mg/kg bw/
                                       UFA = 10x..............                            day, based on
                                       UFH = 10x..............                            decreased growth,
                                       FQPA SF = 1x...........                            epithelial necrosis of
                                                                                renal tubules and
                                                                                cloudy swelling of
                                                                                hepatic tissue.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....    Based on the lack of tumors in a study with DEGEE and carcinogenicity
                                         data available for the structurally similar chemicals, EG and DEG, and
                                        that DEGEE is not mutagenic, DEGEE is not expected to be carcinogenic to
                                                                         humans.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to DEGEE, EPA considered exposure under the proposed exemption
from the requirement of a tolerance. EPA assessed dietary exposures
from DEGEE in food as follows:
    i. Acute exposure. No adverse effects attributable to a single
exposure of DEGEE were seen in the toxicity databases. Therefore, an
acute dietary exposure assessment for DEGEE is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the U.S.

Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, no residue data were submitted for DEGEE. In the
absence of specific residue data, EPA has developed an approach which
uses surrogate information to derive upper bound exposure estimates for
the subject inert ingredient. Upper bound exposure estimates are based
on the highest tolerance for a given commodity from a list of high use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,''
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest levels of
tolerances would be no higher than the concentration of the active
ingredient.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100 percent of all foods are treated with the
inert ingredient at the rate and manner necessary to produce the
highest residue legally possible for an active ingredient. In summary,
EPA chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    iii. Cancer. As discussed above, the Agency has not identified any
concerns for carcinogenicity relating to DEGEE, and, therefore, a
dietary exposure assessment to assess cancer risk is unnecessary.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for DEGEE, a conservative
drinking water concentration value of 100 parts per billion (ppb) based
on screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    DEGEE may be used in inert ingredients in products that are
registered for specific uses that may result in residential exposure. A
screening level residential exposure and risk assessment was completed
for products containing DEGEE as inert ingredients. The Agency selected
representative scenarios, based on end-use product application methods
and labeled application rates. The Agency conducted an assessment to
represent worst-case residential exposure by assessing DEGEE in
pesticide formulations (Outdoor Scenarios) and DEGEE in disinfectant-
type uses (Indoor Scenarios). The Agency is not aware of any use of
DEGEE in hard surface cleaning products. However, this scenario was
used for this assessment considering wide use of DEGEE in other
products. Therefore, the Agency assessed the disinfectant-type products
containing DEGEE using exposure scenarios used by the Antimicrobials
Division in EPA's Office of Pesticide Programs to represent worst-case
residential handler exposure. Further details of this residential
exposure and risk analysis can be found at http://www.regulations.gov
in the memorandum entitled: ``JITF Inert Ingredients. Residential and
Occupational Exposure Assessment Algorithms and Assumptions Appendix
for the Human Health Risk Assessments to Support Proposed Exemption
from the Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID
number EPA-HQ-OPP-2008-0710.
    In addition to pesticidal uses for DEGEE, there are non-pesticidal
uses for DEGEE. However, dermal and inhalation exposure are expected to
be negligible; therefore, a quantitative exposure assessment was not
conducted.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found DEGEE to share a common mechanism of toxicity
with any other substances, and DEGEE does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that DEGEE does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to

evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Fetal susceptibility was not
observed in the developmental toxicity studies with DEGEE in the mouse.
Developmental studies were available via the oral (mice), dermal (rats)
and inhalation (rats) routes of exposure in rodents. Following oral
exposure to DEGEE, maternal (mortality and reduced body weight) and
offspring (reduced mean pup birth weight) toxicity were observed in
mice at the high dose (2,500 mg/kg/day). Following dermal exposure to
DEGEE, maternal toxicity was manifested as decreased body weight at
6,615 mg/kg/day in rats. Developmental toxicity was not observed at
this dose. Following inhalation exposure to DEGEE, maternal and
developmental toxicity were not observed up to 100 ppm (approximately
31 mg/kg/day) in rats. A developmental toxicity study in rabbits is not
available in the database. However, the concern for the lack of this
study is low because toxicity was observed near the limit dose in the
developmental and reproduction studies in rodents (>920 mg/kg/day).
    Evidence of increased fetal susceptibility was observed in a
reproduction toxicity study in the mice. Offspring toxicity was
manifested as decreased adjusted live pup weight and absolute brain
weights and increased liver weights in the absence of parental
toxicity. There is no concern for this increased susceptibility in mice
because these pup effects were observed at a dose 2.5 times above the
limit dose of 1,000 mg/kg/day and a clear NOAEL was established in the
study. It is unclear if there is fetal susceptibility in the
reproduction toxicity study in rats. In this study, it was stated that
increased urinary protein, bladder calculi, epithelial necrosis of the
renal tubules and cloudy swelling of hepatic tissue were observed in
all animals at 920 mg/kg/day (NOAEL 200 mg/kg/day). It is not clear
whether all animals referred in the study include both the parental and
F1 animals or not. However, in any case the concern for fetal
susceptibility is low because the aforementioned effects occured near
the limit dose and the cRfD (2.0 mg/kg/day) will be protective of these
effects.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for DEGEE is adequate for FQPA assessment.
The following acceptable studies are available: Developmental and
reproduction toxicity studies in mice and rats, subchronic and
mutagenicity studies. A 2-generation reproduction toxicity study where
tumors were evaluated is available. Also, chronic/carcinogenicity
studies are available on a surrogate chemical, ethylene glycol. A
developmental toxicity study in rabbits is not available in the
database. However, the concern for the lack of this study is low
because toxicity was observed at or above the limit dose in the
developmental and reproduction studies in rodents.
    ii. Signs of neurotoxicity were not observed in a reproduction
toxicity study in rats. Decreased absolute brain weights were observed
in the offspring at 2,500 mg/kg/day. However, a developmental
neurotoxicity study is not required because decreased brain weights
were observed above the limit dose (1,000 mg/kg/day), the effect
occurred in the presence of maternal toxicity and the cRfD (2.0 mg/kg/
day) will be protective of this effect. Therefore, there is no need for
a developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
    iii. There is evidence that DEGEE results in increased fetal
susceptibility in the multi-generation reproduction study in the mouse.
However, the concern for fetal susceptibility is low because the
effects seen in the offspring (adjusted live pup weight and absolute
brain weights and increased liver weights) occur at 2,500 mg/kg/day
(2.5times the limit dose), the effects occur in the absence of maternal
toxicity, a clear NOAEL (1,250 mg/kg/day) was established and the cRfD
(2.0 mg/kg/day) will be protective of these effects.
    iv. Immunotoxicity studies for DEGEE were not available for review.
However, DEGEE belongs to the glycol ethers class of chemicals.
Immunotoxicity studies were available for ethylene glycol monobutyl
ether, also a glycol ether. This data were used to assess the
immunotoxic potential of DEGEE. Signs of potential immunotoxicity were
not observed in any of the available studies for the surrogate
chemical. Nor was there evidence of immunotoxicity potential in any of
the studies submitted for DEGEE. Therefore, DEGEE is not expected to be
immunotoxic.
    v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated (CT) and tolerance-level residues. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to DEGEE in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
DEGEE.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. EPA determines whether acute and
chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For
linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
DEGEE is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
DEGEE from food and water will utilize 0.10% of the cPAD for the
general U.S. population and 0.31% of the cPAD for children 1 to 2 years
old, the population group receiving the greatest exposure. Based on the
explanation in this unit, regarding residential use patterns, chronic
residential exposure to residues of DEGEE is not expected.

    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    DEGEE is currently used as an inert ingredient in pesticide
products that are registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to DEGEE.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 264 for both
adult males and females, respectively. Adult residential exposure
combines high end dermal and inhalation handler exposure from homeowner
mixer/loader/applicators using a trigger sprayer with a high end post
application dermal exposure from contact with treated lawns. As the
level of concern is for MOEs that are lower than 100, this MOE is not
of concern. EPA has concluded that the combined short-term aggregated
food, water, and residential exposures result in an aggregate MOE of
228 for children. Children's residential exposure includes total
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). Because EPA's level of concern for DEGEE is a MOE
of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    DEGEE is currently used as an inert ingredient in pesticide
products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to DEGEE.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 777 for adult males and females. Adult residential
exposure combines high end dermal and inhalation handler exposure from
homeowner mixer/loader/applicators using a trigger sprayer with a high
end post application dermal exposure from contact with treated lawns.
EPA has concluded the combined intermediate-term aggregated food,
water, and residential exposures result in an aggregate MOE of 267 for
children. Children's residential exposure includes total exposures
associated with contact with treated lawns (dermal and hand-to-mouth
exposures). Because EPA's level of concern for DEGEE is a MOE of 100 or
below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. DEGEE is not expected
to pose a carcinogenic risk in humans based on the discussion in Unit
IV.A.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to DEGEE residues.

V. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for DEGEE.

C. Response to Comments

    The comment was received from private citizens who opposed the
authorization to sell any pesticide that leaves a residue on food. The
Agency understands the commenter's concerns and recognizes that some
individuals believe that no residue of pesticides should be allowed.
However, under the existing legal framework provided by section 408 of
the Federal Food, Drug and Cosmetic Act (FFDCA) EPA is authorized to
establish pesticide tolerances or exemptions where persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by the statute.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for DEGEE (CAS Reg. No. 111-90-0) when
used as an inert ingredient (as a solvent, stabilizer and/or antifreeze
within pesticide formulations/products without limitation) in pesticide
formulations applied to growing crops and raw agricultural commodities
pre-harvest.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from tolerance under
section 408(d) of FFDCA in response to a petition submitted to the
Agency. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because
this final rule has been exempted from review under Executive Order
12866, this final rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,

the Agency has determined that this action will not have a substantial
direct effect on States or Tribal governments, on the relationship
between the national government and the States or Tribal governments,
or on the distribution of power and responsibilities among the various
levels of government or between the Federal Government and Indian
Tribes. Thus, the Agency has determined that Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000) do not apply to this final
rule. In addition, this final rule does not impose any enforceable duty
or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 10, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.920, the table is amended by adding alphabetically the
following inert ingredient:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert ingredients              Limits                Uses
------------------------------------------------------------------------

                              * * * * * * *
Diethylene Glycol MonoEthyl     Without            Solvent, stabilizer
 Ether (CAS Reg. No. 111-90-0).  limitation.        and/or antifreeze.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2011-15266 Filed 6-21-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14325-14327]
[FR Doc No: 2022-05304]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0008; Notice 2]

Daimler Trucks North America, Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: Daimler Trucks North America (DTNA) has determined that
certain model year (MY) 2017-2019 Freightliner Cascadia motor vehicles
do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS)
No. 108, Lamps, Reflective Devices, and Associated Equipment. DTNA
filed a noncompliance report dated January 16, 2019. DTNA subsequently
petitioned NHTSA on February 8, 2019, for a decision that the subject
noncompliance is inconsequential as it relates to motor vehicle safety.
This document announces the grant of DTNA's petition.

FOR FURTHER INFORMATION CONTACT: Leroy Angeles, Office of Vehicle
Safety Compliance, the National Highway Traffic Safety Administration
(NHTSA), telephone<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Overview

    DTNA has determined that certain MY 2017-2019 Freightliner Cascadia
motor vehicles do not fully comply with paragraph S6.2.1 of FMVSS No.
108, Lamps, Reflective Devices, and Associated Equipment (49 CFR
571.108). DTNA filed a noncompliance report dated January 16, 2019,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports. DTNA subsequently petitioned NHTSA on February 8, 2019,
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential as it relates to motor vehicle safety pursuant to 49
U.S.C. 30118(d) and 30120(h) and 49 CFR part 556, Exemption for
Inconsequential Defect or Noncompliance.
    Notice of receipt of DTNA's petition was published with a 30-day
public comment period, on February 27, 2020, in the Federal Register
(85 FR 11450). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) website at https://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2019-0008.''

II. Trucks Involved

    Approximately 74,675 MY 2017-2019 Freightliner Cascadia motor
vehicles, manufactured between May 3, 2016, and December 17, 2018, are
potentially involved.

III. Noncompliance

    DTNA described the noncompliance as automatic illumination of the
stop lamps when the low air pressure warning indicator light
illuminates. Since low air pressure does not necessarily activate the
brakes or result in braking without driver intervention, this
activation of the stop lamps does not meet the requirements of S6.2.1
of FMVSS No. 108.

IV. Rule Requirements

    Paragraph S6.2.1 of FMVSS No. 108 includes the requirements
relevant to this petition. No additional lamp, reflective device, or
other motor vehicle equipment is permitted to be installed that impairs
the effectiveness of lighting equipment required by FMVSS No. 108.

V. Summary of DTNA's Petition

    The following views and arguments presented in this section, ``V.
Summary of DTNA's Petition,'' are the views and arguments provided by
DTNA.
    DTNA described the subject noncompliance and stated its belief that
the noncompliance is inconsequential as it relates to motor vehicle
safety.
    DTNA submitted the following background information on how their
air brake system affects the stop lamps:
    DTNA's air brake system is comprised of two brake systems, primary
and secondary. The primary system controls the service brakes on the
drive axles, and the secondary system controls the service brakes on
the steer axle, in which the higher pressure of these two controls the
trailer service brakes. These two systems are isolated from each other
so that if there is an air loss in one system, the other system will
still be functional to control the vehicle service brakes. When either
one of the systems drops below 70 psi, the low air warning indicator
light on the dash turns ON and the stop lamps illuminate. However, if
this occurs, it does not mean that the drive axle parking brakes being
applied, since the other brake system may still be functional and
keeping the brake from applying. In such a situation, the air that
holds off the drive axle parking brakes would be the higher pressure of
either primary or secondary air brake. In other words, if the primary
air brake pressure falls below 70 psi, the indicator light and stop
lamps illuminate, but the parking brakes do not start to drag since the
secondary air (presumably unaffected) remains high and holds off the
parking springs. In the same manner, the trailer parking brakes are
held off by the higher of either primary or secondary air brake system.
Only when both air systems drop below about 70 psi will the trailer
parking brakes begin to apply.
    DTNA submitted the following views and arguments in support of the
petition:
    1. The normal operating air pressure of the vehicle is between 110
and 130

psi. There is a regulator that turns on the air compressor if the air
pressure is below 110 psi and turns off the air compressor when the
system pressure is above 130 psi. If the air pressure begins to drop
and reaches approximately 70 psi, the air system pressure is not
adequate to maintain optimum operation, so a warning indicator light
illuminates on the dash and a buzzer activates to alert the driver to
this condition. On these vehicles, the stop lamps illuminate when the
warning indiactor light illuminates on the dash. The events induced by
a low air condition after initial vehicle startup are rare and are not
expected in normal operation. If the condition were to occur during
operation, the driver would be alerted to the circumstances with
audible and visual low air warning signals and would be expected to
apply the service brakes and pull over in a safe manner. Additionally,
if the pressure in both air systems drops below 70 psi, the parking
brakes will slowly begin to apply.
    2. The Freightliner Cascadia Driver's Manual states ``If the low
air pressure warning is activated, check the air pressure gauges to
determine which system has low air pressure. Although the vehicle's
speed can be reduced using the foot brake control pedal, either the
front or rear service brakes will not be operating at full capacity,
causing a longer stopping distance. Bring the vehicle to a safe stop
and have the air system repaired before continuing.''
    3. Brakes are commonly applied causing the stop lamps to illuminate
when a driver sees a vehicle display warning or senses that the vehicle
is experiencing a problem. Reducing vehicle speed in relation to a
vehicle operational problem increases safety, providing following
drivers the opportunity to increase the following distance. A low air
warning indicator light would likely cause the vehicle driver to
immediately engage the brake system and bring the vehicle to a safe
stop. Stop lamp illumination for a brake system low air event would
help provide early warning to following drivers to slow down.
    4. DTNA stated, in ``Motorcoach Brake Systems and Safety
Technologies,'' the Federal Motor Carrier Safety Administration issued
guidance, while directed toward motorcoach drivers, that supports the
expectation that a driver, upon receipt of a low-pressure warning,
would apply brakes and pull off the roadway. FMCSA stated: ``Low
Pressure Warning--In most cases, you should notice an air leak or
malfunction before getting a low-pressure warning; however, when a low-
pressure warning occurs, immediately bring the motorcoach to a safe
stop, off of the roadway. Continuing to operate the motorcoach could
result in an automatic application of the park brakes, possibly leading
to a loss of control or a stop in an unsafe position.''
    5. DTNA is not aware of any accidents, injuries, owner complaints,
or field reports related to this condition on the subject vehicles.
    6. DTNA also stated that NHTSA has previously granted petitions for
decisions of inconsequential noncompliance for lighting requirements
where technical noncompliance exists, but does not create a negative
impact on safety:
     In General Motors Corporation; Grant of Application for
Decision of Inconsequential Noncompliance. 66 FR 32871 (June 18, 2001)
a petition for inconsequentiality by General Motors Corporation was
granted by NHTSA. In this instance, certain models could have
unintended CHMSL illumination briefly if the hazard warning lamp switch
is depressed to its limit of travel.
     In General Motors, LLC, Grant of Petition for Decision of
Inconsequential Noncompliance, a petition for inconsequentiality by
General Motors, LLC (GM) was granted by NHTSA. See 83 FR 7847 (February
22, 2018). In this instance, under certain conditions, the parking
lamps on the subject vehicles fail to meet the requirement that parking
lamps must be activated when headlamps are activated in a steady
burning state.
     In Grant of Application for Determination of
Inconsequential Noncompliance with FMVSS No. 108, a petition for
inconsequentiality by General Motors Corporation was granted by NHTSA.
See 64 FR 48231 (September 2, 1999). In this instance, a certain model
equipped with an electronic turn signal was affected by random inputs
that cause the internal timing of the electronic circuit to become
unsynchronized causing the left front turn signal lamp to flash at a
rapid rate while the left rear turn signal lamp illuminates but does
not flash. These conditions can continue after the turn signal lever
automatically returns to the off position.
    7. DTNA believes that a technical noncompliance exists but does not
create a negative impact on safety when the brake lamps illuminate
during a brake system low air warning event. The stop lamp illumination
serves to emphasize the message to following drivers that the vehicle
is experiencing trouble and they should pay close attention. The Brake
Air warning indicator light, on the driver's display panel, shows the
driver that there is an issue with the air brake system. This would
result in the driver bringing the vehicle to a safe stop and having the
air system repaired before continuing.
    DTNA concluded by expressing its belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.

VI. NHTSA's Analysis

    The burden of establishing the inconsequentiality of a failure to
comply with a performance requirement in a standard--as opposed to a
labeling requirement with no performance implications--is more
substantial and difficult to meet. Accordingly, the Agency has not
found many such noncompliances inconsequential.\1\ Potential
performance failures of safety-critical equipment, like seat belts or
air bags, are rarely deemed inconsequential.
---------------------------------------------------------------------------

    \1\ Cf. Gen. Motors Corporation; Ruling on Petition for
Determination of Inconsequential Noncompliance, 69 FR 19897, 19899
(Apr. 14, 2004) (citing prior cases where noncompliance was expected
to be imperceptible, or nearly so, to vehicle occupants or
approaching drivers).
---------------------------------------------------------------------------

    An important issue to consider in determining inconsequentiality is
the safety risk to individuals who experience the type of event against
which the recall would otherwise protect.\2\ In general, NHTSA does not
consider the absence of complaints or injuries to show that the issue
is inconsequential to safety. ``Most importantly, the absence of a
complaint does not mean there have not been any safety issues, nor does
it mean that there will not be safety issues in the future.'' \3\
``[T]he fact that in past reported cases good luck and swift reaction
have prevented many serious injuries does not mean that good luck will
continue to work.'' \4\
---------------------------------------------------------------------------

    \2\ See Gen. Motors, LLC; Grant of Petition for Decision of
Inconsequential Noncompliance, 78 FR 35355 (June 12, 2013) (finding
noncompliance had no effect on occupant safety because it had no
effect on the proper operation of the occupant classification system
and the correct deployment of an air bag); Osram Sylvania Prods.
Inc.; Grant of Petition for Decision of Inconsequential
Noncompliance, 78 FR 46000 (July 30, 2013) (finding occupant using
noncompliant light source would not be exposed to significantly
greater risk than occupant using similar compliant light source).
    \3\ Morgan 3 Wheeler Limited; Denial of Petition for Decision of
Inconsequential Noncompliance, 81 FR 21663, 21666 (Apr. 12, 2016).
    \4\ United States v. Gen. Motors Corp., 565 F.2d 754, 759 (D.C.
Cir. 1977) (finding defect poses an unreasonable risk when it
``results in hazards as potentially dangerous as sudden engine fire,
and where there is no dispute that at least some such hazards, in
this case fires, can definitely be expected to occur in the
future'').

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

    NHTSA has rejected petitions based on the assertion that only a
small percentage of vehicles or items of equipment are likely to
actually exhibit a noncompliance. The percentage of potential occupants
that could be adversely affected by a noncompliance does not determine
the question of inconsequentiality. Rather, the issue to consider is
the consequence to an occupant who is exposed to the consequence of
that noncompliance.\5\ These considerations are also relevant when
considering whether a defect is inconsequential to motor vehicle
safety.
---------------------------------------------------------------------------

    \5\ See Gen. Motors Corp.; Ruling on Petition for Determination
of Inconsequential Noncompliance, 69 FR 19897, 19900 (Apr. 14,
2004); Cosco Inc.; Denial of Application for Decision of
Inconsequential Noncompliance, 64 FR 29408, 29409 (June 1, 1999).
---------------------------------------------------------------------------

    NHTSA notes that DTNA misquoted the decision language pertaining to
a prior inconsequential noncompliance petition (83 FR 7847) by adding
``The Agency agrees with GM that in this case'' prior to the original
statement. NHTSA does not consider this addition accurate.
    The noncompliance, in the DTNA case currently being considered, is
that the stop lamp illuminates when a braking system low air pressure
warning indicator light is illuminated, regardless of whether the
service brakes are applied.\6\ As the subject trucks have two air brake
systems, which split the trailer brakes from the steer axle brakes, low
air pressure will cause a brake application only if air pressure is
lost in both systems. Should only one of the two air brake systems
report low air pressure, the parking brakes would not engage but the
stop lamps would illuminate in addition to the low air warning
indicator light, which includes an audible alarm. The Agency believes
that an alert would prompt the operator to safely pull over and/or
attempt to slow/stop the truck soon after the warnings appear. In that
case, the noncompliance would only result in a momentary illumination
of the stop lamps without the brakes being applied.
---------------------------------------------------------------------------

    \6\ Per FMVSS No. 108, stop lamps should only be activated upon
activation of the service brakes, or a device intended to retard the
movement of the vehicle. See FMVSS No. 108, Table I-a.
---------------------------------------------------------------------------

    If the driver of a subject vehicle did not apply the brakes
immediately after receiving a low air pressure warning, following
drivers would be presented with a false indication that the subject
truck was braking. Further, should there be an air leak, application of
the service brakes will cause the air pressure to further drop, braking
performance may be impacted, and it is also possible that the system
will no longer be able to achieve proper pressure, which subsequently
may cause the parking brakes to engage. As the function of a stop lamp
is to notify other road users that a vehicle is stopping and/or slowing
down, a vehicle equipped with an air braking system where the low air
pressure warning on the instrument cluster along with an audible
warning has been activated will likely prompt the driver to immediately
pull over and/or attempt to slow/stop the vehicle.
    A previous NHTSA interpretation concerning trailer stop lamp
illumination, requested by Wabash National Corporation, explained that
the stop lamps were permitted to be illuminated in the event that the
emergency braking system was activated when significant deceleration
could occur.\7\ NHTSA does not agree with DTNA's argument that the
activation of the stop lamps when the low air pressure warning occurs
would be helpful for a warning other drivers of the brake malfunction.
Nonetheless, NHTSA still believes this noncompliance would be
inconsequential to safety. This is because when a vehicle with air
brakes experiences a low-air event and notifies the driver of a brake
system malfunction, NHTSA believes that the driver would likely respond
by pulling over to the side of the road and taking the vehicle out of
service until the brake system can be repaired. Because the act of
pulling over to the side of the road would result in the intentional
activation of the stop lamps and this sequence of events would likely
occur only once before the vehicle is repaired, NHTSA believes that the
activation of the brake lamps due to the low air pressure event would
be inconsequential to safety.
---------------------------------------------------------------------------

    \7\ https://isearch.nhtsa.gov/files/22036.ztv.html.
---------------------------------------------------------------------------

VII. NHTSA's Decision

    In consideration of the foregoing, NHTSA finds that DTNA has met
its burden of persuasion that the subject FMVSS No. 108 noncompliance
in the affected trucks is inconsequential to motor vehicle safety.
Accordingly, DTNA's petition is hereby granted and DTNA is consequently
exempted from the obligation of providing notification of, and a free
remedy for, that noncompliance under 49 U.S.C. 30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the subject trucks that DTNA no longer controlled at
the time it determined that the noncompliance existed. However, the
granting of this petition does not relieve truck distributors and
dealers of the prohibitions on the sale, offer for sale, or
introduction or delivery for introduction into interstate commerce of
the noncompliant trucks under their control after DTNA notified them
that the subject noncompliance existed.

(Authority: 49 U.S.C. 30118, 30120: delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2022-05304 Filed 3-11-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 28007-28008]
[FR Doc No: 2018-12890]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2018-0022; OMB No. 1660-0059]

Agency Information Collection Activities: Proposed Collection;
Comment Request; National Flood Insurance Program Call Center and Agent
Referral Enrollment Form

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on an extension,
without change, of a currently approved information collection. In
accordance with the Paperwork Reduction Act of 1995, this notice seeks
comments concerning National Flood Insurance Program Call Center and
Agent Referral Enrollment Form.

DATES: Comments must be submitted on or before August 14, 2018.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2018-0022. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Susan Bernstein, FloodSmart Program
Manager, FEMA, Federal Insurance and Mitigation Administration at (202)
701-3595. You may contact the Information Management Division for
copies of the proposed collection of information at email address:
[email protected].

SUPPLEMENTARY INFORMATION: Under Flood Disaster Protection Act of 1973,
Section 2(a)(6), 42 U.S.C. 4002(a)(6), Congress finds it is in the
public interest for persons already living in flood prone areas to have
an opportunity to purchase flood insurance and access to more adequate
limits of coverage to be indemnified for their losses in the event of
future flood disasters. To this end, FEMA established and carries out a
National Flood Insurance Program (NFIP), which enables interested
persons to purchase insurance against loss resulting from physical
damage to or loss of real or personal property arising from any flood
occurring in the United States. 42 U.S.C. 4011. In carrying out the
NFIP, FEMA operates a call center in conjunction with the FloodSmart
website (www.FloodSmart.gov). Together these methods of marketing and
outreach provide the mechanism for current and potential policyholders
to learn more about floods and flood insurance, contact an agent, or
assess their risk.

The information collected from callers/visitors is used to fulfill
requests for published materials, email alerts, policy rates, and agent
contact information.
    Additionally, FEMA and the NFIP offer Agents.FloodSmart.gov as a
resource for agents. Upon website registration, agents can enroll in
the Agent Referral Program to receive free leads through the consumer
site or the call center as outlined above. This information collection
seeks approval to continue collecting name, address and telephone
number information from: (1) Business and residential property owners
and renters who voluntarily call to request flood insurance information
and possibly an insurance agent referral and, (2) insurance agents
interested in enrolling in the agent referral service.

Collection of Information

    Title: National Flood Insurance Program Call Center and Agent
Referral Enrollment Form.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0059.
    FEMA Forms: FEMA Form 517-0-1, National Flood Insurance Program
Agent Site Registration; FEMA Form 512-0-1, National Flood Insurance
Program Agent Referral Questionnaire.
    Abstract: Consumer names, addresses, and telephone numbers
collected through the Call Center or FloodSmart website will be used
exclusively for providing information on flood insurance and/or
facilitate the purchase of a flood insurance policy through referrals
or direct transfers to insurance agents in the agent referral service.
Agent names, addresses, telephone numbers, and business information is
retained for dissemination to interested consumers who would like to
talk to an agent about purchasing a flood insurance policy as part of
the agent referral program.
    Affected Public: Individuals or households; businesses or other
for-profit.
    Estimated Number of Respondents: 59,194.
    Estimated Number of Responses: 59,194.
    Estimated Total Annual Burden Hours: 2,819 hours.
    Estimated Total Annual Respondent Cost: The estimated annual cost
to respondents for the hour burden is $103,335.52.
    Estimated Respondents' Operation and Maintenance Costs: There are
no annual costs to respondents' operations and maintenance costs for
technical services.
    Estimated Respondents' Capital and Start-Up Costs: There are no
annual start-up or capital costs.
    Estimated Total Annual Cost to the Federal Government: The cost to
the Federal Government is $406,941.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: June 11, 2018.
Rachel Frier,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2018-12890 Filed 6-14-18; 8:45 am]
 BILLING CODE 9111-52-P


COUNTRYMARK COOPERATIVE, LLP 1200 Refinery Road Mt. Vernon, Indiana 47620 March 29, 2004 Mr. John Fox US EPA Washington, DC 20510 Re: Pre Rulemaking Comments Phase III Cooling Water Intake Structures Dear Mr. Fox,

Countrymark appreciates the opportunity to be a part of the regulatory process and comment on the Phase III Cooling Water Intake proposals.

As you know, Countrymark Cooperative, LLP. is a regional, farmer owned cooperative which owns and operates a 24,000 barrels per day petroleum refinery located in Mt. Vernon, Indiana. Countrymark Co op employs approximately 300 people. Countrymark is a small refinery as defined by the Small Business Administration.

Our refinery has the ability to withdraw approximately 2 million gallons per day of surface water from the Ohio River. This water is treated and used to supply both process and cooling water for our refinery. The cooling water intake structure is mounted within a permanent barge structure and consists of submerged basin with passive water inlet holes. The water is then screened prior to entering the pump well area. The pump basin area is protected with screens that are inspected and cleaned daily. Typical debris includes vegetation ( sticks, leaves, etc.) and river trash ( bottles, plastic, foam, etc.). Only rarely would fish or other water life enter this area. In any case, it does not appear to become impinged upon the screens.

With this design, direct impingement does not generally occur. The next step is sedimentation and chemical treatment where silts and other suspended material are removed. Clean water then moves from the reservoir into the water supply system. After the water is used, it runs through an NPDES wastewater treatment system and is discharged downstream at essentially ambient temperatures.

Countrymark feels that our current water intake structure design minimizes impingement and entrainment. It is our opinion that no further upgrades are warranted. With that said, we assume that EPA would agree. If not, Countrymark would question the severity and necessity of further mandated controls. Proposed Cooling Water Intake Structure Rules Page 2 of 2 March 29, 2004 Given the previous statements, Countrymark offers the following comments:

1. Additional environmental regulations applying to smaller cooling water intake structures should not be dictated unless there are compelling reasons. EPA has not shown that impingement and similar local issues impact the environment / fish in a significantly adverse way in all but limited examples. Perhaps EPA should consider prohibiting certain designs or susceptible locations ( those with endangered fish, etc.)

2. The Phase III regulations if warranted, should have a minimum flow threshold of no less than 20 million gallons per day, unless there are source stream / lake considerations that add a compelling reason.

3. EPA should not consider just cooling water intake structures. Consider all sources of water intake structures and don't target specific industries or activities. Drinking / recreational / agricultural water withdrawal intake structures also cause impingement / entrainment. It is either a universal problem or not. It does not seem fair to regulate specific users and not all entities with water intake structures.

4. A registration process with each regulated entity would include some requirement for description of the water withdrawal intake structure. Structure with designs less likely to contribute to impingement or entrainment need not have any other requirements.

5. EPA should provide some level of significance in terms of harm caused by excessive impingement or entrainment. This could be in terms of number of the fish entrained per day or other easily gauged metric. Water users could then estimate the potential harm caused by a poorly engineered design.

6. EPA should make available detailed water intake designs that minimize impingement or entrainment and are easy to clean. There is a strong incentive for the water users to use designs that minimize daily or periodic maintenance. Being friendly to the environment is an added benefit. Countrymark appreciates the opportunity to comment on this proposed. Please contact me ( horning@ countrymark. com or 812 838 8133) if you have any questions or comments.

Sincerely,

Donald M. Horning, REHS Regulatory Compliance Manager


Re: Status of Changes to Boilers rules since 2011  Notes Link

Jim Eddinger
 to:
 Higgins, Cortney
                                                            12/12/2012 08:11 AM

Cc:
 RobertJ Wayland, Mary Johnson

 From:
Jim Eddinger/RTP/USEPA/US

 To:
"Higgins, Cortney"<EMAIL_ADDRESS>

 Cc:
RobertJ Wayland/RTP/USEPA/US@EPA, Mary Johnson/RTP/USEPA/US@EPA

Cortney,

Here are updated lists of changes for Boiler MACT and Boiler Area Sources.

                      Changes from the 2011 Final Rules

Boiler MACT (Major Source)
      *Compliance date for existing units extended to 3 years after promulgation of final amended rule.
      *Dioxin work practices
            o   Work practice standards, in lieu of numeric emission limits, for dioxin/furan emissions for all subcategories
      *	Work practice for startup/shutdown
      	o	Revised definitions of startup and shutdown
      `	o	Revise work practice from following manufacturer's recommended procedures to starting up on clean fuels and engaging controls once coal, biomass, or heavy oil is fired.
      *	Reduced the frequency of tune-ups from annual to every 5 years for limited use units and <5 MMBtu/h units in the gas and light oil subcategories.
      *	Removing requirement that new boilers must conduct an initial tune-up
      *PM now considered a combustion-based pollutant for biomass
            o   Separate PM emission limits for each design-based biomass subcategory instead of single limit for all units firing biomass
      *Total selected metals
            o   Alternate TSM emission limits (to PM emission limits) for subcategories
      *CO CEMS
            o   Alternate CO CEMS-based emission limits (to stack test  - based limits) for subcategories with CEMS data, couple with CEMS-based monitoring
      *Emission limit changes
            o   Changes due to new data, QA of old data, Shifting of units between subcategories, and a 99% UPL for CO instead of 99.9%
            o   Existing source emission limits:
            	HCl -  10 limits are more stringent, 3 are less stringent, and 1 is the same
            	Mercury -  3 limits are more stringent, 11 are less stringent
            	PM -  2 limits are more stringent, 7 are less stringent, and 5 are the same
            	CO -  4 limits are more stringent, 10 are less stringent
            o   New source emission limits:
            	HCl -  13 are less stringent, and 1 is the same
            	Mercury -  11 limits are more stringent, 2 are less stringent, and 1 is the same
            	PM -  9 are less stringent, and 5 are the same
            	CO -  3 limits are more stringent, 11 are less stringent
      *Subcategory changes
            o   Separate subcategories for units designed to combust light or heavy liquids instead of single liquid fuel subcategory
            o   Separate subcategories for kiln-dried biomass stokers and wet biomass stokers instead of a single biomass stoker subcategory
            o   A new coal fluidized bed with fluidized bed heat exchanger subcategory
      *	More clearly defining the scope of the energy assessment and allowing for more streamlined assessments, including allowing sources already operating under certain energy management programs to satisfy the assessment requirement
      *	Applicability - clarified that the exemption for boilers used in R&D inclide boilers used for testing the propulsion systems of naval vessels.
      *Monitoring changes
            o   Proposing the use of O2 trim systems instead of O2 CEMS
            o   30-day rolling averages for most parameter monitoring instead of 12-hour block averages
            o   PM CEMS requirement removed for biomass units
            o   PM CEM requirement for other large units changed to a parameter monitoring system
            o	Added alternate method for demonstrating continuous compliance with the HCl emission limit by allowing using SO2 CEMS if source has acid-gas control technology.

Boiler Area Source Rule

 Revising provisions for existing dual-fuel fired units that fuel switch from gas to coal, biomass or oil such that they would still be considered existing sources
 Clarifying that electric boilers, residential boilers and temporary boilers are not part of the source categories being regulated
 Providing subcategories for seasonally-operated boilers and limited-use boilers
 Amending the mercury and CO emission limits for coal fired boilers
 Amending emissions limits
	o    Mercury limit changing from 4.8 lb/TBtu to 22 lb/TBtu
	o    CO limit changing from 400 ppm to 420 ppm
 Removing requirement that new boilers must conduct an initial tune-up
 Extending by two years the initial compliance date for existing area source boilers subject to the tune-up requirement
 Requiring tune-ups every five years, instead of every two, for certain area source boilers: seasonally-operated boilers, limited-use boilers, oil-fired boilers with heat capacity equal to or less than 5 MMBtu/hr and boilers with oxygen trim systems
 Clarifying that, as part of the tune-up, CO measurements may be taken with a portable CO analyzer
 Allowing use of oxygen trim systems
 Revising averaging period for parameter monitoring and compliance to a 30-day rolling average instead of a 12-hour block average
 Revising PM emission limit requirements such that combustion of oil meeting certain sulfur content requirements by new oil-fired boilers is considered an alternative method of meeting the PM emission standard and that such units are not required to meet the PM emission limit
 Reducing the fuel sampling and performance testing requirements such that after demonstration of initial compliance, under certain circumstances, further fuel sampling for boilers subject to a mercury emission limit and further PM performance testing for boilers subject to a PM emission limit is not required
 Providing the option of continuous emissions monitoring to demonstrate continuous compliance with the CO emission limit
 More clearly defining the scope of the energy assessment and allowing for more streamlined assessments, including allowing sources already operating under certain energy management programs to satisfy the assessment requirement
 Revising the deadline for initial notification for existing area source boilers to no later than January 20, 2014
 Revising notification requirement for instances where a boiler switched fuels, made a physical change, or took a permit limit such that the notification is due within 30 days of the change rather than 30 days prior to the change
 Revising various definitions including "startup," "shutdown" and "period of gas curtailment or supply interruption"

Jim
_______________
James A. Eddinger
Energy Strategies Group
Sector Policies and Programs Division
919-541-5426

From:	"Higgins, Cortney"<EMAIL_ADDRESS>To:	RobertJ Wayland/RTP/USEPA/US@EPA
Cc:	Jim Eddinger/RTP/USEPA/US@EPA
Date:	12/11/2012 03:06 PM
Subject:	Status of Changes to Boilers rules since 2011

Hi Bob and Jim,
Can you update the following list of changes made since the 2011 final Boilers rules?   This is a list based on the May draft of the rule, and I was hoping you could help me update it to the current draft of the rule.

Thanks!

                      Changes from the 2011 Final Rules

Boiler MACT (Major Source)
      *Compliance date for existing units extended to 3 years after promulgation of final amended rule.
      *Dioxin work practices
            o   Work practice standards, in lieu of numeric emission limits, for dioxin/furan emissions for all subcategories
      *	Work practice for startup/shutdown
      	o	Revised definitions of startup and shutdown
      `	o	Revise work practice from following manufacturer's recommended procedures to starting up on clean fuels and engaging controls once coal, biomass, or heavy oil is fired.
      *	Reduced the frequency of tune-ups from annual to every 5 years for limited use units and <5 MMBtu/h units in the gas and light oil subcategories.
      *	Removing requirement that new boilers must conduct an initial tune-up
      *PM now considered a combustion-based pollutant for biomass
            o   Separate PM emission limits for each design-based biomass subcategory instead of single limit for all units firing biomass
      *Total selected metals
            o   Alternate TSM emission limits (to PM emission limits) for subcategories
      *CO CEMS
            o   Alternate CO CEMS-based emission limits (to stack test  - based limits) for subcategories with CEMS data, couple with CEMS-based monitoring
      *Emission limit changes
            o   Changes due to new data, QA of old data, Shifting of units between subcategories, and a 99% UPL for CO instead of 99.9%
            o   Existing source emission limits:
            	HCl -  10 limits are more stringent, 3 are less stringent, and 1 is the same
            	Mercury -  3 limits are more stringent, 11 are less stringent
            	PM -  2 limits are more stringent, 7 are less stringent, and 5 are the same
            	CO -  4 limits are more stringent, 10 are less stringent
            o   New source emission limits:
            	HCl -  13 are less stringent, and 1 is the same
            	Mercury -  11 limits are more stringent, 2 are less stringent, and 1 is the same
            	PM -  9 are less stringent, and 5 are the same
            	CO -  3 limits are more stringent, 11 are less stringent
      *Subcategory changes
            o   Separate subcategories for units designed to combust light or heavy liquids instead of single liquid fuel subcategory
            o   Separate subcategories for kiln-dried biomass stokers and wet biomass stokers instead of a single biomass stoker subcategory
            o   A new coal fluidized bed with fluidized bed heat exchanger subcategory
      *	More clearly defining the scope of the energy assessment and allowing for more streamlined assessments, including allowing sources already operating under certain energy management programs to satisfy the assessment requirement
      *	Applicability - clarified that the exemption for boilers used in R&D inclide boilers used for testing the propulsion systems of naval vessels.
      *Monitoring changes
            o   Proposing the use of O2 trim systems instead of O2 CEMS
            o   30-day rolling averages for most parameter monitoring instead of 12-hour block averages
            o   PM CEMS requirement removed for biomass units
            o   PM CEM requirement for other large units changed to a parameter monitoring system
            o	Added alternate method for demonstrating continuous compliance with the HCl emission limit by allowing using SO2 CEMS if source has acid-gas control technology.

Boiler Area Source Rule
      *Created a new subcategory for seasonally operated boilers
            o   Required to complete a tune-up every five years, instead of on a biennial basis as is required for non-seasonal boilers
      *Amending rule to specify that all existing boilers subject to the tune-up requirement would have three years (by March 21, 2014) in which to demonstrate initial compliance, instead of one year to demonstrate initial compliance.
      *Amending the monitoring requirements to allow sources subject to a carbon monoxide emission limit the option to install, operate and maintain a carbon monoxide and oxygen continuous emission monitoring system.
      *Changing the requirement for subsequent tune-ups only for oil-fired boilers equal to or less than 5 MMBtu/hr to a tune-up once every 5 years.
      *Adding residential boilers and electric boilers to the list of boilers not subject to subpart JJJJJJ to clarify that boiler used in residences located at commercial (farms) and institutional (universities) facilities are not subject to the rule.  Also ddded temporary boilers to this list.
      *Revising the definition for "Hot water heater" to include small not water boilers.
      *Amending the mercury and CO emission limits for coal fired boilers.
            o   Mercury limit changing from 4.8 lb/TBtu to 22 lb/TBtu
            o   CO limit changing from 400 ppm to 420 ppm