the nitrogen in manure as a fertiliser, thereby reducing the need for inorganic
fertilisers, would perhaps be a better way of reducing total nitrogen load than
reducing the nitrogen content of manure.
Presence of non degraded AFA in manure or wastewater will impair the
microbial activity in the recipient habitats, lowering the turnover capacity of
the microbiota.
The usage of AFA leads to lower excreta nutrient discharges in pigs and
poultry. Any given diet that improves nutrient absorption will also reduce
nutrient losses with animal voiding.
6.4
Antimicrobial resistance genes in the environment
Faeces from animals fed AFA contains not only bacteria carrying genes
coding for resistance against these substances, but also the substance itself,
thereby providing a selective pressure that may further the spread of the
genes. This is not primarily a problem for the environment, although some
possible implications will be discussed in 6.4.4.
6.4.1 Persistence of resistant bacteria in the environment
In order to have an influence on the environmental pool of resistance genes,
bacteria carrying the genes must persist for some time in the environment.
Animal bacteria would be expected to disappear from the soil surface under

6. Environmental aspects
SOU 1997:132
158
the influence of sunlight, but they may persist deeper in the soil for some
time. Around farm buildings, enterococci and
%COLI
can be isolated from soil
(Parrakova and Fratric, 1980). Mackey and Hinton (1990) investigated the
survival of streptococci and enterococci on straw. After 4 weeks, the
inoculated bacteria could still be isolated although their numbers were
reduced. Davies and Wray (1996) found that salmonellae from infected calf
carcasses could diffuse into soil and persist for up to 21 months, while bacilli
and clostridia from the same source could persist in soil for more than two
years. The salmonellae could also be isolated from wild-bird droppings,
maggots and surface water for 4 weeks after burial of the carcasses. Hinton
and Linton (1982) reported survival of multiresistant salmonellae and
%½COLI
in slurry for at least 7 weeks. Thus, bacteria of animal origin (both gram-
positive and gram-negative) appear to be able to contaminate soil for
prolonged periods of time.
6.4.2 Gene transfer in the environment
Gene transfer occurs readily in almost any environment. It has been shown
that gene transfer can occur in soil between different bacteria, by various
mechanisms (Bale
½ET½AL
, 1988; Henschke and Schmidt, 1990; Top
½ET½AL
,
1990; Cresswell and Wellington, 1992; Lilley
½ET½AL
, 1994). Kruse and Sørum
(1994) demonstrated the transfer of multiple drug resistance plasmids
between various bacterial species in diverse household microenvironments.
Timoney and Linton (1982) showed that transfer of a specific plasmid
between different strains of
%½COLI
from calves in faeces occurred at 30°C
but not at 37°C. This indicates that some transfer systems in animal bacteria
are adapted only to environmental conditions.
Gene transfer to soil bacteria can occur from bacteria that will not
themselves survive for long in the soil. The addition of nutrients, as when
manure is spread on farmland, and the presence of plant roots, provide a
favourable environment in which an increased bacterial metabolism and gene
transfer would be expected (Cresswell and Wellington, 1992; Lilley
ET½AL
,
1994).
When studying gene transfer in the soil microenvironment, many factors
may influence the result. For example, temperature, humidity and pH are
important, as well as the bacterial species used in the experiments. Soil
micro-organisms such as pseudomonads, bacilli and streptomycaetes are well
adapted to growth in the soil environment and may transfer and maintain
resistance genes in these environments better than do coliforms (Cresswell
and Wellington, 1992). Methodological problems such as detection of
transfer when the genes are not properly expressed and the vast amount of
non-described or non-cultivable bacteria present in soil suggest that the
observed transfer frequencies may only be the tip of the iceberg. One gram of

SOU 1997:132
6. Environmental aspects
159
agricultural soil can contain more than 100 000 different bacterial species
(Cresswell and Wellington, 1992). It seems obvious that studies on just a few
of those cannot provide a basis for conclusions regarding the whole
microenvironment.
6.4.3
Persistence of resistance genes in environmental bacteria
Resistance genes in soil microbes may persist for a long time, even without a
selective pressure from antimicrobial substances. Gene transfer from
%½COLI
to soil pseudomonads in a non-sterile, unamended, soil system has been
demonstrated, with a persistence of the introduced gene in the recipient
bacterium for 100 days (Cresswell and Wellington, 1992). If the expression
of resistance genes is costly from a metabolic point of view, resistant bacteria
are likely to disappear in the absence of a selective pressure. However, this
competitive disadvantage may be overcome (see 4.4.5). Bacteria may adjust
to the expression of resistance, lowering the metabolic cost. Bale and co-
workers (1993) studied the survival of
%COLI
and its nalidixic acid resistant
mutants on dry surfaces. Out of seven resistant mutants, five survived longer
compared to the sensitive parent strains. Further, transferable genetic
elements carrying resistance genes may also carry other traits of advantage. If
so, the resistance genes will still be able to persist in the environment.
6.4.4
Possible implications for the environment
Co-transfer of resistance genes and virulence genes has been demonstrated,
not only in animal and human pathogens, but also in plant pathogens
(Amuthan and Mahadevan, 1994). Certain virulence genes in plant and
animal pathogens are similar enough to suggest a horizontal spread (Alfano
and Collmer, 1996). Theoretically, in the presence of a selective pressure for
resistance genes, virulence of plant and wildlife pathogens might increase
and non-pathogenic bacteria might acquire virulence. Although purely
speculative, this merits further investigation. Similarly, possible co-transfer
of resistance to pesticides such as copper or sulphur should be considered.
Transfer of genes occurs readily in the environment.
Resistance genes can persist in the environment both in their original
bacterial hosts and in environmental organisms.
Possible co-transfer of resistance genes and other genes in plant pathogens
should be investigated.

6. Environmental aspects
SOU 1997:132
160
6.5
Summary comments
Little information is publicly available on environmental effects of AFA.
According to accessible data, antibiotic AFA present in soil are degraded by
microbes. Hence, no major toxic effects on terrestrial or aquatic fauna or on
terrestrial plants are expected. Presence of AFA in soil will transiently
disrupt the microflora with potentially negative consequences on nutrient
mineralisation etc. Further, more information is needed concerning possible
effects on modern biogas plants. Presence of AFA and genes encoding for
resistance to AFA in manure is not primarily a problem for the environment.
Such genes will form part of the resistance gene pool available for animal
and human bacteria.

SOU 1997:132
6. Environmental aspects
161
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519-528.
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"EWICK¹-7-
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*OURNAL½OF½!GRICULTURAL½3CIENCES½#AMBRIDGE

669-674.
"EWICK¹-7-¹AND¹4RIBE¹(4
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249-258.
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, 1992.
$ETECTION½OF½GENETIC½EXCHANGE½IN½THE
TERRESTRIAL½ENVIRONMENT
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3ALMONELLA
TYPHIMURIUM
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"ACILLUS½CEREUS½
and
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119-127.
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481-485.
(ENRY¹9
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(ENSCHKE¹2"¹AND¹3CHMIDT¹&2*
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(INTON¹-¹AND¹,INTON¹!(
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*OURNAL½OF½(YGIENE

557-565.
*AGNOW¹'
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227-234.
+RUSE¹(¹AND¹3¸RUM¹(
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,ILLEY¹!+¹&RY¹*#¹$AY¹-*¹AND¹"AILEY¹-*
, 1994.
)N½SITU
transfer of an
exogenously isolated plasmid between
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27-33.
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479-481.
-ACKEY¹%4¹AND¹(INTON¹-
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*OURNAL
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345-348.
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!GRICULTURAL½7ASTES

161-170.
2OTH¹&8¹AND¹+IRCHGESSNER¹-
, 1993. Influence of avilamycin and tylosin on retention
and excretion of nitrogen in growing pigs.
*OURNAL½OF½!NIMAL½0HYSIOLOGY½AND
!NIMAL½.UTRITION

175-185.
2OTH¹&8¹7INDISCH¹7¹AND¹+IRCHGESSNER¹-
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Tylosin on fecal excretion of nitrogen and amino acids in growing pigs.
!GRIBIOLOGICAL½2ESEARCH

147-155.
3#"
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3UTTON¹!,¹.YE¹*#¹0ATTERSON¹*!¹+ELLY¹$4¹AND¹&URUMOTO¹%LKIN¹%*
, 1989.
Effects of avilamycin in swine and poultry wastes on methane production in
anaerobic digesters.
"IOLOGICAL½7ASTES

35-45.
4HAVEESRI¹*¹"OUCNEAU¹'¹AND¹6ERSTRAETE¹7
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reactor performance.
%NVIRONMENTAL½4ECHNOLOGY

491-496.
4HOMKE¹3¹AND¹%LWINGER¹+
, 1997. Growth and feed efficiency responses to antibiotic
growth promotants in pigs and poultry. Report to the Commission on Antimicrobial
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*OURNAL½OF½!PPLIED½"ACTERIOLOGY

417-424.
4OP¹%¹-ERGEAY¹-¹3PRINGAEL¹$¹AND¹6ERSTRAETE¹7
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transfer of heavy metal resistance genes from
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to
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EUTROPHUS
on agar plates and in soil samples.
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2471-2479.
6ERBEKE¹7¹AND¹6IAENE¹*
, 1996. Environmental impact of using feed additives. pp. 38.
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7IERUP¹-
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+UNGLIGA½3KOGS
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69-78.
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!NIMAL
&EED½3CIENCE½AND½4ECHNOLOGY

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6OGTMANN¹(¹/BRIST¹7¹(AUSER¹+¹0FIRTER¹(0¹AND¹!UGSTBURGER¹&
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22-25.

6. Environmental aspects
SOU 1997:132
164

SOU 1997:132
7
Coccidiostats
7.1
Introduction
Coccidiosis is a severe, world wide health and welfare problem in poultry.
The disease is caused by unicellular parasites which grow and multiply in the
intestinal mucosa of the birds. Commercially reared chickens are particularly
vulnerable to the disease due to the intensive production systems.
Since the early 1940s various drugs have been used to treat and/or prevent
coccidiosis in poultry. Coccidiostats have in fact contributed substantially to
the remarkable success of modern poultry production. In the EU
coccidiostats are incorporated in the feed, as feed additives, while in Sweden,
coccidiostats are regarded as pharmaceutical specialities (i.e. medicated feed)
and are only available on veterinary prescription. Included among the
coccidiostats used in poultry are the ionophoric antibiotics and various
chemotherapeutic substances. Two of the ionophores, monensin and
salinomycin are also used as growth promoters, in cattle and swine,
respectively.
7.1.1 The parasite and the disease
Several reviews of the coccidiosis problem in poultry have been published
(Horton-Smith and Long, 1963; Macpherson, 1978; Long and Reid, 1982;
Long, 1990). Since knowledge of the disease is essential for the discussion
about coccidiostats in modern poultry production, some basic information
about coccidia and coccidiosis will be presented in the following.
Coccidiosis is caused by intestinal protozoa of the phylum Apicomplexa.
Most coccidia of domestic fowl belong to the genus
%IMERIA½
Each poultry
species may be infected with several different
%IMERIA
species which are host
specific and of varying pathogenicity. Seven different coccidial species can
infect chickens. The parasites are transmitted via oocysts, shed in the faeces
of infected hosts and ingested by uninfected birds. Coccidia multiply in
epithelial cells in the intestinal mucosa and sometimes also in other organs of
the host. The severity of the infection depends on the coccidial species, host
immunity and on the dose of ingested oocysts. Young birds are highly
susceptible to coccidiosis since they, to a large extent, lack passively
transferred maternal immunity. Immunity is best developed by repeated
exposure to small numbers of oocysts. Additionally, immunity to coccidia is

7. Coccidiostats
SOU 1997:132
166
species specific which means that resistance to one coccidial species does not
confer resistance to another species.
The symptoms of coccidiosis include mucoid to haemorrhagic diarrhoea,
depression, emaciation and depressed growth rate. Sometimes mortality is
high. The location and nature of the lesions in the host intestinal mucosa
depend on the coccidial species.
Birds with clinical coccidiosis can be treated with water-soluble
sulphonamides, amprolium or toltrazuril.
Coccidia are ubiquitous parasites which are easily introduced into poultry
houses. Due to the persistent nature of the oocysts, and the propagation in the
birds, a considerable population of oocysts will be established in the litter
during the rearing period. As commercially reared young chickens, with
insufficient immunity to coccidia, are kept in large numbers in high stocking
density productions systems the disease becomes a severe problem if not
prevented. Chickens reared in traditional, low stocking density units, such as
free range backyard flocks, usually become infected by coccidia but these
birds seldom develop overt clinical coccidiosis as the number of oocysts in
the environment will be comparatively low and immunity develops rapidly.
Unprevented coccidiosis, even if subclinical, has a considerable impact on
the economic profit in the broiler industry. The economic losses of a
coccidiosis outbreak are substantial due to increased mortality, depressed
growth, decreased feed efficiency, medication and increased work load.
It has been shown that coccidial infection predisposes chickens to
intestinal clostridial overgrowth (Dykstra, 1978; Baba
½ET½AL
, 1988).
Interaction between coccidia and various other avian bacterial and viral
pathogens has also been described (Shane
½ET½AL
, 1985; Ruff, 1989).
Taken together, modern broiler production systems require preventive
strategies for coccidiosis control, which today are synonymous with
chemoprophylaxis.
7.1.2 Prevention and chemoprophylaxis
Anticoccidial drugs are classified in the Anatomical Therapeutic Chemical
Classification system (ATCvet) as group QP51A, together with other
antiprotozoal agents (NLN, 1995). Coccidiostats approved for use in poultry
and other food-producing animals within the EU are listed in table 7.I.
In most countries, coccidiostats are incorporated in the feed to
commercially raised broiler chickens and during the growth period to many


consistent among male and female rats and mice in both subchronic and chronic studies and
typically included increased liver weights along with increases in serum clinical chemistry
parameters associated with adverse effects on liver function (i.e., increased cholesterol and
phospholipid levels).  Microscopic lesions in rats and mice included hepatocyte hypertrophy and
hepatocellular necrosis.  In the kidneys, adverse effects were manifested as chronic tubular
lesions and chronic kidney inflamation following subchronic exposure of male rats.  Chronically,
cyprodinil caused increased kidney weights and progressive nephropathy in male rats.  Chronic
effects in dogs were limited to decreased body-weight gain, decreased food consumption and
decreased food efficiency; liver toxicity was not seen in the dog.  The hematopoietic system also
appeared to be a target of cyprodinil, causing mild anemia in rats exposed subchronically
(reductions in hematocrit and hemoglobin and microcytosis).  Although increases in thyroid
weight and/or hypertrophy of thyroid follicular cells were observed at higher doses in the rat 28-
day oral-toxicity studies (both feeding and oral gavage) and in the 90-day oral-toxicity study in
rats, treatment-related changes in thyroid weights or gross/microscopic observations were not
observed in the chronic rat study or in other studies (thyroid hormones were not evaluated in any
study).  A preliminary subchronic immunotoxicity in mice showed no treatment-related effects
on absolute, adjusted, or relative spleen or thymus weights; no effects on specific activity or total
activity of splenic IgM antibody-forming cells to the T cell-dependent antigen sRBC.
A subchronic neurotoxicity study showed no treatment related effects on mortality,
clinical signs, or gross or histological neuropathology.  FOB and motor activity testing revealed
no treatment related effects up to the highest dose tested.  No clinical signs suggestive of
neurobehavioral alterations or evidence of neuropathological effects were observed in the
available oral-toxicity studies.  There was also no evidence of a neurodevelopmental effect in the
rat or rabbit developmental-toxicity studies or in the rat two-generation reproductive-toxicity
study.
Based on pharmacokinetic/metabolism studies in the rat biphasic first order kinetics were
noted for absorption and excretion of cyprodinil, with durations of 0.3-1.2 hours for the first
phase, and 27-65 hours for the second phase.  Excretion was rapid and almost complete, with
urine as the principal route of excretion (48-68%), and >90% of the administered dose detected
in the urine and feces within 48 hours.

Page 10 of 38
There was no evidence of increased susceptibility in the developmental rat or rabbit study
following in utero exposure or in the two-generation reproduction study following pre- and post-
natal exposure.  Fetal toxicity, manifested as significantly lower fetal weights and an increased
incidence of delayed ossification in the rat and a slight increase in litters showing extra ribs
(13 ) in the rabbit, was reported in developmental toxicity studies.  In a rat two-generation
th
reproduction study, significantly lower pup weights for F and F offspring were observed.
1
2
However, each of these fetal/neonatal effects occurred at the same dose levels at which maternal
toxicity (decreased body weight gain) was observed and were considered to be secondary to
maternal toxicity.
An acute neurotoxicity study (870.6200a) is required in accordance with the revised 40
CFR Part 158 Toxicology Data Requirements.  The available preliminary immunotoxicity study
is considered Upgradeable/Guideline due to the omission of a NK cell activity assay.  The
registrant needs to either submit the NK assay or provide justification for why it is not needed.
The complete toxicity profile for cyprodinil is provided in Appendix 1.2, Tables 2 and 3.
3.2
FQPA Hazard Considerations
The toxicity database for cyprodinil is sufficient for a full hazard evaluation and is
considered adequate to evaluate risks to infants and children.  Acceptable developmental toxicity
studies in the rat and rabbit, acceptable multi- and single generation reproduction studies in the
rat, and an acceptable subchronic neurotoxicity study in the rat have been submitted.
3.2.1
Neurotoxicity
In a subchronic neurotoxicity study (MRID 45906101) cyprodinil technical (99.2%) was
administered to 10 /Tif: RAIf Sprague-Dawley albino rats/sex/group at doses of 0, 80, 800, or
8000 ppm (equivalent to 0, 5.8, 54.5 and 601 mg/kg/day in males and 0, 6.3, 58.7, and 631
mg/kg/day in females).  There were no treatment related effects on mortality, clinical signs, or
gross or histologic neuropathology.  Functional Observational Battery (FOB) and motor activity
testing revealed no treatment related effects up to the highest dose tested.  Based on the results of
this study, the neurotoxicity LOAEL for male and female rats was not identified.  The
neurotoxicity NOAEL is > 8000 (601 mg/kg/day in males, 631 mg/kg/day in females.
3.2.2
Developmental Toxicity
<IP_ADDRESS>    Rat Developmental Study
In a developmental toxicity study (MRID 43709033), cyprodinil technical (99.5%) was
administered in 3% aqueous corn starch suspension by oral gavage to 20-23 Tif:RAIf(SPF)
females albino rats per dose of 0, 20, 200 or 1000 mg/kg/day or gestation days 6-15.
Treatment related findings included reduced locomotor activity (one high dose female),

Page 11 of 38
significantly lower mean body weight (16%), body weight gain (65%), gravid uterine weight
(18%), and mean carcass weight (10%), and significantly decreased food consumption (32-42%)
in high-dose females.  The LOAEL for maternal toxicity is 1000 mg/kg/day based on lower body
weight/body weight gain and reduced food consumption. The NOAEL was 200 mg/kg/day.
There were significantly lower mean fetal weights (11%) in the high-dose group
compared to controls as well as a significant increase in skeletal anomalies in the high-dose
group relative to the control, which was due to abnormal ossification (4/20 litters in the high
dose group compared to 0 in any other group), primarily as absent or reduced metacarpal 5
ossification.  The skeletal anomalies/variations were considered to be a transient developmental
delay that occurs secondary to the maternal toxicity noted in the high-dose group. The LOAEL
for developmental toxicity is 1000 mg/kg/day based on lower mean fetal weights and an
increased incidence of delayed ossification.  The NOAEL for developmental toxicity is 200
mg/kg/day.
<IP_ADDRESS> Rabbit Developmental Study
In a developmental toxicity study (MRID 43709032), cyprodinil technical (99.5%) was
administered in 3% aqueous corn starch suspension to 19 inseminated female rabbits (Russian
Chbb:HM, SPF)/dose by gavage at dose levels of 0, 5, 30, 150, or 400 mg/kg/day from days 7
through 19 of gestation. Mean maternal body weight gain (p <0.01) and food consumption (not
significant) decreased, mainly during the first week of treatment in the 400 mg/kg/day group.
Mean body weight gain was 622% less than controls (p <0.01) in this group between days 7 and
13 of gestation. The maternal LOAEL is 400 mg/kg/day, based on decreased body weight gain.
The maternal NOAEL is 150 mg/kg/day.
Fetuses at the 400 mg/kg/day dose exhibited indications of an increased incidence of a
13th rib (not significant). Although there were indications of developmental delays in fetal
skeletons, such as poor or absent ossification of the sternebrae and metacarpals at all dose levels,
only the extra rib is likely to be compound related. Uni- or bilateral hyperflexion of the carpal
joint at the 400 and 150 mg/kg/day doses (not significant) was not associated with the skeletal
changes. The fetal developmental LOAEL is 400 mg/kg/day based on a slight increase of litters
showing extra (13th) ribs. The fetal developmental NOAEL is 150 mg/kg/day.
3.2.3  Reproductive Toxicity
In a two-generation reproduction study (MRID No. 43709034), Tif:RAIf rats (30
rats/sex/dose), with one litter per generation received cyprodinil (99.5 %) in the diet at doses of,
10, 100, 1000 or 4000 ppm (actual intake, males: 0, 0.7, 6.7, 68 or 273; females: 0, 0.8, 8.2, 81 or
326 mg/kg/day) for a 10 week pre-mating period.  Signs of toxicity at 4000 ppm consisted of
lower body weights (12.5%) in the F0 females after the pre-mating period. Increased liver weight
in 1000 (marginal) and 4000 ppm males and females was not supported by histopathological
findings.  Although these were considered treatment related, they were considered to be non-
adverse.  The LOAEL for maternal systemic toxicity is 4000 ppm (about 326 mg/kg/day) based

Page 12 of 38
on lower body weights in the F0 females during the pre-mating period. The NOAEL for maternal
systemic toxicity was 1000 ppm (about 81 mg/kg/day).  Reviewers determined that pre-mating
body weight gain (not absolute body weight) should be used as the basis of the NOAEL.  Signs
of fetal effects included significantly lower F1 and F2 pup weights in the high-dose group during
lactation, which continued to be lower than controls post-weaning and after the pre-mating
period (examination in F1 generation only).  The LOAEL for reproductive/developmental
toxicity is 4000 ppm (about 326 mg/kg/day) based on decreased pup weights (F1 and F2).  The
NOAEL for reproductive toxicity is 1000 ppm (about 81 mg/kg/day).
3.2.4
Pre-and/or Postnatal Toxicity
The database is considered adequate for selection of study endpoints and determination
of a dose/response to characterize the potential prenatal or postnatal toxicity of cyprodinil to
infants and children.  No increase in susceptibility was seen in developmental toxicity studies in
rat and rabbit or reproductive toxicity studies in the rat.  Toxicity to offspring was observed at
dose levels the same or greater than those causing maternal or parental toxicity.  Based on the
results of developmental and reproductive toxicity studies, there is not a concern for increased
qualitative and/or quantitative susceptibility following in utero exposure to cyprodinil.
A developmental neurotoxicity study is not required.   Based on available data there is no
evidence of neurotoxic potential for cyprodinil.  Neurotoxicity was not observed in subchronic
neurotoxicity study or the prenatal developmental toxicity studies in rats and rabbits.  Although
an acute neurotoxicity study is not available, the NOAEL from an acute study is unlikely to be
appreciably lower than the NOAEL of 600 mg/kg/day from the subchronic neurotoxicity study.
3.2.5 FQPA Factor
Since there are adequate developmental studies in rats and rabbits and an adequate multi-
generation study in rats, no residual uncertainties that indicate the need for a factor, and no
evidence of neurotoxicity based on available data, the FQPA factor has been reduced to 1X.
3.3
Toxicity Endpoint Selection
3.3.1
Acute Reference Dose (aRfD) – Females 13-49
Selected Study: Developmental toxicity in the rabbit; MRID 43709032. See Section 3.2.1
Dose and Endpoint for Establishing a POD:  NOAEL = 150 mg/kg/day day based
developmental LOAEL of 400 mg/kg/day was based on a slight increase in the incidence of
litters showing extra (13 ) ribs, which is presumed to occur after a single exposure.
th
Uncertainty Factor (UF): 100x (10x for interspecies variation and 10x for intraspecies
variation)

Page 13 of 38
Acute RfD =     150 mg/kg (NOAEL) =     1.5 mg/kg
100 (UF)
3.3.2
Acute Reference Dose (aRfD) – General Population
For the general population, no effects that could be attributed to a single exposure were
observed in the oral-toxicity studies, including the developmental toxicity studies in rats and
rabbits. Therefore, an acute RfD was not established for this population subgroup.
3.3.3  Chronic Reference Dose (cRfD) - All Populations
Selected Study: Combined Chronic Toxicity/Carcinogenicity-Rat;  MRID  43737602,
44429401 and 44417902
In a 24-month chronic toxicity/oncogenicity study  Tif:RAIf rats (50 rats/sex/dose -
carcinogenicity portion, plus 20/sex/dose laboratory investigations) were fed diets containing 0,
5, 75, 1000 or 2000 ppm (M - 0.177, 2.7, 35.6 or 73.6 mg/kg/day; F - 0.204,3.22,41.2 or 87.1
mg/kg/day) cyprodinil (99.2-99.6%).  An additional 10/sex/dose were fed test diets for 12
months (interim sacrifice).  Survival was slightly lower in males at 2000 ppm relative to control
and other dose groups.  Toxicologically significant findings included increased liver weights in
high-dose males (10.7%) and a dose-related increase in the incidence of spongiosis hepatis in the
liver of 1000 and 2000 ppm males (5, 5, 3, 17 and 23 %, controls to high dose). For chronic
toxicity, the NOAEL was 75 ppm (2.7 mg/kg/day) and the LOAEL was 1000 ppm (35.6
mg/kg/day) based on degenerative liver lesions (spongiosis hepatis) in males.
Dose and Endpoint for Establishing a POD:  2.7 mg/kg/day (NOAEL) based on the
histopathological alterations in the liver (spongiosis hepatis) in males at 35.6 mg/kg/day
(LOAEL).
Uncertainty Factor (UF): 100x (10x for interspecies variation and 10x for intraspecies
variation)
Comments about Study/Endpoint: The selected NOAEL is the lowest NOAEL observed
in the most sensitive species following long-term exposure.
Chronic RfD =     2.7 mg/kg (NOAEL) =     0.027 mg/kg
100 (UF)

Page 14 of 38
3.3.4
Classification of Carcinogenic Potential
Based on the lack of evidence of carcinogenicity in mice and rats at doses that were
judged to be adequate to assess the carcinogenic potential, cyprodinil was classified as “not
likely to be carcinogenic to humans”, according to EPA Proposed Guidelines for Carcinogen
Risk Assessment (July 1999).
3.4
Recommendation for Aggregate Exposure Risk Assessments
When there are potential residential exposures to the pesticide, aggregate risk assessment
must consider exposures from three major sources: oral, dermal and inhalation exposures.  Since
there are no residential incidental oral exposures to cyprodinil, aggregate exposure from food
and non-food oral exposures is not required.  However, an aggregate risk assessment of
combined short-term dermal, inhalation and background dietary exposure is required for
residential handlers because PODs selected for these exposure routes are based on common
toxicological effects (i.e., liver effects).
3.5 Summary of Endpoints Selected for Risk Assessment
Toxicological doses/endpoints selected for the cyprodinil risk assessment are provided in
Table 6 and 7.
Table 6. Summary of Toxicological Doses and Endpoints for Cyprodinil  for Use in Dietary Human Health Risk Assessments
Exposure/Scenario
Point of
Departure
Uncertainty/F
QPA Safety
Factors
RfD, PAD, LOC
for Risk
Assessment
Study and Toxicological Effects
Acute Dietary
Females 13-50 years
NOAEL = 150
mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x
Acute RfD = 1.5
mg/kg/day
aPAD = 1.5
mg/kg/day
Developmental Toxicity - rabbit
Developmental LOAEL = 400 mg/kg/day
based on slight increase of litters showing
extra ribs (13 ).
th
Chronic Dietary
(All Populations)
NOAEL= 2.7
mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x
Chronic RfD =
0.027
mg/kg/day
cPAD =
0.027mg/kg/day
2-Year Chronic Toxicity/ Carcinogenicity- rat
LOAEL = 35.6 mg/kg/day based on
degenerative liver lesions (spongiosis
hepatitis) in males.
Cancer (all routes)
Classification: “Not likely to be carcinogenic to humans”
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to
mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.
NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.
UF = uncertainty factor.  UF = extrapolation from animal to human (interspecies).  UF = potential variation in sensitivity
A
H
among members of the human population (intraspecies).
SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose.
MOE = margin of exposure.
LOC = level of concern.  N/A = not applicable.

Page 15 of 38
Table 7.  Summary of Toxicological Doses and Endpoints for Cyprodinil  for Use in Residential Human Health Risk
Assessments
Exposure/
Scenario
Point of
Departure
Uncertainty
Factors
Level of Concern
for Risk
Assessment
Study and Toxicological Effects
Dermal  Short-Term
(1-30 days)
(dermal absorption
rate = 30%)
Oral NOAEL=
62 mg/kg/day
UF = 10x
A
UF =10x
H
Residential LOC
for MOE = 100
28-Day Feeding/Range-finding - rat
LOAEL = 299 mg/kg/day based on decreased
body-weight gain, increased cholesterol and
phospholipid levels, microcytosis, and
hepatocyte hypertrophy.
Inhalation Short- Term
(1-30 days)
Oral NOAEL=
62 mg/kg/day
UF = 10x
A
UF =10x
H
Residential LOC
for MOE = 100
28-Day Feeding/Range-finding - rat
LOAEL = 299 mg/kg/day based on decreased
body-weight gain, increased cholesterol and
phospholipid levels, microcytosis, and
hepatocyte hypertrophy.
Cancer (all routes)
Not likely human carcinogen
3.6 Endocrine Disruption
As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor
Screening Program (EDSP) to determine whether certain substances (including pesticide active
and other ingredients) may have an effect in humans or wildlife similar to an effect produced by
a “naturally occurring estrogen, or other such endocrine effects as the Administrator may
designate.”  The EDSP employs a two-tiered approach to making the statutorily required
determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a
chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal
systems.  Chemicals that go through Tier 1 screening and are found to have the potential to
interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA
will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2
testing is designed to identify any adverse endocrine related effects caused by the substance, and
establish a dose-response relationship between the dose and the E, A, or T effect.
Between October 2009 and February 2010, EPA issued test orders/data call-ins for the
first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert
ingredients.  This list of chemicals was selected based on the potential for human exposure
through pathways such as food and water, residential activity, and certain post-application
agricultural scenarios.  This list should not be construed as a list of known or likely endocrine
disruptors.
Cyprodinil is not among the group of 58 pesticide active ingredients on the initial list to
be screened under the EDSP.  Under FFDCA sec. 408(p) the Agency must screen all pesticide
chemicals.  Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all
pesticide active ingredients.
For further information on the status of the EDSP, the policies and procedures, the list of 67
chemicals, the test guidelines and the Tier 1 screening battery, please visit our website:

Page 16 of 38
http://www.epa.gov/endo/.
4.0
DIETARY AND DRINKING WATER EXPOSURE ASSESSMENT
4.1
Residue Chemistry Profile
4.1.1
Metabolism in Primary Crops, Livestock and Rotational Crops
The nature of the residue in plants is adequately understood based on acceptable
metabolism studies on apple, peach, potato, tomato, and wheat.  These studies indicated that
cyprodinil is metabolized primarily by hydroxylation followed by sugar conjugation.  Cleavage
of the amino bridge, opening of the pyrimidine ring, opening of the cyclopropyl ring and
formation of thiolactic acid conjugates are minor pathways.  Incorporation into starch was
observed in potato tubers and wheat grain.  The nature of the residue in ruminants is adequately
understood based on acceptable lactating goat metabolism studies.  ARIA and HED have
concluded that the residues of concern for both risk assessment and the tolerance definition
should include the combined residues of cyprodinil and free and conjugated CGA-304075 (4-[(4-
cyclopropyl-6-methylpyrimidin-2-yl)amino]-phenol, expressed in parent equivalents (D345970
and D345182, G. Kramer, 6/4/08).  The nature of the residue in confined rotational crops is
understood (DP# D257898, S. Levy, 2/8/2000).  Adequate confined rotational crop studies
conducted at 2.2x and 1.5x the current maximum use rate for rotated crops (1.3 lb ai/A) are
available.
4.1.2
Residues of Concern
Residues of concern for dietary and drinking water risk assessment and tolerance
expression for cyprodinil are provided in Table 8.  HED recommends that the current tolerance
expression for animal commodities be changed to reflect both parent and metabolite CGA-
304075 (4-[(4-cyclopropyl-6-methyl-2-2-pyrimidinyl)amino]-phenol).
Table 8:  Summary of MARC Decisions for Cyprodinil
Residues of Concern
<s>1</s>
Matrix
For Risk Assessment
<s>2</s>
For Tolerance Expression
Plants cyprodinil
cyprodinil
Livestock
cyprodinil and CGA-304075
cyprodinil and CGA-304075
Water
cyprodinil and CGA 249287
cyprodinil
4.1.3   Residue Analytical Methods
<IP_ADDRESS> Enforcement Methods
Adequate HPLC/UV methods with column switching (Syngenta Methods AG-631 and
AG-631B) are available for enforcing tolerances of cyprodinil on plant commodities.  The LOQs
for these methods range from 0.01 to 0.05 ppm depending on the plant commodities.  Method
AG-631B also contains procedures for confirmatory analysis by GC/NPD.

Page 17 of 38
An adequate HPLC/MS method (GRM010.01A) is also available for enforcing tolerances
in livestock commodities.  This method determines residues of both parent and the metabolite
CGA-304075 (free and conjugated), expressed as parent.  The LOQ is 0.01 ppm for each analyte
for a combined LOQ of 0.02 ppm.
<IP_ADDRESS> Multiresidue Methods
Data are available depicting the recovery of cyprodinil and its metabolite CGA-232449
through FDA Multiresidue method testing protocols (C through E).  Acceptable recoveries were
obtained for cyprodinil in apples fortified at 0.40 ppm using Protocol D.  These data were
forwarded to FDA (G. Kramer, 11/28/1995).
4.1.4
Residues in Crops
There is adequate number and geographic location of apple and pear field trials
conducted with a WDG formulation of cyprodinil to support the proposed amended uses on
pome fruit.  Syngenta Crop Protection submitted residue data from 12 apple field trials
conducted in the U.S. in Zones 1, 2, 5, 9, 10, and 11 and from 6 pear field trials conducted in the
U.S. in Zones 1, 10, and 11 using a water-dispersible granular (WDG) formulation containing


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Rules and Regulations]
[Pages 5306-5310]
[FR Doc No: 2013-01209]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R04-OAR-2011-0043; FRL-9771-2]

Approval and Promulgation of Implementation Plans and Designation
of Areas for Air Quality Planning Purposes; Alabama; Redesignation of
the Birmingham 2006 24-Hour Fine Particulate Matter Nonattainment Area
to Attainment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is taking final action to approve a request submitted on
June 17, 2010, from the State of Alabama, through the Alabama
Department of Environmental Management (ADEM), Air Division, to
redesignate the Birmingham fine particulate matter (PM2.5)
nonattainment area (hereafter referred to as the ``Birmingham Area'' or
``Area'') to attainment for the 2006 24-hour PM2.5 national
ambient air quality standards (NAAQS). The Birmingham 2006 24-hour
PM2.5 nonattainment area is comprised of Jefferson and
Shelby Counties in their entireties and a portion of Walker County.
EPA's approval of the redesignation request is based on the
determination that the State of Alabama has met the criteria for
redesignation to attainment set forth in the Clean Air Act (CAA or
Act), including the determination that the Birmingham Area has attained
the 2006 24-hour PM2.5 NAAQS. Additionally, EPA is approving
a revision to the Alabama state implementation plan (SIP) to include
the 2006 24-hour PM2.5 maintenance plan for the Birmingham
Area that contains the new 2024 motor vehicle emission budgets (MVEBs)
for nitrogen oxides (NOX) and PM2.5. This action
also approves the 2009 emissions inventory submitted with the
maintenance plan.

DATES:  Effective Date: This rule will be effective February 25, 2013.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2011-0043. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30, excluding Federal
holidays.

FOR FURTHER INFORMATION CONTACT: Joel Huey, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. Joel Huey may be reached by
phone at<PHONE_NUMBER> or via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is the background for the actions?
II. What are the actions EPA is taking?
III. Why is EPA taking these actions?
IV. What are the effects of these actions?

V. Final Action
VI. Statutory and Executive Order Reviews

I. What is the background for the actions?

    As stated in our proposed approval notice published on November 10,
2011 (76 FR 70091), this redesignation action addresses the Birmingham
Area's status solely with respect to the 2006 24-hour PM2.5
NAAQS, for which designations were finalized on November 13, 2009 (74
FR 58688). On June 17, 2010, the State of Alabama, through ADEM,
submitted a request to redesignate the Birmingham Area to attainment
for the 2006 24-hour PM2.5 NAAQS and for EPA approval of the
Alabama SIP revisions containing a maintenance plan for the Area. In
the November 10, 2011, notice, EPA proposed to take the following three
separate but related actions, some of which involve multiple elements:
(1) To redesignate the Birmingham Area to attainment for the 2006 24-
hour PM2.5 NAAQS, provided EPA approves the emissions
inventory submitted with the maintenance plan; (2) to approve into the
Alabama SIP, under section 175A of the CAA, Alabama's 2006 24-hour
PM2.5 NAAQS maintenance plan, including the associated
MVEBs; and (3) to approve, under CAA section 172(c)(3), the emissions
inventory submitted with the maintenance plan. No comments were
received on the proposed action. EPA is now taking final action on the
three actions identified above. Additional background for today's
action, and other details regarding the proposed redesignation, is set
forth in EPA's November 10, 2011, proposal and is summarized below. The
following information also: (1) Affirms that the most recent available
ambient monitoring data continue to support this redesignation action,
(2) summarizes the NOX and PM2.5 MVEBs for the
year 2024 for the Birmingham Area, and (3) provides additional
information on events that have occurred since the November 10, 2011,
proposal.
    With regard to the data, EPA has reviewed the most recent ambient
monitoring data, which indicate that the Birmingham Area continues to
attain the 2006 24-hour PM2.5 NAAQS beyond the 3-year
attainment period of 2007-2009, which was provided with Alabama's June
17, 2010, submittal and request for redesignation. As stated in EPA's
November 10, 2011, proposal notice, the 3-year design values of 34
[mu]g/m\3\ for 2007-2009 and 29 [mu]g/m\3\ for 2008-2010 meet the NAAQS
of 35 [mu]g/m\3\. Quality assured and certified data now in EPA's Air
Quality System (AQS) for 2011 provide a 3-year design value of 27
[mu]g/m\3\ for 2009-2011. Furthermore, preliminary monitoring data for
2012 indicate that the Area is continuing to attain the 2006 24-hour
PM2.5 NAAQS. The 2012 preliminary data are available in AQS
although are not yet quality assured and certified.
    The MVEBs, specified in tons per day (tpd), included in the
maintenance plan are as shown in Table 1 below. In the November 10,
2011, proposed action, EPA noted that the period for public comment on
the adequacy of these MVEBs (as contained in Alabama's submittal) began
on March 24, 2011, and closed on April 25, 2011. No comments were
received during the public comment period. Through this final action,
EPA is finding the 2024 NOX and PM2.5 MVEBs
adequate for transportation conformity purposes and finalizing the
approval of the budgets.

                Table 1--Birmingham Area PM2.5 NOX MVEBs
                                  (tpd)
------------------------------------------------------------------------
                                                         PM2.5     NOX
------------------------------------------------------------------------
2024 On-road Mobile Emissions........................     0.96     25.20
Safety Margin Allocated to MVEBs.....................     0.245    23.21
2024 Conformity MVEBs................................     1.21     48.41
------------------------------------------------------------------------

    In the November 10, 2011, proposed redesignation of the Birmingham
Area, EPA proposed to determine that the emission reduction
requirements that contributed to attainment of the 2006 24-hour
PM2.5 standard in the nonattainment area could be considered
permanent and enforceable. See 76 FR at 70092, 70097-70099. At the time
of proposal, EPA noted that the requirements of the Clean Air
Interstate Rule (CAIR),\1\ which had been in place since 2005, were to
be replaced, starting in 2012, by the requirements in the then recently
promulgated Cross-State Air Pollution Rule (CSAPR), 76 FR 48208 (August
8, 2011). CSAPR included regulatory changes to sunset (i.e.,
discontinue) the CAIR requirements for control periods in 2012 and
beyond. See 76 FR at 48322. Although Alabama's redesignation request
and maintenance plan included reductions associated with CAIR, EPA
proposed to approve the request based in part on the fact that CSAPR
achieved similar or greater reductions in the relevant areas in 2012
and beyond. See 76 FR at 70092, 70097-70099. Because CSAPR requirements
were expected to replace the CAIR requirements starting in 2012, EPA
considered the impact of CSAPR related reductions on the Birmingham
Area. On this basis, EPA proposed to determine that, pursuant to CAA
section 107(d)(3)(E)(iii), the pollutant transport part of the
reductions that led to attainment in the Birmingham Area could be
considered permanent and enforceable. See 76 FR at 70092, 70097-70099.
---------------------------------------------------------------------------

    \1\ On May 12, 2005, EPA published CAIR, which requires
significant reductions in emissions of sulfur dioxide
(SO2) and NOX from electric generating units
to limit the interstate transport of these pollutants and the ozone
and fine particulate matter they form in the atmosphere. See 70 FR
75163. The U.S. Court of Appeals for the District of Columbia
Circuit (D.C. Circuit) initially vacated CAIR, North Carolina v.
EPA, 531 F.3d 896 (D.C. Cir. 2008), but ultimately remanded the rule
to EPA without vacatur to preserve the environmental benefits
provided by CAIR, North Carolina v. EPA, 550 F.3d 1176, 1178 (D.C.
Cir. 2008).
---------------------------------------------------------------------------

    On December 30, 2011, shortly after EPA's proposed approval of the
Birmingham redesignation, the D.C. Circuit issued an order addressing
the status of CSAPR and CAIR in response to motions filed by numerous
parties seeking a stay of CSAPR pending judicial review. In that order,
the court stayed CSAPR pending resolution of the petitions for review
of that rule in EME Homer City Generation, L.P. v. EPA (No. 11-1302 and
consolidated cases), also referred to as EME Homer City. The court also
indicated that EPA was expected to continue to administer CAIR in the
interim until judicial review of CSAPR was completed. Subsequently, on
August 21, 2012, the D.C. Circuit issued a decision in EME Homer City
to vacate and remand CSAPR and to keep CAIR in place. Specifically, the
court ordered EPA to continue administering CAIR pending the
promulgation of a valid replacement. EME Homer City Generation, L.P. v.
EPA, 696 F.3d 7, 38 (D.C. Cir. 2012). The D.C. Circuit has not yet
issued the final mandate in EME Homer City as EPA (as well as several
intervenors) petitioned for rehearing en banc, asking the full court to
review the decision. While rehearing proceedings are pending, EPA
intends to act in accordance with the panel opinion in the EME Homer
City opinion.
    Subsequent to the EME Homer City opinion, EPA published several
proposals to redesignate both particulate matter and ozone
nonattainment areas to attainment. These proposals explained the legal
status of CAIR and CSAPR, and provided a basis on which EPA would
consider emissions reductions associated with CAIR to be permanent and
enforceable for redesignation purposes, pursuant to CAA section
107(d)(3)(D)(iii). In those actions, EPA explained that in light of the
August 21, 2012, order by the D.C. Circuit, CAIR remains in place and
enforceable until substituted by a

``valid'' replacement rule. See, e.g., 77 FR 69409 (November 19, 2012);
77 FR 68087 (November 15, 2012).
    Alabama's June 17, 2010, SIP submittal supporting its redesignation
request includes CAIR as a control measure, which became state-
effective on April 3, 2007, and was approved by EPA on October 1, 2007,
for the purpose of reducing SO2 and NOX
emissions. See 72 FR 55659. Due to the legal status of CSAPR at the
time that EPA proposed approval of Alabama's June 17, 2010,
redesignation submittal, EPA was able to rely on CSAPR related
reductions. EPA also recognized that the monitoring data used to
demonstrate the Birmingham Area's attainment of the 2006 24-hour
PM2.5 NAAQS included reductions associated with CAIR. Due to
the uncertainty regarding the legal status of CAIR when Alabama
provided its submittal on June 17, 2010, the State's analysis assumed
that no additional reductions in SO2 or NOX
emissions from utilities would occur above and beyond those achieved
through 2012 as a result of CAIR. To the extent that the Alabama
submittal relies on CAIR reductions that occurred through 2012, the
recent directive from the D.C. Circuit in EME Homer City ensures that
the reductions associated with CAIR will be permanent and enforceable
for the necessary time period for purposes of CAA section
107(d)(3)(E)(iii). EPA has been ordered by the court to develop a new
rule, and the opinion makes clear that after promulgating that new rule
EPA must provide states an opportunity to draft and submit SIPs to
implement that rule. CAIR thus cannot be replaced until EPA has
promulgated a final rule through a notice-and-comment rulemaking
process; states have had an opportunity to draft and submit SIPs; EPA
has reviewed the SIPs to determine if they can be approved; and EPA has
taken action on the SIPs, including promulgating a Federal
Implementation Plan, if appropriate. The court's clear instruction to
EPA is that it must continue to administer CAIR until a ``valid
replacement'' exists, and thus CAIR reductions may be relied upon until
the necessary actions are taken by EPA and states to administer CAIR's
replacement. Furthermore, the court's instruction provides an
additional backstop; by definition, any rule that replaces CAIR and
meets the court's direction would require upwind states to have SIPs
that eliminate significant contributions to downwind nonattainment and
prevent interference with maintenance in downwind areas.
    Further, in deciding to vacate CSAPR and to require EPA to continue
administering CAIR, the D.C. Circuit emphasized that the consequences
of vacating CAIR ``might be more severe now in light of the reliance
interests accumulated over the intervening four years.'' EME Homer
City, 696 F.3d at 38. The accumulated reliance interests include the
interests of states who reasonably assumed they could rely on
reductions associated with CAIR, which brought certain nonattainment
areas into attainment with the NAAQS. If EPA were prevented from
relying on reductions associated with CAIR in redesignation actions,
states would be forced to impose additional, redundant reductions on
top of those achieved by CAIR. EPA believes this is precisely the type
of irrational result the court sought to avoid by ordering EPA to
continue administering CAIR. For these reasons also, EPA believes it is
appropriate to allow states to rely on CAIR, and the existing emissions
reductions achieved by CAIR, as sufficiently permanent and enforceable
for purposes such as redesignation. Following promulgation of the
replacement rule, EPA will review SIPs as appropriate to identify
whether there are any issues that need to be addressed.
    In light of these unique circumstances and for the reasons
explained above, EPA is approving the redesignation request and the
related SIP revision for Jefferson and Shelby Counties in their
entireties and a portion of Walker County in Alabama, including
Alabama's plan for maintaining attainment of the 2006 24-hour
PM2.5 NAAQS in the Birmingham Area. EPA continues to
implement CAIR in accordance with current direction from the court, and
thus CAIR is in place and enforceable and will remain so until
substituted by a valid replacement rule. Alabama's SIP revision lists
CAIR as a control measure, which became state-effective on April 3,
2007, and was approved by EPA on October 1, 2007, for the purpose of
reducing SO2 and NOX emissions. The monitoring
data used to demonstrate the Area's attainment of the 2006 24-hour
PM2.5 NAAQS by the April 2010 attainment deadline was
impacted by CAIR.

II. What are the actions EPA is taking?

    In today's rulemaking, EPA is approving: (1) A change to the legal
designation of the Birmingham Area from nonattainment to attainment for
the 2006 24-hour PM2.5 NAAQS; (2) under CAA section 175A,
Alabama's 2006 24-hour PM2.5 NAAQS maintenance plan,
including the associated MVEBs; and (3) under CAA section 172(c)(3),
the emissions inventory submitted with the maintenance plan for the
Area. The maintenance plan is designed to demonstrate that the
Birmingham Area will continue to attain the 2006 24-hour
PM2.5 NAAQS through 2024. EPA's approval of the
redesignation request is based on EPA's determination that the
Birmingham Area meets the criteria for redesignation set forth in CAA,
sections 107(d)(3)(E) and 175A, including EPA's determination that the
Birmingham Area has attained the 2006 24-hour PM2.5 NAAQS.
EPA's analyses of Alabama's redesignation request, emissions inventory,
and maintenance plan are described in detail in the November 10, 2011,
proposed rule (76 FR 70091).
    Consistent with the CAA, the maintenance plan that EPA is approving
also includes 2024 NOX and PM2.5 MVEBs for the
Birmingham Area. In this action, EPA is approving these NOx and
PM2.5 MVEBs for the Birmingham Area for the purposes of
transportation conformity. For required regional emissions analysis
years that involve 2024 or beyond, the applicable budgets will be the
new 2024 NOX and PM2.5 MVEBs.

III. Why is EPA taking these actions?

    EPA has determined that the Birmingham Area has attained the 2006
24-hour PM2.5 NAAQS and has also determined that all other
criteria for the redesignation of the Birmingham Area from
nonattainment to attainment of the 2006 24-hour PM2.5 NAAQS
have been met. See CAA section 107(d)(3)(E). One of those requirements
is that the Birmingham Area has an approved plan demonstrating
maintenance of the 2006 24-hour PM2.5 NAAQS. EPA is also
taking final action to approve the maintenance plan for the Birmingham
Area as meeting the requirements of sections 175A and 107(d)(3)(E) of
the CAA. In addition, EPA is approving the new NOX and
PM2.5 MVEBs for the year 2024 for the Birmingham Area as
contained in Alabama's maintenance plan because these MVEBs are
consistent with maintenance of the 2006 24-hour PM2.5
standard in the Birmingham Area. Finally, EPA is approving the
emissions inventory as meeting the requirements of section 172(c)(3) of
the CAA. The detailed rationale for EPA's determinations and actions
are set forth in the proposed rulemaking and in other discussion in
this final rulemaking.

IV. What are the effects of these actions?

    Approval of the redesignation request changes the legal designation
of the Birmingham Area from nonattainment

to attainment for the 2006 24-hour PM2.5 NAAQS. EPA is
modifying the regulatory table in 40 CFR 81.301 to reflect a
designation of attainment for these full and partial counties. EPA is
also approving, as a revision to the Alabama SIP, Alabama's plan for
maintaining the 2006 24-hour PM2.5 NAAQS in the Birmingham
Area through 2024. The maintenance plan includes contingency measures
to remedy possible future violations of the 2006 24-hour
PM2.5 NAAQS and establishes NOX and
PM2.5 MVEBs for the year 2024 for the Birmingham Area.
Additionally, this action approves the emissions inventory for the
Birmingham Area pursuant to section 172(c)(3) of the CAA.

V. Final Action

    EPA is taking final action to approve three separate but related
actions, some of which involve multiple elements: (1) The redesignation
of the Birmingham Area to attainment for the 2006 24-hour
PM2.5 NAAQS; (2) under CAA section 175A, Alabama's 2006 24-
hour PM2.5 NAAQS maintenance plan, including the associated
MVEBs; and (3) under CAA section 172(c)(3), the emissions inventory
submitted with the maintenance plan for the Area. The 2006 24-hour
PM2.5 maintenance plan for the Birmingham Area includes the
new 2024 NOX and PM2.5 MVEBs of 48.41 tpd and
1.21 tpd, respectively. Within 24 months from the effective date of
EPA's adequacy determination, the transportation partners will need to
demonstrate conformity to the new NOX and PM2.5
MVEBs pursuant to 40 CFR 93.104(e).\2\
---------------------------------------------------------------------------

    \2\ The adequacy finding becomes effective upon the date of
publication of this notice in the Federal Register. 40 CFR
93.118(f)(2)(iii).
---------------------------------------------------------------------------

VI. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of the maintenance plan under CAA section
107(d)(3)(E) are actions that affect the status of a geographical area
and do not impose any additional regulatory requirements on sources
beyond those required by state law. A redesignation to attainment does
not in and of itself impose any new requirements, but rather results in
the application of requirements contained in the CAA for areas that
have been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40
CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For these reasons, these actions:
     Are not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not an economically significant regulatory action
based on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory action subject to Executive
Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this final rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 26, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects

 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, and Particulate matter.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks.

    Dated: January 9, 2013.
Gwendolyn Keyes Fleming,
Regional Administrator, Region 4.
    40 CFR parts 52 and 81 are amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart B--Alabama

0
2. Section 52.50(e) is amended by adding a new entry for ``2006 24-hour
PM2.5 Maintenance Plan for the Birmingham Area'' at the end
of the table to read as follows:

Sec.  52.50  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Alabama Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                       Applicable       State submittal
   Name of non-regulatory SIP      geographic or non-   date/effective    EPA approval date       Explanation
            provision               attainment area          date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2006 24-hour PM2.5 Maintenance    Birmingham PM2.5              6/17/10  1/25/13 [Insert
 Plan for the Birmingham Area.     Nonattainment Area.                    citation of
                                                                          publication].
----------------------------------------------------------------------------------------------------------------

PART 81--[AMENDED]

0
3. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
4. In Sec.  81.301, the table entitled ``Alabama--PM2.5 (24-
hour NAAQS)'' is amended under ``Birmingham, AL'' by revising the
entries for ``Jefferson County'', ``Shelby County'', and ``Walker
County (part)'' to read as follows:

Sec.  81.301  Alabama.

* * * * *

                                         Alabama--PM2.5 (24-Hour NAAQS)
----------------------------------------------------------------------------------------------------------------
                                  Designation for the 1997 NAAQS \a\       Designation for the 2006 NAAQS \a\
        Designation area        --------------------------------------------------------------------------------
                                     Date \1\             Type              Date \2\               Type
----------------------------------------------------------------------------------------------------------------
Birmingham, AL:
    Jefferson County...........                    Unclassifiable/     This action is     Attainment.
                                                    Attainment.         effective 1/25/
                                                                        13.
    Shelby County..............                    Unclassifiable/     This action is     Attainment.
                                                    Attainment.         effective 1/25/
                                                                        13.
    Walker County (part). The                      Unclassifiable/     This action is     Attainment.
     area described by U.S.                         Attainment.         effective 1/25/
     Census 2000 block group                                            13.
     identifiers 01-127-0214-5,
     01-127-0215-4, and 01-127-
     0216-2.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after January 5, 2005, unless otherwise noted.
\2\ This date is 30 days after November 13, 2009, unless otherwise noted.

* * * * *
[FR Doc. 2013-01209 Filed 1-24-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Rules and Regulations]
[Pages 21885-21886]
[FR Doc No: 2018-10043]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0337]

Recurring Safety Zone; Corpus Christi Hooks Baseball Team/Friday
Night Fireworks

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce safety zones for the Corpus
Christi Hooks Baseball Team/Friday Night Fireworks on odd week Fridays
from May 11, 2018 through August 24, 2018, to provide for the safety of
life on navigable waterways during this event. Our regulation for
marine events within the Eighth Coast Guard District identifies the
regulated area for this event in Corpus Christi, TX. During the
enforcement periods, entry into these zones is prohibited unless
authorized by the Captain of the Port Sector Corpus Christi (COTP) or a
designated representative.

DATES: The regulations in 33 CFR 165.801, Table 4, Line 13 will be
enforced from 8 p.m. through 11:59 p.m., each day on May 11, May 25,
June 8, June 22, July 6, July 20, August 10, and August 24, 2018.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Petty Officer Kevin Kyles,
Waterways Management Division, U.S. Coast Guard; telephone 361-939-
5125, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce safety zones in
33 CFR 165.801, Table 4, Line 13, for the Corpus Christi Hooks Baseball
Team/Friday Night Fireworks regulated area from 8 p.m. through 11:59
p.m. on May 11, May 25, June 8, June 22, July 6, July 20, August 10,
and August 24, 2018. This action is being taken to provide for the
safety of life on navigable waterways during this recurring event. Our
regulation for marine events within the Eighth Coast Guard District,
Sec.  165.801, specifies the location of the regulated area for the
Corpus Christi Hooks

Baseball Team/Friday Night Fireworks, which encompasses portions of the
Corpus Christi Ship Channel. As reflected in Sec. Sec.  165.23 and
165.801(a), entry into this zone is prohibited unless authorized by the
Captain of the Port Sector Corpus Christi (COTP) or a designated
representative. Persons or vessels desiring to enter the zones must
request permission from the COTP or a designated representative. They
can be reached on VHF FM channel 16 or by telephone at<PHONE_NUMBER>.
If permission is granted, all persons and vessels shall comply with the
instructions of the COTP or designated representative. Designated
representatives include commissioned, warrant, and petty officers of
the U.S. Coast Guard.
    In addition to this notice of enforcement in the Federal Register,
the COTP or a designated representative will inform the public through
Broadcast Notice to Mariners (BNM), Local Notices to Mariners (LNM),
Marine Safety Information Broadcasts (MSIBs), and/or through other
means of public notice as appropriate at least 24 hours in advance of
each enforcement.

    Dated: April 27, 2018.
R.A. Hahn,
Captain, U.S. Coast Guard, Captain of the Port Sector Corpus Christi.
[FR Doc. 2018-10043 Filed 5-10-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63641-63642]
[FR Doc No: 2020-22381]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-0928]

Proposed Flight Standardization Board Report, The Boeing Company
737, Revision 17 and The Boeing Company 737 Airplane Flight Manual
Airspeed Unreliable Non-Normal Checklist

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of availability; request for comments.

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

SUMMARY: The FAA announces the availability of the draft Flight
Standardization Board (FSB) Report, The Boeing Company 737, Revision 17
including an addendum describing potential refinements to The Boeing
Company 737 Airplane Flight Manual (AFM) Airspeed Unreliable Non-Normal
Checklist, which applies to The Boeing Company Model 737-8 and 737- 9
(737 MAX) airplanes. The FAA invites public comment.

DATES: The FAA must receive comments on these proposed documents by
November 2, 2020.

ADDRESSES: You may send comments identified by docket number FAA-2020-
0928 using any of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the instructions for submitting comments.
    Fax:<PHONE_NUMBER>.
    Mail: U.S. Department of Transportation (DOT), Docket Operations,
M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.
    Hand Delivery: Deliver to Mail address above between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
    Privacy: DOT posts these comments, without edit, including any
personal information the commenter provides, to www.regulations.gov, as
described in the system of records notice (DOT/ALL- 14 FDMS), which can
be reviewed at www.dot.gov/privacy.
    Docket: You may examine the docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0928; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The street address for
Docket Operations is listed above. Comments will be available in the
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: For questions on the FSB Report,
contact James F. Kline, Aircraft Evaluation Division, telephone 206-
231-3950, email<EMAIL_ADDRESS>For questions on the AFM non-
normal checklist, contact Paul Bernado, Compliance and Airworthiness
Division, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Action

    Section 44701(a)(5) of title 49 of the U.S.C. requires the
Administrator to promulgate regulations and minimum standards for other
practices, methods, and procedures necessary for safety in air commerce
and national security. Consistent with this authority, the
Administrator publishes FSB Reports for use by FAA employees who
approve training programs, FAA employees and designees who certify
airmen, and aircraft operators and training providers, to assist them
in developing their flightcrew member training, checking, and currency.
Additionally, the Administrator publishes this notice consistent with
this same authority.

Background

    In September 2020, the FAA completed an operational evaluation of
proposed operating procedures (checklists) and pilot training as a
result of The Boeing Company Model 737-8 and 737-9 (737 MAX) design
changes. The operational evaluation identified potential refinements to
this Airplane Flight Manual (AFM) non-normal checklist Airspeed
Unreliable. This AFM non-normal procedure was referenced in the NPRM
Airworthiness Directives; The Boeing Company Airplanes (85 FR 47698).
The FAA has posted the draft Boeing 737 FSB Report and an addendum to
the Boeing 737 FSB Report, describing the potential refinements to the
non-normal checklist at https://www.faa.gov/aircraft/draft_docs/fsb/.

Comments Invited

    The FAA invites public comments on the draft FSB Report, The Boeing
Company 737, Revision 17, including the FSB Report addendum.

Ricardo Domingo,
Executive Director, Flight Standards Service, AFX-1.
[FR Doc. 2020-22381 Filed 10-6-20; 4:15 pm]
BILLING CODE 4910-13-P


For more details about the Significant New Use Rules (SNURs) for the following Premanufacture Notices (PMNs), please visit the associated docket.
   * P-13-365, P-13-392, P-13-393, and P-13-471
(EPA-HQ-OPPT-2013-0739)
   * P-13-270, P-13-563, P-13-617, P-13-618, and P-13-619
(EPA-HQ-OPPT-2014-0166)
   * P-14-60
(EPA-HQ-OPPT-2014-0277)