Poly(hexamethylenebiguanide) hydrochloride (PHMB); Exemption from the Requirement of a Tolerance, 1512-1517 [E8-189]
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Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) 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 tolerance 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 6, 2000) do not apply
to this rule. In addition, This 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)
(Public Law 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
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Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 28, 2007.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.571 is amended by
alphabetically adding the following
commodities in the table in paragraph
(a) to read as follows:
I
§ 180.571 Mesotrione; tolerances for
residues.
(a) * * *
Parts per million
Berry, group 13 ...............
*
*
*
Cranberry ........................
Flax, seed .......................
Lingonberry .....................
Millet, grain .....................
Millet, forage ...................
Millet, hay .......................
Millet, straw .....................
*
*
*
*
0.01
*
0.02
0.01
0.01
0.01
0.01
0.02
0.02
*
*
[FR Doc. E8–181 Filed 1–8–08; 8:45 am]
BILLING CODE 6560–50–S
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40 CFR Part 180
[EPA–HQ–OPP–2005–0268; FRL–8345–8]
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).
Commodity
ENVIRONMENTAL PROTECTION
AGENCY
Poly(hexamethylenebiguanide)
hydrochloride (PHMB); Exemption
from the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of the insecticide,
Poly(hexamethylenebiguanide)
hydrochloride (PHMB) on all food when
residues are the result of lawful
application of a food contact surface
sanitizer containing PHMB as a sanitizer
solution in food handling
establishments when applied as a
sanitizer. Arch Chemicals Inc.
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA),
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of PHMB.
DATES: This regulation is effective
January 9, 2008. Objections and requests
for hearings must be received on or
before March 10, 2008, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0268. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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 either in the electronic docket
at https://www.regulations.gov, or, if only
ADDRESSES:
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available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
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:
Adam Heyward, Antimicrobials
Division (7510P), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 308–
6422; e-mail address:
heyward.adam@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
40 CFR 180.940(a) Tolerance
exemptions for active and inert
ingredients for use in antimicrobial
formulations (Food-contact surface
sanitizing solutions. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
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https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2005–0268 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before March 10, 2008.
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 that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2005–0268, by one of
the following methods:
• Federal eRulemaking Portal: https://
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’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
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of December
21, 2005 (70 FR 75805) (FRL–7745-8),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
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pesticide tolerance petition (PP 5F6975)
by Arch Chemical Inc.,1955 Lake Park
Drive, Suite 100, Smyrna, GA 30080.
The petition requested that 40 CFR part
180 be amended by establishing an
exemption from the requirement of a
tolerance for residues of
Poly(hexamethylenebiguanide)
hydrochloride. This notice included a
summary of the petition prepared by the
petitioner Arch Chemical Inc. There
were no comments received in response
to the notice of filing.
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(c)(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. Pursuant to
section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of FFDCA, which requires
EPA to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance and to ‘‘ensure
that there is a reasonable certainty that
no harm will result to infants and
children from aggregate exposure to the
pesticide chemical residue....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. Toxicological Profile
A. Toxic Effects
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. The
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nature of the toxic effects are discussed
in this unit.
There are adequate toxicology data
available to characterize the toxicity of
PHMB. PHMB is a severe eye irritant
and is a moderate dermal irritant and
sensitizer. Acute oral, inhalation and
dermal toxicity are acute toxicity,
category III, which requires the signal
word caution to appear on the product
label as defined in 40 CFR 156.64(3).
B. Toxic Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (NOAEL) from the
toxicology study identified as
appropriate for the risk assessment is
used to estimate the toxicological level
of concern (LOC).
The Agency’s level of concern for
residential PHMB dermal, inhalation
and oral exposures is 100 (i.e. a margin
of exposure (MOE) less than 100
exceeds the Agency’s level of concern).
The level of concern is based on 10x for
interspecies extrapolation and 10x for
intraspecies variability. A summary of
the toxic endpoints for PHMB is listed
in the following table.
TABLE 1—TOXICOLOGICAL ENDPOINTS FOR ASSESSING OCCUPATIONAL AND RESIDENTIAL EXPOSURES/RISK*
Dose Used in Risk Assessment, UF
Acute Dietary (Females 13-50
years of age)
Special FQPA SF
and Level of Concern for Risk Assessment
Study and Toxicological Effects
NOAEL = 20 mg/kg/day
UF = 100
Acute RfD = 0.2 mg/kg/
day
ExposureScenario
FQPA SF = 1
aPAD = acute RfD
÷ FQPA SF= 0.2
mg/kg/day
Rabbit Developmental Study (MRID 42865901)
LOAEL = 40 mg/kg/day based on a reduced number of
litters and skeletal abnormalities.
Acute Dietary (General population including infants and
children)
No appropriate single dose effect was identified for the general population.
NOAEL = 20 mg/kg/day
UF = 100
Chronic RfD = 0.2 mg/kg/
day
FQPA SF = 1
cPAD = chronic
RfD ÷ FQPA
SF= 0.2 mg/kg/
day
Rabbit Developmental Study (MRID 42865901)
LOAEL = 40 mg/kg/day Based on increased mortality, reduced food consumption, and clinical toxicity;
Mouse Developmental Study (Report No. CTL/P/335,
1977 (cited in Report No. 003810, 1978. Section C-9))
LOAEL = 40 mg/kg/day Based on reduced body weight
gain; and
Rat Developmental Study (Report No. CTL/P/1262, 1976
(cited in Report No. 003810, 1978. Section C-11))
LOAEL = 50 mg/kg/day Based on reduced food consumption.
Short-Term Incidental Oral (1-30
days)
NOAEL = 20 mg/kg/day
UF = 100
Residential LOC
for MOE = 100
Rabbit Developmental Study (MRID 42865901)
LOAEL = 40 mg/kg/day Based on the increased mortality,
reduced food consumption, and clinical toxicity;
Mouse Developmental Study (Report No. CTL/P/335,
1977 (cited in Report No. 003810, 1978. Section C-9))
LOAEL = 40 mg/kg/day;Based on reduced body weight
gain; and
Rat Developmental Study (Report No. CTL/P/1262, 1976
(cited in Report No. 003810, 1978. Section C-11))
LOAEL = 50 mg/kg/day Based on reduced food consumption.
Intermediate-Term Incidental
Oral (1 - 6 months)
NOAEL = 20 mg/kg/day
UF = 100
Residential LOC
for MOE = 100
See Short-Term Incidental Oral Endpoint
Short-Term, Intermediate-Term
and Long-Term Dermal Exposure
Dermal (or oral) study
NOAEL= 150 mg/kg/day
UF = 100
(Relative dermal absorption rate =100%)
Residential LOC
for MOE = 100
80-Week Skin Painting Study – Mouse (MRIDs 00066475
and 00104796)
LOAEL = 750 mg/kg/day based on decreased body
weight and liver tumors.
Short-Term, Intermediate-Term
and Long-Term Inhalation Exposure
An appropriate route-specific inhalation study is not available. The oral endpoint of 20 mg/kg/day with a target MOE of 100 (10x inter-species extrapolation, 10x intra-species variation) is used. An additional 10x
route-to-route extrapolation is used to determine if a confirmatory inhalation toxicity study is warranted.
Cancer (oral, dermal)
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Chronic Dietary (All populations)
EPA has classified PHMB as having suggestive evidence of carcinogenicity but the evidence was too weak
to warrant quantification of human cancer risk
*UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = acute population adjusted dose (a = acute, c = chronic) RfD = reference dose, LOC = level of concern, MOE = margin of
exposure
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IV. Aggregate Exposures
In examining aggregate exposure,
FFDCA section 408 directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
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A. Dietary Exposure
PHMB is an antimicrobial that is used
as a hard surface sanitizer and may be
in or on food processing equipment,
premises of food processing plants, milk
processing equipment, milk processing
plants, eating establishments, food
contact surfaces, adhesives, and slurries.
The use of PHMB as an antimicrobial
product on these various surfaces may
result in pesticide residues in human
food. Residues from treated surfaces can
migrate to food that comes into contact
with the treated surfaces which then can
result in human ingestion.
1. Food. The Agency assessed acute
and chronic dietary exposure from the
use of PHMB as a disinfectant and food
contact sanitizer on direct and indirect
food-contact surfaces. This assessment
calculated the Daily Dietary Dose (DDD)
and the Estimated Daily Intake (EDI)
using an FDA model (‘‘Sanitizing
Solutions: Chemical Guidelines for
Food Additives Petition, January
1993’’). The FDA model takes into
account application rates, residual
solution, area of the treated surface
which comes into contact with food,
pesticide migration fraction, and body
weight of the population exposed.
To calculate the EDI (estimated daily
intake) values for PHMB when it is used
as a sanitizer in public eating spaces, it
was assumed that PHMB would be used
at a concentration of 550 parts per
million (ppm), the thickness of the
PHMB residues on surfaces would be 1
mg per square centimeter of treated
surface, and the surface area of the food
contact surface being sanitized to which
a person would be exposed on a daily
basis is 4,000 cm2 (which includes
contact with treated silverware, china,
and glass used by an individual who
regularly eats three meals per day at an
institutional or public facility). It was
also assumed that 100% of the pesticide
would migrate to food.
To calculate the EDI (estimated daily
intake) values for PHMB when it is used
in the food processing industry, it was
also assumed to be used at a
concentration of 550 ppm. However,
specific to this scenario, the exposure
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estimates were calculated using the milk
truck model that is described in the
FDA document, ‘‘Sanitizing Solutions:
Chemistry Guidelines For Food
Additive Petitions.’’ This includes the
assumption that estimates of sanitary
exposure from use in dairy processing
plants significantly exceed estimates
based on other uses with food
processing equipment and utensils. For
the purpose of assessing risks stemming
from food processing uses, parameters
assuming a sanitized milk truck were
used as the worst case scenario. The
various input parameters, such as the
size of the truck, internal surface area,
residual thickness, and application rate
of PHMB were used to calculate
potential residues present in the truck
per liter of food (i.e. milk).
For each dietary exposure assessment
it was assumed that adults (both male
and female) consume 3,000 grams of
food a day and a child, 1,500 grams.
This allowed for an estimation of the
amount of PHMB that is anticipated to
be present in an average adult’s or
child’s daily intake from these uses, and
in turn, the calculation of a daily dietary
dose.
2. Drinking water exposure. The uses
of PHMB are not expected to
significantly contaminate drinking
water sources. As provided in the
PHMB Reregistration Eligibility
Document, ‘‘none of the uses associated
with PHMB are expected to impact
either surface or ground water
resources.’’ Therefore, the PHMB
contributions for drinking water
exposure are considered to be negligible
and are not quantified.
B. Other Non-Occupational Exposure
The residential exposure assessment
considers all potential non-occupational
pesticide exposure, other than exposure
due to residues in food or in drinking
water. Exposures may occur during and
after application as a hard surface
disinfectant (e.g. walls, floors, tables,
fixtures) and to swimming pools. Each
route of exposure is assessed, where
appropriate, and risk is expressed as a
margin of exposure (MOE), which is the
ratio of estimated exposure to an
appropriate NOAEL.
Residential exposure may occur
during application of PHMB to indoor
hard surfaces (e.g., mopping, wiping,
trigger pump sprays) and to swimming
pools. The residential handler scenarios
were assessed to determine dermal and
inhalation exposures. Surrogate dermal
and inhalation unit exposure values
were estimated using Pesticide Handler
Exposure Database (PHED) data and the
Chemical Manufactures Association
Anitmicrobial Exposure Assessment
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Study (USEPA, 1999) and the
SWIMODEL 3.0 was utilized to conduct
exposure assessments of pesticides
found in swimming pools and spas
(Versar, 2003). Note that for this
assessment, EPA assumed that
residential users complete all elements
of an application (mix/load/apply)
without the use of personal protective
equipment.
The duration for most residential
exposures is believed to be best
represented by short-term duration (1 to
30 days). The short-term duration was
chosen for this assessment because the
residential handler and post-application
scenarios are assumed to be performed
on an episodic, not a daily basis.
Based on toxicological criteria and the
potential for exposure, the Agency has
conducted incidental oral, dermal and
inhalation exposure assessments for
PHMB residential use. As noted
previously, MOEs greater than or equal
to 100 are considered adequately
protective for the residential exposure
assessment.
Specific information on the
residential exposure for PHMB can be
found at https://www.regulations.gov,
docket ID No. EPA–HQ–OPP–2005–
0268.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
PHMB and any other substances and
PHMB does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has not
assumed that PHMB has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
VI. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (‘‘10x’’) tenfold margin of
safety for infants and children in the
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case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the data base 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. In applying
this provision, EPA either retains the
default value of 10x when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional FQPA
safety factor value based on the use of
traditional uncertainty/safety factors
and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There is no quantitative or qualitative
evidence of increased susceptibility to
the fetus following in utero exposure to
PHMB in the prenatal developmental
toxicity studies, and no quantitative or
qualitative evidence of increased
susceptibility to the offspring when
adults are exposed to PHMB in the twogeneration reproductive study. In each
study, any development/reproductive
effect observed occurred at doses equal
to or higher than the doses at which
maternal toxicity was observed. This,
together with the nature of the effects
seen in the studies has led the Agency
to conclude that there is no evidence of
increased susceptibility.
EPA has determined that reliable data
show that it would be safe for infants
and children to reduce the FQPA safety
factor to 1x. That decision is based on
the following findings:
i. The toxicity database for
Poly(hexamethylenebiguanide)
hydrochloride (PHMB) is complete for
assessing risk to infants and children
under the FFDCA.
ii. There is no indication that PHMB
is a neurotoxic chemical and there is no
need for a developmental neurotoxicity
study or additional uncertainty factors
to account for neurotoxicity.
iii. There is no evidence that PHMB
results in increased susceptibility in in
utero rats or rabbits in the prenatal
developmental studies or in young rats
in the two-generation reproduction
study.
iv. 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
and will not underestimate the exposure
and risk. Conservative ground and
surface water modeling estimates were
used. Similarly conservative Residential
SOPs were used to assess postapplication exposure to children as well
as incidental oral exposure of toddlers.
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Jkt 214001
These assessments will not
underestimate the exposure and risks
posed by PHMB.
VII. Determination of Safety for U.S.
Population, Infants and Children
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the acute
population adjusted dose (‘‘aPAD’’) and
chronic population adjusted dose
(‘‘cPAD’’). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable uncertainty/safety factors.
For linear cancer risks, EPA calculates
the probability of additional cancer
cases given aggregate exposure. Short-,
intermediate-, and long-term risks are
evaluated by comparing aggregate
exposure to the LOC to ensure that the
MOE called for by the product of all
applicable uncertainty/safety factors is
not exceeded.
1. Acute and chronic risk. EPA
compares the estimated dietary
exposures to an aPAD and a cPAD, both
of which are 0.2 mg/kg/day for PHMB.
Generally, a dietary exposure estimate
that is less than 100% of the aPAD or
cPAD does not exceed the Agency’s
levels of concern.
The antimicrobial indirect food use
acute/chronic risk estimates from
exposure to treated utensils and
countertops as well as from food
processing facility sanitation are below
the Agency’s level of concern. For
adults females of child bearing age (13
to 49 years old), the cumulative (food
utensils and food processing) acute and
chronic dietary exposure risk estimates
are 18.8% of the acute and chronic
PADs. For children ages 3 to 5 years old,
the most highly exposed population
subgroup, the cumulative chronic
dietary risk estimates are 37.2% of
chronic PAD (there are no effects
anticipated for the acute exposures).
Therefore, dietary exposure estimates
are below the Agency’s level of concern
for all population subgroups. Based on
the information in this preamble, EPA
concludes that there is a reasonable
certainty of no harm from aggregate
exposure to residues. Accordingly, EPA
finds that exempting from the
requirement of a tolerance will be safe.
2. Non-occupational risk. Aggregate
exposure takes into account residential
exposure plus chronic exposure to food
and water (considered to be a
background exposure level).
Using the exposure assumptions
described in this unit for other nonoccupational exposures, EPA has
concluded that food, water, and
residential exposures aggregated result
in aggregate MOEs greater than or equal
to 100 for the inhalation route of
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Fmt 4700
Sfmt 4700
exposure and 100 for dermal exposure.
Therefore, these levels of exposure are
not of concern.
3. Aggregate cancer risk for U.S.
population. EPA has classified PHMB as
having no greater than suggestive
evidence of carcinogenicity. The weightof-the-evidence considerations for this
classification are as follows:
i. A treatment-related statistically
significant increase (trend and pairwise) in vascular tumors (mainly
benign) was seen in female rats at an
oral dose that was considered to be
adequate, but not excessive. This was
considered the strongest evidence on
the Agency’s evaluation of PHMB.
ii. Oral exposure to male and female
mice also resulted in treatment-related
vascular tumors seen at an excessive
dose. However, at the next highest dose
level, which was considered adequate
but not excessive, there was a slight, but
not statistically significant, increase in
this same tumor, which added to the
Agency’s concern for this tumor type.
iii. It is noted that dermal exposure to
female mice resulted in an equivocal
increase in vascular tumors seen at only
an excessive dose.
iv. No treatment-related increase in
any tumors was seen in male rats via the
oral route or in male mice via the
dermal route of exposure.
Based on the findings above, the
Agency has determined that PHMB
posed no greater than a negligible
cancer risk.
4. 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 PHMB.
Accordingly, EPA finds that exempting
PHMB from the requirement of a
tolerance will be safe.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under the FFDCA, as
amended by FQPA, to develop a
screening program to determine whether
certain substances (including all
pesticide active and other ingredients)
‘‘may have an effect in humans that is
similar to an effect produced by a
naturally occurring estrogen, or other
such endocrine effects as the
Administrator may designate.’’
Following the recommendations of its
Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC),
EPA determined that there was
scientific basis for including, as part of
the program, the androgen and thyroid
hormone systems, in addition to the
estrogen hormone system. EPA also
E:\FR\FM\09JAR1.SGM
09JAR1
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations
adopted EDSTAC’s recommendation
that the Program include evaluations of
potential effects in wildlife. For
pesticide chemicals, EPA will use the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and, to the
extent that effects in wildlife may help
determine whether a substance may
have an effect in humans, FFDCA has
authority to require the wildlife
evaluations. As the science develops
and resources allow, screening of
additional hormone systems may be
added to the Endocrine Disruptor
Screening Program (EDSP).
When the appropriate screening and/
or testing protocols being considered
under the Agency’s EDSP have been
developed, PHMB may be subjected to
additional screening and/or testing to
better characterize effects related to
endocrine disruption.
B. Analytical Method(s)
An analytical method for food is not
needed. Food contact sanitizers are
typically regulated by state health
departments to ensure that the food
industry is using these products in
compliance with regulations in 40 CFR
180.940. The end use solution that is
applied to the food contact surface is
analyzed not food items that may come
into contact with the treated surface. An
analytical method is available to analyze
the use dilution that is applied to food
contact surfaces. The solution can be
analyzed by use of the
spectrophotometric method.
C. Existing Tolerances
There is no existing tolerance or
exemption from tolerance for PHMB.
pwalker on PROD1PC71 with NOTICES
D. International Tolerances
No Codex, Canadian, or Mexican
maximum residue limits (MRLs) have
been established for any food uses at
this time.
VIII. Statutory and Executive Order
Reviews
This final rule establishes a 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 rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
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15:44 Jan 08, 2008
Jkt 214001
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 tolerance 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 6, 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) (Public Law 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).
IX. 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
PO 00000
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Fmt 4700
Sfmt 4700
1517
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: December 18, 2007.
Betty Shackleford,
Acting Director, Antimicrobials Division,
Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1280 is added to
subpart D to read as follows:
I
§ 180.1280 Poly(hexamethylenebiguanide)
hydrochloride (PHMB) exemption from the
requirement of a tolerance.
Poly(hexamethylenebiguanide)
hydrochloride (PHMB)(CAS Reg. No.
32289–58–0) is exempt from the
requirement of a tolerance for residues
of the antimicrobial in or on all food
commodities when the residues are the
result of the lawful application of a food
contact surface sanitizer containing
PHMB at 550 parts per million (ppm).
[FR Doc. E8–189 Filed 1–8–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0300; FRL–8346–3]
Zeta-cypermethrin; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
zeta-cypermethrin and its inactive Risomers in or on Citrus (dried pulp, fruit
and oil); oilseed commodities (seeds of
borage, castor oil plant, Chinese tallow
tree, crambe, cuphea, echium,
euphorbia, evening primrose, flax, gold
of pleasure, hare’s-ear mustard, jojoba,
E:\FR\FM\09JAR1.SGM
09JAR1
]]>Agencies
[Federal Register Volume 73, Number 6 (Wednesday, January 9, 2008)]
[Rules and Regulations]
[Pages 1512-1517]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-189]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0268; FRL-8345-8]
Poly(hexamethylenebiguanide) hydrochloride (PHMB); Exemption from
the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the insecticide,
Poly(hexamethylenebiguanide) hydrochloride (PHMB) on all food when
residues are the result of lawful application of a food contact surface
sanitizer containing PHMB as a sanitizer solution in food handling
establishments when applied as a sanitizer. Arch Chemicals Inc.
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of PHMB.
DATES: This regulation is effective January 9, 2008. Objections and
requests for hearings must be received on or before March 10, 2008, 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-2005-0268. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 either in the electronic docket at https://
www.regulations.gov, or, if only
[[Page 1513]]
available in hard copy, at the Office of Pesticide Programs (OPP)
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are 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: Adam Heyward, Antimicrobials Division
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-6422; e-mail
address: heyward.adam@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 180.940(a)
Tolerance exemptions for active and inert ingredients for use in
antimicrobial formulations (Food-contact surface sanitizing solutions.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2005-0268 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before March 10, 2008.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0268, by one of the following methods:
Federal eRulemaking Portal: https://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'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 (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 21, 2005 (70 FR 75805) (FRL-
7745-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 5F6975) by Arch Chemical Inc.,1955 Lake Park Drive, Suite
100, Smyrna, GA 30080. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Poly(hexamethylenebiguanide) hydrochloride.
This notice included a summary of the petition prepared by the
petitioner Arch Chemical Inc. There were no comments received in
response to the notice of filing.
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(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
A. Toxic Effects
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The
[[Page 1514]]
nature of the toxic effects are discussed in this unit.
There are adequate toxicology data available to characterize the
toxicity of PHMB. PHMB is a severe eye irritant and is a moderate
dermal irritant and sensitizer. Acute oral, inhalation and dermal
toxicity are acute toxicity, category III, which requires the signal
word caution to appear on the product label as defined in 40 CFR
156.64(3).
B. Toxic Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(NOAEL) from the toxicology study identified as appropriate for the
risk assessment is used to estimate the toxicological level of concern
(LOC).
The Agency's level of concern for residential PHMB dermal,
inhalation and oral exposures is 100 (i.e. a margin of exposure (MOE)
less than 100 exceeds the Agency's level of concern). The level of
concern is based on 10x for interspecies extrapolation and 10x for
intraspecies variability. A summary of the toxic endpoints for PHMB is
listed in the following table.
Table 1--Toxicological Endpoints for Assessing Occupational and Residential Exposures/Risk*
----------------------------------------------------------------------------------------------------------------
Special FQPA SF and
ExposureScenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years NOAEL = 20 mg/kg/day FQPA SF = 1 Rabbit Developmental
of age) UF = 100............... aPAD = acute RfD / Study (MRID 42865901)
Acute RfD = 0.2 mg/kg/ FQPA SF= 0.2 mg/kg/ LOAEL = 40 mg/kg/day
day. day. based on a reduced
number of litters and
skeletal abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population No appropriate single dose effect was identified for the general
including infants and children) population.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 20 mg/kg/day FQPA SF = 1 Rabbit Developmental
UF = 100............... cPAD = chronic RfD / Study (MRID 42865901)
Chronic RfD = 0.2 mg/kg/ FQPA SF= 0.2 mg/kg/ LOAEL = 40 mg/kg/day
day. day. Based on increased
mortality, reduced food
consumption, and
clinical toxicity;
Mouse Developmental Study
(Report No. CTL/P/335,
1977 (cited in Report
No. 003810, 1978.
Section C-9))
LOAEL = 40 mg/kg/day
Based on reduced body
weight gain; and
Rat Developmental Study
(Report No. CTL/P/1262,
1976 (cited in Report
No. 003810, 1978.
Section C-11))
LOAEL = 50 mg/kg/day
Based on reduced food
consumption.
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1-30 NOAEL = 20 mg/kg/day Residential LOC for Rabbit Developmental
days) UF = 100............... MOE = 100 Study (MRID 42865901)
LOAEL = 40 mg/kg/day
Based on the increased
mortality, reduced food
consumption, and
clinical toxicity;
Mouse Developmental Study
(Report No. CTL/P/335,
1977 (cited in Report
No. 003810, 1978.
Section C-9))
LOAEL = 40 mg/kg/
day;Based on reduced
body weight gain; and
Rat Developmental Study
(Report No. CTL/P/1262,
1976 (cited in Report
No. 003810, 1978.
Section C-11))
LOAEL = 50 mg/kg/day
Based on reduced food
consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1 NOAEL = 20 mg/kg/day Residential LOC for See Short-Term Incidental
- 6 months) UF = 100............... MOE = 100 Oral Endpoint
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term and Dermal (or oral) study Residential LOC for 80-Week Skin Painting
Long-Term Dermal Exposure NOAEL= 150 mg/kg/day... MOE = 100 Study - Mouse (MRIDs
UF = 100............... 00066475 and 00104796)
(Relative dermal LOAEL = 750 mg/kg/day
absorption rate =100%). based on decreased body
weight and liver tumors.
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term and An appropriate route-specific inhalation study is not available. The oral
Long-Term Inhalation Exposure endpoint of 20 mg/kg/day with a target MOE of 100 (10x inter-species
extrapolation, 10x intra-species variation) is used. An additional 10x
route-to-route extrapolation is used to determine if a confirmatory
inhalation toxicity study is warranted.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal) EPA has classified PHMB as having suggestive evidence of carcinogenicity
but the evidence was too weak to warrant quantification of human cancer
risk
----------------------------------------------------------------------------------------------------------------
*UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = acute population adjusted dose (a = acute, c = chronic) RfD = reference
dose, LOC = level of concern, MOE = margin of exposure
[[Page 1515]]
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
A. Dietary Exposure
PHMB is an antimicrobial that is used as a hard surface sanitizer
and may be in or on food processing equipment, premises of food
processing plants, milk processing equipment, milk processing plants,
eating establishments, food contact surfaces, adhesives, and slurries.
The use of PHMB as an antimicrobial product on these various surfaces
may result in pesticide residues in human food. Residues from treated
surfaces can migrate to food that comes into contact with the treated
surfaces which then can result in human ingestion.
1. Food. The Agency assessed acute and chronic dietary exposure
from the use of PHMB as a disinfectant and food contact sanitizer on
direct and indirect food-contact surfaces. This assessment calculated
the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI) using
an FDA model (``Sanitizing Solutions: Chemical Guidelines for Food
Additives Petition, January 1993''). The FDA model takes into account
application rates, residual solution, area of the treated surface which
comes into contact with food, pesticide migration fraction, and body
weight of the population exposed.
To calculate the EDI (estimated daily intake) values for PHMB when
it is used as a sanitizer in public eating spaces, it was assumed that
PHMB would be used at a concentration of 550 parts per million (ppm),
the thickness of the PHMB residues on surfaces would be 1 mg per square
centimeter of treated surface, and the surface area of the food contact
surface being sanitized to which a person would be exposed on a daily
basis is 4,000 cm2 (which includes contact with treated
silverware, china, and glass used by an individual who regularly eats
three meals per day at an institutional or public facility). It was
also assumed that 100% of the pesticide would migrate to food.
To calculate the EDI (estimated daily intake) values for PHMB when
it is used in the food processing industry, it was also assumed to be
used at a concentration of 550 ppm. However, specific to this scenario,
the exposure estimates were calculated using the milk truck model that
is described in the FDA document, ``Sanitizing Solutions: Chemistry
Guidelines For Food Additive Petitions.'' This includes the assumption
that estimates of sanitary exposure from use in dairy processing plants
significantly exceed estimates based on other uses with food processing
equipment and utensils. For the purpose of assessing risks stemming
from food processing uses, parameters assuming a sanitized milk truck
were used as the worst case scenario. The various input parameters,
such as the size of the truck, internal surface area, residual
thickness, and application rate of PHMB were used to calculate
potential residues present in the truck per liter of food (i.e. milk).
For each dietary exposure assessment it was assumed that adults
(both male and female) consume 3,000 grams of food a day and a child,
1,500 grams. This allowed for an estimation of the amount of PHMB that
is anticipated to be present in an average adult's or child's daily
intake from these uses, and in turn, the calculation of a daily dietary
dose.
2. Drinking water exposure. The uses of PHMB are not expected to
significantly contaminate drinking water sources. As provided in the
PHMB Reregistration Eligibility Document, ``none of the uses associated
with PHMB are expected to impact either surface or ground water
resources.'' Therefore, the PHMB contributions for drinking water
exposure are considered to be negligible and are not quantified.
B. Other Non-Occupational Exposure
The residential exposure assessment considers all potential non-
occupational pesticide exposure, other than exposure due to residues in
food or in drinking water. Exposures may occur during and after
application as a hard surface disinfectant (e.g. walls, floors, tables,
fixtures) and to swimming pools. Each route of exposure is assessed,
where appropriate, and risk is expressed as a margin of exposure (MOE),
which is the ratio of estimated exposure to an appropriate NOAEL.
Residential exposure may occur during application of PHMB to indoor
hard surfaces (e.g., mopping, wiping, trigger pump sprays) and to
swimming pools. The residential handler scenarios were assessed to
determine dermal and inhalation exposures. Surrogate dermal and
inhalation unit exposure values were estimated using Pesticide Handler
Exposure Database (PHED) data and the Chemical Manufactures Association
Anitmicrobial Exposure Assessment Study (USEPA, 1999) and the SWIMODEL
3.0 was utilized to conduct exposure assessments of pesticides found in
swimming pools and spas (Versar, 2003). Note that for this assessment,
EPA assumed that residential users complete all elements of an
application (mix/load/apply) without the use of personal protective
equipment.
The duration for most residential exposures is believed to be best
represented by short-term duration (1 to 30 days). The short-term
duration was chosen for this assessment because the residential handler
and post-application scenarios are assumed to be performed on an
episodic, not a daily basis.
Based on toxicological criteria and the potential for exposure, the
Agency has conducted incidental oral, dermal and inhalation exposure
assessments for PHMB residential use. As noted previously, MOEs greater
than or equal to 100 are considered adequately protective for the
residential exposure assessment.
Specific information on the residential exposure for PHMB can be
found at https://www.regulations.gov, docket ID No. EPA-HQ-OPP-2005-
0268.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to PHMB and any other
substances and PHMB does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that PHMB has a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at https://www.epa.gov/pesticides/cumulative.
VI. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10x'') tenfold margin of safety for infants and
children in the
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case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base 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. In applying
this provision, EPA either retains the default value of 10x when
reliable data do not support the choice of a different factor, or, if
reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility to the fetus following
in utero exposure to PHMB in the prenatal developmental toxicity
studies, and no quantitative or qualitative evidence of increased
susceptibility to the offspring when adults are exposed to PHMB in the
two-generation reproductive study. In each study, any development/
reproductive effect observed occurred at doses equal to or higher than
the doses at which maternal toxicity was observed. This, together with
the nature of the effects seen in the studies has led the Agency to
conclude that there is no evidence of increased susceptibility.
EPA has determined that reliable data show that it would be safe
for infants and children to reduce the FQPA safety factor to 1x. That
decision is based on the following findings:
i. The toxicity database for Poly(hexamethylenebiguanide)
hydrochloride (PHMB) is complete for assessing risk to infants and
children under the FFDCA.
ii. There is no indication that PHMB is a neurotoxic chemical and
there is no need for a developmental neurotoxicity study or additional
uncertainty factors to account for neurotoxicity.
iii. There is no evidence that PHMB results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
iv. 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 and will not
underestimate the exposure and risk. Conservative ground and surface
water modeling estimates were used. Similarly conservative Residential
SOPs were used to assess post-application exposure to children as well
as incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by PHMB.
VII. Determination of Safety for U.S. Population, Infants and Children
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (``aPAD'') and chronic population adjusted dose (``cPAD''). The
aPAD and cPAD are calculated by dividing the LOC by all applicable
uncertainty/safety factors. For linear cancer risks, EPA calculates the
probability of additional cancer cases given aggregate exposure. Short-
, intermediate-, and long-term risks are evaluated by comparing
aggregate exposure to the LOC to ensure that the MOE called for by the
product of all applicable uncertainty/safety factors is not exceeded.
1. Acute and chronic risk. EPA compares the estimated dietary
exposures to an aPAD and a cPAD, both of which are 0.2 mg/kg/day for
PHMB. Generally, a dietary exposure estimate that is less than 100% of
the aPAD or cPAD does not exceed the Agency's levels of concern.
The antimicrobial indirect food use acute/chronic risk estimates
from exposure to treated utensils and countertops as well as from food
processing facility sanitation are below the Agency's level of concern.
For adults females of child bearing age (13 to 49 years old), the
cumulative (food utensils and food processing) acute and chronic
dietary exposure risk estimates are 18.8% of the acute and chronic
PADs. For children ages 3 to 5 years old, the most highly exposed
population subgroup, the cumulative chronic dietary risk estimates are
37.2% of chronic PAD (there are no effects anticipated for the acute
exposures). Therefore, dietary exposure estimates are below the
Agency's level of concern for all population subgroups. Based on the
information in this preamble, EPA concludes that there is a reasonable
certainty of no harm from aggregate exposure to residues. Accordingly,
EPA finds that exempting from the requirement of a tolerance will be
safe.
2. Non-occupational risk. Aggregate exposure takes into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Using the exposure assumptions described in this unit for other
non-occupational exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs greater than
or equal to 100 for the inhalation route of exposure and 100 for dermal
exposure. Therefore, these levels of exposure are not of concern.
3. Aggregate cancer risk for U.S. population. EPA has classified
PHMB as having no greater than suggestive evidence of carcinogenicity.
The weight-of-the-evidence considerations for this classification are
as follows:
i. A treatment-related statistically significant increase (trend
and pair-wise) in vascular tumors (mainly benign) was seen in female
rats at an oral dose that was considered to be adequate, but not
excessive. This was considered the strongest evidence on the Agency's
evaluation of PHMB.
ii. Oral exposure to male and female mice also resulted in
treatment-related vascular tumors seen at an excessive dose. However,
at the next highest dose level, which was considered adequate but not
excessive, there was a slight, but not statistically significant,
increase in this same tumor, which added to the Agency's concern for
this tumor type.
iii. It is noted that dermal exposure to female mice resulted in an
equivocal increase in vascular tumors seen at only an excessive dose.
iv. No treatment-related increase in any tumors was seen in male
rats via the oral route or in male mice via the dermal route of
exposure.
Based on the findings above, the Agency has determined that PHMB
posed no greater than a negligible cancer risk.
4. 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 PHMB. Accordingly, EPA finds that exempting PHMB from the
requirement of a tolerance will be safe.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there was scientific basis for including, as part of the program, the
androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also
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adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and,
to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA has authority to require
the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).
When the appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, PHMB may be
subjected to additional screening and/or testing to better characterize
effects related to endocrine disruption.
B. Analytical Method(s)
An analytical method for food is not needed. Food contact
sanitizers are typically regulated by state health departments to
ensure that the food industry is using these products in compliance
with regulations in 40 CFR 180.940. The end use solution that is
applied to the food contact surface is analyzed not food items that may
come into contact with the treated surface. An analytical method is
available to analyze the use dilution that is applied to food contact
surfaces. The solution can be analyzed by use of the spectrophotometric
method.
C. Existing Tolerances
There is no existing tolerance or exemption from tolerance for
PHMB.
D. International Tolerances
No Codex, Canadian, or Mexican maximum residue limits (MRLs) have
been established for any food uses at this time.
VIII. Statutory and Executive Order Reviews
This final rule establishes a 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 rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) 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 tolerance 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 6, 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) (Public Law 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).
IX. 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: December 18, 2007.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1280 is added to subpart D to read as follows:
Sec. 180.1280 Poly(hexamethylenebiguanide) hydrochloride (PHMB)
exemption from the requirement of a tolerance.
Poly(hexamethylenebiguanide) hydrochloride (PHMB)(CAS Reg. No.
32289-58-0) is exempt from the requirement of a tolerance for residues
of the antimicrobial in or on all food commodities when the residues
are the result of the lawful application of a food contact surface
sanitizer containing PHMB at 550 parts per million (ppm).
[FR Doc. E8-189 Filed 1-8-08; 8:45 am]
BILLING CODE 6560-50-S
