[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Rules and Regulations]
[Pages 50613-50617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20663]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0950; FRL-9359-5]
Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium
Bicarbonate; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues of Didecyl Dimethyl Ammonium Carbonate and
Didecyl Dimethyl Ammonium Bicarbonate, jointly referred to as DDACB on
food contact surfaces when applied or used in public eating places,
dairy processing equipment, and/or food processing equipment and
utensils. Lonza, Inc. submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment which
would provide for an increase in the final use concentration of DDACB
in products eligible for the exemption from the requirement of a
tolerance. As amended, the regulation will exempt solutions from the
requirement of tolerance residues resulting from contact with surfaces
treated with solutions where the end-use concentration of the DDACB
does not exceed 400 parts per million (ppm).
DATES: This regulation is effective August 22, 2012. Objections and
requests for hearings must be received on or before October 22, 2012,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0950, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm.
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-6233; email address: noble.velma@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Dairy Cattle Milk Production (NAICS code 11212).
Food manufacturing (NAICS code 311).
Beverage Manufacturing (NAICS code 3121).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0950 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 22, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0950, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statue.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more
[[Page 50614]]
information about dockets generally, is available at http://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of December 8, 2011 (76 FR 76674) (FRL-
9328-8), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F7758) by Lonza Inc., 90 Boroline Road, Allendale NJ
07401. The petition requested that 40 CFR 180.940(a), be amended by
establishing concentration limits for DDACB in end use solutions
eligible for tolerance exemption. That notice referenced a summary of
the petition prepared by Lonza Inc., the registrant, which is available
in the docket, http://www.regulations.gov. 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 exemption 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 FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), 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 * *
*.''
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for DDACB including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with DDACB follows.
III. Toxicological Profile
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 nature of the toxic effects caused by DDACB,
part of the Aliphatic Alkyl Quaternary group of compounds, are
discussed in this unit. In assessing the proposed toxicity, the
toxicological endpoints were extracted from the DDAC RED (EPA-HQ-2006-
0338).
The Aliphatic Alkyl Quaternaries are corrosive and highly
irritating to the eye and skin, with moderate acute toxicity by oral,
dermal, and inhalation routes of exposure. These chemicals are
classified as ``not likely'' to be human carcinogens based on negative
carcinogenicity in rat and mouse feeding studies using doses above the
limit dose. There is no evidence of these chemicals being associated
with increased susceptibility of infants and children based on two
developmental toxicity studies and a 2-generation reproductive toxicity
study. Lastly, they are negative for mutagenicity and neurotoxicity.
Specific information on the studies received and the nature of the
toxic effects from the toxicity studies can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2005-0338 Toxicology
Disciplinary Chapter for the Reregistration Eligibility Decision (RED)
for Didecyl Dimethyl Ammonium Chloride (DDAC).
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). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in variations
in sensitivity among members of the human population as well as other
unknowns.
A detailed discussion of EPA's conclusions regarding the toxic
endpoints for the Aliphatic Alkyl Quaternaries can be found at 73 FR
37852, July 2, 2008.
IV. Aggregate Exposure
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residues in food and all other sources, including drinking
water from ground water or surface water and exposure through pesticide
use in gardens lawns or buildings (residential and other non-
occupational exposures).
A. Dietary Exposure
1. Food. In evaluating dietary exposure to DDACB, EPA considered
exposure under the petitioned-for exemption as well as all existing
aliphatic alkyl quaternaries exemptions or tolerances in (40 CFR
180.940(a)). EPA assessed dietary exposures from DDACB in food as
follows:
Aliphatic alkyl quaternaries are to be used as sanitizers on
appliances, beverage bottling, counter tops, food packaging,
refrigerators, tables, and utensils. The use of these actives in
antimicrobial products for use on food or feed-contact surfaces and in
agricultural premises may result in pesticide residues in human food.
Residues from treated surfaces, such as appliances, countertops,
equipment, and utensils can migrate to food coming into contact with
the treated and rinsed surfaces and can be ingested by humans.
The Agency assessed acute and chronic dietary exposures from the
use of DACB as a disinfectant and food-contact sanitizer on utensils,
countertops, and in food/beverage processing facilities. The assessment
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake
(EDI) using modified Food and Drug Administration (FDA) methodologies
for utensils and the Indirect Dietary Residential Exposure Model
(IDREAM) for countertops.
The EDI calculations presented in this assessment for treated
indirect dietary exposures resulting from sanitizing utensils assumed
that food would contact 4,000 cm\2\ (which represents contact with
treated china, glass, and silverware used by an individual who
regularly eats three meals per day at an institutional or public
facility) and that the residual solution remaining on the surface or
pesticide migration fraction is 1 milligram/centimeter (mg/cm\2\) of
treated area. The body weights used for this assessment were 70
kilograms (kg) for an adult male, 60 kg for an adult woman, and 10 kg
for an infant. Based on data provided in a new residue study,
Transferability Equivalence
[[Page 50615]]
among Quats and Measured Food Surrogate Transfer Efficiency (Master
Record Identification Number 46870703), a conservative transfer rate of
43% was used to demonstrate the amount of residues on the surface that
will be transferred to food and subsequently ingested. The maximum
application rate for DDACB on utensils is 0.0033 lbs active ingredient
(a.i.) per gallon of treatment solution.
There are two levels of refinement for assessing dietary exposure
to antimicrobial products used on countertops. The three dimensional
approach, Tier 2, was utilized for this assessment. This conservative
approach uses food consumption and preparation patterns, food-specific
conversion factors that relate the surface area contacting the
countertop with the corresponding weight of the food item, transfer
efficiency, and likelihood of contact with a countertop. Food
ingredients, as presented in the model, are separated into nine
categories and reflect a person's daily diet. Based on the structure of
the model, available countertop residues are estimated and presented as
the amount of residue that is expected to be available for each of the
nine food categories. These calculated available residues are then
combined with the food consumption rate, as extracted from the USDA
Continuing Survey for Food Intake by Individuals (CSFII) consumption
data, and a total daily exposure value is provided as the output. This
value is then compared to the toxicological endpoint to determine risk
to those consuming foods that have come into contact with a freshly
sanitized countertop.
For the assessment of the food bottling/packaging use, EPA assumed
a 100% transfer rate because the food is potentially in contact with
the treated surfaces for very long periods of time. The maximum
application rate for DDACB for bottling/packing of food is 0.0033 lbs
a.i. per gallon of treatment solution. EDI values were calculated using
an approach similar to that used for treated food utensils. Exposure
was assumed to occur through the ingestion of three food products that
might be packaged with treated material: Beverages (alcoholic and non-
alcoholic), egg products, and milk. A calorie intake modification
factor of 0.64 was applied to the EDI for a child to account for the
differences between intake values among children and adults.
2. Drinking water exposure. DDACB outdoor uses are as an algaecide
in wood preservative treatment and a slimicide in secondary oil field
uses. The oil field uses are considered to be contained. The other uses
are not expected to significantly contaminate drinking water sources.
Therefore, the DDACB contributions for drinking water exposure are
considered to be negligible and are not quantified.
B. Other Non-Occupational Exposure
The term ``residential exposure'' is used in this document to refer
to non-occupational, non-dietary exposure (e.g., textiles (clothing and
diapers), carpets, swimming pools, and hard surface disinfection on
walls, floors, tables). DDACB is currently registered for the following
residential non-dietary sites: Homes and day-care nurseries. EPA
assessed residential exposure using the following assumptions:
Residential exposure may occur during the application as
well as post application of DDACB to indoor hard surfaces (e.g.,
mopping, trigger pump sprays, wiping).
The residential handler scenarios were assessed to
determine dermal and inhalation exposures.
Residential post application scenarios such as children's
exposure to treated toys and floors were also assessed to determine
dermal and incidental oral exposures.
Surrogate dermal, inhalation, and incidental oral unit
exposure values were estimated using Pesticide Handler Exposure
Database (PHED) data and the Chemical Manufactures Association
Antimicrobial Exposure Assessment Study (EPA, 1999). 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 the 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 daily basis.
Specific information on the residential exposure assessment for
DDACB can be found at http://www.regulations.gov. Docket ID Number EPA-
HQ-OPP-2006-1024, Review of Petition to Amend 40 CFR 180.940 to add
Didecyl Dimethyl Ammonium Carbonate/Bicarbonate.
C. Additional Safety Factor for the Protection of Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold (``10X'') margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base on toxicity
and 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 Food Quality Protection Act
(FQPA) safety factor (SF). 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 evidence that
Aliphatic Alkyl ammonium chloride quaternaries result in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X except for assessments addressing inhalation exposure. For
inhalation exposure assessments the 10X FQPA safety factor is retained.
Those decisions are based on the following findings:
i. The toxicity database for Aliphatic Alkyl Quaternaries is
complete except for a 90-day inhalation toxicity study in the rat which
was requested in the Aliphatic Alkyl Quaternary Reregistration
Eligibility Document. Due to the absence of the 90-day inhalation
toxicity study, a FQPA safety factor of 10X has been applied to the
oral endpoint to calculate inhalation risks in order to be protective
of any uncertainties associated with route-to-route extrapolation.
ii. There is no indication that Aliphatic Alkyl Quaternaries are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors to account for
neurotoxicity.
iii. There is no evidence that Aliphatic Alkyl Quaternaries result
in increased susceptibility in in utero rats or rabbits in the prenatal
developmental toxicity studies or in young rats in the 2-generation
reproductive toxicity study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment was performed based on
10% transfer rate and tolerance-level residues. Similarly conservative
Residential SOPs were used to assess post-application exposure to
children as well as incidental oral exposure of toddlers.
[[Page 50616]]
These assessments will not underestimate the exposure and risks posed
by Aliphatic Alkyl Quaternaries.
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA's risk assessment for the Group I Cluster is based on an
assessment of the cumulative exposure to all aliphatic alkyl quaternary
compounds. The individual exposure scenarios in the DDAC assessments
(as well as the aggregate assessment in the Aliphatic Alkyl Quaternary
(DDAC) Reregistration Eligibility Decision (RED)) were developed by
assuming that a DDAC compound was used on 100% of the surfaces
authorized on the label that could result in human exposure and summing
the percent active ingredients on the labels for all of the aliphatic
alkyl quaternary compounds when used in combination. Thus, because the
risk assessment for DDAC accounts for exposures to all of the aliphatic
alkyl quaternary compounds, there is no need for a separate cumulative
risk assessment for those compounds. The Agency has not identified any
other substances as sharing a common mode of toxicity with DDACB.
VI. Aggregate Risks and Determination of Safety
1. Dietary risk from food and feed uses. EPA compares the estimated
dietary exposures to an acute population adjusted dose (aPAD) and a
chronic population adjusted dose (cPAD), 0.1 mg/kg/day, which are the
same value for DDACB. Generally, a dietary exposure estimate that is
less than 100% of the aPAD or the cPAD does not exceed the Agency's
LOC.
The antimicrobial indirect food use acute and chronic risk
estimates from exposure to treated utensils and countertops are below
the Agency's LOC. For adult males, the acute and chronic dietary
exposure risk estimates are 9.9% for utensils and 0.8% for countertops.
The aPAD and cPAD for adult females (13-69) is 11.5% for utensils. The
aPAD from countertops for adult females is 0.8% and the cPAD is 0.5%.
For children ages 1-2, the most highly exposed population subgroup, the
acute and chronic dietary risk estimates are 68.9% for utensils and
2.6% and 1.8%, respectively for acute and chronic dietary risks for
countertops. Therefore, dietary exposure estimates are below Agency's
LOC for all population subgroups. The antimicrobial indirect food use
chronic risk estimates from exposure to treated food packaging and
beverage bottles are also below the Agency's LOC.
Specific information on the dietary exposure assessment for DDACB
can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-
2006-1024, Review of Petition to Amend 40 CFR 180.940 to add Didecyl
Dimethyl Ammonium Carbonate/Bicarbonate.
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, the MOEs are greater than the target of 1,000 for the
inhalation route of exposure and 10 for dermal exposure, with the
exception of the short term dermal exposures in females which has an
MOE of 9. However, there is no significant concern for the proposed
increase in use concentrations from 240 ppm to 400 ppm, with regard to
dermal exposure, considering the contributing MOEs used to calculate
the MOE of 9 were derived using conservative assumptions for the unit
exposures and quantity handled. Furthermore there is a low likelihood
that all scenarios (mopping, wiping, trigger pump spraying, immersing
items into a solution and wearing treated clothing items) that were
used to derive an MOE of 9 for dermal exposure would occur
simultaneously.
Based on the toxicological and exposure data discussed in this
preamble, EPA concludes that DDACB will not pose a risk under
reasonably foreseeable circumstances. Accordingly, EPA finds that there
is a reasonable certainty that no harm will result to the general
population or to infants and children from aggregate exposure to DDACB
residues.
VII. Other Considerations
An analytical method for food is not needed. Food-contact
sanitizers are typically regulated by the State health departments to
ensure that the food industry is using products in compliance with the
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 treated surface. An analytical method is available to
analyze the use dilution that is applied to food-contact surfaces. A
titration method is used to determine the total amount of quaternary
compound. If the use solution is a mixture of ADBAC and DDACB, then
high pressure liquid chromatogram with ultraviolet visible (HPLC-UV) is
used to determine the amount of ADBAC. The amount of DDACB is
determined by calculating the difference between the total amount of
quaternary compounds and ADBAC.
VIII. Conclusion
This regulation amends the exemption from the requirement of a
tolerance for residues of DDACB under 40 CFR 180.940(a) resulting from
an increase in the final use concentration from 240 ppm to 400 ppm on
food contact surfaces in public eating establishments, on dairy
processing equipment and food processing equipment and utensils.
IX. 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 final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the 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
[[Page 50617]]
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
X. 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, Aliphatic alkyl quaternaries, Food-contact
sanitizers, Pesticides and pests, Quaternary ammonium compounds,
Reporting and recordkeeping requirements.
Dated: August 9, 2012.
Joan Harrigan-Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.940(a), the table is amended by revising in its
entirety, the entry for ``Quaternary ammonium compounds, didecyl
dimethyl ammonium carbonate/didecyl dimethyl ammonium bicarbonate''
which immediately preceeds the pesticide chemical which reads in part
``Silver ions resulting * * *'' to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
----------------------------------------------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Quaternary ammonium compounds, 148788-55-0/148812-654-1.................. When ready for use, the end-
didecyl dimethyl ammonium carbonate/ use concentration of these
didecyl dimethyl ammonium specific ammonium compounds
bicarbonate. is not to exceed 400 ppm of
active quaternary ammonium
compound.
* * * * * * *
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* * * * *
[FR Doc. 2012-20663 Filed 8-21-12; 8:45 am]
BILLING CODE 6560-50-P