Document ID: EPA-HQ-OPP-2006-0573-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-08-20T04:00Z

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (1/1/2007)

EPA Antimicrobials Division contact: [Ms. Velma Noble, 703-308-6233]

 

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document. 
Please do not remove or alter these comment notes or change the margins,
font, or format in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.]

TEMPLATE:

[Edwards-Councilor Co., Inc., 1427 Baker Road, Airport Industrial Park,
Virginia Beach, VA 23455]

[PP XXXXXX]

	EPA has received a pesticide petition ([PP 6F7071]) from
[Edwards-Councilor Co., Inc.], [1427 Baker Road, Airport Industrial
Park, Virginia Beach, VA 23455] proposing, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.

(Options (pick one)

	

	2. to amend an existing tolerance exemption in 40 CFR 180.940 (a) for
residues of the antimicrobial pesticide formulations containing [N-Alkyl
(C12-C18) dimethyl benzyl ammonium chloride] that may be applied to food
contact surfaces in public eating places, dairy processing equipment,
and food processing equipment and utensils. When ready to use, end-use
concentration of total quaternary chemicals, [N-Alkyl (C12-C18) dimethyl
benzyl ammonium chloride] in solution is not to exceed [400] parts per
million (ppm).  EPA has determined that the petition contains data and
information regarding the elements set forth in section 408 (d)(2) of
the FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.

A. Residue Chemistry

	1. Plant metabolism. [NA-Remove]

	2. Analytical method. [NA-Remove]

	3. Magnitude of residues. [This petition for a tolerance exemption is
for the quaternary pesticide chemical that is currently approved for use
as a food contact surface sanitizer under 21 CFR 178.1010(b)41 and
9c)36.  The economic poison product. STERAMINE 1-G TABLETS, EPA Reg. No.
1561-11, which contains the subject quaternary chemical as its active
ingredient, includes inert ingredients also approved under 21 CFR
178.1010 (b)41 and (c)36 and the GRAS list.

Public Health Regulations governing public food and beverage service
establishments require that all inanimate food contact surfaces be
properly cleaned and sanitized to protect the public health from
exposure to the hazards of disease transmitted through
cross-contamination of these surfaces that may be soiled with infectious
micro-organisms.  

Under Federal Regulations, chemicals used to accomplish sanitization in
public food and beverage establishments are regulated as pesticides
under FIFRA, and are required to be registered by the U.S. Environmental
Protection Agency to insure that, when used as directed, they have been
proven to be effective without causing unreasonable adverse effects to
humans or the environment.  Only these pesticide chemicals whose
residues have been determined to be safe by FDA and which are listed
under 21 CFR 178.1010, are acceptable for registration with EPA as food
contact surface sanitizers.

The subject quaternary pesticide chemical and the formulated economic
poison product containing this pesticide chemical as its active
ingredients, is currently registered with EPA under RPA Reg. No. 1561-11
and is listed under 21 CFR 178.1010 9b)41 and (c)36 for use up to a
concentration level of 300 ppm.  The subject of this petition for a
tolerance exemption is to raise the upper level concentration limit for
the use of this subject pesticide chemical from 200 ppm to 400 ppm.

This petition believes that compliance with current Federal Regulations
under FIFRA and the Food Drug and Cosmetic Act for use of the subject
quaternary pesticide chemical as a food contact surface, is sufficient
evidence to ensure that:

1)	The yearly risk associated with the nonthreshold effect from
aggregate exposure to the residue is not greater than ten times the
yearly risk allowed under the new safety standard.

2)	The tolerance is limited to ensure that the lifetime risk associated
with the nonthreshold effect from aggregate exposure to the residue is
not greater than twice the lifetime risk allowed under the new safety
standard. ]

B. Toxicological Profile

	1. Acute toxicity.  [The endpoint used to perform the assessment for
acceptance of the use of this quaternary pesticide chemical under 21 CFR
178.1010 as a food contact surface sanitizer, is within the current
estimated risk level of concern of FDA and EPA.]

	2. Genotoxicty. [NA-Remove.]

	3. Reproductive and developmental toxicity. [NA-Remove.]

	4. Subchronic toxicity. [NA-Remove.]

	5. Chronic toxicity. [Under 21 CFR 178.1010, the current Reference Dose
(RfD) for the subject quaternary pesticide chemical is considered
sufficient to adequately protect infants and children.  This petitioner
is not aware of any evidence as to whether or not infants and children
are more susceptible to this pesticide chemical than adults.

This subject quaternary pesticide chemical has not been determined to be
a carcinogen or to have a cancer potency factor.]

	6. Animal metabolism. [NA-Remove]

	7. Metabolite toxicology. [NA-Remove]

	8. Endocrine disruption. [PR Notice 97-1 states . . . . “as indicated
in section 408(p)(1) and (2), the agency has 2 years to develop a
screening method, with a total of 3 years to implement such a
program.”  This petitioner is not aware of any evidence relative to
the possibility that the subject pesticide chemical may have endocrine
disrupter effects individually or in combination with another chemical.]

C. Aggregate Exposure

	1. Dietary exposure. [NA-Remove]

	i. Food. [NA-Remove]

	ii. Drinking water. [Food contact surface sanitizer solutions, such as
the subject quaternary pesticide chemical solution, are primarily used
in indoor applications involving manual dishwashing in institutions and
public eating and drinking establishments. These sanitizing solutions
are prepared in sinks within these establishments, where they are used
and disposed of by discharging the sink contents down the drain into the
sanitary sewer or on site waste disposal systems.  Therefore, it is very
unlikely that this pesticide chemical or any of its degradates would
pass through primary or secondary drinking water treatment into finished
water.  This petitioner is unaware that this subject pesticide chemical
or any of its degradates has been detected in ground water or surface
water, or that any State is conducting water monitoring programs for
this pesticide.]

	2. Non-dietary exposure. [NA-Remove]

D. Cumulative Effects

	[This petitioner is unaware of any data regarding any adverse
cumulative efforts from exposure to this quaternary pesticide chemical
resulting from its use as a regulated food contact surface sanitizer. 
The long history of safe use of this pesticide as a sanitizer should
strongly confirm this point.]

E. Safety Determination

	1. U.S. population. [NA-Remove]

	2. Infants and children. [NA-Remove]

F. International Tolerances

	[NA-Remove]