 

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (7/1/2006)

EPA Registration Division contact: [James A. Tompkins. 703-305-5697]

 

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TEMPLATE:

[Cheminova]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
[Cheminova], [One Park Drive, Research Triangle Park, NC 27707]
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 180.364.

(Options (pick one)

	1. by establishing a tolerance for residues of

[glyphosate N-(phosphonomethyl) glycine resulting from the application
of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine
salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium
salt of glyphosate, and the potassium salt of glyphosate in or on the
raw agricultural commodity [cotton, gin by-products] at [210] parts per
million (ppm).  EPA has determined that the petition contains data or
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. [From the glyphosate RED (Residue Chemistry) 21
May, 2008: “The qualitative nature of the residue in plants is
adequately understood. Studies with a variety of plants including corn,
cotton, soybeans, and wheat indicate that the uptake of glyphosate or
its metabolite AMPA from soil is limited, but the residues which are
taken up are readily translocated. Foliarly applied glyphosate is
readily absorbed and translocated throughout apples, coffee, dwarf
citrus (calamondin), grapes, and ears. Metabolism occurs via
N-methylation and ultimately yields N-methylated glycines and phosphonic
acids. For the most part, the ratio of glyphosate to AMPA is 9 to 1 but
can approach 1 to 1 in a few cases (e.g., soybeans and carrots). Much of
the residue data for crops reflects a detectable residue of parent
(0.05-0.15 ppm) along with a nondetectable residue (<0.05 ppm) of AMPA.
The terminal residue to be regulated in plants is glyphosate per se.”]

	2. Analytical method. [From the glyphosate RED (Residue Chemistry) 21
May, 2008: “Plants and Animals: Adequate enforcement methods are
available for analysis of residues of glyphosate and its metabolite AMPA
in or on plant commodities and in water. These methods include GLC
(Method I of PAM Vol. II; limit of detection is 0.05 ppm) and HPLC with
fluorometric detection. Use of the GLC method, however, is being
discouraged due to lengthiness of the procedure. The HPLC method has

undergone successful Agency validation and was recommended for inclusion
in PAM Vol. II; the limit of detection is 0.0005 ppm. For enforcement of
tolerances in animal commodities, an HPLC method with fluorescence
detector is available; the reported limits of detection are 0.01 ppm for
glyphosate and 0.012 ppm for AMPA.”]

	3. Magnitude of residues. [Adequate data concerning glyphosate residues
in/on glyphosate tolerant cotton RACs have been submitted to the Agency.
These residue data support the proposed revision of the tolerance for
cotton “gin byproducts” from 175 ppm to 210 ppm.]

B. Toxicological Profile

EPA has previously evaluated the adequacy and completeness of the
toxicity data base in the Reregistration Eligilibility Decision for
glyphosate. EPA has recently summarized the toxicity and risk profile of
glyphosate in the Glyphosate Human Health Risk Assessment for Proposed
Use on Indian Mulberry and Amended Use on Pea, Dry. PC Code: 417300,
Decision No. 360557 Dated September 29, 2006.

1. Acute toxicity.  [Reference Decision No. 360557]

	2. Genotoxicty. [Reference Decision No. 360557]

3. Reproductive and developmental toxicity. [Reference Decision No.
360557]

	4. Subchronic toxicity. [Reference Decision No. 360557]

5. Chronic toxicity. [Reference Decision No. 360557]

	6. Animal metabolism. [Reference Decision No. 360557]

	7. Metabolite toxicology. [Reference Decision No. 360557]

	8. Endocrine disruption. [Reference Decision No. 360557]

C. Aggregate Exposure

EPA has previously evaluated the adequacy and completeness of the
aggregate exposure assessment in the Reregistration Eligilibility
Decision for glyphosate. EPA has recently summarized the toxicity and
risk profile of glyphosate in the Glyphosate Human Health Risk
Assessment for Proposed Use on Indian Mulberry and Amended Use on Pea,
Dry. PC Code: 417300, Decision No. 360557 Dated September 29, 2006.

	1. Dietary exposure. [Food and feed uses: Tolerances have been
established

(40CFR 180.364) for glyphosate N-(phosphonomethyl) glycine resulting
from the application of glyphosate, the isopropylamine salt of
glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt
of glyphosate, the ammonium salt of glyphosate, and the potassium salt
of glyphosate in or on a variety of food commodities. The proposed
tolerance revision should not change the dietary exposure assessment due
to the change only impacting an animal feed component and the low
percentage of cotton gin byproducts in animal feed diets as compared to
other animal feed items such as matrices from corn, soybean and small
grains. The current tolerance is 175 ppm with a proposed increase to 210
ppm.

	i. Food. [Reference Decision No. 360557]

	ii. Drinking Food. [Reference Decision No. 360557]

	2. Non-dietary exposure. [Reference Decision No. 360557]. 

D. Cumulative Effects. [EPA does not, at this time, have data available
to determine whether glyphosate has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
glyphosate does not appear to produce a toxic metabolite produced by
other substances. Therefore, EPA has not assumed that glyphosate has a
common mechanism of toxicity with other substances. Additional
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 the final rule for Bifenthrin Pesticide Tolerances
(62 FR 62961, November 26, 1997) and in the toxicity and risk profile of
glyphosate in the Glyphosate Human Health Risk Assessment for Proposed
Use on Indian Mulberry and Amended Use on Pea, Dry. PC Code: 417300,
Decision No. 360557 Dated September 29, 2006.]

E. Safety Determination

	1. U.S. population. EPA has previously conducted a safety evaluation of
glyphosate and the adequacy of the data base as indicated in the
Reregistration Eligilibility Decision for glyphosate and in the toxicity
and risk profile of glyphosate in the Glyphosate Human Health Risk
Assessment for Proposed Use on Indian Mulberry and Amended Use on Pea,
Dry. PC Code: 417300, Decision No. 360557 Dated September 29, 2006.

	2. Infants and children. [EPA has previously evaluated the prenatal and
postnatal sensitivity of glyphosate and the adequacy of the data base as
indicated in the Reregistration Eligilibility Decision for glyphosate.
There is no evidence of increased susceptibility in rats and rabbits to
in utero and/or postnatal exposure to glyphosate. EPA has concluded that
there is a complete toxicity data base for glyphosate and exposure data
are complete or are estimated based on data that reasonably accounts for
all potential exposures. EPA determined that the 10X safety factor to
protect infants and children is not necessary as well as the FQPA.

EPA indicates that the toxicology data base is complete, there is no
indication of increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to glyphosate (in the prenatal developmental
toxicity study in rats, effects in the offspring were observed only at
or above treatment levels which resulted in evidence of appreciable
prenatal toxicity). The use of generally high quality data, conservative
models and/or assumptions in the exposure assessment, provide adequate
protection of infants and children. Review of this assessment is
available in the toxicity and risk profile of glyphosate in the
Glyphosate Human Health Risk Assessment for Proposed Use on Indian
Mulberry and Amended Use on Pea, Dry. PC Code: 417300, Decision No.
360557 Dated September 29, 2006.]

F. International Tolerances

[Codex and Mexican maximum residue levels (MRLS) are established for
residues of glyphosate per se and Canadian MRLs are established for the
combined residues of glyphosate and animomethylphosphonic acid (AMPA) on
a variety raw agricultural commodities. As indicated in the recent EPA
FR notice on harmonization of tolerances (Document ID –
EP-HQ-OPP-2007-1170-0006), no international harmonization issues are
associated with the increase in tolerance on cotton gin byproducts.]

