Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65081

* * * * *

[FR Doc. 04–24926 Filed 11–9–04; 8:45 am] 

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0323; FRL–7683–9]

Glyphosate; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 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 

ammonium salt of glyphosate, and the 

potassium salt of glyphosate in or on 

cotton, gin byproducts and cotton, 

undelinted seed. Monsanto Company 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective 

November 10, 2004. Objections and 

requests for hearings must be received 

on or before January 10, 2005.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0323. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket/. Although listed 

in the index, some information is not 

publicly available, i.e., 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 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 South Bell 

St., Arlington, VA. This docket facility 

is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

James A.Tompkins, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., 

NW.,Washington, DC 20460–0001; 

telephone number: (703) 305–5697; email address: tompkins.jim@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 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

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. 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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available on E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/

opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

In the Federal Register of August 18, 

2004 (69 FR 51301) (FRL–7364–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 0F6195, 1F6274, 

2F6487, and 3F6570) by Monsanto 

Company, 600 13th St., NW., Suite 660, 

Washington, DC 20005. The petition 

requested that 40 CFR 180.364 be 

amended by establishing a tolerance for 

residues of the herbicide glyphosate, N-

(phosphonomethyl)glycine, in or on 

alfalfa seed at 0.5 parts per million 

(ppm) (PP 2F6487); increasing the 

current tolerance for cotton, gin 

byproducts from 100 ppm to 150 ppm 

(PP 3F6570); rice, bran at 30 ppm; rice, 

grain at 15 ppm; and rice, hulls at 25 

ppm (PP 1F6274); wheat, forage at 10.0 

ppm; wheat, hay at 10.0 ppm (PP 

0F6195). Monsanto Company also 

proposed to revise the entry for grain, 

cereal group tolerance ‘‘except rice’’ to 

read as grain, cereal group 15 except 

barley, field corn, grain sorghum, oats, 

rice, and wheat at 0.1 ppm (PP 1F6274). 

Monsanto Company also amended PP 

0F6195 to delete the proposal for wheat 

grain at 6 ppm that was announced in 

the Federal Register of April 17, 2002 

(67 FR 18894) (FRL–6830–5). The notice 

stated that tolerances for alfalfa, rice, 

wheat, and cotton gin byproducts 

include both conventional and 

genetically altered crops.

The notice also proposed that the 

tolerances for alfalfa, forage at 175 ppm 

and alfalfa, hay at 400 ppm be deleted 

from § 180.364. Also proposed was to 

amend § 180.364 by replacing the 

current listing vegetable, legume, group 

6 except soybean at 5.0 ppm with the 

current crop group pea and bean, dried 

and shelled, subgroup 6C at 5.0 ppm. 

That notice included a summary of the 

petition prepared by Monsanto 

Company, the registrant. One comment 

was received in response to the notice 

of filing from B. Sachau, 15 Elm St., 

Florham Park, NJ 07932. The 

commenter objected to allowing any 

tolerance, wavier, or exemption for 

glyphosate. The commenter also 

objected to animal testing and stated 

that a more reliable method of testing 

should be developed. This comment is 

discussed further in Unit V.

During the course of the review the 

Agency decided to correct the company 

address to read Monsanto Company, 

1300 I St., NW., Suite 450 East, 

Washington, DC 20005. The Agency also 

determined the tolerance proposed for 

cotton, gin byproducts should be raised 

to 175 ppm and that the current 

tolerance for cotton, undelinted seed be 

increased to 35 ppm.

The Agency has determined that 

based on available data, the current 

tolerances for alfalfa, forage and alfalfa, 

hay are to be maintained and that the 

current listing for vegetable, legume, 

65082 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

group 6 except soybean at 5 ppm is 

correct; therefore, these proposed 

changes are not made at this time. Also, 

even though the proposed tolerances for 

alfalfa, seed; rice, bran; rice, grain; rice, 

hulls; wheat, forage; and wheat, hay are 

included in the risk assessment 

discussed in Units III.C., D., and E., 

these tolerances are not being issued at 

this time.

The Agency is also correcting the 

proposed tolerance expression to agree 

with the current tolerance expression by 

including references to the salts. 

Therefore, the tolerance expression is 

corrected to read: Tolerances are 

established for residues of glyphosate, 

N-(phosophonomethyl)glycine, resulting 

from the application of glyphosate, the 

isopropylamine salt of glyphosate, the 

ethanolamine salt of glyphosate, the 

ammonium salt of glyphosate, and the 

potassium salt of glyphosate in or on 

cotton, gin byproducts at 175 ppm and 

cotton, undelinted seed at 35 ppm.

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish 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(b)(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. Section 

408(b)(2)(C) of FFDCA 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. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and 

Determination of Safety

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. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

glyphosate, N-

(phosophonomethyl)glycine, resulting 

from the application of glyphosate, the 

isopropylamine salt of glyphosate, the 

ethanolamine salt of glyphosate, the 

ammonium salt of glyphosate, and the 

potassium salt of glyphosate on cotton, 

gin byproducts at 175 ppm and cotton, 

undelinted seed at 35 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the 

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies 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 glyphosate as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies reviewed are discussed 

in the Federal Register of September 27, 

2002 (67 FR 60934) (FRL–7200–2).

B. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in 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 the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

Three other types of safety or UFs 

may be used: ‘‘Traditional uncertainty 

factors;’’ the ‘‘special FQPA safety 

factor;’’ and the ‘‘default FQPA safety 

factor.’’ By the term ‘‘traditional 

uncertainty factor,’’ EPA is referring to 

those additional UFs used prior to 

FQPA passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children, primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for glyphosate used for 

human risk assessment is discussed in 

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65083

Unit V.B. of the final rule published in 

the Federal Register of September 27, 

2002 (67 FR 60934) (FRL–7200–2).

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.364) for the 

residues of glyphosate, in or on a variety 

of raw agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

glyphosate in food as follows:

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide, if a toxicological study 

has indicated the possibility of an effect 

of concern occurring as a result of a 1-

day or single exposure.

A review of the toxicity database, 

including developmental toxicity 

studies in rats and rabbits, did not 

provide an endpoint that could be used 

to quantitate risk to the general 

population and to females 13–50 years 

old from a single-dose administration of 

glyphosate. Therefore, no acute dietary 

analysis was conducted for glyphosate.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEMFCIDTM), which incorporates food 

consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Tolerance level residues, DEEM default 

factors and 100% crop treated. PCT and/

or anticipated residues were not used.

iii. Cancer. Glyphosate is classified as 

a Group E chemical, negative for 

carcinogenicity in humans, based on the 

absence of carcinogenicity in male and 

female rats as well as male and female 

mice.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

glyphosate in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

glyphosate.

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) to estimate 

pesticide concentrations in surface 

water and Screening Concentration and 

Ground Water (SCI-GROW) model, 

which predicts pesticide concentrations 

in ground water. In general, EPA will 

use GENEEC (a tier 1 model) before 

using PRZM/EXAMS (a tier 2 model) for 

a screening-level assessment for surface 

water. The GENEEC model is a subset of 

the PRZM/EXAMS model that uses a 

specific high-end runoff scenario for 

pesticides. GENEEC incorporates a farm 

pond scenario, while PRZM/EXAMS 

incorporate an index reservoir 

environment in place of the previous 

pond scenario. The PRZM/EXAMS 

model includes a percent crop area 

factor as an adjustment to account for 

the maximum percent crop coverage 

within a watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern.

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs), which are the 

model estimates of a pesticide’s 

concentration in water in quantitative 

risk assessments. EECs derived from 

these models are used to quantify 

drinking water exposure and risk as a 

%RfD or %PAD. Instead drinking water 

levels of comparison (DWLOCs) are 

calculated and used as a point of 

comparison against the model estimates 

of a pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to glyphosate 

they are further discussed in the 

aggregate risk sections, Unit III.E.

Based on the GENEEC, and SCIGROW models, the EECs of glyphosate 

for acute exposures are estimated to be 

21.0 parts per billion (ppb) for surface 

water and 0.0038 ppb for ground water. 

The EECs for chronic exposures are 

estimated to be 0.83 ppb for surface 

water. The EEC resulting from the 

registered use of direct glyphosate 

application to surface water is 230 ppb. 

Because the glyphosate waterapplication estimate is greater than the 

crop-application estimate, 230 ppb is 

the appropriate value to use in the 

chronic risk assessment. The EEC for 

chronic exposure in ground water is 

0.0038 ppb.

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets).

i. Non-occupational (recreational) 

exposures. Glyphosate is currently 

registered for use on the following 

residential non-dietary sites: 

Recreational areas, including parks and 

golf courses for control of broadleaf 

weeds and grasses, and lakes and pond, 

including reservoirs for control of 

nuisance aquatic weeds. Based on the 

registered uses, adult and child golfers 

are anticipated to have short-term postapplication dermal exposure at golf 

courses. Swimmers (adults, children, 

and toddlers) are anticipated to have 

short-term post-application dermal and 

incidental ingestion exposures. 

However, since the Agency did not 

select dermal endpoints, no postapplication dermal assessment was 

performed.

A post-application incidental 

ingestion exposure assessment for 

swimmers was performed. This 

assessment assumed 100% of applied 

concentration available at maximum 

application rate in the top one foot of 

water column; an ingestion rate of 0.05 

Liter/hour (L/hr), and an exposure 

duration of 5 hrs/day (although a 

toddler is unlikely to be exposed for 5 

hrs/day). Adult and toddler swimmers 

were included in this assessment as 

they are anticipated to represent the 

upper and lower bound of swimmer 

exposures. The respective body weights 

are 60 kilogram (kg) for adult-females 

(since NOAEL is based on 

developmental study) and 15 kg for 

toddlers. This exposure assessment is 

fully discussed in Unit V.C. of the final 

rule published in the Federal Register

of September 27, 2002 (67 FR 60934) 

(FRL–7200–2). MOEs for incidental 

exposure for incidental ingestion by 

swimmers were 7,600 for toddler and to 

36,000 for adult females and therefore, 

do not exceed the Agency‘s level of 

concern (LOC) for short-term nonoccupational (recreational ) exposures 

(MOEs of less than 100).

ii. Residential exposures. Glyphosate 

is also registered for broadcast and spot 

treatments on home lawns and gardens 

by homeowners and by lawn care 

operators (LCOs). Based on the 

registered residential use pattern, there 

is a potential for short-term dermal and 

inhalation exposures to homeowners 

who apply products containing 

65084 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

glyphosate (residential handlers). 

Additionally, based on the results of the 

environmental fate studies, there is a 

potential for incidental ingestion by 

toddlers. However, since the Agency did 

not select short- or intermediate-term 

dermal or inhalation endpoints, no 

residential handler or post-application 

dermal assessment was performed.

A post-application toddler assessment 

for incidental ingestion exposure 

assessment was performed. The SOPs 

For Residential Exposure Assessments, 

Draft, 17-DEC-1997 and Exposure 

Science Advisory Committee (ExpoSAC) 

Policy No. 11, 22-FEB-2001: 

Recommended Revisions to the SOPs for 

Residential Exposure were used to 

estimate post-application incidental 

ingestion exposures and risk estimates 

for toddlers. The following assumptions 

were used to assess exposures to 

toddlers after contact with treated 

lawns: Toddler body weight of 15 kg; 

toddler hand-surface area is 20 

centimeter squared (cm)2, and a toddler 

performs 20 hand-to-mouth events per 

hr for short-term exposures; exposure 

duration of 2 hrs per day; 5% of 

application rate represents fraction of 

glyphosate available for transfer to 

hands and a 50% saliva extraction factor 

for hand-to-mouth exposures; surface 

area of a object (for toddler object-tomouth exposures; surface area of an 

object (for toddler object-to-mouth 

exposures) is approximately 25 cm2; 

20% of application rate available as 

dislodgeable residues for object-tomouth exposures; 100% of application 

rate is avaible in the top 1 cm of soil for 

soil ingestion exposures; and that a 

toddler can ingest 100 milligram (mg) 

soil/day. This risk assessment is fully 

discussed in Unit V.C. of the final rule 

published in the Federal Register of 

September 27, 2002 (67 FR 60934) 

(FRL–7200–2). MOEs for toddler postapplication incidental ingestion 

exposures were 7,200 for hand-tomouth, 29,000 for object-to-mouth and 

greater than 106 for soil ingestion, and 

therefore, do not exceed the Agency‘s 

level of concern for residential 

exposures (MOEs) less than 100.

4. 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.’’

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 

glyphosate and any other substances 

and glyphosate 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 glyphosate 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 the policy statements 

released by EPA’s OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

at http://www.epa.gov/pesticides/

cumulative/.

D. Safety Factor for Infants and 

Children

1.In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. 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 safety factor value 

based on the use of traditional 

uncertainty factors and/or special FQPA 

safety factors, as appropriate.

2. Prenatal and postnatal sensitivity. 

Based on the acceptable developmental 

studies, the Agency has determined that 

there is no evidence of either a 

quantitative or qualitative increased 

susceptibility following in utero

glyphosate exposure to rats or rabbits, or 

following prenatal/postnatal exposure 

in the 2-generation reproduction study 

in rats.

3. Conclusion. There is a complete 

toxicity database for glyphosate and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. The 

impact of glyphosate on the nervous 

system has not been specifically 

evaluated in neurotoxicity studies. 

However, there was no evidence of 

neurotoxicity seen in either acute, 

subchronic, chronic, or reproductive 

studies. and there are no concerns for 

potential developmental neurotoxicity. 

Therefore, neurotoxicity studies are not 

required for glyphosate. EPA 

determined that the 10X SF to protect 

infants and children should be removed. 

The FQPA factor is removed because the 

toxicology database is complete; a 

developmental neurotoxicity study is 

not required; there is no evidence of 

quantitative or qualitative increased 

susceptibility of the young 

demonstrated in the prenatal 

developmental studies in rats or rabbits 

and pre-/postnatal reproduction study 

in rats; and the dietary (food and 

drinking water) exposure assessments 

will not underestimate the potential 

exposure for infants and children.

E. Aggregate Risks and Determination of 

Safety

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against EECs. 

DWLOC values are not regulatory 

standards for drinking water. DWLOCs 

are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water [e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + residential exposure)]. This 

allowable exposure through drinking 

water is used to calculate a DWLOC.

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 L/70 kg 

(adult male), 2L/60 kg (adult female), 

and 1L/10 kg (child). Default body 

weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65085

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

1. Acute risk. Glyphosate is not 

expected to pose an acute risk because 

no toxicological endpoints attributable 

to a single exposure (dose), including 

maternal toxicity in developmental 

toxicity studies, were identified in the 

available data.

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to glyphosate from food 

will utilize 2.2% of the cPAD for the 

U.S. population, 3.9% of the cPAD for 

all infants < 1 year old, and 5.4% of the 

cPAD for children 1–2 years old. Based 

the use pattern, chronic residential 

exposure to residues of glyphosate is not 

expected. In addition, there is potential 

for chronic dietary exposure to 

glyphosate in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in Table 1 of this 

unit:

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO GLYPHOSATE

Population subgroup cPAD mg/

kg/day 

%cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. Population 1.75 2.2 230 0.0038 60,000

All infants < 1 year old 1.75 3.9 230 0.0038 16,800

Children 1–2 years old 1.75 5.4 230 0.0038 16,600

Females 13–49 years old 1.75 1.7 230 0.0038 51,600

Youth 13–19 years old 1.75 2.1 230 0.0038 51,400

Adults 20–49 years old 1.75 1.9 230 0.0038 60,100

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level).

Glyphosate is currently registered for 

use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for glyphosate.

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that food 

and residential exposures aggregated 

result in aggregate MOEs of 1,800 for all 

infants < 1 year old, 1,500 for children 

1–6 years old, and 2000 for children 7–

12 years old. Because the incidental oral 

ingestion exposure estimates for 

toddlers from residential turf exposures 

exceeded the incidental oral exposure 

from post-application swimmer 

exposures, the Agency conducted this 

risk assessment using exposure 

estimates from the worst case situation. 

No attempt was made to combine 

exposures from swimmer and 

residential turf scenarios due to the low 

probability of both occurring. See Tables 

5 and 6 from the final rule published in 

the Federal Register of September 27, 

2002 (67 FR 60934) (FRL–7200–2) for 

detailed discussion. These aggregate 

MOEs do not exceed the Agency’s level 

of concern for aggregate exposure to 

food and residential uses. In addition, 

short-term DWLOCs were calculated 

and compared to the EECs for chronic 

exposure of glyphosate in ground and 

surface water. After calculating 

DWLOCs and comparing them to the 

EECs for surface and ground water, EPA 

does not expect short-term aggregate 

exposure to exceed the Agency’s level of 

concern, as shown in Table 2 of this 

unit:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO GLYPHOSATE

Population subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

Level of 

Concern 

(LOC) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Short-Term 

DWLOC 

(ppb) 

All infants < 1 year old 1,800 100 230 0.0038 16,500

Children 1–6 years old 1,500 100 230 0.0038 16,300

Children 7–12 years old 2,000 100 230 0.0038 16,600

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level).

Glyphosate is currently registered for 

use(s) that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic food 

and water and intermediate-term 

exposures for glyphosate.

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

food and residential exposures 

aggregated result in aggregate MOEs of 

1,800 for all infants < 1 year old, 1,500 

for children 1–6 years old, and 2,000 for 

65086 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

children 7–12 years old. Because the 

incidental oral ingestion exposure 

estimates for toddlers from residential 

turf exposures exceeded the incidental 

oral exposure from post-application 

swimmer exposures, the Agency 

conducted this risk assessment using 

exposure estimates from the worst case 

situation. No attempt was made to 

combine exposures from swimmer and 

residential turf scenarios due to the low 

probability of both occurring. See Tables 

5 and 6 from the final rule published in 

the Federal Register of September 27, 

2002 (67 FR 60934) (FRL–7200–2) for 

detailed discussion. These aggregate 

MOEs do not exceed the Agency’s level 

of concern for aggregate exposure to 

food and residential uses. In addition, 

intermediate-term DWLOCs were 

calculated and compared to the EECs for 

chronic exposure of glyphosate in 

ground and surface water. After 

calculating DWLOCs and comparing 

them to the EECs for surface and ground 

water, EPA does not expect 

intermediate-term aggregate exposure to 

exceed the Agency’s level of concern, as 

shown in Table 3 of this unit:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO GLYPHOSATE

Population subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

Level of 

Concern 

(LOC) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

IntermediateTerm 

DWLOC 

(ppb) 

All infants < 1 year old 1,800 100 230 0.0038 16,500

Children 1–6 years old 1,500 100 230 0.0038 16,300

Children 7–12 years old 2,000 100 230 0.0038 16,600

5. Aggregate cancer risk for U.S. 

population. Glyphosate has no 

carcinogenic potential.

6. 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, and to infants and children 

from aggregate exposure to glyphosate 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate analytical methods are 

available for the enforcement of 

tolerances for glyphosate in plant and 

livestock commodities. These methods 

include gas liquid chromatography 

(GLC) (Method I in Pesticides Analytical 

Manual (PAM II)) and High Performance 

Liquid Chromatography (HPLC) with 

fluorometric detection. Use of GLC is 

discouraged due to the lengthiness of 

the experimental procedure. The HPLC 

procedure has undergone successful 

Agency validation and was 

recommended for inclusion into PAM II. 

A Gas Chromatography Spectrometry 

(GC/MS) method for glyphosate in crops 

has also been validated by EPA.

These methods may be requested 

from: Chief, Analytical Chemistry 

Branch, Environmental Science Center, 

701 Mapes Rd., Ft. Meade, MD 20755–

5350; telephone number: (410) 305–

2905; e-mail address: 

residuemethods@epa.gov.

B. International Residue Limits

Codex and Mexican maximum 

residue levels (MRLS) are established 

for residues of glyphosate per se and 

Canadian MRLs are established for 

combined residues of glyphosate and 

aminomethylphosphonic acid (AMPA) 

in a variety of raw agricultural 

commodities. Codex MRLs exist for dry 

peas and dry beans at 5 ppm and 2 ppm, 

respectively. Canadian MRLs exist for 

peas, beans, and lentils at 5 ppm, 2 

ppm, and 4 ppm, respectively. Mexican 

MRLs of 0.2 ppm exist for both peas and 

beans. Codex and Canadian MRLs for 

beans and lentils, and Mexican MRLs 

for peas and beans are lower then 

necessary to cover residues from the use 

patterns in the United States. The 

proposed U. S. tolerance for the crop 

group peas and beans, dried and 

shelled, except soybeans, is in 

agreement with the Codex and Canadian 

MRLs for dry peas and peas, 

respectively, and are necessary to cover 

use patterns in the United States.

Currently no Codex MRL for cotton, 

gin byproducts or cotton, undelinted 

seed are established.

C. Conditions

There are no conditions of registration 

for the establishment of tolerances on 

cotton, gin byproducts or cotton, 

undelinted seed.

V. Comments

One comment was received in 

response to the notice of filing from B. 

Sachau, 15 Elm St., Florham Park, NJ 

07932. The commenter objected to the 

allowance of any tolerances, waiver, or 

exemption from tolerance for glyphosate 

because there are bad effects from 

glyphosate. The commenter also 

objected to animal testing, because 

testing on rabbit or dog constitutes 

animal abuse, and stated that a more 

reliable method of testing should be 

developed.

The comment contained no scientific 

data or evidence to rebut the Agency‘s 

conclusion that there is a reasonable 

certainty that no harm will result from 

aggregate expose to glyphosate, 

including all anticipated dietary 

exposure and all other exposures for 

which the is reliable information.

Health Effects Guidelines (Series 870) 

recommends that dog or rabbit be used 

for various acute, subchronic, and 

longer term chronic, carcinogenic, 

developmental, and reproductive 

studies. Information derived from these 

tests serve to indicate the presence of 

possible hazards likely to arise from 

exposure to the test substance. 

Currently, there are not in vitro studies 

that can address the questions these 

studies answer. The EPA is currently 

working with the Interagency 

Coordinating Committee on the 

Validation or Alternative Methods 

(ICCVAM) to investigate alternative in 

vitro methods.

VI. Conclusion

Therefore, the tolerance is established 

for residues of glyphosate, N-

(phosophonomethyl)glycine, resulting 

from the application of glyphosate, the 

isopropylamine salt of glyphosate, the 

ethanolamine salt of glyphosate, the 

ammonium salt of glyphosate, and the 

potassium salt of glyphosate in or on 

cotton, gin byproducts at 175 ppm and 

cotton, undelinted seed at 35 ppm.

VII. Objections and Hearing Requests

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 

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65087

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0323 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 January 10, 2005.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VII.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0323, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, 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). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

65088 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

IX. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this 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: October 25, 2004.

Betty Shackleford,

Acting Director, Registration Division, Office 

of Pesticide Programs.

■ Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—AMENDED

■ 1. The authority citation for part 180 

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

■ 2. Section 180.364, paragraph (a) is 

amended by:

■ i. Revising the chemical name ‘‘(Nphosphomethyl)glycine)’’ in the 

introductory text to read ‘‘N-

(phosphonomethyl)glycine.’’

■ ii. Revising in the table the entries 

‘‘cotton, gin byproducts’’ and ‘‘cotton, 

undelinted seed’’ to read as follows:

§ 180.364 Glyphosate; tolerances for 

residues.

(a) * * *

Commodity Parts per 

million 

*** **

Cotton, gin byproducts ............. 175

Cotton, undelinted seed ........... 35

*** **

* * * * *

[FR Doc. 04–25098 Filed 11–9–04; 8:45 am]

BILLING CODE 6560–50–S

DEPARTMENT OF DEFENSE

48 CFR Parts 209 and 252 

[DFARS Case 2003–D011] 

Defense Federal Acquisition 

Regulation Supplement; Contractor 

Qualifications Relating to Contract 

Placement

AGENCY: Department of Defense (DoD).

ACTION: Final rule.

SUMMARY: DoD has issued a final rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to delete text pertaining to 

contractor qualification requirements. 

This rule is a result of a transformation 

initiative undertaken by DoD to 

dramatically change the purpose and 

content of the DFARS.

DATES: Effective Date: November 10, 

2004.

FOR FURTHER INFORMATION CONTACT: Ms. 

Robin Schulze, Defense Acquisition 

Regulations Council, 

OUSD(AT&L)DPAP(DAR), IMD 3C132, 

3062 Defense Pentagon, Washington, DC 

20301–3062. Telephone (703) 602–0326; 

facsimile (703) 602–0350. Please cite 

DFARS Case 2003–D011.

SUPPLEMENTARY INFORMATION: 

A. Background 

DFARS Transformation is a major 

DoD initiative to dramatically change 

the purpose and content of the DFARS. 

The objective is to improve the 

efficiency and effectiveness of the 

acquisition process, while allowing the 

acquisition workforce the flexibility to 

innovate. The transformed DFARS will 

contain only requirements of law, DoDwide policies, delegations of FAR 

authorities, deviations from FAR 

requirements, and policies/procedures 

that have a significant effect beyond the 

internal operating procedures of DoD or 

a significant cost or administrative 

impact on contractors or offerors. 

Additional information on the DFARS 

Transformation initiative is available at 

http://www.acq.osd.mil/dpap/dfars/

transf.htm.

This final rule is a result of the 

DFARS Transformation initiative. The 

DFARS changes include—

• Deletion of text at DFARS 209.103, 

209.103–70, and 252.209–7000 

pertaining to obsolete Intermediate 

Range Nuclear Forces (INF) Treaty 

inspection requirements. 

• Deletion of text at DFARS 209.106–

1, 209.106–2, and 209.202 containing 

internal DoD procedures relating to 

requests for pre-award surveys and 

approval for use of product qualification 

requirements. This text has been 

relocated to the new DFARS companion 

resource, Procedures, Guidance, and 

Information (PGI), available at http://

www.acq.osd.mil/dpap/dars/pgi.

• Deletion of unnecessary first article 

testing and approval requirements in 

DFARS subpart 209.3. 

DoD published a proposed rule at 69 

FR 8150 on February 23, 2004. DoD 

received no comments on the proposed 

rule. Therefore, DoD has adopted the 

proposed rule as a final rule. An 

additional change has been made at 

DFARS 209.202 to reflect the 

qualification requirements for aviation 

critical safety items added to the DFARS 

on September 17, 2004 (69 FR 55987). 

This rule was not subject to Office of 

Management and Budget review under 

Executive Order 12866, dated 

September 30, 1993. 

B. Regulatory Flexibility Act 

DoD does not expect this rule to have 

a significant economic impact on a 

substantial number of small entities 

within the meaning of the Regulatory 

Flexibility Act, 5 U.S.C. 601, et seq., 

because the rule deletes DFARS text that 

is obsolete, unnecessary, or procedural, 

but makes no significant change to 

contracting policy. 

C. Paperwork Reduction Act 

The Paperwork Reduction Act does 

not apply because the rule does not 

impose any information collection 

requirements that require the approval 

of the Office of Management and Budget 

under 44 U.S.C. 3501, et seq.