46900 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408(d). 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). 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) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), 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. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This 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: August 26, 1997.

Peter Caulkins,

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. 346a and 371.

2. In § 180.442, by alphabetically

inserting the following item into the

table in paragraph (b) to read as follows:

§ 180.442 Bifenthrin; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/Revocation Date

Canola, Seed ....................................................................................... 0.5 9/30/98

* * * * * * *

* * * * *

[FR Doc. 97–23720 Filed 9–4–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 186

[OPP–300536; FRL–5738–9]

RIN 2070–AB78

2,4–D; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for 2,4-

dichlorophenoxyacetic acid (2,4-D) in or

on wild rice. This action is in response

to EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on wild rice. This regulation

establishes a maximum permissible

level for residues of 2,4-D in this food
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46901

commodity pursuant to section 408(l)(6)

of the Federal Food, Drug, and Cosmetic

Act, as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on August 31,

1998.

DATES: This regulation is effective

September 5, 1997. Objections and

requests for hearings must be received

by EPA on or before November 4, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300536],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300536], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300536]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Daniel Rosenblatt, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–9375, e-mail:

rosenblatt.dan@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for residues of the herbicide

2,4-dichlorophenoxyacetic acid, in or on

wild rice at 0.1 parts per million (ppm).

This tolerance will expire and is

revoked on August 31, 1998. EPA will

publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq . The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) of the

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) 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) 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....’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for 2,4-D on

Wild Rice and FFDCA Tolerances

The cultivation of wild rice involves

flooding fields. Common waterplantain

(Alisma plantage-aquatica) is an aquatic

plant pest that has established itself in

areas where wild rice is produced.

There are no herbicides registered for

use on wild rice. An analysis submitted

in support of the FIFRA section 18

exemption for this use suggests that

common waterplantain will reduce

yields in Minnesota by approximately

50% in certain areas. EPA considers that

this loss lies outside the range of normal

profitability fluctuation. Such loss

would, therefore, represent a significant

economic loss for growers. Therefore,

EPA has authorized under FIFRA

section 18 the use of 2,4-D on wild rice

for control of common waterplantain in

Minnesota. After having reviewed the

submission, EPA concurs that

emergency conditions exist for this

state.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

2,4-D in or on wild rice. In doing so,

EPA considered the new safety standard

in FFDCA section 408(b)(2), and EPA

decided that the necessary tolerance

under FFDCA section 408(l)(6) would be

consistent with the new safety standard

and with FIFRA section 18. Consistent

with the need to move quickly on the

emergency exemption in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and is revoked on August 31,
46902 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on wild rice

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA.

EPA will take action to revoke this

tolerance earlier if any experience with,

scientific data on, or other relevant

information on this pesticide indicate

that the residues are not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether 2,4-D meets EPA’s registration

requirements for use on wild rice or

whether a permanent tolerance for this

use would be appropriate. Under these

circumstances, EPA does not believe

that this tolerance serves as a basis for

registration of 2,4-D by a State for

special local needs under FIFRA section

24(c). Nor does this tolerance serve as

the basis for any State other than

Minnesota to use this pesticide on this

crop under section 18 of FIFRA without

following all provisions of section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for 2,4-D, contact

the Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute’’, ‘‘short-term’’, ‘‘intermediate

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. Toxicity results at

lower levels when the dosing duration

is increased.

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46903

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(infants less than a year old) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

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 2,4-D and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for a

time-limited tolerance for residues of

2,4-dichlorophenoxyacetic acid on wild

rice at 0.1 ppm. EPA’s assessment of the

dietary 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 2,4-D are

discussed below.

1. Acute toxicity. For the purpose of

the acute dietary risk assessment, EPA

recommends use of a NOEL of 67 mg/

kg/day from the rat acute neurotoxicity

study. The effects observed at the LOEL

of 227 mg/kg/day were increased

incidence of incoordination, slight gait

abnormalities, and decreased motor

activity. As neurotoxicity is the effect of

concern, this risk assessment will

evaluate acute dietary risk to all

population subgroups.

2. Short - and intermediate - term

toxicity. For short-term MOE

calculations, EPA supports use of the

maternal NOEL of 30 mg/kg/day from

the oral developmental toxicity study in

rabbits. The Lowest Effect Level (LEL)

was 90 mg/kg/day, based on abortions,

ataxia, decreased motor activity, cold

extremities during gestation, and

decreased weight gain. For

intermediate-term dermal MOE

calculations, EPA recommended use of

the NOEL of 1.0 mg/kg/day from the 90–

day oral toxicity study in dogs. The LEL

of 3 mg/kg/day was based on clinical

chemistry changes and lesions in the

kidneys. For short- and intermediateterm inhalation risk, EPA concludes that

exposure by the inhalation route was of

no concern and that this risk assessment

was not required for any exposure

duration.

3. Chronic toxicity. EPA has

established the RfD for 2,4-D at 0.01

milligrams/kilogram/day (mg/kg/day).

This RfD is based on a 1–year oral

toxicity study in dogs with a NOEL of

1 mg/kg/day and an uncertainty factor

of 100. The LEL of 5 mg/kg/day was

based on alterations in serum chemistry

with corroborative histopathological

lesions in the liver and kidneys.

4. Carcinogenicity. EPA’s Cancer Peer

Review Committee has classified 2,4-D

as a Group D chemical (‘‘not classifiable

as to human carcinogenicity’’) on the

basis that, ‘‘the evidence is inadequate

and cannot be interpreted as showing

either the presence or absence of a

carcinogenic effect.’’

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.142) for residues of 2,4-D as the

acid or various of its salts and esters, in

or on a variety of raw agricultural

commodities, including rice. In

addition, there are also tolerances for

2,4-D for meat, milk, and eggs. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

2,4-D as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. Wild rice

is not uniquely identified in the system

which the Agency uses to calculate

acute and chronic dietary risk.

Therefore, the Agency must estimate the

additional exposure to 2,4-D associated

with this use. Based on the proposed

tolerance level and the probable low

average consumption of this

commodity, the Agency believes it is

likely that any incremental increase in

acute dietary risk would be negligible.

In addressing this area, the Agency

assessed the potential acute dietary

exposure from 2,4-D based on all of the

chemical’s existing tolerances and uses.

For this analysis, EPA assumed

tolerance level residues and 100% croptreated. MOEs were calculated for all

population subgroups. MOEs ranged

from 112 for infants (less than 1 year

old) to 558 for males and females 13

years and older. Although these MOEs

do not represent a level of concern to

EPA, if the analysis were to incorporate

anticipated residue levels and actual

percent crop-treated, the MOEs would

be even larger. Therefore, this

assessment should be viewed as

conservative.

ii. Chronic exposure and risk. As

mentioned above, wild rice is not a

commodity that is uniquely identified

in the Agency’s current food

consumption data system. However,

EPA has estimated that the incremental

chronic dietary risk from this Section 18

use of 2,4-D on wild rice adds less than

1 percent to the RfD values for this

chemical. For the purpose of assessing

potential chronic dietary exposure from

2,4-D, EPA assumed Anticipated

Residue Contributions (ARCs) for major

identifiable subgroups of consumers,

including infants and children, from the
46904 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

existing uses of 2,4-D. The RfD values

range from 58% for non-nursing infants

less than 1 year old to 31% for the U.S.

population (48 states).

2. From drinking water. In examining

aggregate exposure, FQPA directs EPA

to consider available information

concerning exposures from the pesticide

residues in food and all other nonoccupational exposures. The primary

non-food sources of exposure the

Agency looks at include drinking water

(whether from ground or surface water),

and exposure through pesticide use in

gardens, lawns, or buildings (residential

and other indoor uses). Based on data

available to EPA, 2,4-D is soluble in

water. The average field half-life is 10

days. The chemical is potentially

mobile, but rapid degradation in soil

and removal by plant uptake minimizes

leaching. A Maximum Contaminant

Level (MCL) of 0.07 mg/L has been

established. In addition, the following

Health Advisories (HAs) have been

established: for a 10-kg child, a range of

1 mg/L from 1–day exposure to 0.1 mg/

L for longer-term exposure up to 7 years;

for a 70 kg adult, a range of 0.4 mg/L

for longer-term exposure to 0.07 mg/L

for lifetime exposure.

i. Acute exposure and risk. EPA

developed acute exposure levels for

adults and children assuming the high

end residue value of 57.1 micrograms/

L in drinking water. Adult exposure was

calculated to be 1.6 × 10-3 mg/kg/day.

Child exposure was calculated to be 5.7

× 10-3 mg/kg/day. The child exposure

calculations assumed a body weight of

10 kg and all the drinking water

consumed in the United States was

assumed to contain the high end level

of residues (57 micrograms/L). The

assessment is quite conservative since

only just over 2% of all wells monitored

from 1979-1991 contained detectable

residues of 2,4-D. The adult calculations

assumed a body weight of 70 kg and the

high end of residue (57 micrograms/L).

The acute NOEL for 2,4-D is 67 mg/kg/

day. The acute MOE is thus calculated

to be 42,000 for adults and 12,000 for

children.

ii. Chronic exposure and risk. The RfD

for 2,4-D is 0.01 mg/kg/day. Thus, the

levels of adult and child exposure

correspond to a chronic dietary (water

only) exposure of 16% of the RfD for

adults and 57% of the RfD for children.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause 2,4-D to exceed the RfD if

the tolerance being considered in this

document were granted. The Agency

has therefore concluded that the

potential exposures associated with 2,4-

D in water, even at the higher levels the

Agency is considering as a conservative

upper bound, would not prevent the

Agency from determining that there is a

reasonable certainty of no harm if the

tolerance is granted.

3. From non-dietary exposure. 2,4-D is

currently registered for use on the

following residential non-food sites:

ornamental turf, lawns, and grasses, golf

course turf, recreational areas, and

several other indoor and outdoor uses.

This herbicide is widely used. By

volume, 2,4-D is among the top

pesticides used in non-agricultural

settings. EPA does not have data on

hand upon which to base calculation of

non-dietary exposure of 2,4-D for

purposes of inclusion in an aggregate

risk assessment. However, there are

several characteristics of 2,4-D which

suggest the chemical presents a low risk

from non-dietary, non-occupational

exposure, particularly the chemical’s

high acute toxicity NOEL, the short half

life in soil, low dermal penetration and

high acute dietary MOE. Further, EPA

has concluded that for the purposes of

short- and intermediate-term risk, the

inhalation route was of no health

concern.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) 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.’’The Agency believes that

‘‘available information’’ in this context

might include not only toxicity,

chemistry, and exposure data, but also

scientific policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether 2,4-

D 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, 2,4-D 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 2,4-

D has a common mechanism of toxicity

with other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. EPA calculates acute

aggregate risks by taking into account

MOEs from food and MOEs from water.

As described above in this document,
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46905

for the subgroup U.S. population the

MOE for food is 223, the MOE for water

is 42,000. Taken together, the aggregate

MOE is 222. This figure does not exceed

the Agency’s level of concern for acute

dietary exposure.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to 2,4-D from food and water

will utilize 47% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is infants and children. See

below for a discussion of the analysis of

the risks for that subgroup. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to 2,4-D in drinking water

and from non-dietary, non-occupational

exposure, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to 2,4-D

residues.

D. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children. i. In assessing the potential for

additional sensitivity of infants and

children to residues of 2,4-D, EPA

considered data from developmental

toxicity studies in the rat and rabbit and

a two-generation reproduction study in

the rat. The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from maternal pesticide

exposure during gestation.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines 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. EPA believes that reliable data

support using the standard 100-fold

safety factor (usually 100 for combined

inter- and intra-species variability)) and

not the additional tenfold safety factor

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard safety factor.

ii. Developmental toxicity studies. In

the rat developmental toxicity analysis,

the maternal NOEL was greater than 75

mg/kg/day at the highest dose tested

(HDT). The developmental (fetal) NOEL

was 25 mg/kg/day, based on delayed

ossification at the developmental LOEL

of 75 mg/kg/day. In the rabbit

developmental toxicity study, the

maternal NOEL was 30 mg/kg/day,

based on ataxia, decreased motor

activity, cold extremities, and decreased

body weight gain at the LOEL of 90 mg/

kg/day. The developmental (fetal) NOEL

was 90 mg/kg/day.

iii. Reproductive toxicity study. In the

2-generation reproductive toxicity study

in rats, the parental (systemic) NOEL of

5 mg/kg/day was based on degenerative

effects in the kidneys of males and

decreased body weight gain in females

at the LOEL of 20 mg/kg/day. The

reproductive (pup) NOEL was 5 mg/kg/

day, based on decreased pup weight at

the LEL of 20 mg/kg/day. The

reproductive effects occurred in the

presence of parental toxicity.

iv. Pre- and post-natal sensitivity. The

pre and post-natal toxicology data base

for 2,4-D is complete with respect to

current data requirements. In the

developmental toxicity study in rats,

evidence of toxicity occurred in

developing fetuses (NOEL of 25 mg/kg/

day) in the absence of maternal toxicity.

This finding suggests that extra prenatal sensitivity may be present in rat

fetuses exposed to 2,4-D in the absence

of maternal toxicity. However, the

results from the developmental toxicity

study in rabbits demonstrate that

maternal toxicity occurred (NOEL of 30

mg/kg/day) in the absence of

developmental toxicity (NOEL of 90 mg/

kg/day), thus suggesting no extra prenatal sensitivity. Since the

developmental NOELs for rats (25-fold)

and rabbits (90-fold) are greater than the

RfD NOEL of 1 mg/kg/day from the 1–

year oral toxicity study in dogs, an

additional uncertainty factor to protect

infants and children is not warranted.

v. Conclusion. Based on the

reproductive toxicity study in rats

discussed above, there does not appear

to be an increased sensitivity for preand post-natal effects. Based on these

findings, EPA concludes that reliable

data support use of the standard 100-

fold margin of exposure/uncertainty

factor and that an additional margin/

factor is not needed for 2,4-D to protect

the safety of infants and children.

2. Acute risk. EPA has determined

aggregate MOE calculations which

incorporate exposure to 2,4-D from food

and water. The aggregate MOEs for 2,4-

D are: 111 for infants less than a year

old, 147 for children 1-6 years old, and

556 for females 13 and older. These

MOEs do not exceed EPA’s level of

concern. Further, they were prepared

using conservative risk estimates; data

refinement would result in lower acute

aggregate exposure estimates. Therefore,

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to 2,4-D residues.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to 2,4-D from

food and water will utilize 87% of the

RfD for nursing infants, 115% for nonnursing infants, 114% for children 1-6

years old, and 100% for children 7-12

years old. EPA notes that the food

exposure estimate is partially refined

while the water estimate is quite

conservative. Further refinement using

additional anticipated residue values in

crops and percent crop-treated

information, and well water monitoring

data would result in lower chronic

dietary (food) and chronic dietary

(water) exposure estimates, thus

reducing the aggregate risk estimate.

Given these factors, along with the

completeness and reliability of the

toxicity data, EPA concludes that there

is a reasonable certainty that no harm

will result to infants and children from

aggregate chronic exposure to 2,4-D

residues.

V. Other Considerations

A. Metabolism in Plants and Animals

The nature of the residue of 2,4-D is

adequately understood. The regulable

residue is 2,4-D per se, as established in

40 CFR 180.142. No livestock feed

issues are raised by this action.

B. Analytical Enforcement Methodology

EN-CAS Method ENC-2/93 is

available to enforce this time-limited

tolerance on wild rice.

C. Magnitude of Residues

Adequate residue data are available to

support a time-limited tolerance for

residues of 2,4-D in/on wild rice at 0.1

ppm. Wild rice hulls, obtained from

processing, have no recognized food or

feed use. Secondary residues are not

expected in meat, milk, poultry, or eggs

from this use since no feed items are

associated with wild rice. Further, the
46906 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

label restricts against use of treated

water to irrigate other crops or to water

livestock.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican maximum residue limits

(MRLs) for use of 2,4-D on wild rice.

Therefore, international harmonization

is not an issue for this commodity.

There is a Codex MRL of 0.05 ppm for

2,4-D on rice, a Mexican MRL of 0.1

ppm for 2,4-D on rice; and a Canadian

MRL of 0.1 ppm for 2,4-D on cereal

grains.

VI. Conclusion

Therefore, the time limited tolerance

is established for residues of 2,4-

dichlorophenoxyacetic acid in wild rice

at 0.1 ppm. Since the FQPA has

eliminated the distinctions between

processed food, feed, and raw

agricultural commodities, the tolerance

in § 186.1450 is being renumbered and

transfered to § 180.142(a)(12). Therefore,

§ 186.1450 is being removed.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by November 4,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is 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

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (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.

VIII. Public Record

EPA has established a record for this

rulemaking under docket control

number [OPP–300536] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408(d). 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). 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) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408 (d), 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.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46907

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 180 and

186

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Animal

feeds, Pesticides and pests, Reporting

and recordkeeping requirements.

Dated: August 25, 1997.

James Jones,

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. 346a and 371.

2. Section 180.142 is amended as

follows:

i. By adding a heading to paragraph

(a), by redesignating paragraphs (a)(1)

and (a)(2) as paragraphs (a)(1)(i) and

(a)(1)(ii), respectively, by designating

the introductory text of paragraph (a) as

paragraph (a)(1), and by adding new

paragraph (a)(12).

ii. By redesignating the introductory

text of paragraph (b) as the introductory

text of paragraph (a)(2), and paragraphs

(b)(1), (b)(1)(i), (b)(1)(ii), and (b)(2) as

paragraphs (a)(2)(i), (a)(2)(i)(A),

(a)(2)(i)(B), and (a)(2)(ii), respectively.

iii. By redesignating paragraphs (c)

through (k) as paragraphs (a)(3) through

(a)(11), respectively.

iv. By adding a new paragraph (b).

v. By adding and reserving paragraphs

(c) and (d) with headings.

§ 180.142 2,4-D; tolerances for residues.

(a) General. * * *

(12) The following tolerances are

established for residues of 2,4-D (2,4-

dichloro-phenoxyacetic acid) in the

following processed feeds. Such

residues may be present therein only as

a result of application to the growing

crop of the herbicides identified in this

section:

(i) 5 parts per million in sugarcane

bagasse and sugarcane molasses.

(ii) 2 parts per million in the milled

fractions derived from barley, oats, rye,

and wheat to be ingested as animal feed

or converted into animal feed.

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for 2,4-dichlorophenoxyacetic acid (2,4-

D) in or on wild rice in connection with

use of the pesticide under a section 18

emergency exemption granted by EPA.

The tolerance will expire on the dates

specified in the following table.

Commodity Parts per million Expiration/Revocation Date

Wild rice ............................................................................................... 0.1 ppm August 31, 1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

2. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348, and 701.

§ 186.1450 [Removed]

b. Section 186.1450 is removed.

[FR Doc. 97–23684 Filed 9–4–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety

Administration

49 CFR Part 571

[Docket No. 85–6; Notice 12]

RIN 2127–AG05

Federal Motor Vehicle Safety

Standards; Hydraulic Brake Systems;

Passenger Car Brake Systems

AGENCY: National Highway Traffic

Safety Administration (NHTSA),

Department of Transportation.

ACTION: Final rule.

SUMMARY: This document amends

Federal Motor Vehicle Safety Standards

Nos. 105 Hydraulic Brake Systems and

135 Passenger Car Brake Systems to

accommodate the brake systems on

electric vehicles. The amendments

address unique characteristics of brake

systems on electric vehicles, such as

regenerative braking, and are intended

to assure safe performance for those

brake systems. The amendments of

Standard No. 105 apply to electric

trucks, buses, and multipurpose

passenger vehicles. They also apply to

electric passenger cars that have not

availed themselves of the option of

conforming to Standard No. 135, which

is mandatory for all passenger cars

manufactured on and after September 1,

2000. The amendments to Standard No.

135 complement those made to

Standard No. 105.

DATES: The amendments to both

standards are effective October 20, 1997.

Compliance with Standard No. 105 is

mandatory as of September 1, 1998.

Compliance with Standard No. 135 is

mandatory as of September 1, 2000, the

effective date of Standard No. 135.

Petitions for reconsideration of the final

rule must be submitted not later than

October 20, 1997.

ADDRESS: Petitions for reconsideration

should be addressed to Docket 85–6;

Notice 12, and submitted to Docket

Room, NHTSA, Room 5108, 400

Seventh St. SW, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Samuel Daniel, Vehicle Dynamics

Division, Office of Vehicle Safety

Standards, NHTSA (Phone: 202–366–

4921).

SUPPLEMENTARY INFORMATION:

Table of Contents

1. Background

2. Issues relating to Definitions

3. Partial failure (Standard No. 105)

4. Issues relating to RBS:

A. RBS as part of the service brake system

B. RBS braking effects

C. ABS control over RBS

5. Issues relating to warning indicators:

A. Red ‘‘BRAKE’’ lamp as signal of RBS

failure

B. Common ABS/RBS malfunction warning

indicator

6. Issues related to compliance testing:

A. Procedure for determining battery state

of charge

B. Procedure for charging batteries during

burnish

C. Procedure for recharging batteries

D. Testing in gear as opposed to testing in

neutral

E. Testing at low state of charge

7. Issues relating to test conditions:

A. Initial brake temperature (IBT)

B. Static parking brake test

C. Stops with engine off (Standard No. 135)

8. International harmonization

Effective dates

Regulatory analyses: