Federal Register / Vol. 63, No. 34 / Friday, February 20, 1998 /Rules and Regulations 8573

anticaking agent for animal feeds is safe

when used in accordance with current

good manufacturing practices.

In accordance with § 571.1(h) (21 CFR

571.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Veterinary

Medicine by appointment with the

information contact person listed above.

As provided in 21 CFR 571.1(h), the

agency will delete from the documents

any materials that are not available for

public disclosure before making the

documents available for inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before March 23, 1998, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 573

Animal feeds, Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Veterinary

Medicine, 21 CFR part 573 is amended

as follows:

PART 573—FOOD ADDITIVES

PERMITTED IN FEED AND DRINKING

WATER OF ANIMALS

1. The authority citation for 21 CFR

part 573 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 573.280 is revised to read

as follows:

§ 573.280 Feed-grade calcium stearate and

sodium stearate.

Feed-grade calcium stearate and

sodium stearate may be safely used in

an animal feed in accordance with the

following prescribed conditions:

(a) Feed-grade calcium stearate and

sodium stearate are the calcium or

sodium salts of a fatty acid mixture that

is predominately stearic acid.

Associated fatty acids, including

palmitic acid and minor amounts of

lauric, myristic, pentadecanoic,

margaric, arachidic, and other fatty

acids may be contained in the mixture,

but such associated fatty acids in

aggregate do not exceed 35 percent by

weight of the mixture. The fatty acids

may be derived from feed-grade fats or

oils.

(b) The additives meet the following

specifications:

(1) Unsaponifiable matter does not

exceed 2 percent.

(2) They are free of chick-edema

factor.

(c) The additives are manufactured so

that in aqueous solution they are

exposed for 1 hour or longer to

temperature in excess of 180 °F.

(d) They are used as anticaking agents

in animal feeds in accordance with

current good manufacturing practices.

Dated: January 30, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–4223 Filed 2–19–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MI58–01–7266; FRL–5967–3]

Approval and Promulgation of State

Implementation Plans; Michigan

AGENCY: Environmental Protection

Agency.

ACTION: Final rule.

SUMMARY: This rulemaking finalizes the

United States Environmental Protection

Agency’s (USEPA) disapproval of the

State Implementation Plan (SIP)

revision submitted by Michigan

containing start-up, shutdown and

malfunction (SSM) regulations which

would apply generally to sources

covered under the applicable SIP. This

action is being taken under section 110

of the Clean Air Act (Act).

DATES: This final rule is effective March

23, 1998.

ADDRESSES: Copies of the documents

relevant to this action are available for

public inspection during normal

business hours at the U.S.

Environmental Protection Agency,

Region 5, Air and Radiation Division, 77

West Jackson Boulevard, Chicago,

Illinois 60604. (Please telephone

Kathleen D’Agostino at (312) 886–1767

before visiting the Region 5 Office.)

FOR FURTHER INFORMATION CONTACT:

Kathleen D’Agostino, Environmental

Engineer, Regulation Development

Section, Air Programs Branch (AR–18J),

U.S. Environmental Protection Agency,

Region 5, Chicago, Illinois 60604, (312)

886–1767.

SUPPLEMENTARY INFORMATION:

I. Background

On March 20, 1997 (62 FR 13357), the

USEPA published a document

proposing disapproval of a SIP revision

containing Rules 336.1912, 336.1913

and 336.1914, which was submitted by

the Michigan Department of

Environmental Quality (MDEQ) on May

16 1996. Rule 336.1912 requires that a

source be operated in a manner

consistent with good air pollution

control practices for minimizing

emissions during start-ups, shutdowns

and malfunctions, and contains notice

and reporting requirements in the event

of start-up, shutdown or malfunction.

Rules 336.1913 and 336.1914 excuse

excess emissions resulting from startups, shutdowns or malfunctions,

providing that the notice and reporting

requirements in Rule 336.1912 are met.

The rationale for USEPA’s proposed

action is explained in the notice of

proposed rulemaking and will not be

restated here.

II. Public Comments/Response to

Comments

This section summarizes the

comments submitted during the public

comment period for the notice of

proposed rulemaking and provides

USEPA’s response to those comments.

The comment period closed April 21,

1997. Adverse comments were received

from the Michigan Department of
8574 Federal Register / Vol. 63, No. 34 / Friday, February 20, 1998 /Rules and Regulations

Environmental Quality, the Michigan

Chamber of Commerce, the Michigan

Manufacturers Association, General

Motors Corporation and the American

Automobile Manufacturers Association.

Comment: USEPA’s proposed

disapproval is not supported by section

110 of the Clean Air Act (CAA). There

is no specific language in section 110

that provides the USEPA with the

authority to disapprove Michigan’s SSM

rules. Section 110 contains no

provisions that prohibit the type of

exemption and affirmative defense

contained in the SSM rules.

Response: It is true that section 110

does not explicitly address SSM

regulations. However, under section 110

of the Act, USEPA is required to

determine whether a SIP submission,

inter alia, provides for the attainment

and maintenance of the National

Ambient Air Quality Standards

(NAAQS). Because SIPs are developed

to attain and maintain ambient-based

standards, any emissions above the SIPapproved limits may cause or contribute

to violations of the NAAQS. USEPA

believes that SSM regulations which are

too broadly drawn can threaten

attainment and maintenance of the

NAAQS. Therefore, EPA believes that it

is reasonable to interpret section 110 to

prohibit generally applicable SSM

provisions.

In addition, § 110(a)(2)(A) of the Act

requires that SIP submissions contain

enforceable limitations. Enforceability

deficiencies, i.e., overly broad bypass

provisions and definitions of

‘‘malfunction,’’ are discussed further

below. (See USEPA’s response to the

comment that Michigan’s SSM rules are

consistent with the 1983 memorandum

from Kathleen Bennett.)

Comment: Because CAA regulations,

e.g., 40 CFR part 63, already allow for

protection which is broader than that

proposed in the Michigan rules, the

USEPA is without authority to proclaim

that enforcement discretion is the only

avenue for an SSM process to proceed.

It is illogical to argue that Michigan’s

SSM rules do not comply with the CAA

when CAA regulations provide for at

least as broad protection against

enforcement.

Response: The statutory and

regulatory focus of NESHAPS (and

NSPS) is fundamentally different from

the SIP program and different policies

apply, i.e., technology-based standards

as opposed to the air quality objectives

of section 110. The Bennett memoranda

recognize that the attainment and

maintenance of the NAAQS cannot be

assured with overly-broad SSM

provisions. EPA continues to believe

that the health-based objective of SIPs

make general SSM provisions

unacceptable, even though such

provisions may be appropriate for

technology-based standards such as

NESHAP and NSPS.

Comment: There is a substantive

difference between the position set forth

in the Bennett memoranda and the

protections afforded by both 40 CFR 63

and the Michigan SSM rules. The

promulgated Federal and State rules

provide that there is no violation if the

requirements of the rules are met. In

contrast, the USEPA’s memoranda

position provides that there is a

substantive violation of the CAA which

then becomes subject to its enforcement

discretion.

Response: The USEPA acknowledges

that the Bennett memoranda recognize

all periods of excess emissions as

violations of the applicable SIP standard

whereas periods of excess emissions

occurring during start-ups, shutdowns

or malfunctions may be excused under

40 CFR part 63 for NESHAPS. For the

reasons discussed in response to the

previous comment, USEPA believes that

this is a reasonable distinction.

Comment: The USEPA misconstrues

its authority under section 110 of the

CAA. The United States Court of

Appeals for the District of Columbia

Circuit recently affirmed that the

USEPA is not authorized under section

110 to dictate to states the methods to

be used to achieve and maintain

compliance with the National Ambient

Air Quality Standards (NAAQS). Rather

the D.C. Circuit recognized the

relationship between the states and

USEPA as one in which the states

determine how best to regulate emission

sources to achieve and maintain

compliance with the NAAQS while

USEPA is limited to determining

whether each state’s program will

achieve the required air quality

standards.

In promulgating the SSM statutory

provisions and corresponding

regulations, Michigan has exercised its

power to ‘‘determine which sources

would be burdened by regulations and

to what extent.’’ Provided that

attainment and maintenance of the

NAAQS is the result of Michigan’s

overall implementation plan, the

USEPA is not authorized, under section

110, to reject portions of Michigan’s SIP

that differ from the USEPA’s

enforcement policy.

Response: USEPA agrees that the CAA

places primary responsibility upon the

states to formulate requirements it

deems appropriate to protect air quality.

However, the CAA does not grant states

unfettered discretion. Rather, the CAA

and USEPA policy form a framework

which states must work within when

developing SIPs. (Some programs and

requirements are expressly set forth in

the CAA, e.g. inspection and

maintenance, reasonably available

control technology.) Furthermore, the

Act charges USEPA with the

determination as to whether the state’s

choices will result in attainment and

maintenance of the NAAQS. For the

reasons previously discussed, USEPA

believes that the effect of Michigan’s

SSM regulations is to create uncertainty

as to whether this statutory goal can be

accomplished. In addition,

§ 110(a)(2)(A) of the Act requires that

SIP submissions contain enforceable

limitations. Enforceability deficiencies,

i.e., overly broad bypass provisions and

definitions of ‘‘malfunction,’’ are

discussed further below. (See USEPA’s

response below to the comment that

Michigan’s SSM rules are consistent

with the 1983 memorandum from

Kathleen Bennett.)

Comment: Inconsistency with USEPA

policy is not a valid reason for

disapproval of a State Implementation

Plan (SIP) revision. There is no

reference to the Bennett memoranda, or

any other policy, in section 110 of the

CAA. Therefore, it is inappropriate to

base the disapproval of Michigan’s SSM

rules on such policy memoranda.

Statutory authority, and not policy

memoranda, should be the basis for the

disapproval.

Response: As noted previously, it is

appropriate for USEPA to clarify

regulations and statutes with written

policies and guidance documents. In the

context of rulemakings on SIP

submissions, the public has an

opportunity to comment and respond to

USEPA’s policies that interpret the

relevant statutes and regulations.

Through rulemaking actions, such as

this, USEPA can determine whether to

modify its policy or whether it still

stands by its policy interpretation in

light of any public comments. In this

case, USEPA continues to support the

policy established by the Bennet

memoranda for the reasons stated in

those memoranda and in this

rulemaking action.

Comment: EPA’s disapproval of

Michigan’s regulations, based on

internal policy memoranda, is

groundless. The SSM rules are the result

of a publicly conducted work group,

and were promulgated in accordance

with all applicable State laws. The

rationale offered by USEPA is not the

result of a lawfully conducted notice

and comment rulemaking process, nor

does it cite any specific portion of any

rule or statute with which the SSM rules

are inconsistent. The substantive rights
Federal Register / Vol. 63, No. 34 / Friday, February 20, 1998 /Rules and Regulations 8575

of the regulated community are affected

by the enforcement discretion

interpretation contained in the Bennett

memoranda. Therefore, rulemaking is

required in order for the interpretation

contained in the policy memoranda to

be enforceable.

Response: Policy documents generally

interpret the statute and do not establish

binding requirements. Therefore, they

are not subject to notice and comment

rulemaking. As discussed above,

rulemaking such as this provides the

public with an opportunity to comment

and to question USEPA’s policy

interpretations. If a sufficient basis had

been provided for USEPA to revise or

deviate from its policy, the Agency

would do so. However, the comments

submitted have not persuaded the

Agency to change the existing policy,

nor its application with respect to the

Michigan SSM rule.

Comment: The enforcement discretion

approach is insufficient following recent

statutory and program changes. Title V

of the CAA requires that the

Responsible Official certify, under

penalty of imprisonment, all data as

truthful, accurate, and complete and

requires periodic submittal of

certifications by the Responsible Official

detailing the compliance status of each

facility. Thus, the Responsible Official

for each Title V source has a duty to

disclose any noncompliance with any

applicable regulation. In addition, the

1990 Amendments provided enhanced

criminal penalty provisions and revised

the citizen suit provisions, increasing

the likelihood of CAA enforcement

actions. If an owner or operator of a

source has knowledge that a process

during startup or shutdown would

possibly violate an emission limitation

and proceeds to startup or shutdown the

process, that knowledge could satisfy

the intent requirement for a criminal

prosecution. In many cases, compliance

with applicable regulations during

startup, shutdown, or malfunctions is

technically or economically impossible.

The SSM regulations contained in

Michigan’s SIP provide owners and

operators of facilities with the

appropriate protection against

prosecution for startup problems of

older facilities.

The enforcement discretion approach

asks the regulated industry to rely on

the exercise of discretion by both state

and federal agencies. In addition, if such

dual discretion does occur, nothing

prevents citizens from pursuing a civil

action to impose penalties on the source

for the emission violations. Because of

the enhanced federal and state statutes,

the creation of criminal liability, and the

lack of protection from citizen suits, a

reliance on enforcement discretion is

insufficient.

Response: With respect to start-up

and shutdown situations, it is USEPA’s

general policy, as set forth in the

Bennett memoranda, that: ‘‘Startup and

shutdown of process equipment are part

of the normal operation of a source and

should be accounted for in the planning,

design and implementation of operating

procedures for the process and control

equipment. Accordingly, it is reasonable

to expect that careful and prudent

planning and design will eliminate

violations of emission limitations

during such periods.’’ If there are

circumstances where a source cannot

comply with the SIP during start-up,

shutdown or maintenance situations

despite careful and prudent planning

and design, the State should address

these particular problems in

development of (or revision to) the

underlying rules applicable to those

sources and not through overarching

excess emissions provisions. (Any

revision made to the state’s rules to

address these concerns must be

submitted to USEPA as a SIP revision

request.)

USEPA is cognizant of the various

remedies under the Clean Air Act for

SIP violations, including those available

under the criminal suit provisions of

Section 113(c). It should be noted,

however, that no criminal action may be

brought under that section unless a

person knowingly violates the

applicable requirement ‘‘* * * more

than 30 days after having been notified

* * * that such person is violating such

requirement or prohibition* * *.’’

Thus, the scenario envisioned by the

commentor is not realistic, unless

appropriate notice is given and the

violations continue. As discussed

earlier, where there is such a likelihood

of continuing violation, sources should

seek relief through the SIP revision

process.

USEPA also believes that the

commentor’s concern about the

perceived inadequacy of an enforcement

discretion approach is misplaced. The

CAA has long provided for enforcement

of SIP violations. Moreover, the

revisions to enforcement provisions in

1990 were not intended to impact

substantive regulations. Rather they

were included with the recognition that

the CAA has, at times, been difficult to

enforce. USEPA further notes that

reliance on the judicial system and

courts’ equitable discretion provides

further protection.

Comment: Michigan’s SSM provisions

are consistent with the February 15,

1983 memorandum from Kathleen M.

Bennett, Assistant Administrator for

Air, Noise and Radiation to the Regional

Administrators entitled ‘‘Policy on

Excess Emissions During Startup,

Shutdown, Maintenance and

Malfunctions.’’ The SSM rules contain

all of the criteria required to be

considered by the regulator in

determining whether enforcement

action or discretion is warranted.

Response: The criteria referenced

above are to be considered when

determining whether to exercise

enforcement discretion for periods of

excess emissions caused by a

malfunction, not to excuse those

emissions. As discussed previously,

because SIPs protect ambient-based

standards, any emissions above the

allowable may cause or contribute to

violations of the NAAQS, and therefore

cannot be excused. State and federal

agencies (and citizens) need to be able

to seek relief where public health may

be threatened by periods of excess

emissions.

Furthermore, the criteria referenced

above apply only in the case of

malfunctions. They do not apply to

periods of excess emissions caused by

startup, shutdown or maintenance

(unless the excess is attributable to a

malfunction occurring during those

times). Start-up and shutdown of

process equipment are part of the

normal operation of a source and should

be accounted for in the design and

implementation of the operating

procedure for the process and control

equipment. Accordingly, it is reasonable

to expect that, in most cases, careful

planning will eliminate violations of

emission limitations during such

periods.

Moreover, even if USEPA did

determine that the state could excuse

these emissions, there remain issues

which make the rules unapprovable.

The definitions of ‘‘malfunction,’’

contained in 324.5509(1), part 55 of the

Michigan Natural Resources and

Environmental Protection Act and R

336.1113(d), Michigan administrative

code, do not limit malfunctions to

failures that are ‘‘infrequent’’ and ‘‘not

reasonably preventable,’’ and are

therefore too broad. [See e.g. 40 CFR

60.2] Frequent or reasonably

preventable excess emissions would

tend to indicate an underlying problem

with the design, operating procedures or

maintenance of a source and therefore

should not be considered a malfunction.

The State’s bypass provisions in SIP R

336.1913(3)(b) and R 336.1914(4)(b) are

also too broad. USEPA policy regarding

bypass states that ‘‘* * * if effluent

gasses are bypassed which cause an

emission limitation to be exceeded, this

excess need not be treated as a violation
8576 Federal Register / Vol. 63, No. 34 / Friday, February 20, 1998 /Rules and Regulations

if the source can show that the excesses

could not have been prevented through

careful and prudent planning and

design and that bypassing was

unavoidable to prevent loss of life,

personal injury or severe property

damage.’’ [Memorandum dated February

15, 1983, from Kathleen M. Bennett,

Assistant Administrator for Air, Noise

and Radiation entitled ‘‘Policy on

Excess Emissions During Startup,

Shutdown, Maintenance, and

Malfunctions’’]. The USEPA continues

to believe that this is a necessary policy,

and that the bypass provisions

contained in the State’s rule are

inadequate for the reasons stated in that

policy.

In addition, the alternate emission

limitations for startups and shutdowns

in R 336.1914(4)(d) could

(impermissibly) allow relaxations of Act

requirements, including NSR

limitations, New Source Performance

Standards, toxics requirements

(NESHAP, MACT), etc. Finally, the

State SSM regulations provide no

authority for MDEQ to review and

require revisions to a source’s written

emission minimization plan for normal

or usual startups and shutdowns. Such

authority is necessary to ensure that

operating practices for startups and

shutdowns meet good engineering

practice for minimizing emissions,

similar to the authority R 336.1911

currently provides for State review and

revision of written preventative

maintenance and malfunction

abatement plans.

Comment: The USEPA’s position is

not consistent with existing, longstanding regulations, and not consistent

with its own rulemakings in other

state’s SIPs. Unless the USEPA intends

to rescind 40 CFR 63 and other state

SIPS as being inconsistent with the

CAA, and then propose a general rule

consistent with its internal memoranda,

the USEPA’s argument that Michigan’s

SSM rules do not comply with the CAA

is without merit.

Response: As previously discussed,

the difference in approach between the

technology-based NESHAP rules and air

quality-based SIP rules merits the

different treatment for provisions

concerning SSM excess emissions. With

regard to the suggestion that USEPA’s

action on the Michigan submission is

somehow inconsistent with its action(s)

with other state submission, without

additional information on which state(s)

the commentor is referencing, USEPA

cannot reasonably respond to this

comment. However, as noted

previously, USEPA continues to support

the policy established by the Bennett

memoranda for the reasons stated in

those memoranda and in this

rulemaking action. It should

nonetheless be noted that, even if the

commentor had identified such an

inconsistent action, USEPA would not

be precluded from disapproving

Michigan’s SSM submission.

Southwestern Pennsylvania Growth

Alliance v. Browner, 121 F. 3d 106 (3d

Cir. 1997).

Comment: The USEPA does not

identify any deficiencies with Rule 912.

Therefore, Rule 912 should be approved

as part of the SIP.

Response: USEPA acknowledges that

it did not cite any deficiencies for Rule

912 in its notice of proposed

rulemaking. However, USEPA believes

that when Rule 912 was adopted by

Michigan, it was promulgated as an

integral part of the SSM regulations; i.e.,

the protection granted in Rules 913 and

914 is contingent on meeting the

operating, notification and reporting

requirements in Rule 912. In this case,

approving Rule 912 while disapproving

Rules 913 and 914 would result in

establishing operating, notification and

reporting requirements for sources

without granting the protection to them

contemplated by the companion rules.

Under existing case law, USEPA may

not partially approve a state SIP

submission if such action will result in

the approved rules being more stringent

than was intended by the state when

they were adopted. See Bethlehem Steel

Corp. v. Gorsuch, 742 F. 2d 1028 (7th

Cor. 1984); Indiana and Michigan Elec.

Co. v. U.S.E.P.A., 733 F. 2d 489 (7th Cir.

1984).

III. Final Rulemaking Action

To determine the approvability of a

rule, USEPA must evaluate the rule for

consistency with the requirements of

the Act, USEPA regulations and the

USEPA’s interpretation of these

requirements as expressed in USEPA

policy guidance documents. While

USEPA understands the concerns raised

by the commentors, rules 913 and 914

remain inconsistent with the Act and

the applicable policies by which USEPA

must evaluate submittals. Therefore, in

today’s action, USEPA is finalizing the

disapproval proposed on March 20,

1997.

Nothing in this action should be

construed as permitting, allowing or

establishing a precedent for any future

request for revision to any SIP. The EPA

shall consider each request for revision

to the SIP in light of specific technical,

economic, and environmental factors

and in relation to relevant statutory and

regulatory requirements.

IV. Administrative Requirements

A. Executive Order 12866

The Office of Management and Budget

has exempted this regulatory action

from Executive Order 12866 review.

B. Regulatory Flexibility

Under the Regulatory Flexibility Act,

5 U.S.C. § 600 et seq., EPA must prepare

a regulatory flexibility analysis

assessing the impact of any proposed or

final rule on small entities (5 U.S.C.

§§ 603 and 604). Alternatively, EPA may

certify that the rule will not have a

significant impact on a substantial

number of small entities. Small entities

include small businesses, small not-forprofit enterprises, and government

entities with jurisdiction over

populations of less than 50,000.

USEPA’s disapproval of the State

request under Section 110 and

subchapter I, part D of the Clean Air Act

does not affect any existing

requirements applicable to small

entities. Any pre-existing Federal

requirements remain in place after this

disapproval. Federal disapproval of the

state submittal does not affect its state

enforceability. Moreover, USEPA’s

disapproval of the submittal does not

impose any new Federal requirements.

Therefore, USEPA certifies that this

disapproval action does not have a

significant impact on a substantial

number of small entities because it does

not remove existing requirements and

impose any new Federal requirements.

C. Unfunded Mandates

Under section 202 of the Unfunded

Mandates Reform Act of 1995, signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated costs to State,

local, or tribal governments in the

aggregate; or to private sector, of $100

million or more. Under section 205,

EPA must select the most cost-effective

and least burdensome alternative that

achieves the objectives of the rule and

is consistent with statutory

requirements. Section 203 requires EPA

to establish a plan for informing and

advising any small governments that

may be significantly or uniquely

impacted by the rule.

The EPA has determined that the

disapproval action promulgated does

not include a Federal mandate that may

result in estimated costs of $100 million

or more to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal disapproval

action imposes no new requirements.

Accordingly, no additional costs to
Federal Register / Vol. 63, No. 34 / Friday, February 20, 1998 /Rules and Regulations 8577

State, local, or tribal governments, or to

the private sector, result. No new

Federal requirements are imposed.

Accordingly, no additional costs to

state, local, or tribal governments, or the

private sector, result from this action.

D. Small Business Regulatory

Enforcement Fairness 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. USEPA 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 the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

E. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by April 21, 1998.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. See section

307(b)(2).

V. List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Intergovernmental

relations, Reporting and recordkeeping

requirements.

Authority: 42 U.S.C. § 7401 et seq.

Dated: January 30, 1998.

David A. Ullrich,

Acting Regional Administrator, Region V.

[FR Doc. 98–4003 Filed 2–19–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 157

[OPP–250125; FRL–5764–3]

Termite Insecticide Bait Stations;

Exemption From Adult Portion of

Child-Resistant Testing Specifications

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Exemption Order.

SUMMARY: This Order grants a 5–year

exemption from the senior-adult test

and younger-adult test effectiveness

specifications, described in 16 CFR

1700.15(b)(2) (Ease of adult opening),

for prefilled, nonrefillable termite

insecticide bait stations not designed or

intended to be opened or activated in a

manner that exposes the contents to

human contact. Products qualifying for

this exemption must still fully comply

with all other child-resistant packaging

(CRP) effectiveness, compatibility, and

durability standards, as well as all other

requirements of 40 CFR part 157. CRP

certification for products relying on this

exemption must specify that the

package does not comply with the

senior and younger adult effectiveness

specifications per this exemption. This

exemption was requested by Griffin

Corporation and FMC APG Specialty

Products, who suggested that a package

that does not require opening or

activation to put into use should not

require adult ease of opening testing.

DATES: This exemption Order becomes

effective on February 20, 1998 and

expires on February 20, 2003.

FOR FURTHER INFORMATION CONTACT:

Rosalind L. Gross, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460,

Telephone number: (703) 308–7368, email: gross.rosalind@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Griffin

Corporation and FMC APG Specialty

Products requested an exemption from

the senior-adult test and younger-adult

test effectiveness specifications,

described in 16 CFR 1700.15(b)(2) (Ease

of adult opening), for prefilled,

nonrefillable termite insecticide bait

stations that are not designed or

intended to be opened or activated in a

manner that exposes the contents to

human contact.

I. Background

FIFRA 25(c)(3) requires EPA’s CRP

standards to be consistent with those of

the Consumer Product Safety

Commission (CPSC). EPA’s CRP

regulations at 40 CFR 157.32 require

that CRP for pesticides meet the CPSC

packaging standards (effectiveness

specifications) and testing procedures

set forth in 16 CFR 1700.15(b) and

1700.20. The CPSC Poison Prevention

Packaging Standards in 16 CFR

1700.15(b) provide that CRP, when

tested by the method described in 16

CFR 1700.20, shall meet certain childresistant test, senior-adult test, and

younger-adult test effectiveness

specifications. In 16 CFR 1700.15(b)(2),

the senior-adult test and younger-adult

test effectiveness specifications are

discussed with reference to the senioradult panel test of 16 CFR 1700.20(a)(3)

and the younger-adult panel test of 16

CFR 1700.20(a)(4), respectively.

The EPA CRP regulations provide that

exemptions from compliance may be

requested on a case-by-case basis for

specific products based on technical

factors (40 CFR 157.24(b)(3)). The

regulations further provide that any

such exemption decision will be

published in the Federal Register, will

be for a specified length of time, and

will be applicable to any product with

substantially similar composition and

intended uses.

II. Requested Grounds for Exemption

As support for the exemption request,

Griffin Corporation and FMC APG

Specialty Products advanced the

following arguments:

The purpose of adult testing is to

ensure that the package is not difficult

for adults to use properly. If CRP is

difficult for adults to open, the concern

arises that the package may be disabled

or left unsecured to eliminate the

difficulty of reopening it. Under such

circumstances the contents would be

accessible to children. In the case of

prefilled, nonrefillable termite

insecticide bait stations not designed or

intended to be opened, this concern

does not arise. There is no risk that an

adult will disable or fail to resecure a

difficult to open package, because the

packages need not be opened or

activated in order to function properly.

As there is no concern that an adult will

disable or fail to resecure such a

package, there is also no concern that

the contents of disabled or unsecured

packages will be accessible to children.

Instead, from a child safety standpoint,

the only relevant question regarding

such packages is whether they can

prevent a child from gaining access to

the bait.

III. Agency Determination

The Agency has considered the

Griffin Corporation and FMC APG

Specialty Products exemption request