[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Rules and Regulations]
[Pages 25168-25169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12151]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 156

[OPPTS-00238; FRL-5785-2]


Labeling Requirements for Pesticides; Respirator Compliance 
Policy Statement

Agency: Environmental Protection Agency (EPA).

Action: Policy statement.

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Summary: The National Institute for Occupational Safety and Health 
(NIOSH has developed changes to the regulations at 42 CFR part 84 that 
set forth certification standards for non-powered air-purifying 
particulate respirators. EPA has determined that all 42 CFR part 84 
respirators meet or exceed all 30 CFR part 11 respirator (hereinafter 
part 11 and part 84 respirators) requirements, and that respirators 
certified under part 84 will be considered the equivalent of a 
respirator certified under part 11. EPA will allow pesticide handlers 
to use either part 11 or part 84 respirators to satisfy non-powered, 
air-purifying respirator requirements for pesticide applications. The 
Agency will publish an amendment to 40 CFR 156.212 to reflect the NIOSH 
changes in particulate respirator designations and a Pesticide 
Registration (PR) Notice to direct registrants on how to modify product 
labels.

EFFECTIVE DATE: This document is effective April 24, 1998.

FOR FURTHER INFORMATION CONTACT: Yvette Hellyer, Toxics and Pesticides 
Enforcement Division (2245A), Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460, Telephone: 202-564-4033, E-mail: 
<a href="/cdn-cgi/l/email-protection#1d7578717164786f33646b786969785d786d7c337a726b"><span class="__cf_email__" data-cfemail="7e161b1212071b0c5007081b0a0a1b3e1b0e1f50191108">[email protected]</span></a>; or, Judy Smith, Field and External Affairs 
Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone: 
703-305-5621, E-mail: <a href="/cdn-cgi/l/email-protection#e99a84809d81c7839c8d90a98c9988c78e869f"><span class="__cf_email__" data-cfemail="6c1f0105180442061908152c091c0d420b031a">[email protected]</span></a>.

I. Background

    On July 10, 1995, NIOSH modified its existing regulation, 30 CFR 
part 11, and changed the certification standards for non-powered, air-
purifying particulate filters. The NIOSH change was made to update and 
upgrade certification tests developed in the 1930's by the Bureau of 
Mines. The new regulation, 42 CFR part 84, requires that respirators 
certified under 42 CFR part 84 undergo a different test using a more 
penetrating particle size than in the past and takes into account the 
presence of oil in the contaminant.
    The NIOSH certification changes require that manufacture and 
certification of part 11 respirators cease on July 10, 1998; however, 
distributors and other respiratory protection product sellers can 
continue to sell their existing supplies. In terms of additional NIOSH 
certification changes, canister type respirators that are certified for 
use with pesticides will not be made after July 10, 1998. Combination 
respirators, those certified for use for paints and pesticides, will 
also not be made after July 10, 1998. Certification requirements for 
all other respirator types, such as powered air-purifying respirators 
(PAPR) were transferred from 30 CFR part 11 to 42 CFR part 84 without 
change.
    To minimize the impact of the manufacturing transition from part 11 
to part 84 respirators, all particulate respirator manufacturers now 
sell part 84 respirators and are now phasing out part 11 respirators. 
Manufacturers cannot precisely estimate when the existing supply of 
part 11 respirators will be exhausted, but a general consensus in the 
industry estimates this will occur in 3 years.

II. NIOSH Certification Changes and EPA Determination

    NIOSH certifies part 84 respirators using a more rigorous testing 
method, and EPA has determined that part 84 respirators provide at 
least as much protection to pesticide handlers, applicators, and users 
as part 11 respirators. As a result, a pesticide user may substitute a 
part 84 non-powered, air-purifying particulate respirator for a part 11 
respirator even though the pesticide product label requires use of a 
part 11 respirator, and EPA will not initiate an enforcement action for 
misuse of the product. This substitution will only be allowed until the 
pesticide product label change from part 11 to part 84 respirator 
requirements have been completed. Following the pesticide product label 
change to part 84 respirators, this substitution will no longer apply.

III. Information for Registrants

    EPA plans to require label changes for pesticide products because 
of the NIOSH certification changes, and this will impact pesticide 
registrants. EPA will issue a Pesticide Registration (PR) Notice that 
will call for registrants to add 42 CFR part 84 language to the 
existing respirator language (30 CFR part 11) on current product 
labels. The Agency also intends to amend 40 CFR 156.212 to incorporate 
the new NIOSH designations for dust/mist filtering respirators and 
organic vapor-removing cartridge respirators. The revised rule will 
affect the pesticide product labels with part 11 respirator 
requirements, i.e., those requiring either a Mine Safety and Health 
Administration (MSHA)/NIOSH-approved dust filtering respirator (known 
as a TC-21C) or a MSHA/NIOSH-approved organic vapor removing cartridge 
respirator with a prefilter approved for pesticides (MSHA/NIOSH 
approval number prefix TC-23C), and will require the addition of 42 CFR 
part 84 language to the product label.

IV. Information for Pesticide Applicators

    Given that both part 11 or part 84 respirators meet respiratory 
protection requirements for pesticide products, the Agency is confident 
that allowing pesticide handlers to use part 84 respirators will assure 
applicators of an adequate supply of acceptable respirators.

V. Compliance and Enforcement

    The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
section 12(a)(2)(G) states that it is unlawful ``to use any registered 
pesticide in a manner inconsistent with its labeling.'' EPA has 
determined that both part 11 or part 84 respirators will provide 
adequate protection for users. Therefore, EPA considers the part 84 
respirator to be the equivalent of part 11 respirators for the purpose 
of complying with the label of

[[Page 25169]]

pesticide products for application-related activities. EPA will not 
consider the substitution of a part 84 for a part 11 respirator a 
misuse. Furthermore, EPA requires pesticide handlers, applicators, and 
users to comply with all the requirements of 40 CFR 170.240 regardless 
of whether the respirator is part 11 or part 84.

VI. Conclusion

    EPA recognizes that part 84 respirators offer applicators 
equivalent levels of respiratory protection, and the supply of part 11 
respirators will be exhausted in the next 1 to 3 years. EPA also 
recognizes that pesticide handlers must have an adequate supply of 
respirators that provide adequate respiratory protection during 
application. Effective immediately, EPA will not find misuse violations 
against applicators who use either part 11 or part 84 respirators to 
satisfy existing product labels that require part 11 respirators.

VII. Regulatory Assessment Requirements

    This action does not impose any requirements. As such, this action 
does not require review by the Office of Management and Budget (OMB) 
under Executive Order 12866, entitled Regulatory Planning and Review 
(58 FR 51735, October 4, 1993), the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). For the same reason, it does not require any action 
under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. 
L. 104-4), Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994). In addition, since this 
type of action does not require any proposal, no action is needed under 
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, does not 
apply because this action is not a rule, as that term is defined in 5 
U.S.C. 804(3).

List of Subjects in Part 156

    Environmental protection, Labeling, Occupational safety and health, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: April 24, 1998.
Jesse Baskerville,
Director, Toxics and Pesticides Enforcement Division, Office of 
Regulatory Enforcement and Policy Assurance.

[FR Doc. 98-12151 Filed 5-6-98; 8:45 am]
BILLING CODE 6560-50-F


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