Attachment E 

Class Determination Regarding Confidentiality of 6(a)(2) Information 

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[Federal Register: December 15, 1999 (Volume 64, Number 240)] 

[Notices] 

[Page 70019-70020] 

From the Federal Register Online via GPO Access [wais.access.gpo.gov] 

[DOCID:fr15de99-56] 

ENVIRONMENTAL PROTECTION AGENCY 

[OPP-100152; FRL-6392-4] 

Disclosure of Information Obtained Regarding Unreasonable Adverse 

Effects of Pesticides on the Environment; Class Determination 

AGENCY : Environmental Protection Agency (EPA) . 

ACTION: Notice of Availability. 

SUMMARY: This document announces a class determination by EPA that 

safety and efficacy information submitted under section 6(a) (2) of the 

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) is not 

entitled to confidential treatment. This determination will enable EPA 

offices to respond more quickly and efficiently to requests for 

information submitted under section 6(a) (2). 

DATES: The class determination took effect upon its issuance, on 

September 28, 1999. 

FOR FURTHER INFORMATION CONTACT: For technical information contact: 

Kathryn S. Bouve, 6(a) (2) Officer, Office of Pesticide Programs 

(7502C), U.S. Environmental Protection Agency, 401 M St., SW., 

Washington, DC 20460. Office location: Information Services Branch, CM 

#2, 2d floor, 1921 Jefferson Davis Hwy., Arlington, VA. Telephone: 

(703) 305-5032; e-mail: bouve.kate@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

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EPA: Federal Register: AGENCY: Environmental Protection Agency (EPA). 

You may be potentially affected by this action if you are a 

pesticide registrant, i.e., any person who holds, or ever held, a 

registration for a pesticide product issued under section 3 or section 

24(c) of FIFRA. Potentially affected categories and entities may 

include but are not limited to: 

Categories 

Industry ............................ . 

NAICS 

Examples of Potentially 

Affected Entities 

32532 Pesticide manufacturing 

This listing is not exhaustive, but is a guide to entities likely 

to be regulated by this action. The North American Industrial 

Classification System (NAICS) codes will assist you in determining 

whether this action applies to you. If you have questions regarding the 

applicability of this action to a particular entity, consult the person 

listed in the FOR FURTHER INFORMATION CONTACT section. 

II. How Can I Get Additional Information, Including Copies of this 

Document and Other Related Documents? 

1. Electronically. You may obtain copies of this document and 

certain other available support documents from the EPA Internet Home 

Page at http://www.epa.gov/. On the Home Page select ''Laws and 

Regulations'' and then look up the entry for this document under the 

''Federal Register- Environmental Documents.'' You can also go directly 

to the ''Federal Register'' listings at http://www.epa.gov/homepage/ 

fedrgstr/. 

2. In person. The Agency has established an official record for 

this action under docket control number OPP-100152. The official record 

consists of the documents specifically referenced in this action and 

other information related to this action, including any information 

claimed as confidential business information (CBI). This official 

record includes the documents that are physically located in the 

docket, as well as the documents that are referenced in those 

documents. The public version of the official record does not include 

any information claimed as CBI. The public version of the official 

record, which includes printed, paper versions of any electronic 

comments submitted during an applicable comment period, is available 

for inspection in the Public Information and Records Integrity Branch 

(PIRIE), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, 

Arlington, VA, from 8:30a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The PIRIE telephone number is 703-305-5805. 

3. Fax on demand. Using a faxphone call (202) 401-0527 and select 

item 6045 for a copy of Class Determination 1-99. 

III. What Is the Determination Announced in this Document? 

On September 28, 1999, EPA issued Class Determination 1-99. In the 

Class Determination the Agency determined that safety and efficacy 

information submitted pursuant to FIFRA section 6(a) (2) is not entitled 

to confidential treatment, and that if such information is submitted to 

EPA under a claim of business confidentiality it may nonetheless be 

disclosed to the public, subject to the provisions of FIFRA section 

10(g). This determination covers information both currently in the 

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Agency's possession and submitted in the future. 

A. What is Section 6(a) (2) of FIFRA? 

On September 19, 1997, EPA published in the Federal Register (62 FR 

49370) (FRL-5739-1) a rule implementing section 6(a) (2) of FIFRA. This 

rule is codified at 40 CFR part 159, subpart D. As explained more fully 

in the 1997 Federal Register rule, under FIFRA section 6(a) (2) 

pesticide registrants are required to submit to EPA reports of adverse 

effects related to product usage, product defects, or lack of product 

efficacy, as well as new information derived from scientific studies 

which pertain to unreasonable adverse effects of pesticides on the 

environment. 

B. What is Safety and Efficacy Information? 

Section 10(d) (1) of FIFRA requires disclosure to the public of all 

information regarding the effects of any registered or previously 

registered pesticide on any organism or the behavior of any such 

pesticide in the environment (subject to certain exceptions, discussed 

in the class determination). EPA has used the term ''safety and 

efficacy information.' ' as a label for the information required to be 

disclosed by section 10(d) (1). Information submitted under section 

6(a) (2) is largely safety and efficacy information. 

C. What is Section 10(g) of FIFRA? 

Section 10(g) protects the proprietary rights of pesticide 

registrants and applicants in data submitted to support applications 

for pesticide registration, by limiting disclosure of such data to 

persons who affirm that they are not, and will not deliver the 

information to, a business engaged in the production, sale or 

distribution of pesticide products in countries other than the United 

States (except when the data submitter has consented to such 

disclosure). In Class Determination 3-85, Disclosure of Reviews of 

Pesticide Test Data (50 FR 48833, November 27, 1985), EPA announced its 

interpretation that section 10(g) applies to information which consists 

of a complete unpublished report of a study, test, or experiment 

submitted to EPA by an applicant or registrant under FIFRA, or which 

consists of excerpts or restatements of any such report which reveal 

the full methodology and complete results of the study, test, or 

experiment, and all explanatory information necessary to understand the 

methodology or interpret the results, and that section 10(g) does not 

apply to information of a more summary nature. 

D. Why has EPA Issued the Class Determination and Published Notice in 

the Federal Register? 

Under EPA confidentiality regulations at 40 CFR 2.207, the Agency 

may issue determinations regarding the application of the 

confidentiality regulations to an entire class, when such a 

determination serves a useful purpose. In this case, a class 

determination promoting expeditious processing of section 6(a) (2) 

information subject to confidentiality claims will assist the Agency in 

responding to requests for this information and in making the 

information more widely available. Because under section 2.207 one of 

the purposes of issuing a class determination is to make known the 

Agency's position regarding the manner in which information within the 

class will be treated, EPA is publishing notice of the class 

determination in the Federal Register. 

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List of Subjects 

Environmental protection. 

Dated: December 7, 1999. 

Marcia E. Mulkey, 

Director, Office of Pesticide Programs. 

[FR Doc. 99-32185 Filed 12-14-99; 8:45 am] 

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