Federal Insecticide, Fungicide,
and Rodenticide Act
Compliance/Enforcement
Guidance Manual
Policy Compendium
U.S. Environmental Protection Agency

Washington DC  20460



Issued by


Pesticides and Toxic Substances
Compliance Monitoring Staff

and

Office of Enforcement  and Compliance Monitoring

-------
•''x'-
                   STATES ENVIRONMENTAL PROTECTION AGENCY
                          MAR   5 1984
 MEMORANDUM
 SUBJECT:
 FROM!
 TO:
FIFRA and TSCA Compliance/Enforcement
Guidance Manual Policy Compendiums

A. E. Conroy II, Director
Compliance Monitoring Staff
Office of Pesticides and Toxic Substances

Glenn Unterberger, Directpr
Office of Legal and Enforcement.^ Pol icy
Office of Enforcement and Compliance Monitoring

Addressees
      As part  of  our  effort  to produce guidance manuals for
 personnel  involved  in  case  development activities for the
 United States Environmental Protection Agency, we are trans-
 mitting to you the Compendium of Operative Enforcement Policies
 for the Federal  Insecticide,  Fungicide, and Rodenticide Act
 (FIFRA) and the  Toxic  Substances Control Act (TSCA).  The
 Compendiums not  only identify those FIFRA and TSCA compliance/
 .MiCor ;e"ien i. g'; i.J.: .ic^s  and policies  i.hat arc- <:TCJ eni-. ly in effect.,
 but they also provide  a  mechanism for organizing such memoranda.

      We intend to update the Compendiums periodically and
 we welcome comments  on them or on policy issues that might
 be addressed  in  the  future.  Questions or comments on the
 contents of the  Compendiums can be  addressed to Ted Firetog
 (FTS 426-7503) or Barbara Paul (FTS 382-7826).

-------
                             -2-
Addressees:

Regional Counsels
Associate Enforcement Counsel for Pesticides
  and Toxic Substances
Director, Office of Criminal Investigations
Director, NEIC
Director, Air Management Division - Region I
Director, Air and Waste Management Division - Regions II,
  IV, VI, VII, VIII, and X
Director, Environmental Services Division - Region III
Director, Waste Management Division - Region V
Director, Toxics and Waste Management Division - Region IX
Attachments
cc:  Assistant Administrator for Pesticides
       and Toxic Substances
     Assistant Administrator for Enforcement
       and Compliance Monitoring
     General Counsel
     Senior Enforcement Counsel

-------



-------
Table of Contents
This Compendium contains  the following FIFKA compliance/enforcement-related
policies and guidances  currently in effect.

Any questions or comments concerning these documents  should be addressed
to:

     Director of Compliance Monitoring Staff
     Office of Pesticides and Toxic Substances (EN-342)
     U.S. Environmental Protection Agency
     401 M Street,  S.W.
     Washington,  D.C.   20460
TITLE OF DOCUMENT
    DATE OF  DOCUMENT
                            Technical Guidance

Institution of Pesticides Enforcement Policy
Statements (PEPS)  [40  Fed. Reg. 19,526]

"Water Purifiers"

"Guidance for Enforcement Actions Involving
Water Purifier Products"

PEPS #3:  Certain  Enforcement Policies to be
Followed During the  Phased Implementation of
FIFRA Section 3 [41  Fed. Reg. 13,984]

PEPS #4:  Preventive Pest Control Treatments
in the Absence of  Target Pests  [41 Fed. Reg.
28,005]

Pest Control Devices and Device Producers
[41 Fed. Reg. 51,065]
            5/5/75


            8/30/75

            3/15/76


            4/1/76



            7/8/76



            11/19/76
FIFKA Compliance/Enforcement
Guidance Hanual  1984

-------
Policy Compendium
    Table of  Concents
"Enforcement Priorities in Structural Pest
Control

     a)  Establishment Inspections of Pest
         Control Firms

     b)  Pesticides Use Inspections

     c)  Prosecutorial Discretion in Pesticide
         Use Enforcement"

"Enforcement Policy Applicable to Bulk
Shipments of Pesticides"

"Federal Pesticide Act of 1978"

Notice of Rescission of Pesticide Enforcement
Policy Statements (PEPS) Nos. 1,2,5,6,7  [44
Fed. Reg. 33,151]

Enforcement Policy R^g<»i.\Hng Failures to
Report Information Under §6(a)(2) of FIFRA  [44
Fed. Reg. 40,716]

Agency Interpretation of Requirement Imposed
on Registrants by §6(a)(2) of FIFRA  [43 Fed.
Reg. 37,611]

Suspended and Cancelled Pesticides '(Booklet)

Pesticide Use and Production by Veterinarians;
Statement of Policy on the Applicability of
the Federal Insecticide, Fungicide, and
Rodenticide Act to Veterinarians [44 Fed.
Reg. 62,940]

"Enforcement Actions Concerning Nonhazardous
Pesticides Devices"

"Federal Facilities Compliance"

Statement of Policy on the Labeling
Requirements for Exported Pesticides, Devices,
and Pesticide Active Ingredients and the
Procedures for Exporting Unregistered
Pesticides [45 Fed. Reg. 50,274]

"Request Procedures for Pesticide Samples and
Followup on Pesticide Complaints"

"Enforcement Facts and Strategy; Compliance
Monitoring Procedures; Water Purification
Devices"
             1/24/77
             7/11/77


             8/22/78

             6/8/79



             7/12/79



             8/23/78



10/79 (2nd Revision)

             11/1/79
             12/19/79


             1/16/80

             7/28/80
             7/30/80


             10/80
FIFRA Compliance/Enforcement
 Guidance Manual  1984
ii

-------
Policy Compendium
                Table of Contents
"Routine Use of SEC '10-K' Statements in TSCA
and FIFRA Civil Penalty Actions"

"Regulation of Public Health Related
Disinfectant Products"

Pesticide Registration, Reregistration, and
Classification Procedure; Clarification of
Policy Issues on Special Packaging [46 Fed.
Reg. 51,104]

"Strategy for the Enforcement of the
Child-Resistant Packaging Regulation Under
FIFRA"

"General Compliance Strategy for Products
Subject to the FIFRA Label Improvement
Program"
                         10/17/80


                         '12/17/80


                         3/3/81




                         6/8/81



                         4/21/83
                           State Related Guidance

"Primary Use Enforcement Responsibility"

"Review of State Certification Plans Pursuant
to FIFRA Section 26"

"Clarification of Primary Use Enforcement
Responsibility Guidance"

"Appropriate Documents to be Presented by
State Inspectors Conducting Pesticide Use
Inspections in States Having Primacy"

Federal Insecticide, Fungicide, and
Rodenticide Act, State Primary Enforcement
Responsibilities [48 Fed. Reg. 404]

"Final FY84 Cooperative Agreement Program
Guidance"
                         1/4/79

                         3/14/79


                         3/4/80


                         12/18/80



                         1/5/83



                         4/21/83
               Cancellation-Suspension Enforcement Strategies
Aldrin Dieldrin

"Continuing State Registration of Products
Containing Aldrin and Dieldrin for Which Uses
Have Been Suspended"
                         1/10/75
FIFRA Compliance/Enforcement
iii
Guidance Manual 1984

-------
Policy Compendium
                Table of Contents
Chlordane-Heptachlor

"Enforcement of Administrator's Decision and
Order Suspending Most Uses of Heptachlor and
Chlordane"

"Clarification of Heptachlor/Chlordane
Suspension Order"

"Status Report on Heptachlor/Chlordane
Suspension"

"Heptachlor/Chlordane Suspension Order
Enforcement Strategy"

"Heptachlor/Chlordane Suspension Order
Enforcement Strategy—CORN USE"

"Continued Enforcement of Suspension of
Registration for Certain Products Containing
Heptachlor and Chlordane"
                         1/15/76



                         1/22/76


                         2/19/76


                         3/23/76


                         8/27/76


                         11/23/76
Mercury

"Conclusion of Mercury Cancellation Proceeding"

"Enforcement of Mercury Settlement"
                         10/28/76

                         1/6/77
2,4,5-T and Silvex

"Enforcement of Administrator's Emergency
Orders Suspending 2,4,5-T and Silvex
Registrations"

"Further Guidance Concerning Enforcement of the
Administrator's Emergency Orders Suspending
2,4,5-T and Silvex Registrations"

"Further Guidance on the Cancellation and
Suspension of 2,4,5-T and Silvex"
                         3/7/79
                         4/5/79
                         8/20/79
Other

"DBCP Suspension Order Enforcement Strategy'

"General Compliance Strategy for Products
Suspended Under §3(c)(2)(B) of FIFRA"

"Toxaphene Cancellation Compliance"
                         11/7/79

                         7/2/82


                         1/1/83
FIFRA Compliance/Enforcement
iv
Guidance Manual 1984

-------
Policy Compendium    	Table of Contents


                          FIFRA Program Compendium


FIFRA Compliance Program Policy Compendium

Compendium Index:


Title	     Policy Number

Use Recommendations                                                2.1
Labeling of Outer Containers              ^                         2.2
Shipment Prior to Registration                                     3.1
Distributor Registrations                                          3.2
Fumigation of Truck  Vans on Flatbed Rail  Cars                      3.3
Custom Blenders                                                    3.4
Production of Pesticides for Personal Use                         3.5
Contract Manufacturing                                           \  3.6
Written Examinations for Private Applicators                       4.1
Custom Blenders                                                    7.1
Release of Pesticide Production Data                               10.1
Using Registered or  Experimental Use Permit Pesticide in
  a Manner Not Included on the Label or Permit                     12.1
Closed Application Systems - Updated                               12.2
Authority for Use Inspections                                      12.3
Making Restricted Use Pesticides Available to Persons
  Without Pesticide  Applicator Certification                       12.4
Pesticide Processing in Foreign-Trade Zones                        17.1
Waiver of Notice of  Arrival Requirements                           17.2
Special Local Needs  Labeling                                       24.1
Child-Resistant Packaging                                          25.1
Transfer of Use Enforcement Primacy to the States                  26. 1
Referral of State Misuse Cases to EPA                              26.2


       Additional Sources of FIFRA Compliance Enforcement Information
General Enforcement Policy Compendium

GM-1     "Visitor's Releases and Hold Harmless                      11/8/72
         Agreements as a Condition to Entry to EPA
         Employees on Industrial Facilities"

QA-2     "Professional Obligations of Government                    4/19/76
         Attorneys"

GM-3     "Memorandum of Understanding Between the                   6/15/77
         Department of Justice and the Environmental
         Protection Agency"

GM-4     "'Ex Parte' Contacts in EPA Rulemaking"                    8/4/77
FIFRA Compliance/Enforcement              v            Guidance Manual  1984

-------
Policy Compendium
GM-5 "Conduct of Inspections After the Barlow's
Decision"
GM-6 "Contacts with Defendants and Potential
Defendants in Enforcement Litigation"
GM-7 "'Ex Parte' Rules Covering Communication Which
Table of Contents
A/11/79
10/7/81
12/10/81
         are the Subject of Formal Adjudicatory
         Hearings"

CM-8     "Quantico Guidelines for Participation
         Litigation"

GM-9     "Agency Guidelines for Participation in Grand
         Jury Investigations"

GM-10    "Reorganization of the Office of Regional
         Counsel (Includes Administrator's Memorandum
         of September 15, 1981)"

GM-11    "Coordination of Policy Development and Review"

GM-12    "General Operating Procedures for EPA's Civil
         Enforcement Program"

GM-13    "Case Referrals for Civil Litigation"

GM-14    "Criminal Enforcement Priorities for the
         Environmental Protection Agency"

GM-15    "General Operating Procedures for the Criminal
         Enforcement Program"

GM-16    "Regional Counsel Reporting Relationship"

GM-17    "Guidance for Drafting Judicial Consent Decrees'

GM-18    "Implementation of Direct Referrals for Civil
         Cases"

GM-19    "Consent Decree Tracking Guidance"

GM-20    "Guidance on Evidence Audit of Case Files"
                         4/8/82


                         4/30/82


                         5/7/82



                         6/23/82

                         7/6/82


                         9/7/82

                         10/12/82


                         10/27/82


                         8/3/83

                         10/19/83

                         11/18/83


                         12/16/83

                         12/30/83
Penalty Policies (These may be found in the
Appendix 4 of FIFRA Compliance/Enforcement
Guidance Manual.)

Guidelines for Assessing Civil Penalties Under
Section 14(a) and Citation Charges for
Violation of FIFRA

Memorandum (22 Apr 1975)—Interim Deviation
from Civil Penalty Assessment Schedule
FIFRA Compliance/Enforcement
vi
Guidance Manual 1984

-------
Policy Compendium	         	Table of Contents
Memorandum (11 Jun 1981)—FIFRA Enforcement
Policy Interim Penalty Guidelines
Miscellaneous Sources  (These sources are not contained in this Compendium
                       but may be obtained from Headquarters.)

EPA Delegations of Authority Manual

EPA Manual of Pesticide Misuse Review
Committee Policy, Procedures, Cases, and
Advisory Opinions

EPA Security Manual

Multi-Media Compliance Audit Inspections
Procedures

NEIC Policies and Procedures Manual
(Multi-Media)

Notices of Judgment

Office of Pesticides Programs Policy and
Criteria Notice Manual

Pesticides Inspection Manual

SFIREG Charter
FIFRA Compliance/EnforcementviiGuidance Manual 1984

-------

-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF ENFORCEMENT
         OFFICE OF GENERAL ENFORCEMENT
         PESTICIDES ENFORCEMENT DIVISION
             INSTITUTION OF  PESTICIDE
         ENFORCEMENT POLICY STATEMENTS
         Reprinted from the Federal Register of May 5,1975
                    (40 FR 19526)

-------
   Institution of Pesticide Enforcement
           Policy Statements

  I. 1972 Amendment* to the Federal
insecticide, fungicide, and Rodenticide
Act. On October 21,  1972, the Federal
Environmental Pesticide Control Act of
1972  (Pub. L. 92-516;  86 Stat. 973; 7
U.S.C. 136 et seq.) was signed by the
President. This legislation amended the
Federal   Insecticide,   Fungicide,   and
Rodenticide  Act of 1947 (61 Stat. 163
(1947);   amended  at  78  Stat.  190
(1964); 7 U.S.C. 135  a-k; (hereinafter
referred to  as FIFRA)).
  These amendment: expanded the reg-
ulatory scope of pesticide control.  They
contained r.ew  substantive provisions
regarding  pesticide  registration,  and
the registration of products sold only
in intrastate commerce. They extended
regulatory jurisdiction  to  provide  a
means to regulate the application or
other use of pesticides. Since the enact-
ment  of  the  lit"2  amendments, the
Agency has  issued regulations imple-
menting many of the new substantive
provisions of the Act.
  The 1972 amendments also made addi-
tional  enforcement tools available to
tht Agency. These inciude the authority
to assess civil money  penalties, to  issue
civil penalty  warning citations, and to
issue stop sale orders and stop use or-
ders. \S'here necessary,  the Agency has
published rules  of practice  and  other
enforcement  guidelines implementing
the new  enforcement  powers  author-
ized in FIFRA.
  While pesticide enforcement activities
have been conducted  for some  time by
EPA  and its predecessor agencies, the
Agency feels that there is a need  to in-
form  the  pesticide  chemicals  industry,
the pest control industry, and  the gen-
eral public regarding the pesticide en-
forcement policies of  the Agency, par-
ticularly those which  have arisen out of
the  implementation   of   FIFRA  as
amended. Publication of these  policy
statements will increase  the  predicta-
bility  of  Agency enforcement actions,
estaolish  enforcement  precedent  and
will focus analysis within the Agency
upon those  questions regarding pesti-
cide application or other use which are
of general importance. It is anticipated
that the  further dissemination of the
Agency's enforcement policies will  re-
sult in additional compliance with the
law by all  segments of the pest con-
trol industry and by the general public.
  II.  Scope of  Pciticide  Enforcement
Policy Statement (PEPS). The Agency
hereby announces  the  initiation  of  a
series of Pesticide Enforcement Policy
Statements  (PEPS). These PEPS are
designed to  inform  those engaged in
the formulation, distribution,  sale, ap-
plication or other  use of  pesticides, as
well as  interested segments of the gen-
eral public, of the policies  adopted by
the Agency in the exercise of  its prose-
cutorial discretion in  the  enforcement
of FIFRA as amended.  PEPS will be
issued periodically by, and at the discre-
tion of, EPA's Office  of  Enforcement.
The  Agency  distinguishes  between
statements  which  define  the  Agency's
regulatory jurisdiction and statements
which report  the Agency's  exercise of
prosecutorial  discretion.  Where   an
Agency  statement defines the scope of
FIFRA jurisdiction,  the  Agency  shall
inform  the  public  by means of regula-
tions promulgated by the Administrator
of EPA. Where an  Agency statement
reports  the exercise of its prosecutorial
discretion,  the Agency shall inform the
public  by means of published notice;.
This series of Pesticide Enforcement
Policy  Statements represents  an  exer-
cise of prosecutorial  discretion. Accord-
ingly, each  PEPS will be  published in
the "Notices" section of the  FEDERAL
REGISTER under the signature of the As-
sistant  Administrator  for  Enforce-
ment. If the Administrator promulgates
regulations which affect matters  con-
tained  in  a prior  PEPS, the  Office of
Enforcement will revoke or amend such.
PEPS  to  conform to such subsequent
regulations.
  Enforcement  policies  announced in
this series of PEPS will remain in  effect
ur.iii amended or  modified by subse-
quent published PEPS or by subsequent
regulations promulgated by the Admin-
istrator. On or before October 22,  1976,
the  Agency  shall  have  re-registered
all of  the  pesticides registered  prior
to  the-passage  of  the  1972  amend-
ments as well as all  pesticides sold only
in  intrastate  commerce. It shall  be a
part of this re-registration process to
incorporate  on  the  approved   label,
where   appropriate,   the  policies   con-
tained in  these PEPS. As the contents
of these PEPS are incorporated in the
approved   product  label,  such  PEPS
will be  revoked or amended.

  This  series  of enforcemsnt  policy
statements is intended to address issues
which  are of national significance and
which will not be expeditipusiy resolved
through the section 3 registration proc-
ess. It  shall not lessen the ability of a
State to  further  regulate  the  sale or
use of  a  pesticide under section  2-1 (c)
of  the  Act (7 U.S.C. 136 v.  (c)). No

-------
 PEPS will be issued to resolve a prob-
 lem which clearly represents a "special
 local need" as provided in section 24 (c)
 whether or not a state has implemented
 such a state registration program.  The
 Office of Enforcement will not utilize
 the  PEPS to preempt a State (author-
 ized  to  do so  by the Administrator)
 from registering a pesticide for a "spe-
 cial local need."
  The series of PEPS will deal with all
 aspects  of the pesticides  enforcement
 program of the Agency. It is  antici-
 pated that  the  bulk  of these policy
statements will disseminate pesticide en-
 forcement  policy  regarding  (a)  the
 registration of products  .sold  only in
 intrastate commerce, (b)  the implemen-
 tation of enforcement  remedies  con-
 tained in the  1972  amendments,  and
 (c)  the   regulation  of the  application
 and other use of pesticides.
  This series of policy statements is in-
 tended  to  clarify  and  illuminate  the
 Agency's policy regarding the enforce-
ment of  FIFRA. Accordingly, every ef-
fort will  be made to provide cl<>a>  ""._
 specific instructions to the reai:.. i, »o
the content and implementation of such
policy. Where questions  regarding the
interpretation of Pesticide Enforcement
Policy Statements  arise,  the  Agency
will   adopt the  rules  of  construction
generally applied to statutory  interpre-
tation. The meaning of language  used
in a policy  statement will  reflect  the
definitions given to the words in every-
day  discourse or adopted by  the Agency
in the implementation of the Act. Pass-
ages will be interpreted  to give  effect
to the passage so that no part  of the
PEPS will be inoperative,  insignifka-
tion, or void,  and to  insure  consistency
with the overall intent and objectives of
the  Agency  in  formulating  an^  an-
nouncing the  enforcement  policy  con-
tained in  the  statement.  Further,  the
Agency  in  interpreting  these  policy
statements  will  apply  an  objective
standard in  giving  those  PEPS  the
meaning  which would be  assigned  to
them by  an ordinarily prudent and rea-
sonable man.
  The Agency  in enforcing these policy
statements  will apply a similar  stand-
ard  to determine  that level o± compli-
ance and understanding normally asso-
ciated with the actions of  a prudent and
reasonable man. The  Agency .-ofognizcs
the need  to continue regulation  of :he
pesticide  industry and pesticide use, in
particular, in a common sense manner.
However, circumstances  in which  re-
peated and knowing abuse  of this policy
has  occurred may require  an appro-
 priate  enforcement  response  by  t1"
 Agency. The Office of Enforcement
 tends  to  utilize  the  full range of ei_.
 forcemeat tools  'in  the  regulation  of
 these  uses including minor Notices  of
 Warning pursuant to section 9(c), civil
 penalty warning citations, civil penalty
 assessments, stop use orders, criminal
 prosecution and injunctive relief.
   A. Enforcement policy  with regard
 to inf ratface products. Section  3 (a)  of
 FIFRA as amended established for the
 first time Federal jurisdiction over pes-
 ticides sold only in intrastate commerce.
 It is clear from  the legislative history
 that this expansion of Federal jurisdic-
 tion was one of the most important as-
 pects of the new legislation. The Senate
 Committee on Agriculture and  Forestry
 noted in  its first paragraph comparing
 the 1972 amendment with the prior leg-
 islation that:
   (FIFKA of 1947  dot*  not) * •  • regulate
 pesticides moving  only in intraatate commerce.
   The  amndnentf  (to  FIFRA)  which  U  *
 registration tnd  labeling  law,  would extend
 th«  refutation of  pesticides to their  manufac-
 ture and use. and  Federal regulator?  authoritin
 would apply throughout tile Statei.  not just to
 the interstate commerce of pesticides  (H. Rep.
 No. 92-511. »2d Cone, lat Sen. 12 |1371)].

   On January 9. 1973, the Administra-
 tor  of  EPA published in the  FEDER
 REGISTER  (39 FR 1142) a timetable i
 the  implementation of the 1972 amend-
 ments.  This  document  sc:  forth  the
 Agency's  plan  for  implementing  the
 amendments to  the  FIFRA,  informed
 the  public as to the date when  specific
 provisions of the  amendments  became
 or would become effective,  and  indi-
 cated  the  general  form and   content
 that various regulations  would take.
   With regard to the implementation of
 the  registration provision of  tht;  1072
 amendments, the  Implementation  Plan
 noted that (except with recard  to can-
 celled or suspended products) that:
   (u)ntil auch time  aa section 3 of (FIFRA
 aa amended) Is  implemented,  but  no  later
 than 2 rears after  its date of  enacisent,  intra-
 atate shioaienU  will be  allowed  to  the same
 extent aa under prior law and will, until  such
 time aj section 3 U operable, be subject to regu-
 lation under State law (39 FR JU3).

  The series of  PEPS will disseminate
 the enforcement policy of  the Agency as
 it  pertains to the phased registration
 of intrastate products. The Agency has
 stated  its view of the current enforco-
ability  against  intrastate products of
 those statutory  provisions of  FIFRA
 which do  not relate to the registrati'
requirements 01 FIFRA  as amend
and which became effective upon enact-

-------
 'tent,  or which  have since been  effec-
  uated  by regulations  (39 FR  36973.
 36975).  During  the  implementation  of
 the registration  provisions of FIFRA
 as amended  with respect to intrastate
 products, PEPS  will  be  used  to an-
 nounce enforcement  policy  regarding
 questions  involving  the  registration
 status  of  intrastate  products  or the
 applicability of  particular sections  of
 the Act to such  products.
   B.  Implementation  of  Enforcement
 Remediet.  The  1972  amendments  con-
 tained  new  enforcement  remedies not
 authorized in the prior legislation. Fore-
 most among these are the provisions for
 administratively  assessed  civil  money
 penalties, civil  penalty  warning cita-
 tions,  stop  sale  orders, and  stop use •
 orders. FIFRA  as  amended  also ex-
 pands  the Agency's  authority to peti-
 tion a federal  district court of  compe-
 tent jurisdiction  to  order the  seizure
 for confiscation or condemnation of vio-
 lative   pesticide   products  (7  U.S.C.
 136k (b)), or to specifically enforce and
 prevent and restrain violations of the
 Act (7 U.S.C^136n(c)). These  provi-
 lions  represent important  additions  to
 the  administrative   powers   of  the
 Agency.
 v  The  provisions authorizing the use  of
 these  new remedies are deemed in the
 'Implementation  Plan to  have  become
 effective upon  the  enactment  of the
 amendments. On July 31, 1974.  EPA
 promulgated final rules of practice gov-
 erning proceedings conducted in the as-
 sessment  of  civil   penalties   against
 persons  alleged  to  be  in  violation  of
 FIFRA (39 FR 276561). These rules  of
 practice established procedures  where-
 by persons alleged  to have violated the
 Act may be given notice of the charges
 against him, and may  receive  an op-
 portunity to request a  public hearing
 regarding  (1)   the  facts  constituting
 the alleged violation, and (2) the appro-
 priateness of the civil penalty which  is
 proposed  to  be  assessed.  They estab-
 lished  procedures for the  conduct  and
 final disposition  of such  actions. The
 Agency has  also published Guidelines
 for the Assessment of Civil Penalties.
 These  guidelines reveal the manner  in
 which  the Agency  assigns  specific  dol-
 lar penalties against persons  who  vio-
 late specific  statutory  provisions  (39
 FR 27711).
   Pesticide Enforcement Policy State-
 ments  will also be used to disseminate
 Agency policy regarding the triggering
\of specific enforcement  remedies, the
'procedures which the Agency- will  fol-
 low in  applying such remedies, and the
 application  of  enforcement  remedies
 which existed under the prior legisla-
 tion  (such  as criminal penalties or no-
 tices of  warning)  to substantive provi-
 sions  contained  in  the  1972  amend-
 ments.
  C. Expantio* of Regulatory JtirisdiC'
 tion to Control Pesticide  Use.—1. Back-
 ground.  In recent years people  have be-
 come increasingly  sensitive  to the risks
 certain  pesticides  have  inflicted  upon
 man  and his environment.  The Presi-
 dent  noted in his 1971  environmental
 message, that "the use and misuse  of
 pesticides has become one of the major
 concerns of all  who are interested  in
 better environment." In outlining the
 need  for additional  regulatory  author-
 ity over pesticide  use,  the President
 stated that:
  (t)b« administrative processes  contained  IB
 the  (current) law  are inordinately cumbersome
 and time  consuming, and there is no authurity
 to deal with the actual  uie of pesticides. The
 labels  approved  under the Act specify the uses
 to which  pesticides miy be put,  but there is
 no way to insure that the label will be read or
 obeyed. The  comprehensive  strengthening  of
 our pesticide control U«s is needed (H.fl. Rep.
 No. S2-511, 92d  Conf. (1971)).

  A  primary emphasis  of the  1972
 amendments was to expand the regula-
 tory jurisdiction of the Federal  govern-
 ment to  include the regulation  of pesti-
 cide use. The House Committee  on Agri-
 culture
  • •  • found lie greatest ne«J  Cor revision of
 existing law to  be in the areas of strengthen-
 inc  regulatory controls on the uses  an
-------
 FIFRA sections  12(«)(2}(G),  12(a)
 (2) (H), and 12(a) (2) (I), respectively
 •(7  U.S.C. 136 l(a)(2)  (G).  (H>: and
 (I)).  The Senate Committee on Agri-
 culture  and  Forestry noted the funda-
 mental  nature  of  the  expanded  use
 regulation authorized by FIFRA 1972:
   Registration  for  «p«ei/lc  u»es under speci-
 fied conditions, as  well  11 directions for  use,
 warning* and  cautions,  eonstilut* the  major
 nesms  to central pesticide us* under prcunt
 law.  But thtr* ii nothing in  the present lair
 requiring thtt  thoae  dirtctioni. warnings.  and
 caution* b* followed.  The provision! of the bill
 requiring compliance  with I he labeling, pro-
 viding  for classifying pesticides  for restricted
 oae. In some cases requirinir thtt they be applied
 by or under the supervision of a certified appli-
 cator, and in other eases  requiring them to be
. subject  to different regulatory restrictions are
 the  key new authorities  of  the bill.  (S. Rep.
 No. 92-838. 92d Cong., 2d Sess. 21  (1972)).

   Z. Scope of Use  Regulation. The term
 "use"  in this document  and  in  subse-
 quent PEPS is to be broadly interpreted
 and applied. The term "use" shall refer
 to any practice  or act  of handling or
 release of a pesticide, or  exposure of
 man or  the environment  to a pesticide.
   The  term  "use  pattern"  means the
 manner in which  a  pesticide is applied
 or  otherwise  used,  particularly when
 considering1  such  factors  as  (a)  the
 target  pest,  (b)   the crop or animals
 treated, (c)   the  application  site,  and
 (d)  the application technique and rate.
   The  definition of the terms "use" and
 "use pattern" will be further clarified
 in the  series of  Pesticide Enforcement
 Policy  Statements.
   3. Regulation of I'csticirle L'if.'^
 ing  of section  12(a) (.') (G).  Consider-
 able  thought has  been given  to  the
 meaning of the word' "inconsistent" as
 it is used  in FIFRA as amended. The
 reports of the committees which drafted
 the Act evidence repeated  attempts  by
 Congress to define  the term and to an-
 ticipate the administrative construction
 which would be applied by the Agency.
 In the Supplemental  Report of the Sen-
 ate Committee  on Agriculture and For-
 estry, Senator  Allen  noted:
   On  the day that  this  bill is  enacted  it will
 become illegal to  use >nx peaticW- in a man-
 ner that fa  incontinent .vith tbe labeling. Tie
 Committee on Agriculture and forestry worked
 with  tbe Environmental Protection .Agency over
 a period of some weeks la see if there was not
 a  better  word than  "inconsistent"  but  was
 unable to solve this problem  (Supplement..' Re-
 port to S. Rep. No. 92-838 51  (1972)).

   In its delincrn*:ons on the 1971 ve.'-
 sion of what became the  1972  amend
 ments,  tbe House Committee  on Agri-
 culture "• • * recog-nize(d)  the need •-
 apply the standard of use 'inconsistei
 with  respect to labeling in a  commoi..
 sense manner" (H.R. Rep. 92-511, 92d
 Cong. 1st Sess. 16  (1971))..
   The Senate Committee on Agriculture
 and Forestry,' while aHd.res.sing the ap-
 plication  of  the term "use inconsistent
 with  the  label", noted  that:
   This  bill would regulate  tbe use of a pesti-
 cide for the first time. • • • The  Committee
 eonsidered an amendment to the bill to  assure
 that such use would not be prohibited, but con-
 cluded that this was  a matter  which  would
 have to be left to tbe good sense of the Ad-
 ministrator, the manufacturers, and  the users.
 It is the hope of the Committee that  by proper
 administration  of the  labeling and  the labels
 approved ny him. the  Administrator will  be
 able to make it  clear  to users that  such uses
 are  not prohibited IS.  J!«p.  No.  92-838,  92d
 Coog, 2d Sess.  16
   Congress ultimately determined that
 the  regulation  of pesticide  use pre-
. sented problems of suScient detail and
 sophistication that the precise substance
 of standards  regulating pesticide use
 should be left to the informed discretion
 of the airency administering the legis-
 lation. This  congressional defeie""!  to
 the  discretion   of  the  adrriinkti-af.ive
 agency  is  common  in   circumstances
 which  involve determinations of r, d"
 tailed  and  precise  nature;   Cor.?re:
 routinely  delegates   to  administrative
 agencies  the  responsibility" of making
 such regulatory determinations within
 the  standard  which   Congress  articu-
 lates and consistent   with  thnt  br-au
 public  policy which formed  the impetus
 for the legislation in  the first pla^c.
   4.  Implementation  of section  12
-------
   .! intent  of the Administrator in  in-
_ .ituting a case-by-case review  of pcs-
"ticide use cases to provide a mechanism
 for the  development of a uniform  na-
 tional policy regarding the enforcement
 of section 12(a) (2) (U). This provision
 ia  the  only  provision  of  section  12
 which was deemed to require specialized
 policy interpretation by the Agency.
   In September 1974, the  Office  of En-
 forcement initiated the Pesticide Mis-
 use Review Committee (PMRC)  to re-
 view on a case-by-case  basis  all  en-
 forcement actions involving  the  misuse
 of a pesticide, and to address (by means
 of PMRC Advisory  Opinions)  general
 questions  of  pesticide  use  practice
which require policy-level attention. The
 PMRC is comprised  of personnel from
 the  Agency's  Office of  Enforcement,
 Office of General Counsel  and Office  of
 Pesticide Programs.
  The Agency  has  taken  the position
that any use of a pesticide in contraven-
tion  of  its  label provision  is,  strictly
speaking, a  violation of the FIFRA and
may subject the violator to  civil or crim-
inal  sanctions.  Notwithstanding  this
narrow  construction of section  12(a)
 (2) (G), the Agency recognizes that the
FIFRA, including section 12(a) (2) (G),
  ust be administered in a manner which
  Jl achieve compliance with the statu-
tory  mandate without  placing  unrea-
sonable  or  unworkable  burdens  upon
producers and users  of pesticides. The
Senate  Committee on Agriculture and
Forestry expressed the hope chat by the
"proper  administration of  the  labeling
requirements,"  by  "administrative  in-
terpretations of the  law"  and  by the
"labels  approved by him," the Admin-
istrator  will be able to make  it clear
to users which  pesticide uses are and
are not allowed.  (Supplemental Report,
S. Rep. No. 92-838 92d Cong. 2d Sess.
51, (1972)). In the course  of its  imple-
mentation of the 1972 amendments, and
»s a  result  of its experience with the
PMRC, the  Office of Enforcement has
recognized the need to better inform the
public regarding pesticide  enforcement
policy, and  the remedies  available to
regulate  pesticide  formulation,  distri-
bution, use and application.
  This narrow  construction  of  section
12(a)(2)(G)  will  continue  to  be re-
flected in  the  Agency's pesticide en-
forcement policy except insofar  as ex-
plicit  and  well-denned  exceptions  to
this narrow construction   are enumer-
~ted in the  series of PEPS  announced
  1 this document. The Agency  may, in
•ui'e exercise of  its prosecutorial discre-
tion,  announce  in   subsequent   PEPS
that  specific  pesticide  applications or
other uses which are not explicitly pro-
vided for on the approved product label
may  be  performed  without  subjecting
the applicator or user to prosecution.
  III. Solicitation of Public Comment.
The  Pesticides  Enforcement   Policy
Statements relate directly  to  internal
Agency  procedures  and  practice  and
constitute "interpretive rules" or "gen-
eral statements of policy." As such, the
Agency does not solicit public comment
regarding  matters  published  in  this
series  of notices. However, interested
persons may submit written comments
regarding  the policy set  forth  in  this
PEPS to  the Pesticides Enforcement
Division  (EN-342),  Office of Enforce-
ment. Environmental Protection  Agen-
cy, Washington,  D.C.  20460.   Three
copies of the  comments should be  sub-
mitted to  facilitate the  work  of the
EPA  and others interested in inspect-
ing the document.
  Dated: April 30, 1975.
             ROBERT L.  BAU'M,
      Acting  A$sistant  Administrator
             far Enforcement,

-------
          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                          WASHINGTON. D.C.  20460
                                                       OFFICE OF ENFORCEMENT
To:       Branch Chiefs                                 AUB^ 01975
          Enforcement Directors

From:   A.  E.  Conroy II, Director         ,[   f~  f         "~TT
         Pesticides Enforcement Division   «^ i  L^ t  \_ ^^,-^~^J— h —
                                             ^*      '         /*"" \
Subject:  "Water Purifiers"                                  ^->
               *
I.  Background;

   In recent months the Agency has experienced a dramatic increase
in activity relating to products which purport to purify water,  to ensure
clean water,  to filter water, or to remove bacteria and other disease-
causing microorganisms. While these "water purifiers" do not represent
a new area of interest to the Agency, there being a history of enforcement
actions relating to this class of products, the volume of recent activity
is a  departure. The detection of these products in greater numbers and
their elevation to a level of greater Agency attention might be  explained
by broadened surveillance procedures adopted following passage of the 1972
FIFRA amendments and by the appearance on the market of these products
in ostensibly greater  volume as a result of  current public interest in the
safety of public drinking water.

   Notwithstanding the Agency's willingness to register "water puri-
fiers" which  can be shown to be safe and effective, and the fact that
some of these products have been registered, there may be a number
of these products which qualify as pesticides by virtue of their claims
and/or chemical construction that are being manufactured and sold
without registration,  and are thus in violation of the Act. Those
"water purifying" products which qualify as devices are  subject to the
misbranding  provisions of the amended FIFRA. Any violations relating
to either of these categories of products should be dealt  with in accord-
ance with normal enforcement procedures which are reiterated in the
section following:

-------
                                 -2-

II.  Enforcement

    1.   Surveillance

             Because of the acute public concern about drinking water
        safety following the release of results of EPA's National Drink-
        ing Water Survey of SO cities, and the potential of that report to
        create increased business interest in the manufacture and distri-
        bution of "water purifying" products, special attentidn should be
        given to locating and examining these products for the purpose
        of determining whether they come under the jurisdiction of the
        Act,  and if so,  whether they are in compliance with all require-
        ments.
             •
    2.  Sampling

           • When a  '\vater purifier" is discovered either at a distri-
        butor or in a  producing establishment, it should be sampled
        (either physical or documentary)  and the appropriate regional
        coordinator notified at headquarters, The regional office,  the
        headquarters PED regional coordinator, and the Registration
        Division staff should jointly determine in each case: 1) whether
        the product qualifies as a pesticide or device, 2) if necessary,
        whether it is  registered or properly branded, and 3) whether
        the sample complies with registration and/or other require-
        ments.

    3.  Stop  Sale

             If the "water purifier" qualifies as a pesticide  and it is
        •not registered, or if it is a misbranded device, a stop  sale
        should be issued against  the producer or distributor establish-
        ment where the sample was obtained. If at the latter, the sample
        should be traced back to  the producing establishment and a
        stop  sale entered there as well.  A  stop sale order pursuant
        to the provisions of section 13(a) of the Act may be entered
        on the basis of nonregistration or misbranding against the pro-
        duct  at any producer or distributor  establishment.

    4.  Testing and Recall

             Immediately upon determination of non-registration of any
        "water purifier" deemed subject to  the jurisdiction of the Act a"s a
        pesticide, or upon finding any "water purifier" which qualifies as
        a device, the product sample should be forwarded for chemistry,
        efficacy, and safety testing.  We have been advised by the  Tech-
        nical Services Division,  OPP, that  the facilities at either Belts-
        ville, Maryland or the Mississippi Test Facility, Bay St. Louis,
        Mississippi,  are preferable for this type of chemistry analysis.

-------
                              -3-

        The Beltsville laboratory can perform efficacy and safety testing.
        Coordination between the regional office and the' appropriate
        laboratory supervisor is important. Dr. Ronald Davis, Beltsville
        laboratory, (301) 344-2137,  should also be contacted prior to
        forwarding samples to Beltsville for efficacy and safety testing.

           A finding that the  product is ineffective or dangerous may
        result in the need to institute recall procedures by the manufac-
        turer. Any consideration of recall should be made in strict, accor-
        dance with the procedures of Section 12 of  the Case Proceedings
        Manual and with the full knowledge of the headquarters PED
        regional  coordinator.                        ,

    5.  Other Enforcement Action

             Where a "water purifier" registration or misbranding viola-
        tion has occurred, Agency officials may consider the usual range
        of enforcement sanctions including a notice of warning pursuant
        to Section 9(c)(3) of the Act,  a Section 14(a)(l) civil  complaint or
        a criminal referral under Section 14(b).

III. Interim Standards

         The Registration Division, Office of Pesticide Programs has
    developed an "Interim Standard for-Water Purifiers." This document,
    a copy of which has been sent to each Region, will aid Agency officials
    and the public in clarifying questions regarding the applicability of
    FIFRA to certain categories of these "water purifying ' products and
    the standards which those qualifying as pesticides must meet for
    registration.

-------
                                                           I • t 
-------
 I.    There are three Federal Laws which must be conformed with when  t'v



 treatment of drinking water is under consideration.  They are:  (1) T-



 Federal  Insecticide, Fungicide, and Rodenticide Act (FIFRA), as a.T.ondid


 (Public  Uw 92-516);  (2) The Safe Drinking Hater Act (SDWA) (Public  Law


 92-516), and (3) The Feed Additive's Ar.;c-nd;;-,2nt of the Federal Food, Drug,


 and Ccsr^ic Act (Section 409).  Both the FIFRA and the SDWA are admin-


 istered  by the Office of Hater and Hazardous Materials and the Office of


 Enforcement of the Environmental Protection Agency (EPA).  The Federal


 Food, Drug, and Cosmetic'Act is administered by the Food and Drug


 Acninistraticn, Department of Health, Education and Helfare.




 II.    It has been held that products represented to purify, filter or


 ensure clean water, correct bad water or give pure drinking water or


 cooking water,  constitute representations that they will remove bacteria


and ether disease-causing microorganisms.  Thus, water purifiers sold
                                                      »

under labeling  with or without representations of efficacy against


bacteria or other harmful microorganisms are identified as "pesticides"


or "devices" as those terms are defined in the Federal  Insecticide,


 Fungicide,  and  Rodenticide Act, as amended.   [Ref:   Giant Food, Inc.
                              t

VS. Federal Trade Coraiission,  Docket 7773, 322 F 2d,  997 (1963).]


Based upon  this legal decision, any chemical or device represented by


statement or implication to be a water "purifier",  or  to provide "pure",


 "potable",'or "safe"  drinking  water is subject to provisions  of the three

-------
laws ciMd i-cvo.  Also, any product, or device containing'a substance
which his no knov;n vr-lue other than pesticidal, will autcnr.tic5.lly be
considered a "pesticide", subject to regulation by the Environmental
Protection Agency under the Federal Insecticide, Fungicide, and
Roricnticide Act, as amended.
       Products or devices which are intended or represented solely to
re:rcve odors, chi-icals, debris, coloration, or any substance other
               •
than those identified as "pests" in the FIFRA, as amended, and do not
contain a pesticide are not subject to regulation under this law.  They
rr.ay, hov;ever, be subject to regulation under other Federal Laws.
Products of this type cannot be represented by statement or implication
as ''water purifiers."  They nay be represented as water "clarifiers,"
"filters," "deodorizers," (or other terminology deemed by EPA not to
be a pesticidal representation).

III.   Eased upon the Interim Primary Drinking Water Standards published
by the Environmental  Protection Agency (FR, Vol. 40, No.  51 - Part II,
Friday, March 14, 1S75), municipal  drinking water must be potcble from
both a microbiological and chemical standpoint.  The use of so-cr.lled
water "purifiers" such as treated filters, or physical  filters on
municipally treated tap water for the purpose of rendering microbiolociically
potable water more "potable" is grossly misleading to the consumer.   Such
devices actually trap the few bacteria (at.a contaminant level  permitted in
accordance with USPKS Standards for Drinking Water)  that may be present in
treated tap water, causing them to  accumulate,  grow,  and  concentrate.   From
a  microbiological standpoint,  these devices are actually  potentially  more

-------
cl'jitrv-.sr-tal  than  bsiieficial  to  hu.r.an  health;  ar.d present a potential



her.lth  hazard which would  not exist if  they were not used.



        It  is well recognized that  potable  municipal  drinking water from



the  tap must have the chemical  purity set  forth  in  the  Proposed Interim



Standards  for Primary Drinking  Hater  as  referred to;earlier.   Since

                                                        >

irr-pl-:-::entaticri of portions of the  Safe  Drinking  V.'ater Act dealing with



the  removal of "chemical contaminonts  end/or impurities  (other than



microorganisms) from municipal  water  supplies will  not  be immediate,



the  use of untreated coarse filters,  clarifiers,  or. deodorizers may



be desirable frc:n the standpoint of improving the chemical  quality of



drinking water received from the tap.   It must be emphasized  that



devices of this type are not subject  to  the provisions  of the Federal



Insecticide, Fungicide, and Rodenticide  Act, as  amended,  but  nay be



subject to regulation under other  Federal Laws.




IV.    There are instances where chemically and/or microbiologically
                                                     t


impure  raw v.'ater may be the only available source of  supply;  eg.   (1)  in



certain rural areas where it mc-.y be routinely used, and  (2) as  an



emergency source of supply for  campers,  hikers,  hunters,  tourists,  etc.



In such instances, the treatment of this raw water is essential  to  render



it potable from both a microbiological and a chemical standpoint.



       The use of pesticidal  filters  (or water-purifiers) on  raw waters of



the  typss described above must  be demonstrated to be efficacious and safe



according to the requirements outlined below.   The only  difference  in the



registration requirements  for the treatment of raw water on a routine

-------
-:i3i: in rural areas, end the  temporary  emcreoncy  use  described above
.-.•ill 12 U:i necessity for an adequate ironitoring system  when the treat-
ran'; 'involves rav: v:uter on a routine basis.

V.     At the present tiirs, numerous types of  water  filters  ^--orporating
silver ?.s an antimicrobial agent  are being imrketed  and  adv.-   ;ed v/idely
                                                        i
throughout the country.  The following reference summarizes  .  •'.• status of
this che.'vicsl vi'vsn ysed as an  antimicrobial  additive.  "The  use of silver
as a driiiiVing water disinfectant  has been rr.uch rrcre  popular  in Europe than
in the United States, end a voluminous literature  is available on its
cpplici'.icn to v:ater disinfection.  A c,cmprehensive  revie-.v of  the subject
has been published in two papers  by Zi;~iermr;n  (1952),  and  in a recent
p;--r by V,'ccdv,'2rd (l£-53).  Additional infor~£tiOii  on its cl igodyna.-ic
action, chemistry end types of products  available  can  be found in
Chapter 2'-..  Generally, the literature on the  effectiveness  of silver in
•.vater disinfection is confusing and rather contradictory.  This  confusion
                                                      *
is in part a reflection of the variations in test  procedures and, in  some
cases,  the result of failure to use a neutralizing agent in  the  reported
tests.   Inability to recognize or appreciate some  of the unique  properties .
of silver also has contributed to discrepancy.
       The marked tendency of silver to  adsorb onto  surfaces can
seriously interfere with bacteriologic tests of its effectiveness.  This
property of silver has been carefully studied  by Chambers  nnd  Prcctor (1960).
       The low concentrations of  silver  used or suggested  for  use in  water
disinfection necessitate the use  of a very sensitive and accurate
analytical  procedure for measuring silver concentrations.  A number of
procedures  have been employed (Feigl, 1928; Chambers, Proctor  and ((abler,1962;

-------
Ur.ar:.. li£3; Lc:,v::rdi, 1954), but a  really   .  .sfactory  technique  I.as  net
yet bear, dsvele-'jed."  [P.ef.  Lawrence and  Clock,  Pi si i;f ccti m ,St-=ri 1 i zaticn
ond Prgsf.Tvr.ticr., 1953, Lea Febiger, Philadelphia,  Pa.].                 :

VI.     Assuming that the water purifying  devices  (referred  to  in V.  above)
can be demonstrated  to be both safe and efficacious,  the only warranted.
claims for such products based on the chemical and  microbiological  tests
herein described are essentially as follows:
        1.  This product (or device) has been thoroughly tested tc
            insure that the silver  concentration  in the drinking  water
            will never excseJ the maximum  level of  50 parts  par
            billion allowed for potable water.
        2.  This product has been thoroughly tested to  demonstrate
            that it meets the standards for providing microbiclccjically'
            potable water under stringent  conditions against Escherichia
            col i.
        Claims differing in essence from the above  fcr  exceed '.hose suppor-
table by the requirements outlined herein  and in the Public Health Service
Drinking Water Standards (1932) which are  currently being implemented, and
such claims are. therefore, not permitted  on labeling or in advertising  of
water purifiers unless additional  evidence of effectiveness is submitted,
evaluated, and found to fully substantiate such eddcd claims of
effectiveness.
VII.    Requirements to support claims permitted in VI.  (1) and (2), above,
are as follows:  Since there is currently  no known  "standard" raw water,

-------
for the rurpocss cf standardization and uniformity, dechlorinatcd,
sterilized tap water will be used in the laboratory testing of  treated
filters (water purifiers).  A chsnlcsl analysis cT this test water must
be submitted together with the results of testing.  Additional  evidence
of pcit-fcr-.ance and/or efficacy of these treated filters, using  raw v/ster
nay eUo ho mean'ir.gful provided the raw water used in such tests is
       Tha consumer cannot be expected to have the capability of perform-
ing a chemical  analysis •'«• oiie r£',,' water he inay be forced to use.
Therefore,' those water purifiers which require any limitations on the
che.-icol content of Taw water (ey., chlorides, sulfatcs, iron, turbidity,
pM, hydrogen sulfide, etc.) to insure orfectiveness which cannot be
readily determined by sensory perception arc impractical r/i si easing,
unwarranted, and unacceptable for registration.
       A.  Chenical Analysis for Silver Concentration in Treated
         '  Drinking water.  (This test is designed for the sole
           purpose of determining the silver content of the
           effluent water after treatment).
           1.x Chemical analysis for silver must be performed
               by the Atomic Absorption Method .on at least
               ton different complete units, each representing
               a different batch preparation of the silver-
               impregnated filtering medium.
           2.  Tap water must be used to challenge each unit.

-------
         3.  The unit must be challenged intermittently (to include


             an 3 to 10 hour  non-use or stagnation period) and the


             effluent sampled (and iiiir.-diately analyzed) at frequently


             defined intervals (recorded as water volume) during the


             expected lifetime of the filters (as represented by the


             manufacturer) to determine any variations in concentrations
             •
           •  of the silver present in the effluent.  The flow rate

             utilized must be specified, and the total volume of water

             filtered to demonstrate the "life-time" of the filter rr.ust

             be provided.


         4.  Parameters such as pH and temperature of the.water before

             and after treatment must be provided.


         5.  The requirement for conducting a silver analysis immediately


             after sampling is mandatory because of the unique property


             of silver to  quickly absorb into the surfaces of the
                                                   9

             collecting containers.


         6.  Unless disposable equipment is used in the chemical  analyses

             for silver, as well  as  the bacteriological tests, all  equip-


             ment to be re-used must be treated  to remove adsorbed  silver

             as follows.  (See attached "Notes"  for procedural suggestions.)


     When the chemical  analyses of the effluent  water have demonstrated


that the maximum allowable concentration of silver (50 ppb)  released by

the treated filter has  not been exceeded during  the life of  the filter,


the bacteriological  assays outlined  in (B)  below should be undertaken.

-------
E.  Bacteriological Assays.  (This test is designed
    for the sole purpose of determining the bacterio-
    logies! efficacy of water purifiers).  Escherichia
    ccli has been selected as the- tect microorganism
    because it is the- ceir-only recognized indicator
                                                •
    organism prescribed in the United States Public
    Health Service Drinking Hater Standards, of 1952.
    1.   Bacteriological assays v/ill  be conducted
        on samples of the interr.ittent efriuer.t
        collected at the beginning,  middle, and
        end of the represented lifetime of the
        filter,  en three separate units.              -
    2.   D.echlorinated,  sterilized tap water seeded with
        Escher:ch1a coli (ATCC 11229) at  a con-
        centration of 200,000 to 300,000  micro-
        organisms per ir,l must be employed in
        the test.  This inoculum level  must be
        determined by actual  plate count  using
        Bactc-Tryptone  Glucose Extract Agar as
        the plating medium, and the  results
        submitted.   This artifically "con-
        taminated" v:ater should be prepared
        from a 24-hour  nutrient agar slant of
        the test  organism and 100 ml  of this
        inoculum  reserved as  a-control.

-------
3.  The effluent i*;;st bG sampled at the ihre':
    prescribed intervals, after a holding p.:
    reco;n:r.ended by the manufacturer.
4.  The flew rite, pM, temperature, and si'lvc-r
    ion coricentrcticri of the water effluent rc'jst
    be determined at each test interval, and
    •
    included in the results reported.
5.  Bacteriological assays should be conducted
    on two one hundred ml samples at each interval.
    To the two samples and the control  add 1.0 ml
    of a sterile neutralizing solution  containing
    5£ sodium thioglyccllatc and 7.3%  sodium
    thiosulfate (according to directions on the
    label  with respect to the holding  period).

    Both the filtered neutralized (test) water and
    the neutralized,  unfiltered, inoculum (control)
    must be tested by the Fermentation  Tube Test (as
    outlined in the Standard Methods for the
    Examination of Hater  and Waste-water,  American
    Public Health Association,  Inc., 1740 Broadway,
    New York,  New York  10019).   Both the MPN
    ("most probable number"),  and an actual  dilution
    plating of the test arid  control  waters  must  be
    conducted.   In conducting  these  tests,  lactose

-------
               broth should b2 used  for  the fomentation  tubs
               tests; and plate counts should  be r.adc usiny
               Difco Tryptcne Glucose Extract  Agor  (TGE)'.
               Since pure cultures are to be used in these
               laboratory tests,  no  differentiating medium
               is necessary.  If  naturally contaminated
                                                        i
               rcw water-is tested,  appropriate differential
               and confir-.atcry media must be  employed.

       It s!~.C'.'ld be clearly understood that both the chemical and bacterio-
logical tests outlined in A. and  3.  above may  also be conducted by the
Environmental Protection Agency Laboratories,  but only after submission
by an applicant of satisfactory test results.  These results nay require
confinr.aticii by EPA Laboratories  before  a find decision  can be reached
concerning registration.
NOTE:  The standards outlined herein are tentative, as indicated by
       the title.  Final standards which may or may not differ from
       these will.ultimately supersede this document.

-------
                                       NOTES
                      Ap Scir-lv- CD.-'it.jiriers  (U.-.e  ;;nd  Clc-nino)

I.  Si:.:;;le Collection (13 x 150 capped soft,  glass  test  tubes).
    1}  Collect £ppro/.i::;atL':y 15 ml of sample  in the test  tube.
    2)  As soon as possible add three drops  of concentrated  HNC'3
        to the sa~pic and cup.
    3)  Ir.vert test tube 3 or 4 tin:os to mix sample  and  cone.  HMOs.
                                                              i
    4)  Sr..".ple is now ready for AA analysis  of Ag+.
    Note:   Always colject at least two samples for analysis.
II.  Cleaning procedure (only for test tubes  which have  been  used with Kf'Os to
    inhibit Ag adsorption).
    1)  Soak IS x 150 soft glass test tube in  3% Ni^OH  for 30 nrin.
    2)  Using test tube wash rack wash in Hobart Laboratory  Washer  as
        described by .-.•asher manufacturer.
    If the test tube has been used to collect  a  Ag samale  without the use of
    H;.'G2,  use the following procedure prior  to the NK4:Jri soak.
    1)  Fill  test tube with cone.  HN03 and allow to  soak  5  min.
    2)  Discard this K,'^.
    3)  Repeat S.tep 1  two additional  times.
    4)  Then go to l-i^CH soak as described previously.
    Cleaning Procedure for flasks  used in Ag-3ac-T Kill  Tests  (250 ml
    Erlenir.syer).
    1)  Add~25 ml of cone. HK03 to flask.
    2)  Swirl manually or mechanically for five  minutes.   Hake sure  entire
        wetted surface is contacted by tiie HN03.
    3)  Discard this HoiO?.
    4)  Repeat Step 2 two additional  times.
    5)  Soak flask in a 3% HMOs solution for 30 minutes.
    6)  Soak flask in a 3« NF^OH solution for  30 minutes.
    7)  Wash in Hobart Laboratory  Hasher as described by manufacturer.

-------
         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON. D.C. 20460
                                     MAR  1 5 1976
                                                     OFFICE OF ENFORCEMENT
  Subject:   Guidance for Enforcement Actions Involving
            Water Purifier Products                  '

  From:    A.%E. Conroy n. Director
            Pe*sticides Enforcement Division

  To:       Enforcement Division Directors
             Pesticide Branch Chiefs
  Background

      On August 20,  1975, the Pesticides Enforcement Division issued
  guidance to all Enforcement Division Directors and Pesticide Branch
  Chiefs concerning water purifiers. Subsequently,  at the direction of
  the Assistant Administrator for Enforcement,  this policy was modified
  by  telephone to provide for a hazard review prior to imposition of a
  stop sale.  This policy,  applying to both intra and interstate water
  purifiers,  was formalized by memorandum of the.Assistant
  Administrator  on January 19, 1976. It is anticipated that PEPS #3,
  dealing with the phased implementation of section 3 of the Act, will
  be published shortly.  This PEPS establishes  a general procedure
  and policy for dealing with nonregistered intrastate products  consist-
  ent with the water purifier policy  as modified.

      The following represents a compilation  and summarization of
  policy and procedures as they have developed to date with respect
  to-water;purifier products.  Thislguidance should .suggest a. pattern
T^eneraUy^consisteht^vith-your'pibsjent program activities and is  —
  intended to provide a clarification and collection.of existing policy.

-------
                             -2-
Policy;
    In the exercise of its prosecutorial discretion, the Agency has
determined to allow a narrow category of water purifier products
which qualify as pesticides under the Act but which have never been
registered federally or by the states to continue in commerce
pending section 3 registration or denial of registration, provided
all  the following conditions are satisfied:

    1)  producer or distributor can show no knowledge of the
       applicability of the FIFRA -registration requirements;

    2)  use pattern and formulation of the product in question are
       substantially similar to EPA registered products,  provided
       no ingredients have been cancelled or suspended and no
       residues result which exceed stated standards for  drinking
       water;                                      ;

    3)  minimum labeling <*nd packaging requirements as provided'by
       40C.F.R. §162.17(f) are met;

    4)  application for federal product registration is made within 60
       days after notice  of the requirement and pursued in good faith;
       and              '     .            :"

    5)  the product is produced in an establishment registered pursuant
       to the requirements of section 7 of the Act, or for  which appli-
       cation is submitted within ten (10) days after notice of the
       .requirement.                                 »

Procedure;

    1)  Sampling ~  When a water purifier is discovered either at a dis-
tributor or in a producing establishment, it should be sampled (either
physical  or documentary) and the appropriate regional coordinator
at headquarters notified and supplied with the following information:
            ncLnrp^-i^^he.product^	   '"   —  —"
     tr.  the claims made for the product;
     c.  the ingredients of the product,  if stated on the label or if
         obtained from other sources;
     d.  the use directions  of the product (in summary);
     e.  the name and address of the producer:

-------
                                 - 3 -

      f.  information relevant to a determination that the producer or
         distributor had prior.knowledge that the product was required
         to be registered,  including: 1) contact with the regional office,
         including inspectional staff, concerning the product in question
         or a similar product;  2) contact with the Registration Division,
         including the filing of  an application for registration; 3) contact
         with Pesticides Enforcement Division concerning establishment
         registration or other enforcement matters concerning the
         product at issue or  a similar product;  and
      g.  any other information that may be useful in reviewing the
         product.                                    '

 The coordinator should also  be informed as to whether or not a
 registration pecket should  be mailed to the firm by the Registration
 Division.

    The inspector should inform the producer (directly when sampling at
 a producing establishment  or by tracing back when sampling at a distri-
 butor) of the Agency's  general  policy with  regard to these products
 and of his obligation to pursue  registration under sections 3 and 7 of
 the Act. The  inspector should provide the  registrant with necessary
 information for him to proceed to apply for product and establishment
 registrations and should inform him of his obligation to pursue both
 registration activities  in good faith upon receipt of further instructions.
 [This information should oe supplied even  though the section 3 knowledge
 determination may not yet  have been made. ]

     2)   Stop Sale  Where a water purifier does not meet the  terms
 specified by the Agency in  the exercise of  its prosecutorial discretion,
 detailed above, a stop  sale should be imposed against the violative
 product. Where such products are initially located and stop saled
 in the chains  of distribution,  follow-up action should be taken to
 locate the producer of the product for imposition of a stop sale at
 that location also.  Stop sales should also  be issued to any additional
 distributors who, through routine surveillance activities,  are found
 to be selling a product which has been stop saled at the producer.
                      _ " •         "-    — N                   •  "
	-" 3)•±gr..Uow=up=«=Shgi'ild  thc-pVqducer'qf_aJ3top-saled water purifier^
 product-be abie to show, subsequent to the stop sale action,  that he
 can meet the  conditions for this interim stop sale exemption,  or that
 he can modify labeling to avoid classification as a pesticide  or device,
 the stop sale  may be vacated. Conversely, if a  product is initially
 determined to meet the conditions for the stop sale  exemption but later
 found not to meet these conditions, a stop  sale should then be issued.

-------
                              - 4-
    In any case where the exemption is permitted, follow-ups should
be made periodically to determine whether registration activities are
being pursued in good faith.  The first such follow-up should occur
shortly after the initial visit.  If it is determined that a producer
has not pursued either section 3 or 7 registration in good faith, a
stop sale should be imposed. Vacation can be considered if meaningful
registration activity is resumed by the producer.

4) Other Enforcement Actions -  All producers of unregistered water
puriiiers who had no prior knowledge of the requirement to obtain
federal registration,  and who filed an application for registration within
60 days after being informed of this requirement, or who cease the
sale and distribution  of water purifiers, shall be issued  a section 9
(c)(3) letter of warning.  All  other producers shall,  in addition to a
stop sale action, be subject  to the penalties provide-.-' "nder section
14 of the Act.

Conclusion;

    Notwithstanding the  prospect that issuance of stop sales  in this
area may be  substantial,  at  least until producers take steps adequate to
qualify.for stop sale exemption,  FED is of the view that  the policies
and procedures set forth here represent a viable and equitable acco-
modation of the needs of w'ater purifier produers and distributors with
the obligations of the Agency to regulate pesticides  in a manner which
insures the public safety.

-------
INITED STATES ENVIRONMENTAL PROTECTION AGENCY
            OFFICE OF ENFORCEMENT
        OFFICE OF GENERAL  ENFORCEMENT
        PESTICIDES ENFORCEMENT DIVISION
             PESTICIDE ENFORCEMENT
            POLICY STATEMENT NO.  3
      CEITAIN ENFOICEMENT POLICIES TO BE FOLLOWED
          DIHING THE PHASED IMPLEMENTATION
               OF  FIFRA SECTION  3
       Rcpiintcd fioin I he I cJei j| Keghlci of A|iiU I. IV 76
                   (41 IK 13984)

-------
   THURSDAY.  APRIL  1.  1976
            NOTICES
   PESTICIDE  ENFORCEMENT POLICY
          STATEMENT NO..J
 Certain Cnfofcafit«ni Polltlaa To fle  Fol-
   lowad Ouilng  Ihe Phatad. luipl«in«nta-
   lion of flFftfc Section       • -,
        I. UtNtaAL BACKGROUND

   On  May  6. 1075. the Environment*!
 Protection  Agency *CI*M published In,
 the  FKOHAL Itccmta *  document  en-
 titled "Institution ol Enlorccuie.it Pulley
 BUtemenU" MO Fed. Reg. 103201. It WM
 ilie  Agency's purpose In th^ttlullug  IUU
 •erica ol Pe&tltldc Enfurceiucnt Pulky
 BUUmenU nrt lludentl-
 clde Act. M Amended In 1012 *nd  107ft
 IP.I.. OJ-6U. 10 81 at  B13; IM.. B4-UO. Id
 BUI.  161;  1 U.8.C. UO ct aeq.;  hercln-t
 after  relerred lo  u  PI>llAt. rtFa *re
 publUlied by EPA'«  Ofllcc vl Enfoice-
 ment.  Unless oUiecwU* exprcuely  pro-
 vldrd. •, FEI>3 indicate* luiw the Avency
 will eneiclie IU piMccutorUI discretion.
 and does not Interpret Ihe law or other-
 wise defliie what Is and vhat Is not  law-
 ful  conduct under t'JMlA. A detailed ck-
 pU nation Ol the purpose and acupa of
 tha FL'pa  aerlea  WM act  forth In the
 May a. 1979.  PBosa*L HicuTia noUca.  '
   On July  1, IB76. tha Agency pnuuul*
 gated regulttlona governing reglatraUoa.
• rercgUtratlon and claaalflcatlou proc**
 4ur«a purauaAk to F1FHA Mellon ft IM -

-------
 I'd I, Hot'  2B2I3I. The srrlluit 3  rrtfiiln-
 ftuits bi-CitiMC elftM-llve oil Alien:.! 4. 1975.*
 Tit*;  u'Kuliilloiis i>rc*«*iloe tuoccduies and
 l»&  In  lite  197] amendments. The
 Aurncv hits nl li mptrd loiniiileiiiriiltlic.se
 htcntnc.lm clumps  lit a commuii tciue
 inaniti-r rnilMiij; itilnliiiiuii disruption l*»
pi'silcidi! in iimfnrlinvts. diMiihulms, and
 UM-IV  *hilc al  Hit:  iiinic  lime uccmn-
 pIKhtim  the rhiinur* rc-milicd  by C»m-
 firsv Arfontiii:;lv. lh« Arrnry  has pro-
 vided for A iwiluil of  imn.trd titi|tlrinottla-
 ll«u of Hie new rcmiiiriitrnls. Tills PKI*3
 aildirs-cs  tcn-fjil  |(ii|K»rUitt  problem*
 which li;tve nrlwit dm hii: Itic phn.:cd tm-
 |tl''iiirnl;il|on of Ihg  modification* to  the
 tY>t<-rn| irKlMrallon prortrnm. and hidl-
tiil.-i Hie  iwdlciet wlilrlt the Agency will
fo'.ow  In  1 1 use arms  diirln* Hie  Iniple-
niniliillim   period.    fiin-clflruliy.  IliU
 PUPS:
  I. lle*.i|vr*  certain  (|ucsiluut which !»•»•
 •(Urn  rcitfcinlMtf  thv  • iilhoilty  of Sl»tc*
 titidrr KIFIIA lo • niiio'l'* ih* dltlrliMiUoii.
 t »!•!** «iiii»» niovcutriil In cuninwir* uf pcMl-
 Cld* pr inflict * t|uiMi|;h •clloil* lAteit iinttrr
 •!•!•  I**. litrltiillnii  (Hale  rr^lilrailnti  uf
 |M\II. Mr product*  | P trill |
  3  lUfiiKnc-, *l«N-.i-% t>( p*MUlU« proiliu-ti
 twltlclt wfic d«*tuMr  rrcltln t'«
 • trirl-nl  uii'lrr ircllon lain) il> (A| Of  Pl-
 f|IA  lu |>c-iuill  |l tt ruttlliiiKd nm;*r iili-iu lit
 (nututri. t-  1,1  rcrlftln cU*M-j of lit?.* fM-nil-
 Ctd« |iiM  urnrdluj
 Ihflf  rrcliKitbMi uuttcf PII-'ltA. |P»rl III)
  1   DclliicnUi  I ho  ilicunimMiii'M uttder
 K'fililt «itI»i.i-Mn lit (UsfrHttiii felll IM r«rt-
|>(>.H||IC|. oil ft tlmii liv ir;i:i*-k:t|-tii|t '•»«' i'cil-
*f»ll]r ir/.l',lcrr<| |M.--,iti i.lf |»IH| m:«. Jl'.ni IV|.

   Ai slulcd lit Ihu dm'iiiiinit  aiiiin|itii.lii(
the int< iilwiiof (he I'tl'S M-iti-n, I he iK)M-
clra ititiiiMinri-d In a iT.rtJ will iimuin lit
clTcct until nnicntlr«l ur itioy Liilisci|iiritl ir^iilj-
lion.t pruiiuilciiti'il b>  Ihe Aduiini..lr;ilor
llrcnti^e tin; |kollclc\ minuiiiifcd In l*:irU
II anil III of Oils Pt'l'S ficiluin oitl> dur-
IHC  Ihc i»|i:isrd linplviiiciitiilltHi nf  the
nioilinculloiti to Ihc fi'donl  ii'i:tsli:*iirui:i'niii.  Ihc  rnfurrvmcut iMilfc-KA fin*
iiutiiirrd tit 1'iirl.*. II  uOd III of  ilnx rCP3
will irniitlit in rdrrt ili>i- to thni dnlr.
   Klnnllv. llir  Accnt v ruiitu.fi^ (h -l (,,<>.
 nu-nl* 4indr* .illi- 1  t';»iirnMii <>f I'll'ltA
 Hid n'Kiihil luiis pnuiiiiluali'd tlii'ii-niuk-r.
 which are he yon* I  the n.i-ot>« uf lhl.% I'tTS
 Tliti&c oil tor ri'tjiiUrmeuU  Incliitlc. with
 out IIIMJ|;I(IUII. Ihc (olloulitQ;
   I.  iet-tifilkCf|iiM(;  tl»   |l It'll A
 M t.uo*t «: 10 cm r^ii iu'j(;
  2. ffi|iilifiin-Ml*  Hi., i  t,|'A  liikprctuiD  !>•
-,  u> oirfiiiiklinttfiiia •ltd u-.-orilk
                          Vl»UII»M* Of
•MMUf mil* WtTllt'll |J I fit HA 4*111011
t-UJM'H;
  &. liKlhlttlli.ini. w,;^ln,t iMlnlllfiiMint *.r !«.-•••
urtn l-'IFflA '

  Tfic  I'JTl am.-iidinciit& tu  1 IKItA kltf.
liUlfaiilly  bto;nl«'i icil  Ihu  Kt-dtral  re-
iiitticuu-ui for tcn«^,ttuUuii o( ^^li^tvtta
by  inukliitf  It unlawful  lor
• ny |tcrMtii in mny  *I«|«  lo  Ulatrlbul*. Mil.
uil«r lor »•!«. hulJ for **l«. fthlp. deliver fur
ftlkluiiMiil. ur ic*.*l*« Uitd lift*lii|| iwrccvlvcd)
                            nny p*TM»n »nf
                i I* I
lu FIFIIA)  |m RA.  Pft'|
ia(K|(l|(A|| irinphiibU
 llon  3  ii-|;itl:ill*tit .  wfti*
 'l *>i »*i. Id. i* MM *MI Julv J,
 I'flU'J). -IM«I It-catiu- rlfn--
Itna. In Hi* I-CII-M iiiui 4ii«-r
107) |<0 »>'!
llv* on rtu-ti-t
lltxi dKta  tlic
cwr. i/iu buniit  lu M-t-lliiii  «<•!  of tlMt I'J74
AHtvtidHiC'H-i. cnfiirfciiifitl  nfll'MI Cimlil l«ii
b« l«hi:n fur vlulm» of (i:«|iiircniftitlii cUcc-
tiuUd by  Ihe nc<« r.!i;Ml.»tuim. nnill im 4j.i«>i
after Iba d^lo of publlcullmi, I r . Ofiittorr J,
U73.
    lM*y'N lr,;n| |iil>-| |iirl Jlh ..... ' Hi*' >•!!<•« I '•!
    lull rfinrniiiMcutt unu ihf liHfil* iM.-,n,)tr
   .i.l.illMii-, .in  Ilia  (iilhciilv  ••!  ln.tlr*  i<»
(:»>• |tt  Iti  i.nu  tit i -line-.. A I'l.l-S tl.-:i
lMtt:i|ti':l UK- l.i« »•• ..tlte»-vl J- !•«•• J Ith.- «•
It JM'I  »li.il  •••  ••'••  •-4»lti| »'  it'll- •
I'll HA  ^t -ii  II-. % In. i. iin-f. ,.i< ; i-iUfii
I'JU'U »lilfli lii'-»|.«ri-.  iltr  .'••" utlt li.-
tiiUI|13AIC»..«<
|»tl»l|> I.  Ill  f.M I MII-tlKrlltl-  ^11 »M»|-»
. I'ic.  ou.ly.  the l-VducMl r««b.liatli>»  re-
 quirement hud uidy upftlled lo pvtllclde*
 In inf<:rifufc commerce. U Ui clear from
 ^IIG  It'iiblutlvc hliloiy  thol t«i«nilon of
    'e*al  |»cslkldc rf^olullon	lo
      HIS entirely  within * Ui.Bte 8UU'*
     rt<|». No. 02 BJB. 02J Cong . 3d SCM. I
 U072M  wan one of Ihe tn(H.l Impoitunl
 Ahpccts tit II* new Icgl.lution. The lloui*
 Committee  on  Acrlcullurc noted H»  IU
 nisi  iii.ragrjj'h  cuiiiimilna  il»   '87J
 mnendiuent with  the I'Mor  leg L'lot Ion.
 that:
 llio »..,. uUuwt.n |to »-miA| • - ". ».l»leh l«
 • re(tik)f«-lufo »rtd  u»«. end. Ft tit MI I r««(iU-
 lory *tun*HlllCN woulJ »p|>»r ttoro«iil»«»«i ih»
 OlAlc*. not Ju«l  lo III* iDlrot*** comifterc*
 uf p*Bilcldci (II  fi»pt. Ho. 02 All. »JJ Cong..
  UitkM.. IJ (l«7»tl
 lUo 3*:nat«  CommlUe«  on Commerc*
 noted  that, while  pi lor to  1011 KUTtA
 did not "regulate uc*tlclid|tnR|  »i»f
                                                *itf chftii|t« in Ihe t»twl or Ut>rllim •»* a l'*d-

                                                         il  |N-illI.«|M.|. which I* *»••!
                                                bf  ftddnm  UMI.  b#c»m«  h»  MI dulng  Ib*
                                                BlkliM  would  o* p«riullllitH  th»  Utolilbu-
                                                lk>i« of  ft p«»il<*hia  predict twl  it|itti*fed,
                                               * piiriUKUC IA V1F1IA. ftiid  llid*itt prohlDllro  undrf nmA  Addition-
or ollieiwlt.c mith «»'« »l  1 .n'«»«.nt*" • ' "
COiiimctt:*:  of ft ft .ll'-idC  (if-'luct -'.^n
WILS uol itltcudy ici(i:.t*:n  t b; UFA."  'IhU
cxtliiliuL\hn.citt  of  Uluto  uuihorHy  la
aulhoil/e the inovrmtiit In lOmmcice ot
l»e&tlcldc pioducls  »hMi w«ic not  Fed-
erally rtkUtereddld not. howcvi^. bivbina
effective ImmcUlftlcly upon  the  tnacl-
meiii of Uie 1012 QineudmeiUt to IH It A.
Rather. II became ctlcctUe ••rt Aut;uU 4,
1015. Hie  eOectivc  date  of the MKUU-
tloiu whkh the  Agency  >rouiulgutcd to)
Implement •ecllon 3 ol the t&l? nincnil-
ntetils.
   In  order  to  provide lor  on orderly
Uamljioii to  tlte  new  reci-^trAllun  re-
quirement*, section 162 17 of the
X ri'vuliitioiu  established >i eclal
Alon.t  retiardlnv   Intru&tate   pesticide
products which hud valid State le^Utra-
tlons on  Au«uat 4, 1019.  Section  162.11
provided  that  rcgUlrnnU of such prod-
uct* could inbuilt, wllliln dO day* of Uie
effective dale  of Ihe tecllnii  3 iegulit-
tloni, a  notice of  application  fur  Fed*
cral rcitlslrailG... |'iodu<:li with ie:;|iccl
la which iuch a notice was tiled Kithln
Uie time picicribcd were allowed  to re-
main  lit  coinmcKu  i.cndhiK  fln^l  de-
cision either ni>inoviiiu or denying Fed-
eral u-j;Mral|jM &nbicct  to Ccitaht con-
L-.v Ihc State
 regKtiutloii of a i>rodm;l which hud  a
valid tiUtltf  rcuUtiiillbti  on   Auifiibl 4.
 101^. And with  rest ect to which  notice
of  application  fur Ftdrr^l  i central tun
 wa« fllvd on or before October 3. 191&.
   ficcllon 2«c>  of  ill HA itlvL-s the  Ad-
atit\Kli»to( auUioiiiy tu  uivc  buck lo
 atnlcft  ftome  of  their authority  which
 WMI cKtliiRuUlied on  Aiigu.it 4. 191$. 6tc-
 tl.iii  2i(ct aulhorl/ci the AdmlnUlralor
 to certify a Stale torcghtcr pcitlcldeafor
 '•AIHCIU! locul  necdi".  um>n flndlne  Ihal
 the IHule I*
 r«|k*bl» vt  *k«iruiii|;  adr<|ii*l«  cutilruU  lo
 a«t*ir« lliKl  lictfl^l'At'uM* u»u*d bf ll| will
 b« lu mcco»J with Ilia  puipoici  \ot t'lFllA).

 Piopo»d  rcgulutlons lo Imitlcmenl  MC-
 Iliin 94ict  Mere  published lit Uie FIUCHAL
 llccisica on September 3. IK1& MO  Fed.
 Iteg. 40&3(1. Ttie Agtiu*y U cunently In
 Uic  proceii   ol evdluiilliitf   comments
 which were received, end prtparliig Hnal
 rejtulailoni.  llie preamble to the  i»io-
 pn.\fd regulatlon\ pnnounccd ait Inteiira
 *C4 tloit   24«'t»   r-f- •' '- '•:•:  i-:-C  :•*—.->
Su i-t ;iur>ui.T»;  ^t  ^:.« !.:«,  •rm.i..uiUL

-------
t nliflt ;iium U I'-MIC iirrcliil lotr.il nrrd*
m'iMi:i*n-ir. pur*u;int in &rrllun  24«r».
   r'tniilly, il u niipurlunl lo note Hint
srcimu  '24-iti  of f'IKIIA expressly  au-
llioruc* suite  irittil:illikii of  the siile or
us? of itcsllcldc*. piovMrd I hut sitr|t tee-
nluilun ilncs not pcrmli  any &otc or u»
prohibitcit  liv  MFltA.   ThU authority
tlruily penults A  Slate  lo  reuMcr or
c'.hrrwUc i Tiiulwlc the distribution or use
o( pr-Uli'ldtf  products tvhh:h have bet-n
Mc^iTcd piir&u.mt lo PIP1IA.
   lit  nummary. Mllcr August 4.  IfllS  A
bi;ite may rcgKler or othcrwl.se author'
l/c Die  |ntia:tlute inlc.  distribution or
other ntovi-mcnl lit hitniftlute commerce
of the following lyiK'S uf |*r&Urld<: prod-
ucts:
  I A  |M>Mlci>J«  |>iol«tri *lilch h»d  *  vhlld
Bi*tc  ir|:i«irill<>n  «"»  A UK till  4.  101&.  and
WUU (C^icd l4t «MCtt « lialU-r Uf *.r)[UIC*lllr>llcin wa* filed *>*(<*« Oc-
loiter a. IB'*4;
  2 •  prttirliU  piudiici fur »  »|>*Cl*.l ItH'ftl
n«il. |>f»>ld*d in*l Hi* mat* li«i been c*r-
llllcd  |M,i*n»iil  U> flKHA fcrctluit  2*(ct. lo
Ifctiir (!)• lyjitt uf K|itCl*l ItiCftl ItCrd. t«i;Utr*-
tloit f onf«rrlied; ftitd
  3 •  r*%Hrl.lo  |>rotl*tut*u»nt lo FIH* A,

III. EnrolCCMKNT SVATUS or NON'Kk'OlM-
   All.lf  IU CIS-Hint*  PRODUCTS   DUIIINO
   PiiAbtt)  IMM.CMCHTATION   or   KlPltA
   BtCIIOH X
                A. CCHtlAL

   SiTtlun IKaHIHAI of FIPItA IIIMBCB
U unlawful  for any person In any Stute
In dltlnbui*. f*tl_ 4ifl«» fur *•!«•. hold lot »•!«.
khip.  dtllvvr   dv tM(tm*iil. of r«r*u*  *itd
|having •*> iccclvcd) drllvcr or bttcr Ii> *!••
H**T.  to  »ny  pciii>U * "  • »»\>  }>cMtvliU
tflilch U ttul K|;liltr*a |pur*u»nl lo >'lfr'HA|.

   r«.Tsnris who vltiUle Ihli |>rovl&lu» Mrc
•ubkct  la  mliircrtncitt ll;thlllly  imOer
FIHIA. llic Aprncy  will review curli nl-
IcKtrcl  viuhiitun itml will as^tiiii riiforre-
nii-nl liAblltty to any i*crmn <»• drfltifd
by FIPltAt out of whose Action or follura
to art the violation trust  Upon K  nndint
ol eiiluiceiiu-lit liability the Aiieiiry may
Iftke the  fullowhiK lypo of  eitfuimtient
tctloiu  under  HFiM:   U>  Isiunnre of
noltrtt uf «*ritliia under FTFRA  section
ft»c>Ot in the crsa o( minor vlulohoni.
(}i coniiiitfiicciucnt of civil  or  rrlutlitul
proceedings  under f-'IKltA ccctlou  It. <3>
Utukitcc ol tlop'SHle orders, itop-nte or-
drrt. or  removnl orders under  Plt'ftA
*ectloii in»>.  or  (41  com me nee rue ni of
procredintcs  In  *n aiiprbprlnte  Pcxleral
District Couil  1fc> tj>^cinc»lly to enforc*
trie Act or to prevent fti*d rc&lrtln vtoU-
Uom of the  Act  IPlrltA *ectlon  ll to «ca« or confUctle pektlclde«
which vtoUU tpoclOcd provUlon* of Ui*
                                             Act II'II'HA
                                                                  IJibt |.
  Ttm:u muniifTS.  AND  TIIIIH  rHium'c-
  I4LNT STAtllg HIRING riiASID I»I|-I.|:MI.H
  t*ll*>M 01' VIV»4 til-.TtUM 1
I.  I'cjrrilde J'roilurfi ktttntifattttirtt
  FtiimulalriS far  the f'mt Ttmc  Alter
  Auvufi 4. /97$
  PitiducU  In  Ihla  caltcory  are  lho*«
rieitinl fur ihc first  time nfter the cflrc-
llvcdaleof the new arclton 3 rrr.tihilltma.
The Hulttlnv com eiit b«hUitt ||tc Aueiir.y'ft
policy uf phased luiplrntenlatlttn of the
hew refilfclrallmi reuulremcnli  Is la dli-
1'itpl oj lllllc u« IM>&&| tie the niftnufitt:-
l\ltc and dlslrllmtloil nf  (icoduclt which
were lit commerce  before the  efUv.Uve
dale of the new lequlreinmU. i-onsliUnt
with the A^ciicy'i dlichurvc of Its  «ug-
meutcd fCf-iKmslUlUiUa  muter f'lt'OA..
This policy lift* no uppltcublllly to pusll-
cUlo pruduct^ nfiufuclurcd tor (he ftrtt .
time after Any)...i 4. 11*15.  Accordinitly,
l\ke  Agritrv will Inke enforceiueitt ftcllon
•Uidiist any  IUIMMI  dhlrlbtitlnff. *cllln(
or otherwise htovlng In tnlrastute or In-
lerst^tu commerce »ny pr%tlchle product
mbmiluclui^tl  tor  lUt  Ar&l lime  »ll*r
Auc.1%1 4. 197S.
2.  I'atliidc  1'ioituctt llunufar.txrfit  or
  FtH niulatftl I of the first Time Prior fo
  Auuutl  4. IV75
a. fof.^Mt I'r.M/UL-fi OfifribufrJ. 5
(itlicr*>lie i>ltn>*-d   in  |u(tr*fn/e  Co
tnritc Ilejurc Auousl 4.  J97S.
   rrathldvi  iinxtucts  In thU
 weie «iil*jL'i .1 lo the Pedcml  rCK
 rcfpilrciucnt  bcfora Augu.sl  4.  10'JS Tlie
 rhunc<"*  1*1 thu inmlieinciil fur Pctlfiul
 legKlrulluit  tllcc !e< I no chunue  In th«
 •tutus  of lltL-.M; prod tic U uiidi-r P1PUA.
 Acfordtnulv. the |Hillcy of phased Implu.
 ineittatliiit uf the changes In the Pcdvrul
 rmUtKitiiin  rrnulrcmcnt has  no  appli-
 cability with icsi*ct to products In this
 cutmury. nnd the Acr"''V  will l>i mosl
 clrciim:>l»ncea lithe enforcement  uctUm
 ftl>ulnst nny  pi-r*on distributing, idling
 or othi-rwtjc moving any kuch pioducU
 In Intcr&tiite or lntrnsl:itc commerce.
 6. Prifi' life riurfucf! Wftrtbutttt, Sold ur
   Otherwise tlt-ntd Sutrlt  In  fnfruifuf«
   CommctCf flr/or« Auvtitt 4. I97i i"ln-
   tratlale prmlncli"!

   lit  Intraitate   rettirltte    Producli
 Which Had Vt,H>   r>I the  trrUtin  1  '
  recnhillons anlhurUcil persons thiclud-
^ Ini! Dilate and Pcdcial MUCH tic** who held
  'wild,  au»le  rriitilnt lions  lor pesticide  '
   imdiicts on  Aunisl 4. IB1&.  lo submit.
  wHhln CO days lie., by October 4. 19741.
  notices of  application 'or FVdcral ie«i»-
  IritUon. lit pmrtlce.  Ihc Agency  has c«-
  lendcd thl* i:ime upporlunlly lo pcf&oiu
  (Including SUte or  Federal  agencies)
  who  had  on Auguftl 4.  I91S  valid pci-
  rnlMlon puuuant la oilier procedures au-
  thor ire d  by Slate law leg- Uie Cullfur-
  iiln  "use  vuriattce'*  procedure I   It dts-
  tilluiiu. it (I ur otherwise move a pesti-
  cide  product In  littiu^lnlc commerce ur
  lo list a pe&tlchlo product within  a filala
  la a  manner htconsliteitl  with  IU ap-
  proved labeling.
    Puiiuunl to seclloii 102.11. Ihc timely
  nthifi of a notice of application with re-
  spect lo a product In this  category has
  ImiKnliinl consequences on the status of
  the product dm  Inn  *'»* Implementation
  period. Specifically, section  Ifi2.l?la> al-
  lows  the distribution or sale of the prod-
  uct  In Inirastale commerce  (tending  a
  final dccMon  on the Federal rccl^lra-
  tluii  application, provided lhal the prod.
  ucl fralUiflca ceiluln mlnliuuni require-
  ments bi  arens such  as  labeling  and
  packiiylux. Tlicsc minimum require me til*
  arc sel out In section Iti2.17if)  uf the
 . section l  rcguhiiions, and ore rcslalcd
  \bclow In IhU PfePS.'
  )  An nolcil.  section  Itf2.t1*at only un-
 Xlh"rl/cs the  dlslrlhullnii or other inove-
  mtnl In lull astute commcicc of  quullfy-
  tnfl  siute  ri-|:l:.lt.-icd  produtU. wilh  re-
  «|ii;ct lu which notices uf api'llculltm for
  fidirHl recall»i(.ion  were filed by Octo-
  ber 1.  1015. In the exercise of IU prose-
  culorlil dbcrcllou, the Aftcncy will *en-
  ernlly not lake enforcement action under
  ftrt llou  l2(a»(IUA>  uGjln.U   |>ciM>na
  shlpplni;. ilMilbulhUf or moving In  lii-
   Ici'^tuU: coinmeicv un httra&lalc product
   which otherwise sutb.flcs  Ihe  ret|*ihe>
   nifnu of  40 OH MTCIIOII 162.11, provided
   lhat Ihc  pioilucl in Intrmkd  for distil-
   but Ion for ttse uc tfllc fnr use only within
   the fititle wliL'iC  the pitHtucl Is icfclilercU
     Inlmstule |>c»lkMv inoducls «llli valid
   Slule icttlvliullotts 01  ulht-r  valid StiiU
   aulhi»'l/a|lon» un Aucu^t  4.  I UTS, wilh
   tcvi'itcl lo «UMi uolicci u(  uuplicultuu
   I or t'fdcinl rrcKirolloii wt-re  not tlmclv
   flli-d riinnot luwfully be dlslrlliulcd. suit!
   or o!hci'v.'l.st niuvril lit biterslule or litti J-


     • At piurldcd In i|i* Mcclluii 9  tttiul*tIons.
   |M(M)lt« Mclllf A |>fuJllCl III lltll Cftl*|'.ury lU ft
                                              fttulr cuuuttrti'i-  Itt vlcv; *i| iti<- (:ut H\M
                                              M>nt;il  pioccduit ;  wric inctu ihc  new tcqunv-
                                              tncntt fur ptfuhwU in lh» cl»;i.. ihfio
                                              U  110 bnsl»  (or  rxrii'lNim; fi'i^'crntcnt
                                              illr.ciirllon nllh i»'Mn:t:l lu HIUM: pioxlucU
                                              fur fthU'h Ihc r.pffl:i| piorcttmcs  u'eie
                                              tuA  ft>tluM,cnl,  Arviiillttf ty, \\\t .\nettry
                                              will  u^inule  rnftirci'ittc i^ pMH'ccdin::«
                                              auuliiM person^ (ii:-tiibniiikit.  &L*lliiiti, or
                                              ulhciMl.tc movht::  hi lnli;tsi:tU- ur lull i -
                                              Hate vommttcv »w?.tK ttlt products »hl. U
                                              had  vulM Btiile ircMiMlOn:'  01  other
                                              valid Slate itiithoiUiilioith on  Am;u»t  4.
                                              19V5. but for which iku  llmvl*  n«Uicc --f
                                              oppllcntlun I or I'Vitciul  icQi'.tt.'ti-m n.<^
                                              (lied
                                                • 2t   tnttt»\tt»tf   fVtfiridir    J'jofii «»!•/.-  J/cl.
                                              Luio on Anuu-,1  4.  f?7>
                                                Inlraslulv  |T>.tit:ldc  ,MiMhicts lit  Hits
                                              class were bi-iui: dnilillmlcd m  O||U:IVI|MT
                                              moved  lit  Inlii^luic it  unique Hltrit^liy
                                              on AUKUSI 4. 1U75. uiuUs ;ipphf;ilil ui comny Victwt'tk
                                              filnte mul  F'etlcriil ^nctnmcnts  alone
                                              mllitiile niiititi.%1 i-xi-iriM- of rnliMrrinmt
                                              dl'.ciellan wilh tr:.prcl lo &u» li imwludv
                                              Thricfore.  cnloicciiM'tn  uriutti wtu W
                                              litkcit  ni|itln->i uity  IK'I: on ill:-li ihuliiMi.
                                              Kulllnil  or olIn-iwiM-  moving  any  kin U
                                              product In lu!rr:.|-ilc or inlmil;tl« cuiu-
                                              IIIL'ICC.
                                                <3> lnfia\f«fr Pnulm l\ C'luiti/lcif «J
                                              PciffflnYs Unttrr HH:A  Out  Not  Suit-
                                              ti-it  f» Statf /».  Au-
                                              gust 4.  IDTi MIC foiislil.-ied I*   he  (n;Nll-
                                              cldr:i under  KH'IIA. but  wnc  nut »nu-
                                              Jccl  to  icul'.lrittiiiit ur ullu-r  :iulhiiri';i-
                                              Hun  iC(|Ulrenirnis imiti'i :>i>|«lii:ilitii Si ;t It-
                                              law.  l>enen>lini;  UIKIII  thc^  Slnlr  cnit-
                                              ccritcd. Mich priMlurlt in iy iMchnle «'*'i'-
                                              lithi  «ll.-iliifcci:inl.%. .tiinlli/ci^.  (MMU-l.lf-
                                              icillllzcr blciitts and piiMlticl.\ 4-i>nl:ihiinu
                                              anlliiilrittLlul  ii;*riti.s IniemtMil  f*ii* lh*t
                                              puiUlcntlun  uf  dthikini:   wal-r  'Miim1-
                                              tlntfs rcfctrrd lo .1^ '•HIH<>I iiiiiinvis"* .
                                                On BcptfittlM r II. I ft 'I I. In  u I- f 01 M*I.
                                              ItLCisita  iiolht:  ntllllrtl  ."Nulu i>  Coii-
                                              rcininv Kcileial ll*iiuiiruirnts  I'M HCM»>-
                                              Imlloit- lut nutate  IV.-.li, |i|r.\"  liltl  l'i-il.
                                                         I. the Ai;i-nt y .tl:il«-*l lltm
m»nncr
                                                              ):
                                                                                                                      eiifu(c*ni*iii t
                                                                                                                                     40 crn
                                                                                                                                                 n«fi.
VtilCtl »»• dclitfil •. |w ,ii, i i, «
but wtll*-lt Mr** Dot  lf,;:4l|t-  |
r«MUlcictl unilcr •|i|>iK-->iilVHrf*|  «r.;UI
In -ibUllun wf ri»JIA »ft«( tli
•it (he 
-------
 7'hl.t i>ii>lill>llum Kit* Included) In Ihr w»:-
 tlon 3 ri'i:iiiult*iii*. »«»1 Is imw cotttflint ni
Pi u(J iiCU ctiftttttly  iM-lof •lil|>i>rd,  dltlilU-
tiltil. and tulil •ulclf within |iili*,-.i*t* t.-'>iii-
nicir* •nil »liloti *ie iiot lci;4ll)' rn|«li nl to
It* f<-,:t .It it.l iiuilrr Sl;il« UMT imiil nice! III*
ir,;l:>irillili*Miriil  of Hi*  Acl U ll»*
|jrpdu..t  IN » (tollildc •  • * Hu |>ef-*>« in»y
(IKlrltiulr. ii-tl, oflcr  Iwr *«t*.  lioUt lor  •»!*.
Utlivtt ii« tMimirut. l>IU:;il)lr Sl.ilcliiw tvereiiolufloidfd the
otiforlitntiy  ol flllnv  l HI UK- • of npullfii-
lloi)  lei  FVilrtnl  iTjjlsluttlon. and  1-011-
llniilntt  tu dl.itriluitc llu* product pemllntf
fiittil m-lloil on their hYik-rul rceMiittluil
opiillr.nlloiiv A* Initialled In M-Ulon 102 -
nic». It h now Ill.-eill  la dt.-lrlhnte. sell
or olhri'M'l.se nutcc any me It product* til
liilei kluU*  or  hilritaliitc  c on mi* rte.  un-
less  i lu-y  ate  ivutslvivd  puibiinnl  to
Pi Pit A.
  One of the fimdiitnciilul u.sMiinplloii*.
uiuli-ilvlni; (lie di:rl»M>ii nut to iniikc Ihc
nollt:c ii( nitptlrulloii procedure uvtilluhtc
ti» llu-M! product* K-US lit (i I U wu» not po:;-
iiljlc Id make luloiiucd judgment* con-
ret'iilnit nhcllu'r llu-»e inculucU tu a clasi
ri'iK'ittlly t>it (IsDi'd  iiiiiiliiniin  ktaiuluitU
In Miih  nrcas ns lutxlhifl. iiutkacdtg mul
jnoUiirl  funiiiiliiMoii. iKcniu.c Uicy  huJ
never htm  subjcrt  to itny  refill rutloii
It'Qiiltt'lilCIll,   AltOllH;r  kt-y  UMtnil|itlt)il
linilrilylnit Iliu upiMOitch tukcii wtlh H:-
n|»c«;l to tht-fc |»)Otlucu  witfc Ihui It woiihl
be  i>u<>stMc  to i»ro<:ek< npiillrittloiik foi'
Pi'ilcinl iiui^tnilluii ol aucli i>«o«lii( Is mi-
     it auin* tnkluiiclrtl  piudufU  olttch  kr»  (MK||-
    k pur*u«itl to f'lf-'IIA from BlMlfl i«itl*lr«-
      r*(|Miiciitcitl>. For ch*iit|ili lh« rc^tilu-
       of lit*  tiuia  wC Waihln«lu«i  pioviil*
fur ut«
                     iift.:l«iili.  or
                     ||iii«. puhllc
                      tc In |>til*Ilc
     Di«nlb. tor ltlit|tun PckHCIil*
     Act  If tli* UWI >nd claim* du  not «•-
          Til U7O|a>.t0tctU» Vlaich 13. tttll.
    u olhcr  luiUHcr*. Bi«le» h«»» not «««r-
    (-• 4  trtfuUtory  JiulidlctloH  ov«r  CM lain
    ir« orf |>ruduft4 whlcli *•• peilltlil**  pur-
    ni  to >*I
                                             *(rr Ihc I'JI?  l-'irilA |nl»i  lo II u-  clh-c-
                                             U\c  tl»(c  of  llti^ Mellon 1 it-cut ttt'tum
                                             1'hiis. one u( (In: |K iuiiii-y |tui IMI lcnil>i'i 17. ID! I I-'toi»*i  Itii-i*>iiH no-  '
                                             tUc w.»i tu tiUrfl |*nxliu'i'ii. u(  |iiuil. n  lo  Ihc  «-lli:t:llV4
                                             ttdic o( thu siciUui U ivutihiiUms.
                                               M;iiiy pi4Mltirci^ of  |»H «!*(«•( i In  IhK
                                            class ui'c Miiall Lir.lnt'>:.« s. mill nl>l>.nvi>lly
                                             tit Mni»« ltist.(iu:t-:i aullt c o( tht* nnuhc-
                                             nti'iil  tu <>li|;ihi  Kcili-ral rrr.isLi';iliiMi bc-
                                            'Joic the i-lTcL-llve (  M-rtloit  I21UH IHAl
                                             ullh  ie.N|iCcl  lu iJi'iXluut^  In  this  tlitsx
                                             %uulU be ^cilously aUtmitlve, 1C not (;U.il,
                                             In  tlic.sc MIHI II busliir.ssrs. MoiTin'cr. the
                                             Aiftfncy  believes th:it .some |uu«lui:ls hi
                                             tltla irluis  meet luliilmmu  UaiuUuda lit
                                             such  areas ut  t.ibcllnu. p:irkiiciuu  nntl
                                             (uiiitululloi). uitd p<»ic no i; i inter Im/md
                                             to  tniin or  tho  nu'lruiiiiicnl  th;»n  other
                                             pliHluiit^ tt'hlrh  1114: belnit nlluweri  to rc-
                                           •  tnalii In mmiiicire  lu'iuhiit! it full icvlrw
                                             of  uiut  llniil ilct.l:.loii on b|i|tlicitLli>iia for
                                             Futlcriil iri*lsli:itlt>il. Acco»ilmi;ly. wlillu
                                             the dlitilbnlloH, katc. or olhcr inuvrmciil
                                             lu  tntiQ&Uite  or hiici&liile  roimnerce of
                                             pro«luct!>  In this clusj ut this  time  Is  a
                                             *iuhuiuii  u(  icciU'n i am  M 1 1 1 A » .  the
                                             Af;cm:jr, In the  exercise of IL«  |>ro.secii-
                                             L'nliil dl^:itllon. will not cencmlly  tako
                                             rnfoicenu-nl action auahi&t iri«lui-rr  ur dl .lr|l»ilui I. nil i.»
                                            hlMiwl*(lc« tif  III*  rr<|illl*:tii*iil  In (iblwiit
                                            rtd-:r»| i*cl-.lf.«tliii* |4ir  |K« |>rtMliirt |irlitr l»
                                            tli» cllccttvc dftt% ill IhK >t-rUtm J iri;itt*iU>»-;
                                               |ll| 'I'll* lit* |ulltlll*. Mlltl ftirilllllBiMlll >l(
                                            lha (MiHltifl Kftll'.ly  lit* f rt|itlirnn-ii» - ,.|H'I i.
                                            n«ii iivin^.
                                               I III |   'I'll* |Minliir|  nitl-llcn  the  l.tlM-ltt.M.
                                            |Nirll«ltl|l|t  Mild  liiri'iii|.lll>il(  r4;(|llllcl(K Illn
                                                      lit -IU I'l'rt  H'2I7|I|. *iut ti--i»*i-«|
  III) 1'lit- (titMln.rr t.r 4l|>liltiiilui  •..iln.lirt
Ihr  ni|tilit Hiritls s.-M-.-maU  brlt.w  Kltli  ir-
s(H:.:l IM itl.l:, ..... «•  Ixlci.il |l<(^l~>4i-«>l-ru4ucl  inuv  lukc
pluce until iurh ilup *alc order h;»-. brcit
vncnteil. The ilop *.ale  oiJcr inity be vn-
rMt«:d If lufoirnalioii t\ |>iovlUr bill-it It tutu lull
  rnnipli.mre with  all  the  rrrinhi: incuts
  .spctlJird nlmvc. In addition  to the l.s-
—sUiincu ol » stop siite ordur, |ieri.om dU-
    hnlbi".. silllui; or olhct rtlse luovlnu lite
     uliict In mmmcicn limy brt *ub|rrlrd
   . ollu'r   rcuiiti Inl
  ill:.c clloii  \ '. be rsrirlsrd only until the
  pi*o«i icI I-  D :eoi'd»*i| full  r'c»l*-inl  ic;il*-
  |i:ill.>n oi n  totlc.c of tie 11 lit I nl rci;t.U"ii-
  II'.n for  the prniliK-.t  Is I  surd  II  rrvis-
  tuition I* dented, roiilhinrd 4lKli ibntioii.
  *;ilr ur itlhrr lutivt'uirnt ol the proilurl til
  i-iiiiiini'iri*  will rc'ult In i-ufurtcuti'nl  m--
  |l«iit   undrr   section   I3UI <|l -
  irntlon  Aiul.  In prtitlruliii.  «lirlli«*i-  Ihc
  |M:r&on (mil ;ipi>tird lor 1-Vdi'rnl rcci.'.!!"-
  iloit wllh rr:-i»rrt Ui «»lh«-r prmlucU |tio-
'rrtucitj by hint not Mibji:rl to 3tAt«  ir^iu-
    Mnn lu the |»rilod bclon* the efltn-llvi?
    It*  of  the Kertloit  3 n-iiulutlon*   It  In
„ ..ipurlttitt  to  note, however. Hint In  «H-
  liounilnic this  iKillry  the Aitciicy  Li itnl
  inuklnic luck of knowledge of Uic rcqulic-
  incut lor IVilciul ri-g%lra|lon  nn afnrni*-
  llve UffriiM}   la  *  violation   of  ccclloii
  !2fa>tlMA»  In  Hit* or  inty  other  lii-
  utAiicu.  litxttnd. the AuRiicy l.t hid k" nil n if
  Uittt U »'1I1 m»l Initiate or puiMie ciilaice-
  ment action itKttlnst n |»cr^nu  for *  viola-
  tion ol PI Pi 1A  section  l2(aM|MA». In
  ciues where U U itcrsuartcil U»*l the per-
  son  d!4 not have knowlttUo  of thb rc-
  qnlrenti'itl. provided thai the other con-
  dltloiu  controtllni the rxrrcls* of prose-
  cuiorUI discretion In thli  hutance *r*

     til) Hrqutremcntt Hrgartltng V>€ Pat-
  tern*  anil Formulation  ol  (fie frtx/ucl.
  Prodnru which fall In thl* C!A»» must be
  aubilAiillally  *lnilUr  to  pro|  lit* Mi« pMiiKiti* i.  iiu.  ,; ---- ••  •  »r«
                                                                                                                   •ubslikniuiif •imtl^i in tl-c  ii ; JJ^IIKHI vi
                                                                                                                   a  proUiict Wlltt a  v»IM IVurr^I lt-|;lbli*ll*» a •ukttniiiiititp tlmiiar  luimuu-
                                                                                                                   tton.

                                                                                                                   Tlio  dt'lcrinlnAtluii  nn  lo   u net her  &
                                                                                                                   produrl is *iib\tniitlully  jlmllur  to prod-
                                                                                                                   uct* with valid Frd>'i-iil ic^lstiAtlix^ will
                                                                                                                   tio tnnilo by  Ilir  bcb-niiAc AIM)  tcrhnkul
                                                                                                                   Itri.soiinel In Hie Aurm y': 4HM»c of I't-sll-
                                                                                                                   cUlc rn>i:rnni!t.
                                                                                                                      In mKlltliMi. the piotliu'l  tntiiL not  be
                                                                                                                   n  pruilitcl  u'lllt  tiny  of  Ihc folloivnig
                                                                                                                   rh:ii*iii tciUlk.-i:
                                                                                                                      1 1)  Any |i(tttli*f| i-.>iil;ilnlii|; NII  «ciltc (H
                                                                                                                   hwil liti-.tvai'-iil mil nnn^lnr:! In Miiy  tl'A-
                                                                                                                   lf|:l: ll-tcil |M.-ltl|-|.
                                                                                                                      |J)  Any |niHlti«-| Mhlrlt r*Mil:iliii  kit •Cl|«*
                                                                                                                   4>r Inert li«t*ifillrni «lililt w»j» lucliidrtl In a
                                                                                                                   |tfiHhtct  *.t*it-« trf.i«(4Atlnu  Uo» bccu   *ut-
                                                                                                                   |>eiMlftl in ritui-clleil  liy KI'A bri'MUM It con-
                                                                                                                   iKIuril llt^i litgrrHliriil. ur v»hlcli  !>•-* b««o Id*
                                                                                                                   •ul>K>'fc "' •"  *;t*A tuMiiv  of Intent lo •«•-
                                                                                                                   l»*iitloii.t  *llh
                                                                                                                   rrj;»rtl tu »ucli litRrvillciiLa;
                                                                                                                      f.l|  Auy piottuci •«< usa wliltt* U »ulv»t»i»-  ,
                                                                                                                   luilv MiulUr  lo *, ptitdii^t or m*  h**  bt*o
                                                                                                                   it 10  »iib|rt:! i*f  • imtlt:« ol dtitial of ic^uifk*
                                                                                                                   Ibiit |»>ibil(|iea In lha Fin*K«i.  ni^iank  put-
                                                                                                                   •iiMiit la .t«clluii J|C||U|  ul  fiFUA; or
                                                                                                                      (II  Any t it • xl ti<; | or tit* »lili*li tJn r*«^on-
                                                                                                                   ftbly b« *Rp4-clc oa
                                                                                                                   or tu loot! 4>r feed »mte»i tt»c  «-,e  ti •upportcd
                                                                                                                   liy tl»« Ht.-cr>i>ry  t»l«r»ii4.'cv *n4-iii|ttluu^.  ur
                                                                                                                   uilicr £l'Ai*ii4.rj tinJi-1/ i|i« ^'ctleral Food. Omg
                                                                                                                   •ud Owiucili: Acl  (VI  UliC. tjrc'luo 30 1  c|
                                                                                                                   '***!  !• "*'  tb|  vlolkid  Miiy «|i|illCrtl>lt) •tftnd«r4
                                                                                                                   liiUCd  MM tier  Ih*  Sale  Dtliihlii^ t\>tcr  Act
                                                                                                                   («J  UUC. ItOI  ct *«M |.                      :
                                                                                                                      tllli  lictfuircM£'tt  tu Obtain
                                                                                                                   Itft/ittration. I'craoiis dl-'klllhutlni;,  sell-
                                                                                                                   ing.  or  othcrwUv  niovlnic  In  Intricate
                                                                                                                   cooiiiieico  rut   tinrrcKlricil  lulra.slate
                                                                                                                   pr4Mhtrt In this irlu-ss inuM tnilKilc an up-
                                                                                                                   pllcitlloit  I4»r  Pc4lcl;il  iri:l:.tinlloti  :indj
                                                                                                                   pursue IhK nppllcittion In i;o.xl fniih In
                                                                                                                                                                  •A» (i^rd in till* I'KI-.I. Ilir ICIMI ."lon.uila-
                                                                                                                                                                llnii"  tifti  Hi* Mini*  mi-Mitlug  *i f|t«  leini
                                                                                                                                                                -p«sllfMa fontttilAtloii" lu tli« fctton l.ic|*u-
                                                                                                                                                                Ullont:
                                                                                                                                                                       'fit* Icrnt 'pcillclil* fmiiiuiAllon* m*Au«
                                                                                                                                                                    Hi* •ubit*nc« of  i*il«lui*  nf *uoil*ncc>
                                                                                                                                                                    cu(uiayt
                                                                                                                                                                    Cr'U
                                                                                                                                                                  •A*  used  tu ihl*  I'Eltl.  tti*  Itrm
                                                                                                                                                                 «tUr«t" h«» th*  **in* rnc»nlnf (l**o It  la
                                                                                                                                                                 b» »*ellun 3 r*|ul»tiun*:
                                                                                                                                                                       'Iti*  l«rm  *ui« |**tlc(n*  m*»n*  Ih* *
                                                                                                                                                                             la «bich  &  p<*tlctd» U *|>|>ll*o,,
                                                                                                                                                                    •f pMllctd* *.|t|itl4.-BUo«:
                                                                                                                                                                       III  TftUd f«(.
                                                                                                                                                                       (3)  Crop of *uluitU  li««i
                                                                                                                                                                       |l|  AppliCkilun *H«.  *n4

-------
older to sutlsly ihti rvfiulrtmtnt. the per •
son limit:
  (1} MU an ap pile • i km for r«d«r«l trgM-
lt«ii« oilier*!** m0*rit lu ruiitnic'r* lit vl<>-
Ul It'll uf »«flian lammiM:  t*nu« *tic rrjUlrftiiiiii •|fuct»*
Tito Agency caution*  that It will review
the status u| Applications (or Federal lew
Ut ration lor prcducla  In  Ihlx flan  on a
rrgidur busts.  Person* found not to  be
puisnfng on Application lor Ptdernl rei:*
Islrallon |a good latili will tw subject Id
Appropriate enforcement action.
  (Iv) KfQunenientt fitpardln0 f.nbcf/ria
and Packaging and  Other ~Sn»»jVrii.  In
lite Implementation Plun wltlrli wi».«  pub-
lished In the  FVOCMAI RrciiTH  shortly
After rnuctment o( the 1872 Amrndmi-nU
to PI Fit A. trie Accnty provided * llsl uf
ihe requirements impost cl by the  aim-iid-
menti on tuirastnte pesticide products In
such tircM*  AJ labeling and /ot nml;i(imi.
lift  Fed. Hri  1)43.  January 7. 19*11
The&e re  pc&tlcldti  tnamif ;tc -
liners  And distributors, and tit older lo
Assure  the  «ute<>l  possible tU^cintu
of  this Infoitnattoii.
   (11 Minimum Labrllny Requfrei
  Ilie {libeling of  All  |ntr*.sUle |ic^
product* * tilth are itoi Fedecfcltv rent*'
(ered intisi conUIn At * minimum th«
(alowiittf  elciuend. plut-ctl  pioituueulty
with inch roiis|»lcuousnrss 'Aj eomiiJit-d
with ntlier words, tiAtcnteiUa. or older
(rapliic miitler* A* to render II  llhelr to
be  read And understood by •» oidlnury
(iidlvlduol  undi'r  cu*lomory  cundi Haiti
of purchAse und u%e Isee FlPRA, icclliiiui
3<(jMlMti «nd IZIaMIMEl I;

  !•)  Htcrtikry  dlt«ctloMt tor ui«  |>«*
                           *»<*  i>(*iiu
   fl>| H«r*«t*ry |>r«c»Mt
 •tBflilit(*  |»:« ftt'UA.
 •nd iai*l II.  JM.I Mini | I I ,t:i |; I til tilt
  I It i '111.-  trt:«>ltMMttii   tiMMilM-r  A---li:it.-J
MiMli-r M-I i MII  1  in t-rifii v-i»i*l»"tiiih-Mi  irt
  In itdihlioii. ihr liiliftlii-t tit A proiiurl
RiiINt  ntil fimlalit ;»iiy >hilrmrul. dc^lyll
or ci'H'lili- ii-i'ii-M-nliitiiHi n-hiltvc tin-it-
Id wlilfh ii (til -i- m mlsli-iidlitH in Mny
pnitlriiliit  Kiiv   I IKK A. ;«-t(iom  3« I • -K» I. .iiid Mif prod-
uct lllii.it lldt he  ;iil luill;iliii|i 01. «ir  bd
offrii'd lur  Mtlt* imdrr iti«> ititmi! m, uu*
oilier  po.stii i,|,.   | vi.r  FlfltA.  *:iluir  |H-.-.lit !,!.•  iiitHlnrlA  «|ilcli
Aie not  Frdci;itly io:l>ifictt HIC stilus I
lo tlu> lull*.« miM4  U- -iMtlithwil l/
  tt'irr  !>••«  I'lPIIA.  *.-. Muni  lictll)|l)i
             rim*.  --.:i
                                     (U*
   In kcriiliii; ivllli tlir  r.cnviiil objective
 ol arhlrviiif:  u  Ammtth  tt:m.-.ttinii to Hi*
 new  rr<|ulri:tiifiitt, th,; Xi;nu y Intend*
 to Apply Hit's*- tfiitiiiriiiritiK lit A  com*-
 man MM»:.<* niunnri'  (ieneiully. enforce •
 uicul ni lloa  *i» be takrn when, hi tho
 Aflcnrtr'A   jndj:mrid.   drvlullnn.i   liuui
 thf* e tciimt vt»cuts  m ft istnniflrnnt Attd
 niii;h! n-Mili  In M-I iuu\ liurnt  to mint or
 the    etmtoinm-nt.   In  addition,  tho
 Ai;cnry  TXIMTIH to ruofdlimlc enforci:-
 luenl ailitmi. \\lltt klate oncntlf^  entr-
         it'.-.Hrldc  irunlntoiy   rr.spni^l.
 vuircmcnt   r.NtabtKUmcnts   In  wltlct.
 Intra^ltitc |»e>llrlde  pnxtucl.-.  ore pro-
 duced  Ittwe  tii-4Mt MiUjccl la tht:  t-.-.tuU-
 ll&hinml rrijl%li utjiui ri'«|iiireiiiriil of sec-
 tion 1*»i  ol I'lKltA  since <>ct. Accordlnidy,
 Iiersons  inodtiiiiiu  lut4(i-.tulc  piodut-*
 tit   uniL-cl\|e(i:d  rslalilKIunrnt.t  h/
 *lncc Octottci 21. I!>'M, bcca In  vlolutV
  of section iiAl. and IIAVA l>ceit «ub|ecl M
  tnfofcement  mclUm under  riVHA  *tc-
  Uon  llUMlta.). In Uie exerclat of IU
^eufurctmetiX  U^cn-Uvo, Aivd tubjtcl la
  Uio MndtAtton fcial d belo*. Uit Afe'ncf
  »IU not tttke tutoi cement ftctlou undet
,. *tcl lor 32< •! (1> (L>  Afnlnsl • person tor
  vlatoltuA. itclion 1<»i  by ficduclnf la
  *.n  jnregUtercd  esMbllstimeiil  An un-
  regUteicd Inlnut&U product lublett la
  lldi  cubpurl  (I.e. A  product nol cubjccl
  lo  * Qt»U rcKtalfAtion requirement!. If
  Ihe  person  lubmltj  An Application for
  eiUblb) uncut  rcglUiaUoo  wllMn  Ua
  <10> d«y« After  noUnc»llon that h* U
  subjecl lo tlte cstabllshtnenl re«Ulr»tioa
  requirement. However. Ilia Agency wtll
  only afford  Udi grace period In cue*
  where  U h*t determined Utal U*  pro-
  ducer did nol know aboul Uie «*Ubltah-
  mcnl registration rc4utretne.nl,
  IV. COWVKASIOM  Off A FH»l*»tAT
    TCMCU 1'nOOOCt TO A 0T«
    P»O.»UCt S*TlirYlNQ T1IK RiQUU
    or«OCFIt IA2.I1
    Currently, many producU which poc-
  •esj Identical clieodCAl fonnulaUon* Ar«
  valtdly regUU-rcd wlUi  both Kl'A  and
  BtaUi  agencies. In aome cases, however.
  Uie Federal And BVr.it labi-U cunUtn dif-
  ferent provision*, reflecting Uio  ternia of
  their icvpccUve  (Itale or Federal reftl*-
 slruUoi\«,  with regard lo Uia method  or
   :ttlc o( Application, l&rgel pesla. proicc-
 - live  do! Mi uc requirements, or  other
  wanting »iul prcciultonary aUleineitU.
    KlFftA aectlun I7  lUAkc* U
  unlawful "to dcUvti. alter, deface, or de-
  Alroy. In  whole or In part, any Ubellng
  rc^ulrcU under ihta Act." Tl\e attUccdent
  to Uda provlilon In 'lie 194? Act Itcctlon
  licMli;  II Out  loarwA* Interpreted U
  proldbli n»o»l stick cilng or pasting  over
  of A Federal label by A Stale label  or »ny
  removal of A  Federal  label for  replace-
  ment by  A QUU  label. The Accepted A|- ,
  tcrnollvts have been til lo rcpuckAge or
  rcformulaU and rejiackag* A Pede tally
  registered product lo product) •>  8Uta-
  rcfrbter.d pioduct. or  (21 lo obtain *
  Federal regbitrAtlon for  Uie Slale-rcgU-
  t*:red product. Untiled lo use only In U»«
  6tute In question.
    Tlie  Agency believes UiAt there  U Jus-
  iUlcvlloa for  Uie exercise of pro«ecuto-
  rial discretion regarding  certain  vlola-
   Uun« of section I2iai t)» . during th«
  pliued tin piemen IA Uon  peilod  for  lha
  p«:w regt>lr«tlon rc>iulrenienu. Thua. Ui*
  Agency will  not Uke enforccmenl AC Uon
  undcriecUonl2iA)ia>IA> MgaUuitApcr-
  •on who  convert* * Federally rtgUlered
 vyoaUclO« producl lolo A chemtc^ly Idea*
 UcAl OUU ifil-Uifd pro Intl. In lha fol-
 lowing tiivu!H\tuiiccfc:  •
   (II "111* ic'iili'iig flfiU rt^tstcred pc«»
 llctde prwtuct tatlan't U.« t'^ulieotenu
 of 4J Cm 113 If. T>"-1 U. Ut« prenJucl
 must li*v« It"'I * VAltd HtAte rcaUUaUon
 or other valid tilr.te nuihcrlr.tUcn on Au-
 (iut 4.  1116; A notice of Ap.kltcellori for
 Federal rentstrutlon mi'it ha ve teen Alcd
 U-fora October 3. IB71.  AJid Utc product
 pitut aalUfy lh« mmimuni requiremmiU
 In auch Art*i ••  Ubcllng, packaging And
 pioducl formulation act out lit 162 ITU*.
 And rclleratcd In PArl III of tht« PCFS.
   <2i Conversion la Acconipli.hed by
   *a>  comj.lrfeli/ repluctng  or  coveting
 the Federal label with the Slate label; or
     Adding aiippleinenUry  Ubellng.
 approved  by  Ute  OlMc. which  Mcom-
 panlej any movemenl of Uie product In
 commerce, fluclt  ttipplemental labeling
 nnt*t contain Uia proper CHA E*l*blUh-
 menl Number; 
   O>  No  confudloit reaulU  lo lh« con-
 aumer.  AA lo •   cly caullbiia. direction*
 for me. IngrcdlenU. eClcacy und accept-
 ance by various reguUUng  agcncle*.
   It U empliOAlzed lhat eiUorccmcnl ac-
 tion will  be taken  under acrllon  )3
 I2XA) with re&pect to person* sUcker-
 Ing, parllAlly re-JnbcUnt, or performing
 any other Acl which only paitUlly cb*
 •cures the Approved. l»b?l on a Federally
 tcglstcrcd product, lit addition, conver-
 sion must rcaull In A product which aal-
 isnua all   the requirement* of 40  CPU
 162.11. A  conversion which icaulu In any
 other lype of product b ouUlde Ui« acopo
 of  UiU sec I ton. Thuj. a con yen Ion of *
 Federally registered producl Into an In-
 trastaU  producl of  the  lype which I*
 not regulated by Ihe 0Ute in which U U
 lo be *old or used (described In Pari Ifl
 IBl (2Mb) Ol  of tl.b Pistil will rcaull
 bk  enforcement  aft Ion  under section 12
 UU2UAI of Fl Pit A    •   ..

            V. PUBLIC COUMKNT ' •
    Ttte AdmlnUtiatlve   P/ocedure* Acl
 U  Ua.C.  |553«b)| inovldea  UiAl Ihe
 aollcluilon of cummcnU I* nol irqulre>J
 of Federal ageitclr^ for  "UilerprcUtiv*
 rutea. general alateinettia  of policy, or
 rulea of  agenty oigAnteailon pioceditre.
 or piMcltce w EPA  luu delermUtetl  that
 this PEPS falls  within IhU eiempttuii
 from  lh« requirement la  solicit  public
 comment. Accordingly.  Ihe  Agency U no:
 •olldtlng public cointitenl (euerdl:i« oial-
  Urs published  lo  UiU  notice. However.
 InUresled person* m«y «ubmU written
 coinmciiU rcgArdliig' the policy act forth
 In Oils PEPS to Hit Peattclde L'nforcc-
 tnenl UlvUlon  iEN-343>.  O01c« ol En-
. lorccmcat, UJJ. KnvlronmenUl ProUc-

-------
Hull /\f curf. 4111 M 81. 8W.. llconi 3414.        Dated- Mnirh H. 1019
Wefthfnclnn. I>.O. ?OI00. Tlirrr toplrt of                     STANLEY W. l.ccno
thrff tnniitiriiU tlmulil tit jubmlllrd la                  Anltlaal Adminlilraiu'
/•rllllflte (he nark of Hie CrA and othtr*                          /or £'n/orrrmrnf
InlfifMr.l In In.ixTlln. .nch durutnrnU.          (fn „„, „ 0411 rllrf , ,,_,
                                       10

-------
UNITED STATES ENVIRONMENTAL PROTECTION AGE
             OFFICE OF ENFORCEMENT
         OFFICE OF GENERAL ENFORCEMENT
         PESTICIDES AND TOXIC SUBSTANCES
              ENFORCEMENT DIVISION
             PESTICIDE ENFORCEMENT
             POLICY STATEMENT NO. 4
           MEVEMTIVI «il CONTROL TREATMENT* M
              THE ABSENCE Of TARGET PESTS
              d Ciom th. Pc7«
                    HI *'R ?«OOS)

-------
     PESTICIDE ENrOIICEMENT POLICY
             STATEMENT NO. 4

    revenliva P*H Control TieatmenU In Ih*
           Absence of Taifitl Ptsli

          I. GtNtuiAL BACKGROUND

    On  May  6.  1075.  the  Environmental
  Prolei-lion  Agency (KI'A)  publish^! |n
  tliu  KIJJUIAI.  lltxiSTUi ti  document  en-
  titled  "Institution of tnfuitviucnt Policy
  Statements"  (40 K«l. Rvjr. I!t52G). It wa»
  tltu  Ai;em-y'*  purpose  in  inslilulinK  thla
  tvrlvt  of  iViilicldc  Knforccnuml l*oticy
  filuUmviits  (TIM'S)  to liifonn  Ihe  K*-n-
  crol  public anil  |*:rk*m» enRiiRud In  Ihc
  formulation,  distribution,  inte.   applica-
  tion, t»r other UM of  prslicid**  of  !«•
  policies adopU-d by the Agency in the en-
  forcement  of the  provision* of  the  Fed-
  eral  Insecticide, Fungicide, unit  It mien ll-
  ci.le  Act. as  ann-mlrd  In  I'J12 mid  l!>76
  (PI.  U2-5IC. 86  Slut. (173; T.L. B4-MO,
  89 SUI 761;  7 U.S.C. 1.1G ft trg.; herein-
  after  referred to  aa  VIFUA>. PEI'S are
  prepared •nd published by  Kl'A'i Office
  of  Knforrumi-nl.  Unk-ss  otherwise  pro-
  vided.  • Pt:PS Indicates bow the Agency
  will enorelac  its prosetrutorlal discretion.
  and doct not  Interpret Ihc  law  or other-
  wise drfine what is and wliat is not lawful
  cotiducl under KIFUA. If th« AdmlnUti*-
  tor  sul»t>e<|ucnlly promulgate*  regulation*
. wtmh  interpret  t'lKRA. the OrTtce of  tii-
  'oict-nivitt will revoke or •mvitd any prior
   VKI*B  whifh is  inruiisJbUnt  with  vurti
.. r«Kululitini. A dct»iled explanation of (tie
  purpose mid Kupc of thu  aerlci of I'KI'S
  wu> sut foith in the May 6. 1U76. Ftnt-i*L
  ItiuiiSTi;* nutirc.
    FVdcml  reKul«t|i>n of the us«t of pcitl-
  titles  w«s  cslublhhcd  for the ftrtl  lime
  with  Vbe enavli%*»t  of Ihc  I97Z  auu:n4-
  nit-ul«.  nu-fiAcally  Ihiuu^b  the provi-
  klonw  «.f KlFltA section .1(d)M>. teclion
  4 and  arc I ion  I2U)<2)<<:).' Any person
  who uses • rtijiiatt-rt*! pciticldc In * man-
  ner iiHontislent  with  its  UUllnr l>  In
  violation nf  the Acl  and  may be  tuhjitt
  to civil or  criminal  sanctions.*  However,
  »a set forth In the lecivlative history. Con-
  f rea»  intended  that  K PA  enforce  lb<
  prohibition  of acction l2(a)(2M<*>  in  *
  beouuntm  ac-nio  manner   and  not   pro-
  hibit  uses of  regiitered pejlicidci which
  ar« In  no  way  harmful and which  have
  demonstrated beneficial cfTecta.'

    II. Pum-osc ANU Score OP Tina PEPS
    This   policy  statement   concerns  ih*
  preventive  u>a  of  rrnisltrtd pesticides
  on a commodity or crop, or the  pesticidal
  treatment  of  an  environmental  area  In
  the absrnca of  a  target  pcsL*  Whether
   }revcntiva p*st control  trcatmcnta In th«
   bsuic* of a  target pest constiluU viola-*
tlona «f  FIKIIA  tertian  UUH^Mi;)  la
• i|urst)an which ari>r> In many r;*lr^ro(les
of  (M-al  i-iNiliul  idi-ludiiiK. I'til  no|  limited
lo. structural a'td ftffriruUural p»-il  con-
trol.


  •mil* M.tk.«  »(4>»tt  •)  ti i.u.  t»  »ut
|lll yii»U,-i  ik*( »• »«(i ••! tin **al.*f*ifc>« M
• |H.l.rt4«, lk« Afv* «4 tl.r ••|IM|*-
Mi*i«r.  U ai* Ji« i *!*..•. tnkf  ir^unr  S*«  «•
CtM f..i |«i 2 |Cii.
  »IIHA ••«tk.« «t*l«ll  II USC.  UCbi.i  (III
•M|»«tl« Ik*  A4iullt* «l
«**• ^rillciil.'*. Tk* A«r
•M! liitiil*J |u:
  III Ap|ttM*IW« *•! • *»*4UlJ*. l**•!*«
**»*  k-a-l)*^  attl *«p intuM'4 »««(w*»l*uir  ActlwB
U «r tn-«r Ikr •»••• «f MHi-lio**"* :
  lit S).M»«r crttiMtt IH,  |>«*tlrt4.* *ik4  |t**tWU*
•••Ulnrt.; »IH|
  ill |>U|x>.a| *(|l..Mi I.H  |4.-.|i(t.|.« *»4  p«*ll«l4«
•»•!•«•*>• "  |«S CKH |K?Jlu»lt.
  Tki* 4>-A»ilt»tt ••!  tk.-  Utfti "I.**" ku  t««R
tt4»i>l*4  k* Ikr Ulfi..- «4  I.Ml ..... t... ftl  U Ik* •»-
|MC*M.-«|  »l |u-*lMMlr UUrli«« ti«.|rr  »"ll It A •*<-
lk>« Itt.lllltlil.
  * Itux.r  CHMMitUv «•  A»if»llHi».  II H  ftrp.
NM. »2 (II. S2»4 C»M« , I'l t*'-" I* imil : S'««U
Cv«H*wiM»«> •* Affilcwlt'tir *•»! F ».*.!.»•  H.  Or».
NM. « >«, «JH4 iU.*.* . >4 S-- '  U |l»1il. A- Ik*
8***lr C.rfKmllli* »«  AatirullMir  **4  Fwi*-i>l«r
•»U-4:
   (••M^niHIM

  • S*nol« Cummttl*r  h* Ai(Wuli«>* *n4  f«f •
«•!(». S.  Hr|> N« tl SIS. S14 C««« . S4 »•*•. II
Illllt. A*  Ik* S.n«U- C»M*illtr* w* AB.U-'llof*
•w* I'vrMltf *l>l«.|:

-------
     1'lti- Ajtcnry enfinimijrs previ-nliv* p»-\l
  ruiilrtd mruMHL'i which do itul rdiidre the
  list*  itf rhfininJ prnticidr*.  such  as ex»d
  **nil;ilion |>rartiiTi, tin*  rMuhlMiiiifiil  of
  jihvHfnl l>urri«-ri to pr*ls. and liilrurnlf d
  iwst  m.'mutft'ith'nl   prm-fdurr*.  lluwcvcr.
  tlu* use of  |»rslu-idt*s lit  nn-vt'iillvu treat-
  ntfiils Is  a  coniinmdr  rernifnln-d  and nc-
  i-f|ilrd |h-Nt  4-milrol  practice  t*.K.. In Ihc
  0;- 1 Ji Mi Jin it- nt uf |*-»liridc tiiiirii-ru iiK.iintl
  iiiM-t:t i|;tni;ii;v including  imprrf;itiillufi uf
  WUIM|;  in  the (iruliTliuii  wKainst  null-nil;
  tu  |ir«il4Tlioii Minimi  jilunt  dis^i-ii's;  iind
  In lh»* MSI* 4>f prc riiHT|*ent livrl>iriilt*a}. In-
  tfiv^lid  |K-I fcunh hiive Inquired itilu  the
 fire uuiM'tntr* unruduclB I*
 ili-VMifil  f t»l i* i* trill with IliC  |>Ur|iU&vS Mild
 vliit-cllvcM uf r'lFUA.
   StvliiM*  2rls. ItOM'fVcr,  tlu  twit alfiniialivi'ly uro-
 vi.h-  fur  UN-  us*.-    *ilwr*e
 (•(fiYli uf itrbtM'iik.1!,  thu AjrciKJ' will con-
 liiiuii  U» |*k« ciifoit-vnicia action  atfnluat
 Ilio>c   IMTMMIB  who  nt>us«  OK-  pr Art ice
 of  nirvriilive |n'.tl ronliul anil uitncCfi-
 •aiily  intrtnlurc  rKrniicals Into |)ie  rn-
in.
                or  *:m-otrtMt:HT
    Ill Ihi* exercise of  II» pru»et.-u|uri»l dll-
 t * Hi i tn  I lie  Agency  hat determined that
 il  will not  t!i-ii(T»lly  intitule an enfuivv-
 mntl  iii-linti nirniiisl  a  pcrum  who  use*
 M n'i:itlL'ni|  iK-atii'tile In • preventive pot
 fuiilrid  iH-ftliiM-iil  in  the nhiwiM-o wf the
 tuii-i-l  i»«*:»l  wlirtv all  ol   the   f»l low in*
 rundilinn5 air met;
   (A)  II..  tul-.l uf  the pfslirHr uhiih la
 uiu*M!  in n  pi«'vrnllvi>  ciiparily,
  •(I.I.-I  Pl'PS  In no  way llmlla eiifurre-
niMit lialijlily fur a vinlaltun  of any  i-f-
liiin:itlvr  l:iUMni;. rri|uiirnirnt InrliMlinR.
hul  nut liiiiilt-d tu.  «loaai;e  rnle. ^ippllra-
titm  IUI-||Ii)ilt»'».
  All at Hit* limiting and  dcniiinit  pro-
                      IV.  Ki.AiumATioN  nv KN»CHU»:M»:NT  l*»i.-
                        14 V  |I»4;*HIIIN(;  Pitt VtHTIVU Pi;ST Cttfy1
                        Illlil. TUlUTMKNTS
                      A. Nil  AH'IIIMATIVt: I-AHFJ. |-HtlHIHITK»N u
                               fM»:vt:HTivi; m»:AT»H:NTS
                        Whfir the  KI'A -arrrftlnl lulir) ^|n-fin-
                      rally   pruhitiila  |ircvnil|ve  ni-:.t  r<>iilrul
                      trciilnu:tttn.  I lie  A^tmy  will ulrirlly  t-n-
                      furru ttic  (tiovliiiinn of MTtiuti  12fnM2)
                      |G>  nf the Art.  When* the  KPA n.r.i.U.I
                      lulirl Is silfitl  rfKurJiiitf |in-vvnlivi; trvhl-
                      ntrikl.  the AK^'»cy will iiinhc a  |ii'f»ump-
                      lion  In  fuvnr  uf  au^h  preventive tr«'itt-
                      nit: nts  biiltjifl  lu  the  IliiiUu lions  uf .scc-
                      liun  (H)  ui»l  (C)  U1ow.»
                         D. I.IHM.IIKMWII
                       l'r«'vciilive  in-st coulru)  licntiitt-'iita are
                     IM-rniibsililu if Ihv  lali:>'t |»«v.l niuy u-uioii-
                     ably  be i'»n»-*teil lu iitfrst the  urea lu  L*
                     ti'i-aifJ.  Win HUT  u  pent  iiifrsluliun  U
                     likely tu uix'ur in  m u'vcn itiluulioJi  will •
                     b«  tk-lciiuiiif*! by  the  Afiviu-y  un a <*a&c-
                     by-fitse  Uj-sia.   Thix   rii-ltrriiUiintiuii  will
                     l«  l>»9^'«l upon  II it:  Ai;«-ticy'«  knuwti-tli»
                     uf  |M-*| tuffs! a limn  In the  pru|msrtl ui«
                     •ilc ur n|i|»lifiilii>n  enviioiiiu«-iit. and  un
                     rf«'U|;tilyt!il jM'bl cunlrul pmclires.

                       c. bAfcrv ANH  trucAcv ur I-H>:VI:NTIV£
                        I'ruvrulivc  jw-al    conlrul  trealnti'iit*
                     tnu&l  he  |MMfiirnu'i|  in • in.iiuifr  whuh '
                     Itt Silfc illlll  ffHrUlioUi  ailll  %vhi('ll «'OI^*|
                     furma  lu  I;IMH| (wsl  rmitrol  prftclitf.   fV
                     tli-lmiiiiiiiti;  w lie I he i  a  prt-vculivi; |M*. *•*
                     ruuliol  H|i|itit«licm   mnfunui   to  K«KMI-
                     |»«-.sl c*>Mtiol  practire  the Agency will (a)
                     ext-iriae  its legislative nmmUU'  In pru-
                     ti'ct  ninn  *nI«WH|IVI  lir*lH»itt« or  |« ir(ul*ilf .
                     »rbr.l..l*4 .r.|i.kl.N,H|«  In It,* »!..,•<,  -I •r||.«
                                                 may  t*  •|>t.|l<4 U Ik* •W*»d*»  u(  •» •fi.                         ,


                                                I-.. In ...l...*(.,. ,fc, ,«.,*.tV(r".  r,r,nl|."
      l»'lli.iv m«-
i *—"ci'v:"»      ^;;,.v;zr:.w J^;vr!i' •JT-i, ii\.?\*
1 part of  lhl»      ttAf-  ,i  UHC  mikbil:  Mr* th«  «*i-il .« i
                    H..... *-.	•-.        -   '  -       -  ^
                                                                                                                                   V. rUDLIC COMMENT
                                                                                                                     \   The AdmlnUlratlvc  Prucedura  Act  {6
                                                                                                                      USC. 6&3lirv rol  finlh
In  this  PUPS I- Ihr P.ili«'.U> an.I T»\lr
Suhslanrrk  rJiif..ire,,u-iit   Hivi,i..n  (F.N
342k. OAire t.f  Knft.irrniritt. M.S.  Knvir-
onmenUl  P.ol.-flin.i Acrmv. 401  M  5t.
SW . Itouui ir.^l. Wu.OiiMt.'1-.n. Or  20!f.rt
Thrc*1 ruul*'tt »f lln-sc fnitiiiifiil* »h>prr|inir  »urh
docuinciila.

  Dated: July I-

-------
                                                       WOTK30
                                                                         51065
 PEST COMTRAL  DEVICES  AND  OF/ICE
              PRODUCERS
     Consolidation and C.'arificaticn of
             Requirements

              I.
  •  ?.equl«mer.ts  applicable  to   pest
      I  devicrs  ir.i  device  producers
;      j«n set  form  in  various  resvla-
•-. - promulgated pursuant to the Fed-
eral  Insecticide. Fur.r.cide. and  Rodea-
tlclds Act, as amended 'E6 Sin. 373: 89
Slit.  751:  7 U.S.C. 136 etseq.)    of FIFRA to mean:

 * * • »uf iii^j'_anc9 or nlrtuj'C of subsCAAcn
intea^es  .'or rirerentliji. destrorm^.  irppl-
'•i:^.  or rruucau.-v; aar peat, ana nj\f »uo-
• '•»<««  or  ni:\mr« of  «utv>:k,ncu»  inteaCe4

c«n*.
                                           Tbtu. U an  aj-Ud« u*o« ptxrci&aj or
                                         aj«thAaic*I rrMKni  to  tn9k dentroy,  re-
                                         pe«U. or t&iUoto toy pUat or «"'ni»i  u/8
                                         decUred U) tw » port at 44 CTB 183. H. It
                                         Li congldered  to b« a darted. 11 th- vrUcJa
                                         theorponte*  a  ivtbiUnoe or mli.ure of
                                         iiitviUnffxM intended to prrrent, doatrxry,
                                         repe^J. or mltUata aA7  p«at. It U COQ-
                                         fldered to b« 4 portickJa.
                                            D. Dmcxa QXT»JXCT to ra^ ACT

                                           fteetloa 23(c)(4)  Of FOTIA  (7 0AC.
                                         U«w(o)«))  pmTlde* UlAt Uio Aflmlnli.
                                         trator may ipeolfr UIOM cla&sea of de-
                                         vice* which ihjUl bo iubject to any pro-
                                         vlaion of  p*rwraph  2(q) or section  7  (7 OS.C. 134«)
                                         of thU Act upon his detenniaaUon that
                                         application of mch provision  U necea-
                                         lary to effectuate the purpo»u of toij
                                         Act. On July  3, 1975. the Administrator
                                         promuJgated refflilaaona  (40 ?JL 28243)
                                         Amending 40  CFR Put 153 punuaat to
                                         this authority.  40 CTR 183.1S nowpro-
                                         vtdea that devices u defined  In t'Lt'HA
                                         tectlon 2 (1) and 7 Include but a-re
                                         not limited to:
                                         reruUUooi. no tpeci&omUoo u made. For
                                         purpown ot eaforeoaont. ti>« Aaoncr «U1
                                         eoojMar Lboo« cUoxx of dorlcu declared
                                         to bo tublect to reoaLaUou under (Action
                                         15 (c) (4) of the Act M »ul. .ct to
                                         Uoo under vccUoci 8 aad  17 M well.
  (A)  Ccruia  cluirlol*?  light
man* (ir Uten
(except  --so«   coatuola;  lutiULCcu  or
mizturo of ;lct£u),
»na uluuoDle tferlca.  for vsicn cltloj «--e
B44a u>  kill.  la*cc'.r»t«. eauip.  or  lup-
pres* :he ;rarth ot ruogl. s«et«nt. or «ITJJ<:• u iciil
or eatrap  :truio  lHM«ti: aod  O)  note
•Jiumiwn,  »auad  rp«l ceruia mjiauaali.

  The preamble further species those
Instruments declared  U) be of a character
unnecessarr to be subject  to this Act  La
order to carry out the  purposes of the
Act. These Include :
                                           (1) Tho*» vhtea  dep«nd  for :tielr eSec-
                                         tlreocsi more upon  t£« per.'arciaace of tie
                                         p«r*on uiinf t&e device t54a oa  th« ?t d«Ttc« itself,  tnd
                                           (21 Ties* vblca  operiK u co'np rer-
                                         Ubrate anlroaLs.
                                           Product  t«o«nllr  falling  viibia tAeM
                                         two ealeforte*  include r»c and rnoux trapa.
                                         fly iwaiten. Ullage equipmeot for ve*d eoa-
                                         trol and £jb, trap*.

                                           Section  8 of FLFRA  '7 U.S.C. 136f)
                                         provides  for  such record-keeping1 and
                                         record  Inspection  requirements  as  the
                                         Administrator determines necessary for
                                         effective enforcement of the Act Sec'.loo
                                         17 specifies the requirements to ti placed
                                         on the  icrxjrt and export of devices.  In
                                         neither of these sections Ls  there a pro-
                                                that  the Admir.ist.-a tor   dccla.-'
                                                i:(.'^cs  of  dov.cci iubjrc'.  to these
                                                 of tlie AC'.: ind '.:\ ihc i'.'.taJs-nt
  IV.  ScrxMAjr or  rffRA  PIOVISIOHS
         ATPUCUU.TO DIVICM

   Any uutrumeat declared to be a device
 under -40 CFR 162.15  U. upon Lntnxjuc-
 Mon Into ch&rioeU of trade, subject to the
 proTtsloni discussed below. ThOM provi-
 aions of the amended  FITRA which per-
 tain to  devices are In many respects sim-
 ilar to  those under the 1947 FXFRA (81
 SUt. 163: 7 UJ.C. 13S-135k>. In  both
 Acts the Agency U authorized to Inspect
 records showing the delivery, movement.
 or holding of  device*  (7 U.3.C.  I35c.
 130x) :  to  obtain samples  of any device
 In the marketplace (7  U.S.C.  135d. 136gi ;
 to seize  any nlsbranded device (7 U-S.C.
 135s. USk) : Co Initiate criminal proceed-
 ings a«alrut  aoy person  vlolaun? any
 provision of the Act (7 rj J.C. 135f. 136/> :
 and. In  cooperation with  the Secretary
 of the Treasury, to sample, examine, and
 detiln  anr Imported  device whlchr vjo-
 lates the provisions of the Act <7 UJSiC.
 135h. 1380).
   The dlSerences In the provisions of the
 two Acts  with  respect to requirements
 applicable to devices, lie primarily In the
 Treater speci£cat:oa of Jurisdiction and
 regulatory requirements provided by the
 1972 amendments.  For example, while i
 device,  unlike a  pesticide.  U ="o: subject
 to the section 3 registration  requirement
 of r'Lt'KA. section  13  of :he Act maies
 clear the iniest  of. 'Jie A:: that subject
 devices  and ?-.-Mns dealir.j w.th ds'/icw
 be held respouibis far those obligations. •
 other thaa rsslstratioc. that  are Imposed
 by i:e  Act. Jurisdiction to resale de-
 vices  Is  erpar.ded  to  :n:ra- as veil  u
 Interstate cosmercs  (7 U.S.C.  I36j-'i)
 (1».  SUnilarly. sectior.  9'a>  of  'J-.e
 irr.endec! riTHA s?«c-_1«  that intry .'or
 ths purpose of inspect:.-.?  and obtai.-.ir.z
 samples of devices  "paclcaged.  labclsd,
 and released .'or shipment is  permitted
 Into "any estabiishi-.ene or  other plac:
 where   •  • •  devices  are  held for dis-
 tribution or sale (7 a.S.C. 136?(a)).
   With  respect to a-fZrrnatlre regulatory
 requirements,   section  CfqHD  of  the
amended FirRA expands  the  definition
of misbrar.ding ^  it  applies to devices
subject  to the Act (7 U.S.C.  136(l».
Section  7 of   the  amended  FTfRA  is
totally  new.  r-quirin? the  registration
of establishments which produce devices
declared  subject to the Act  i"  U.S.C.
 136e). In addition  to  the  provisions  or
the Act  allowlne the  inspection of  rec-
ords kept b» producers and  distributors
of devices, section 8 the require-
ment; of scciiori 8.
                                      IfClSIll. VOl  
-------
                                                       NOTICES
 /.  ii>»oiaviojT or anenrre Rxqonu-
     • team Arrucxnj TO Dmca
                                  Pro-
 fUfsrj  07 r.i'.C. ;;$(.!)(;)). TTUh pro-
 (nuliatlon of the resuiatior.s at 40 CTT?
   '.IS.  which invoked the authority of
   .Jon  23(c>(4>  to specify devices sub-
  -t  to  sections  CCqJ  and 7 or tie Act.
 tha  labeling requirements o£  the 1947
FITRA  to which device] had been sub-
ject were eaoanded (7 UJ3.C. 133(1) (1) ) .
Those misbrandliLg provisions of section
:'. la summary. a device will b«
 subject  Co eaforcesaent action If
  3rtee» viu t» •derated);
  J(q)(l)(C): It  if  «Ji  LoJUCoa  at. or  U
offered for •*!• under ttt """« or uiotber
                 to*

               '< act
  J(a.)(I)CD): IU Ub«l
 «»S»u*aia«nt.
  3(q)'(l) (*) :

              IS
  3(q) (1) (O) : It Ucks in L&KJUAU.
or emu'Joo
  40 C57.  UXlO(a) (5) pnjvidea aa tfl-
 Urpnutloa of wiut U:e Lem "false and
 siSlAaiis^ s-_»7 delude  in  the coatert
 oi PlfAA *eci2ea 2(q) (1)  (A) siisbraad-
                             '. cocecra*
                  at '-i« product;
         or — "I— *.<—i ri*'-=r=t mr.-nrn-
                  of v&a product;
        o* procure re.- pu.-7>o*e»

          or
  AAj rt«bnD«at Cirrcilj or LsdJ
         »t *ji» &tma» u
 io<:cr*e4 07 &&7 « tectton 2S(c>  to be subject
M  the  provutooj  of  *ectioa 7 or  tha
Act."
  S«rtan 7 ^apooa thre<- bwta requlre-
***r*M-  d} ReifiJLn£loJ3 of devlee-pro-
duciij-  -rtabOstaJtao.   (2)  laheUn*
walch rejects the  EPA  establishment
number assigned to the eatahlbhcLont In
which the device -vu produeeil and  (3)
aubmiiilon or annual production reports.
  All eatabUshnrenta In walch devices •
subject to the Act are produced must be
registered with the Environmental Pro-
tection  Agency M  producing establish-
ments. This includes foreign establish-
ments In  which derleo shipped  to  the
United States are produced, u 'well u
establishments located In the United
States which produce devices for export.
  To register  establishments, producers
should  obtain from on SPA regional
odco the  Application  for Registration
of  Peraclde-Produclnr Establishments
(EPA Porm 3540-3) . The applications re-
crulre juci information as the name  and
address of the company  headcru&rten
and the names and- addresses of all  de-
vice-producing  .establishments  owned
and operated by the company. This  ap-
plication  must be submitted to the  re-
gional- oCca an or before January   13.
197& Upon receipt of a completed  appli-
cation, the regional oCce  «-*»-• n register
AJ*>»EI •^ff hlfihmfnft  listed  and *^*« ^  as-
sign each establishment in £?A estab-
lishment  number.  This S?A establish-
ment cumber must be diiplayed  on all
devices  released for shipment by the «-
tablUcj=ent after 90 days t/ter the pro-
ducer Is noticed of the assigned nuaiber.
  The production  reports  (EPA  Form
:s«-l«>  must b Brand came  of derice,  (2)
                       of
                             ir.d address of shipper. (3)
                            ive.-j-.? earner. (4)  Date received.
                       and (5) C'J.nmitles rceelred.
                         These recorcu shall be reuined for t»-o
                       yeorj.
   1*9.2(d): riwords ihowlnr the r allow-
 log infarmaUon regarding the thunaent
 of devices: (1) Drand name of device, (2)
       and address of Um.o  :jslgaec, (3)
       of originating CArrLer.  (4) Date
 shipped or delivered for shipment, and
 (3) Quantities  shipped  or delivered for
 shipment.       ' •  •
   These records shall, be retained for t-»o
 years.
---169^(e>:-iaventory-recardj- with T«-
 spect to the  trpea and  tmminfj  at de-
 vices la stock which he oaa  produced.
 These records may b« disposed of when
 a more current Inventory record Is  pre-
 pared.
   169.2(h): In the case of  derlcea  In-
 tended solely for export O  any foreign
 country, copies of (he speclflcaSons or
 directions ot the foreign purchavr for
 the production of tha devlcaa. ThAta rec-
 ords ahall be retained for fro ye&a after
 expiration of the contract
   Pursuant to  the aadortty  oi tec'-lon.
 8(b) of the Act. 40  CFR l«9J(b) r«ru>e3
 that distributors,  carriers,  dealers-  or
 other persons wbo sell or deliver (or. of-
 fer to sell or deliver) devices declared
 subject  to the Act.  allow Inspected -of
 the records' they hare pertaining to the
 following:
   (1) The delivery or holding  of the de-
 vice and quantity odd: (3) Data of ship-
 ment and receipt;  (3) Xame and address
 of consignee and consignor;  acd  (-4)
 guarantees received' pcrrjant.to
 12(b)U).
   D. Section  17. Inverts and Ezycrii (7
 U3.C. llSo). On Aisrust 1. 197S; reg-Ja-
 tlons (19 CTR Part 12.1) for the Imple-
 mentation of section  17,  Imports «.--d De-
 ports, wers published In the Ptsixc. P-ts-
 art» f40 PP. 3r:i). These rerilaaocs
 recnilre that devices produced  by foreirs.
 manufacturers  and  Imported iECo  ^:-
 United States compiy with  aJ3 req-uire-
 taenU applicable to domeffCc  producers.
 Ln  addition,  the reffulafiocs reanlre in
 Importer to- submit to SPA a XoCce of
 Arrival  of Pesticides  and Devices (Z?A
 Form :540-1. avaflahle  it any E?A of-
 fice) for review and  determination  u to
 whether the shl.nmf-it ahould be campled
 and/or permitted  esiry Into tie United
 States. The Act also provides  that sam-
 ples may be collected and t^mmin^ ^cd.
 that ahlpmentd may  be  permitted entry.
 detained until brooght  into cccnpUance,
 destroyed, or re-ejcported.
   With  respect  to device*  produced ta
 this country  for export. *ecUon 17(a) of
 the FTFRA   as  amended lequlres  that
 such devices must  be prepared or packed
 In accordance with the  *pecincaUooj or
 directions of the fccelca purchaser and .
 that producers of  nich  device*  must
 maintain bookj  and record* pursuant to
 section S(«>.

      71, ExTotcMcnrr A«mtoiirratj
   Section 9(a)  (7 U.S.C.  13S(g)(»» of
 the Act authorises oflcers of the .\SK£cy
 to  Irjpcct any  e»tacUshm«it or other
 place wbere a '.avlce  U held  for dUtnsu-
 Uon or sala in order to obtain a tampie of
 the device as packaged, labeled  and re-
 leased for shipment,  and *a.-npl«j of any
 contaJncrs or la.' tlLag for the devure. Of-
 flcers of the  Agency  are alto »uihorUed

-------
  to Inspect boots and reoonli' re.
   Pursuant to »ection I7(») (2) (B) of Cie
  Act, It U unlawful Tor any s«noa to re-
  fine to ten or to permit tnspesCtoa of
  boo hi and recants. or to refuse to permK
  inspection of an establishment. Pursuant.
  to. section 12(») (1) (F1 or the Act. It la
 unlawful to tea or distribute any device
 which  Is tnlsbrmnded.  Finally, pursuant
 to section 12(a) (2) (L)  of the Act, it far
 unlawful to Tiolat« any provision of *«e-
 Uon  7.
   Upon a fln/ authorizes In
 run seizure proceedings In a federal dis-
 trict  court against any derice which  is
 misbranded or which, when used In ac-
 cordance with the requirements- Imposed
 under the Act causes unreasonable ad-
 verse  e£ects   upoa  the  environment.
 Finally. th« Administrator nay Jee
copies' of these comments should be  sub-
mitted to facilitate the work of the  EPA
and oth«n interested tn ^specttnz  such
documents.
  Dated: November 8. 1976.
              ST.un.rr '.7. Lxcuo.
            A.t)Lttant A.dminiitra:or
                    tor En/oretment.
 |FR Doe.10-J«l!« Filed I l-!S-7a;«: «i «m|

-------
NOTICES                                                52513

                          *'•'•  ;   ••' *- (TOX. ««-»l        ,  -.

                        .PEST CONTROL DEVICES PROCEDURES
                             Consolidation and Clarification of •'•
                         ••': • _ • .. ... . v Requirements
        \                  "•  ••'!';'•  •'Correction

                          Iri PRJ3oc. 76-34119 appearing on pace
                         510S5 In tbe brae for Fr2dar. Korember
                         19. 1976, on page 51063,  middle  column.
                         third ruH  paragraph, la the 12U2  line.
                         "Januarr  18. 1976'.'  should have read
                         "January 13. 1377".   ;.
      cecisrjj, voi. 
-------
       UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                       WASHINGTON. O.C. 20460
                         2 4 .ISM 1977
                                                   OFFICE OF ENFORCEMENT
MEMORANDUM

TO:

FROM:
Regional Administrators

Stanley W. Legro
Assistant Administrator
    for Enforcement
SUBJECT:
Enforcement Priorities in Structural Pest Control

  a) Establishment Inspections of Pest Control Firms
  b) Pesticide Use Inspections
  c) Prosecutorial Discretion in Pesticide Use
     Enforcement
I.   Purpose.
    This memorandum (a) provides supplemental guidance to the FY 77
Regional Plan and Program Guidance with regard to the performance
of establishment inspections of structural pest control firms, and the
inspection of pesticide use by structural pest control operators, (b) sets
forth criteria to be applied by the Regional Offices in  determining which
pest control establishments should be the object of establishment inspec-
tions,  (c) sets forth criteria to be applied by the Regional Offices in deter-
mining whether to perform a pesticide use  inspection  of structural pest
control activities, and (d) informs the regions of the manner in which the
Office  of Enforcement will exercise its prosecutorial  discretion in regu-
lating the sale, distribution or use of pesticides in the structural pest
control industry.

II.  Background.

    The implementation of a comprehensive program to  regulate pesticide .
use and to perform pesticide use inspections continues to be an important
emphasis of the Agency's pesticide use enforcement program during FY 77.
The Agency has determined that its limited inspectional resources should
be  utilized primarily to observe those activities which present  the greatest
risks of harm.  The Agency intends to exercise its  prosecutorial discretion

-------
in a "common sense" manner which will prevent unreasonable adverse
effects upon people and the environment,  and will foster professionalism
and compliance with the law among structural pest control operators.
The Office of Enforcement is developing similar supplemental guidance
to direct inspectional activities and establish enforcement priorities in
agricultural and other non-structural pest control.

     All structural pest control firms which supply and apply pesticides
for hire are deemed by the Agency to engage in two distinct activities
which are subject to regulation under the FIFRA.  First, in contracting
to perform pest control services, they are deemed to hold pesticides
"for distribution or sale" within the meaning of FIFRA section 9(a).
Indeed,  the price paid by the customer for the application necessarily
reflects the cost of the service and the cost of the pesticide.  Secondly,
while actually applying the use-dilution preparation of the pesticide,
they are deemed to "use" pesticides.  A relatively small number
of these structural pest control firms also engage in a third type of
activity, i. e.,  in the production, formulation, or repackaging and
sale of pesticides for use by other persons.

     A structural pest control firm which simply supplies and applies
pesticides  (i. e., a firm which is engaged in the distribution or sale of
pesticides  while performing pest control applications for hire i* .subject
to enforcement liability as an "other distributor" under the provisions
of FIFRA section 14(a)(l), but is exempted from the establishment regis-
tration requirements of FIFRA section 7 under the provision of 40 CFR
167. 2(a).  A structural pest control firm which also engages in the pro-
duction,  formulation, or repackaging and sale of pesticides for use by
others,  is  subject to enforcement liability as  a "registrant . . .  wholesaler,
dealer,  (or) retailer" under the provisions of FIFRA section 14(a}(15, and
is subject to the establishment registration requirements of FIFRA section
7 as implemented in 40 CFR Part 167.

HI. Supplemental Guidance to the FY 77 Regional Guidance and Program
     Plan.':

    The FY 77 Regional Program Plan specifies the number of establish-
ment inspections and use observations to be performed by each Region.
The Regional Guidance notes that one aspect  of the Agency's use enforce-
ment program is the "audit of professional pesticide users such as struc-
tural and agricultural pest control operators. " The Guidance also provides
that the Regions should "devote approximately thirty percent of their
pesticide enforcement resources toward ensuring compliance  with all use
requirements...." Elsewhere, the guidance provides that another, thirty
percent of the Regional resources will be devoted to assuring industry      -
compliance by performing establishment inspections  and other surveillance
activities.

    Structural pest control operators are  constituents of both the pesticide
distributing and pesticide using populations.  Accordingly, some percentage
of each Region's  inspectional activities should be devoted to the performance
of establishment inspections and use inspections  of structural pest control
activities.  The Office of Enforcement has determined that approximately

-------
                              • 3 -

fifteen percent of the Region's industry compliance activities should be
devoted to the inspection of establishments of structural pest control
operators,  and that approximately fifteen percent of the Region's audit
of professional pesticide users should be devoted to the performance
of use inspections of structural pest control activities.  This allocation
of resources will result in each region expending approximately five
percent of its pesticide enforcement resources in performing establish-
ment  inspections of structural pest control firms and five percent of its
resources in performing use investigations of structural pest control
activities. Accordingly, the following number of the establishment
inspections and use inspections performed in a Region by EPA personnel
or by State personnel functioning pursuant to a Cooperative Agreement
should involve structural pest 'control operators:

   ACTIVITY             NUMBER OF INSPECTIONS BY REGION
Establishment
Inspection
Use Inspections
I
8
10
n
15
7
HI
20
9
rv
44
30
V
24
12
VI
27
9
VII
26
U
vm
5
5
EX
30
12
X
15
18
IV.. Establishment Inspection of Structural Pest Control  Firms Which
     Produce,  Formulate or Repackage Pesticides.

     A.  Establishment Inspection of Structural Pest Control Firms Which
         Engage in Production Activities.

     FIFRA Section 9(a) authorizes officers or employees duly designated
by the Administrator to conduct administrative inspections of places where
pesticides are  "held for distribution or sale. " Pest control firms which
produce, formulate, or repackage  pesticides for use by other persons
have long been a party to the regulatory process.  The pesticides which
they produce, formulate, or repackage for use by others  are subject
to the  pesticide registration requirement of FIFRA section 3. Further-
more, their establishments have been subject to the establishment
registration requirement of FIFRA section 7 since early 1974.

     Inspections of their establishments are conducted for the purpose
of inspecting books and records which are required to be  maintained
under FIFRA section 8(a), and of obtaining samples of pesticides or de-
vices which are packaged, labeled, and released for shipment pursuant
to FIFRA section 9(a).

     The establishment inspection  of such pest control firms is designed
to assure compliance with product  registration, formulation,  packaging,
and labeling requirements,  to collect and develop evidence to support
enforcement actions when violations are found, to determine whether
the required books and records are being maintained,  and to determine
whether procedures for the disposal and storage of pesticides, pesticide
wastes,  and pesticide containers are being complied with.

-------
    The establishment inspection of pest control firms must conform in
all respects to the procedures for establishment inspections provided in
Chapter 9 of the EPA Inspection Manual.  The Consumer Safety Officer
(CSO) should discuss  with the owner, operator,  or agent in charge of
the establishment the purpose and potential enforcement ramifications
of the inspection.

    B.   Criteria for Determining Whether to Perform an Establish-
         ment  Inspection of Structural Pest Control Firms Which
         Engage in Production Activities.

    During  FY 77,  each region will be expected to conduct establishment
inspections  of some structural pest control firms which produce, formulate
or repackage pesticides.  In determining which firms to visit, the region
should consider:            '                   ,

    1.   No Prior Establishment Inspection. The implementation of
        tne  registration requirement witn respect to pesticides which
        are  sold only in intrastate commerce materially increased the
        number of establishments  which are subject to establishment
        inspection under FIFRA by virture of their production, formu-
        lation or repackaging activities. The Regional Guidance
        provides that firms which have not previously been inspected
        will be inspected on a routine basis.  Unless  re-inspection is
        dictated by the other criteria, establishments which have once
        been inspected shall not be re-inspected until other establish-
        ments have once been inspected.

    2.  Suspected Violations. If, on the basis of prior inspections, or
        of reports from other Federal or State agencies or from the
        general public,  the Region has reason to believe that evidence
        of violations may be discovered thereby, an  establishment
        inspection of  a firm which produces,  formulates, or repack-
        ages pesticides may be undertaken. Such firms may be
        inspected as frequently as necessary to  assure compliance
        with registration, formulation,  packaging and labeling re-
        quirements. As appropriate, the Notice of Inspection must
        specify that a violation is suspected.

    3.  Specific Assignment. An establishment inspection should be
        conducted whenever EPA headquarters,  another Region, or
        another governmental agency requests that such an inspection
        be performed.

V. Establishment Inspection ofStructural Pest Control Firms Which Supply
    and Apply Pesticides for Hire.

     A. Establishment Inspection of Structural  Pest Control Firms Which
        Supply and Apply Pesticides for Hire.   ~'

     All structural pest control firms which produce, formulate, or
repackage pesticides  also engage in the  sale or distribution of pesticides
in the course of supplying and applying pesticides for hire.  Such firms
are also subject to administrative inspection in their status as distri-
butors.; Even though  numerous structural pest control firms do not

-------
engage in the production,  formulation, or packaging of pesticides for use
by others,  they nevertheless supply and apply pesticides for hire and are,
thus,  subject to administrative inspection under the authority of FIFRA
section 9{a).  Such distributor inspections may be conducted for the
purpose of inspecting books and records which are being maintained by
the firm  as authorized by FIFRA section 8(b), and of obtaining samples
of pesticides or devices which are packaged, labeled and released for
shipment._!/

     The establishment inspection of such pest control firms is designed
to determine whether pesticides which are packaged, labeled,  and released
for shipment conform with all applicable packaging and labeling require-
ments, to collect and develop evidence to support enforcement actions when
violations are found,  and to gather  information which may be voluntarily
supplied by the firm regarding the scope and nature of the firm's program
to train and provide technical assistance to its service technicians.

     Insofar as the establishment inspection of a firm which only distri-
butes pesticides conforms with the  establishment inspection of a firm
which produces, formulates, or repackages pesticides for use by others,
the procedures for establishment inspections provided in Chapter 9 of the
EPA Inspection Manual must be followed.  The CSO should discuss with  the
owner, operator, or agent in charge of the establishment the purpose and
potential enforcement ramifications of the inspection.  Additional instruction
in performing these inspections is provided in part V.C. of this document.

     B.  Criteria for Determining'Whether to Perform an Establishment
         Inspection of Structural Pest Control Firms Which Supply and
         Apply Pesticides for Hire.

     During FY 77, each  region will be.expected to conduct establishment
inspections of some firms which supply and apply pesticides in the course
   17
    FIFRA section 9(a) does not authorize inspection of any place where
pesticides  are being held for use or are being used. Accordingly,  such
places cannot be inspected except pursuant to a search warrant obtained
upon a showing of probable cause that a provision of FIFRA has been or
is being violated, or pursuant to the voluntary consent of the person in
charge  of the premises,  e.g.,  the homeowner or restauranteur.   The
pest control operator who only applies pesticides provided by the cus-
tomer likewise is not subject to inspection by the Agency under the
authority of FIFRA section 9(a).

    It. is the ^opinion of the Agency that pesticide concentrates or. use-
dilution preparations of end use products which have been transferred
into service containers are "released for shipment" within the meaning
of FIFRA section 9(a).  Service containers utilized for the temporary
transportation or storage of pesticides must comply with abbreviated
labeling requirements of PEPS No. 6. Failure of the service container
to bear such abbreviated labeling will constitute a violation of FIFRA
section 12(a)(l)(E) which makes it unlawful for any person "to sell . . .
offer for sale,  (or) hold for sale-.  . . any pesticide which is ...
misbranded. "  Under the provisions of PEPS, No. 6, such a violation
would subject the violator to civil or criminal penalties.

-------
of providing pest control services for hire, but which do not engage in the,
production,  formulation, or re-packaging of pesticides. In determining
which firms to visit, the region should consider:

    1.  No Prior Establishment Inspection.  Relatively few establishment
        inspections of structural pest control firms have been performed
        since the implementation of the 1972 amendments to FIFRA.  The
        Regional Guidance provides that firms which have  not previously
        been inspected will be inspected on a routine basis. Unless re-
        inspection is dictated by other criteria, establishments which have
        once been inspected will not be re-inspected until other establish-
        ments have once been inspected.

   2.   Suspected Violations. If, on the basis of prior inspections,  or of
       reports from other Federal or State agencies or from the general
       public, the Region has reason to believe that evidence of violations
       may be discovered  thereby, an establishment inspection of a pest
       control firm which  distributes pesticides may be undertaken.  As
       appropriate, the Notice of Inspection must specify that a violation
       is suspected.
                                 /
   3.   Nature of the Pest Control Business.   Firms frequently engaging
       in those pest control activities which are identified in Section VI
       below as priority areas of enforcement concern should be selected
       for inspection first.  The regional office may have  no knowledge of
       the principal type of pest control business  engaged  in by the firm
       prior to its first visit to the firm. Where such information is known,
       the Regional Offices should assign inspectional priority to firms
       utilizing the pesticides (or active ingredients), or the application
       practices outlined in Section VI below.

   4.   Size of the Pest Control  Firm.  Regions should seek to  inspect
       firms representing a wide range of business sizes.  The  inspection
       of larger firms will maximize the coverage and exposure of our
       inspectional activities.  The inspection of smaller firms  will estab-
       lish an enforcement presence among such firms.

    5.  Specific Assignment.  An establishment inspection  should be con-
       ducted whenever EPA headquarters, another Region, or another
       governmental .agency requests that such an inspection be performed.

C.  Elements of an Establishment Inspection of Structural Pest Control
    Firms Whicn Supply, and Apply Pesticides for Hire.

    1.  Elements "of Establishment Inspections Which are AutHbrized by  ..
       jf'i.fc'KA Section
           The following elements of an establishment inspection are
       authorized purusant to FEFRA Section 9 (a), and constitute an
       integral part of an establishment inspection.  All of the procedures
       for performing establishment inspections provided in Chapter 9 of
       the EPA Inspection Manual must be complied with in all details,
       particularly with respect to the requirement to provide proper
       identification, to give a proper Notice of Inspection,  and Receipt

-------
   for any samples collected.  The results of the analysis will be
   returned to the establishment from which the sample was collected.

   a. Inspection of Books and Records.  As  needed,  the CSO should
       inspect the boolcs and records which the firm may be maintaining
       as required by FIFRA to collect and develop evidence to support
       enforcement actions. Upon specific request for information relevant
       to an Agency suspension or cancellation proceeding, an in-depth
       inspection may be undertaken of records showing the delivery,
       movement or holding of pesticides,  as provided in FIFRA section
       8(b).

   b. Sampling of  Pesticide Products.  While performing an inspection
       of a pest control firm,  the CSO may collect samples of pesticides
       which have been packaged, labeled and released for shipment in
       accordance with the procedures outlined in Chapter 12  of the EPA
       Inspection Manual.

   c.  Review of Abbreviated Labeling.  The CSO should specifically
       review the abbreviated labeling which the firm has placed on any
       service containers containing pesticides which have been released
       for shipment and which are being used to temporarily store or
       transport pre-measured quantities of pesticide concentrates,  or
       pre-mixed use-dilution preparations of pesticides.  The abbreviated
       labeling must conform with the standards contained in  PEPS No. 6.

2.  Discretionary Inspectional Activities Which are Voluntary With the
   Firm and Which May be Engaged in Only with the  Consent  of the
   Company!             '                     "

           The following activities are not  a regular part of the establish-
   ment inspection conducted pursuant to FIFRA section 9(a). They
   constitute discretionary activities which the CSO may engage in only
   with the voluntary consent of the owner, operator, or agent in charge
   of the establishment.

   a.  Review of Company Training and  Educational Programs.  While
       periorming an inspection,  the CSO should discuss with company
       officials whether the company (or its liability  carrier) sponsors
       an on-going training program. The  CSO should also determine
       the extent to which the company has participated in programs
       to certify appropriate personnel to use restricted use pesticides.
       This review should be conducted to  stress the need to train service
       technicians regarding-such matters as the necessity for use consistent
       with labeling provisions, pesticide toxicity and hazards to man and
       common routes of exposure, potential environmental consequences
       of pesticide use  and misuse, factors influencing pest recognition,
       pesticide formulation and dilution procedures, and factors  influenc-
       ing pesticide toxicity, compatibility, synergism and efficacy, appli-
       cation equipment and methods of procedure. [See 39 FR 36450-51]
       The CSO should  request to receive any available information regarding
       the company's training and educational program so that appropriate
       officials at the Regional Office may review the training program to

-------
                               - 8 -

       determine its nature and scope,  and to evaluate its general adequacy.
       The CSO should explicitly advise company officials that the review of
       the company's training program is voluntary with the company.

    b.  Collection of Company Technical Bulletins or Manuals.  While per-
       forming an"inspection, the CSO should discuss  with company officials
       their procedures for supplying their service technicians with adequate
       technical bulletins and manuals to inform them of precise procedures
       to be followed in performing particular pest control activities.   This
       review should be conducted to stress the need to provide service
       technicians with technical bulletins  or manuals regarding such matters
       as precautions necessary to guard against injury to people or the
       environment, factors influencing pest recognition, factors influencing
       pesticide toxicity,  compatibility, synergism and efficacy, the use,
       calibration and maintenance of application equipment, and specific
       application procedures used to apply various formulations of pesti-
       cides, solutions and gases appropriate to the pest  control problem
       at hand.  [See 39 FR 36450-51]. If the company has prepared technical
       bulletins or manuals, the CSO should  request to receive all  available
       materials  so that  appropriate officials at the Regional Office may
       determine their nature and scope, and may evaluate their general
       adequacy.  The CSO should explicitly  advise company offficials that
       'the review of the company's technical bulletins or  manuals is voluntary
       with the company.
                                                                 •
VI.  Pesticide Use Inspection of Structural Pest Control Activities.

     The Regional Office should perform a pesticide misuse investigation
whenever there is reason to believe that provisions of the Act have been (or
are being) violated.  In the absence of a suspected violation (and as resources
permit), the determination to perform a pesticide use  inspection  will typi-
cally be  made after the establishment inspection has been completed, and
upon a review at the Regional Office of the  Establishment  Inspection Report.

     In performing use inspections of structural pest control treatments,
the CSO  must follow the procedures provided in Chapter 15 of the EPA
Inspection Manual, particularly with respect  to the requirement to give
a Notice of Use/Misuse Inspection.  In determining whether to perform a
pesticide use inspection,  the Regional Office  shall consider:

     A.   Nature and Scope of the Training and Technical Support Program.

     The sponsorship by the firm (or its liability carrier)  of a training and
•technical support program which is adequate, if complied with by the service
technicians,  to foster good pest control practice will generally mitigate EPA's'
desire to perform pesticide use inspections.  The absence of such a  training
and technical support program will increase the value to EPA (and to the firm)
of performing use investigations. Furthermore, failure by the firm to have
performed the training and testing necessary to certify appropriate  personnel
to use restricted  use pesticides will increase the value to EPA  of performing
pesticide use inspections.  Persons who engage in structural pest control as
a secondary (or "moonlighting") occupation may warrant particular  scrutiny.

-------
                              - 9 -

    B.   Nature of Pest Control Activities Engaged In By The Firm.

    The Agency intends to scrutinize most carefully the use of (a) those
particular active ingredients, or (b) those particular  application techniques
or methods which pose unique risks of harm or which have been the source
of pesticide misuse in the past.

    1.   Pesticides (or Active Ingredients) Which Warrant Particular
        Emphasis"!

    The use of the pesticide class or active ingredient listed below is deemed
to warrant particular scrutiny because (a) the products  are  widely used in
structural pest control and have been involved in prior misuse cases,  (b)
the pesticide is registered for use by application methods which pose inherent
risks of harm to  children,  adults, or domestic animals, or (c) the pesticide.
or active ingredient is particularly toxic to humans or domestic animals.

    The following pesticides have been identified by PTSED as warranting
particular emphasis.  Accordingly, the CSO should seek to  accompany the
service technician to  observe pest control applications which involve the
use of the following pesticides:

              a.  Phosphorus Paste Products
              b.  108Q;  Sodium monofluoracetate
              c.  1081;  Fluoracetamide
              d.  Restricted Use Pesticides
              e.  Category I Pesticides

     [This list may be revised by PTSED, or by a Region upon the concurrent
of PTSED, as dictated by the regulatory objectives of the Agency, or by local
pest control practices within the Region].

       2.  Enforcement of Particular Structural Pest Control Activities
           or Pesticide Treatment Methods"!

     The Agency particularly desires to scrutinize application methods
which pose serious risks of harm to people or the environment. Accordingly,
the CSO should seek to accompany the service technician to observe pest
control applications which involve the following pest control activities or
treatment methods:
                             •
         a.  Fumigation Treatments;  The use of fumigants in the treatment
             of buildings or other structures such as storage  elevators or
             grain bins;

         b.  Treatments of Areas or Establishments in Which Food is
             Processed, Prepared or Handled;  The use of  appropriately
             registered pesticides in residential or commerical kitchens
             or other places where food is processed, prepared or other-
             wise handled;

-------
                               -10 -

         c.  Rodent Control Treatments;  The use of rodent control prod-
             ucts in household or public health baiting applications.

     [This list may be revised by PTSED, or by a Region upon the concurrent
of PTSED, as dictated by the regulatory objectives of the Agency,  or by local
pest control practices within the Region].

    C.  History of Compliance,  or Report of Pesticide Misuse.

    When the establishment  inspection arises out of a history  of violations  or
a report of suspected pesticide misuse, the CSO should seek to accompany
the service technician to observe those pest  control applications which are
similar in nature to those involving prior misuse, or which involve the treat-
ment methods noted above.

VII. Prosecutorial Discretion in Initiating Enforcement Action for Violations
     oTParticuiar Labeling Provisions By Structural Pest Control Operators.

    The Agency's mandate to protect  people and the environment from unrea-
sonable adverse effects of pesticides is the overriding consideration in the
development  of enforcement policy. Any use  of pesticides in a manner which
results in harm or which poses an unreasonable ri-k of harm will subject the
user to enforcement liability.

     PTSED has identified a number of provisions of the Act relating to pro-
duct registration and labeling which are of particular importance in structural
pest control.  The-violation of these labeling  provisions would generally poj
"particular risks of harm, and have in the past resulted in serious injury to
persons  exposed to these risks. It is the policy of the Office of Enforcement
that any  violation of the following provisions  will, in  most cases, subject the
violator  to civil or criminal  enforcement sanctions:

    1.  Unregistered  Pesticide; The' sale or distribution of any  unregistered
       pesticide.

   2.  Cancelled or Suspended  Pesticide; The use, sale,  or distribution
       of any pesticide which contains an active ingredient whose regis-
       tration has  been cancelled or suspended because of human health,
       environmental or efficacy considerations in a manner inconsistent
       with the terms of the Final Order.

   3.  Specific Prohibitions;  The use of any registered pesticide in any
       manner whicn is specifically prohibited on the label.

   4.  Use Site; The use of a registered pesticide at a use site not provided
       on the label.

   5.  Dosage Rate;   The use of a registered pesticide at a higher dosage
       rate than that provided on the label.

-------
                              -11 -

    For example, a pesticide is used at a use site which is inconsistent
with the labeling if it is used indoors when the label bears use instructions
for outdoor applications only,  if it is used in hopper cars when the label
bears no instructions for use in hopper cars,  or if it is applied by a
broadcast mechanism when the label  provides for use only in cracks and
crevices. Additionally, a pesticide will be deemed to have been applied
at a higher dosage rate than that provided on the label whenever the amount
of active ingredient disbursed (per unit area or  per unit time) exceeds  that
provided on the label.

    Most EPA labels bear only affirmative use instructions.   Since pro-
hibitory statements are used only where the activity mentioned is strictly
prohibited, the violation of any prohibitory statement will, in most cases,
subject the user to enforcement sanctions.

-------

e X^TZ *   UNITED STATES-ENVIRONMENTAL PROTECTION AGENCY

 V*'<<«oM<^                     WASHINGTON. D.C.  20460
                              JUL 11  1377
                                                            OFFICE OF ENFORCEMENT
     SUBJECT:   Enforcement Policy Applicable to Bulk Shipments of Pesticides

     TO:       Regional Enforcement Division Directors
               Pesticide Branch Chiefs
     I.   Purpose

          It has come to our attention that  an  increasing practice among
     manufacturers and distributors of pesticides involves  the  transport  and
     transfer of pesticides in large guantities,  i.e.,  "bulk".  I/ Among the
     reasons that manufacturers and distributors  prefer to  handTe pesticides
     in bulk rather than in small  individual containers are the following:  1)
     the need to properly dispose  of excess  numbers of  containers is eliminated;
     2) less warehouse space is required:  3) labor and handling costs are re-
     duced;  and  4) inventories can be more  accurately  controlled.

          In the interest of energy and resource  conservation and offimproved
     safety measures in pesticide  handling,  it  is incumbent upon the Agency to
     encourage and endorse these practices in so  far as they are consistent with
     the broad purposes of FIFRA.   Because the  practices involved in "bulk" ship-
     ment and transfer are in some cases unclear  in or  are  unaddressed by the Act
     and regulations, the development of an  enforcement policy  to define  the
     limits of the "bulk" shipment and transfer practice is needed.
     VFor purposes of this policy,  the  term  "bulk" refers to any volume of
     pesticide greater than  55 gallons or  100 pounds held  in an individual con-
     tainer.  Examples of bulk quantities  of pesticides are: creosote  in barges,
     weed oil in tank cars,  liquid herbicide in tank trucks or rail cars, or
     any of these in standing storage  tanks.

-------
                                  -2-

II.  Policy and Rationale

     A.   Policy Summary

         For purposes of enforcement of the Act, it is the policy of the
     Agency that so long as the transfer of a registered pesticide in "bulk"
     involves only the changing of the product container with no change 1)
     to  the pesticide formulation, 2) to the product's accepteoT.abeling
     (with exceptions noted in Part III B and C below, and 3} to the iden-
     tity of the party accountable for the product's integrity, the new
     product resulting from transfer will be considered as encompassed
     within the terms of the registration of the product which was trans-
     ferred.  This rationale applies to the transfer of supplementally
     registered products, as well as to the basic registered product.

     B.   Rationale

         The basis for this policy is published in the Appendix to PEPS
     No. 6 (41 Fed. Reg. 55932) as follows:

          FIFRA section 3(a)  [7 U.S.C. 136a(a)]  provides in pertinent
     part that

          * * * no person * * * may distribute, sell, offer for
          sale, hold for sale, * * * to any person any pesticide
          which is not registered with the Administrator.

          Before a pesticide product which is not encompassed
          within the terms of an existing registration enters
          the channels of trade, a separate registration must
          be obtained.  Changes in the formulation of a regis-
          tered product, changes in accepted labeling, as well
          as any repackaging  of a pesticide into another con-
          tainer will activate the registration requirement,
          unless the purposes of product registration would be
          fully met by carrying forward the Federal registra-
          tion of the constituent product.

          The broad purposes  of the registration process are
          four fold.  First registration of a product provides
          a mechanism for the review of information regarding
          the safety and efficacy of the pesticide as proposed
          for use (and as likely to be used)  under widespread
          and commonly recognized practice.  Second,  registra-
          tion of a product provides EPA with the opportunity
          to review the proposed label and labeling of the
          product.   To support registration,  such labeling must
          clearly communicate the directions  for  use  for  the

-------
                                    -3-

           product and such warnings and precautions as are neces-
           sary for the safe and efficacious use of the pesticide.
           Third,  registration of a product identifies the party
           accountable for  its integrity of composition, labeling
           and effects resulting from use.   Fourth, registration
           of a product is  the mechanism which assures that this
           relevant information is communicated to the ultimate
           user of the product.

III.   Elaboration  of Policy Relating to Specific FIFRA Requirements

      A..  Section • 3

          The commercial transfer of a pesticide in "bulk" may, at various
      stages of the shipping or distribution process,  involve changing  the
      container of the pesticide.  Because  "changing the container" or
      "repackaging" amounts to production within the meaning of 40 CFR
      167.l(c), and because the resulting product is a pesticide and is
     • being held for sale and distribution  within the  channels of trade,
      it is subject to the  registration requirements of section 3.  The key
      to determining the applicability of ss-ction 3 to a repackaged bulk
      product is whether the purposes of registration  continue to be satis-
      fied upon further sale and distribution after transfer.   These pur-
      poses outlined above  include:  safety  and  efficacy review,  label review,
      identification of the accountable party,  and communication to the user
      of relevant  information.   Thus,  to the extent that a bulk transfer
      involves changing the container, e;g.,  repackaging a registered end-
      use pesticide with no change to the pesticide formulation,  its labeling,
      or the accountable party,  the repackaged  product is encompassed within
      the terms of the original  registration. This means that  the original
      registration will have satisfed the purposes of  section  3 as to the
      repackaged pesticide.  Conversely,  if  any  of these factors change, the
      corresponding purpose of registration will be unsatisfied,  thereby
      activating the registration requirement for the  repackaged  product.

          In the context of the  bulk transfer practice the most difficult
      of these criteria to  satisfy is accountability.   For  purposes of  this
      policy, the  accountability requirement will be considered as met  when
      a  pesticide   1)  is transfered  in bulk  at  an establishment owned by the
      registrant as specified in 40  CFR 162.3(dd)(l),  2/ 2)  is transferred
 2740 CFR 162.3(dd) provides:

     (dd)  The  term "operated by the same producer" means (1) another regis-
 tered establishment owned by the registrant of the pesticide product or
 (2)  another registered establishment operated under contact with the regis-
 trant of  the  pesticide either to package the pesticide product or to use
 the  pesticide as a constituent part of another pesticide product provided
 that the  final pesticide product is registered by the transferor establish-
 ment.

-------
     at a registered establishment operated under contract with the regis-
     trant within the meaning of 40 CFR 162.3(dd)(2), or 3) is transferred
     at a registered establishment owned by a party not under contract to
     the product registrant, but who has been furnished written authoriza-
     tion for use of the product label by the registrant. The written
     authorization may apply to a supplemental registrant's label as: well
     as to a basic product label.  If a supplemental registrant's label is
     involved, the written authorization must still be supplied to all trans-
     fer points by the basic registrant. The supplemental registrant cannot
     satisfy the written authorization requirement.

         This provision for satisfying accountability may be utilized at
     as many points down the chain of distribution as the product regis-
     trant cares to authorize. However, at any point where a pesticide is
     transferred and repackaged in bulk by a person other"than the regis-
     trant, his agent as provided in 40 CFR 162. 3(dd}(2) or one authorized
     by the registrant under written agreement with the registrant to
     transfer the product and to retain use of the registrant's label,
     the requirement of accountability has not been met.  The resulting
     transferred and repackaged pesticide is considered a different pp->-x-
     cide no longer encompassed within the terms of the original registra-
     tion and is subject to separate registration under section 3.

         Sale and distribution of a pesticide transferred and held for sale
     under conditions other than the three outlined above and therefore
     in a manner which fails to satisfy the conditions of registration,
     will subject the party responsible for such transfer, and for subse-
     quent sale and distribution, to the sanctions of section 12(a)(l)(A)
     of the Act for sale and distribution of an unregistered pesticide.
     Failure to supply the required label, with each sale will subject
     the seller to enforcement liability under section 12(a)(l)(E) for sale
     and distribution of a misbranded pesticide.

     B.  Section 2(q)

         Section 2(q) lists various types of information which must appear
     on each pesticide label.  In those cases (outlined in Part A above)
     where the conditions of transferal repackaging do not activate the
     section 3 registration requirement, the original registered label
     will, be attached to the transferred product; 3/  however, this label
     must reflect the establishment number of the establishment at which
3/ Label placement must conform to the requirements of 40 CFR 162.10 (a)
T4)(ii)(A) and (B)

-------
                                  -5-
     the product was transferred (unless otherwise specified in part C
     below)  and the appropriate net content statement. Failure to include
     accurate establishment registration and net content information on
     the label subjects the tranferor to enforcement liability .under
     section 12(a)(l)(E).
     C.  Section 7

         Regulations pursuant to section 7 (40 CFR Part 167}  provide that
     the act of repackaging constitutes production and thereby activates
     the need for establishment registration.  All establishments,  there-
     fore, in which bulk pes.ticides are transferred or repackaged are sub-
     ject to section 7.

         The Agency has  determined, however, that the purposes of the Act
     are not substantially furthered by enforcing the establishment regis-
     tration requirement for repackaging or transfer establishments when
     such repackaging or transfer is performed by an establishment  owned by
     the same person who previously produced the product within the meaning
     of 40 CFR 162.3(dd)(l).  Thus, for purposes of this policy, establish-
     ments owned by the ^eg istrant^which_engage..only..in.. tr ansf er_and_repack-
     aging":in~buiK ne^d-ftat^e^reglst^er&d.pursuant to section 7 and products
     eraTJsTerred arxTreoackagecTIn such establishments may retain the. label
     showing the number  of the establishment in which the original  product
     subject to transfer and repackaging was produced.

         However, when the repackaging or transfer is performed in  an
     establishment owned byjgjperson other than the__reg.istrant e.g., by
     'aTperson operating  under^contract t"o~th"e~TegTstrant pursuant to 40
     CFR 162.3 (dd)(2) or by a person authorized by the registrant,to use
     his label on the transferred and repackaged pesticide, that establish-
     ment must be registered and the product label must show  that establish-
     ment number.  This  label modification may be accomplished by sticker-
     ing.  Failure to register producing transferring establishments as de-
     fined at 40 CFR 167 (other than those specifically exempted in this
     policy statement) and to reflect the establishment number on transferred
     products, may subject repackagers to the sanctions of section  12(a)(2)(L)
     of the Act for violation of section 7 and section 12(a)(l)(E)  for sale7
     and distribution of a misbranded product.                            \
IV.   Examples
     A.   A registrant ships a bulk pesticide to a new owner  (dealer/distri-
     butor).   The dealer holds the pesticide in labeled  storage tanks until
     the material is sold in bulk quantities to end-use  applicators,  with
     the original label accompanying.   The dealer's establishment number
     is  on the label or container.  The basic registrant has furnished
     the new owner (dealer) written authorization for use of the regis-
     trant's label.   The purposes of Section 3 registration  are satisfied.

-------
                            -6-

B.  A registrant ships a bulk pesticide directly to an end user (cus-
tom applicator, farmer, etc.)-  The label accompanies the shipment
and is placed on the user's tank.  No new establishment or product
registration is needed for the bulk container since the labeled
product is fully registered and has been sold intact to the user.
C.  A registrant ships a bulk pesticide to a new owner (dealer/
distributor).  The registrant furnishes the dealer written authori-
zation for use of the registrant's label only to accompany material
from the dealer's tanks to end-use applicators.  If the dealer sells
from his tanks to a second dealer for subsequent sale to an end user,
the purposes of registration are not served by the sale to the second
dealer.  The accountability requirement will not be considered met by
virtue of non-authorization of the registrant's label for such an
action.  The product will be considered not registered and the dealers
will be subject to enforcement sanctions under sections 12(a)(l)(A)
and  12 (a)(l)(E) for selling and distributing unregistered and mis-
branded pesticides.

    Responsibility for movement of a product from the registrant to
Dealer A to Dealer B and to the user is considered analogous to a
registrant that sells a sealed 55-gallon drum of a pesticide to a
dealer who sells the drum to another dealer.  If the drum was then
decanted into ll/5-
-------
                              -7-

F.  A tank car of pesticide from which commercial applicators meter
off into their own tanks, without being put into a dealer's holding
tank, would be exempt from new producer establishment registration.
It is considered that the original container has not been changed
in delivery to the applicator and the tank car label (placard) will
bear the producer's establishment number.  The commercial applicator
would be bound by the general labeling requirements of PEPS VI if
the pesticide is transported or stored.  The application of PEPS VI
to agricultural pest control operators will be elaborated in the
enforcement policy for custom blenders and custom applicators.
                                    A. E.  Conroy II, Director
                                 Pesticides and Toxic Vubstances
                                      Enforcement Division

-------
          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON. O.C. 20460
                              22AUG  1978
                                                          OFFICE OT ENFORCEMENT
MEMORANDUM
SUBJECT:  Federal Pesticide Act of 1978

TO:       Pesticides Branch Chiefs
          Enforcement Division  Directors


     Shortly, Congress is expected to enact, and President Jimmy Carter is
expected to sign into law, the Federal Pesticide Act of 1978 (FPA), spending
the Federal Insecticide, Fungicide, and Rodenticide Act(FIFHA).  Full
implementation of these amendments will require extensive participation
from your Offices, the regulated industry, and the general public. 'This
memorandum is intended to set forth certain interim enforcement policy
prior to development of an overall Agency Implementation Plan.  This interim
policy is effective Lnroediately upon signature of the legislation.  Violations
of the Act that arise previous to passage of the FPA should be dealt with
in accordance with regulations or policy in effect prior to the effective
date of the new amendments.

     For purposes of organization, I have grouped this policy under common  '
headings.

     a.  Actions Affecting Pesticide Users

            1.  Distributors vs. Applicators.  -   A previous policy memorandum
         from this Office (March 25, 1976) considered pesticide applicators
         viio supply and apply registered pesticides in the course of performing
         pest control services to be sellers and distributors of pesticides.
         An amendment found in FPA will overturn this policy to some extent.
         "For hire applicators"!/ are no longer to be considered sellers or
   For purposes of this memorandum "for hire applicators" are those viho hold
   or apply registered pesticides or use dilutions of registered pesticides
   consistent with section 2(ee) of this Act [definition of the term "to use
   any registered pesticide in a manner inconsistent with its labeling), only
   to provide a service of controlling pests without delivering any unapplied
   pesticide to any person so served.

-------
                                  -2-r
         distributors (and thus subject to Sl4(a)(l)" penalties)  unless:  1)
         they hold or apply an unregistered pesticide, or  2)  they deliver
         any unapplied pesticide to the customer. .  In either  of  .the above
         situations, a "for hire applicator" would  be considered a seller
         or distributor for any violation of FIFRA,  and  subject  to the higher
         penalties set forth in sections 14(a)(l) and 14(b)(l).   Because of
         the Congressionally mandated change in the status of certain "for
         hire applicators", whereby they can no longer be  considered as  sellers
         or distributors, Pesticides Enforcement Policy  Statement No. 6, "Use
         and Labeling of Service Containers for the Transportation or Temporary
         Storage of Pesticides is no longer applicable to  the activities of
         the "for hire applicator."

            2.  Cownercial Applicators. -  ..Any^applicator"(except a private
         applicator) whojises or supervises the use of a restricted use  pesticide*
         v)hether*or~"not*S;iat^plicator'-iS"certified, ts^^camiercial applicator
         subject-to the higher penalties of sections 14(a)(l) and 14(b)(l}.

            3. Penalties. -   Any "for hire applicator"  who violates any provision
         of FIFRA while holding or apply!rr; a registered general use or  unclass-
         ified pesticide is liable for a m^imum fine of $500 for the first
         offense and $1000 for subsequent cffenses  in accoraance with language
         amending section 14(a)(2).  The new penalty scherrie follows:


             Applicator       GDP2/       RJP3/       .     Maximum
             Category	~	Fine	
                                                      14(a)(2)
             	warning   $500  $5000
             Ccnsnercial        X                                  X

                                           X                             X

             "For Hire"        X                                  X

                "X                             X

             Private           X                        X

                                           X            X

             Others            X                        X

                                           X                             X
2_/ General Use or Unclassified Pesticide
3/ Restricted Use Pesticide

-------
                              -3-


    .Until a new civil  penalty matrix  is issued,'vhen considering the size
    of the business, the  following  interim matrix should be used to
    determine  the maximum penalty:

        Category I & II - 1st Offense  $250;  Subsequent $500

        Category III,  IV  & V -  1st  Offense 500;  Subsequent $1000

    Violations of the Act that  arise fron  independent acts, but which are
    part of the same series  of  events,  should  be assessed as a single
    offense.  As previously  stated, it  is  our  position that any violations
    that occurred prior to the  final enactment of the FPA are subject to
    the provisions and interpretations  of  the  law prior to the amendments.
    All outstanding cases will  continue to proceed on that basis including
    cases there the civil penalty conplaint has  not been issued.

       4. Use Inconsistent with Labeling.  -   The term "to use any registered
    pesticide in a manner inconsistent  with its  labeling" has .been defined,
    eliminating the need  for some Pesticides Enforcement Policy Statements
    (PEPS).  Certain use  practices  previously  covered by PEPS .are now
    permissible without resort* to the  admininistrative mechanisms found
    in those PEPS.  These include:  1) use  of a pesticide at less than labeling
    dosage (PEPS 1), 2} use  of  a pesticide for the control of a target pest
    not named on the labeling,  if the site is  included on the labeling
    (PEPS 2 & 5), and 3)  use of any. application  method not prohibited by
    labeling (PEPS 7).  Also, though not the subject of a PEPS,  the mixing
    of a pesticide with another pesticide  or with a fertilizer,  if not
    prohibited by labeling,  is  permissible.  In  addition, any use of a
    pesticide in conformance with sections 5,  18, or 24 of FIFRA, will not
    be considered use inconsistent  with labeling.

b. Registration of Establishments

Names, of pesticides or active ingredients  used in producing pesticides
vfcich have been submitted pursuant  to section  7(c)  of FIFRA are  no longer
considered as confidential records  or  information.   Requests for such
information under the Freedom of Information Act  may be granted.

c.  Books and Records

The FPA will require that inspectors present their  credentials,  along
with a Notice of Inspection  citing  the  reasons for  the inspection prior
to conducting a books and records inspection.  Since this procedure is
required currently by the Pesticides Inspection  Manual,  no change in
procedure is necessary.   However, all personnel  should be made aware
that these procedures are now required  by  an amendment to section 8 of
FIFRA.

-------
                                    -4-


     d.  Unlawful Acts.

     An amendment to section 12(a)(2)(F) would  permit  the  sale of  restricted
     use pesticides to uncertified persons  for  later application 'by  certified
     applicators under regulations issued by  the Administrator,.  Until  such
     regulations are pcorulgated, the procedures for permitting such sale
     found in Part IX of  the preamble to the  Classification  Regulations (43
     Fed. Reg^ 5783, Feb. 9, 1973) shall govern.   In brief,  a State  must have
     in effect laws or regulations dnch 1) require an uncertified person
     to furnish written evidence that a certified  applicator will  use the
     pesticide and 2) require that pesticide  dealers keep  records  of such
     evidence before uncertified persons could  purchase a  restricted use
     pesticide.

     I have attached a memorandum, dated July 26,  1978, vhich discusses, in
brief, the FIFRA amendments.  Ihis memorandum has  an Appendix which  contains
draft language of the amendments as they would  appear  vhen inserted  into the
PIFPA.

     As previously mentioned, a plan for implementing  the  Federal  Pesticide
Act of 1978 is currently  under development within  the  Agency,   iour  input
into any regulations, guidance or policy that will flesh out these amendments
is strongly encouraged by this Office.  Any comments or questions  you have
concerning the amendments should be directed  to Jack Neylan  (755-0997).
                                                  A. E. Conroy II,
                                              Pesticides  and  Toxic&^ubstances
                                                    Enforcement Division
Attachment

-------
          Federal Register / VoL 44.
  [FBI. 12*3-2]             .

  Pesticides and Toxic Substances
  Enforcement
    On September 30.1978, the President
  signed into law S. 1673. the Federal
  Pesticide Act of 1373 (Pub. L 35-036.92
  Slat 319; hereafter "FPA"). which
  amends the Federal Insecticide.
  Fungicide, and Rcde.iticide Act- as
 'amended (Pub. L 92-51G. 08 SUL 973;
  Pub. L 94-t«L 39 Slat r3fc 7 USC126 et
  teij: hereafter referred fo-as "HFHA"). -
  As 4 result of the new amendments.
  CCTtCii. vi uic rsaacid* iniCitiKr.'tfc- .
  Policy Statements (PEPS), whici.
  established an adjainistTitiv'e
  iseeianisci to permit certain p'e.» '-cide • •
•  uses which otherwise would have been
  In violation of FIFrlA. ar= no longer   •
•' Becessary.-Thc- purpose cf this Notice u .
  to announca the rescissian of th? .
  affected PEPS and ?o cisruss some of
  the amendment1; in the .'-PA that affect
  pesticide enforcement p;.'l.:y.   .

  (1) Rescission of Pesticide Enforcement
  Policy Statements (FEPS) Aw. l ?.. 5,
  and?    '    .         '  .

 ..  On May 5.197S. the- Environmental'
  Protection Agency f7~BA) published ia
  the Federal Register a document entitled
  "Institution of Pesticide En/oicament

  Policy Slatsmerstj" (40 fed. ne%. 1S32S
..(137sn.lt-was ie Aganey'j pvrpesein
  lastinrcrg this series cf ?*;tic'de
  Esfarcement Policy Statements C?E?S)  !
  to inform the general public and persons
  engaged in  the famuliticn. distribsiion.
  sale, arrplicstion or other use of        j
  pesticides, of  the polices adopted by the-
  Agency in the enforcement of the  "    :
  provisions of the FITRA. Tae PEFS'were
  prepared and  published by E?A'.« Office
  cf Enforcement.
    Federal regulation of the usa-of    -: ;
  pesticidss was asrabiished for-the first "
  time with the enactment of the 1972
  amendments, specifically through the
  provisions of FIJRA sciion 3Cd)(l).
  section 4 and section l2(a)(2)(G). Ssca'on
  12f.a](2J(G) cade it unlawful for any
  person to use a registered pesticide in a
  manner iacsniisrsrrt with ita labeling.
  However, as set forth in die legislative
 history. Congress intended that EPA
  enforce the prohibition of section'
  12(a)(2!(G) in a "coiiion sense manner"
  and left open in many isstsrxM exactly  .
  what constituted a "use acaisisrest
  with [a pesricde'sj bbeiieg."
    The FPA broadens the construction of
 lecion 12(a)(2;(C) of FTFHA by  adding a
 new subsection 2(ee] which for the first
  toe defines the  tana ":o use any  ;
 registered pesticide in a manner •  .
 inconsistent with its Uneiina."
No.-112 / Friday,  fune 3. 1979  / Notices	
                                        or distributor for any violation of FIFRA.
                                        aad subject to the higher penalties set
                                        forth in sections li(a|(l) and l-ub](l).
                                        Because of the Congressional!1/
                                        mandated change in ±s status of "for
                                        hire applicators." PEPS No. a. "Use and
                                        Labeling of .Service Containers for ±e  __
                                        Transportation or Temporary Storage of..
                                        Pesticides" is'cp longer applicable to.chs
                                        activities of the "for hire applicator."
: According to the language of the new
 subsection, it is a violation of section
• 12(a](2](G) to use a regis:ered pesticide •
 "!n a manner not permitted by the    •  •
 labeling" with the exception of four
 specific areas. The areas specifically   :
 excluded rorn enforcement under
  * 12(a)(2!(C] include: (a) the ase of a
  pesticda at less than label dosage (PE?£ (3) Cantizuatior.
  1 J "; (b) the use of a pesticide for the      Zs/cnre.Tie.-tt /alley SiateRer.a (PEPS)
  control of targefpests net named on the ; A'«. 3 and 4
                                           Two of .he existing PEPS are not
                                       .
                               ng C?£?S

    Thus, the new section 2(ee) defines by-
  law certain uses which will not be
  considered inconsistent with labeling  i
  that previously were defined by PEPS, f
  The new definition provides exemptions
  fronrthe strict label language for risers/
  applicators only. Persons who distribute
   'Whil« pc?5 Mo. l txduccd certain prxlaca
  wlaei amid not be aitd il leu tAia libci dsn?
  n^.-adcflticdei. ursiu coaroi ?r:ducu. tad
  «nitii*r/dijin/»e:act>—

                                          (SJ Oef:nitian of "Producer"

                                            The FPA amends the dafinition of
                                          "producer" to add the following:
                                            Th« dilution by indi'/iduals 01" forsujataa
                                          pesdcdes for their s\vr\ uis and jcsardt-j to
                                          •Jie direcs'otis oa rs^stered labels shaii ^ot of
                                          itseti r*sult a such :nd:v;d-jais but"?
                                          iaciudea ia the definition of "producer" far
                                          the pcrposes of this Act.
                                            This arrendzrsnt wakes starjrory ±e
                                          Ajeccv'i loT!g-rtar.dir.s policy at r.ot
                                          e=r.iiaerag persons who dilute-pesriodes as
                                                               z;e \a tiia jaie aad/
         ucicss i _  —3-,- -
or disaisucon at tie-'pesnc-de."

  This .-ortce hereby rescinds PE?S Nas I  »
3. 3. and 7.                         ' ~
                                                                                                     s:~'j;r far
                                                                                 I«iTrry G. MiUs
                                                                                 (Ta.Cce.J9.inra m«i a-r-r

-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF ENFORCEMENT
         OFFICE OF GENERAL ENFORCEMENT
         PESTICIDES ENFORCEMENT  DIVISION
              PESTICIDE ENFORCEMENT
             POLICY STATEMENT NO. 1
      USES OF REGISTERED PESTICIDES AT LESS THAN
                LABEL  DOSAGE RATE
  Bcpriated from the Federal Register of May 5, 1975 (40 FR 19629)
                       and
             September 17,1975 (40 FR 42914)

-------
 Faille I da Enlaicemenl Policy Sliternsnt
                  No. I

  USE OF REGISTERED PESTICIDES AT
       LESS THAN  DOSAGE  RATE

   1. Ituckyrvund. On Hay  6. IU76. (ha
 U.S. Environmental Protection Agency
 published in the  KUUMAL  Kcuisna  •
 document entitled "Notice of (he Insll-
 lutiuu of a Scries of Pesticide Enforce-
 ment  Policy Statements"  (PEPS)  (40
 Fit IUU6). It was the Agency'* pur-
 pose. in  instituting  thia series of Policy
 Statements  to inform  those engaged In
 the formulation,  distribution, attics, ap-
 plicution or oilier  use of pesticides, as
 well os  interested segments  of the «en-
 eral public,  of policies adopted  by the
 Agency  in Iho exercise  of its proaecu-
 loiiul discretion  In the  enforcement of
 the Federal Insecticide, Fungicide. and
 KotJenticide Act as amended fKIFUA).
 It was  suggested in tint notice Hint *
 large number  uf  these  Pesticide  En-
 furccnient   I'oiicy   Statements   would
 Involve  purlftuiar  aspects  uf pesticide
 use.
   These PEPS are prepared and pub-
 lished by EPA's  UlVice of Enforcement.
 The series  uf  PUPS, insofar  ua they
 may rcytti'd pesticide  use, represent an
 • pltliculiuM  of  the  Agency's prosccuto-
Sfiul discrt-liun.  In exercising itd prusecu-
 •uiiut tliscvution, the Agency &tiivct to.
'providu thut level of control over rcftu-
 iHled activities which is consistent With
 its public trust and Its  atululory man-
 date to  protect man  and the environ-
 ment  (ruin iUe huzurds  ai^bclalvd vttth.
 the furniuluiiun,  distribution, nale, ap-
 plicution or  ottier  use  of  pesticides.
   In making enforccinent policy deter*
 niinuliuns, the Oftice of  Enforcement
 con bide r» the  rcguUloiy |»-  U |im».

   Whctoer • particular use U to he con*
 •Idcrcd **bcncflcial'* or "harmful" U •
 jcUrminatlon to be mad* by (he Ag*n-
 ly. U U presumed for enforcement pur-
poses (hiit the uflimittive provisions of
ft product label uhich ar« accepted  by
(he  Agency  In  cunjuncliun  with  the
product's, ieKi&t(uti<>n contain aUowhUft
uses for  (he product. Accordingly,  an
application or other use of a registered
pesticide  which is not arhrniatively pro-
vided on the approved label may he COn-
tide red to be a use of a  retjUlcied pes-
ticide  "in a  manner  inconsistent  with
Its  labeling" and inuv subject the  vio-
lator j|o civil or criminal  sanction*.
  The  Qincc of Knfuictmrnt, In the CK-
ercis«  of  U* uru&ecutoiitt  diicrelion,
may determine thut tome uses or appli-
cations which are not affirmatively pro-
vided on the label are, nonetheless, to be
allowed. The Agency  has instituted the
serif a  of pu&lkidu Enforcement Policy
Statements  to provide public notice of
Instances In which deviations from the
precise language of  Che  product l»be|
will not subject the user to enforcement
liability. It U understood  that no devia-
tion from the aliiimalive provision!! of
an   approved Itibej   shull  be  allowed
which  Is  not explicitly countenanced In
A published  Pesticide  Enforcement Pol-
icy Statement.

  The  kitiaativtf  hUtoiy  of  the  IU72
amendment^ to FlFltA su^Rests that it
was the  intent uf COIIKIV&S (u ensure
(hot the Agency evaluate the meaning
of  the  term ''mcottsUu-itt  wilh  the
label"  in  a commun ucnsu manner. The
House of JU-pri-st:tiUlivcs Ctmimitlee on
Aericultuic  BpfciAcully  uddrrs^ed this
is^uo aa it relates to the  use  of  u  iccis-
teicd uettticUe at a  dosu^tt  rule  lowvi
than that approved on the label:
•»»»  W  utrri  b/  •  |>riljciliir*((*« at *
|u*«f  44liHk»a  Itaau (hat •pccififa ou  ih* Ub«l.
Will* U woulJ ubtluutl* bi  d.(.nrt...M  lii i>*«.


|k« C«i«Aintll««  r
-------
tired ulitill iv ill (»r  Mill mil)  aubject
the  U5ci to prosecution,  bill doc*  nut
tit lino  jidticitlr  u|>j»lifali4in  or   use
priulnvx which >ttt (itf tiu twl\ violate
I-in;A  s.-.-ii..i   uu)UM«:'  If  ih«
Ailniiiii:.li aIri:)fl'-|i|iriilii>ii ur  uar  In)  IB recdm-
mi-ml>'il in  w citing by u knowledgeable
i-xpri I,  (h) ti,  ••fliriicious against  (lit)
liiij:**!  pest, aild has only lM'lu-fici;il nf-
Jv-cls. tit muit ami  thv vuvivomvictil.  (v.)
is pi-rfuriiifd  in  iicri'i dance  with all
other label iit>lructiona ;md precwntiin.j.
nnd  (tlj is  nut ivpi'iili'd at llio low Jns-
&);«.•  u.U  »>• frc^iu-ntly us  tu result in u
lotul pcbticnlu duba^e higher Ihuh that
fipt-fitifd  on tbu nppruvi'il  labi-|.

lh«*  following iicetitt uf  pcatleiuc  U:.e:
A^rifiilliirul  ji«-st  t-unliol, animal  pest
conti'dl. fuit-sl  jii-sl cuntiul,  r IK lit-of-
way  pt-ii fuiitiiil,  tirniinit'iilnl  and turf

prst  fiiiitidl,  ind'i.ilriiil,  iitblitutlnniil,
Slinctuinl nnd Jie.dtli relutcJ pest con-
tiul.  publu1 Ii4-allh pent  control, moa-

und   drinonstrulimi  und  rraeurch  pest
cbntiol. Not\vithalundiiu: the above, the
applii'ntiun or u.ie  ut  a  Ictaer dusui;c
rate  of a  rudenlii:idu( Urmlle control
product ur  antimtcroliial agent auch  us
a  iliainit-'itaiu.  auniti/fr.  or  fungicide
undfi any  clrcumalances  ia prohibited.
All of the limiting nnd defining provl-
jootis  conlttiiivd  in  the .puragruphs
which follow  arc  an integral  part  uf
Ihia  pulicy  slulenu-nl.
  111. ^uuiicotifiljr o/ Ike  rcificitfc fe'«-
furermrut Tu/icu Statfttitut Kft/ttrJiim
Lettir  l)jjj,>r«.—A. Rrcommendation
of K*'.iiM~K~dfiobf«  Exptrt.  A
*VHiUc»tor "or  uaer may apply
lured  pesticide  ut a  doaaye  rale hf»s
tbun tnat vthlch  uppuura un  tin: act"*;1-/
(l font i til pia.'lttt's. Tliia I'L>Cr b<*Lh, us tin;  C4(uill^i
uf thu  fitfiim^tIIIIL'C  muy  iei|uiic.  It
mu^t  bi- I't'cu^iiJ/cd,  liowcvcr.  that  the
Agency   hn^  neither  u^^-Hyvil   iiur  u|t-
pruved thu cllieucy of the pfbticiilu  up-
pliculion or ui.c ul u lower douwxe rale.
   II.   t'ttnlnct  Kfficttcy  mid  //MIIH/M!
£.'{frcf*.  Tim  Agency  will cunatrne liny
iippliculion ui ust ul luaa than lliu label
dosugii uhlch ia ineflU'uciuns or which ia
In 11 ny wuy luiritiful  lu man or the cn-
viruiiinenl tii bu u uau inrunaitiUrnt witli
thu lalu-lini;  na |uohibiled in the Acl.
Knfurcrnicnl action will be taken on  u
c«ibc by-cu^u  b:i:iia for  auch vltilatoia
where lepi-Hlui) jibuso of  thia policy  ur
coiitinuud burnt tu man or Die environ-
ment  liati occuircd.
   Ait  bppliv'tttiuii  ov UAe  is iuvlltcuciutn
if il iVaiilta  in the con I iul of  autial ini-
tially  fewer pc^ls  Ihun {a normally as-
aociott-d  with  pesticide use in compura-
ble  vnviroiiniL-iilal
Ihuu
purlieu^.   	„	
ma/ depend  upuu the ccticttc
                                                 ioU-d with pesticide ust  in compura-
                                                   viiviruiiiiiL-iital  ciieutualuucck  of
                                                 n  ia intended.  The tilicacy  of  mi/
                                                 ticuUr ueaticidt:  appllcutlon or ui
                                                 y dcuend upuu  the ccticttc eooxoOii^
 tlon of Die larifcfc pe.l. pval population
^•_ '*muies, environmental clrcuni.-itancea.
 ifi-.-Kiupliu' und  climatic  fact urn, and
 Ihu  itffAuuce  dilif»  aity  other  Ubvl  provision! or
 ilii'L-Lliun  fur  UAU.   I.obet  pi'uviiluni
 whifh  iniihl  Lu  complied  with  at  all
 lUiu-y   (rc-Kordlea*  ul  the  application
 du>uu    utc)  include hut ure not liinfteJ
 lo slu .1 meiila regarding  piojucl  niix-
 iii|{. \ >a \,\\K  und  i»«).arttliDn. uppHca-
 UMII  .11- hod*, reentry alomlardi, pro-
 , i-tti't  lolhiiiK or  rifuipnient,  product
 an(.-»•'" ul  a doMiye rule abuvc  llio  lobt-l
 (^     i*  aliictly prohibited and will aub-
 J,    thu uaer lu criminal or civil pciiwl-
 tii-a.  In  lituutions  wlu-ic  lur^vl  pfcsta
 run no  loii^ei  Im conlrullvd  will)  lubcl
 recoiniuendcd level a  bc-i-au^c of  pest
 i-t-ainluiu'u or  other reuaoiu.  il will La
 lici'i'saury fur thu re^istmnl  lo petition
 Ihu  Agency fur  uu  aivpmpiiaiu amend-
 liifiil  of ilia  re^iateied  IbbelinK.  Thla
 art ion  ij neceaaaiy (I) lu ensure that
 proposed IIICIUMSL'* in label doauiccs  uro
 properly vvalublei) In ifhpecl to huinun
 or  cnvnuiiiiienlhl  hoxm'da as r«i)uircJ
 by the amended  KIKItA  ur  (2)  lo  de
 tutiuiitu  if ihu   |irupt>aen*utioH  o/  I'tittcutc  Enforce-
Html  f'uticy Statement. This  Pesticide
Cnfurculiicnt  I'uliey SluU'incnt will TC-
inuin  In  t-lfett tmlil anu-nded  or modi-
fied by  •uuac^iivnl publish ktl  Ft PS t»r
by regulation! pioinul^ulcd by the  Ad-
iiiini^lialor.  Thu Agetu-y  will evaluate
ihu policy  announced  lieiein  lo  deter-
mine  ihuuu areas  of  pesticide  u»e  or
thoae cla*iea uf  pealicide product* In
which piuLletna arise, ficvocaiion of the
peimttiuiou  to  use  Icsse r tlu*agba  In
specific kiiuuliuiia nuy result from * de-
Itrininuliou  by  the Agency  thut such
application or use ia either inL-iHcucioui
«r hai'niful  to niun or Ihu enviionnieiit.
   V. I'ttllie  <;0iMtni-ii(. Tho I'tra re-
late directly to internal A^cocy  proce-
dures and  prttvlice und constitute "in-
terpret Ive  rulea"  or   "nencrul  blatc-
liienU of pulley".  Aa auch, llie Agency
dues nut solicit public  coiniuent regarJ-
Ing mailer*  published in  t«i» aerie* of
notices.   However,  Interested  persons
tnay aubiult  written (.•uinnivnU record-
ing the poliey set forth in  IhU 1'KPS to
the  PeslicJdta  Knforceinent  Division,
C  the
comments should tic hubinilted lo facili-
tate the work uf  the  EPA  und  others
Interested In  in-^pecthiK the document.
   Dated: Apiil UO, 1076.
               (luntiir I,. UAUM,
       Acting  A).  This  notice informed
the  pesticide industry  and ihc jceneral
public  of the  Agency's policy permit-
tltiK tha use of a  legi^lertd pesticide »l
less than  label  dosage  rules providing
thai the u»e l»  IV recommended iit writ-
ing  by a knowledgeable expert, 2)  Is
cfhVecluua. against the  target pest. 9) Is
pci formed la accordance with all other
label instructions and pre;«»yrr-», aj^i
4)  U  not  rsp«at«-J  *t  t£« I;w  ^«Ja~«
raU  ao frcauuiily  a« to taault  in *
total pesUcUc dusa^e Ulghtr than that

-------
   UJI                        '•.'-. . |M  IV  •
 j.»:-u'ii|:  -    -i      • , ••;  - - u|)ti'(I  l»y  lh«
 .^;;.n.y a.ij  .tec*1 i:«>*  • /I'luin  subject to
 |)tc rif|iiiri'nitiit fur  full iltiattj;en s|ietl-
 fu-J for ceiliiin  iiroJucta in  1'Kl'S  No.
 1.
   Tliu  U.S.  tCiiviioimicnttil  Protect ion
 Agency  licirby  rvviacs   Pe&liiritli:  Kit-
 fuiircim-Mt  l'.,ll.y Slutcincnt  Ma.  1  <40
 KR IDyJD, M»y  6. l'J76),  Section  II,
 I'umKint'li  Two, iji'iiltnce Two to rtud
as fulluwa:

   tlulollllltBlltllMI  Ih*  •Loi,..  It* •l>l-lli-B|t««
•r M»*  »t • Ut**r du*««*  !•(• «>l • n*ti>-itif(lJ*,

•uth ••  • ditii>f*tl*ltl nr ••ftllUcr  *>bUh  b
lnl«i«l*4 (»r •Uuelufal. liittllullnHftl  ot dutncalb
          anir cl'tu(u«i*iic(i  I* |>n>hl
               UuuuiT  L.  UAUM,
         ctiny  Auiittant  A dm in'* I rotor
               /or  Kit/orctmtnt,
               10,  1U76.

-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENO
             OFFICE OF ENFORCEMENT
         OFFICE OF GENERAL ENFORCEMENT
        PESTICIDES  ENFORCEMENT DIVISION
              PESTICIDE ENFORCEMENT
             POLICY STATEMENT NO. 2
    USE OF REGISTERED PESTICIDES FOR THE CONTROL
            OF UNNAMED TARGET PESTS IN
             STRUCTURAL PEST CONTROL
      Bcprinted from the Federal Register of September 5.1975
                    (40 FB 41175)

-------
   PESHClDE CNrORCEMENT POLICY
           SYAUMEHT HO. 1

Uw of Reglitered Pesticides For Iho Con-
  Irol of Unnamed Target Pest* In Struc-
  tural  Pest Control

  I. (Irnerat Unckgroutiil.
  On  Miiy  6. IIH6, the Environment*!
Protection Agency (EPA) published In
tjii: l''t:in:u,\L  lt*;cmt;u a document en-
titled "Institution of Enforcement I'ol-
Icy Statements" <40 FH  IUS2G). It WBI
thu Agency's purpose in Instituting this
•eriea of Pesticide Enforcement Pulley
Statements {PEPS)  to Inform  the gen-
eral public  and persons engaged In the
formulation, distribution, sale,  applica-
tion, or other use of pesticides, of the
policies  stapled by the Agency in the-
enforcement of the  provisions of the
Federal Insecticide. Fungicide.  and Ro-
denticldc Act. us amended (Pub. 1- 92-
610; BG SUl tl73; 1 U.S.C. 1'JO et sea.,;
hereinafter  referred  to *s  Klfr'RAl.
PEPS  are  prepared and published  by
EPA's  Office of  Enforcement. A do-
lulled e K pi to notion  of the purpose and
•cope of PEPS  wa»  set forth In the
May 6. 11)76, FU>UIAL  KKUISTLII notice.
  federal regulation of the use of pes-
ticides  waa established  for  the  flrst
time with the enactment of  the  11172
amendment a,  inccifkally  through  the
provlaion* of PIFllA section 12(a)(2)
(C). Any person who uses  a  registered
pesticide in a manner Inconsistent with
lit labeling is in violation of  the. Act
«nd may be subject to  civil or criminal
•a net Ions, However, as set  forth in the
legislative -history.  Congress  Intended
thst EPA  enforce the  prohibition  ol
•ectlon   12(a) (2) «j)  In a  "common
•ense manner*' and not prohibit the use
of registered pesticides which are In  no
way harmful and  which have demon-
st ruled btMiciiviul effects. (House  Com-
milU-u  un Agriculture, II. It.  Utl*. No.
02-011, D2J Conn-, lot  Sc^a. 1G (1011).
and Semite Couunitteit  on  Agriculture
and Forestry. S. Kep.  No.  Hi! -838, 02d
Cung.,  2d Sess. 16  (\»12)\.
  As the ttenuto Commit tec on  Agricul-
ture and Forestry stated:
  • • •  it U IW UIUI of  lk« CttmaUlr* lk*l
l*«4 ••IIMCIIMU »a * UWI
  la view of the legislative hUtory con-
cern iiif the use of rcgUter«d pe« lie ides
 for the control uf unnamed lurgel peals.
 thia I'KI'.S touch* i> upon mill t or a which .
 may appear  to l«;  jut i:>>. in  that  the  target.
 pest differs  from  that  listed  on the •
 Approved label.
   ttecently, many interested people huve
 •ought  permission  from  El'A to. use .
 registered pesticides  to control  minor
 or infrequently encountered pests which
 appear in. on, or adjacent tu any struc*
 ture when such pests  ate not named  on
 the approved label of the pesticide. Con-
 sistent  with the |egi&lstlv«  history  of •
 tection  12,  El'A  has deter.
 mined that  under  the  specified  condi-
 tions and  limitations set forth  below.
 use  of  a  registered  pesticide  against
 unnamed pct*U does uat warrant prose-
 cution for  violation of section  12 (a)
.
i <•/ a Kcyittcrcd I'ttiUldc  /or •.
trol ol  Umnumtd Tarytt  /*««!•
clurgf P««f  (\ntrol.
   II. Uli <•
 (&« Co
 in Stntcl

-------
  The Agency lifts dvtet mined that the
 use uf a ri'eisicri'd |ie ut (lie  lyne o( kilo which
is to  hi! In-tiled;
  (II) Kiihcr (1)  (lie user is u  knowl-
t:dt;cubli: expert in itlrudnial pest con-
tiol  who has  himself rvcumniciitlcd Hie
ui>c uf u ic-gisti'ivd pesticide u^uinst tlte
unnamed turret pest; or (2) (he uae lit
recommended iit  writing by  a  knowl-
edgeable expert in structural pest con-
trol;
  (C,) No  pesticide  registered  foi  use
bcuinbt  I lie tmjji't  pest In,  cm,  or fcd-
jacent lu any si nu11 u it  in  reasonably
available lit  the geographic  nicu  in
tvhirh Ihu pesticide Is to lie ustrd;
  (It) Tlic user complies with all other
inalriicliiins, wauiin^s. piccautioiis. and
prohibitions which appear on the label
»tui  litbvlmi;  uf the  product which is
used; mid
  > niuu  or the environment.
  All of the limiting and defining pro-'
 visions  contained in  the  paragraphs
 wit if It follow un-  uu  intercut  pavl of
 this  I'tl'S. Whether the user has rea-
 suitably  met  the  criteria  act .forth lu
 this   I'l^l'S will be  determined  by tlte
 Agency  on  a ease by-cu*** tails. The
 burden uf fallowing that (he criteria set
 foi l|i )K~ r i-in  has been met  res la with
 the person applying  or otherwise usintf
 a ifjtisU'irJ pesticide for the  control of
 uiinaniL'd target pests In structural peak
 control.

  111. Applicability vf the  jYfcdciiii! i.'n-
 jvrnmtHt JMicj/ Stuteaunt Rtyaidinff
 VKI-  of J*Y!/'*'• "o*  JVjiiicitfi-*  /wr (Ac
 Cault'Ol.o/ UiinuiiH'J Tat'fftit Pettt.
   A.  /'a. -il  the  SiHtifit; Type  of i'lfo
 H'Au/i  u (u but  lotth iu  this &t»U-
 inL-nt allows (lit: UbL>  of u n,'i;UlL-rcd jie&-
 licide iiguiust  unnaitied  taiyet  iivutt
 only  when  I lie »|>|ili>:iitioii lb inuJu at
 the  »|t4.-4-jnc  ty|>u uf use site  fur which
 I lie  product  U le^islervJ.  'J'lils uolicy
 U|i|ille^  lo the  use of  it-K^leicd  pcttll-
 ti*i*.'i  in. OK. ur  udjutrvtil  to enclosed
 likuii-nmdi;  it I'uel u res  nuch  Bit  huinun
 dwell inj;s,    institutions     (jucluijint;
 tcliuob biid ho»uiljb). industrial e^tub-
 likhineiit^, non-coinnierclul  ureenhouse*
 iind other struciurei used  lor  the pro-
 tection uf ttlored. piocck^cd, ur lunnufac-
 lured ittoducU. Thu rtl'S daei ua. for
txum)du, ultow any uvr&uu tu us« a |ie»-
tii-ide which ia ri-t:isleieor appli-
cation or  use  which  is  not  related lo
structural  pest . control. No  pesticide
ITgUlcred  solely for  agricultural ut>e
may be used fW  the contiol of unnuiurd
lai|;el pests in,  on, or udjucenl  to any
structure.
  ll. Jfi'cuujrm-mJMfiuii by u Kuatt'UJyf-
ubte Ksptit in Sli-ficfitiot **t»l fVtilrul.
  I. IV/iuiiiutt   of  the  Term "Kauwl- .


  The  lei in "knowledgeable  expert In
structural |M-sl  control"  refer*  to any '
per.NOD who (I) holds u college or high-
er level  decree in ei)tumoh>r.y ov  uthev
science related tu pest  control;  or (2)
bus live  (6) ur more  years of practical
expei'ienci*  In |>iofi-s::iuiml pi-si control;
or  (3) is the Bup.-i vKory ollieial  of the
fiini.  organisation  or A^i-ncy making
the application  u -hit  is  responsible for
muting  tvvltitivul jud^iueula  rtKUfditij;
pest contiol pi uctiri;; or  (4) is  cei tl-
lied hy  11  Stule pursuant lo KIFItA
Section -1 to use resiiicled n.se (testicidi'S
In  indnsliiiil,  iniilllnOonul,  all uctnrul
or  health related pest control (40 Ci'lt
  Kmmted|tCbtiU: ek^tcrla hi  the  ftehl  uf  •
bti'beturitl |»csl eontrol may *ilao  include
Aiiulilied  |iclttona i'injtluyt;d  by Ol|;&-
'nizationa sui'h Ha State Cooperative Kx-
ien.sioti Service*. Federal. Sliilc,  or loco!
depart men Is   or  ugt-ncie.s,  01*   jtuldic
health  Cervices.
  2. U*C la u  Jtllun//i>/|/CH{'/i: t*J|*fll  IM
Sli'ttetttral  fV«f Coutml.       „,
  A iL-Kisleied |>e^ttiiih- nitty tu:  u|i|dicd
or  ollitiwise  u^eil  fur  tin- control  ut
uimunifd turret jn-bts by n "knuwifit^e-
fchle expert  In blrnrtuiul  pe.st control"
If (Init  ek|ielt  hinuidf niiiki\s the judg-
ment that kueh use is rllieuciuns  ui;tiinal
the iiniialiu-J tui|;et |H-sl. ftltd llmt Bilth
use is  not or  will  hut  be  harmful  tu
man ur the environment.
 '3. f{fei>mmoidiifiu» of Kttoivft  tf^fti&U
KrfH'i't in  XIi actuml i'fut  ('vtitrvt.
  A recihtered |KslteidL- nmy Iw  unidied
or  utheitvifcu  ur.ed for the control ul uii;
Dumed  turret (tests  by u |»ci IHUI who ia
Hot hinibi'lf a  Lnou'letli;eahle ex|i»:il  in
ktiuclurul  |ie&l control  only if  the  up-
pllcuiiut) ur use liu> l>ce.n  retounnunilcd
In  writiiitf Ly u knowledueoblc expert.
  These rccomniendulions will be m*du
part of the letorda uf lie*I control  oc-
tlvilie*. Sul'.icii'nl ••ccord* must  bo kept
todcttcrihc bccuru..ly thu clicuinatuncci
of  tha  peat  inftbtaUon,  the  )»*«llcld«
tecaiumenJed for cauicul of the proh-
 Um, th« result* of llui trealmeiit, and
 'Sc name uitd addret* of tho knowledge-
   ;lu  rx|ivit.  These  records  ehall  bo
   .itintaincd by  the  |>erson  who  appllei
 or ptherwiwj  utiei  the  pesticide for a
 period of ftlx  (0) inonlhl fioni the duto
 of wppllcutlon ur uae. Itccoinmrndatlona
 of u knuwledgeuhlu ekpurt In itructural
 pest control muy be in  the form of  ar-
 ticles  |itibliahed  In  cut rent  HcJentllc
 lournuU, nianuala. or  other  technk*!
 Lulletitia  ur  cpecinc  instruction!. The
 applicator ur uai-r  inunt  have obtained
 Iho  written  recommeinlutiuii  prior to
 the time  of the  iipnlicution. lie  inuat
 nmke  kuch recoinniendutioiu available
 li>  mi  ofHciul   rejiieaentotivc   of   the
 Agency upon  requecl.
   4.  fc'n/i»i:euie»( Liability.
   The  responsibility  for  thu tnfe and
 ellicaclous U4o of the pesticide  and  for
'full compliance with  the  terms  of thU
 1'Et'S muy test with either the uppli-
 cwtor of  the  ki>owlcd|;c-ublu expert iu
 stiuL|ur*l petit control  or both, as  the
 vtiuUiuk  und   the  ciruum*>tuncu&  may
 require.
   A knowledccublu  vxpeit in structural
 p«nt control  who  peitfoniilly uiea  or
 •upurviaes the use of  a registered peatl-
 cide u^aiiul unnuined target punts is re-
,ii»on>tible  for the  proper  use  of  the
   •itiride  und fur  the  eftk«cy  uf  the
    •duct  u|>ainst  the unnuined  lurget
 • v-bt.  The  ekperl  in  this  jtofcilion  is
 therefore  al^o  subject  lu enforcement
 liabiliiy fur uny misuse  of the pesticide.
 In nil applications pcrfoi mcd  by per-
 •oni other than a knowledgeable expurt,
 the primary  reaponaibility  for  coni|ill-
 uiiCe  reals  with  the  ptrsoii who pcr-
 fornit.  the Mctuiil applkutlun. Enforce-
 in cut  action  will  be considered on a
 ca^c by-ease  bbfiia  for   violations  In-
 volving si|;nilicant harm  to man or  the
 environment  or  deviations  from   tha
 provision* uf section II  (A) through
 estieide for
 the control of an unnamed target pest
 lieithei  modifies  oilier iubcl piavt>tons
 or directions for  use, nor authorizes the
 use of the uesticidu in  u  manner liicun-
 sislent with  uny other label provision,
 including diietlioita for use, precautiuu-
 ary  lubclinu and warninu  slutemenlk.
 Label provisions which  must  be  com-
 plied wiih tit »U  times regutd(*::>$ «>f the
 Uifcl pest include, but are Hot limited
 to. blaU-inenis  re^ardini; product  mix-
 Inu. loiidiiiK  and prepurulion. applica-
 tion methods, label dosage  rule (except
 as  iirovided  in  I'fcl'S  No.  I,  jo  r'H
 JOuZU),  structure reentry limes, protec-
 tive clothing  of equipment, |iiuduct and
 container  transportation,  mid storage
 and disposal. Alihuutfh it  Is  not  com-
 mon  practice,  where  u  registrant de-
 sires   expressly   to  prohibit use  of  a
 pesticide a git Hist named or  unnamed
 pests and the label so provides, it bhull
 U a violation •<{  FlKltA svctiun  12'.a) .
 (2)
-------
of  Kt'ilcinl M^i-ncicB for "iiilcrpri'ltilivfi
rtilfa,  t;i-iu'iul   btuU-ittcnU   of  policy,
rules ul u£«*itry ortiuiiization, prod-dnic,
or practice." Tim 1'ErS rclutc directly
to iiiU-rnul Attu.:y jiioccJurcs *nJ prac-
litc  «nJ  cuit^tiitiit:  "inter (i re live rule*"
or "tcutrwt  a(a(uiuculi u<  imllcy."  A*
»ucl>. this j>t>ltoy »luUuieut In Ha  vvilliin
Ilio  Bcujtc of lliiu vneni|ttM>u.  However,
Intcir*U-il licrauiu may aubtnit  writlcn
coin in (.'a Is  iV£urJiii£   the  policy   xvl
forlli  u. ||>U i'lJl'S to ll.c P«j(UiJ«s
tnf'.iL-.M.H'nt |>ivi>ion  (DC  3J'.:>, Olllce
t>(  t»foiccm»:»t,  U.S.  ttwiruntitcnlkl
PiuU'.ti.m A|;«ncy. 4U1   M  Si.  S.W.,
UOGIII  3624,  Wuslitiiclun.  U.C.  204GO,
Three copita of  llicsc  conum-nli  should
be nubfiiittLii  to fucilitiiti:  thu work of
the  EPA and  ulhcra  ihUrCMtcJ  iu  iu-
tpecliiitf »u«:li docuiuviits.
  D*Ud: August 2U. lt>76.
              iiTAHLtV  \V. LCtiMO,
           A*»i»ttiiit Adminittratur

-------
UNITED STATES  ENVIRONMENTAL PROTECTION AGENCY

              OFFICE OF  ENFORCEMENT

         OFFICE OF GENERAL  ENFORCEMENT

         PESTICIDES AND TOXIC SUBSTANCES

               ENFORCEMENT  DIVISION
              PESTICIDE ENFORCEMENT,

              POLICY STATEMENT NO. 5
             Use of Registered Pesticides for the Con-
             trol of Pests Not Named on the Label in
             Agricultural and Other Non-Structural
             Pest Control
       Reprinted from I lie Federal Register of September 21. 1976

                     (41 FR41142)

-------
   ptsncinr  rnroRccMf NT rot»cv
           37AlLMtNf NO.  5
Use of lfi*i'i»lo»cd Pesticides  far (ho Con-
   trol nl P  publUhed  In
the1  FEDERAL  REcrsTcft a document en-
titled  "Institution of enforcement Policy
SLiiU'incnU"  (40 FR 19526). It was tho
Agency's purpwe In Instituting this se-
ries of Pesticide  Enforcement  Policy
6luU>mcnta  to Inform the gen-
eral public and persons cngnecd  In the
formulation,  distribution, sale, applica-
tion, or other us  of pesticides of Uio
ix>llcles adopted] '»j '.he  Agency In tho
eiiforccnicn   of ' n   provisions  of tho
Federal Ins/cUcI' e. Fungicide, and Ro-
dentlcldc  Ac1., a: at iended  In  1972 and
1076 (Pub. I*. »2-61fl.  80 Slat 973; Pub.
L. 94-110. 69 Stal. 751; 7 0.8.C.  I3S  el
sen.; hereinafter referred to aa FIFRAl.
PEPS ure prepared  and published by
E'PA's  onice  of  Enforcement.  Unless
olhcrwl:.e expressly provided, a  PEPS
Indicates how the Agency Hill excrcbe Its
prasecuUirial discretion, and does not In-
terpret the law or otherwise uYflne what
It and what La not lawful conduct under
FIFHA. The  Office of Enforcement wltl
revoke or emend  any P£PS which, fire
Inconsistent with regulations  Interpret-
ing  FIFRA   which   are  subsequently
prornulKnted by the Administrator. A de-
tailed  explfliwllon of (lie  purpose  and
ocopc  of  PKP3 was  Kel forth  In the
Muy 5, 1975,  FEDERAL REGISTER notice.
   Federal regulation of the use of pesti-
cides  was established  for the flr&t time
with Uic enactment of the 1972 amend-
ments, specifically through  the  provi-
sions of KIM*A  section 3'dXI), section
4. and section 12.' Any person
»lio iii.c.*: n rr^li-tfl ^••• Urtih In u man-
ner  incon.'.l-.lcitl with  li:> lnh-llMtt  It  in
Violation of  the Art int'l limy !;<; Mibjcct
to civil or rilmlniil Mtuctlitn.t.' llo-ACVi-r.
Coii«f(;3 |jit»ndf<1 thivt PI'A rnfnrrc tho
prohibition of »ecH"ii  l2(aK^KOt  In •>
"common «nsc nnumer" and nut  pro-
 hibit uses of regbU-rcd pesticides  which
 axe In no way harmful and  whJch have
 demonstrated beneftclul effects.*

   IT. P unjust AMD SCOPE or T>ns PKPS

   A. Control o/ Improbable.  Unanttel*
patcd, or Other In/rc-ntcntlu Occurring
Ptstt. Pestlcldefl arc cctnmonlv re^l.tUred
   TlrTlA  action 3  (7 USC.  I3fi»
 (d)(I)|  provide* that aa pnrt of ilia rtg-
 i*tration of • pesticide, the Administrator
 •ball  rla-^lfy each pesticide for general  or
 for renlrlcted us*, or for bnih gfncttl ut.t
 and rritrirt^l ur« u the Administrator.  In
 hla dlcr.retton.  may  require. |Sca 40 CFK
 Pan iai.3 | tntfiowtra tha  Admlnl.sirntor to pto-
•cribe niaitdafda for  the cerllflcation  of ap-
plicator* of restricted u«e pestlcldei.  Tn«
Agency hb-t promulgated rripilatlooa  eitab-
luniug certain categoric* of commcrUI (nro-
feaslonal) anpllcalora and aetnng forth min-
imum alaudanla Uiat comroerctal and prl-
*at« appllcatora uutt meet before they ar*
certlfled  to the  peettclde* claaalOed  uodrr
rmtA aecllOD  • for Mre*Ulcta4 UM" (40
Cm Part 1711.
         aectlon !3Uir:«O) (TV AC  |30|
 (•> 13) (Oil  proildr:i  fiat  It U unlawful
 /or "any perwn to u*e .tuy  rrgKterrd ptiU
 tide In a manner liirorti;«Itni with tin label*
 lni(." ThU xectlon brrurr 9 *(T«llve iifion the
 dale of enactment of rlfttA an4 »"m detrr*
 mlnad bf the Administrator to be «flf Im-
 plementing  (FIFRA  imptcmeniatlon Plan.
 •0 Fed. IteR. IH3|.  Ttie regulation* lm}>la-
 DtrnilnK the rcjfljlnttlon (irnrl-sion  of the
 1673 amend me uU drflnc pe-itlclda "UM" to
 mean
   "Any act  of handling or relea*e of  *'
 peetlclde. or eipoaure of  man or thr envi-
 ronment to a nealf'-lde through acts, Includ-
 ing but not limited to:
   (I) application  of »• pentlclde. Including
 mixing and loading end anjr required *u"er-
 ihorjr action In or near the area of appll-
 aatlnn;  and
   (31 oiarof-o  act Inn/:  r«.r  pentlcldeM  aD.
  ••Hou.ie Commlttrc  on  Agriculture.  H H.
 Rep.  No. 93 flll.  02d  Cong,  Int a«-«.  10
 (1071); 6enat«  Commlttrc  on  AKHctilturc
 end Fire* try. 6. «ept. No. 67 fl-lfl. 03d Cong..
 2d 6e«v 10 (10721.  11, e f>nale  CommtlU«

 • tAnrturd  Ihnt the Afnry •tioul'f applj  la
 cuforcliig a^nmu prMirl.lr muitne:
   • • * U le the belief of Hie  Commlllrc that
 tli« me of tne word "l>iruitiUl*iit" rh'iuld ba
 rea«l «nd adtnliiliiered |u a «ny ao a.i to Hjll
 pen til let urity uron thn<« Individual* who
 have  dUre^arded  InMriiri Inna on  a leb<|
 that *ould titdlraie to a man of ordinary In-
 telligence that  UM n4>t In accordance with
 eurh Inunicllonj n UK lit riidan|;er the cafety
 of others or lite environment
  •Senate Cnmmlltre  on Agriculture  and
 Forestry. 3,  H*pl  Ho 82 a.io.  974 Cong  24
 6ea». M (I073|. Aa the Senate Commlltte oa
 Agriculture and Fore % try elated.
   (1)1 la not the Intention of the Commute*
 to prohibit  any u* which le in no  war
 harmful, and, which  baa only  beneficial  ef-
 fect* on man and ble co'ilroamea*. .

-------
 lor the control or |*sl/i attacking major
 coinmiHllffr*,  crops or trculmcnt Areas.
 Acrordinrl). nmny  prsl*  which  mnv  b«
 mcoimt*Trii  In  iii;i it-ill tnral  or  other
 noii-^tnit tutal  pest  control .sltuntlom
 m;iy not be li.sUMon Hie 'label of pesticide
 products rct:lil*Trd for u.se on the com-
 modity, crop,  or area  when; the pest U
 encountered.  tTA  Is  nwnic  thsit  pests
 jinty iippenr which  ore Impinbnble. mi-
 nnttclpulfd. or  otherwise  Infrequent  In
 thrlr occurrence.  Tlic  suddenness  of
 iliPir Infr.slnlton*  may not  allow  suffi-
 cient time  to  enable  the registrant  to
 meet KI*A standards for registration anil
 laiM'llng. Furthermore, the infrequent or
 sporadic nature of such unnnmed pesU
 limits  the  economic  lucent I ves of  the
 agricultural chemkitl Industry to register
 these uddl(lonn) pcit control uaea.
  The use  of  a registered pesticide to
control a ccsl  not named on  the  EPA
urccptrd label would not generally post
different  risks to  mnn or  the environ-
ment than  would the use  of such pesti-
cide  to control jtc.sts  (vhlrh arc  named
on  the label  tvhrn used  In  n  mminer
consistent wilh  nil other  label inMruc-
lions. Accordingly. It cnn Crnerftlly be
found tlmt such use ngnlnst nn unnamed
pexl Is as safe us Uiia«
of prallcldc UKO which relate to IhU calegury
of pest*. Fot tiamjJlc. puriuant to flPHA MC-
tlon 18. Federal or Blutc »(tencte« maj obtain
•ntcrgency eirmptloiis from the rcglotratlna
requlremenU for (tie control nf petit ti>rc»L«.
Uon* which conolltitU • unique crtaU. «|>e-
olfic amergeiicy. or n threat to public health
•net for  ihe  control of which no  pestlcldo
rrglitrrrd for the purtlcolar uce lt»vnlluble.
 |40CFnP« Senate Committee
on Agriculture and  Fore*try noted that
   (t)h« purpuna of |*ccl|on 24(c)(  !• to glv«
a State tli* opportunity to meet expeditluuoly
tad with less coat and administrative burden
on the registrant, the problem of registering
for local UM a  pesticide needed to treat »
pent Infestation which (* a problem lit »uch
Bt*te but !• oot aufOclently widespread to
warrant  the espenaa uid difficulties of Pcl-
eral registration.
fienat« Bepon No. 03-430. daUd June 7, 1073.
and Part n of the «ame Report. daUd Octo-
ber a. 1013; Ate alao Houae of ReprcMiitatlfa*
Report No. W1-611, dated «kj>Unib«r 38, I&71.
 Atlmlitltilrutor to lutfr nrtulilWif*! qiuO-
 Uytiitf pniKKUivs) U> LtAue til/it* r^KUlra-
 tiuiu piiinmtni to  KIKItA r^-thMi Z4IO.
 1*lil« Interim n-rllnYtitloii prc>.  Miut  ttlntt*
 Imve HppllL-U fur and h**e brrii grunUd
 Inln im riTtUlcAtion  to t-v>ne UUil« renta-
 tnttlonji for "s|M-clnl local  nerds* pur-
 auitnt lotMTtlon 24(c>.'
 •  C. Ai>plicat>Uttu  ol the Administrative
 U,; fianUrn Enabltottt'd in tfili I'Kt'S  In
           to  Uie titatc  K-RlMmtlonA  for
        l locul nrcd.i" |>rovKlL-d In FlhllA
          24. pra-urutortul   dlscnrtltm
 wilt  bo  rxerclxcd  imdfr  the  nuidltlom
 (.perilled  In  this I'KI'3 in renolve |>rot>*
 Irm-. ml.slng m the rnnirnl of unnnimx)
 l efll<:iicy dnla lUTdcd  to HUJ>-
 port a rcRLitrntlun for the nnnnntnl |K-st
 U unftvaUable.  and  tct  the   failure  to
 control the  unnumrd  pest  may  be rea-
 sonably en pec tod  to rau5e  mntcrlaj In-
 Jury  to the  commodity  or area  to  bo
 IrenUxl.
   Thu ndmUtLstmtlvc innhnnlim e.sUib-
         In  this PKPS  compl^nirnln  the
         section  :M*r*  rrristratlon pro-
 grntu for "ftpwlal locul  nccdfi  " NotwlUi-
 BUndhift this I'tFS, the Aurncy e* pec la
 tluit  the KUitnuiry  inertiunIsm  for  re-
 6]h)nding  to siiec in I  local  pest  control
 need*  (I.e., KIF11A sc<:tlon 24'c> >  will be
 utlll7cd lo provide  BUitc r.-clstriitlnm for
 applications |M-rfonnrd for the control ol
 pebt Infc-itntiiMLs which are recurring or
            In their occurrence.*
   * at*u-a may  bo ceilllled b» rnt1*Ur p**-
 Uclde pfOducU for local nr minor pr«t prob-
 laina under the following c!ti nnisUti<.T*t:
   1*bcru >A no KfA-riKLMrrril |>mtloia« prnd-
 Uct tut tha UM> In qur«ilun.  or there U an
 BI'A-reyl'tered prattclde product, bul It !• not
 avallal>la, e.g.. cannot be nMained In suniclant
 quautlty. or the-re U an ICI'A-rrKlatfred pr*tl-
 dd« product  which, nnuilnaJly. U aulUbla
 but. U  uard  In accordance- with the labe-l.
 would not b* a* aafa or a4 efllcaclniw undar •
 local condition* (40 m 4^J639: September X
. 1»76|.
   • li atiould  b« DOt«d that the availability
 uf Ua* admlnlatratlte  mechanuirn provided
 lu Uil*  F.KI-3 m no way llmiu tbc right or
 any paraoa auihoruwd to do ao lo *e*k a
 BLat*. regtalratloo purauant to FTP^IA accUot
 MK| 'ur UM UM of  a PodaraJ!r  iMfUUrvd
          tor U*» ooutrol of Uoprobahle, iu>-
           d. cycllcaJ. or otbtr lofrequcotiy
   L>. further  Kfjiii'mn-nli /n*pm--, lidlug |iur->ub.iit
to KlI'llA section 1'i-ai, to udd  further
rc^t i IL llona  regurdlitif  tin-   u-sc   of  •>
P*tlerulJy-r*-KlAUn-il  pnNluct. or lit  ac~
oonlaiioe  with  fiitiir.  Uw, to  prohibit
partlrulnr  uses of  Fi-dcrttlly-rcKL'trrvO
poatjcldra wlUiln Umt .Si*ic Tlie Aacncj
autttclpale-i tlmt fituU-A mnv elect U>raer-
cUe Uie powers set ft»iUi In wrtion  24'n>
la Uie two si^^inc wuy . el*lxirutv^ IIOUMJ r< of n P.-d-
eriUlv-rr^tiU'red pnxl ;<•>. ulll n'M  n/Tocl
 Uio AKCHCV'* OTICL.I; of  t>rw,«-< uu>iuU
dL^crrtlon  undrr  r7f-11.l  An ui>|>hr;ttnr
or other p<:ruin  who ioui|»llr.t *iUi  Uie
requlrcmcnu 0et forth m 3
Ikhctt by n Stair pnrMinnt Ui KIUlA rcc-
Uon 2*(a»  may   l*c  .•i:lt|<-ct .in hahlllty
only under Statr law All i^mom per-
formtmt AppllCQtinn.-t purr.imut to the  ad-
ministrative inrrlinnlr.nl *ct forth In LhU
PtTPH  arc  <-nconnt»wlracrU wiUtiu  that  NtAte  by  i>> icing
their name*  on a h-I  ot knowh-dKrable
CK|«:rt'.. or by sumr olhcr rnmns nrcept-
able Ui the fltftte  Kurh Stntr mtiy estab-
lish more .Mrlnpent Mu.ndurd.% than  thfVie
which arc mu-<) m Si- linn fll C nnd IV.
C. below. No person  will be rlrt'mr'l to be)
A know htlRPivnlr I-XIK rt within th' rnrnn-
IIIR of th« PEPS nnl.-.%  hir  niM-u  th«
minimum standard  r,t-i forth  In .Srrtlua
III. C. nnd IV. C, birl-iw.  n-K^rdl'-rj of
having b*-cn (leslrnutrd aj  a kitowlo^ge-
able rxi>crl by a Sutr.
   2. Kln-.tion by f/rr  .VMfe  tn Conttuct  a
rrrat'plinittan Itfut'-w i-i  the  n>-rum-
mcndatian of the Krmu lntvrnbtr /;rp.-r/.
Eiu:h State may clcrt Ui review Individ-
ually fiuh rccoinmcii'lailon  made  by  •
knowledt'cutile expert jjnor to the time
of the  pesticide apfhcailon  lor the con-
trol of the unnamed i^st  .States  exer-
cUIng  thts election  will eMnbll<.h  their
own procedures for i>erforming LhU pre-
appllcallon review.
.10. SUHMAHT OF  ENrOKCCWCHT  POLICY
   RKC.HHDIHC nn  Use  or  A  RCMSTIJIIQ
   PKSTICIOC rot TUB CONTIOL 'or Acu-
   cuLTtnui.  on OTIIE* NON-STBUCTORAI,
   Pun NOT NAMKO OH rue

-------
   The  U449 of a registered  pr«tlclde to
control pcatJ  not nnnted nn the lalxl or
labeling commute.' a UnlaUon of K1KUA
•cctlon 12in' <2i e3llclde  la regis-
tered for it%e at the type of site or Appll-
calbin environment fuid on the commod-
ity. cn*p, or aren which Is to be treated;
   «C>  The list to recommended In writ-
Ing by an Imllvldunt ulio Is A knowledge-
able extort la the appropriate ore* of
agrlr.uliural or other non-structural pest
control;
   iD»  Tbe  trcomniendAtloo   of   the
Imottlcdgrnble expert  la submitted  to
the 3tal« Control Agency;
     No  pratlclda  rr-gtet*rcd  for  u»o
against the agricultural or other non-
structural IK*I to  reasonably  avallablo*
In the  gr-c«raphlc ftn*a  In which Uie pea-
tlclde ts to I* used;
   IP)  Tlie user compiles with all  In-
structions,  warning*,  precaution*,  and
prohibitions on  Oie  lul>ol and  labeling
of the prirfluct wlift-h is imc-d, other than
those  pertaining  to Uie peats against
which UH; pretlclde la U> be  used;
   (G»  The Kel(i-tod  |H**tlrlilp  doe-s  not
rontnin an UitfrcdW nl  Included In  a>
product u-hu&e n-KtsLrntlon Is the subject
of a notice of  Intent  in  cancel or sus-
pend,  or  whose ret; 1st rat Ion  has  been
3u&|*nrraj part of thb  PETS.  Whether the
user h«5 rrruonatlr  met the crtUrlfl act
forth  In  thla PEPS  wUI be determined
by the Agency on a caae-bj-cuc bub.
 The biirdm of .Nlmw IIIK that Uir criteria
 net forth benpln hn*e born met n-sU with
 lh« peisfin applyliiH or othrnrlw using
 a rrRl.il^rtil |«v;l|rtife for the  control of
 flfrrlrullnrnt  or  other  non-sfnictunU
 I*?Is which arc not named on the ftp-
 proved product lohrl.
 IV. EHBOXATION or Co»pmoH3 RCOAIID-
   INC Usr tir Iteci.^Tciiro Prsncrom roil
   me . CONTROL  or  AGNICCLTDBAI.  o«
   Omr.a  Nori-SrnticTuiiAL  Prsra NOT
   NAMED on m« MBKL
   A.  Trcatnu-nt  of  tmprobablt,  Vn-
 antlctpatrd  or  Other  Infrequently Oc-
 curring /Vjfj (except  Ilacterta. Fung-
 usci. Viruses or Other Pathogens t, Tli*
 odinlnlstrnllve  mechantam  ott forth in
 thlj I'KPS may be utilized  only to con-
 trol pr.iUi  which  are  Improbable,  un-
 anticipated  or  otherwise Infrequent bi
 their orrurrenrn. Tlie knowlctbxntbl* fx~
 pert  ivho  nuiki-A  the  rrconinu-ndAtlon
 mast rrrtir> Utut  Uie iunmm>d  |H*t to
 bo trciil4.it ti approprtttuely luliii eased by
 IhLi l*KPS. The  use of a rrfflsterrd pra-
 tlclde against unnnmed fienta  which are
 not Improbable. ununtlrlpnUxl. or other-
 wise Infrninent  In their occurrence wtU
 subject  Uie knowledgeable  e*|M*rt and/
 or the  user  to  civil  or criminal sanc-
 tions lu notctl in Section IV. C-4 of UiU
 PRPS.
   Hie  odmlnLstrutlye mechant«in ««Ul>-
 tUhrd In thU I'KI'-'i rnar not he utlllrrrf
 If the  pest to be controlled  la  a bac-
 tcrlum, funguJi. vlnia  or other  mlcroMi*!
 life form which  la  pathogenic to mnn or
 anlinab. In effect, thla  limitation re-
 moves from Uie &o>pe of thU PEPti ajitl-
 mlcroMal aftenti (Ore 40 CFK  1032]
 and  runplcldca  |6ea 40 CHI :fl2 3(fT»
 (8>) Intended for preventing, do«troybig.
 repcUuig or mltlRatliiK hu.nian or onUuul
 pathogens.  Therefore.  Ui  order to con-
 trol  an unnamed  human or nnlmal
 pathogen.  It will be ne^ciiary to obtain
 an amended rctfl.itration under I-TFHA.
 Thb llmltntlon upon  the ccopc of IhU
 PEPS Is baaed UJMIJI a finding that the-
 cfDcacy  of  dUinfccliuita,  sttnltlzcrB,
 sterHIura.  bacturlo^tAui, or other anti-
 microbial products used ag&ln.st human
 or animal  pathogens has unique filgnlfl-
 cance.  In  Uiat especially  ncrlutM c<»n-
 aequcnces may result If such a pesticide
 Is not In fact c (I lead a us In the treatment
 of this category of  unnnmed PCS6s.
  D  Vie & the Specific Type  of Site or
Appttcalfon  Environment  and on  the
Commodity, Crop,  or  Area  Which it to
be Treated. The policy act forth  In thb
PEP8 applies to Uie use of a  registered
pejUclde for Uie control of unnamed ag-
ricultural or other non-structural
 only when the application b ma^Ic at Uio
 epochIc  type of u-sc alU1 or appllcatl«»n
 ciivlrtinmrnt HI id on a commodity, crop,
 or  urr,a  which ajipcars on  trie  EPA-
 acccjttcd label of the product used.*  For
 example, this PEPS In no way authorizes
 the URC of a pesticide which b registered
 for use In, on, or adjacent to structures
 for any agricultural or other out-door
 application which Is not  related to struc-
 tural pest control.
   Thl.t policy applies to the use of regis-
 tered pesticides In  agricultural  applica-
 tions fur the production of agricultural
 crops," In outdoor or Indoor applications
 on  animals," In forest nest control,'* tn
 ornamental  and turf pest control.4 In
 seed  treatments. In rlcht-of-vroy  pe&t
 control." and  In public health and reg-
 ulatory pest control."
   C. Recommendation of o Knowledge-
 able Expert in Agricultural or Other Non-
• Structural rat Control—1. Meaning of
 the Term "Knowledgeable Expert"—<»)
 Qualification* of Knowledgeable Experts.
   'Die Agency  Intends In  this PKI'3 to
 allow the use of registered pesticides for
 tlie control of unnamed pests where sucli
 applications provide efficacious control of
 tlie unnamed  pest.  To achieve this end,
 the Agency  requires all  persons necking
 to control unnamed pests to obtain the
 written recommendation of a knowledge-
 able expert.  To be considered  to be  *
   ' An evaluation of the behavior of pesticide
 reolduco on Mi* commodity or crop to wlilch
 a pentlclde • applied U an In tag* a I part ot
 the rn;'"lra'l< ** °' *nf pesticide. Strict con-
 form if wlf>t  all other condition] of tlilt
 I'ECS will  r it  irevent the (junrnntlne telznro
 of tlie  con- IHI 'Itf or crop If Illegal residues
 aro discovered thereon.
   ** Agricultural commodity and crop appli-
 cation* include, without limitation, tobacco,
 pcaiiULi.  cotton, feed  grains, noybeans and
 (orngo  vc^otalilen. amnil  fruiln. tree friitts and
 nula. UA well  0.1 on ^ra.s.slniid> and lion-crop
 agrlciilliiral innds.
   11 Animal appllcatlona Include, wlllioiit lim-
 .Itatlon, heeT cuttle, dairy cattle, awlne, ahecp.
 horhC5. goats,  poultry  and  II res toe It, Teatl-
 cldal  treat menu made  to places in  which
 inch ant mala are confined  must be made In
 accordance with the provisions on the label of
 Ine prttlctde uaed In  tha treatment, or td
 accordance with tbe provlslotuj of {'El's No, 3.
    'Torrst pest control I Delude* without llm*
 Itallon pcatlcld0 appllactltina to forests, for-
 est nuraerlM. and foreal aced producing area*.
    MOraament*l  and turf  pest cooLrol la-
 eludes, without limitation, application*  OD
 ornament*! trcaa, ahrub*. flawara. and lurf.
 It Include* application* In
 kniiwlrdftritble e\i«Tl within the tnenn-
 b>K of Ihl-i I'KPS mi lu'llvldiinj inu t hnve
 Obtained  sulHflrnl  fv Indent rd»M't*UoO
 and/or pntctlcul rk|>crli-nrc In tho paitlc-
 ulur in-st control nrra In which the rec-
 onimcndatlun Is being made. Person.-; who
 hftvo any of Uie foilinvlng cnmblitntlorts
 of quullfylng tcchnlcnl experience  and
 Cilurtillon may qunllfy to  he knowledge-
 ablo experts within the meaning of thti
 PEPS.

    Experience:    Qualifying  /Tducodon
     0 yearn	  LX-MI 'hari fiaccalureat*
3 year* .......
2 year* -------
1 year ________
                      iu rtU.irf-ala Degree.
                      ftAl'i* l>egree.
   As used tn thtx PEPS, (he terms "qual-
 ifying exi>cr1ei)C<;" and 'qualifying edu-
 cation" refer to practical p<'*l contn>l ex-
 perience or furmnl acndnnic training la
 the particular pcr.t control area or aca-
 demic discipline in  whlrh  the rccotn-
 niendntlan Is nntJc n-s a result of which
 tho  knowtedgcnhlc exi>crt has  become
 familiar with  the  following elements of
 pest control  practice:
    /Vificidcv the pesticide (or active
 Ingredient) to be used to control the un-
 namcil pc.st;
   lilt Use Site and Prst Control  Envt'
 ronnn'nt: the commodity, crop  or area
 to be treated: and the cllmntlc; seasonal,
 and  ncocrnphlc < harnct'M l-dcs of  tho
 locate:
   (111) Pest: the clo/is and nature of tho
 unnnmed pest U> IK controlled;
   Ov> Application lUethtxl: the method
 of preparing and applying the  pesticide
 as Instructed on the label of the pesticide
 selected for use.
    Examples of "Knowledgeable Ex-
 perts", Qualinetl |*erwms  employed by
 such  organizations as State CcojHirpllve
 Extension Services. Stale land grunt col-
 leges, Federal, State, or local Agricultural
 departments or ni;«mclrs. or public health
 agencies may be considered to be "knowl-
 edgeable  experts." Others  may Include
 pest management apeclallsls or cortsul-
   " Itinht'of-way pi-tt control Includes, wltb*
 out tinillatlun. application^ on roads,* elec-
 tric |x'werllnes. pipelines, and railway rlghU-
 of-way.
   M futiilc bealth and  regulatory pe&t con-
 trol Include* peat control activities engaged
 In bj State.  Federal or other governmental
 •mpluyeea using or «u per vising tbe me peitl»
 ctdes in public health program* for tne man-
 agement and control of pest* having medical
" and public bcaltto Importance, or la the con-
 trol Of other regulated peat*.

-------
 Cant*. Cimllfled academician* employed
 try private uLsMtutfuru and scientist* nn-
 pkiyrd by A (Mfiipujir owning or manag-
 ing  the  /(inn  or  other Application  «lt*
 may ftl5O be knowliiJneahJe expcrla. Ad-
 dlUofioJIy. ftcfcnluilji and other  j>er»orui
 employed by a manufacturer, distributor.
 iomiulnu>r, or  user will be deemed to bo
 knowledgeable  experts within the nicrui-
 big of thut PEl'S If such iJcrsons ara rv*
 •possible- for  ton king UvhiitcaJ Judg-
 niaild regarding  Utc  development and
 u*< of pjtrtlcular pesticides tor active In-
 gredlt-iiLi) or retfitrdlng particular pesl
 control practiced.
   (O  Lirnttuttons. NotwIUi.iUuidliiR  Uie
 above, no pen-on  wluue pnnrlpnl /unc-
 tion or primary bource of personal In-
 conie (eg., fair* commission) Is direct IT
 derived from promoting the sale or dis-
 tribution of the pesticide  (ur active In-
 gredient) which Is recommended for UftO
 m*y  provide the recommendation  re-
 quired of n knowledgeable expert under
 tills PEPS. Under no clrcuni.-tranrcs may
 any fnlea representative, marketing em-
 ployee, or advertlsliiK agent of any innn-
 ufarturer. distributer or formiilator or
 Hiiy other person rho has A prlmnry per-
 tonal economic Interest In promoting the
 sale or distribution of a product provide
 the   rcconmiendatlon   required  of  a
 knowledgeable expert."
   2. Contents ol the itccommcndation o/
 the Knnirtctltffaltlt; Ervert. Each recom-
 mendation jmulc by a knowledgeable ex-
 pert for  lite use of a registered jjcstlclde
 /or the control uf unimined aK'ileuIturnl
 and other non-structural pest-i fthnll be
 nmde In writing and shall tse signed luid
 dated. In funking the recommendation
 Uio knowledtfcabJe  exiwit must USMIJC
 klin»df  that the i»esl to be treated t>  im-
 probable, unanticipated or Infrequent la
   •*Thlt prohlblMun U r.iiur.lmt wllli ttir.
 provblon* of rifllA iu>rtluii UfMUHUl.
 ftUlrh m*kM U unlawful fur «ny iirrttun In
 tar SUI* to distribute, irll. vtlfr /or Ml'-,
 hold /or «aj*. »hlj>. deliver fur .sliljunritl. ur
 rrrelr* and (btiltitf mo riXvlffli  • pint (>/
 IU dUtnbuUou or M!« *nb«NintUHj' dJllrr
 rroro any cljlrtu wad* for It ••! * pnit uf Ilir
 •i«i*joiat rmjulrvd la conim'tiitn Mlttt  It*
 r«ulAir*ilon  uodtr  lection 3   / tlinphitsia
 •dd*d; 7  U6C.  MOJ(A) (I) (B) |.
   It U noted, however, that pnifi-v.limnl pr*t
 control op*nt*?n  wtio «r* dm-iii*^j  by  lli»
 A«r»uirr U> bold pMttcldM '/or dlntrlbuilun or
      wllhla Ut» OJ«*OJD( Of r/FHA m»y bo
        lo b* kootr|«df«»til* «ip«ru» witliltt
          of o/ U>to PCP8 I/ Ui«/ tac«t Ut*
          l  or  u
       a Ittte PKF&
 Ju occurrence wltltUi (lie meaning of thij
 l'FJ'3   Tim  recommendation  ot  the
 k.nowlecst
 wUJ be AlloMTd. Uie conuijodity. crop or
 •reft on which the application ia l« be
 nmde. the dnlrfi or dunitlon for  which
 Uie  recoiimit'iidailou I* aiipllcable. Uie'
 pesticide to be used, tind the unnnmeU
 pent which tc  to be contrulJed.
  The  reconunendutlon of  the knowl-
 edgeable expert must refer to either  the
particular formulation of active Ingredi-
ent (Identified by the percentage of AC-
 Uve Ingredient) to  which  the recom-
mendation applies. If the recommenda-
 tion refer* to  a particular formulntlon of
active Ingredient, the proprietary product
 used  to control the unnamed |>cst must
contain that exact formulation. The ap-
plicator or user inu-st have obtained the '
 written recommendation of  Uie knowl-
cdttcuble expert prior to Uie time of the
application. HP must make n copy of <2ifG>, U ts unl.ittluf for Any pt'r.snu
 to "use any re^Kleicd pi'&tlrltk* In a man-
 ner   lncon.<.|.st<'nt  with  ltd  hibclmu/'
 F1FI1A cnforrrmciit llnhlllty for Uie mii-
 lue of |H'Mlc(d« fnHi primarily upuii the
      .lo ujser or applicator. Particular!/
where the pesticide application Involve*
a devtiitlon from the uses which are al-
lowed on  Uie accepted lubtl. any person
who niUra. loada. nppllta. Btorea. or dla-
poecs of  tiny registered pesticide In  a
manner Inconsistent  with tU labeling
may bo tubjcct to civil or crbjilnul &unc- .
tlons under KIFRA."
  The knowledgeable expert who person-
ally u.sca a registered pc.-.tlclde agulnst
unimmci]  iwst  Is  responsible for  the
proper use of the ncstli-lde tuid for Ui«
etllency of the product  iiftiiliut Uie  un-
named pest. In addition, the expert who
personally lupervlses Uie actual  use or
Application la Idnuelf coiiMdercd to "use"
the pesticide  within the meaning  of
FU-'HA flection 12fO>. and la thua
subject to FIFHA enforcement llabUltjr
for uny misuse ot the pesticide which oc*
curs under hts supervision." The respon-
sibility for compliance wiUi all applicable
hibclliiK requirements,  and with nil of
the provisions of Uils PEPS U assumed by
the person who u^es or  supervises the
o.te of the product.
  b. Civil Liability. It it not the inten-
tion  of the Office of Enforcement that
this I'EJ'S should In any way affect the
civil  Hublllty In  dAm.U'<>.<; of A knowl-
edj;ca>>le expert.  TW*  PKI'S Is not In-
tended to Increase the li-.k  of liability
bryimd that  which Ls  Inherent  in the
ordinary execution of  one's duties In
oireihu: pot  control Advice to users, or
In  J.UPCI vising  pt-stlcldc applications.
Nur is lhi.. forest, orrwiacnfcU, seed
 treatment, or rl provide on experimental
 basis for evaluating the need for a Stale
 registration  Issued  |.-ur&unnt  to FTl-TOA
 section  24fc> to respond lo Identified
 special local  pe.it rnntrnl needs.
   The State  Control Agency shall main-
 tain a record of  (hr recommendation of
 Uie knowledgeable  expert for two <2>
 years from the date of Ihe recommenda-
 tion.
   E. Avallat't'ity of a Pesticide Keg-
 istcretl /or  Use  Apainst the  Pest.  Any
 registered pesticide whlrh ts currently In
 the channels of  commerce  In the geo-
 graphic Area where the u.scr  resides or
 does business Is nrc.s-umed. for purpase«
 of enforcement, to be reasonably avail-
 able for the  control of all pes^s nnncd
 on the label. In determining whether a
 pesticide  which  is registered for  use
   •* Wher*  the  reroiiinieoUudoQ   of   'He
 kuowlrdtfCftbte fiptrt  do«  not  tefrt lo •
 proprietary pcntlclde product, but rrffin lu-
 •U»d to ft fortuulftiltfii wild • •tlpiilatcd
 percent Active liigredlrut, U U lh« rr.if>oii.il-
 bllltjr of the p*r*on »'liu uocn or ftppllc*  ib*
 pestlcld* lo  select  a proprietary  pfnOuct
 wblch contain* the AMiJtilMrd  pfrrcut  of
 •ctlv* In^rcdtfiit »nd whirh U reglctrrevl tot
 u*« »t tb* uo« *lt« or In Ihe *|>pllCM.ion  *n-
 Tlrunnient  In wbJch «u uniounrd p*tt  »p>
 pcara,
   "Mftny flUtU pea tic Id* Uw« problblt  ih«
 rftcommeadfctiuru of th* u*e of • reKt'-Ured
 p«utlcld* la * muiDcr lnroii*Lit«at with lu
.. *oc«pt* *f-
 f«cU thv lltbUlly under *ppllc»bl« fit*t« <*«
 ol a koowfldgeBbl* •*p*/t who nc-
 U>« UM of a pMtlctd* la A m*nn«r i
 •DtwtUiU*!*	

-------
 Atf'UfMC (ha  t*r*<*t  |irat  it  rrawoiiaMy
 avitUiiMe,   UM  A gruff  will  *omk)«r
 vhrtlier:
   is)  The iuwr haj contacted  onic'lnfe
 of wiflte or Federal fluencies which e*er-
 rl.M? rcKiiliitory authority In the arra of
 pesdcMe u*e, or lias otherwise miule •
 reittoimbld effort to ascertain whether
 any pt'.*ticlde  has teen registered  tor
 the con fro) at the pest;
  )  The u.'rr  tins  attempted  to pro-
 cure any  Mich pesticide registered  (or
 tlie pest from his normal sources  ot
dlAtrlbiitfon; and
  *c» Jt b reasonable  to conclude that
 no pe^lfcfde registered /or the  control of
 the pest could be obtained within a rea-
 sonable time from  another distributor
 In  the geographic  nrea in which  the
 pesticide wiu  to be used.
 No claim ot unavailability may be made
 on  tlie baM* of cost or profitability.
  F. Directions for .Use and Other Pre-
 tautionary Labeling  The use ot * regis-
 tered pesticide for  the control of un-
 named pa- U In accordance with the pro-
 visions of this PET8  neither modifies
 other Intel pro visions  or  direct Ions  tor
 use, nor uuthorUej the use of the i-istl-
 clde In a manner Inconsistent with any
 otli?r  lit be 1 provisions, Including, with-
 out limitation, directions for use, and
 prei-nu tip nary  Inbrlln?  and  wanting
 statements. Under no circumstances docs
 this I'EI'8 penult any  activity which Is
 expressly prohibited  on the label, Label
 provisions which inii^t  be  compiled with
 at all times rtrurdle.vt of Lhe pest treated
 include, without  limitation, statement*
 regarding  product uiljilng, loading and
 preparation, application methods, label
 do&jme rules (except na provided In  an-
 other published PE1*8>. application fre-
 quency  or pre-harvt'5t Intervals, field
 reentry Intervals, proU-dlvc cloDilng or
 equipment requirements, product pack-
 aging  and transportation requirements.
 and atoroee and disposal  practices.  Al-
 though It Is not common, where the label
 of a registered pesticide expressly pro-
 hibit  use of the pesticide agalrut un-
 named pests. It  shall be a  violation of
 FIFRA section >2 (2> endcd outweigh  the
risks. Neccsaurjly. no  such finding will
have been  made by the Administrator
with respect to the use of pesticide prod-
ucts containing  the Ingredient* In Ques-
tion UKiiimt pests which are not named
on the  Inbel of  the product;  thu-use of
the product cannot be extended to un-
named pests unless and until the Admin-
istrator  has  determined  through  the
reclsti'JttJon jirotf.ts that the  benefits of
the use miluclch the risks.
  Somewhat  different   considerations
warrant the exclusion from Uie scope of
this PEPS of products containing Ingre-
dients Included  In products subject to a
notice of Ink-lit to cancel or suspend.
The Issuance of such o notice Indicates
that  a substantial question  of safety
exists with  respect  U> the use of prod-
ucts ronlalnUig the Ingredient hi  ques-
tion.  Until  this question of sufi-ly lias
been thoroughly explored In the cnncd-
latlon  or suspension  hearing,  prudent
public pulley dictates that the product*
be restricted to those use* which are  ex>
preuly provided /or on Uie product label.
                                  cnU-
  "It afaould b« not«d that tbto
gorf of ptatlelilc* WM cipllcltlr
from  th«  •peclnl  local tto»dk reKlatratloa
prognm UOdcr FIKHA vectlon 24(c).  Bc«
proptwod rcfulktloai »t 40 C1TR I03.153(e) (3}
(U).
 ,*H»ttt»t««l UMt of '» p««IIcl(l» u* c*n-
eellMl only upon • finding tb»t tucb 1100*
POH mn "uiurtiv.Minkbla rlik to m»n or th»
•avlronnieal. t»klng bito  account Ui« «co-
Domlc. *ocl«J and environment*! cosu  «nd
b0a*OU Of f«»cb  u«),' (7 USO |3<]fbl>H
T7i» decision  to iuflprnd the registration of
• pesticide for certain oaei 1> based  upon »
finding that >uch u*c» POM an "tounlncnl
liajeard", !,•., "that th« continued uae of to*
f>es ttc Id* during th* tlm«  required for cao-
C*ll*tlou proceeding* would b* likely to re-
sult In unreasonable adverae effect* on ID*
oDflroomcot  • • •- (7 U.SO.  138(1)).  Ap-
plying tbU atatulor/ • tan dud  In dctermJo-
lo| wbetber  or not to aiup^nd  tb« regU*
txatloo of certain utet of * pe*tlcld« »Uo U»-
volfea • careful balanolng of Ut* eo«U  aod
tuu*AU of UM UM« la
  It ITiKfurf Sfftcaey. Ttw p«Uclde ap-
plicAtfon for Uie control of unruuued
prat  mu:it be efOcnclor.3. or mujil IT*-
aonably b* e*i>cct*
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF ENFORCEMENT
         OFFICE OF GENERAL ENFORCEMENT
        PESTICIDES  AND TOXIC SUBSTANCES
              ENFORCEMENT DIVISION
             PESTICIDE ENFORCEMENT
             POLICY STATEMENT NO. 6
             STRUCTURAL PEST CONTROL
        USB and Labeling of Service Container! (or the
       Transportation or Temporary Storage of Pesticides
             rom Ike KeikrJ llegulcr of December 23, I97A
                    (41 fli 5M32)

-------
                    rrsi COMIHOL
Ut«  *n published in
the  rVotiAL  ItLcisTta  ft  document co-
ll I led "Institution of tiiiforccmciit Policy
Si'alcmwiU"  140 FH ltt»2ol.  It was the
AKvncy'B purpose Ui Instituting UiU ae-
rtc-i  of   Pesticide  Enforcement  Policy
Statements  (PEPSI  to  Inform Uie gen-
eral public •tid  persona engftijcd In tlie
formulation,  distribution, tale. applica-
tion, or other use of pcillcldus of the poli-
cies »tlov>lctl by U« Agency Ui (he exer-
cise of Us proseculorlul discretion In the
enforcement  of  the  provisions of the
Federal insecticide,  Funittclde. and fto-
dentlclde Act. as 0 mended \n 1012 and
1875 I Pub. I.. 92-61(1; 86 Slut. 973;  Pub.
I,. 04-140; fl& Slut. 7S1; 7 U.fl.C.  136 el
•eq.; hereinafter referred to  tu MKHAl.
PEPS arc prepared and published by
KPA'a Ofllcc  of  Enforcement.  Unless
otherwise expressly provided, a PEP3 In-
dicates how the Aiccucy will  exercise it*
priuibcutorlal  discretion, and dues not tn-
tcrpicl the Ifcw or otherwise define what
Is und what Is not lawful conduct under
F1FRA. The  OlAce of Enforcement will
revuke or amend any PEPS which  U In-
con&btenl wllli  regulations Interpreting
 F1P11A which are subscQucutly  promul-
gated by the Admlnbtrator.' A detailed
explunblloii of the purpose »nd scope of
rt'l'S was. stt fottn In the May 6.  1976.
 }'tui.*4L HtcisTkia notice.
   IS. Sulicrt and Scope at Thij PEPS.
   Tl>la l't:l'ti  oddies&ta  two pesticide
 trutu>|toitutloti   ond   stot'iiga  practices
 which urc commonly cngducd In by pro-
 Icssionul btructuru! i»cst control opera-
 tors, 'lite llrit practice consists of trans-
 ferring or repuckuglng uurtluiis of A pea-
 Uctd«  co*iccutr*u* Into * service  con-
                                   •xcmp-
 lum  Iron •ufwrccinoixt BAOCUOIU whlcb  U
 ctutlm»d lu Wu» l*d*3 will b* cupMiMdcd by
 puf*a»ni to Mctlun 3&(L> of lit* Act,
   •Am UMd In (tiU Ptl*3. ttti Ufin "pc»llci^«
tutiu-r * ii>r  tin: IHIM*' «  "< lu»»i-'i-.itlftg
U tu tbu wi'i'Utuil.." :.li>-. nt i.f Uuu.'Xwr-
IIy hlurluu  tlie  l>i::lirlilc |iil>ir'i«i  i>pl*n~
cation. Ilila piuclUe nll»w& Hie i«  .t coa-
trol upcrulor to |tutrhii:.e  luige tinixnti-
tles uf a pcUlclile cuiu:tittiute  and then
nit*. t.lovu. at:U tiuii:-i*O(i bntulh-r \&r-
tluiu  for  octuu| nppllf:utlon.
   The second pi net Ire addressed  In tUU
PEPS Involves  the utilisation of service
cuntaiiiers for the ine-mtu^uro and pre-
inUturo   of quiinlltiir.t  of  uie-dilution
prep^'ratloiu '  of iK-'bllclUti at  ft &ioi~ugo
tile  prior tu  application, and fur  the
trun.s|iortatlon of &nch use-dilution l»iep-
»rutloii5  to  the upplicutlon  «IU.   1'ltcse
pructlces  ICSMTII the possibility of bpllluge
>l the ftpultculion &Uc,  and  help  to In-
jure tlmt accurate and con*>UU;nl  tloiace
levels are u&cd  with eucli uppllcuUoi..
   111. Jurisdiction  lo ttcyulatt the  Ute
aiitl   Lobcliua  o/  Service  COitlulueiAl
  ' It  Is  the opinion of the Atfcnry thnt
'pioftrsslonal pest coiniol  openttoi* ^\\Q
 cltetotcaU which lii^ not been dUuted Qr »1-
 icred a* h|*«c!&«« or *d*ci provided oo tu t>cctpvp4 l*b«l
  * A* tucti Hi iiii* i**;ra, tii* tcmi "kci»ic«
 coitlblner" nteans «ity  coitltilnar utlllicU  lo
 hold. HUH*, or tiani>|KxL  & ptMlckdo ronccn-
 trtt* t>f a pc«iiclO« use-ulluiloit t»re|>urfcUoa.
 Alher Hi• 11 (•! Ute uilxlitul UbvUtl cuikikii^er
 provided by the iu*tiufkCUir«r. (b>  t)i> mr»4-
 brliig devtca. or 1C)  the apitttcfctton devtc*.
 Cuitlklutir*  lued lur iho ruettvctf mid dU-
 (K»kl tif pa^llclji.'k »iitl litii:tt pctiLt  |e B . con-
 t*luent ii:«J (o recover itxi^nt ti*U *|>|jArft<
 tutica tu4;«ihct  with  dt*J rutleatti «tc not
 d«ciaiil to be «rn'tc« canimiiL-ni wlililn lit*
 lit can lug of Hut I'lirS. |'«!illc|dfis lu t>m:li ton-
 t»lnvr* uiual  be Imildlct) and UUpi^t-a uf  III
 ftt inftitucr cotwuieni with  Ilia dl?.(>oMil  In-
 Alniciloiis on lli« ei'A-»ccc|>Uil l^bcl or |>ur-
 »ii*iit lo tli« Ret&duiKiideU |*[OceJnrcH (or
 bLipOMtl  ktid Sloi»KO l^*»«*d uy lh< A^citcy
 piirsttiktil to  KirUA AC«:iio 11  IB.
   * A» u»cd In IhK l'f:i'3.  Hie tcnn *V',e-dUu-
 lloii pie|(Mr*lloM" intmn i> pciillcldfti prc|k>r«-
 tluii  whlcb U Hilled wlflt • tilla«iit ^nd  »l
 a rnU 4pcclllcd on lli« loi**l or UDcllny wlilcb
 pibdum 111* coAi:cut(nllau  t,f ll)0 pe^llCld«
 lor a pjirUciiUr p>ii|Mj%c £-r e««n pi.ivl-lcj on
 •itch Accepted Ul>*l ut litbchiii:. '  *
  •Tills part t*I PKI'y N» B r«|iief uls an uut-
 Ilitc  ol llt« Agon* y • !CK*I lnlerpfil.ilii.fi  of
 Ihe cllect of  lh« lala kiiicikdincniA aitd ltt«
 implcnwnltnc  riKuUiiaii* on  Ut*  •uttturlly
 at  III*  Agency  to (egulule  !!«« ACllvUlc*  of
 P**t  cuiitrul  opcr*li.rb «Uh reipcci Ui the
 IUA c( »errlce con<»lnei^. As  I it tl 1C* led utio**,
 Ptl-H |[*(icr»l|j descrllM lu>«r llt« A^^iu-'V will

 flPHA. Aa to thU Ut«t*uvc. »oy [Ktftlou of a
 l*Ef3 which UtUfprcU the  Iktj will b« *c-
 oompkoled by aO «*t*r**» Indication that in*
 portion  u In  jtct InUrpreilr*. Ajl Interyr*-
 ilv* |*OiUun« ut a ftfa tt»»* lh« COiicurKnc*
 Of ih« Af«nci'« OflU:* of Oenercl Counsel. For
 a n»or«  deUlieJ cipukltloo  of lh« Agency**
 |urUdlctloa io rctfulai« ill* us* »ud l*u«lU)g
 of *crvlc* couWlMAri,  «•• th«  A pi* ad I • u* thU

-------
 eupply unit apply i»r:vtlcttlM lor htic rn-
 (uiie In the distribution or tale uf pr»-
 llrldr* ivlihln  the meaning of KiritA.'
 ril HA *cctkm 0ial auUiotlzca II.c Ai:cn-
 cjr to perform without a wuirunt Uie nd-
 nilnt-.trutlvc  Inspection of  places where
 |H:stK-ldc3 arc  "hrld (or distribution or
 *u)e." These  Inspect toni rimy  bo  per-
 formed  for  the  purpose   at obtaining
 entnpics of pesticides. Including  the con-
 lent* o( service containers, of reviewing
 (libeling on pesticides.  Including Uic ob-
 bruviuied  labeling on acivlcc conlulnera.
and  of  Inspecting  book a   and  records
 which lint firm  muy muuiluln  regard-
 ing the  delivery, movement, or  holding
of pcsdi'Ults,  us authorized by KJF11A
 section a f>l|rlii4
pr&iu|ir*fc In Hi* Appendix
to llil* I'tPS.
  TttU cunftliuctlun oC Plt'llA U O«ll iac*ul
Ui tiled the conetruciton  t>f ulher fr'cdurij.
61* t«.  or loc»l U».» or rcgulAtlon* auch  4«
|*M» *>r irgttlMlloix dCblliiK with  *«lcs U«.
•nvivloyturui UctuMUf. vfhtcU Itc«i\ft1»g. lu-
trlllly bonding, of ullitr »lnill*r w&tUrM.
  ' ITilfl policy Blitlciiieiit np^llCfl OiUj lo 111*
ulMUAtioii  c.1 BcrvUa conUliiui* by ilructiukl
pett cuntrul u|>«intOf«  fur tin lrtitaport*Uon
or 1«iik|Hfr»ry tUii*n* uf "•iul-u*»" pcattcldc*
wtilcl.  (•)  bcfcr on litclr Ubn dlicetlun* for
pllc«llnit. of  */• Already  yr«p»r*d  lu  •
inf-dlltillou preparation for th* ouulrol of
j»r.l* No |'/f|U't.1»  vnK'b tt I:itfudr4 •Oltlf
                                    '
   crx'ir* ccni«ji>fT
 vl run ii i nil.  )l<»t-evrr.  to  reipitiv  e*ch
 Mrvlcu cotilnhirr  to bciir a full eitd-lb«
 label may i.mtri hilly Inhibit t)io litlll7»-
 tlon of fcci'vlcc  cuiitutiicin by oLrticlnikJ
 pest control oi>cralttra.  Accordingly, the
 OlUco  uf  Knforcfiiicnl. In the vxurr.lsc of
 1U  tuiKtccutorlnl  dlicrcllon, Im* deter-
 nthicd that U will  rclr&tn Irom piujiccul-
 li>M  fctriaturul  peit  control  oi*crulor«
 under I IhUA «cctlun I3lu>  for the uUU-
 Lullou of service containers lu truosport
 or IcniiHimrlly  it ore cnd-uie i>e^tlcldea.
If  all  of  (he  fallowing  condltloiu  and
ILiiltutloiui arc met:
  (A)
       to tha
                   Ud Ubcl.  »«t:ur<;ly  »t-
                    cuiil«liter. liicluU** tli»
  t. ft.tiuiJis Concentrate. II tit* j»e»lUld* U>
IM transported ut otured In  th* Mirvlc* con-
te liter in » pc&tlclda cuitcctttr«t«:
  • . The iiftin*. ftUUreaa, and t*l«phou* Itunt*
bcr u| Ilio pent coutrut Qrm;
  b. product name;
  C. CPA RrulfctrftiUm number;
  d. Hum* *.nd p^rceuliura of vctlv* lii|;r*dl-
*iil>; Miitl
 '•. ±ll|:ii«l wonl from registered ULcI.
  >. Uic-dU|irlun PrepormtlOn. It tit* peatl-
e«tleld«:
  •. The nun*. *ddm», «nd t^lcplion* imui-
l>cr of the pent couUol Arm;
  b. Frodncl iimn*.  preceded by  th*  wort!
"llllii tvil";
  «. t'HA  rceUtrtttlou utiitibvr. preceded  by
Iti* worUa "Uwrivcd fruin";
  d. NKIII* •ud pcrccitlAK* of kCtUo tit|;rcdl-j
•tit •* diluted; «nd       '
  «. filt;ii*l word from th* rfgUttticd Ifbcl.
  (llV  A rafeteitt:* copy of tl\« £l'A->«:cftvtp««r on tb« BPA accepted
Ubcl  or  Ubellng ul  th* re)(Utere)  Tli* •*rvtc« con I Aliier conform* lo  all
FMpecta  vrtttt  *ny  ftppllcabl* cotttabter  or
packaging re^iilrcnienU for pe>lt<:ld« ptod-
uct*. and
  (B| in* pOAttclil* In Oi« *crvlc« conl*lit*r
         , MCtli>it l9(a)OMB|  I* (eiierallf
            auute Vbkt tlt» lurntttlatUrtt of
 Ih*  product (wbclttcr  In  th* original  uu-
 brokett conUlnar or Untutored ln'ii» a wrvlc*
 container) conform* lo th* *tr«ueth. uurlly
 or  other  »lbnd»r<)«  ol  qiutllx  wlilcl^  w»i*
 •cccfiled.  by  Ih* Aiteucy In tb* rc|[i*liatloo
 pfoc<**;  that l»u«hng  adet;uaW to  cUarly
 commuiileal* UM loctructkiru »ud ueceaiary
 warnlDg prccautloiui to p«r»iiu* Itatidllutf th*
 p*4tlcld«  accooipaul**  th* pruduct  la  U»*
 cbantial*  of trade; and that tb* Meutlty otf
 Ut*  p«r»uo rttpottelble (W Uv* lateifrlly o<
 tb* product aod IU lab*IU}| U alwafi aecar- i
a|>|tlt**ti"ii or other une by an wilier pomea.


  1110  llnilUng and dcAnlng  provision*-
odiUlrn-d In section Vol Uila PETS are
an  elaboration  of   the  conditions  A
through B above. WheUier the user ha*
reasonably  met  Uie  requirement*  jet
forth In Uils PEI'B will be detvnnlned br
Uio Agency on a case-by-case basta. Tho
burden of allowing U»ut the ixQUlrcmcnU
act forth herein liuvo been met reaU with
the i»cr*uii  engaging  In  the traAsporla-
Uon or temporary atoragc of a registered
pesticide in a eervtce container.*
  V.  Elaboration  ol the  Pcittddc*  K*~
forccmeni  Policy  aepordlntr  t/»«  and
Labeling o/ Service Container*.
  A.  Abbreviated  tube lino /or Peiticlde
Concentrates  ur Uie-Dtluliun  Prepara-
  'Die abbreviated label Ins noted above
b deblgntxl to assure Ihut adequate In-
foriimlloit  reuurdlng the  particular for-
mulation und/or dilution of the product
can bo  ascerlulnixl  in case  of medical
emergency, Tito abbreviated label must
Include  thc£li;iiul word Io.tr, "Warning."
"Caution." "Poison," together with skull
and cross boncal which upr»eara on the
accepted label of the eml-usc product, or
which la appropriate to the use-dilution
preparation of Dm I product If speeded
Oit the ncccpltU Inbi-V  No other  written
or  graphic material may  appear on Ih*
acrvlirc container. lliU  service coiilulner
labeling U subject toltie FIPRA prohibi-
tions against false or mL.leudlug cUU-
menU on product hibcld.
  The abbreviated, lube! mu&t be clearly
legible and aecurely attached to Die serv-
ice container throughout  the  acdve life
  •TttU PKrtt la no way affect* th* author-
ity of ft 8Ut*. aclloc pursuant to fIFIlA tac-
Itoo i**t»), to add further rcalrlftloii* re-
gard! ug itia *ul* or use of » Pc. o*ay  b* aubjocl  b>  liability
 Uiulor Ulal* U«r. All |ifi>Oite ullllcln^ MrTU*
n.Mit*lnfb |Mir*u*ut l.t ll.U r^Tr> «r* m-
*>iii*n«s| !•* f«HillUtlr» lltri«M*l*«w Mtltl *|*^
                                                 ol ttto  e*4*l»tu«-i «tf until Ukr toiiUlncr
                                                 hu.'i hCL-n(»rO)":i|y ill"|M.:.ci|bf or lecyclnl.
                                                 Tlic abbicvlutcd Inhcl inual IM: replaced
                                                 a* frequently u.\ nrcetisiiry |o meet thfse
                                                 reiiiUxctnenta.**
                                                    When acverul &nrvl«:e containers. ca« h
                                                 conUtlnlng pc.:l)cldc conceatrnti^ or ^e-
                                                 dltutlon iirepnriiUuna. are ilor il or con-
                                                 tained In a larger coini'Ai'liiten i Of curo*-
                                                 Ing CUAC, each IndUlduul uepflcc contain-
                                                 er tntist bear  Utc  abbrevluted label  de-
                                                 scribed above.
                                                 *' 11.  Reference  C**t>v  o/ Xi*A~ Approved
  A reference copy of the El'A-accepted
end-use label bearing use  Instructions.
precautionary ^tiilcinci.ls,  anil  medic**!
treiktincnt tnfAiuelions nuut b-: retained
by the flnn at IU place* of buaine&a. It U
the respoiiBlblniy of th'i Arm aa well as
of the acrvkc tcchnlclnn who perfonns
each pest control application to assure
thwl  pesticides are  u&cd la Uie  manner
•peel fled on  the  accepted  labeling.  To
achieve thU  goul, Uie linn ahould  train
Uie service U-chnlcltn regarding Uie pro-
visions arid precautions which itnpeur on
the end-use lahct. and provide technical
appllcaUan Instruction* aa 'netreasary,
   C. Djrecifuni /or Uie and  Oilier- pre-
 cautionary Labeling.
   All dtreel)OILS for use UIH) all witrniug
 and precautionary statements which  oi>-
 pcur on Uic und U.M) Lib*:I pertain to  the
 use of the ucstli-Ulc lu a {.civlce trtmlamer.
 Tills includes, without llmltallon.  UitK>d
 ktbcl ^tiktenicnu  |>ci'Uttiilng  to  applica-
 tion  site,  turgel  pi-hla,  product miking
 and preparation nroct-iJurea.  nppllcatlan
 niellioil  and  di^tge  rate,   protective
 clothing   or  eiiulfimcnt  ro«|iiiiciiicnu-i.
 storage i>nd dlsfM>t>;il  practices,  or  other
 precautionary  lubcllng  and   warning
 atalcincnts,u If u  t.'iWI enprc.ssly prohib-
 its Ilia transfer ol  a itrudi'.ci C.'ota  Uie
 original container bito a service cc.nUilu-
 er, ony violation of  that prohibition will
 coiuUtute  a violation of Plt'ltA sect too
 ia, and may &ub)ett  the user
 to enforcement sanctions.
   "Tit* label iitaf be of any appropriate uva-
 terlAl. aucti fta ptper. guinntcd p^pcr. melal
 foil Imprinted by h*nd or by lyp«*rlt«r. or
 a metal Ug requlrlnij •tamping.' A* needed
 to maintain clear legibility, the label may b*
 covered with a clear plait tic film or acal. or
 placed In a ccllt.pbane.  glaaetna. or other
 tr*n*p*reul covering  The Ubcte a>»y b* *t-
                                                                                                                                                               •>.•;**«« *.••.*.>& ft

-------
   U. Container JAM and I'*c*n*tnff *y-
 •r alft o( B pr.itlc!do ft>r uao by aitotlKt
 pcraon  wtHilil ice. ilie. or murk-
tiU3>  lilentinctl with food, feed.  tcvcr-
•tca. drugj or cornet l£j tiny not  be ui>ed
a* service cunlainera for ptsttcldu. Scrr-
Ir* ctmUtUiero nnd their caps or closure*
miist be of such coftttructlon and design
a* to wiUuttaiui bojt&rtU of nmtual osng*
without breaking, ruijturlug. bi* Icuklog.
The design iuiul aUo be nucli u to focll-
ilutv the rumovul ul the i*»tlclUe without
rLJt of bHUajte.
  E. FrvMbiffon Xtra'nJt further Sate or
aXilrlbuCkm.
  The service container holding the peat-
Ic lilts  niniil refill tin lit the «olo and actual
iHU±>es!.ton ol the Ann utilizing the acrv*
ke container. It nmv neither be aold, dla-
trll.ulcil, nor given uwiiy for two by aii-
otlier  jwrsuii. Any such sale, distribution.
 Of 1(1 * mauikcr cnUMial«ul will* UM d!a|
 MiaUuctloiv* on  tu* KPA-«j»|>ruvc«l product
 talid tir (Hiraimul to lti» ttecoiuiucndrd Pro-
 ccduira fur DU|Xj»al *jid titornc* of Prallclde*
 t«auM lij Hi* Agency purctiaol to KM LA «ec-
 HAD 10. rMrttt«rnior«,  tb* *orrlc* euuli*ln*r
 miui be »a»*l »nd re-u»ed la * atamvcr whtuk
 will avoid  tti* lomamliiatloD of Hi* pollcld*
 CoiiceulrAttf ar u.->o-dUulloa preparation ot
 the ncfllcld*. Any  containing HOD  due  lo
 iHUltf rinsing  priM-'cUtirea will h*  a violation
 of flfllA Motion Ul»UM (Bl »nd iivxj cub-
 |t>:l me user to cnft>rocin*al •Aii^dun*.
   >*ftnt\ occtlon  »(«)()> n^powcn*  Ut»
 Adii)lubtntU>T *  *  * to «at»l>IUl) »UnduiU
 t*b^
 It&tivd una«r tba auttMrilf wf Ih* rolooa l*l«-
 »Uh re^itct lu tl>«  p»ci»t;o. troutftluer. oc
 ••rfcpitlua >n which • |>c*tlt;ld«  or «Uvlr«  to
 oafa n( ttiU Act;
   Ifowever, no »ucli rvOt»tnerlng or pt£k*<-
 liifi rMjUltcutcuU It&v* y«t been prbniul|t*t0«J
 l*y live ^dtiilnUlralor. Cimiiill«nc« wKQ tti*
 pruvUloii* of !».(« rtl'3 d/>« nut noee«a*rljf
 iftii^/y n.j»|tc»»le re£|ulfouieot4  of lal«tim
       oiM  ixi^urUU wtilca b»r«  been pro-
       lcd b] Ui* DO, pupMtiaeut of Tr»ja»-
          - kt 4ft CVB fWU ITI.in. (41 Ife
                    . 1PTD].
 ••ctloii 3. and UiouiliiblliJtairiil rvutilik-
 Uoa icautrctueuV of VI ill A  Section  1. 1
 Ai)y fiulo or duirlbutlon of ft |x-^Uclilo  in
 • Bcrvli:e conttthier for Hue  by another
 pcraon will fiuhjcut the  seller or distrib-
 utor to liability  under  HFUA vellum
 12tl)lA>  un J l3(a)(2)(L).
   VI. Public Continent.
   Tlio  Atliiiinl^lr»tlve Procedure  Act  <4
 U8C  &53ll>»  provides thai the nollul-
 (utton of comments U  not  required,  of
 Vcd^rui   Bffcnclcx  for  "lyU'i prttuttvo
 rulca, generu] tflutenieitu of policy, rultJ
 of bgeucy  orguiilukilou, procedure,  or
 practice." £PA lioa determined Hint thla
 PU'S  tuUa within thla  exemption  from
 Uia reqtilrvnieutj to solicit fciubllc co*u-
 mettt. AccorJltiHly. Ui6 Agency U not to*
 llclthfg pxtbltc comment regarding  mat-
 ter*  publtsbrd  In thb notlco. However.
. In U rented ix^r.-iOiia on* Invited, to submit
:wrttlcii cunnut'uU ruuturdlutf U»e i*ollcy
|»ci furth  bt llila I'EPS. These coutmuiiU
 ahoidd bo addrc^u.-d to the PfrStlchlej and
 Toilc Subsluuccs fcnforticmtnt Dlvl&tan
H£N-342t. Office  of Enforcement.  US.
 Knvlronntentul I'rotectlun Aiiency. iul  M
 Street.  8 W .  Uoum 3634. Wo&limBbon.
 O.C. 20400. Three copies of these com-
.oieiiU should  be BUbinlltcd to f^cJUUU
 Uie work of the  EPA and others Inter -
 ctttct] hi Inspect big cuch document.

   Uited:  December  17. lOlfl.
                 STANLETW. 1x0*0.
                       /or fn/arctmcnt.
            T»i* UBK AND L*bn-iNO or 8m f-
   II t* tlte u|flulo» «l til* AKviuiy lltnl Ui«
   riiu  "*llaIf)l(uU»",  "flcll".  "oOw (ur fed***
   d "buld" lor •»!»•• u  Vb*> *r» w»*d tu
 rfFltA *pplf to Ih* tyfilu*] Mftlce work <*l
         t pc*l cuUliul Ol»tfe.Ul"' ***
'hire.1  Tin A£6ucy flndc  Cltat  ihl*
 Itlon o( PlfRA (»ud lit* regulatory c«iii>«-
 queue*;* wlilch It tmpll«a) U counts I* ut wlUi
tUi* ftuulktoiy kclicnu of fr-U-aA *ud wlib tU
 IcgUUtlva nUuuy. Th» BciuU Oiuuttlttc* **n
 Atfrtcullur* ftnd IVrealry onvUianciJ  thki th»
(level of regulatory •enitiny to wtafon. |ie«>pl*
 wotild fa* tubjcit under MXflA ihould bi. la
 aitd Ih* pe§t cunlrul operator U hti*4 toMy
>IO pcrtofiii th* pwillcld* »ppllc*tl^a. lb« peat
 control operator wuuld not b* owiwtJortd to
>b« dUVrlbutlng. MUlDg.  or boiaing for «U-
 tributloa  ur  amJ*  tb» peaUcId*  vfclch  M |
  ti»*  ol tti«Ur
wllta  th*
eUU  pcDclllfi*  wvuld  b**fcoc**«4 "fur  an
often*.* by p«r»o*(»> (h (n« biulncia of m»k-
to|, or •pl'lyl'if pcaddtle*."'
   I. F/JMA Section t—Htfflttrmtw* t
   r'mtA Mctloa •'»> |7 UOO 13«*<*> pro
.vide* ti\ pcEUucul part ttuxt

 • * • uo peraon  *  • •  ru*y duulbuto, ••!!.
 eflir lor Ml*, bold lor *»l*. • » • lo any p*r-
 ao» ai»y pe»udtl« «Ulcb U not t cgUWrid vlth
 th* AdmlnUtrator.

   it«(ur« a p«*Ucld* product witlcb bi  Dot
 »boOmp**aad wttbta ttk* i«inu «C »n »iUUag
 rvKUIrailoa  «alcr»   tb*  cfUiuieU ol  tr*d*
 a Mparal* r*gi*traUoa  nauat b* **bl«U"«d.
 ObkO^M in  th* lormul*tlou of a rcnltitcrW
 prutlittft. cliMuge* lu acceptod labeling. *4 w»fl
 a« aoy  repackaging of a pesticide luto au-
 Dthar coitlalncr  will oxUrat* th* reglnU*^.
 iiua raqutremaut.  uulwa th*  purpc*M of
 product r^KUUKiloa would b« fully ua*t by
 carryiug forward  th* Vcd*nd regUU»tk>n of
 th* constituent product.*
   Tb* Agency -Auda thut a poc.tlvld* con-'
 owntntt* *>r a .«uM-dltutlun  ptepftttxVtEm of  a
 n^UiAred cnd-tu*  pcKticid*  which roKiaJua
 wlitiln  tin) ttula and *ctutJ  pocKMtluo ol'th*
 f«pttck»ger/raforiiiulktor throughout IU dla-
 Wlbulton. aul» aud UM 1* *ncouipaaaed within
    •£itiphn»U added, aupplenuittal Report (4
  S.  Hup.  No. 62 OJti.  bid Cong, au y«»  M
  m (ur  n*«
  review Of lufoniiatJoa regnrdli'g  th* aafelf
  »Ud vtUCftCf Ol th* pcatlCtU* M JKHpObOd It*
  U£* (and a* likely to b* u»cd> undor  wlila-
  «pr<:«d atitl  communly •reet>gtil*fd pr*cltc*.
  tivuoud. ir{ljtralloi) of a  prmlucl pruvlUa*
  l£l*4 with tlio  dppurluRliy to review Ih* pro-
  posed label and Ubcling t*t Um product. To
  aupport rigUlrallbo. .inch  Iwbellng  mu*t
  clearly cuiruaiUfilcata ih* dlreclloii* iu* u*a
  it* |li* product anil  *uch"w«niliigi *ad pr*-
  cautlon* a5 »*a necaaaary  for  th* aita and
  •meaclGU* UM of  Ih* poatluld*. Third. r*gU-
  tralloo of a product |d*ntUlo*  tba party ao-
  •uunlabl* fur Ita totegrlty ol oxMrtpoiltloo.
  rab*l.ng  and  affocU  reoultt&g   frota U**.
           rogl*Uatloa ol a pCOOuct  U  CU*
            '      &MU.TO*  UU UtU r*t***»i
                    l£»Blo*>ua to th* nfltttl
«t>» trini* «*f Ih* »«it.
*l»t pioduct and U U><— >
p* ojiuii*.' o» u>* i(ii"f
•(•craiora who h-^id p' -ilvl-'r* to iinrcitu*y
aiul ball peatluKU* I'W »piilktlU.-4 l.y t>th«t
  Kraoua t»r*  con«l *'Uldl; Ibu (." ">1 >j» acU*->
fly ravarlably activates th* ti jb.l»< loo •%•
                     accllon > mJ f^ltoo t.
    lubject au*4t pcwtl'iovra to tUtlllly
 nrru n^iion U|aj(i)(A}  *lul  ^^i
   It u th* opluiao ol  Iba  Jtgvb./ thal.th*
 mortar liita a acrvlo* oinUincr of * r-cHitld*
 «oiif«u|rala or a ui^-JlluUt>o pre|jaralloa dt
 a rtuktcred pcailcitta.  tin  aciordn<«.a  with
 lU *u4-Ua« lab«Uiitl)  tlu«% not  re^uU*  lh.a
 •«paiat* regUtrullun ^t tha u«>* ft/rmulailop
 •o k>ug a* th* transferred pcaUntU* cooceul-
 rat«*or tha ua*-dUuuon p*repM-*lluu rrfiuaui*
 WltlUu Ul* aola aud actual  poe.-eii.ilou oJ th*
 poat conlrul operator performing tuo U»oa-
 ler. lu aucli caaea. th* trooafcrrcd quaullty
 ct Uta pvotlctd* couccntrala or th* Uha-dilu-
 llou praparatloa 14 «iicorbp*£4t:d  wllhla th*
 Uruui of tb* rcg Utra tlau of IL* c0n-itllu«nk
 prwduct;  thua.  Ih* ptupo*e«  of  PIK11A *ac-
 Itoii • bav* beau aathOlwU by Ui* loglbtrutluo
 ol th* «uigiual prM>Uchl« within the oieaumg of KIMiA.
  lluwtver. tha luet llmt fiiTUCtm*l.pL'.t con-
  trol  operntor* dl^liluiita or Kll  p« stlcIdea
 dt>ea not. aUndJiig Alone, r*i|iilr4: lha rcgKira-
  llou of any pet tic Ida- jirtjUuel rtaultlug (roru
  Ih* rc'cruiulatluii ur r«-j>ut:k»h'lug  Oy an op-
  tttttor ut  a currently ic^ui^fcd utoUuct. Tha
  rellicrwla« »*tia-
  Oed  with ie»pecl to itio  vf>eriiior*a  tuiutu-
  lallun.       •-.         .     -
   * Wbei* tba a*w i>n.llc!U* p*u\tuct tantatua
  at all  llioca withlu  Hie auta  ihat tl*«
  pafituld*  when tih«d in accor»t*nc« with dl-
  r*cuon* will aot  generally  cautf*  unrca^r-o-
  ahl* adverca* aficcta on  CT*UI'OT i|«* «n*lrt.h-
  mont. lli« dlrecltooa.'warnlugB aud preoau-
  Uua« ol  Ui* -Acc*pt«d laUtfl »ill bat* beta
  eauiuuiucalcd. M iha ultimata uaec.«( UM
  pavticld*. aloca  tha  dLmibuUir/hcU
-------
  ll  U nulrd 1 1 ml  thl* pnlli-p *|i|ilU?« only
to end-tin* jiCill-'ttli'«.  Any  refotinuUilon t*
             at
                         it til
     Hi* r*»1*w of Ui* «btwitl»i*«l
    ah t* KdUM) Ut «ueb *erikc« cooUln»r«.'
pt-ktlclde »|>|iiutfci|  only fur until ill act mlttf
Unea  lor Ilia  pti(jj»«o uf  ftirl|ior  UlulrlUu-
lion *>f AMU. wilt teltvat* tl>» it^tiUMttott te-
(julreutenl of PirilA. Tite*»J*ur tlltlrlhutlun
of *ut;h *  |i nut i in (irluf  to  ftii|iru*iil uf  a
•cftHiHte r«t;lhir«ttuii li • * tut t>ei «tti[« wliu fcuu-
ply knd k|iply |M'<>ilt*tii<:* lit peffurinliij*  pe^t
Control »crvlt:r* *itt dctfm-d la "dl.Mrlbui*,**
Of "t.tftl.** pehUcidti*  tiy  (ivruuil lit »tiy  ktftlo to (11*-
Irlbiile.krll. uUcr fur IJA|«. hold for Mlo. •  •  •
to toy |jt,TM'il  * •  •  (£) »ny |itwllclUt klilclt
la * *  • >iit»lir*»0ed.
  A piLBtU-lilo  cuiiccnlrttl* (tf »  iirMt-tlllutlOti
prc)>uriuiun U  niUl'r«.nUcil If  It*  lubAling
lull*  t«  nieol  tti« htaiiiltril*  fc*t  tt>rlh  to
FlrliA  »ectli>ft  aim. 'Ilia ««lo  ur  dl.irlbu-
lluii uy A •liticlurul  |»ritl cmiirul upcr«U>r of
ptMillclUcB lit kvrvlce IM it In lucre  W)IOM> l«b«U
do noC cuti(i.ii*iu  wlllv tli* requirement a of
riKllA *e*;iluii 2(l(O) ftud Buiy *ub-
l*cl tit* u*«r- Uk elvtl o* tf tiniit*,t kAnctloti*.
   It U uot«d ttiftt Ui* *et of t>n-at«»aurttig
or pr*>mlalnt • p*«Ucld« M provided  on  Ibe
»i)d*u**  Ub«ho( ootuUtuU* »Q «cI of pc»ll-
eld* UM  wtibla  U>* tu«*olu« of  n>VA MC-
tioo l»|kHa)(0).  Accordingly.  «uch pr*-
>n»ftftuilug ftua  pt*-fbl»lu{  of »nd-UM pcr.ll*
Fide*  ID  uuikltig u»«-dlluLum pr«u*i*,iiot4*
 mu.l couforin  ftllb all tppllo.bl* ui,«l in-
 *Uuetluoa.
   ril'IIA LCctlvil I>|R)  kUlltutl^tk 1 1> ft A^'tusy
 Ht finer, fur the |tt«r(n»o« of cundiicllng rou-
 liua liu.|it.-i:Ut»i». "Ni>|r  rhiubllhlutiuitt or ulher
 pluir* whvi* |ic.-,llt:ta*'t * * * hr« helU fur dl«-
 irll>ni|i>a oc «»!«." KIl'ltA t-ccll.m 9((l( de-
 Ancd «ft «3lobtuliiuei>l *•  "miy i>luc« »litr«
 * |>ckilt:ldfl oi il«vU-u !• iiruiluceu. or bcld fur
 dlMilUulUtu ot  *ftle." 1'tiU |tcu*lrtlou  ^uUiur-
 Izca teufrunilf.tn liih|tcetluii* of  HIB Utuliict*
cotttkltteo, VT »t>itUk;»tluit UtvltmJ  ul ptet
conlml  t>|>vrM(t>ru  vuliu  aiiititly  mid  «|>ply
prii Kldcs fur ttlra *
   1-lFHA •c«:H.u»  U|N> iMrtliul  i>iti»idc» tlik»
kiicli liiLiieclluiia  ni«y un ucrfuinit-il "for Ui»
pin |>i*>a  o/ |iii:|fcrllH|j nnd iiltlalitlfig BMIII-
iilcM  uf kiiy  uvsllrldvJi •  • * p^ckuKt-d. t«-
lt«lcd *ud reKitwd for «ltl[ittieiit. • ' •" Htich
lii.tpeotiuiLj inny  lit elude  tli* priKluet luiiu*
pHiitf *i)d Ul*«l ia*l««r bf pckllthla |iruJ«icU
held fur ai&tiibvUUML oc ulc b|  tlt« »tntc-
liurtl pci.1 control uucf^tor.  including  lit*
Miiitplliig  uf  utMllcldo  c•-
dlhtttbtt  |>i'fc|»ttikllutu tit MlvU:* Ct>nl*4nii»,
  * lloutln*
*J*o liiclud* *.  r*vl*w of my book* *nd rec-
ord* rrg^rdliiB !!;• furmulftuoa. producllou
ta tr.|>*ck*gtni of'pv*tlt:|d(» wbtcb lh* *lr.»o-
lur»l pe*| couirol  optrittor m»jr b* tcq,uU«d (
la k*ep pur*ukut  to FiyiLA  *cotlCMf * *ad ^
tb* r«fful»Uon* pmtuu>K*Ud lb«T*uud*r *t
tOCfHIWt l«. ftectlou •(») *lM«mpo«*r*
U>* A|*oay to Inspect record*  vbl«b lh« firm
iuy ouiAt4On  r*«Mdlo« tb* d*Ut*rf. tuo»*-
MMftt. or boldtng oC puucld**.
   • It  Ik  tit*  bplttttm  uf  ttl*  Atttt
 PlrltA kcclluii B|«) due* inn niilliu
 kdinitl.lrMtifa  liia|^xil'ni  of  f>i*cr
 being iikea. The ftiliitliilkinkllve lii«urclluu  Of
 tufh  |ii»t.-c.t niuy be  |>« rf united only upon

 piruiKiiy  uwiicr.  or  under tb« kUlt4Wtiy  of
 * •t'knrtt  wurr*nl lulled pnrbu*nt  U/ flUlA
 Aevllun U(b)  upon » •huwUin Io a cwurl  of
 cum|M:lcivi  jurU4luiloa IUH  lb« p
           b*v* bM»  vloUUd.

-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF ENFORCEMENT
         OFFICE OF GENERAL ENFORCEMENT
        PESTICIDES AND TOXIC SUBSTANCES
              ENFORCEMENT DIVISION
             PESTICIDE ENFORCEMENT
             POLICY STATEMENT NO. 7
           , PESTICIDE ENf ORCFMENT lOllCr STATE-
           \  MEHV NO. 7 AERIAl 4IVLICATION OF
            \ RCGISTCRLO PtSIIClDCi
                      fi»2l|tt0)

-------
 I't siK.tnr i NIOHCIMI HI POI icv si Are-
    MINI  NO.  7 AHUM APl'ilCAIlOH Of
    rtrtasitfito pEsucmr.s
          I. OKMIIKAI UACKUNUIINO
*    On May 6.  1076.  Hits  f uvuoiintrnlal
  Protection  Aeciny  iKl'A)  published In
  thn  KII*I:HAL  UtGi^riii a document  en-
  tltlid "Institution ol KnfitrrL-mcnt Polity
  einttmniti-  UO Vft I0&26>. II Wfts llw
  Ai;eiiry's pnr|MJse In lii.stiltiUnu this series:
  of 1'estlcide  Knforccm«:nt Policy Slulc-
  u tents  (PfcU'S) to I n (n i in  Hie  fctneiul
  putillc and IUTMHIS cnuaccil In Hie form-
  ulation. distribution, fiule, application or
  olhcr  use  of pesticides, uf the  policies
  adopted  by the Agency  In  Uic enforce-
  ment of the provisions of Hit! Federal In-
  bectlciilc.  l-liiiKtcide.  and  llodcittlcldo
  Acl, us nmeuiteU l\\  1012 uiuft 1915 tPub.
  L  U2-&I6;  tlfi GUI. 973;  Tub. L. 84-MO.
  flOKtut. 741; 7U.G.C. UGct&eu.; herein-
  after referred to oa KIKHA). PKP3 are
  prcpiitx-d und  published  by El'A's Otlice
  of  Enforcement.   Unless otherwise ex-
  pressly provided,  a PEP3 Indicates  how
  tho Acvncy will exercise 1U nrosecutorlal
  disci ctlun, und docs not Interpret the law
  or otherwise define  what la and what is
  nut  lawful conduct under FII'UA. It the
  Ai)ititnliV V ol I'jU-f'y V.  M
 fiectioik V below.              •-
    II. PUBI-OSK 4HO
                             Ul* TlllS PEPS
     This I'KPU seU fotth the Auciicy'a en-
   forecincut |iolli:y muitrUliitt the ucrlul up-
   lillcutlon uf pesticides whose label*  bcnr
   thu rt'sjiccllvu ly|tca  of uppllcullon lu-
   &trui:Uoti5 vtilch ftrfc  I lit til in Section V
   buloiv.  Ii  reiterates  csi:tbli:,hcd  policy
   prohlblltng uei'lul ui'i'hcittiun where lubcl
   liislnicliuna  Gi»Lc:lflcuIly  prohibit  bueh
   ust. ft ulso e^tublLblica un mlmhilstrntlve
   niech^nlsnt i>ursuunt  to which, pesticides
   who:.*: LibcU bcur no unimiullvc Instruc-
   tions t'ir utitul  aiiiillcatluu may, und«:r
   condillt  - t  cnunclntcd herein, he fippllett
   by air w,l tint Incurrlnif Kt'Jeral cnforce-
   i.-tent   .11 urtloitt.  This  bdtululstruilve
   irechu  hi a a&Mirca Ihut fu> Uic prb|io^cd
   at rlul jpi tlcatlou will be evaluutcd  by a
   knowledgeable expert to uscerluln tho ef-
   ficacy und fitifcty of the appllcutlon, uud,
   thut  tb> thu upproprlute Elate fluency
   will bo  liifonncd of the pesticide lormu-
   lultons which urc bciiu,' recommended for
   acriul unpUuittlon wllliln Ihu Bute. Tne
   tdmlnlstratlvo nteiJmnlsin set  forth In
   Uils PEPS  U applicable only  to  prodncU
   bcarhui  mpplleauoa   liulructlom   de-
                   »' i n
                 P* ui
   *.  IfcULtUl  JUNl:.bUlHIN  10 »UUtAIC
               rt :>IU'll>i:  UUL '  •

    frVderal re^uMum ul 4lte use' of pcxtl-
 cldci  was eitiil.ltrhnl  lor  the lir^t time
 with thu eiiactimnt of the  I07J PlFllA
 amendments,  spcciiically  Ihrouitli  Uic
 jHoviuumuf k-'lV'ttA ^clioulid' ill.sec-
 tion 4. Olid bcetlon l2«ul*2HOi.' Any
    •Tlilv i>wit  «if  i'KI'a HO. ?  ic|trf.srm* *it
  OUltllie ul  lh» A^finy'a In;* I  hiltri|trcl|ttlOii
  «f llic eltuci  wf  IliO IUV3 niueii(JiMt*iii* nit«l
  |iii|ilcnietilliit| rri;iiluiluii3 mi  lit*  MM thorny
  uf Ilia At;vii<:y In ic^uiula tlto ys.c of rrcU-
  tcitU  i**»Ucldi-s.  Ittcliitlluu  Ihi niclUiMl  of
  •ppllk-alUiu ol ku*~n j»f&ttt!Uc*. Ai luUicftKd
  kl>u»0.  I'EV3 |ft-iui4ll)r  Ui.r..-r|bc  how  lit*
  Auciicy will eioicl'^ lu |>fi>-ii-L-u|uf Ul di.->rre-
  IIOii tutJ<« FIFI1A.  At lu UU- III^IAIICC. Mtiy
  portion of  ft I'UI'S whtclt lnivt|tri;i-t the t*w
  hill  La ftCL-OinpAitlfil  by  ftll Cm|iio:-i lnUICu-
  lluii Ui*t Hi* |HMllon  It Ii4 IUL-I nil«t|irctlve.
  All lulerpitillva |>uillo»n  at M ria'3 little !!>•
  Culictirrtlicu of Ilia AIU-IIL- y'* OniCfe ul delimit
    'KIF1IA bccllun 3(U|(I)  |7*U.UC.  IJCa
  (JM'H  proiuicj i|,at »H |t.iit uf llic d'ui^lio-
•  ll»u uf * |)04tlclJo. liiu AdiiilnUlr'uior  hhi.ll
  cln^^lfy Cittli |ic.sil*:ii|u fur r.ciifr*! »i*.e ur fur
  re^ldcli-d »t*t:, ur I'M' hull* i;tncr^l u^a MM4
  icalilclud tt^e ny tliu  AiltiiUtruti>r, in lilt
  dl*cittlloii. may  i\<|iilre. (lit o «0 Crll  l*urt

    KM'HA tifCllun  iln)(l)  <7 U^iC.  I3i;b4«t
  (|||  eiii|MJWt-«!i  tlm  Aditiiiil >if%tnr  to |irc-
  •crlhi; alituiluril-i JIT Hie cciilllrwilxn of *p-
  p.lcnturs of iciu[<-tfU MIC |jcsili:idc;i. Trie
  A*t*>"Cy Ilk*  bt IllllXly^lCtt  ri-|.lllftlHjll-i f!>l&U-
  Itililui; cerlKlu r«U-(!i.f»es uf coininrii IA!  (pru*
  f c^^lonal) itp|>i|riilut*i mid fci'llliig IKI lit nil til-
  mitiii kiuiidard-i llini cdntmcrclal  And prlvai*
  fti>|MU'atnt» IIIUM itttnl ttctuic Ilicy ure corll-
  flt'U \O uui pcbll. tilt1:; i:|itv>lllrj undiT scctlbti
  3 (nr "it-slilclfd  u:.v." {•tit I'I'U P«ri 111.)
                                (T USC. UtiJ
   "Miiy pciai-ii In u-rfi any rf|;(iiL-tcd ('isilciUe lit
   • inmnit.-r  liicon*il^it itt  u'lili  I la Ifiitrllng.**
   1'ltl^ bcctiuu brrniiio cllc. life upoit' Ilio d*le
   ol cuaciiMCttt of f'llllA mtd  «•*» dcitrutliicd
           llil|>lciit>:nl»ll>i*i I1.*it. 39 Fit llt^).
   "lite ucu.ullutn Hiir>Uiitrnniiu I he leglMra*
   llun |iMivls|tut of llic IU12 •i.icndnieuis tlcHa*
   |uic  of man
   Of I hO CllWlrOtllltCIll I" ft  |r*:tllCl«JC  llltt>U|[ll
   •cm. luciudlim bui nul iinuicd to: (I) Appli-
   cation bt  ft l>tSttttilli. tt)i:l tit) tllg HtUlllQ ftllll
   lukdlim ftud any re;ilun
   in of  ncftr  lite airu uf •p|>n> Allan; O| tiiar-
   »yo ai:Uuifk lor  |>t-.li<:i<|i<..
              itcn
                              ucn.  (tb
                  i ol ilw term "tuc" has been
   mUoptcd by UM OOtca ul Ciklurccincnt In IK*

-------
|>crbim  who tt>vi  t* registered pesticide
In n  munner Inconsistent with tit hibcl-
Ini; Is in vlolutlon  ol Ihe Ad und inn y be
subject  to civil or criminal sunclloiis.
  It  la  iliu ophilun  uf the  Agency ilial
the   Dtrlitl  tii>pliciilttm  ttt   *  pesticide
whoic label beam  no uillrmullve  uislruc-
lluik  fur tieiliit  tfppIkHtluii constitutes a
Violation of. hccUtm U.Ul (hut
Ihe method uf uppliL'iiifoii Is Inconsistent
with Ihut wtuVh Appears on Uie  tt'A  nc-
Ct-'plcil label. *I1ns  la Ihe ease even where
ncrlttl uppllcullun at thut pesticide muy
have  bi'comu  a   cuniiium  pc^l control
priiclk-e.  However, us set  forth In  the
legislative  hUlory.  Cunmcsi  intended,
thut  EI'A ei iforce  the  prohibition of sec-
tion  12Mttil be rculslercil  (40
CKii IfiMUbll.'  Ueview oC Uiebc  ilatu
   •ItoiiM  Couiiimiep  on  Agriculture, II II.
 Hep. flo. VI  61 1. 02nt;..  Ut  ti«*4.  IS
 (IU71|; Senate Cumnil|t«M.it Apiculture and
 Fur ft, l ry. B Ilip  No u? 03B. V2nd Cuiiu .  2(1
 lieiiallUa only UJH.H Ilitiio HtdJvld-
 UAli wli<» lirtVc dl.-iri'tiitrited luMfucilulia on •
 Ub*:l iitat K-OU:rt*.  10
 lie?)): Senule Commit ue on At;il>:ultiir« *nd
 l-.ire-.liy. 3. (Up.  No  P'/ II3B. 02nJ Calif..  Jd
                 At i
                                        « on
 Agriculture and l-'uii^n
   Jl|t I* nut  lite liilriulun Ot III* Caumilltc*
 to |iiu:ilblt any u ;c miii,:lt u lit no wny h«nn-
 fui. Riiti * LI* rt itii^ on y bcucQclal  eiftxu on
 itiKii unit |,i.i coi-lr-miiietit.
   •'ll'e  r«j;til ui'iiiit liiiiilriucullii^  (l>«  It&t*-
 littllaii  j(io»lx;,»u  uf tlic  1072  autcoduicnU
 n^iilia  i.|.(>llcunu lo f,«lli«t  ry und'ur rltld Iran wltUti
 tlntulaic wim.l uitf cuudttioat, Tlvef* U«*
 -K-III v*iy »<:cordliitf 10 the ciiftr»ci«rlii|r« of
 ina rlicntlr*!. ih. (ypa o| (ufumUltuit.  tU*
 Ur*;et |w»t. Ih* tu« |iftll*rn». tad lll« Dttlh-
 od« *iiit I iiu« of
                  ( Uie ticiu IIW-CM »ry to
ftccuini»lL.h the liruad piiriniscs uf prod-
uct  reels) ration.*                          '
  lit tonstdeflni' » product /or rci:b>trrf-
llon, ihu Agency innkes jipuclfli:  flticocy
and safety uvaliinllons  with r»-sp*xl U>
application  tcrhnliiues,   hwhiilliiif   un
aualy»t!> al  Ilia  iiruito-sed   upi>hciillou
^ulpmciit.  ini-tluMl,  timing, und  ftlUi.
Pcsllcltlc proitucu wtacU do  not piuvlde
directions  for a puiti»:nl«r use or uppll-
cutlon un:thud,  have  cvru-rully not been
tubject U>  fculcly ukktl tllicacy rculew Uy
Uie Agency with icspcct to  fcucli UiO or
 application method.   Accordhti:ly,  It U
 the policy of the Olllce ul Enluicctntul
 that  pcillflilt-a  bcurliitf Caleuory V und
 Calcituiy  VI Uhefe nluy bo upplled by ulr
 only  pursuant to the •Afeguanls tiiub-
 lhhe<| In this I'Kl'd
   c. i»ir»cT or TIII: rtrti* neutcisi NATION
                   ruoi^k^s
   On July 3. 1075, thu Aycucy  pruinul-
 HiittU rei;ululluits uuveriihiu the iri;Utra-
 tion. r<:it-ifhliiitlim onJ clitssin<:iilion of
 pc£llt:|di:s  pttrsiiiiiit to flKltA  &ct:Uim 3
 UO  C:i It   I'uil   1621. Thou iccnliittuns
 pri'bcitbo'   pi-uceilurcfl and poll^urs  Koy-
 eratiiti thu FeiU-.tMl pi-sllcUtc rettUlrullau
 procuui.  and uic Ucsli;ncU to Impleniciit
 (he chnnnta to tltui pruuium wlntli  \vcrei
 nmiulutfd  by*   CUIIKIUSI  In  the   1873
 aiiiendiiu-ntti.
   As a  part of  tho reri'ulslruilun proc*
 ess. ti'cry |H.'btlchlc product which  limy
 be liir|MA<« ot llta  rt^bilrdtloii
  pruotfn* »rc faur fold Ftt*t. r<-i{Utruil»it i.r »
  pririluet provide-* a iiieci.niiUiit tt>r the  view
  Of InlorinalKm n^unJIittf Ilio lately tit it tt-
  fitMf ol Ilia  ptf'IKtd* AI pitjpu-L-il  tt>r  uuo
  <«»d M Ilkaly 10 IK- used} m.dvr t'Kleiitrcu.l
  *nd conini4>n1)f recciinl/rd pracllc*. t^irund.
  rr|[l*lrutloii of N  puiiluc! |'n..|ilr* yA'A Ultli
  Iht  uiipiwtiiiilly to tvrlrw the |>rt>|jty.i-d luhcl
  AII>| InbeMiitt uf Hit- product. 'Jo tilp|Hirt fr^.
  iMinllitti. hiich luht'lliiif ruif>t clf«ily cutit-
  natitl^Ml* the itiri-cllun* lur u^a for the |.r...|-
  Utl  b'ui «uch wurnlii|;> Aitl  |>r«fftiilluii:i «a
  AIL- tuii^s^ry fur I ho sale and ejfkj.tuti* i.so
  ol ilii |N.".il:tnc 'Ihlrd. ii-i;Uir4tloii4jf »piod-
  uct  liteiiiilli-s  ilia p.iriy kccum.iat.le  for lU
  littBjiliy of L-ui»pi> (rum u»e. Koutiti. te^it^.
  Itoii uf * prtxtuct  u Uie niccli«fiUiii ulilrli
  •k^urc*  Hint  UiU  rclcvftiii  luforiiiittlon u
  «oimnuntc*ied w tl>» ulllni*u  u>cr  of  ih«
  product.
a u*c of the pcr.ilclUc bi u nmnner lncu»-
sbU-nt with Its lubellnu und inny tublecl
the user to civil and criminal auiiclloiu.*
    IV. BttUt-ATUKlf MOLi: Of lilt KT*1I»
  Hits I'tH'a In  no wuv uIU'cls  Uic au-
thority  of u  Stulc.  ar.thib' imr&unnl to
IMFKA fitclhm 2iia>. to adit lurlhei it-
*til;:t' •  •  iTi;uii||nii the  use nf »  i-Vd-
era It;.  .   •  n*d product, or. In Accord-
AIH:C  11.n Hi.tte law. to piohllilt particu-
lar  ir.c:t  of  re.U-f:illy-ieKl:ilt:red  iH-sll-
cUU-s wlttiln tltut tiuuc  lite  Aitci»:y on-
tlclp:ites Unit Stales umy vlcet toexeicls«
Ihu pOAi-rs set luilh  lit wulton 24*ut  In
thu two &pi.-cinc  wnya elaborated bi:low,
11 le election by u State lo Impose lui thcr
nstrlctluiu  UIKIII  the ti.su  tt-llhhi that
Btute of a Ktulvrully-rccistcred product
will  not uilC41 the Aiti-nuy's excixt\e  of
pio&ecuturlul dtscretiun under PlKKA. An
 appllcutur or oUicr i>erwin who complies
 with  tin; rcqnlrvnienU eet forth In Occ-
 tluna VI and VII of  thb I'tl'S to avuld
 llubthtv under Fit HA, but \vho OK.-.S not
comply with tho additional ri*tiu)rcnu'iits
rstnblislicd by u State pui.sunnt to l-'IFlt A
ecction 2-liu>. liny  be subject to liaitilUy
under til ale law. All persons i>crfornilnff
upplk.ttluiu pursuuiit to the udtuinL'Uru-
tivc  mcclmnlsnt  set forth  In thb  PCP3
av< eticnurufiud to lumtUurl^u themselves
with  applicable  tilule rcculutlona.
*.  U LCI I ON  MV Tilt: &TATC TO  I>«3ICH*TK
          filulc  inuy  elect to 6pcclflcally
 de-j|(;nuio cctnpclciit  Individuals to  be
 ktiuwli'ilt'.cablu vxpcrti within that Slule
 by plai-luit their names on a list of l-nowl-
 rilttcublu cxpurU. or by came other mcuiu
 oc.:.-|'i ii.le  lo the Stittu. L'uch Slate  may
 L*iiiblr;ii mure Btrln^cnt stundiirds  thon
 Ihusc whk-h  tuc listed In &:r.ituu VlltU)
 teluw. No person will  be deemed (o  be a
 kivowU-dtfealilo expert  wliUtu the  meim-
 Inu  of  this  PKl'S  unli-Si  he meets Ihfl
 minimum Kiontliinls set forth In Section
 VflUlt below. recurOk'U of Imvlng  been
 di.'sli;nated us u knuwleducablu expert by
 a State.
 • .  LLIIC7ION  »y TIIC STATi:  TO CONDUCT A
   fMCAITt-ICATIUrf HUVH.'VV OP Til* IJCCOM-
   MLNUATION or Till: UNO W! LDtirAMLC i,'X-
   PCIlT
                lit laicudcd BA • Ivinporiuy ^d-
  jiiiui lu und not ft icpUcemeni for iliu *uc-
  lloti 3 rc^Ulruiion/riTt|;|Mralloii priwtv.. or
  for  lltu  proyr^rn  ftulliorlzvd und.-r  I'I Kit A
  rccilon  3<(cJ  purkumit to uluch tltkies ut»ir
  luue ffi|;tsUalloii* lor "t>p«:lMl  local o.-ed^."
  UJMJII Hie  coiitplcllou of  tlie (erc^uuwtl'm
  tiruccki.  Ihfi*  ataiulory  ntct'tianl'mt   will
 Virn*)d»  tfi*  otily ntenai  of
  Eucli  Btutu insty fit-el to  revti-w tndl-
vtduully  rut'li if. tH Al'l'l tl'AlldK Mt.TltUU

  Whether a  &pi:ritic pi^tiflile  inuy be
HCitully itpplU-'tl de|N:iid.i upon the afipll*
cut buit liistructUitis  vililcli up|i*-:\r ou the
El'A-ueceplcd |;ibrl. Ctmiui>»n churacter-
UtU-H ol pf-iticiile labet lii^liilcliui^ luctl-
ilate the uroupmi; <'f pesticide labels iJito
alx general cuu-yorU-i:*
  Calf 901^  |. — l^dcU  wttlc.h  btuf , c&ptlctt
• nd  bdt.-(|iidi« •|>|>IU-BlK-u|inn o|
tnt |>cktK.tUc *-
  C.ili-yutf fl/.--l*lM-U  «lilcl>  b*4r only »f-
aiitittitvn  luttr«»:«tiiii-i  |«t  ^fitttitd ttpptt^ft-
llun. and which \>t*r  oiiirr dilxil^u *>r di^age
rH» m*ti»cttun» »»»•* »'»-t.»»|»n»vll»r. ptrf»u-
tloitBfy  ftl*iBnienl«   M lilcli  *i«! liiciiitniiiieiil
             •|>|lllO»l|ii« Ml  M Illkttri  Ol  |»*>l
             iillco  Hitd  •pjdtuatlun  t£cti-
 Wtttl
   Cuff gory  IV.-" l4»l»»-l*   winch   hcur •  no
 •lUruiMit'* t;i uuml »>r  Mritut »;>|ftU"iti>>n tu-
 •Iruclloiu, Dul w lilt It lM-ai dlliilliiii i>f
 uicitia wliU'li «re  lit. 4.11-. iMml wiiu u-rnl
 liliL-Aituit *•» & mantr «t |f ••! coiitim |n«ct
 •ltd «|<|i|ic«iloii if<'lm»lii|;v."
   CmrffiMjr  V — 1
 kiJtiiii»liv« ltttlru>
 tUiit. lint whteli l»'»t r Uiliillini tir tii«,»i;e
                                                                                                                                                                                              Mint it   W,.f  only
  * The  »|i|>llc»lluii  lnMiin.-tt.iiis  M ttlcb  »p-
|it* u( tin ViUit r«'i;lst» tcil jtftitWUtu witt c'Uiloitn
to fiiu ul lite r.lK citlci;nrlrj( uf Ut-i-l |)(nvij|oru
trl tmilt Itvtclu. A  uttiulicr of Tlt'tlA, p(O-
*L;iout in^i' IK.* uillRfil l*> itiiu-ml Ihu r«;i;isiift-
lloit uf a |»ttt.»xui wtilt Ucitv(- II.
f»r i lie  |>ii»jMjM--a i>f I In..  I'M-ii,  la  •iiotlttr
IrtUwl .-AttfJtT   'It I*:"*  MuluUtty   lni.Ut* Of
Aiiii-itdhiir u  rcc.l:.iiHil>iii  lo milliiirl/c  lfi«
fturtul t*|i|ktt<:itiitm ul stfU |>c?.'.tvtdv.% include
Ilia  IE.MIMIICC of a Si (tit iri;iilrull<>i|  Under
Ft fit A Mttlfttt 24| i" >. t» *mn>tllit|; tliu *itsl-
I'M: rcitf.li.iHoM uitdiM  I'll'IIA 3*:Cll-Jit  3.
  * ft*  etumpte, « lulft tm.y ptnvtd*: "KAf
Arrliil  •jiplli-nlMifi  ID  brush  nloui;  utility
In  13 to  |&  i;u|ioii\ «,f H.iU-r pvr A»'IO uslag.
tV.c aiipfu|)itutn  tjpu  ol  IMUIII ot otini to<«-
dilit c<|iil|iinimi."
  '•fin  *Mwm|cl miy proklJc: "bo
ttoi k|>ply by hir."
  " Kor ••ftinfil*. • 1*1*1 m*y  provide;  "Ap-
ply at 9  (allont ptr  *cra in OO.J K«lluui *jf
«Atcr. Uftln^ ground «-|ulpuicnt."
  " for ciarnpl*. ft l»Lcl  may provide: "Apply
•1 a KBlloiu per  ft«e lit '-tOQ K»lloiiA ol water.**

-------
 lii.Uuirllnii*  kiiil ullier prcvBtilltmary »i*l«-
 intttU MliHfi nr romliieitl with »trlii I Mf>||i||i*lli>it l«t-luu»li't[i'.*"
  dilt-'-itr y   VI. - - l_.' •»:!»  which   tw*r   no.
 •Oilu.-id*a  KK'iiiul t  fc«H*l •pplli^llot  til*
 Uriii-ticn.-:.  but whl..i bear «• liter dlluUan m
 d"^A^e mtu liiktitiriiiiiis •ml  MUer |.ftrm-
 lluntiiy Llitlri.irnli ul.Uh Arc ei-iibUinu with
 tt;)'-'4

 VI.  Su&lMAUf i'*'  h'mOHCtMKWT I'ULICV
  Itt'UAhUlNU Tilt AtlllAL ArrLICATK'H O*'
  KACII  I.AUI-L CAitconv  or ULOISTEKK&
  I'rmluiiU. Ix'.trliii; the labeling described
lit Catci;oiy t above nmy be legally up-
plied by uir uhi.ii Klicit application  i»
pcrforim-d  Iti Ui'toidunce WlUi ult aerlaj
application Instruction!.
   «' imonfEutnr  roticv  RccAKDirta
           CATIXOMV II l_Abt:ta
  I'rudiirts bcarmi: the labeling described
lit C.Mf^ury II  ubove may nut bo lecully
applied by  air under any circumstance*.
C. ttOIIMCL'MlNr I'lll.ICV HtCAMDINU  CATK-
     GUKY 111 A«D CATLUOMV IV  LA»C1.S
  I'roducU beat mi; Die liibellng described
In Cutccury 111 or Catenary IV above ntuy
nut  be dually  applied by ulr except  II
*uch ocilM  application  Is  authorized
Under u titiitc rciiUirnilun Issued pursu-
ant  tu  Ktt'ltA  section 24 (cl.  or  Koine
oilier AUtiutory iiiechimlsin.
I>. tHI'UNC^ML'Nr rut 1C If ftCCAIIUlHC C*TE-
    COKY V AND CAM-COHY VI  LAbtLA
  In the e*en be of 1U prosecutor In I dis-
cretion, lite Agency will  not Inltlulc en-
forcement uclluii • person  who aeitalty
upphc* n icuUlercd iMMicldc which tours
Culi-yory V or CuUi;ory ] V labeling where
all u( liu-  fulluulni: conditions are  met:
  I. The M-lecicd pc&lk'ide  I* registered
fur u*f! UL thu type of kite or uppllcutlun
environment HI id uti the connnodlty. rrop.
or m tii which li U> be trebled.
  2. Hie use  is rectumitended In wrlllr.R
by bit mdtvlduul »hu t> ti kinj*lwli:e.ible
VRpcii in HIL- iipi>iii|iiliit« ureu of oi;rl.-ul-
tuful or other ouUloor |>c.%t control;
  3. Tin- nviM	cndutiun of the kiMul-
rdt;itibiu t-n|M.T( jr. ^ubtitlitctl to (he Suite
Control Aerify;
  V Ilic U' IT complies with all ln:.lnw:-
lioii.s. tt.li n.  ..; . inefHiilluiis, and prohibi-
tions tin t' r l.tbel (i I id  l.tbellni;  ol  ItlU
pitxliu 1 u! .-h it nit'il, other than tlio.su
jurliiii:  .i;  lo I lie npi'li<:iUl(>n melho4l,
11 nriitiuh of  the enforce-
meat i»uluy wiUi repaid  to Cutt'^ory V
und Ctttri;estirid"S Iwurlnu Cutciiury  V  and
Cutruoiy VI labels when the application
Is nuiilc nt thn Apecidc tvpc of iii.« tllo or
applU-atlon  envlrunmeiil  and.  us  appli-
cable,  on u commodity, crop,  or  uteii
which  np|)i ;ira  on tho label of the prod-
uct iist-d.'- For cxumpk-. this I'lU'S In no
 wny uuthnrbies the ugrlcultui'ul or other
outdoor  ulleuilon of & nt-bUdde which
 in rruL-iten-d solely for we In btniclurul
 |.Cit control.
   This (Milley applies to the u.'.c of leuls-
 teied pestUjldctt In uarlculturul appllcu-
 tlona for tho production of uiirlcultuiul
I NO
              on u( lint b*;l>*»lar of pcotk'ltia
              e ctiiiiiiMijlty or m'jt to which

              u  of nny pcMiciJo. Tl>« Avrial
   " t\tr ckkiiipl*. • Ubcl iiuy t»uvld«: "Apply
At 2 c»lt»in» per «Cfc In 40 (Uloiu of WAlcr.
utlit|( grotniiJ <(|ulpi)irnl.**
   "Fur ciKiiiplc. » Ubcl IUAJ pro*Id*: "Apply'
At 10 puuud* per «eic.M
                >
iCi'BiUlii^ kcctat bi>|illcwll4>u have Ixca cub-
liilltrd U> «nJ «u*ly£cd by tt*A nu>y icxull In
Itlrgnl  tr.Miliici. btrltt coiihirtnliy  «*Ub all
t-ll.er «;(.ti(lliUm« uf thU  fKCS will  not pre-
vent Hi* tjiikr»ntlii« or MUt*r« ot ih* coin-
fnodily or ciop it IIU|;«I rttlduca ftrc UUcav-
•r«d lhcr»oii.
 cro|wi." In  fore-st |M*L i- 'nlrol.1* In onia-
 ntcnlul and turf pt-^i- t- iitrol,"1 tn rlitlii-
 of-wny  pvst  roiitiul.'   and  In  public
 ticitlllt »nd regitlutoiy i-cat control."
                                                                                                                lilt  Uie i'llc «»td !'«*!  C'6»tti>|
                                                                                                              roiimcnf: the roimmMhtv. crop or  urt-u
                                                                                                              lo be UcuUd. an>l ihe cln:iutle,.
    tixrr.Hr IH AUUII:HLTUHAI. OH oruta OUT-
    IHHt*  I'tST CUN1UOL
    I. Mtnnlno o/ the Term "Knowledge-
 able   Kfi»,-it"—(ft)   Quail fiat ttuni   ol
 Kuoii'l'-'ifui^iidlt*  Experts. '11 ic  Atfcncy lu-
 temU in this I'Kl'B lo »ltow the fttrtul aj»-
 pllcittiou of rfdU.leied |)otii:ldes beurlng
 Category  V or Catrtoi-y Vf labels where
 finch ucrlu) application Utale und elllca-
 clous. lViM»ns secktnu to aerlully apply
 pc.%tlcldea  beurliig such labt^U t:il.  To Iw  considered
 to be ft knowledtfublo expert with In the
 invanlnir  of  this  HKl'S.  mi  Individual
 must have achieved one of the following
 coinblnutloiu  of quulKytnd   experience
 and/or tiuullfylng education:
     Qumttfylng Cipcnence and qualifying
                  KtluCitlton
 • *••(» with Lew ih«it li^ccAUurcAto.
 9 ytur» wllti U^tXttlAUicdio.
 3 years  with Ma*Ura l>t|:rce.
  I year wllU Uut:U>r»ta.

    As ti^ed In tlib TEI'S. Ute tcnns "qual-
  ifying experience"  and "cpmli/ylnu  cdu-
 cuttoik" refer to pructlcul pest control ex-
 < ikirlcncu or formal academic  training lit
  the particular  pot control area or uca-
  dcnttc ctlbcltiUuc ii\ which the recommen-
  dation  Is i nude, us a result of which the
  knowledgeable ex|*ert  hus became knowl-
  educubic about the fallowing elements, of
  ptsi control practice:
     Hi I'estk-tde: the pt^tlctdi- product yt>eBiis ftiid f(.ruKe vcgcU-
  blf«  aiiiali fruiu. Uc« itulti «i,tj  Mii\.  A>
  well »* itntbUiidk Biid unit-ctup ft^dcuUiuftt
  Cunuii'Kllly ftppllratlttiu.
    "^.re»l peat control nicludrs  wlllmut llni-
  I1.1I..O. I«-MU-|.10 Mpl'IICfttlODS to I.-CU  10*-
  eal uursci UN. AIKI |.>i »«,| n-ed producing «rcA«.
    "•OfiiNUicnUI  »()d  |M(C  peal control  In-
  cludes. wuiuMii liMiit.it.,,,.  «p|,||c*clon  on
  ornui.iri.ui u««». mUtubs. nuwtn kn« turf
    - Ultiht-of-wky peii oMilrol Includes with-
  out IliiillitUmi. aiipin••lion* on ro«uu. rleclrlc
  puModiucB. |*|peiiue«. •tid itllwof riKlil-of-
  w»>fc.                           *  •
    »PuUie I.r.lih .nd rc^uutoiy p«t eon.
  Irol Includes, wlihaul IlinUaUt. itnd
                                                                                                                                           '
of prcpurlne unit ii|iplyli.i< the i»e^tlcldt9
cebtctcd lur U:.<:. und the > i.^ki itlikh nmy
ttttund the ncriul upplkuiioit of the peatt-
ctvic.
    EiQinvtt't it/  KuoH-tettff'-ubtc Ex-
pfrfj. Qimllfltd p4;i'Min^ einplfiyrd by tuctt
       .iitjuna us tjlale Cooprrattve En-
         Services. liiaie lund grant cU-
     . Fedcrul, tilnlc. or by private  Imtl-
tullona   anil  bnmitl.sU   ciupltiyed  by
companies ownhnt or inunuitlnK IITITU or
other  application  sites   may  aba  be
knowledgeable experts. Additionally. »cl-
enti&u und oihcr pona empK>ycd by a
iniinufuctuter. dl.iirlbiilor. loi'inulntor. or
user.  Including the user  Itlin^tU, will be
deemed  to  be  knowledgeable  expert j
within the meanlnc of tin'. PEPS If «ucli
persona are res|ion.\llilc for maklne'lcch-
nkiil Judttnteiits recurdliiu  thu  develop-
ment and  use ol  [tuilkulur pesticides
products  (or active lnuredlenu>t  or ic-
gaidliifi part|i:ular pest control piacUcca.
Including application teclinolo^y.
    Limitations. Ntttwiih^taiidlng the
above, no |H.'is*m who^c  principal  func-
tion or sli:nllli-unl MHIIC'C of PLT:.>JIIU| In-
come *e U-. sidr:i c<>iiiinl^::iun> ta directly
derived from pnnnoilng  (lie sulo or dl.t-
UlbntlbJt of the |n.-:.ili:ldu product (or ac-
tive ingredlenti which Is rccoiuinendcd
for  uso muy i>n>vldv  the rccoiiniit-nda-
tlon required of A kmnvli-djjeablc exiH-'it
under this  l't'1'3.  Under  ho  clrcuin-
atances  may  any  (i.ilei   representative.
marketing   etnployeu,   or  ' advertising
agency of any inaniifaclurer. dlstribui/ir
or foriuulator. or any other (teiMin who
lias u iigntilrunt pcr&onul tconcrilc til-
U-rest In promo tin y the sale or distribu-
tion of » product provide tr.c iccom-
nicndallon  miiilred of a knowledgeable
  *TI)U prolilUl|..it  l?t C'ttiMhlria Mlih |li«
provision*  of Hr«A k
-------
  X Content* of tnm  RecomntsnJatton
of the Jfn.->«'f''rf|?mMe tipftt. Encb r«c-
ouiiiu'mlailun ritiido hy a knou'lcdifeablo
expert fur Ihe ncrlul application of 1*3-
tlrUka bearing CuU'toiy V or Category
VI liibt-U rluilJ bd nmdo In wrllUig und
thall lie signed and tin tod. The i-ccoui-
mcmUton of  Uto ktmxvlt-ilsvuUe  tsitrt
nuiil *i>celfy the pt£tlrlde (or active In-
Ifn-dlent)  to  be  ii»pltniilmi equl|>incnt to bo u*cd and
lu calibration, airplane *i*ed. wind velo-
city, pciUcUia drift,  and environmental
or ecolu(:ti:iil precautions.
  The  applicator or mer must liavo ob-
tained  lUc written  rccoiumcudaUuu of
Iho kiuiv i. ditcuble expert prior  to Ihe
lluic of  NIC application. lie  must uioke
a copy  u( mi, u  rccninmendullan  avull-
eblc to  ait ofllclul representative of El'A
uiK>u n.-QHrM. Unlcsj olherwbtf provided
Uirrcm. Uie recommendation of a knowl-
edgeable e.ipcrt shall remain In effect for
the growing season or application t>citod
In which (he rej omnu-ndollon «n$ inudc.
  The   recommendation  of the  fcnuivl-
edftCnblc expert will b,: vi.lld only  hi Iha
iitttlo hk which the recommendation waa
given and In which Uie ai-rlul application
b to occur. A recommendation which hu»
been properly executed pursuant to this
PtlPa may be relhd upon by other pesti-
cide applicators  wllhtn Uic  Elule. pro-
vided that all of the term*  and Condi-
tion* icg.. pest.  Uipuuraphy. application

 liluuiiou or aata** wlUilii  Ilia  irte*ati*u o(
 I li'RA. Uucli  pruft»&lon»l  appllratora may
 l>e dantivot Ui  b* hi»owltrt«
 v. It It lit lit* inr&tilnit i>f tlna f El*a If th*7 in eel
 Ui« «Uitd*rdj uf  quAlltylng «i|>c*l*iic« and/
 or  qu»Jir>'liiK  «duc»lloh •«!  forth  to  IliU
      *»i'Drt uiu»t i*r«r lo •Mhcr (»t th« par*
    ulfcr ^c'lU'lite pruilucl which U U> b« ««rl-
    f  *ppll«il (Itlt-nlldcd by proprietary n»ni«
      by KHA Rrgl*lifttit Nuiiibrr|. or (b>  ih*
    Ccu(«^t> of kCllv* lii(ircdl«itt to mltlch !>>•
   .iiniiuctiJalltin ft|*)il)ri If ih« recommenda-
    n  i«Ur» to % |>uttcvil*r fi>rmulkttou of
   il -  'n^redleni.  th» pioprUUxy  product
   ft-t wu«i War CkUgory V or C*lu of the in'.'-llcldo
and for full  t-omi'Hnnce with  I he* tcrmj
of tlvla l't:i'3 may ICM. wllh, illlttr lite
applicator  or the knou-leilciMiblc expert
or bolli. us Iliti  ciinlllt;^ ;.im-lhe  circutn-
etuiices tuuy rcuuliv. fc'lt'UA *n(uiccmciit
Iiubllily /or the  ml-suso of itcftllcldca fulli
primarily upon  Uto pc^llchlu tucr or ap-
plicator, und nut upon the kuowrducuble
expert who has recommended tilth  use.
Tarllculurly  when: the pcilicldu Appli-
cation Involve^ a dtvlulluii (ruin  Iho use*
which »rO  allowed on tli» ticc'iptcfl lubel.
any person  who mixes, Imub,  nppllca.
fttorcs or disposer of Any rc^l^tcrcd pt*-
tlclde  In a manner Inconsistent  wllh Ha
lalx;Utig may be subject lo civil or crimi-
nal   tanctlous   under   Mi-'RA.**  Ilio
knowledgeable ekpcrt who both rccom-
mcmla uiul ucilally applies u rtubttrcd
pesticide which bvura  a Cutecory  V or
CalfKory VI lubel is p« r son i inly respoml-
tlc for the proper use ol the pesticide and
for Ihe culcty and efficiency of the prod-
uct. In addition.  Uie expert who reconi-
metuU and  personally  tuiwrvl^s  tun
oerlitl appllcutlon of »uch a pesticide h
hltiutif cniiildert'd to "u^e" the ptitleida
vllhln tUc iitcatilutf of  fr'lt'UA tcctton
l2(u)(2XO), ninl  Is.  thus,  subject to
K1FUA cnforccineiit llublltty for any mis-
use of the pc^ttcUta wldcli occurs under
till lUpCrvLilon."
   ib)  Ciutl Liability, it U not Uie Inten-
tion uf Uie  Olfl.ce of Enforcement that


   '* Wlicr*  !!)•   rcroinmendklhiu   of  lli«
 knuwUdjeubt« etf.ttl duct not refer  to  *
 proi>il«l*ry pc: llrldo product, bul  refer* l»-
 tlead  IO •  (ttricul tit acitva lnicrcatci>t. It  U
 th« r«*potitlli|l|ly  of  tli* jnifw>ii  wlw> me«
 W appllva  Ilie |>»llritl«  to »cleCt ft proprte-
 l\ry piodncl  vt.fch (*| t*c*t* <*lc*oi» V or
 CUrtfury VI Ubtltng. (b) coitl*tii« tl>a «tl|>-
 '.tUutl p»ic*nt of »clt»»  lu^rcdUnt, ftud fot
 1%  rcvliUiod  f^ir u*« «t th« us* in* or In
 the *i)oUCfttlCiti •itvlruniiiKUt In fclilch •erl«l
 •pptlcBtlua !• la occur.
   *• Many tilat*  |*»tuld» Uwt prublhlt Iho
 irco'iunenrtntlon ol th» u>» ol  ft  i*BH>lef*d
 praili'lue in a inttn\ei luconM»leut with 1U
 •ctrrptcd Ulielitiif  TUU FKra It* no way aJ-
 fcci* iba tt«Ulllir uuilcr  applicable Olal* law
 of a  kaowlcU«cabl* c»pcr( who T«coint«ond4
 U>« u»» uf « pektlctO* ta ft atwiuar  lucoftilnl-
 •ut wttll IU IU*lin«.
 thb  I'tl'b fthould In any way a flee I thd
 civil Uubllily  la doinuKCi  of ft  knowl-
i cilccublo expert. This PtP3 does  not ln-
 crea.sc the rUk ol  llubiltly beyond that
 whldi Is Inherent  In the ordinary rxe-
 cutlo:t o' one's duties In ollcrlnc pest con-
 trol  ''li-lce to users, or In  super vbhif
 pttiti. id.i  uppllcatlons.  Nor   dues Hill
 Pl£I*3  exempt a  Ituowli-dKCablo  cxi>ert
 from possible civil llwblHty lor damage*
 nrlslntl  out of his own  negligence. Any
 kiiowlctliccuble cxjKTt nuty be llublc pur-
 suit i A lu rclevutit filale luw for damages
 which  result  from  a  recommendation
 which he makes.
 c. NOTIFICATION  or  rue sr*Tt CONTROL
   t. tteuntng at (n« Tatm  "Statt Con-
 trol Autnct/". Aa used  In  thU PEPS the
 term "State Control  Agency" relent  to
 that uuency which has been designated
 within ciich titute  to regulate Uie use of
 pesticides  In agricultural, forest, orna-
 mental. turf, rlttht~of-way, or regulatory
 ptst control, respectively. In niuit cafie*
 the Slute Control Agency will be the
 Stale agency which has been dc^tcnuted
 by  the Governor  to be Ihe Slut* Lead
 Ac.cncy  pursuant  to  the  provisions  of
 MKUA section 4.  and Iho Stale Plan
 aiibmltled  pursuant  to  40  Part  111.
\Wlierc Ihe SluU Ix:ud Accncy 1s not the
/Slulc Control  Aucncy within the nu-an-
 httf o( thb: PEPS, the blulu Leud Ai:cncy
 !kuUr,u  The  Slule Control Agency
 for each Stale may adopt Its own proce-
 dures and policies (or this  proceca, sub-
 ject to the  rt  years from the dutc uf tlm recoin-
 mrnUnHon- Eath  filuta 'shall ddi>pt IU
 own policies mid piucedurc; for mforra-
 bitf pcillcldc uie is or  applicators of the
 rccom mend u t Jons which haie bi'cn made,
 •o such Other  IISLTK may ueilnlly  apply
 CuU:i;ury V or Category Vl  pesticides for
 which a prior recuiiunrndallun has been
 executed pursuant lo thb PDP3.
     K. OIMCCTIOHS *~OI USC AIJO OIKta
   Tlie aerlul appllraiiou oC  a rc
pesticide which beurs a Category  V or
Cutt'tfory VI label pinsuunt to tlm pro-
visions  of  thU 1'1'rS  nciihcr iiiadiAcs
other label  pro vl-. ions or directions for
use. nor authorises Ihu u*e of the pesti-
cide  In  a mnntu'r Inrunst.slnit whh any
Other label  proi'ttlous. |iii-|udlni:. wllh-
out limitation, ultwr iht'c*~Uon> (or u^e
und  prtcuulloiiary  t;iW)iui;.  pr  other
warnJnif slulemenU- Undi-r no chcum-
ttanccs  does thU ri'.J*li pi-umt uny ac-
tivity which Is cxpn-fMy luithihilrd on
Uie Inbel. Ijibel  prnvl-.ioiis  whlrh  must
be compiled with ut »H ttim-r. rfi'.;»rdl(^s
of the appllrullon method, im hide, with-
out  llinllAtl^ll.  sl:> trim-lit:.  rrmrdiflK
pvmluct nilxluti. lu-.itUut: mtd  pf«pui;»Hu».
t(iri;et pests (except ut i»rovided hi other
published P£PS>. appliculli.n fn-qiiency
or tntcrvuls. fluid reentry lnu-rvnl:.. pro-
tec tlvo  clothing  or  equipment mpjire-
metiU. product piicknglnu uuJ tiituspor-
tulluu  tct|uireiuenls. und  storage  and..
dlsiKuul practices.
       r. riiooucx CAI cur cniCACir .       '

   Tho aerial  applicallon of ft product
pursuant to the  ttdmlnlMi alive inec*m-
nlsin e.sHldlihcd In this  rtl'S inu;,t be;
cafe and eiTicuclous. or  mu.si rvu.sonubly
be expected to be sale and ullicaclou*. An
applicution or ui*j v.til bu considered to.
be safe and tflicarious If ll hus be'ncnciul
ell ecu when applied by nir imd at'liievcs
that  level  uf  PCM  control  which  is
normally a^sou luted  wltli the use  of the
pesiictdc, and docs  not  cuu^c hurin to
people or the environment.
          vui. ruat-ic COMMLHT . •

  Ttie Admlnlstrallve Procedure  Act 14
UiiC.I ifijtbl) piovIJt-i that the solid* '
tiLtlon of commenU Is not  resulted of.
PetleiaJ   auencles  fur   "Interpretative'
rules, fenerul staUmenU uf ixillcy. rules
ol agency organization,  procedures,  or

-------
prortlcrt.** KI'A has ilrltrniilnnt  IhAt thb
PW3 fnlls within  (hii L-xt'inpiloii from
Uio  ivqulrfmuut  lo tulle 11 pul'llc com-
nicul  Accordingly. the Agency Is nut co-
lic 11 liifr t»ulillc coinnu-nl rccuiUhitf nmt-
tera iMibllshert  In IliU notice. Uuvcver.
liittfi£.sl'.tj i>cit>unc ure liwIU-U to fvulmilt
v>rlllcn conitiiciiLi rrL'uiJinc thu it.llcy
set  furlh  In IliU Ft I'd These canna. uU
kliuuld lm uddrc.s^cd lo Uia
IKN-'Jl'Jt. Ofllce of  Kitforceaicnt.  U.S.
Environmental |Vo tret ion Afcnty, 401 M
Strei-l SW.. I loom 3624. Wu^llliiL'toti. D C.
20*60. llucu copies of  llu-:.o coiiununU
should be subuttlU-U lo faclliUU; the work
ol the Agency und of others InU-rcstott In
kn&pecttntf cuch ducxtnunU.
               8r«Htcv W. LKCRO,
            An tit ant Administrator
                     for Enforcement.
         0. 1077.

-------
therefore entitled to purchase the volu..iC of
motor jjnsoline ecjuiil to the amount furnished
by Addie dunr;! the corresponding months of
:he Nov.-mhpr 1-J77 IhmnRh Ortobcr 1'.r78
b.ise perio«i.
Atlantic flvh field Co.. Las Angelas. Calif-
    DRO-CC29. motor gasoline
  On June 8.1979.1 the Atlantic Richfield
Company. 515 S. Flower Street. Room 3077,
l.os Angeles. California 90071 (ARCO). filed a
Notice of Objection in which it indicates (hat
it will contest an Interim Remedial Order for
Immediate Compliance (1ROIC) which the
DOE Office of Special Counsel issued to it on
May 25.1979. In the IRO1C. the Special
Counsel found that (i) during May 1979
ARCO violated the DOE Mandatory
Pelroieum'Allocation Regulations by refusing
to supply Meier Oil Service. Inc. of Ashfcum.
Illinois (Meier) with volumes of motor
gasoline which Meier had certified as
necessary to supply its customers that are
engaged in agricultural production, (ii) the
violation was continuing, and (iii) Meier's
customers would be irreparably harmed
unless an IROFC were issued immediately.
The IRO1C directed ARCO to make available
to Meier 100.000 gallons of motor gasoline.

Tenneco Oil Co.. Houston, Tex.. ORO-C22&
    crude oil
  On June 5. 9179. Macmillan Ring-Free Oil
Co.. Inc.. 90 Park Avenue. Nsw York. New
York 10016. filed a Notice of Objeclicr. :oaa
I.itertrr. Remedial Order for Immediate
Compliar.ee which the DOE Southwest
District Office of Special Counsel issued to
Tenr.eco Oil Company on May 24.1979. In the
Ir.tcrim Remedial Order for Immediate
Compliance, the Office of Special Counsel
ordered Tunncco to make available to kern
Courtly Refinery 5.000 barrels per day of
crude oi: from its Yowlumne Field properties.
in addition to the 2.0CO barrels per day of
crude oil which Tenneco is already supplying
to Kern.

Wilshire Oil Co.. of Tex.. Oklahoma Ciiy.
    Ckla.. DRO-O22S. crude oil
  On June 5.1979. Wilshire Oil Company of
Texas, (Wilshire). 7ih Floor. 200 North
Harvey. Oklahoma City. Oklahoma 73102, '
filed a Notice of Objection to a Proposed
Remedial Order which the DOE Southwest
Enforcement District issued on April 27.1979.
In the Proposed Remedial Order, the
Enforcement District found that during the
pe.-icd from February 1976 through December
lire. Wiishire committed pricing violations in
connection with (he production and sale of
crude oil. According to the Proposed
Remedial Order, Wilshire's violations
resulted in overcharges to its customers of
SI 19.085.
,TK tk*. 79-2157; Filed r-ll-ro: 145-«n|
BJUJNG COOe MSO-01-41
 ENVIRONMENTAL PROTECTION
 AGENCY

 IFRJL 1270-Sj

 Enforcement Policy Regarding
 Failures To Report Information Under
 Section 6(a)(2) of the Federal
 Insecticide, Fungicide, and
 Rodenticide Act
 AGENCY: Environmental Protection
 Agency.
 ACTION: Notice setting forth a general
 statement of the Agency's policy
 concerning the exercise of its
 enforcement  discretion to regard as
 unactionable some failures to report, or
 delays in reporting, information required
 to be reported by Section 6(a)(2) of the
 Federal Insecticide. Fungicide, and
 Rodenticide Act. as amended (FIFRA), 7
 U.S.C. § 136 d(a)(2).	

 SUMMARY: This Notice describes a
 number of circumstances in which the
 Agency will not seek or recommend civil
 or criminal penalties against pesticide
 registrants who fail to report
 information concerning the risks or
 benefits of their registered pesticide
 products, despite the fact that reporting
 is required according the Agency's
 interpretation of FIFRA § 6{a)(2).
. DATES: July 12.1979.
   Effective Date:
   Comments wii! be most hejpful if they
 are received on or before October 10,
 1979.
 FOR FURTHER INFORMATION CONTACT!
 John J. Neylan  III. Office of Enforcement  (EN-
   342). Fjivironmental Protection Agency. 401
   M Street. S.W.. Room 3632. Washington.
   D.C. 20460. Telephone: (202) 755-0630.
        or
 Edward C. Cray, Office of General Counsel
   (A-132), Environmental Protection Agency.
   401 M Street. S.W.. Room 535. Washington.
   D.C. 20460. Telephone: (202) 755-0638.
 SUBMIT COMMENTS TO: John  J. Neylan III,
 Office of Enforcement (EN-342),
 Environmental Protection Agency,      •"
 Washington,  D.C. 20460.
 SUPPLEMENTARY INFORMATION:

 Introduction
   Section 6(a)p) of the Federal
 Insecticide, Fungicide, and Rodenticide
 Act. 7 U.S.C. 136d(a)(2), provides that  -
   If at any time after the registration of a
 pesticide the n>'istranl has additional factual
 information regarding unreasonable adverse
 effects on  the environment of the pesticide.
 he shnli submit such information to the
 Administrator.
   On August 23. 1970. EPA published in
 the Federal Kn«ister a memorandum
 prep.'ircd by the EPA General Counsel
 and adopted by the Administrator
 entitled "A?..ncy Interpretation of
 Requirements Imposed on .Registrants
 by Section 8(a)(2) of the Federal
 Insecticide. Fungicide, and Rod&nticide.
 Act." 43 FR 37611 el seq. The
 memorandum, which was prepared to
 response  to a directive by the
 Administrator, explained in detail the
 Agency's views concerning proper  •
 interpretation of the statutory reporting
 requirement established by Section
 6(a)(2).
    The conclusions  in the August. 1978
 memorandum were based on the
 pertinent legislative history and on the
 principle  that the language of Section
 6(a)(2) should be construed consistently
 with the overall regulatory approach
 established by Congress. The General
' Counsel concluded that section 6(a)(2)
 requires each registrant to submit any
 item of information in his possession
 which pertains to a pesticide product for
 which he holds a registration and which,
 if true, would be relevant to an
 evaluation of the risks and benefits of
 the pesticide product, unless such
• information consists solely of
 unsolicited lay opinion or has been
 previously submitted.
    Though the August. 1978
 memorandum rejected the notion that
 Congress intended trial Section 6(a)(2)
 be given a narrow  or restrictive
 interpretation, the  memorandum noted
 that
    The Agency might conclude that although
 information of a certain kind is subject to the
 5 6{a)(2) reporting requirement-(as interpreted
 by this memorandum), registrant reporting of
 that kind of information is not essential to th«
 Agency's functions *  '  " In such a case, it
 would be appropriate for the Agency to
 announce publicly (by Federal Resistor notice .
 or otherwise) that ii will not consider a
 registrant's failure to  submit that kind of
 information to be an actionable violation of
 J 6(aj(2).

    This Notice constitutes EPA's first
 statement regarding particular types of-
 .information which, though arguably
 pertinent  to evaluation of risks and
 benefits and otherwise reportable under
 section 6(a)(2), are  not currently needed
 by EPA in order to  properly discharge its'
 statutory  responsibilities under FIFRA.   •
 and thus need not be submitted by  .
 registrants. Dy publishing ihis Notice.
 EPA does not intend to alter or amend in
 any way its interpretation of the
 requirements imposed on registrants by -
 section-6fa)(3), but rather to specify.
 until further notice, certain instances In
 which a registrant's failure to submit
 information to FPA  will not be treated
 as an actionable violation of section
6(a)(2).

-------
  The provisions of this Notice are
   C^ to a large extern on assumptions
      (!:c resources F.PA will linve
      d'.' i» the near term future for the
        i' ip.fnrmalion submitted under
      5 6(al(2), a'«
-------
   (iii) After such corrections, the
 information no longer need be reported
 under any provision of (his Notice.

 Discussion
   The result of any controlled study in
 which exposure to a pesticidal
 substance is associated with a toxic or
 adverse effect are clearly pertinent to
 evaluation of risk and arc thus legally
 rcportable under Section 6(a)(2).
 However, unless new lexicological
 information suggects that reliance on
 material previously submitted to EPA
 may have resulted in underestimation of
 risk, or that prior information was
 otherwise inaccurate, misleading, or
 incomplete, submission of such new
 information is not likely to materially
 affect the registration status of products
 containing the substance tested EPA
 will not treat failure to submit
 toxicological information which is
 essentially corroborative as an
 actionable violation of Section 6(a)(2),
 but will insist on submission of any
 toxicological data which indicates that a
 pesticide may present different or
 greater hazards than previously
 identified.
   However,  when a particular pesticide
 product is involved in an RPAR
 proceeding under 40 CFR 162.11, or in
 suspension or cancellation proceedings
 ur.der f!FRA § 6(b) or 6(c). or where
 ^registration is underway, the scope of
 EPA's information needs is considerably
 broader. In such circumstances,  the
 ultimate status of the pesticide depends
 on a  comprehensive Agency
 revaluation of the pesticide's risks and
 benefits, including an assessment of the
 reliability of previously submitted
 material and extent to which it has been
 corroborated. Thus, if a particular
 substance is  the subject of a
 reresistration. RPAR. suspension, or
 cancellation  proceeding. EPA will treat
 failure to submit any toxicological
 information linking that substance with
 any toxic or adverse effect as an
 actionable violation of Section 6(a)(2),
 regardless of whether or not such
 information merely confirms or
 corroborates prior data.
   By the Jime a study is "completed",
 checking and volidntion of-data should  .
 normally also be complete. We will
 nonetheless allow the registrant a-
 reasonable period, not to exceed 30
 days, to check for data errors which the
 registrant believes may have formed the
 basis for an opinion about what the data
 signify, and to seek a  corresponding
 modification  of the opinion.
  On the other hand, if it is not the data,
 but the expert analysis, conclusion, or   .
opinion itselfwith which ihe registrnnt
 disagrees, the registrant's remedy is nc.
 to withhold the information from EPA.
 but to submit with the § 6(a)(2) report
 his own analysis of the information's
 significance.

 B. Incomplete Toxicological Studies

 Policy
  Failure to submit information to EPA
 which concerns the results of an
 incomplete study of the toxicity to any
 organism of a registered pesticide
 product or any of its ingredients.
 impurities, metabolites, or degradation
 products and which is otherwise
 reportable according to the "Agency
 Interpretation of Requirements Imposed
 on Registrants by Section 6(a)(2J of the
 Federal Insecticide. Fungicide, and
 Rodenticide Act," 43  FR 37611. will not
 be considered an actionable violation of
 FIFRA § 6(a)(2) unless the information
 concerns:
  (1) An acute effects study or other
 study utilizing a testing regimen lasting
 90 days or less, in which all testing has
 been completed,  a preliminary data
 analysis or gross pathological analysis
 has been conducted, final analysis has
 not been completed, and a reasonable
 period for completion of the final
 analysis (not longer than 90 days
 following completion of testing) has
 elapsad. if comparable information
 concerning the results of a complete
 controlled study would be reportable
 under paragraphs I. A(l)-{7) of this
 Section:
  (2) A chronic effects study or other
 study utilizing a testing regimen lasting
 more than 90 days, in which all testing
 has been completed, a preliminary data
 analysis or gross pathological analysis
 has been conducted, final analysis has
 not been completed, and a reasonable
 period for  completion of final analysis
 (not longer than one year following
 completion of testing) has elapsed if -
 comparable information concerning the-  '
 results of a completed controlled study
 would be reportabla under paragraphs I.
 A(lH7) of this Section; or
  (3) Any study in which testing or
 analysis of results is not yet complete
•but in which serious adverse effects
 have already been observed which may
 reasonably be attributed to exposure to
 the substance tested, because the affects
 observed in exposed organisms differ
 from effects observed in control
organisms, are atypical in view of
historical experience with the organism
tested, or otherwise support a
reasonable inference of causation.
 Discussion

   In developing a policy rcgnrding
 which failures to submit otherwise  '
 reportable information from incomplete
 toxicological studies should be treated
 as actionable violations of Section
 6(a)(2). EPA has determined that it is not
 necessary at this time to require
 submission of preliminary or incomplete
 toxicological information, except in
 certain specific circumstances. The
 criteria selected are designed to
 accomplish two fundamental regulatory
 objectives. The first objective is to
 provide an incentive to registrants to
 complete analysis of toxicological data  '
 within a  reasonable time, especially if a
 preliminary appraisal suggest that a
 pesticide may present different or
 greater hazards than previously
 identified. The second objective is to
 insure that any preliminary findings arc
 reported to EPA as soon as there is a
 reasonable basis for concern, even
 though further testing or analysis may
 be necessary before the observed
 hazard can be defined or quantified.
   We do not believe that it would be
 currently useful to insist on submission
 of preliminary °r inconclusive data on a
 routine basis. On the other hand, no
 registrant who fears that submission of
 a completed study might jeopardize any
 of its registrations should be permitted
 to indefinitely defer or postpone
 completion of analysis of potentially
 significant data. Accordingly, we have
 designated an appropriate period—up to
 90 days for.acutc studies, up  to one year
 for chronic studies—during which the
 registrant may engage in further
 analysis  designed to refine the data
 prior to submission.
 Example   •
   A registrant conducts the first study of the
 acute effects of ingestion of a certain
 pesticide on rabbits. A prior acute study of
 the same pesticide using mice found that
 exposed mice experienced increased
 mortality due to liver damage. The registrant
 notes increased mortality of unknown origin
.In the exposed rabbits. Following completion
 of the test  regimen, the registrant may take »'
 reasonable period, not exceeding an
 additional 90 days, for investigation of the
 significance and cause of the increased
 mortality. After that period has elapsed.
 failure to submit information concerning the.
 study to EPA will Be treated as an actionable
 violation of Section 6(a)(2). regardless of
 whether or not  Ihe analysts is yet complete.
 because information concerning a completed
 study in which toxic effects have been
 observed in a different species than
 previously reported would be reportable. Of
 course, the registrant will always be entitled
 to supplement any initiul submission with tfi8
 results of subsequent analysis. •

-------
  Certain types of preliminary
experimental observations and findings
are sufficiently serious that they should
be reported to EPA immediately. In
general, we will not treat failure to
submit information concerning any
incomplete study in which testing is still
underway, or for which the prescribed
period for analysis of results has not yet
expired, as an actionable violation of
Section G(a)J2) unless serious adverse
effects have been observed which are
sufficiently different from effects
observed in control organisms or in prior
experience with the species tested that
the registrant may reasonably assume
that the adverse effects are associated
with the pesticidal substance being
tested. Even though preliminary
information may not always be
sufficiently complete or definitive to
warrant immediate regulatory action,
preliminary data may indicate a need
for immediate modifications of or
additions to the study protocol, provide
a basis for requests for further
information under F1FRA § 3(c)(2)(B), or
convince EPA to conduct or sponsor
additional research.
Examples
  (1) A registrant conducts a two-year study
of the effects of chronic exposure to a certain
pesticide on rats. Nine months after the study
commences.-study personnel observe that a
large percentage of the exposed rats have
developed ocular opacity of the type
associated with formation of cataracts. None
of the control mice exhibit a comparable
abnormality. Though the test is incomplete
and (he evidence that the pesticide is
inducing cataracts is not yet definitive, the
registrant  may reasonably conclude that the
ocular abnormalities are attributable to
exposure to the pesticide, and the observed
effects must be reported to EPA.
  (2) A registrant conducts a two-year
controlled study of the effects of chronic
exposure to a certain pesticide on mice. Six
months after the study commences, several of
the exposed animals die. Upon dissection.
Jtudy personnel observe that the dead
animals have developed a type of tumor
which is rarely observed in the strain of mice
being tested. Though a substantial portion of
'he test regimen has not been completed.
pathological evaluation of the tumors is also
incomplete, and the evidence that the
Pesticide is tumorogcnic is not definitive, a
reasonable inference arises that the unusual
lumors are attributable to exposure to the
pesticide, and the observed effects must be
icportcd to EPA.

C. Epidemiologicd! Studies
Policy

  Failure lo submit information to EPA
*hich concerns any  completed
cpidumiologica) study (or  portion
Hereof) involving correlation or
association between exposure to a
 registered pesticide (or any of its
 ingredients, impurities, metabolites, or
 dogrndatinn product) »ml adverse
 effects in humans, and which is
 reporluble according to the "Agency
 Interpretation of Requirements Imposed
 on Registrants by Section G(a)f2) of the
 Federal Insecticide. Fungicide, and
 Rodenticide Act." 43 FR 37811. will be
 considered an actionable violation of
 FIFRA § 6(a)(2) regardless of whether or
 not the registrant considers any
 observed corre-lation or association to
 be significant.  .

 Discussion

   Unlike most studies, which can be
 designed and controlled in advance,
,epidemiologies! studies are generally
 retrospective in character. As a
 consequence, it is often difficult to
 assess the impact of various
 uncontrolled variables on the magnitude
 of any observed correlation, and
 competent experts can reasonably
 disagree regarding the practical
 significance of epidemiological findings.
 On the other hand, epidemiological
 studies can be an indispensable source
 of information on the critical issue of the
 risks associated with human exposure.
 Thus, it is important that EPA be able to
 independently examine for relevance
 any epidemiological information
 concerning pesticide exposure, and we
 will consider any failure to submit such
 information to be an actionable
 violation of Section 6(a](2). Registrants
 may supplement any submission of
 epidemiological information with a
 statement describing any reservations
 they might have concerning the
 information's validity or significance.

 D. Efficacy Studies
                          r*
 Policy

   Failure to submit information to EPA
 which concerns any study of the
 efficacy of a registered pesticide product
 and which is otherwise reportsble
 according to the "Agency Interpretation
 of Requirements Imposed on Registrants
 by Section.6(a](2) of the Federal
 Insecticide, Fungicide, and Rodenticide
 Act." 43 FR 37611. will not be considered
 an actionable violation of FIFRA
 §  6(a](2) unless:
   (1) The information demonstrates that
 the pesticide may not perform in
 accordance with any claim by the
 registrant regarding use to control
 organisms which may pose a risk to
 human health, including any of the uses
 identified in 40 CFR 102.10-2(d}(:>). (3)(i),
 44 FR 27932, 279-12. May 11, 1970; or
   (2) The information concerns any
 deficiency or reduction in the ciaimtd
 efficacy of any use of a registered
 pesticide, if such use is subject to a
 Rubuttablo Presumption Against
 Registration proceeding, suspension
 proceeding, or cancellation proceeding. •
   EPA will not consider a delay in
 submission of information which is
 otherwise reportable under paragraph
 (1) or (2) above to be an actionable
 violation of FIFRA § 6(a)(2) if the delay
 is for a reasonable period, no longer
 than 30 days from the date the registrant
 first receives  the apparently  reportable
 Information. In addition. EPA will not
 consider failure to submit such
 information to be an actionable
 violation of FIFRA § 6(i](2) if. prior to
 the expiration of the period mentioned
 in the preceding sentence:
   (i) The registrant discovers that any
 analysis, conclusion, or opinion which
 would have caused  the information to
 be reportable was predicated on data
 that were erroneously generated,
 recorded, or transmitted, or on
 computational errors:
   (ii) Every author of each such
 analysis, conclusion, or opinion has
 acknowledged in writing that the
 analysis, conclusion, or opinic.v was
 improper because of the use of the
 erroneous data, and has corrected the
 original analysis, conclusion, or opinion
 accordingly; and
   (iii) After such corrections, the
 information no longer need be reported
 under any provision of this Notice.
 Discussion:
   In most instances, EPA will not treat
 the failure to submit information
 concerning the efficacy of a registered
 pesticide product as an actionable
 violation of Section  6(a)(2) unless such
 information indicates that  the pesticide
 may not perform as  claimed when used
 to control organisms which pose a
 potential threat to human health. We
 have taken the position that the utility
 and efficacy of many pesticide products
 can best be verified  by the mechanism
 of the marketplace. See 44 FR 27932,
 2793&-40. May 11,1979. However in
 some instances where use of a
 particular pesticide appears to involve
 substantial hazards, EPA must evaluate
 the efficacy of the pesticide, in addition
 to the magnitude and value of its use
 and the feasibility of substitutes, before
 determining whether or not the risks
 associated with use  of the pesticide are
 acceptable. Accordingly, whenever any
 use of a registered pesticide is the
subject of an RPAR,  suspension, or
cancellation proceeding. EPA will treat
failure to submit any study which
concerns any deficiency or reduction in  -
the efficacy of the product for the u'se in

-------
(«:<>stion ;>s an actionable violation oi
Section 0{a){2).

II. Incident Reporting             ;

,1. To*:c or Adverse Effects

Policy
  Registrants may receive information,
other than the results of controlled
studies, concerning specific incidents in
which toxic or adverse effects have
been attributed to exposure to the
registrant's pesticide product. This
information may come to the registrant's
attention through a variety of sources.
including but not limited to: product
lii'bility.cjaims and complaints;  "
information obtained directly, or
through field representatives, from
dealers, growers and pesticide users:
reports  from agricultural extension
agents and federal and state regulatory
agencies: information received from the
general public: information received
from a poison control center and
information reported by plant managers
and employees. Failure to submit
information of this type which is
otherwise reportable according to the
"Agency Interpretation of Requirements
Imposed on Registrants by  Section
0(a)(2] of the Federal Insecticide.
Funair.ida. and Rodenticide Act," 43 FR
37611. will not be considered an
actior.abie violaiion of FIFRA § 6{a)(2)
unless or.a of the following three sets of
criteria  apply:
  (1) Human Incidents. The information
concerns  an incident in which: (a) The
registrant has been informed that some
person suffered an adverse
physiological or behavioral effect (other
than local damage to or irritation of the
skin of tha type commonly associated
with dermal exposure, when the lable
provides adequate notice, of such a
hazard):
  (b) The registrant has been informed
that the affected person may havl been
exposed lo the pesticide, or to one or
more of its ingredients;
  (c)(i) The registrant has verified that
the person did suf'er an adverse effect
and was exposed to the pesticide, or
  (ii) The registrant has received
sufficient  information to enable
investigation of whether or  not the
reported adverse effect and exposure
occurred, n reasonable period of time for
investijr.tion h;is elapsed, and the
registrant  is not aware of facts which
establish th.it the reported adverse
effect or reported exposure  did not
occur: and
  M!fi) Thii rivjistrant has concluded
fha*. ;hr: :ifr<:cl rr.ay have resulted from
tl'.L-  c\:;;o:;.iJi:. Or
   (ii) The registrant has been advised b>
 any individual whose opinion is
 reportable under Section G{a)(2)—i.e..
 and employee, consultant, or qualified
 expert—that the effect may have
 resulted from the exposure, and is not
 aware of facts which conclusively
 establish that the reported adverse
 effect and reported exposure were
 unrelated.
   (2) Incidents Involving Other Non-
 Target Organisms. The information
 concerns an incident in which:
   (a) The registrant has been informed
 of an adverse effect on non-target fish or
 wildlife, domestic animals, or plants:
   (b) The registrant has been informed
 that the affected fish, wildlife, domestic
 animals, or plants may have been
 exposed to the pesticide, or to one or
 more of its ingredients;
   (c){i) The registrant has verified that
 the reported adverse effect and
 exposure did occur, or
   (ii) The registrant has received
 sufficent information to enable
 investigation of whether or not  the
 reported adverse effect and exposure
 occurred, a reasonable period of time for
 investigation has elapsed, and the
 registrant is not aware of facts  which
 establish that the reported adverse
 effect or reported exposure did  not
 occur; and
   (d)(i) The registrant has concluded
 that the effect may have resulted from
 the exposure, or
   (ii) The registrant has been advised by
 any individual whose opinion is
 reportable under Section 6(a)(2)—i.e. an
 employee, consultant, or qualified
 expert—that the effect may have „
 resulted from the exposure, and is not
 aware of facts which conclusively
 establish  thaVthe reported adverse
 effect and reported exposure were
 unrelated; and
   (e)(i) The registrant cannot
 demonstrated that the pesticide
 exposure resulted from improper use, or\.
   (ii) The labeling of the pesticide does
 not provide reasonable notice of the risk
 of adverse effects of the.kind reported.
   (3) Series of Incidents. The
 information concerns any series or
pattern  of individual incidents as to
 which:
  (a) The registrant has been informed
 of the same kind of adverse effect on
 humans, non-target fish and wildlife,
 domestic animals, or plants:
  (b) The registrant has been informed
 that the affected organisms may have
 been exposed to the same pesticide or to
one or more of its ingredients:
  (c) For each individual incident, either
   (i) The registrant has verified that the
 rtpot ted adverse effuct and reported
 «j.xpo?ura .iid occur, or
   (ii) The. rests-rant hns received
 sufficient information to enable
 investigation of whether or not the •
 reported adverse effect and exposure
 occurred, a reasonable period of time for
 investigation has elapsed, and the
 registrant is not aware of facts which
 establish that the reported adverse
 effect or reported exposure did not
 occur.
   (d) For each individual incident the
 registrant is not aware of facts which
 conclusively establish that the reported
 adverse effect and  reported exposure
 were unrelated; and
   (e) The series or  pattern of incidents
 would not be expected unless the
 reported adverse effects were caused by
 the reported exposures.
 Discussion
   Information concerning incidents in
 which toxic or adverse effects are
 attributed to pesticide exposure varies
 considerably in specificity and
 accuracy. Some reports received by
 registrants are so vague or implausible
 that they would be unlikely to provide a
 basis  for administrative action. On the
 other  hand, some incident reports  may
 contain  unique and valuable information
 on the hazards and environmental
 impacts associated with actual use and
 practice, information which cannot be
 readily derived from  laboratory data
 alone. Thus, we have endeavored  to
 select sets of criteria  which will give
 practical assistance to each registrant in
 identifying those types of incident
 information which  are currently needed
 by EPA in order to  properly discharge its
 statutory responsibilities. Each set
 criteria contains the following elements:
 (1) a report of a toxic or adverse effect.
 (2) a report of pesticide exposure. (3) an
 opportunity for investigation of the
 accuracy of the reports, and (4) a basis
 for an inference that the toxic effect and
 the pesticide exposure were related.
   Demonstrably inaccurate incident
 information need not  be submitted to
 EPA under Section  6(a)(2). If a registrant
 can clearly demonstrate that a reported
 toxic effect or pesticide exposure did
 no! occur, or that the effect and
 exposure were unrelated, we will not
 treat any failure to report an alleged
 incident as an actionable violation of
 Section 6(a)(2). However, failure to
 investigate the  accuracy of any report or
 allegation which could be investigated
 will not be considered lo excuse non-
compliance with Suction 6(a)(2). 3y
adopting this policy. HP A docs nrt      _
intend  to attempt to impose any sort of

-------
 duty or obligation on the registrant to
 investigate incident reports, but rnther
 lo accord the registrant a reasonable
 opportunity to investigate incident
 information. In any event, the
 responsibility for determining the
 significance of any potentially useful
 incident information which has not been
 either verified or rebutted must
 ultimately reside with EPA.
    Information concerning incidents in
. which humans exposed  to a pesticide
 have experienced toxic or adverse
 effects is extremely useful in, e.g.,
 evaluating the occupational risks
 associated with pesticide use, or
 deciding whether a method of applying
 the pesticide should be prohibited.
 Receipt of incident information
 regarding adverse effects in humans is
 particularly important because of the
 ethical unacceptability of deliberate
 clinical exposure and the difficulties
 associated with predicting human
 toxicity on the basis of animal data.
 Thus, we may consider any failure to
 submit incident  information concerning
 any toxic or adverse effect  in humans
 (except for local skin damage or
 irritation warned against on the label)
 which includes the basic elements
 previously identified and which is
 otherwise reportable under Section
 6(a)(2) to be an actionable violation of
 F1FRA, regardless of the circumstances
 which resulted in the pesticide
 exposure. In contrast, we will not treat
 failure to submit information on any
 single incident involving toxic or
 adverse effects on other non-target
 organisms as an actionable violation of
 Section 6(a](2) if the registrant can
 demonstrate that (1)  the pesticide was
 used improperly, and (2) the label
 provides reasonable notice  of the risk of
 adverse effects of the kind reported.
    Incident information concerning toxic
 or adverse effects has little  current
 utility for regulatory purposes and need
 not be submitted to EPA under Section
 G(a)(2) unless the information is
 predicated on a  conclusion, opinion, or
 reasonable inference that the reported
 effects were related to pesticide
 exposure. Failure to submit  information
 regarding any single incident of this type
 will not be treated as a violation of
 Section 6(a)(2) unless the registrant has
 concluded that the reported effect may
 have been caused by the reported
 pesticide exposure, or has been advised
 by any individual whose opinion is
 reportablo (according to  the "Agency
 Interpretation of Requirements Imposed
 on Registrants by Section 6(a)(2) of the
 Federal Insecticide, Fungicide, and
 Rodenticide Act." 43 FR 37611) that a
 causal relationship may have existed.
 Examples
   (1) A registrant receives a report from an
 unidentified snurcu indicating that an
 agricultural employee experienced
 respiratory difficulties after working in a field
 where a pesticide manufactured by the
 res'stranl hnd recently been applied. The
 report is sufficiently detailed to enable
 investigation of its accuracy. A few days
 later, the registrant discusses the alleged
 Incident with a toxicologist. who stales that,
 in his opinion, the reported respiratory
 •ympions could have been caused by
 exposure lo the registrant's pesticide. The
 registrant will be given a reasonable time to
 Investigate the incident. If the registrant
 subsequently discovers facts which establish
 that the reported adverse effects or reported
 exposure did not occur, or which conclusively
 establish that the respiratory difficulties
 experienced by the exposed individual were
 caused exclusively by some factor other  than
 pesticide esposure. the incident need not be
 reported. Otherwise, information concerning
 the incident must be submitted to EPA.
 because the toxicologist is a qualified expert
 whose opinion is reportable under Section
 6(a)(2],
   (2)A registrant receives a report from an
 agricultural extension agent indicating that
 fish were killed in a creek adjacent to a Held
 where a pesticide manufacture by the
 registrant had recently been applied. After
 investigation, the registrant concludes that
 the reported fish kill probably resulted from
 exposure to (he registrant's pesticide.
 However, the registrant also discovers facts
 which establish that the pesticide was
 improperly applied, by an individual who
 disregarded a statement on the label
 expressly warning against use in
 circumstances where contamination of
 surface waters might result. Any single
 incident of this sort need not be reported
 under Section 6(a)(2).

   If a registrant has been informed of a
 series or pattern of  incidents in which
 the same kind of toxic or adverse effects
 have followed exposure to the same
 pesticide, a reasonable inference of a
 causal relationship  may arise from the
 existance of the series or pattern  itself,
 even in the absence of a specific
 conclusion or expert opinion to that
 effect. In such circumstances, any       ,
 requirement that the registrant
 specifically conclude or be advised that
 a causal relationship exists is
 superflous, and registrants will be held
 legally accountable under Section 6(a)(2)
 for failure to submit information
 regarding any significant series or
 pattern of incidents  involving the same
 kind of toxic or adverse effect  and the
 some pcsticidal substance. Moreover,
 even  if a series or pattern consists of
 incidents which would otherwise  not be
 reportable under this policy, because
 each incident  involves predictable
 effects on nontarget organisms resulting
from improper use. we will likely treat
 failure to report such information in on
 aggregate form as an actionable
 violation of Section 3(a}(2). tlPA needs
 this type of incident informntion
 because the existence of widespread or
 routine misuse of pesticide products
 may be a basis for changes in labeling,
 additional restrictions on use. or other
 regulatoiy action.
 Example
  The registrant has received a number of
 reports, from various sources, of unusually
 high mortality in birds feeding in or near
 fields where the registrant's pesticide has
 been applied. Though some of these reports
 were not specific enough to enable
 investigation of their accuracy, the registrant
 has identified a scries of specific investigate
 incidents in  which it appears that an unusual
 number of birds died following use of the
 registrant's pesticide. However, the registrant
 has not determined whether or not the
 pesticide was responsible for the observed
 increase in bird mortality, and no employee.
 consultant, or qualified expert has indicated
 that a causal relationship may exist.
 Nevertheless, if the existence of the series of
 unexplained incidents is sufficient to support
 a reasonable inference of a  causal
 relationship, failure lo submit information
 concerning the incidents will be considered
 an  actionabie violation of Section 6(a)(2).

 B. Failure of Efficacy

 Policy

  Registrants  may also receive
 information concerning specifc incidents
 in which il is asserted that the
 registrant's pesticide product failed to
 perform as claimed against designated
 target organisms. Failure to submit
 information of this type which is
 otherwise reportable according to the
 "Agency Interpretation of Requirements
 Imposed on Registrants by  Section
 6(a)(2) of the Federal Insecticide,
 Fungicide, and Rodenticide Act," 43 FR
 37611, wil! not be considered an
 actionable  violation of FIFRA § 6(a)(2)
 unless one  of the following two sets of
 criteria apply:
  (1) Immediate Hazard  to Life. The
 information concerns an  incident in
 which:                        „...
  (a) The registrant has been informed
 that a pesticide product did not perform
 as claimed  against target organisms:
  (b)(i) The registrant has verified that
 the reported failure of efficacy did
 occur, or
  (ii) The registrant has received
 sufficient information to enable
 investigation of whether or not the
 reported failure of efficacy occurred, a
 reasonable  period of time for
 investigation has elnpsed. and the
registrant is not aware of facts which
establish  that the reported fniiure of
efficacy did not occur; and

-------
   (c) The failure of the pesticide i.
 perform as claimed involved any use
 ac;;iin.st organisms which, unless
 controlled. may pnai; an irrjr.ecliute
 hnzurd to human life.
   (2) Health Risk. The information
 concerns any series or pattern of
 individual incidents as to which:
   (a) The registrant has been informed
 of the same type of failure to perform as
 ciaimcd against target organisms;
   (b) For each individual  incident, either
   (i) The registrant has verified that the
 reported failure of efficacy did occur, or
   (ii) The registrant has received
 sufficient information to enable
 investigation of whether or not the
 reported failure of efficacy occurred, a
 reiisonnble period of time for
 investigation has elapsed, and the
 registrant is not aware of facts/ which
 establish that the reported failure of
 efficacy did not occur and
   (c) The failure of the pesticide to
 perform as claimed involved any use to
 control organisms which may pose a
 risk to human health, including any of
 the uses identified in 40 CFR 162.18-
 2(d)(2). (
 Discussion

   We will not treat any failure to submit
 information concerning incidents in
 which a pesticide did not perform as
 claimed against target organisms as an
 actionable violation of Section 6(a](2)
 unless the reported failure of efficacy
 involved organisms which pose a
 potential threat to human health. This
 policy reflects a judgement by EPA that
 the efficacy of pesticide products which
 are not used to protect public health can
 usually be adequately tested by the
 dictates of a competitive marketplace.
 See 44 FR 27932. 27938-40. May 11, 1979,
 Moreover, except in those instances
 where a reported failure of efficacy
 involved use against organisms which
 may pose an immediate hazard to
 human life, it is not likely that we would
 consider any single reported incident of
 failure of efficacy to be a proper basis
 for regulatory action. Therefore, we wiU
 not treat any failure to submit incident
 information concerning .failure of
 efficacy  against  organisms which may
 pose a risk to public health,  but do not
 pose an immediate hazard to human life.
 as an actionable violation of Section
 6(a)(2) unless such information concerns
 any significant series or pattern of
 comparable failures of efficacy. As in
 the case  of incident information
 involving toxic or adverse effects,
registrants will be afforded a reasonable
opportunity to investigate any reported
failure of efficacy before such
 information will be considered
 rcporlftblo.

 III. Ki:i>fi.-rinj f>f Other [tifnrm.ilion

 Policy

   EPA will not consider failure to
 submit information of any kind other
 than those kinds of information
 described in Sections I and II of this
 Notice as an actionable  violation of
 FIFRA § 6(a)(2) even though such
 information would otherwise be
 reportablc according to (he "Agency   •
 Interpretation of Requirements Imposed
 on Registrants by Section 6(a)(2) of the
 Federal Insecticide, Fungicide, and
 Rodenlicide Act." 43 FR 37611. unless:
   (1) After a reasonable period of time
 for verification or investigation of the
 information has elapsed, the registrant
 is not aware of facts  which establish
 that the information is incorrect: and
   (2) The registrant Knows, or
 reasonably should know, that if the
 information should prove to be correct.
 EPA would regard the information,
 alone or in conjunction with other
 information about the pesticide, as
 raising serious questions about the
 continued resistrability of one or more
 uses of any of the registrant's pesticide
 products, or about the proper terms and
 conditions of registration of any such
 product.

 Discussion

   In Sections I and (I of  this Notice, we
 have established policies concerning the
 types of information which, insofar as
 we are aware, have bean the subject of
 most of the inquiries made and concern
 expressed by registrants with regard to
 FIFRA 5 6(a)(2). There are. however.
 many other categories of information
 which may be reportable under FIFRA
 § 6(a)(2), including additional
 information concerning: the identity and
 amount of impurities and degradates of
 pesticide products in  the product as
 sold: degradation and fate of pesticides
 in the environment after application or *"
 use: soil, plant, and animal metabolism;
 bioaccumiilulion by Various life forms;
 identity and quantity  of pesticide
 residues on raw and processed
 agricultural commodities and foods;
 levels of exposure to applicators, farm
 workers, bystanders, food consumers, -
and other persons; drift of pesticides to
ncn-targut areas: and  a variety of other
inforr.:ation which might affect EPA
decisions concerning the continued
registrubility ot a  product cr the
appropriate terms and conditions of
registration.
  In this Notice we have not attempted
to establish with specificity, fur each
 category of such information, which
 failures to rc.iort information we will
 not treat as actionable violations of
 FIFRA § G(uj(2). In part, this is because
 we are interested in receiving the views
 of the pesticide industry and other
 interested persons concerning what our
 policy regarding such information
 should be. It is likely that we will
 modify this Notice in the future to
 announce a morn specific Section G(a)(2)
 enforcement policy concerning some or
 all of these types of information.
    However, in order to provide some
 immediate guidance to registrants, we
 have set forth in this Notice a general
 policy covering nil information not
 described by Sections I and II of the
 Notice. It allows registrants a
 reasonable period to verify or
 investigate apparently reportable
 information, prior to actual submission.
 In deciding whether a delay in reporting
 was reasonable, we will take into
 account the seriousness of the problem
 suggested by the information, as well as
 the kind and amount of verification that
 would be desirable. If. during this
• period, the registrant learns of facts
 showing that the information is
 incorrect, the information need not be
 submitted and failure to report will not
 be considered an actionable violation of
 Section 6(a)(2).
   In addition, we will not treat a failure
 to report information as an actionable
 violation of FIFRA 5 6{a)(2) unless the
 registrant knew, or reasonably should
 have known, that EPA would regard the
 information as pertinent !o the question
 of whether the product's registrations
 should be cancelled, suspended, or
 modified in some respect.
 Example
   The registrant knows that the original EPA
 decision to register his product for use as a
 soil insecticide in corn fields (the only
 registered use) was based on the belief that
 no residues of a particular, highly-toxic
 metabolite of the product would appear in
.•corn planted in fields treated with the
 product during the spring. In January the
' registrant, learns of a study conducted by a
 university scientist showing that residues of
 the metabolite in question have appeared in
 corn grown in fields which were properly
 treated with the product. If true, this  report
 would indicate that use of the product may
 pose a serious hazard to food consumers.
 Accordingly, the information must be
 reported to EPA unless, during a reasonable
 period of time for investigation or
 verification, the registrant learns of facts
 establishing it is untrue. One meuns of
 verification would be to conduct independent
 field trials during (he corning growing season.
However, wailing for (he results of field trials
would require a dnlay of at least SMO monlhi
in reporting. Given the serious import of the
information already available, a 9-fnontb

-------
 iHny would be unrRRaonably long.
 ,\l!crr.«t!vvly. the leg^trant could contact the
 vmnli-.l \vt\n conduced the st'jiiy ami review
 une ra.«/ ;i i!j Tor I'lrurs. A review of this type
 ..vnulil pr-jluliiy require ID days or loss. The
 .Agency woulii regard lhi:r of olij'.'i-.iwi'ly defined categories
 of information which need not ba
 submitted. Failure to submit information
 in any of these categories will not be
 treated as an actionable violation of
 Section 0(;i)(2). While the specified
 categories are not intended to
 encompass all information which could
 conteivably come lo the attention of
 Agency personnel, they do indicate
 which lypcs of information are most
 likely to be routinely examined or
 reviewed by EPA.
 V. Case-by-Caso Exercise of
 Prosecutorial Discretion
 *
 •' EPA will not automatically seek or
 recommend civil or criminal penalties
 whenever it discovers an apparent
 violation of F1FRA § 6(a)(2) of a type
 which is considered actionable under
 this Notice. Decisions in such cases will
 be based on a careful evaluation of all
 pertinent information, including any
 explanation offered by the registrant.
  Dated: July 6.1979.
 Man-in D. Durmug,
 Assistant Administrator for Enforcement.
 |FR Doc 79-21564 Filed 7-11-7?. &i5 ui|
 BILUNO COO£ 8MO-01-M
 [FRL 1270-€)

 Illinois State Implementation Plan;
 Notice of Deficiency
 AGENCY: U.S. Environmental Protection
 Agency.
 ACTION: Notice of Deficiency; Illinois
 State Implementation Plan.

 SUMMARY: As a result of Illinois
 Appellate Court action on September 27,
 1978 which vacated regulations
 pertaining to particulate and sulfur
 dioxide emission standards USEPA
 finds the Illinois Slate Implementation
 Plan to be deficient
 FOB FURTHER INFORMATION CONTACT:
 Maxine Borcherding, Air Programs
 Branch, Air and Hazardous Materials
 Division, U.S. Environmental Protection
 Agency, 230 South Dearborn Street,
 Chicago, Illinois 60604. (312) 353-2205.
 SUPPLEMENTAL INFORMATION: This
 notice  contains a summary of the
 findings of the EPA Regional
 Administrator for Region V from an
 assessment of deficiency of the
 implementation plan for the State of
Illinois.
  On May 31.1972 [37 FR 10862)  under
Section 110 of the Clean Air Act and 40
CFR Part 51. the Administrator
substantially approved Illinois' control
strategy for the attainment and
maintenance of l!m not:;.".,' primary
and secondary standards i'.ir sniiur
dioxide emissions iind p,ir!i
-------
  WEDNESDAY, AUGUST 23, 1978
         PART IV
   iNVIRONMENTAL
    PROTECTION
      AGENCY   -
 PESTICIDE REGISTRANT
      REPORTING
   . REQUIREMENTS  '-
  Agency interpretation and
Revocation of interpretative  Rule

-------
IC060-OI I

 Title 40—Protection of Environment

   CHAPTER I—ENVIRONMENTAL
       PROTECTION AGENCY

            CFRL 952-21

PART  162—REGULATIONS  FOR  THE
  ENFORCEMENT OF THE  FEDERAL
  INSECTICIDE, FUNGICIDE, AND RO-
  DENTICIDE ACT

  Revocation of Interpretative Rule

AGENCY:  Environmental Protection
Agency (EPA).

ACTION: Revocation of interpretative
rule.

SUMMARY: EPA revokes a regulation
containing  an Agency interpretation
of the reporting requirement imposed
on registrants by section 6(a)(2) of the
Federal  Insecticide, Fungicide,  and
Rodenticide Act, as amended (FIFRA).
This revocation  is issued  because the
Asency has concluded that the regula-
tion  inadequately expresses the Agen-
cy's interpretation of the  requirement
imposed by FIFRA section 6(aX2).

EFFECTIVE DATE: August 23.1978.

FOR .' FURTHER   INFORMATION
CONTACT:

  Ed-.vard C. Gray.  Office of General
  Counsel (A-132), U.S. Environmental
  Protection  AK.-ncy.  401  M  ',,   et
  SW.. Room 425 West Tower, Wash-
  ington. D.C. 20460,  telephone 202-
  755-0638.

SUPPLEMENTARY INFORMATION:
The Agency  has concluded that  40
CFR   162.8(d)(2)  inadequately  ex-
presses the Agency's Interpretation of
the requirement  imposed by FIFRA
section  6(aX2). The Agency's  review
was prompted by currently pending
litigation seeking to have the regula-
tion set aside (.Chemical Specialties
Manufacturing Association  and Na~
lional Agricultural Chemicals Associ-
ation V. EPA. CA No. 77-1938, U.S. Dis-
trict Court lor the District of Colum-
bia).
  The Agency's  General Counsel re-
cently issued a memorandum concern-
ing the requirements  of FIFRA sec-
tion 6
-------
                                                    NUIiLti
                                                                     37611
16560-01]

   ENVIRONMENTAL PROTECTION
              AGENCY

             CFRL 952-31

     PESTICIDE REGISTRANT REPORTING
            REQUIREMENTS

Agency Interpretation  of Requirement!  Im-
  peted on Regittronlt by Section 6(a)(2) of
  lh« federal Insecticide, Fungicide, and  Ro-
  u'enticide Act

  This notice sets forth the Environ-
mental  Protection  Agency's interpre-
tation  of the reporting requirements
imposed on registrants of pesticides by
section G(a)(2) of the Federal  Insecti-
cide. Fungicide,  and Rodenticide Act,
as   amended  (FIFRA).   7  U.S.C.
13Gd(a)(2>. The  memorandum of the
Agency's General Counsel  dated  June
30,  1978, which  is set forth below, is
hereby adopted  as  the  Agency's  posi-
tion.
  Dated: August  14. 1978.
              DOUGLAS M. COSTLE,
                    Administrator.
            (Memorandum]
Subject:  Nature  of reporting require-
   ment under FIFRA section 6(a)<2).
From:  Joan Z.  Bernstein.  General
   Counsel (A-130).
To: The Administrator (A-100).
Through: AX (A-101).
                     JUNE 30. 1978.

            BACKGROUND

  This  memorandum  sets  forth  in
detail this Office's  views  concerning
the proper interpretation of the regis-
trant reporting requirements  imposed
by Section 6Cax2) of the Federal In-
secticide. Fungicide, and Rodsnticide
Act. as amended (FIFRA). It responds
to your May 10  directive that such a
discussion  be  prepared.   Since we
merely state here what  we believe the
statute  requires, publication of  this
memorandum  would  not  by   itself
Impose any new  or  additional require-
ments, but would constitute  a state-
ment of the Agency's position with re-
spect to the matter.

             QUESTION

  What  information must a registrant
submit to EPA in order to comply with
the  requirement of' F1FRA  Section
S(aX2)?

              ANSWER

  In  our  opinion,  FIFRA  Section
5(a)(2> imposes the following require-
ment:
  A registrant must submit an item of
information to EPA if:
  (I) The registrant possesses  the in-
tormiUion and it pertains  to a pesti-
:ide for which that registrant holds a
registration under FIFRA; and
  (2) The  Information. If true, would
be  relevant to an Agency decision re-
garding  the  risks and benefits of the
pesticide. I.e., an Agency decision re-
garding  the registrability of the pesti-
cide or regarding the proper terms and
conditions of the registration  of the
pesticide.
  (b) Notwithstanding (a) above. Infor-
mation need not be  submitted to the
Agency  to the extent that it consists
solely of opinion(s) or  conclusion(s)
expressed by persons other than any
person:
  (1) who  was  employed or retained
(directly or  indirectly) by the  regis-
trant to express an opinion or conclu-
sion which relates in any way to the
pesticide's  properties, effects, risks or
benefits: or
  (2) from  whom  the registrant re-
quested  the opinion(s) or conclusion(s)
in question: or
  (3) who by virtue of his  knowledge.
skill, experience, training or education
would be permitted  to testify  to the
oplnlon(s) or conclusion(s) under Rule
702 of the  Federal Rules  of Evidence.'
  (c)  Notwithstanding  (a) and  (b)
above, information need not be  sub-
mitted to the Agency if  it has previ-
ously been submitted to the Agency in
writing  or if it has been  accurately
tabulated or summarized  in a previous
written submission to the Agency.

             DISCUSSION

I. THE STRDCnjRE OF FIFTtA  ANT) THE ROLE
          OF SECTION 6(a)(2)

  The Federal Insecticide,  Fungicide,
and Rodenticide Act. as amended in
1972  by the  Federal Environmental
Pesticide Control Act (hereafter re-
ferred to as "FIFRA"), completely re-
structured  the Federal pesticide regu-
latory scheme and redefined its thrust.
FIFRA was changed  "from a labeling
law  into a comprehensive  regulatory
statute  that  will  henceforth  more
carefully control the manufacture, dis-
tribution, and  use  of pesticides."8 As
the  House Committee on Agriculture
summarized in its Committee Report:

  The Committee found the greatest  need
for  revision  of existing laws to be in the
areas  of strengthening  regulatory  controls
on the uses and users of pesticides, speeding
up procedures  for barring pesticides found
to be undesirable: streamlining procedures
for making valuable new control measures.
procedures, and materials broadly available;
strengthening  enforcement  procedures to
protect against misuse of these biologically
  •Rule 702 provides: If scientific, technical.
or other specialized knowledge will assist
the trier of fact to ur.der.uar.d the evidence
or to determine  a fact  in issue, a  witness
qualified as  an expert by  knowledge. skill.
experience, training, or education, may tes-
tify thereto in the form of  on opinion or
otherwise.
  'House  Committee on  Agriculture.  H.
Rrpt.  No. 9:-Sll. 92d  ConE..  1st  sess. 4
(1971) (hereafter "House Report").
 effective materials: and creating an adminis-
 trative and Iccnl framework under which
 continued   research   can  produce  more
 knowledge about better ways to  use existing
 pesticides as well as developing alternative
 materials and methods of pest control.'
  It Is clear 'that  Congress' primary
 purpose in enacting the 1972 amend-
 ments was to insure that pesticicdc use
 would be subject to a thorough envi-
 ronmental and  human  health  hazard
 review.4 .
  Under FIFRA, with certain  excep-
 tions no pesticide may be distributed,
 sold or otherwise placed in  commerce
 unless it  has been  registered. FIFRA
 section 3(a).  $ 12(a)(l)(A).  Extensive
 Information on the risks and benefits
 of using the pesticide must be submit-
 ted to the Administrator before it can
 be  registered.  FIFRA section 3(c). A
 pesticide  Is eligible  for  registration
 only  If the Administrator determines
 that it will perform its intended func-
 tion without "unreasonable adverse ef-
 fects on the environment," particular-
 ly  "when  used in  accordance  with
 widespread and commonly recognized
 practice," and  that it is otherwise ef-
 fective and properly labelled, FIFRA
 section 3(c)(5).
  If it appears to  the  Administrator
 that  a registered pesticide  no  longer
 meets the  registration  requirements,
 he  may Initiate proceedings to either
 cancel the  registration  or change its
 classification if he finds  that the pesti-
 cide  "generally  causes  unreasonable
 adverse effects  on  the  environment."
 FIFRA section  6.
  In each instance where a determina-
 tion is required for registration;  can-
cellation or suspension, the controlling
standard is the same, i.e., whether the
 pesticide causes or  is likely to cause
"unreasonable adverse effects on the
environment." A pesticide which  was
originally registered on the basis that
it would perform its intended function
without unreasonable adverse effects
  'House Report at 4.
  •House Report at 13. 20. and Senate Com-
mittee on Agriculture and I-'orcstry. S. Ri-pt.
No. 92-838.  92d Cone.. 2d sess. 5 (1B72J
(hereafter "Senate Agriculture Report").
                            FEOrRAt REGISTER, VOl. 43, NO. 144—WEDNESDAY, AUGUST 23, 1978

-------
 on the environment might sxibsequent-
 ly be  found to violate that standard If
 the registration was bas»-d on an Incor-
 rect   evaluation  of  the  information
 available at  the  time registration  oc-
 curred or  if new  Information  raised
 questions about  the continued rcgis-
 trability of the pesticide. The need  for
 information  relating to the risks and
 benefits  of  a pesticide after registra-
 tion is. therefore, just as important  for
 effective administration of FIFRA as
 the need for information to  Initially
 register a pesticide.
  Accordingly,  PIFRA  provides  the
 Administrator with a variety  of tools
 to insure that he is kept current on in-
 formation  relating  to the  risks and
 benefits  of  registered pesticides. One
 of  these, is  section  6(a)(2),  which  re-
 quires registrants to submit informa-
 tion after resistration to the Adminis-
 trator.5  Since  approximately   35,000
 pesticide products are currently regis-
 tered  \vith EPA, it Is not difficult to
 understand   why  Congress  imposed
 such a duty to keep the Administrator
 informed   on   registrants.   Section
 6(a)(2) of FTFRA prescribes the regis-
 trant's responsibility as follows:

  Information—If at any time after the reg-
 istration o( a pesticide the registrant has ad-
 ditional factual information  regarding  un-
 reasonable adverse effects  on the environ-
 ment of the pesticide, he shall submit such
 ir.formp.ticn to the Administrator.

  It is an accepted canon  of statutory
 construction to interpret the language
 of a stature in a manner which is con-
 sistent •j.-ith the overall goals of  the
 s:atu;e. The U.S. Court of Appeals  for
 the District of Columbia, in interpret-
 ing a  statute administered by the Fed-
 eral Trade Commission, expressed this
 principle ns  follows:

  In determining the  legislative Intent, our
 duty  is to favor an  interpretation which
 wo'jld  render th3 statutory design effective
 in terms of the policies behind Its enact-
 ment and  to avoid an interpretation which
 would  make such policies more difficult cf
 fulfillment, particularly where • • * that in-
 terpretation is consistent with the plain lan-
 guage  cf  the  statute. See Bird v.  United
 S.'C.Yj. 187 U.S. IIS. 124. 23 S. Ct. 42. 47 U
 Ed. 100 (1902); United States v.  Blasius. 2d
 Cir.. 397 F. 2d 203. 207 n. 9 (1963). cert, dis-
 mis.-ed. 393 U.S. 1008. 89 S..CX 615. 21 L.  Ed.
 2d 557 C9GO). "tl]n the absence of an  un-
 mistakable directive." we cannot "construe
• the Act in a manner which runs counter to
 the broad  goals which Congress intended it
 to effectuate." FTC v. Fred Meyer, Inc.,  390
 U.S. 341. 349. 88 S.  Ct. 904. 908 19 L. Ed 2d
 1222 (1968).  National Petroleum Refiners
Association v. FTC. 482 F. 2d 672, 6B9 (D.C.
Cir. 1973).
  From  the plain language of section
Ctn><2) we  know that the submission
requirement of that section applies to
persons  holding  registrations; that  it
refers to information concerning the
registered pesticides; that if  refers to
"additional" information, i.e., informa-
tion  which  has  not previously  been
submitted to the Agency; and that  it
refers only to information which the
registrant itself  possesses. From there
the Inquiry must focus on the meaning
of the terms "regarding unreasonable
adverse  effects  on the  environment"
and "factual information."

  II. WHAT IS "INFORMATION REGARDING
 UNREASONABLE ADVERSE EFFECTS ON THE
            ENVIRONMENT"?

  Some  registrants have argued for a
restrictive  interpretation  of  the  sec-
tion 6(a)(2> disclosure requirement by
advancing the notion that the section
leaves to the  registrant the determina-
tion whether an item  of  Information
shows that the  pesticide  causes "un-
reasonable  adverse effects on  the envi-
ronment." However, this position over-
looks  not only the plain language of
section 6(a)(2> and its legislative histo-
ry hut also the  role of section 6(a)(2)
in the FIFRA statutory scheme.
  The  language of  §6. See also FIFRA sec-
tion 20. which authorizes the Administrator
to conduct research to  carry out the pur-
poses of the Act and to  undertake monitor-
ing.
  •The legislative history Is clear on this
point. According to the Senate Committee
on Commerce. "Paragraph (2) of subsection
(a) requires a registrant to furnish-lnforma-
tion  to the Administrator regarding unrea-
sonable adverse  effects on the environment
after his  pesticide is registered. While this
provision  allots the  registrant to  judge
whether  the information pertains to any
unreasonable adverse effect, he will be sub-
ject to the penalties of section 14 should he
possess such information and not. make it
available  to the Administrator. Senate Com-
mittee on Commerce, S.  Rept. No. 92-970.
92d  Cong.. 2d  sess. 37  (1972) (hereafter
"Senate  Commerce Report")." A  proposal
by the National  Agricultural Chemicals As-
sociation  (NACA), which would  have re-
quired the registrant to submit "factual In-
formation indicating  that the registered
pesticide  ft« substantial adverse  environ-
mental  or health effects." was adopted in
one of  the early House  Committee prints
but was later dropped in  favor of the pres-
ent "regarding"  language. Committee Print
No. 2, H.R. 4152 (June 22. 1971 (emphasis
added). Had Congress  adopted the  NACA
proposal,  the restrictive  Interpretation of
section 6(a)(2) advanced by some registrants
would be more worthy of consideration.
effects arc unreasonably adverse to be
made by the Administrator, not by the
Individual  registrant.  Tho term  "un-
reasonable adverse effects on the envi-
ronment"  is  defined  in  §2(bb)  of
FIFRA  as "any  unreasonable  risk to
man or the environment, taking Into
account the economic, social, and envi-
ronmental costs  and  benefits  of  the
use of any pesticide." In other words,-
it calls  for the Administrator  to bal-
ance the benefits of use of a pesticide
against  the risks of its  use.1 Plainly
there  is no finite scale for measuring
where the balance should be struck. In
interpreting  the   Administrator's  au-
thority  to conduct  a risk-benefit as-
sessment under FIFRA, the U.S. Court
of  Appeals for the District of Colum-
bia has  emphasized repeatedly  that
" 'FIFRA.  confers broad discretion' on
the Administrator to find facts  and 'to
set policy in the  public interest.' Well-
ford v. Ruckelshaus,  142 U.S. App. D.C.
88.  91. 439 F.2d  598. 601 (1971). See,
also, EOF v.  EPA, • • '  150 U.S. App.
D.C. at 354.  465  F.2d at  534 (1972)."
Environmental Defense Fund [hereaf-
ter "EDF"] v. Environmental  Protec-
tion Agency   thereafter  "EPA"],  510
F.2d 1292. 1297 (D.C. Cir. 1975;  EDF v.
EPA,  543  F.2d  998, 1005 (D.C. Cir.
1976);  and see EDF v.  Ruckelshaus,
439F.  2d  584 (D.C.  Cir.  1971). This
broad  discretion  is  necessary in  part
because there Is  frequently great un-
certainty  concerning  just  what  the
risks and benefits are.••Even more im-
portant, however, is the fact that in
balancing risks and benefits the Ad-
ministrator is  performing a task which
is intrinsically policyir.aking in nature.
In  deciding,  for  example,  whether  a
health ris's should  be borne by one
group  in order for  another group to
enjoy the benefits of a pesticide prod-
uct, the Administrator is  performing a
public, official function  which  no pri-
vate group is qualified to perform.*
  'House Report at 14; and Senate Agricul-
ture Report at 4.
  •The Administrator must often rely on
extrapolations from laboratory data, pnlmal
studies,  and  clinical  studies  in  order to
assess the risks,  and ha must rely on esti-
mates of economic impact in order to assess
the benefits.  The risks  and benefits  (with
their associated uncertainties) must then be
balanced to arrive at a final decision.
  •Various  practical  considerations   also
point out the fallacy of the idea that the in-
dividual registrant Is to make a risk/benefit
balancing decision in order to know.whethcr
an item of Information  the  registrant pos-
sesses must   be  submitted  under section
6CaK2!. For instance. If a registrant were re-
quired to submit Information under section
6(a)(2) only it he had first concluded  that
the Information showed that his  pesticide
caused unreasonable adverse effects on the
environment, he would In effect be conced-
ing that the pesticide should be cancelled.
and there would be no need for further ad-
versary proceedings of the type contemplat-
ed by section C(bMd). CK'arly the statute iJ
not intended to function in this manner.
                              FEDERAl REGISTER, VOU 43, NO.  144— WEDNESDAY, AUGUST 23, 1978

-------
                                                     NOTICES
                                                                     37613
  Moreover,  pesticide regulatory deci-
sions Involve much more than whether
or not a pesticide should be registered
at all: the Administrator is required to
make a number of decisions about  the
terms and conditions of registration
which  are   not  expressly  stated  In
terms of "unreasonable adverse effects
on the environment." Among these are
decisions concerning the pesticide's la-
beling and packaging.10 and decisions
concerning whether additional restric-
tions beyond labeling should be  Im-
posed."  Decisions concerning these
and  other terms of registration must
be made when the Administrator reg-
isters a  pesticide product in the first
instance. However, the Administrator
has the option of changing some or all
of these terms or conditions after reg-
istration, as remedies short of outright
cancellation.  In situations  where  he
determines that without such changes.
the  pesticide would generally cause
unreasonable adverse effects."
 • It  Is in this context that the regis-
trant must decide " whether to submit
the  information.  If  the information
would be relevant  to an Agency deci-
sion on the continued registrabllity of
the pesticide or  to the  proper terms
and conditions of the pesticide's regis-
tration, and the other requirements of
section  6(a)(2) are  satisfied, the regis-
trant is required by section 6(a)(2) to
submit   the   information    to    the
Agency." Naturally the registrant is
under a duty to make such decisions
about the relevance of the information
in an objective manner  and to be  in-
formed concerning the kinds of infor-
mation  upon which the Agency mar
wish to rely in making regulatory deci-
sions.
  A broad  range of Information nor- .
mally would be relevant to the Admin-
istrator's decisions concerning the  re-
gistrability of a pesticide product,  -in-
cluding the  terms and  conditions of
registration.  As discussed  above,  the
basic  test   of  rcgistrability   under
FIFRA  is whether the pesticide causes
"unreasonable adverse effects on the
environment"—in other words, wheth-
er use  of the  pesticide poses  risks
which are greater than  its benefits.
Accordingly,   any  information   on
either risks or benefits relevant either
to the terms and  conditions of regis-
tration or to  the question whether the
  "See. e.g., FIFRA sections 2(q). 3Cc)(5)(B).
and 25(c)(3).
  "S*e FIVRA sections 3(d) and 4.
  "Sec. e.g.. FIFRA sections 3(J) and 6(d).
  °S«?e footnote 6. supra.
  "This docs not require a registrant to an-
ticipate future advances In scientific knowl-
edge, however. The relevance  of Informa-
tion  Is to be assessed by  contemporary
standards. Nonetheless, an advance in scien-
tific knowk-dxe may require the submission
under section 6d)(S) of older  information
which was not previously relevant. For ex-
ample, see hypothetical number 5, infra.
 pesticide should be registered at all Is
 information  "regarding  unresonable
 adverse effects" which  must be sub-
 mitted If  the other requirements  of
 section 6(a)(2) are satisfied.

  III. WHAT IS "FACTUAL INFORMATION"?

  This term Is not defined In the Act,
 and Its meaning must therefore be de-
 rived from ordinary  usage in light  of
 the broad  goals  which Congress in-
 tended to effectuate by passage of the
 1972 amendments.
  Unfortunately, the legislative histo-
 ry  does not contribute  much to the
 analysis.  An  early  version  of  what
 eventually became section 6(a)(2) re-
 quired the registrant to submit "any
 information."" Thereafter,  the Na-
 tional Agricultural Chemicals Associ-
 ation sponsored an amendment chang-
 ing the wording to  "factual Informa-
 tion." " This change was eventually
 adopted by the House without  expla-
 nation," and the entire section under-
 went  further revision In other respects
 before enactment. Thus, there  is no
 recorded  legislative  history  that ex-
 plains what Congress intended by the
 term "factual Information."
  The legislative history also does not
 Indicate whether  these changes were
 made  in conjunction with changes  in
 the  companion provisions  governing
 the preregistration disclosure require-
 ments imposed on the registration ap-
 plicant. Although  the terms "informa-
 tion"   and  "scientific  information"
 appear elsewhere  in the Act. there is
 no  indication  that Congress attached
 any particular significance to the word
 "factual"   in  section C
-------
J I U >.'t

vide an  appropriate  basis for rcKtila-
lory decision by the Agency.
  This approach requires the  submis-
sion of information  which EPA  m.iy
ultimately determine  to  be  insuffi-
cient, when considered in liRht of all
other information bearing on risks and
benefits, to warrant regulatory action.
In this connection, it has been argued
that the  registrant should be  permit-
ted to delay  submission until it has
verified the accuracy or reliability of
the  information.  That argument Ig-
nores a fundamental aspect of  the reg-
ulatory scheme: the assessment of the
accuracy  or reliability  of information
as a basis for regulatory action is to be
made by  the Administrator,  not the
registrant.                           .
  Moreover,  In providing procedure?"
for the suspension and  cancellation of
pesticide registrations. Congress recog-
nized that protection of the health of
the   public   and  the environment
cannot wait  until  evidence of unrea-
sonable adverse effects becomes  con-
clusive  or universally   accepted.  By
granting  the  Administrator authority
to suspend pesticide registrants to pre-
vent an "imminent hazard". Congress
clearly anticipated that the Adminis-
trator would  have  tc  act  swiftly
(either before a hearirc °r after an ex-
pedited hearing)  upon new informa-
tion,  even before  the  '.".formation
could be definitively evaluated.  The
Act defines an imminent hazard  as a
situation  that  "would be likely to
result  in  unreasonable  adverse  ef-
fects". FIFRA secUons 2(1) and  6(c),
and the courts have  repeatedly recog-
nized that "the function of the sus-
pension decision is to make a  prelimi-
nary assessment of evidence, and prob-
abilities,  not an ultimate resolution of
difficult Issuer". EOF v. EPA, 510 P. 2d
at 1298. quoting EOF v. EPA. 465 F. 2d
523. 537 (D.C.  Cir.  1972).
  Congress imposed on  registrants the
responsibility  to submit to the  Admin-
istrator information  he may  need to
prevent  imminent hazards. The Act
would be subverted if registants were
permitted  to  '.vithhold  information
merely because, they doubted its valid-
ity, or because the  information  had
not yet been verified to their own sat-
isfaction,  or because the information
was contained in a "preliminary", "in-
terim" or  "partial" report.
  The same principles apply to deter-
minations  the  Administrator  must
make regarding cancellation. The Act
does not permit the  Administrator to
wait until conclusive  proof on  adverse
effects has been  developed.   Rather,
cancellation proceedings (cr hearings
to determine whether a  pesticide regis-.
tration   should    be   cancelled   or
changed)  must be  initiated "CUf it ap-
pears to the Administrator that a pes-
ticide generally causes unreasonable
adverse effects on the  environment,"
               NOTICES

 FTFRA,   section   6(b).   (Emphasis
 added).11 Evrn after the conclusion of
 the  cancellation prorpcdinss.  the Ad-
 ministrator may act  on evidence that
 is disputed. EOF  v.  EPA, 489  F.  2d
 1247, 1252 (D.C. Cir. 1073). The Act's
 adversary hearing provisions recognize
 that the accuracy or validity of infor-
 mation submitted  will frequently  be
 subject to  vigorous dispute by the reg-
 istrant. The purpose of the adversary
 hearings  is  to ventilate  and resolve
 such disputes.  But  the hearing process
 would  be  undermined  if  registrants
 could unilaterally  withhold from the
 Administrator   information  that  he
 could properly consider at a  hearing,
 merely  because the Information could
 be subject  to legitimate dispute."

 IV.  EXAMPLES OF INFORMATION WHICH
  MUST  BE, AND INFORMATION  WHICH
  NEED NOT BE,  REPORTED UNDER SECTION
  S(a)(2)

  The  following  examples illustrate
 the  foregoing  discussion  (these are
 only examples, and by no means con-
 stitute  a complete  listing of the kinds
 of information which must be report-
 ed):
  1.  The  registrant receives  a report
 that a degradation product of his reg-
 istered  pesticide  causes  an  adverse
 health  effect.  This information  must
 be reported, since it clearly pertains to
 the effects of the registered pesticide.
 Similar  information  concerning any
 impurity or metabolite of the pesticide
 would also have to be reported.
  2.  The registrant receives  a report
 that an aerial applicator, contrary to
 label directions, applied  registrant's
 contact herbicide in a manner that  al-
 lowed the  pesticide to drift onto adja-
 cent fields, causing harm to  the non-
 target  vegetation.  This   information
 must be reported.
  3.  The  registrant  learns  that   a
 person  intentionally drank a pesticide
 in a suicide  attempt,  and  suffered
  "One of the most fundamental and well
settled concepts  in the FIFRA regulatory
scheme is that the burden of proof of rcgis-
trability always  rests  with the registrant,
and not with the Agency. See. e.g.. EOF v.
EPA. 510 P. 2dat 1297.
  "One reason some registrants may be  re-
luctant to submit information under section
6
-------
                                                                               37615
           V. INFORMATION THE AGENCY DETERMINES
               REGISTRANTS NEED NOT SUBMIT

            The agency might conclude that al-
           though Information of a certain kind
           Is subject to the section 6(aH2) report*
           Ing  requirement  (as  Interpreted  by
           this memorandum), registrant report-
           Ing of that kind of Information Is not
           essential  to the  Aeency's  functions.
           (The Agency might, for  instance, con-
           clude  that information of a  certain
           kind available from sources other than
           registrants is sufficient for Agency de-
           cision-making, and thus  that informa-
           tion of  that  kind which registrants
           may also possess is not needed by the
           Agency.) In such a case, it would be
           appropriate  for  the  Agency  to an-
           nounce publicly (by FEDERAL REGISTER
           notice or  otherwise) that it will not
           consider   a  registrant's  failure  to
           submit that kind of information to be
           an actionable  violation  of   section
           6(a)(2).
            Of course. It Is for the Agency, not
           the registrant, to  decide that  alterna-
           tive information sources are adequate
           for  the Agency's needs. Until  the
           Agency announces that it will not seek
           to enforce Its section  6(a)(2) right to
           obtain a particular kind of Informa-
           tion, that information must be report-
           ed by registrants.
            CFR Doc.,78-23553 Filed 8-22-78; 8:45 am]
FEDERAL REGISTER, VOL. 43, NO. 164—WEDNESDAY, AUGUST 23, 1978

-------
/
United States         Office of
Environmental Protection   Public Awareness (A-107)
Agency             Washington DC 20460

Second Revision October 1979 QPA 159/9	


Suspended

and Cancelled


Pesticides

-------
Suspension
and
Cancellation
List
Prepared by
Pesticides and
Toxic Substances
Enforcement
Division
This booklet has been compiled for the purpose of summarizing and
clarifying Agency actions on those pesticides which have been
suspended, cancelled, or otherwise restricted. It excludes cano
tions on those use patterns that were cancelled by Pesticide Rtlfev-
tion Notices based on "residues," "no residues," and  zero
tolerances," as well as notices of cancellations to single registrants.
Pesticides which have been voluntarily cancelled by some but not all
registrants, and have not met or- exceeded "risk criteria" established
by the Special Pesticide Review Division are also excluded.

This list is not a statement of Agency policy, but is primarily de-
signed as a quick reference guide to be used by Regional EPA in-
spectors. However, the list can also serve as a general reference  for
anyone involved or interested in pesticide regulatory work.

Material for this edition of the booklet was compiled as of October
1979. This is the third edition of this publication. Future Agency  ac-
tions will necessitate updating and republishing this booklet, and
this will continue to be done periodically.

Comments on the accuracy and completeness of this list should be
sent to:
Pesticides and Toxic Substances
Enforcement Division IEN-342)
Environmental Protection Agency
Washington,  D.C. 20460

-------
Peslicide/Use Affected    Action
                                                                         Reference
 Atdrin
 Arsenic
 Trioxide
 Basic
 Copper
 Arsenate
BHC
Bithionol
Chloranil


Chlordane
 Cancelled, all uses except  those in the following
 list:
 1.  subsurface ground insertion for termite control.
 2.  dipping of non-food roots and tops.
 3.  moth-proofing by manufacturing processes in a
 closed system.
In excess of 1.5%, labeling which bears directions
for home use is unacceptable, and a warning
against home use is required. The following
statements must appear in a prominent position:
"Do not use or store in or around the home" and
"Do not allow domestic animals to graze treated
area."

Voluntary cancellation, all products. The sale,
distribution and use of existing stocks is permited.
All registered products have been eliminated. In
some instances these products were voluntarily
cancelled, in others lindane was substituted for
BHC non-gamma isomers. These non-gamma
isomers may be sold, manufactured or distributed
for use in the United States.


Cancelled, products intended for:
1. direct contact with the skin or can be exp"!3d
to be in direct  or continuous contact with the skin.
2. use in textiles or other materials likely to come
in contact with the skin.
3. household use.

Voluntary cancellation, all products.
Under the provisions of the Administrator's accep-
tance of the settlement plan to phase out certain
uses of the pestcides chlordane and heptachlor.
most  registered products containing chlordane will
be effectively cancelled or their applications for
registration denied by December 31,  1980. A sum-
mary  of those uses not affected by this settlement,
or a previous suspension, as well as a summary
of those uses affected (Phase Out Uses) by this
settlement, including the pest to the controlled.
PR Notice 71-4
March 18. 1971:
Accelerated Decision
of the Chief
Administrative Law
Judge
May 27. 1975 and
trie order Declining
Review of the Ac-
celerated Decision of
the Administrative Lav
Judge issued by ihe
Chief Judicial Officer
June 30.  1975;
39 FR 37246
October 18.  1974.

PR Notice 67-2
August I. 1967:
Interpretation No. 25
August 1968
42 FR 18422
April 7. 1977
                                                                         43 PR 31432
                                                                         July 21. 1978
 PR Notice 68-13
 August It. 1963
42 FR 3702
January 19. 1977


PR Notice 74-11
Decemoer 2, 1974
41 FR 7552
FeOruarf  19. 1976
FIFRA Docket No. 336,
et. al.
March 6.  1978
PR Notice 78-2
March 23. 1978

-------
Pesticide/Use Alfecied    Action
                                                                      Reference
Chlofdane
tcontinufdl
the site of application, the end-use dates and
use restrictions, follows:
1. Uses not affected:
   a.  subsurface ground insertion for termite con-
   trol (clarified by 40 FR 30522. July 21. 1975, to
   apply to the use of emulsifiable or oil concen-
   trate formulations for controlling, subterranean
   termites on structural sites such as buildings.
   houses, barns, and sheds, using  current control
   practices).

   b.  dipping of roots or tops of nonfood plants.
2. Uses affected  (Phase Out Uses):
   a.  Registrations for control of ants on citrus in
   the States of California  and Texas will be effec-
   tively cancelled or denied by December 31,
   1979. Restricted to use on acreage under an In-
   tegrated Pest Management program involving
   the release of beneficial insects (parasites and
   predators) to maintain populations of harmful
   insects (scales, mites, mealybugs) at an accep-
   table level. In California,  this use  is permitted
   only pursuant  to the provisions of the ap-
   propriate State of California permit and prescrip-
   tion use programs.
   b.  Registrations for control of imported fire ants
   on lands not presently used or to be used for
   food or feed production or grazing for a period
   of two  years following treatment  are effectively
   cancelled or  denied by December 31.  1980.
   Distribution and use is restricted to nine states
   IAL. AR, FL, GA.  LA, MS. NC, SC and TX).
   Use shall be restricted to mound treatment;
   broadcast or aerial application is prohibited.
   c.  Registrations for control of cutworms on
   grapes  in the State of California will be effec-
   tively cancelled or denied by July 1, 1980. This
   use shall be restricted to application by ground
   equipment only. Use shall be permitted only
   pursuant to the provisions of the  appropriate
   State of California permit and prescription use  j
   programs.                                    I
   d.  Registrations for control of grasshoppers on |
   flax were effectively cancelled or  denied  by
   October 1, 1978.
   e. Registrations for control of white grubs,
   strawberry rootworm, strawberry root weevil or
   crown girdler, strawberry crown borer and black
   vine weevil on strawberries were  effectively
   cancelled or denied by August 1,  1979. This use
   was permitted in California only pursuant to
   the provisions of the appropriate State of
   California permit and prescription  use  programs.

-------
Chlordane
Iconttnuedl
Chlorobenzilate
     f. Registrations for control of imported fire ants
     and Japanese beetle larvae on nursery stock,
     for compliance with Federal or State Quaran-
     tines, and for control of the black vine weevil
     on nursery stock for  compliance with State
     Nursery Certification Regulations will be effec-
     tively cancelled or denied by December 31,
     1979. Restricted to use on land with nursery
     stock grown for balled and burlap'pe'd,  bare root
     or container stock. Use on turf is prohibited.
  D  Note: Phase Out Uses listed above may be ap-
  plied by certified applicators only. The end-use
  dates for Phase Out Uses should be those dates
  listed above, unless the production  limitations im-
  posed by F/FRA Docket No. 326 et. a/, is exceeded
  earlier.  Pesticide products in existence 90 days
j  before the effective date of cancellation or denial
I  of a Phase  Out Use may: 11.1 be distributed, sold
i  or otherwise moved in commerce, and used: pro-
  yided that the pesticide  shall not be used inconsis-
  tent with its labeling, and 12.1 may be relabeled by
  or under the authority of a registrant for another
  Phase Out Use not a/ready cancelled or denied.
  and any pesticide product so produced shall not
  count against the production limitation for the
  other Phase Out Use.
 Cancellation and denial of registrations of Chloro-
 benzilate products for uses other than citrus uses
 in Florida, Texas, California,  and Arizona. Not-
 withstanding the above, registration of Chloroben-
 zilate products for citrus use in these four states
 will also be cancelled or denied unless registrants
 or applicants for new registrations modify the
 terms or conditions of registration as follows:

 1. Classification of Chlorobenzilate products for
j these citrus uses for restricted use, for use  only by
! or under the supervision of certified applicators.

! 2. Modification of the labeling of Chlorobenzilate
j products for these citrus uses to include the fol-
| lowing:

    a.  Restricted Use Pesticide - For retail sale  to
    and use only by certified applicators or persons
    under their direct supervision and only for those
    uses covered by the certified applicator's cer-
    tification.

    b.  Genera/ Precautions —
       1.) Take special care to avoid getting
       Chlorobenzilate in eyes, on skin, or on
       clothing.
       2.) Avoid breathing vapors or spray mist.
|  44 FR 95*8
I  February 13. 1979

-------
 PesliciOeiOse AiiecieO   ucuun
 Chlorobenzilate
 (continued!
DBCP
DOD (TDE)

4
       3.)  In case of contact with skin, wash as
       soon as possible with soap and plenty of
       water.
       4.)  If  Chlorobenzilate gets on clothing,
       remove contaminated clothing and wash af-
       fected parts of body with soap and water. If
       the extent of contamination is unknown,
       bathe entire body thoroughly.  Change to
       clean  clothing.
       5.)  Wash hands with soap and water each
       time before eating, drinking, or smoking.
       6.)  At the end of the work day, bathe entire
       body with soap and plenty of water.
       7.)  Wear clean clothes each day and launder
       before reusing.

    C.  Required Clothing and equipment for Ap-
       plication  —
       1.) One-piece overalls which have long
       sleeves and long pants constructed of finely-
       woven fabric as specified in the USDA/EPA
       Guide for Commercial Applicators.
       2.) Wide-brimmed hat.
       3.) Heavy-duty fabric work gloves.
       4.) Any article which has been worn while
       applying Chlorobenzilate must be cleaned
       before reusing. Clothing which has been
       drenched or  has otherwise absorbed concen-
       trated  pesticide must be buried or burned.
       5.) Facepiece respirator of the  type approved
       for pesticide spray applications by the Na-
       tional Institute for Occupational Safety and
       Health.
       6.) Instead of the clothing  and equipment
       specified above, the applicator  can use an
       enclosed tractor cab which provides a filtered
       air supply. Aerial application may be con-
       ducted without the specified clothing and
       equipment.

|    d.  Handling Precautions —  Heavy duty rubber
j       or neoprene gloves and apron must be worn
|       during loading, unloading,  and  equipment
I       clean-up.

  Suspended, all registrations of end use products,
  except for the use on pineapples in Hawaii. The
  sale,  distribution or movement in commerce  for all
  suspended uses is prohibited.
 Cancelled, all products containing 000, a
 metabolite of DOT.
FIFRA Docket No:
338. 399 and 400.
October 27. 1977;
42 FR 57543,
November 3. 1977
FIFRA Docket No.
October 29. 1979.

PR Notice 71-5
March 13, 197>

-------
DDT
2,4-0
Dieldrin
Disinfectants
Endrin
  Cancelled, all products, except the following list of
  uses:
  1.  the U.S.  Public Health Service and other Health
  Service Officials for control of vector diseases.
  2.  the USOA or military for health quarantine.
  3.  in drugs,  for controlling body lice. (To be
  dispensed only by a physician.)
  4.  in the  formulation  for prescription drugs for
  controlling body lice.


  Products  bearing directions for use on small grains
  (barley, oats, rye, or wheat) must bear the follow-
  ing label precaution:
  Do not forage or graze treated grain fields within 2
  weeks after  treatment with 2.4-D.

  Most uses cancelled.  See Aldrin  for uses allowed.
j Cancelled, products bearing labeling claims involv-
1 ing the terms "germ proofing," "germ proofs,"
 and "germ proof."
 1.  Cancellation of uses on:
    a.  Tobacco.
    b.  Cotton in all areas east of Interstate Highway
    #35 (includes all states east of  the Mississippi
    River, Arkansas, Louisiana, Missouri, and por-
    tions of Texas and Oklahoma).
    c.  Small grains to control all pests other than
    the army cutworm, the pale western cutworm,
    and grasshoppers.
    d.  Apple orchards in Eastern States to control
    meadow voles.
    e.  Sugarcane to control the sugarcane borer.
    f.  Ornamentals.

 2. Denial of application for new registrations for
 the above uses (I. b.-e.l, as well  as for the use of
 endrin in unenclosed  bird perch treatment.
                                                                          PR Notice 71-t
                                                                          January IS. 1971
                                                                          and 37 FR 13369
                                                                          July 7. 1972
PR Notice 67-7
October 12.  1367
Reregistration Guid-
ance package 23-4
PR Notice 71-4
March 18. t971;
Accelerated Decision
of the Chief Adminis-
trative Law Judge
May 27. 1975 and
the order Declining
Review of the Ac-
celerated Decision of
the Administrative Law
Judge issued by the
Chief Judicial Officer
June 30.  IS7S
37 FR 37246
October 13.  1974.

PR Notice 69-13
August 3. 1969
                                                                         Unnumoered PR Notice
                                                                         May 20. 1964

                                                                         44 FR 43632
                                                                         July 25. 1979

-------
Endrin
/continued!
  3. Cancellation of the following registrations of en-
  drin products unless registrants modify the terms
  and conditions of registration as specified below:

    a. Use on cotton west of Interstate Highway
    #35 (must modify label to add statements 5. a.,
    b.. c., d., e., f., and g.).
    b. Use on small grains to control army cut-
    worms and pale western cutworms (must
    modify label to add statements 5. b., c.,  d., e..
    f., and h.).
    c. Use on apple orchards in Eastern States to
    control the pine vole and in  Western States to
    control meadow voles (must modify label to add
    statements 5. q., c., i., r., j., k., and I.).
    d. Use on sugarcane to control the sugarcane
    beetle (must modify label to add statements 5.
    q., c., m., and n.).
    e. Use for conifer seed treatment (must modify
    label to add statement 5. o.).
    f. Use in enclosed bird perch treatments  (must
    modify label to add statements 5. t.,  c., and p.).

  4. Denial of applications for new registrations  for
  any  of the above endrin uses (3. a.-f.l, as well as
  for the following endrin uses unless the applica-
  tions are modified to meet the terms and condi-
  tions specified herein.
    a. As a tree painting (in Texas) — must modify
    label to add statements 5. s. and c.
    b. On alfalfa and clover seed crops (in  Col-
    orado) —  must modify label  to add statements
    5. b., c., d., e., and f.
    c. On  small grains to control grasshopper (in
    Montana) — must modify label to add
    statements 5. b., c.. d., e.. f., and h.

i 5.  Label Statements:

    a. For  use  in areas west of Interstate Highway
    lf3S only.

    b. Required Clothing for Female Workers —
    Female ground applicators, mixers and loaders
    and flagpersons must wear long-sleeved shirts
    and long pants made of a closely woven fabric,
    and wide-brimmed  hats.  Mixers and loaders
    must also wear  rubber or synthetic rubber boots
    and aprons.

    c.  Warning to Female Workers — The United
    States  Environmental Protection Agency has
    determined that endrin causes birth defects in
    laboratory animals. Exposure  to endrin during
    pregnancy should be avoided. Female workers

-------
esnode/Uie Allected   Action
                                                                      Reference
ndrin
:ontinued>
 must be sure to wear all protective clothing and
 use all protective equipment specified on this
 label. In case of accidental spills or other
 unusual exposure, cease work immediately and
 follow directions for contact with endrin.

 d.  Equipment —
    1.)  Ground Application  — For use with
    boom-nozzle ground equipment. Apply at
    not less than 5 gallons total mixture, water
    and chemical, per acre. Do not use nozzle li-
    quid pressure at greater than 40 psi (pounds
    per square inch). Do not use cone nozzle
    size smaller than 0.16 gallons per minute
    (gpm), at 40 psi such as  type 02-25 or
    TX-10, or any other atomizer or nozzle giving
    smaller drop size.
   2.) Aerial Application —  Do not apply at less
   than 2 gallons total mixture of water and
    chemical per  acre. Do not operate nozzle li-
   quid pressure over 40 psi or with any fan
    nozzle smaller than 0.4 gpm or fan angle
   greater than 65 degrees such as type 6504.
    Do not use any cone type nozzles smaller
   than 0.4 gpm nor whirl plate smaller  than #46
   such as type  04-46 or any other atomizer or
   nozzle giving  smaller drop size. Oo not
   release this material at greater than 10 feet
   height above  the crop.

e. Application Restrictions — Do  not apply this
   product within 1/8 mile of human habitation.
     Do not apply this product by air within 1/4
   mile or by ground within  1/8 mile of  lakes,
   ponds, or streams. Application may be made
   at distances closer to ponds owned by the
   user but such application may result in ex-
   cessive contamination and fish kills.
     Do  not apply when rainfall is imminent.
     Apply only  when wind  velocity is between
   2 and 10 mph.

f.  Procedures To Be Followed if Fish Kills Oc-
cur or if Ponds are Contaminated — In case of
fish kills, fish must be collected and disposed of
by burial. Ponds in which fish kills have occur-
red, and user-owned ponds exposed to endrin
by application at distances closer than otherwise
prohibited, must be posted with signs stating:
"Contaminated: No Fishing." Signs must re-
main for one year after a fish kill has occurred
or for six months after lesser contamination
unless laboratory analysis shows endrin residues
in the edible portion of fish to be less than 0.3
parts per million  (ppm).

-------
Pesticide/ Use Allected   Action
Endrin
Icontinuedl
 g.  Prophylactic Use — Unnecessary use of this
 product can lead to resistance in pest popula-
 tions and subsequent lack of efficacy.

 h.  Pests for Which This Product May be Ap-
 plied — This product may be  applied to control
 the following pests only: army cutworm; pale
 western cutworm; grasshoppers. .(Currently
 grasshoppers may only be included on endrin
 products for use in Montana.)

 i.  Application  Restrictions —  Do not apply this
 product within 50 feet of lakes, ponds or
 streams.
      Do not apply this product within 50 feet of
 areas occupied by unprotected humans.
      Do not apply when rainfall is imminent.

 j.  Equipment — Apply by ground equipment
 only.
      Use a very coarse spray with minimum
 pressure necessary to penetrate ground cover.
 Do not apply as fine spray. Power air blast
 equipment'must be modified to meet the above
 application restriction. Consult the State recom-
 mendations for acceptable methods of adapting
 equipment.

 k. Prophylactic Use — Uft.iiicc":9ary  use of this
 product can lead to resistance in the vole
 population and subsequent Is.X of efficacy.

 I.  Pests for Which This Product May be Ap-
plied — This product may be applied to control
 the following pests only:
   Eastern United States — Pine Vole (Microtus
     pinetorum)                               \
   Western United States — Meadow Voles     I
     (Microtus  species)
             *
m. Application Restrictions —  Apply  only with
low-pressure ground equipment. Cover furrows
with soil promptly after application.

n. Pests for Which  This Product May Be Ap-
plied  — This product may be applied only to
control  the sugarcane beetle.

o. Application Restrictions —  Do not sow
treated  seed when large numbers of migratory
birds are expected.

p. Special Warning —  Do not  use within one
mile of  roosting sites or within two miles of
nesting sites of peregrine falcons, as  identified
by the United States Fish and Wildlife Service.

-------
Endrin
/continued!
 Fluoroacetamide
Heptachlor
    q.  Required Clothing for Female Workers —
    Female applicators, mixers and loaders must
    wear long-sleeved shirts and long pants made of
    a closely woven fabric, and wide-brimmed hats.
    Mixers and loaders must also wear rubber or
    synthetic rubber boots and aprons.

    r. Procedures  To Be Followed if Fish Kills Occur
    —  In case of fish kills, fish must be collected
    promptly and disposed of by burial. Ponds in
    which fish kills have occurred must  be posted
    "Contaminated: No Fishing." Signs must re-
    main for one year after a fish kill has occurred
    unless laboratory analysis shows endrin residues
    in the edible portion of fish to  be less than 0.3
    ppm.

    s.  Required Clothing for Female Workers —
    Female workers handling or applying this pro-
    duct must wear long-sleeved shirts and long
    pants made of a closely  woven fabric, wide-
    brimmed hat, and rubber or synthetic rubber
    boots and  aprons.

    t. Required Clothing for Female  Workers —
    Female workers handling this product must
    wear long-sleeved shirts  and long pants made of
    a closely woven fabric, wide-brimmed hats, and
    rubber or synthetic rubber aprons.
I Labeling amended to allow use only inside of
I sewers against the Norway and roof rat.  This use
j is restricted and may be applied only by a certified
 applicator or a competent person acting under the
! instructions and control of a certified applicator.
  Under the provisions of the Administrator's accep-
  tance of the settlement plan to phase out certain
  uses of the  pesticides heptachlor and chlordane,
j  most registered products containing heptachlor
j  will be effectively cancelled, or their ap-
i  plication for registration denied by July 1, 1983. A
I  summary of those uses not affected by this settle-
;  ment or a previous suspension, as well  as a
  summary of those uses affected (Phase Out
  Uses) by the settlement,  including the pest to
  be controlled,  the site of application, the use
  restrictions, and end-use dates, follows:
  1. Uses not affected: see chlordane
 2. Uses affected (Phase Out Uses):
    a.  Registrations for control of cutworms on
    field corn will  be effectively cancelled or denied
                                                                        Label amendment ac-
                                                                        cepted by OPP
                                                                        November 2. 1979
PR Notice 74-11
December 2. 1974
41 FR 7562
February  19. 1976
FIFRA Docket No. 336.
et. al.
March 6.  1378
PR Notice 78-2
March 28. 1978

-------
Heptachlor
(continued}
 by August 1, 1980 in States with EPA approved
 restricted-use permit programs and immediately
 in all other States unless and until those States
 obtain and maintain EPA approved restricted
 use permit programs. Use shall be by certified
 applicators only, and shall be applied only by
 soil broadcast or soil incorporation. The follow-
 ing  crops shall not be grown, in a field treated
 with heptachlor in  the year of treatment or the
 following year: legumes (including soybeans,
 alfalfa,  clover, peas,  peanuts and other beans);
 root crops (including potatoes, sugar beets and
 rutabagas); oil crops (including cotton and saf-
 flower); vegetable crops; tobacco or pumpkins.
 Silage shall not be  cut from a field treated with  |
 heptachlor in the year of treatment or the        j
 following year. Corn which has been  treated     I
 with heptachlor  shall not be followed with any   j
 other dairy or meat animal forage crop nor shall  j
 livestock be permitted to have access to treated
 land for a period of two years following treat-
 ment.
 b. Registrations for control of seed corn beetle,  j
 seed corn maggot,  wireworm, false wlreworm,   |
 southern corn rootworm and kafir ant on: (1.)    '
 barley, oats,  wheat, rye and corn will be effec-   !
 lively cancelled or denied by September 1, 1982;
 and  (2.) sorghum will be effectively cancelled or
 denied on July 1, 1983.  May be used  by com-
 mercial  seed  treatment companies only.          j
 c.  Registrations for control of citrus root _weevil  ';
 larvae and Feller's rose beetle larvae on citrus in  '
 the State of Florida will  be effectively cancelled   \
 or denied by  December  31, 1979. Use shall be    ;
 by certified applicators only, and may be applied  :
 by soil incorporation only. •
 d.  Registrations for control of ants on pineap-    ,
 pies in the State of Hawaii will be effectively
 cancelled or denied by December 31,  1982. To    i
be applied by certified applicators only.           :
 e.  Registrations  for control of narcissus bulb fly  j
on narcissus  bulbs will be effectively cancelled    •
or  denied by  December 31, 1980. Use shall be    |
by certified applicators only. The following pro-   '
tective procedures will be required for persons    j
engaged in treating narcissus with heptachlor:    !
   1.) wear heavy natural rubber gloves and
   clean water proof  protective clothes and
   goggles.                                    j
   2.) bathe immediately after work and change  !
   all clothing, wash  clothing thoroughly with    j
   soap and  warm water before reuse. .-•'         j
   3.) in case of contact, immediately remove

-------
Heplachlor
I continued 1
Kepone
                    I
      contaminated clothes and wash thoroughly
      with soap and warm water.
      4.1 wear a pesticide respirator jointly ap-
      proved by the Mining Enforcement and Safe-
      ty Administration and by the National In-
      stitute of Occupational  Safety and Health
      under provisions of 30 CFR Part II.

G Note:  The end-use dates for Phase Out Uses
should be those dates listed above,  unless the pro-
duction limitations imposed by FIFRA Docket No.
326 et. al. is earlier exceeded. Pesticide products in
existence 90 days before  the effective 'date  of
cancellation or denial of a Phase Out Use may: 11.)
be distributed, sold or otherwise moved in com-
merce, and used; provided that the pesticide shall
not be used inconsistent  with its labeling, and 12.1
may be relabeled by or under the authority of a
registrant for another Phase Out Use not already
cancelled or denied,  and  any pesticide product so
produced shall not count against the production
limitation for the other Phase Out Use.

All registered products containing Kepone were
effectively cancelled  by May 1,  1978. A summary
of Kepone  products, their registration numbers, ef-
fective cancellation dates, and disposition of uses
of existing  stocks follows:
1. Inaccessible Products
   a.  Antrol Ant Trap, Reg. No. 475-11; Black Flag
   Ant Trap, Reg.  No. 475-82; Grant's Ant  Trap,
   Reg. No. 1663-21;  Grant's  Roach Trap, Reg.  "
   No. 1663-22;  Grant's Ant Control, Reg. No.
   1663-24;  and  Dead Shot Ant Killer, Reg, No.
   274-23 were cancelled  as of May 11, 1977.
   Distribution, sale, and use  of existing stocks for-.
   mulated prior to May 11, 1977, was permitted
   until such stocks were exhausted.
   b.  Black Leaf Ant Trap, Reg. No. 5887-63; Hide
   Roach and Ant Trap, Reg. No. 3325-4; Lilly's
   Ant Trap With Kepone,  Reg. No. 460-17;
   T.N.T. Roach and Ant Killer, Reg. No. 2095-2;
   Johnston's No-Roach  Traps, Reg. No. 2019-19;
   Mysterious Ant  Trap With  Kepone, Reg. No.
   395-19; Magikil Ant Trap With Kepone, Reg.
   No. 395-21; Magikil Roach  Trap With Kepone,
   Reg.  No. 395-25; Ant-Not Ant Trap,  Reg. No.
   358-20; Nott Roach Trapp, Reg. No. 358-129;
   E-Z Ant  Trap  Contains Kepone,  Reg. No.
   506-109; Tat Ant Trap. Reg.  No. 506-126; and
   Ant Check Ant Trap, Reg.  No. 506-129 were
   effectively cancelled on May 1, 1978. Kepone
   already in the formulation process may be for-
   mulated  into inaccessible products between
  now and May 1.  1978. Distribution, sale and use
 41 FR 24624
 June 17. 1976:
 42 FR 18885
i April II. 1977
| 42 FR 38205
 July 27.  1977;
 FIFRA Dockeu, Nos. •
I 392 et. at.
' October 27. 1977:
 and the affirmation
 of FIFRA Dockets
 Nos. 332 et al. by the
 Judicial Officer
 December 13. 1977  .

-------
                                                                      Reference
Kepone
/continued!
Llndane
Mercury
    of Xepone products formulated prior to May 1,
    1978 was permitted until such stocks were ex-
    hausted.
 2. Accessible Products: all of these products were
 cancelled as of December 13, 1977. Distribution,
 sale, and use of these products is now unlawful.
 DNote:  the following definitions-are included in
 order to  distinguish between the two categories of
 Kepone products.
 1. Inaccessible products: includes those enclosed
 Kepone traps made from metal or plastic as well as
 metal stakes containing enclosed Kepone bait
 which are hammered into the ground.
 2. Accessible products: includes those which, in
 normal use, would be removed from their con-
 tainers, as well as foil or cardboard covered traps.

 Cancelled, for use in vaporizers.
 Cancelled, all uses except the following:
 1. as a fungicide in the treatment of textiles and
 fabrics intended for continuous outdoor use.
 2. as a fungicide to control brown mold on freshly
 sawn lumber.
 3. as a fungicide treatment to control Dutch elm
 disease.
 4. as an in-can preservative in water-based paints
 and coatings.
 5. as a fungicide in water-based paints and
j coatings used for exterior application.
 6. as a fungicide to control "winter turf diseases"
j such as Sclerotinia boreales.  and gray and pink
I snow mold subject to the following —

12
    a.  the use of these products shall be prohibited
    within 25 feet of any water body where fish are
    taken for human consumption.
    b.  these products can be applied only by or
    under the  direct supervision of golf course
    superintendents.
    c.  the products will be classified as restricted
    use pesticides when they are reregistered and
    classified in accordance with section 4(c) of
    FEPCA.

 C Note: For purposes of the settlement agreements.
 "winter diseases" refer to the forms of snow mold
 which can attack, and damage the fine turf of greens.
 tees, and aprons.
PR Notice 69-9
April 28. 1963
\f and R Docket
19
December 2. IS/.

PR Notice 72-5
March 22. 1372
FIFRA Docket Nc
et al.
December 22. 19',
41 FR 16497
Ap«> IS. 1976
41 FR 26742
June 29. I97S
41 FR 36068
August 26. t976

-------
 P«aticlde/Use Allected   Action
                                                                        Reference
 Metaldehyde
 Mlrex
OMPA
10.10'-Oxybisphen-
oxarsine
Labeling for metaldehyde snail and slug baits must
have the following statement on the front panel of
the product label:
This pesticide may be fatal to children and dogs or
other pets if eaten.  Keep children and pets out of
treated area.

All registered products containing Mirex were ef-
fectively cancelled  on December 1, 1977. (A
technical Mirex product made by Hooker Chemical
Company is unaffected by this Settlement Agree-
ment.  However, since Mirex produced under this
registration may be used only in the formulation of
other pesticide products,  the registration was
useless after December 1, 1977). All existing stocks
of Mirex within the continental U.S. was not to be
sold, distributed, or used after June 30,  1978.
   Harvester Bait 300,  Reg.  No. 38962-5, may only
be used for the control of the pheidole ant, Argen-
tine ant, and fire ant on pineapples in Hawaii. The
effective date of cancellation for these uses was
December  1, 1977;  existing stocks as of December
1, 1977 may not be applied aerially after December
31, 1977, but may be sold and used (other than
aerially) indefinitely.

The application of Harvester Bait 300 is subject to
the following restrictions:
1. Aerial Application: No  longer permitted.
2. Ground Application
   a.  Permissible in all areas of infestation pro-
   vided that there  is no ground application to
   aquatic  and heavily forested areas or areas
   where run-off or flooding will contaminate such
   areas.
   b.  Treatment shall be confined to areas where
   the imported fire ants are causing significant
   problems.
G Note: the following definition is included in      \
order to clarify the ground application restrictions:   •
  Aquatic areas: encompasses without limitation    i
estuaries, rivers, streams,  wetlands (those land and  '
water areas subject to inundation by tidal, riverine,
or lacustrine flowage),  lakes, ponds, and other
bodies of water.

Voluntary cancellation, all products.
Product labels amended to eliminate use in wind-
breakers and baby pants.
                                                   PR Notice 74-7
                                                   July I, 1974
                                                                         FIFHA Docket No. 293
                                                                         October 20. 1976
                                                                         41 FR 56694
                                                                         December 29. 1976
41FR218G9
May 28. 1976

Special Pesticide
Review Division's Posi
tion Document on 10,
lO'-Oxybisphenox-
arsine
Approved April 20. I97S

            13

-------
Pesticide/Use Affected   Action
Parathion
(Ethyl)
PCB'S
Phenarzlne
Chloride

Polychlorinated
Terphenyls
Predacides
Quaternary
Ammonium
Compounds

Safrole
Seed
Treatments
                                                     PRNoiice71-2
                                                     AontS. 1971.
                                                                        PR Notice 70-23
                                                                        October 23. 1370
                                                    42 FR 59976
1. Registration of ethyl parathion limited to those
packed in one gallon containers or larger.
2. Manufacturers and formulators of registered
ethyl parathion should be in compliance with the
standardized safety label that was enclosed with
PR 71-2.

Elimination (all  use as active or inactive ingre-
dients).

Voluntary cancellation, all uses.
  Elimination (all use as active or inactive ingre-
  dients).
  All agency heads are to prevent the use of
  chemical toxicants in any Federal mammal/bird
  damage control program or on  any Federal lands
  where the field use of such toxicant is being
  employed to kill a predatory mammal or bird, or
  where the field use of such toxicants causes any
  secondary poisoning effects on mammals, birds, or
  reptiles. However,  chemical toxicants  can be used
  on an emergency  basis when no other method is
  available and the use of the toxicants  is essential to
  protect human health and safety,  to preserve a
  wildlife species threatened with extinction, or to
  prevent substantial irretrievable  damage to na-
i  tionally significant natural resources. Notwithstand-
  ing these provisions, agency heads may authorize
  the use of sodium cyanide in  Federal programs or
  on Federal lands subject to the  26 restrictions cited
  in this booklet.
 Cancelled, for use as a sanitizer in poultry drinking  ! PR Nonce 73-5
 water.                                            ' August29. 197.
                                                            . 19',


                                                   PR Notice 70-25
                                                   QctottwS. 1370
                                                                        Executive Order'
                                                                        37 FH 2876
                                                                        Ftbruar/9. 1972.
                                                                        Executive Order
                                                                        40FRX611
                                                                        July 22. 1975:
                                                                        Executive Order
                                                                        41 FR 22233
                                                                        JuntZ. 1976
 Voluntary cancellation, all uses. The distribution,
 sale, and use of existing stocks of Surf-Kote Pet
 Repellent, Reg. No. 1811-8, and Scram Dog
 Repellent Spray. Reg. No. 239-2057, are permitted
 only by persons other than the registrants.
 Cancelled, all registrations of these products not
 containing a dye or discoloring agent which will
 impart an unnatural color to the seed. Exceptions
 to this are products bearing directions for use sole-
 ly as planter box treatments.
                                                 I 42FRII033
                                                 I fctoruarylS. I:
                                                 \ 42FR 16844
                                                  March X, 137
                                                 I «FR 29957
                                                  June 10, 1977
                                                  PR Notice 70-
                                                  JuntK. 1970
                                                  PR Notice 70-
                                                  OcroOeria. I.

-------
Silvex
                   T:
Sodium
Arsenite
Sodium
Cyanide
  Chlorodioxin contaminants not allowed.
  Suspended, all pesticide products containing sil-
  vex for forestry uses, rights-of-way uses,
  pasture uses, home and garden uses, commer-
  cial/ornamental turf uses, and aquatic weed
  control/ditch bank uses.
  D  Note:  The only allowable uses  for silvex are on
     rice, rangeland,  sugarcane I field and stubble),
     preharvest fruit drop  of apples, prunes, and
     pears, and non-crop uses. Non-crop uses of
     silvex include use on  or around non-crop sites,
     including fencerows,  hedgerows, fences (not
     otherwise included in suspended uses, e.g.,
     rights-of-way, pasture); industrial sites or
     buildings (not otherwise included in suspended
     uses, e.g., rights-of-way, commercial/ornamen-
     tal turf I; storage areas, waste areas, vacant lots,
     and parking areas.  The following definitions are
     included in order to help clarify the suspension
     orders for 2,4,5-T and silvex —
     Range is non-pasture grazing land on which
     forage is produced through native species, or
     on which introduced species are managed as
     native species.  This precludes land on which
     regular cultural practices of the nature con-
     tained in the pasture definition  are followed.
     Pasture is land producing forage for animal con-
    sumption, harvested by grazing, which has an-
    nual or more frequent cultivation, seeding, fer-
     tilization, irrigation, pesticide application and
    other similar practices applied to it. Fence rows
    enclosing pastures are include as part of the
    pasture.
  Unacceptable for home use if compound is in ex-
  cess of 2.0%, and  the following warning state-
  ments must appear on the label:
  "Do not use or store in or around the home" and
  "Do not allow domestic animals to graze treated
  area."
  Cancelled and suspended, all uses for mammalian
  predator control except; the registration of sodium
  cyanide capsules for use in the  M-44 device is
  allowed for the purpose of controlling certain wild
j  canid predators subject to the following 26 restric-
!  tions:
j  1. Use of the M-44 device shall conform to all  ap-
  plicable Federal, State, and local laws and regula-
  tions.
  2. The M-44 device shall be used only to take wild
  canids suspecte'd of preying upon livestock and
  poultry.
  PR Notice 70-22
  September 28. 1970

  44 FR 15917
  March 15, 1979
                                                                        44 FR 41536
                                                                        July 17. 1979
! PR Nonce 67-2
! August >, 1967
I Interpretation No. 25
| August 1368
                                                                       \
 PR Notice 72-2
 Marcr>9.  1972
 10th Circuit Court's
 Vacation of the Wyom-
 ing District Court's
 Predcide Injunction
 December 2. 1975
 40 FR 44726
 September 29, 1975
 41 FR 21690
 May 27. I97S
 42 FR 8406
 Febnjar/ 10.  '977
                                                                                    15

-------
P9s(icide/Us« AI lee led   Action
Sodium Cyanide
Icantmueii)
16
  3. The M-44 device shall not be used solely to take
  animals for the value of their fur.
  4. The M-44 device shall only be used in instances
  where actual livestock losses due to predation by
  wild canids are occurring. M-44 devices  may also
  be used prior to recurrence of seasonal depreda-
  tion,  but only when a chronic problem exists in a
  specific area. In each case,  full documentation of
  livestock depredation, including evidence that such
  losses were caused by wild canids, will be required
  before appliation of  the M-44 is undertaken.
  5. The M-44 device shall not be used in: (1) Na-
  tional or State Parks; 12) National or State Monu-
  ments; (3) Federally-designated Wilderness areas,
  (41 Wildlife refuge areas;.(51 Prairie dog  towns; (61
  Areas where exposure to the public and family pets
I  is probable.
!  6. The M-44 shall not be used  in areas where
  threatened or endangered species might be
|  adversely affected. Each applicator  shall be issued
J  a map which clearly indicates such  areas.
j  7. The M-44 device shall not be placed within 200
1  feet of  any lake, stream, or other body of water.
j  8. The M-44 device  shall not be placed in areas
)  where food crops are planted.
j  9. M-44 dp-i^ea snail not be placed within 50 feet
j  of public rights 01 way.
j  10. The maximum density of M-44's placed in any
I  100-acre pastureland area shall  not  exceed TO; and
1  the density in any one square mile of open range
j  shall not exceed 12.
|  11. The M-44 device may be placed in the vicinity
j  of draw stations (livestock carcasses), provided
,  that no M-44 iJevice shall be placed within 30 feet
I 'of a carcass; no more  than 4 M-44  devices shall be
i  placed per draw station; and no more than 3 draw
|  stations shall be operated per square mile.
!  12. M-44 devices shall be inspected at least once a
I  week  to check for-interference  or unusual condi-
I  tions  and shall be serviced as required.
|  13. Used sodium cyanide capsules  shall  be dis-
j  posed of by deep burial or at a proper landfill site.
I                                                  j
j  14. An M-44 device  shall be removed from an area j
  if, after 30 days, there is no sign that a target      j
  predator has visited the site.

  15. Damaged or non-functional M-44 devices shall
 be removed from the field.
  16. In all areas where the use of the M-44 device is
 anticipated, local hospitals, doctors, and  clinics
 shall be notified of the intended use and  informed
 of the antidotal and first-aid measures required  for
 treatment of cyanide poisoning.

-------
Sodium Cyanide
  17.  Bilingual warning signs in English and Spanish
  shall be used in all areas containing M-44 devices.
  All such signs shall be removed when M-44 devices
  are removed.
    a. Main entrances or commonly used access
    points to areas in which M-44 devices  are set
    shall be posted with warning signs to alert the
    public to the toxic nature of the cyanide and to
    the danger to pets. Signs shall be inspected
    weekly to insure their continued presence and
    insure that they are conspicuous and legible.
    b. An elevated sign shall be placed within 6 feet
    of each individual M-44 device warning persons
    not to handle the device.
  18.  Registrations for sodium cyanide capsules to
  be used in the M-44 device may be granted to per-
  sons other than State and Federal agencies; pro-
  vided, that such persons shall be authorized to sell
  said capsules only to State and Federal registrants,
  except that Indian governing authorities on reserva-
  tions not  subject to State jurisdictions are  also
  eligible to obtain registrations. Only State. Federal,
  and Indian registrants shall be permitted to sell,
  give or otherwise distribute sodium cyanide cap-
  sules to individual applicators. Such State, Federal
  and Indian registrants of sodium cyanide capsules
!  shall be responsible for insuring that the restric-
!  tions set forth herein are observed  by individual ap-
j  plicators to  whom such registrants  sell or  distribute
•  such capsules and/or M-44 devices. State, Federal
!  and Indian registrants shall train applicators, and
!  such training shall include, but need not be limited
i  to: (1) Training in safe handling of  the capsules
i  and  placement of the device; (2) Training  in the
I  proper use of the antidote kit; (3) Instructions
.  regarding proper placement of the device; and (4)
!  Instructions ir. rocordkeeping.
{  19.  Each authorized M-44 applicator shall  keep rec-
i ords dealing with the placement of  the device and
j the results of each placement. Said records shall
! include, but need not be limited to: a. The number
i of devices placed, b. Tne location of each device
: placed, c. Tlie date of each placement,  as well as
I the date of each inspection, d. The number and
j location of devices which have been discharged
j and  the apparent reason  for each discharge, e. The
  species of animal taken,  f. All accidents or injuries
  to humans or domestic animals.
I  20.  M-44 devices and sodium cyanide capsules
j  shall not be sold or transferred to. or entrusted to
.  the care of. any person not authorized or  licensed
j  by, or under the supervision or control of  a
i  Federal, Indian,  or State registrant.
i  21.  All persons authorized to possess and use

-------
Pesticide/Us* Affected   Action
                                                                      Reference
Sodium Cyanide
I continued I
Sodium
Fluoride

Sodium
Fluoroacetate
Sodium
Hypochlorite
 M-44 capsules and devices shall store said devices
 under lock and key.
 22. Each authorized or licensed applicator shall
 carry an antidote kit on his person when placing
 and/or  inspecting M-44 devices. The kit shall con-
 tain at least six pearls of amyl nitrate and instruc-
 tions on their use. Each authorized or licensed ap-
 plicator shall also carry on his person instructions
 for obtaining medical assistance in the event of ac-
 cidental exposure to sodium cyanide.
 23. One person other than the individual applicator
 must have knowledge of the exact placement loca-
i tion of all M-44 devices in the field.
! 24. Supervisors shall periodically check the
 records, signs, and devices of each applicator to
 verify that all applicable restrictions, laws, and
 regulations are being strictly followed.
 25. In areas where more than one governmental
 agency  is authorized to place M-44 devices, the
 agencies shall exchange placement information and
 other relevant facts to insure that the maximum
 number of  M-44's allowed is not exceeded.
 26. .Registrants and applicators shall also be sub-
 ject to such other restrictions as may be prescribed
 from time to time by the U.S.  Environmental Pro-
 tection Agency.

 Cancelled, for home  use if the product contains
 more  than 40% of this compound.

 Cancelled  and suspended for use in mammalian
 predator control. Label should have instructions for
 predator use blocked out.
18
 P° Vi
-------
Pesticide* Use Affected  Action
                                                                        Reference
Strobane

Strychnine
2,4,5-T
Thallium
Sulfate

Toxaphene
Vinyl Chloride
 Voluntary cancellation, all products.


 Cancelled and suspended'for use in mammalian
 predator control.  Label should have instructions
 for predator use  blocked out.   ..
 Chlorodioxin contaminants not allowed.

 Suspended, the following list:
 1.  all uses in lakes, ponds, or in ditch banks.
 2.  liquid formulations for use around the home,
    recreation areas and similar sites.
 3.  all uses in forestry,  rights-of-way and pastures.

D Note: The only allowable uses for 2,4,5-T are
   for rice, rangeland and non-crop uses. Non-crop
   uses include uses at airports; fences,  hedgerows
   (not otherwise included in suspended uses e.g.,
   rights-of-way, pasture!; lumber yards; refineries;
   non-food  crop areas; storage areas; wastelands
   (not  otherwise included in suspended uses,
   e.g., forestry/; vacant lots; tank farms; in-
   dustrial sites and areas Inot otherwise included
   in suspended uses, e.g., rights-of-way I. For
   definitions of range and pasture see si/vex.

 Cancelled, the following list:
 1. all granular formulations for use around the
 home, recreation areas and similar sites.
 2. all uses on food crops intended for human con-
 sumption. INote: use on rice not finally cancelled^

 Cancelled and suspended, all  products.
Cancelled, all uses of toxaphene products bearing
directions for use on lettuce and cabbage except
the following:
1. Cabbage at application rates of 4.0 Ibs. ac-
tual/acre must have the warning statement "Do
not apply after heads start to form. "
2. Lettuce at application rates of 5.0 Ibs. ac-
tual/acre must have the warning statement "Do
not apply after seedling  stage on leaf lettuce.  Do
not apply after heads begin to form on head of let- •
tuce.

Cancelled and suspended, all pesticide products
containing this compound, whether an active or in-
ert ingredient, for uses in the home,  food handling
establishments, hospitals or in enclosed areas.      i
4) FR 26607
June 28.1976

PR Notice 72-2
March 9. 1372
10th Circuit Court's
vacation ot the Wyom
ing District Court's
Predacida Injunction
December Z 1975

PR Notice 70-22
September 23. 1970

PR Notice 70-11
April 20. 1970

44 FR 15874
March 15. 1979

44 FR 41S31
July 17. 1979

PR Notice 70-13
May I. 1970
PR Notice 72-3
Marcn9.  1373
PR Notice 69-5
feofuarv M. 1969
PR Notice 74-5
AorilJO. t974
40 FR 3494
January 22. 1975
                                                                                      19

-------
 Cross Index
4-A/lyl-f, 2-methylenedioxybenzene: See Safrole
Aroclor: See Polychlorinated Biphenyls and Polychlorinated
Terphenyl
Arsenous Oxide: See Arsenic Trioxide
Benzene Hexachloride.  other Isomer of: See BHC
Benzene Hexachloride.  gamma isomer: See Lindane
Compound 1080: See Sodium Fluproacetate
Chloroethylene: See Vinyl Chloride
Decachlorooctahydro —1.3.4-metheno-2H-cyclobuta
-------
                  F<"d
 required to keep special records on such
 treatments. This comment was rejected
 since most of the information specified
 by the commenter is routinely kept by
 veterinarians in their office files, and
 since the incremental'benefits
 obtainable from such records wodd not
 justify imposing such a requirement on
 veterinarians.
   These comments are available for
 public inspection in the Chemical
 information Division (TS-793). Office of
 Toxic Substances. EPA. Room E-447. 401
 M Street, S.W.. Washington. D.C. 20024.
 from 9:00 a.m. to 4X30 p.m.. Monday
 through  Friday.
   Certain minor changes rn the policy
 statement have been made since its
 proposal, however, in order to clarify or
 correct certain deficiencies in the
 proposed policy. For example, the
 sections relating to hepackaging and
•Dispensing of Pesticides and Production
 of Special Pesticide Formulas have been
 modified to require that the basic
 labeling information described therein
 be physically attached to the pesticide
 package, if space permits. In addition, in
 cases where  the size of the package
 precludes insertion of human safety
 precautionary statements on the
 package itself, certain specific
 precautions must appear on a tag
 attached to the package.
   Also, the final policy statement
 clarifies  that veterinarians dispensing
 special pesticides formulations will be
 covered  by the exemptions described
 herein only when the special blend is
 formulated for use on an affected
 animal. Special blends intended for
 other purposes (e.g.. space sprays) are
 not covered by the exemption and must
 be registered by the veterinarian.
   Accordingly. non>e is hereby given
.that the Office of Pesticide Programs
 and the Office of Enforcement intend to
 implement immediately a policy on (h*.
 subject of veterinarians using and
 dispensing pesticides, as described
 below.
Use of Restricted U« Pesticides
   Under  sections 3. 4. and 12(a)(2)(F) of
FIFRA. no individual may use a
restricted use pesticide unless he is an
applicator certified under a plan
approved by EPA. or is under the direct
supervision of a certified applicator, or
is expressly exempted from the
certification requirement Regulations
promulgated under section 4 in 1974
established an exemption from the
certification requirement for
veterinarians who use restricted use
pesticides in "the course of their normal
practice" (40 CFR 171.4(e)). The
regulations explained, however,  that this

-------
                  Federal Roister  /  Vol. 4-?. No. 213 / Thursday. November 1, 1D79  / Notices
                                                                        62941
 exerr.ptior. cloas not apply to
 veterinarians wlio JI.-R "in (lie business
 of applying pesticides for hire, publicly
'''elding themselves out as pesticide
  iplicators. or engaged in large-scale
 .se of pesticides"'(-10 CFR
 17i.3(b](l)(ii)j. Activities such as these
 would not be part of "normal practice,"
 and veterinarians would have to be
 certified lo use restricted use pesticides
 for such purposes. Although the meaning
 of a "normal practice" is broad and may
 vary according to local needs, some
 activities clearly do not come within the
 scope of that term. For instance,
 application of pesticides  by a
 veterinarian as a "principal or regular
 occupation" (30 FR 36447 (October 1.
 '974)). or solicitation of pesticide
 application business by veterinarians, is
 not considered  part of a "normal
 practice." Veterinarians who use
 restricted use pesticides for such
 purposes, or in  any other manner which
 is not part of their "normal practice,"
 are required to  become certified under
 an appropriate  approved State or
 Federal certification plan, unlr--? 'r.ey
 use such pesticides under the direct
 supervision of a certified applicator.
  Although EPA strongly recommends
 that vcrierinarians keep abreast of
 advances in pesticide use and
 technology through appropriate
 professions! continuing education,
   'crL-cfiaris who practice within the
   nds of-;0 CFR iri.^Jej are exempt
 .. jra the cerufication requirement. EPA
 interprets this exemption as also
 extending to  regular employees of a
 veterinarian \vhen-applying restricted
 use pesticides "und^r the direct,
 supervision"  of the veterinarian. Such
 supervision requires, unless the
 pesticids labeling specifies otherwise,
 that the employee be a competent
 individual, acting under the supervision
 and control of a veterinarian who is
 available if and when needed, even .
 though the veterinarian is not physically
 present at the time (section 2(e)(4) of
FIFRA). Veterinarians are. however.
subject to civil and criminal penalties
for violations of FIFRA, including
misus2 of pesticides, commi.'ted by
employees under their supervision (see
section :4(b](4)  of FIFRA). Additionally,
veterinarians (unless they have become
certified applicators) are not authorized
to supervise the  use of restricted use
pesticides by uncertified persons other
 than their employees.
  Similarly, undur section i:(a)(2)(F] of
FIFRA, veterinarians, as all other
persons, ore forbidden to dispense
restricted  use; ncsiicidns to uncertified
persons, including thoir clients, ur.loss
    issly allowed by EPA regulations.
 ! lowcvnr. EPA wilt consider the nued of
 veterinarians to dispense a particular
 pesticide to clients as part of any future
 decision on whether to restrict use of
 such a pesticide.
   Finally, veterinarians, like all other
 persons, must use all pesticides,
 including those not classified for
 restricted use, consistently with their
 registered labeling. As authorized by
 section 2(ee) of FIFRA, this includes use
 against a pest not specified on the
 labeling as long as the animal or site
 treated is so specified, unless use
 against that pest is exprr.ssly forbidden
 by the Administrator of EPA.
   Any veterinarian who usns or
 dispenses pesticides in violation of the
 provisions of FIFRA. as described
 above, may be penalized under section
 14 of FIFRA for such actions.
 Repackaging and Dispensing of
 Pesticides
   Sections 3(a) and 7(a) of FiFRA, and
 regulations thereunder, require every
 "producer" of pesticides to register all
 pesticides produced by him, and to
 register the establishment in which they
 are produced, prior to sale or
 distribution of such pesticides. By
 regulation, the term "producer" includes
 all persons who "rspack&ge or
 otherwise change the container of any
 pesticide * *  *" (40 CFR 167.1 (r) and (u)J.
 Therefore, a veterinarian who preserves
 or otherwise dispenses a pesticide in a
 new container, or a container which he
 has altered by changing the package or
 its labeling, after receipt of the original
 product, is considered a "producer." The
 veterinarian is then legally responsible
 for registering such a product with EPA
 (even though the original product may
 already have been registered by it's
 producer); for registering his
 establishment: for complying with all
 applicable labeling and packaging
 standards established by EPA; and for
 keeping all records required of
 producers under section 7(c) of FIFRA
 and 40 CFR 167.5.
  However, EPA rccogni/es the
 substantial benefits which may be
gained by permitting veterinarians who
obtain pesticides in bulk containers to
 dispense such pesticides to clients in
 individual containers better suited to the
 specific casn for wh'ch each pesticide is
prescribed. EPA also recognizes the care
with which most veterinarians
prescribe, repackaae, end distribute
pesticides. Therefore. EPA.  as a matter
of policy, will not subject veterinarians
who prescribe and dispense1 repackage!
pesticides in the requirements imposed
on "producers," provided th;;t the
following minimal conditions arc met:
   1. The repackaged pesticide is
 registered by EPA for a use consistent
 with the uso for which the pesticide is
 prescribed,  and the EJ'A registered use
 is not classified aa restricted.
   2. The veterinarian supplies the client
 with labeling for the pesticide which
 contains:
   (a) The common or trade name(s) and
 percentage^) of the active ingredient(s);
   (b) The EPA product registration
 number:
   (c) Use directions for the use
 prescribed;    .
   (d) The name and address of the
 veterinarian;
   (e) An antidote statement;
   (f) Directions for disposal of the
 pesticide and the package dispensed lo
 the client and
   (g) Human safely precautionary
 statements, including but not limited to:
   (i) "For application to animals only."
   (si) "Keep out of reach of children."
   (iii) "In case of accident, contact local
 physician immediately."
   If there is sufficient space on the
 package dispensed to the client, ail of
 the information specified in {a)-[j)
 above must be physically attached !o
 llis package.
   If space on the package is not
 sufficient to psrmit direct attachment of
 labeling containing nil the information in
 (a)-(g),  then, at'a minimum, the
 information specified >n (a), (b>. (c). dr.d
 (d) must be physically attached to '.he
 package. In  addition, in such a case, the
 human safety precautionary statement
 specified in  (gj above must be physically
 affixed  to the container by wire, plastic,
 or similar means.
   The information required by (e) and
 (fi above may be supplied to the client
 in the form of supplemental Ic.beiing.
 which may,  if appropriate, consist of ths
 original labeling of the pesticide as
 received by the veterinarian.
   3.  The container in which the
 pesticide is dispensed to the client is a
 child-resistant package as described  in
 40 CFPv  162.16 of the "Special
 Packaging" rule (44 FR 7695). unless thfl
 veterinarian has determined that there
 is no reasonable possibility thai the
 package will come within the  reach of
 children.
  4. The pesticide is prescribed and
 dispensed to ihe client for thu tr&Llrnenl
 of a specific pest problem, on  a casu-by-
case basis, as part cf the vct.eriv:ar:?.n's
 "normal practice."
  In addition to meeting tbe above
requirements, all veterinarians
distributing pesticides are urged to
discuss  bbcling directions with !hu     ;
Client at tiie  tin!*; the pesticicie is
dispensed.

-------
 C2942
Federal  Renter  /  Vol. 4-4.  No. 213  /  Thursday.  November 1. 1979 / Notices
   A.-.V veterinarian who repackages and
 dispenses pesticides, and who does not
 «a::s:y csnii;ons (1) thrc'^h (4) above.
   :f. crrp'y with a'.', federal registration
   .: :r:c:t' »r?ir- retirements for
 •producers." and nay be penalized
 u.-.d?r section 14 of FLFRA for failure to
 d: sc.

 Fr.-Jui±:? and Dispensing Special
         Formulas
   Veterinarians who prepare their own
 special products for treatment of pests,
 other ths.-. by mere dilution of a
 registered pesticide in accordance with
 its labeling. may also be "producers." If
 the product formulated by the
 veterinarian is a "new animal drug" (as
 dcfl.-.sd L-. 21 U.S.C. 321(w) and
 321(g)(l)). the product and the
 veterinarian aie subject to regulations of
 !.'.: U.S. Food and Drug Administration.
 U. however. the product is not a "new
 animal drug." or an animal feed
 containing a new animal drug, and is
 intended to prevent, repel, mitigate, or
 destroy any pest, it is a pesticide
 (section 2(u] of FI7RA) and is subject to
 ths primary jurisdiction of EPA. The
 veterinarian is then  considered a
 "producer" under FIFRA section 2(w).
   As described above, "producers" are '
 ordinarily required to register products
 and establishments, to keep records,
 ar.i to ceet labeling and packaging
   T.d=rcs. If. however, the veterinarian
   jduces a special pesticide biend
 ooiely for his own use. or use by persons
 in his presence and under his immediate
 supervision, then the veterinarian is
 exempt from these requirements (see,
 e.q.. 40 CFP. 162.3'^;: 162.S(a); 167.2(a)).
 Nevertheless, when mixing or using
 special pesticide blends, veterinarians
 ere still required to comply with the
 LbciL-.- circciicns of. any registered
 pesticides used. In addition. EPA
 recoramends that labeling meeting the
 minimum standards  of 40  CHI Part 162
accompany the special blend, in order to
 promote safe use, storage, and disposal
 of such pesticides by the veterinarian
 and his employees. Also, when applying
a special blend which may leave a
residue in  or on an animal intended for
use as food, the veterinarian must
ensure that the ingredients used have
been granted necessary clearances
under the Federal Food, Drug, and
Cocmcric Act
  Oa the other hand, veterinarians who
 formulate special pesticide mixtures for
 distribution to others are legally subject
 to all registration, labeling, and
 packaging requirements imposed on
 producers. However, EPA recognizes the
 benefits which may be obtained by
 ''owing veterinarians to formulate
   ducts to meet unusual cases.
                     Therefore, EPA will not subject
                     veterinarians who dispense such
                     products to these requirements if:
                       1. The special pesticide blend is
                     produced  by mixing two or more
                     pesticides already registered by EPA, or
                     by adding new substances to an EPA
                     registered persticide.
                       2. Special blends made from
                     registered pesticides classified for
                     restricted  use by EPA are not dispensed
                     to uncertified persons. •
                       3. The special blend is formulated and
                     dispensed in accordance with
                     recognized clinical practices and not
                     primarily for purposes of
                     experimentation.
                       4. The product is prescribed solely for
                     application to an affected animal
                     consistent with the labeling  of any
                     registered product used as an ingredient
                     and the use directions in the labeling for
                     the registered ingredient  do  not prohibit
                     the mixing performed by the
                     veterinarian.
                       5. The special product is prescribed
                     and dispensed to individual  clients of
                     the veterinarian on a case-by-case basis
                     to meet specific pest problems.
                       6. The veterinarian supplies the client
                     with labeling for the special  product
                     which contains:
                       (a) The common or trade name(s) and
                     percentage(s) of active ingredient(s);
                       (b) The EPA  registration number for
                     each registered product used as an
                     Ingredient
                       (c) Use directions for the use
                     prescribed, which are consistent with
                     the directions found  in the original
                     labeling for the registered products used
                     as ingredients;
                       (d) The name of the veterinarian;
                       (e) An antidote statement
                       (0 Directions for disposal  of the
                     pesticide and its container and
                       (g) Human and environmental safety
                     precautionary statements including, but
                     not limited to:
                       (0 "For application to animals only."
                       (ii) "Keep out of reach of children."
                       (iii) "In case  of accident contact local
                     physician immediately."
                       Lf there is sufficient space  on the
                     package dispensed to the client all of
                     the information specified in (aHg)
                     above must be  physically attached to
                     the package.
                       If space  on the package is  not
                     sufficient to permit attachment of
                     labeling containing all the information in
                     (aHg)' then, at a minimum, the
                     information specified in (a), (b), (c), and
                     (d) most be physically attached to the
                     package. In addition. In such a case, the
                     human safety precautionary'  statements
                     specified in (gj  above must be physically
                     affixed to the container by wire, plastic,
                     or similar means.
   If the original labeling or any of the
 ingredients would satisfy the
 requirements of (e) and (f). copies of t.-t
 labeling may be supplied to the client to
 fulfil] those requirements.
   7. Tne container in which the special
 product is sold to the client is a child-
 resistant package, as described by the
 "Special Packaging" rule, unless the
 veterinarian has determined that there
 is no reasonable possibility that the
 package will come within the  reach of
 children.
   In addition to meeting the above
 requirements, all veterinarians
 distributing their own special  products
 ore encouraged to discuss labeling
 instructions for the special product  with
 the client at the time the pesticide is
 dispensed.
   Veterinarians who do not meet these
 conditions when distributing specially
 formulated pesticides must comply  with
 all registration, recordkeeping. labeling,
 and packaging requirements established
 for "producers." Failure to comply may
 result in the imposition of penalties
 under section 14 of FIFRA.
 Special Packaging
   As mentioned above, it is-expected
 that veterinarians who "produce"
 pesticides for their clients' use will
 frequently be subject to the
 requirements of the "Special Packaging"
 rule by its own terms, That is. a
 veterinarian producing a pesticide
 which meets the toxiciry requirements of
 the "Special Packaging" nde. and which
 is intended for "residential application",
 as defined by that rule, must package
 the product in a child-resistant container
 before dispensing-it to a client
  In addition, in those cases where  that
 rule will not apply by its own terms, but
 the prescribed pesticide may come
 within the reach of children, use of
 child-resistant packaging  by the,'
 veterinarian is a prerequisite to
 exemptions from registration,
 recordkeeping, and labeling
 requirements described in the  preceding
 sections of this policy.  t
  These facts, coupled with the practical
 difficulty that some veterinarians may
 have in determining whether a
 prescribed pesticide is subject to the
 terms of the "Special Packaging" rule,
 make it to the veterinarians' advantage
 to comply with the rule whenever there
 is a reasonable possibility that a
 prescribed pesticise may come within
 the reach of children. Therefore. EPA
 strongly encourages veterinarians to
voluntarily comply with packaging
 standards established by the rule when'
 dispensing any repackaged or  specially
blend 3d pesticides.

-------
                  Federal  Register / Vol.  44,  No. 213  /  Thursday, November 1.  1979 / Notices
Stale Regulation of Veterinarians
  This policy statement concerns only
EPA policy under FIFRA and federal
regulations. It docs not ;tffcct State or
local regulatory restrictions .covering
veterinarians who deal with pesticides.
Therefore, all vctcrinariiins should
consult their local professional
associations, licensing offices, and State
and local pesticide regulatory agencies
for detailed information on local
requirements.
  Dated: October 16.1973.
Edwin L Johnson,
Deputy Assistant Administrator fur Pesticide
Programs.
  Dated: October 2-4,1979.

Richard O. Wilson,
Deputy Assistant Administrator far General
Enforcement.

|FR Doc. 79-13.134 Filed 1WI-7* US am]
BILLING CODE 6560-01-M


IOPP-30000/33A; FRL 13SO-1]

Rebuttable Presumption Against
Registration and Continued
Registration of Pesticide Products
Containing EPN; Extension of Period
for Submission  of Rebuttal Evidence
and Comments
AGENCY:  Environment.!) Prelection
Agency (EPA). Office of Pesticide
Programs.
ACTION: Extension of comment period.

SUMMARY: EPA has extended the period
for subniittal of rebuttal evidence  and
other comments in regard to the
rebuttable presumption agiiinst
registration (RPAR) of pesticide
products contuining O-ethyl O-(p-
nitrophenyl) phenylphosphonulhioute
(EPN).

DATE: The comment period closes on
December 28, 1979.

FOR FURTHER INFORMATION CONTACT:
Mr. Patrick Miller, Special Pesticide
Review Division (TS-791), Office of
Pesticide Programs, Room 722, Crystal
Mall Building *2, 1921 Jefferson Davis
Highway, Crystal City, Virginia 22202.
Telephone: 703/557-7973 Ext. 24. The file
supporting the Agency's presumption
against EPN is available for public
inspection at this location.
SUPPLEMENTARY INFORMATION: Oil
September 4. 1979, EPA issued an RPAR
against EPN. This notice was published
in the Federal Register on September 'J9,
1979 (44 FR 54304). The regulations
governing RPAR's provide that the
applicant or registrant of these pesticide
products shall !>-••? 'ovly-five days from
the date this notice is sent to submit
evidence in rebuttal ->'. ihe presumption.
If good cause is shown, however, an
additional sixty days may be granted in
which to submit evidence (40 CFR
  The deadline for submitting rebuttal
evidence in the RPAR notice was
October 29. 19"9. Requests for -in
additional sixty days in which to submit
evidence to EPA have been received
from registrants and othu-is who were  •
affected by  the notice of presumption.
They have specified a need for
addi:ional time to r^jpund to the risk
 presumptions set forth in the Scplumbc;
 19 notice (i.e., delayed neurotoxicity in
 test animals and aculo toxicity to
 aquatic organisms) and to assess
 proptM ly the benefits of EPN.
   The Agency concludes that additional
. time would be beneficial to ensure the
 submission of complete and accurate
 responses  to this notice of presumption.
 Therefore, all registrants, applicants, for
 registration, and other interested
 persons shall  have until December 28.
 1979, to submit rebuttal evidence and
 other comments or information. These
 submissions should bs sent to the
 Document Control Officer, Chemical
 Information Division -TS-703). Office of
 Toxic Substances, EPA. Room 447, East
 Tower. 401 M Street. SW., Washington,
 D.C. 204GO.
   All comments should bear the
 identifying notation "OPP-30000/33A."
 Comments received on or before
 December 28, 1979. will lie considered
 before the Agency decides whether a
 notice shall be issued under 40 CFR
 162.11(a)(5)(ii) and 7 U.S.C. V43(dKB)(l].
 Comments received after December 28.
 1979, shall be considered only to the
 extent feasible, consistent with the time
 limits imposed by 40 tFR icr..ll(a){5)(ii).
 All  written comments filed will bs
 available for public inspection in the
 office of the Document Control Officer
 at the above address fro:n H:'.)0 a.m. !o 4
 p.m. on normal business cays.
   Dated: October 20. 1JT.1.
 Edwin L. Johnson.
 Deputy. •\ssistant Administrator far Ptmttciite
 Program*.
                                        3ILUNfl COS: 6500-fll-U
 FEDERAL COMMUNICATIONS COMMISSION

                                Canadian Standard Broadcast Stations; Notification List

    List of new stations,  proposed changes in existing stations, deletions, and corrections,  in  assignments of Canadian
 standard broadcast stations  modifying  the  assignments of Canadian  broadcast  stations contained in the appendix  to the
 recommendations of the North American Regional Broadcasting Agreement Engineering Meeting Jan. 30, 1941.

 September 19. 1979.
                                                     '
                                                   Canadian List No. 3C9
   Can tellers
                     location
                                      Pcwcr
                                       kW
                                               Antenr.a
                                                           Scneduie
                                                                      Ciass
                                     Antenna
                                     hfiijni
                                     Occt)
                                                                                       G^ou.vl syst
                                                                                                          Of OP>:i
 cso
 CMBS
            irm:mi. Qviebec. N. <5 1 9 1 7". V.'.
             73"1fl'3t5" (Cn«ii.j-^ o* studio
             location troiTi S!. Jran)     ,
                                     IOO/5N  OA- 1 ....... ___________
                                        10  NO-ISO

-------
           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON. D.C.  20460
                             DEC 1 9  1S72                   OFFICE-OF ENFORCEMENT
 SUBJECT:  Enforcement Actions Concerning Nonhazardous Pesticide Devices

 TO:       Pesticide Branch Chiefs
           Enforcement Division Directors
                                                             i

      Section 13 of the Pesticides Case Proceedings Manual states that  the
 issuance of a Step-Sale, Use or Removal Order is mandatory  for devices
 whose laceling bears false, misleading, or fraudulent claims. I/  This
 guidance is based on section 13 of FIFRA, which grants EPA  the authority
 to pre'^nt the further distribution and sale of any pesticide or device
 found to be in violation of the Act.  However, the question has teen raised
 in a case involving an electromagnetic rodent repelling device whether a
 section 13 Step Sale Order is an unconstitutional seizure and deprivation
 of a person's property without due process of law because of the absence
 of an opportunity for an administrative determination as to the validity
 of the Order.  As a result, PTSED is developing a regulation governing the
 issuance of Stop Sale, Use or Removal Orders covering certain classes  of
 pesticide devices.  The regulation being developed would provide persons
 who are distributing or selling ncnhaznrdcus devices which  do not present
 immediate huran health or environmental risks, with an opportunity  for an
 administrative review of the validity of the Stop Sale Order.  This review
 would take place prior to and independent of the adjudication of the alleged
 violation through the civil penalty process.

      Until such a regulation is implemented, it is the Office of Enforcement's
 policy that in any case of a misbrancing violation involving a ncnhazarcous
 pesticide device, it will be necessary to complete civil penalty proceedings
 before issuing any Step Sale Order.  Thus, in cases involving nonhazardous
 devices regulated by FIFRA, a Civil Penalty Notice should be issued and, if
 .a hearing is requested, the adjudicator/ proceedings completed before  issuing
 a Stop Sale, Use or Removal Order.   If the respondent fails to request a
,timely hearing once he has received a Civil Penalty Notice, a Stop Sale Order
 V  Case Proceedings Manual, Section 13(1}(B)(2)(a)(3), TN 76-2 (10-76)

-------
                                    -2-

can be  imposed.  A Stop Sale  Order  can also be imposed once a Final Order
has been  issued  pursuant  to a Consent Agreement with the regional office.
However,  any Consent AcreeiTEnt concerning  a misbranced device should require
as a minimum the immediate halt to  any further sale or distribution of the
devices.  If the respondent does  request a hearing pursuant to section 14
and the regulations set forth in 40 CFR Part 168,  a Stop Sale Order should
not be  imposed until the  completion of the administrative proceedings and
the issuance of  a Final Order.  However, it is not necessary to wait for
the respondent to exhaust all avenues of appeal (i.e., appeal to the appro-
priate  U.S. Court of Appeals)  before issuing a Stop Sale Order.

     It should be noted that  this policy extends only to those devices found
not to  pose an immediate  human health or environmental risk but wiose labeling
is found  to bear false, misleading,  or fraudulent  claims.  Other classes of
devices,  especially those v^iich do  pose human health or environmental risks,
will continue to be treated under the mandatory provisions of the guidance
found in  section 13 of the Case Proceedings Manual.   An example of a device
^iich would still warrant the mandatory issuance of a Stop Sale Order, not-
withstanding the discretionary policy outlined in  this memorandum, is a
vater treat-ient  device whose  labeling makes false, misleading, or fraudulent
claims  to purify rsv well water or  other untreated water supplies.  A ;icre
detailed  classification of devices  subject to this policy will be out.lined
in the  proposed  regulation.

     Nevertheless, in certain cases involving ncnhazardous devices it may be
necessary or appropriate  to take  further action to prevent the continued dis-
tribution and sale of the devices before the^ completion of the civil penalty
proceedings.  In such cases it may  be appropriate  to seiza the devices pur-
suant to  the authority in section 13(b)  and/or to  seek an injunction pursuant
to the  authority in section 16(c) to prevent their further distribution and
sale pending the outcome  of the civil penalty proceedings.  These actions
require the prior concurrence  of  EPA Headquarters  as outlined in sections
13(11)(A) and 18(D)(3) of the  Case  Proceedings Manual, and must be referred
to the  Departnsnt of Justice  for prosecution.  2_/
2/The authority to institute  in rem  (seizure) proceedings  is vested concur-
rently in the Regional Administrator and Assistant Administrator  for Enforce-
ment [Chapter 10-2, EPA Delegations Manual],

-------
     If ycu have dry questions  about  the  colic/ or procedures outlined in this
r?erxrar.dur., or need assistance  on a case-by-case basis in prosecuting persons
fcr the sale and distribution of misbranded,  ncnnazardous pesticide devices
clease ccr.tact Jcseph Virgilio  of FTSED at  2C2-472-3701.
                                       A. E. Conroy  II
                                    Pesticides and Tox
                                          Enforcement D

-------
                          JAN
   KEMORAHD.ua.
   SUBJECT:  Federal Facilities Compliance

   TO:       Clyde B.. Eller, Director
             Enrorceraent Division, Region IX
        This is in response to your memorandum of  December  19,  1979,
   requesting a further determination on  the  issue of  civil  compli-
   ance against Federal facilities.  Your memorandum stemmed front
   earlier telephone conversations between our staffs  in  which  we
   indicated a preference for core informal enforcement actions
   when dealing with ot&er Federal executive  agencies.

        Executive Order 12088 (copy attached) sets forth  policies
   governing compliance with environmental standards by Federal
   facilities.  The- thrust of £.0. 12088  is that the Administrator
   Ip.culd notify en Executive Agency when it  has baen  found  to  be
   m violation of a pollution control standard.   That agency,  in
   turn, should jrcsptiy consult wi.th the Administrator and  provide
   a  plan to achieve a-nd maintain compliance  with  the  pollution
   control standard.  Th"e Administrator is directed to make  every
   effort to resolve conflicts regarding  the  violation.   If  the
   Administrator cannot resolve the conflict, he is directed to
   request the Office of Management and E-udget to  resolve the
   conflict between the agencies.  Section 1-604 further  provides
   that these conflict resolution procedures  are in addition to,
   and  not in lieu of, other enforcement procedures.

        It is the express policy of the Agency to make every
   effort to resolve sup.b conflicts with other Executive  agencies
   in accordance with E.O. 12088.  This policy is consistent with
   the  thrust of E.O. 12035,in favoring inter-agency settlement
   over more formal enforcement actions.  This is so in the  con-
   text of administrative procedings as well  as in the context  of
   in-court litigation where the Department of Justice has indi-
   cated it would not allow the EPA to file suit against  another
   Executive Agency.
                              CONCURRENCES
-H
             /"/f
f o
rm 1320.1 (12-70)
                                           OFFICIAL FILE COPY

-------
                            -  2  -
     It is the policy of the  Department of  Justice (DGJ).not
to involve the Judicial Branch  in  resolving Executive Branch
pr.oblens.  DOJ would intervene  against EPA  if  we  attempted
any such filings on our own behalf.
     The- goai^in- necftfeiatiag—settlements  uh*»n  nn  Executive
ia-found-to-be—in-violation-of—a—pollution  control:standard is ..
not to assess penalties but  to obtain  compliance.   Expeditious
compliance mig-h't be obtained  solely on the  b«sis of such settle-
ment between the agencies.   To the extervt  that  every effort to
resolve such conflicts with  other Executive agencies has not yet
been r.^cio, the consideration  of  other  enforcement  options would
be inappropriate.

     An example of one such  agreement  is  the Federal Facilities
Compliance Agreement between  EPA and the  Department of the
Army (copy enclosed).  This  agreement  established  expeditious
compliance schedules for the  Department of  the  Army Material
Development and Readiness Ccimand (DA3.CCM)  facilities which
were in violation of provisions  of the Clean Water Act and the
Clean Air Act.  As outlined  in an April 13, 1979,  raernoran-Suia
frcrs the Director, CE Office  of  Program and Management Opera-
tions, to the Regions! Enforcement Division Directors, this

  th Executive agsr.cies in the future.

     I hope that this information will be  of help  to ycu.  If
I can be of any further assistance, olease  contact rae at
(202) 755-OS70.
                              A.  E.  Conroy  II,  Director
                            Pesticides  and Toxic Substances
                                Enforcement  Division

-------
               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY


  DA*Te.     December 19,: 1979

SUBJECT:     TSCA Civil Complaints Against Federal Facilities

          Clyde B. Eller
  PRO-     Director
  	Ertforc^rognti Division, Rggion IX	  .O	
    — -
    TOi
          Director
          Pesticides and Toxic Substances Enforcement Division
          In telephone conversations with your staff/ we have
     seen informed that PTSED will not concur in a civil
     complaint against a federal facility.  Because of Executive
     Order 12088, PTSED prefers that a settlement with a federal
     facility be embodied in an informal compliance agreement.

          It is our position that a federal facility should be
     treated in the same manner as any private company.  A civil
     complaint should be issued against a federal facility which
     violates TSCA and any settlement should be embodied in a
     consent agreement.

          Our position is not inconsistent with Executive Order
     12088, which states:

          "These conflict resolution procedures are in
          addition to, not in lieu of, other procedures,
          including sanctions, for the enforcement of
          applicable pollution control standards."

          Because a number of completed federal facility
     inspection reports are awaiting enforcement action, we
     request a prompt resolution of this issue.

          If you have any questions, please contact me or Keith
     Takata of my staff at (415) 556-8008.
 EP» FORM ti20-« 
-------
           U.S. ENVIRONMENTAL PROTECTION AGENCY


                         WASHINGTON, D.  C.




 Department of the Army                       Federal Facility


—_ 	and- .	   		      	  .-Compliance	
"UTS. Environmental  "                        Agreement;

                    «

 Protection Agency
     The Environmental Protection-Agency (EPA) and the Department of


 the Army CArrr.y) are the parties to this agreement which is entered into



 pursuant to Executive Crder 12038, October 13, 1978 (43. FR 4770").


 The  Office of Management and Budget and the Department of Justice


 take cognisance of this agreement pursuant :c their respective duties


 to assure compliance with the environmental laws  under Executive


 Crde1" 12-88 2nd the particular statutes herein ^ccrssssd.


     scc?r


 1.   This agreement is entered into by the parties to- a s-s-ure-compliance

                        9
 by the-Department of Army Materiel Development and.Readiness Command
                        •

 (DARCOM) with the Clean Air Act (CAA) (42 USC 7401 et sec.) and the



 Clean Water Act (CWA) (33  USC 1251 et seq.), and implementing


 regulations.


 2.   This agreement is not and shall not be construed as a permit  under



 the CWA nor'shall it relieve the Army of any legal obligations under the

-------
 CWA which are in addition to or different from matters covered in this




 agreement.  This agreement does not modify the terms of the State




 Implementation Plan (SIP) governing each subject facility, nor-shall it




 relieve the Arny of such ST?  responsibility under the CAA.  This  agree-




 ment in rtQjtfay--a_gfog»a_rpquiremgft£s far o»ch f»C*lity ^? frpply tC th?  '	




 appropriate EPA regional office and State or regional environmental




 agency for all applicable air quality permits.




     Authorities




 3.   The duties of the Army to operate its  facilities in compliance with




 the Clean Air Act and the Clean Water Act are prescribed in section 113




 of the  Clean Air Act (42 USC  7418) and section 313 of the' Clean Water




 Act (33 USC 1323).  Executive Order 1208? was promulgated to ensure




 Federal compliance with applicable pollution control standards.  This




 agreement contains a "plan"  as described Li section 1-501 of Executive




 Crder 120So to achieve and maintain compliance with applicable  air and.




 water pollution centre! standards.




     Statement of Facts




 4.   The following DARCOM facilities are owned, operated, or under the




 control of the Army:




     a.   Sewage Treatment and Industrial Wastewater, Aberdeen  Proving




Ground,  Aberdeen, Mar/land.




     b.   Sewage Treatment and Industrial Wastewatec Annistcn Army




Depot, Annistcn,  Alabama.

-------
    c.   Industrial Waste Treatment. Eclston Army Ammunition Plant,


Kings port, Tennessee.


    d.   Industrial Waste Treatment, Lone Star Army Ammunition Plant,


Texarkana, Texas.     "      '~  '    ~"	
    e.	Pink Water Treatmentr~MIlan Army AramunittOft=
                             •.•;•.•"•"'.

Tennessee.


    f.  Sewage Treatment and Industrial Wastewater,  New Cumberland


Army Depot, .New Cumberland, Pennsylvania.


    g.  .Industrial Waste  Treatment, Pine 51 uff Arsenal, Pine Bluff,


Arkansas.


    h.  Industrial Waste  Trsatmer.t, Radfcrd Array Ammunition Plant,


Racforc, Virginia.


    i.  Sewage Treatment Plant, Redstsr.e Arsenal, Alabama.


    J.  Sewage Treatment Plants, Seneca Army Depot, Romulus, New York.


    k.  Sewage Treatment Plant, Industrial Wastewater, and Boiler Plant,


Tobyhanna Army Depot, Tobyhanna,  Pennsylvania.


    1.  Industrial Waste'Treatment and Deactivation Furnace, Lake City
                       »
                       •

Army Ammunition Plant, Independence, Missouri.


    ra.  -Contaminated Waste Process, Iowa Army Ammunition Plant,


Middleton, Iowa.


    n.  Boiler Plant/ Rock Island Arsenal, Reck Island, Illinois.


    o.  Demilitarization Facility, Savanna Army Depot, Savanna, Illinois.

-------
5.  Twelve DARCOM facilities named la paragraph 4(a) through (1)

are presently In violation of the statutory compliance deadline of the

Clean Water Act,  to wit, CWA section 301 (33 USC 13111.

    Four DARCOM facilities named in paragraph A(lLthrough-Col	

presently" have. state~grantad..vananca
•M=»«=»«V1=MF»
these variances have not been submitted to or approved by EPA as a

modification of the SI?.

    The compliance status under the CAA of the Tobyhanna AD identified

Li paragraph 4(k) is undetermined at this time because of measures

presently being undertaken at the facility. It has been in periodic,

marginal violation in the past.

    Ccmc'i^ncs Scr.sduIss

5.  The Compliance Schedules for the fifteen DARCOM facilities named

in paragraph 4  ars intended to achieve compliance as expediticusly as

practicable, pursuant to section 1-501 of E..O. 12088, and are set forth

as Attachments a through o to this agreement.  The attachments are

incorporated into and made, a part of this agreement.  The schedules
                        •                                •
were determined after consultation between the Army and E?A.  The

schedules contain interim requirements reflecting design, and construction
                      *
milestone dates. Wherever reasonably possible, the Army will expedite

the schedules.
                                  4

-------
    Fundinc

7.  The Army shall request all funds and/or authorizations from the
                  •                        f
Congress necessary to achieve the compliance schedules.  These

schedules are fixed and definite- except-to the--extent--that-the-Congra*s-
cf therUnltad-States-cay f8u to approve budget"and/or authorization-	=

requests for these projects.  Steps to be taken in'seeking funding shall

be consistent with Sections 1-4 and 1-3 cf Executive Order 120S3  as

implemented by the Office of Management and Budget Circular A-106  (as

amended).

    Reeortlnc Recuirements.

3.  The Army shall submit a progress report no later than ten days after

tr.e date for achievement of each incremental stsp in the-compliance

schedules ar.c upon the final compliance 02:3 as  set forth in the Attach-
        *
tnents.  The progress  reports will be submitted to the EPA Regional

office responsible for the particular facility and the appropriate State

or regional environmental agency,  as identified on the Attachments.

The status  reports shall indicate compliance or non-compliance with

the schedule.  In the  event of non-compliance, the report shall include

the cause cf non-compliance and any remedial actions taken.

    If delay is anticipated in meeting any schedule date the Army shall
                                                   i
immediately notify the EPA Regional office and the State or regional

environmental agency, in writing,  of the anticipated delay, describing

in detail the anticipated length of delay, the precise  cause cr causes

-------
of the delay, the measures taken and to be taken by the Army to




prevent or minimize the delay and the^ timetable by which the measures




shall be implemented.  The Army win take action to  minimize any dc-
                                                                .



The Regional Administrator shall tnakg-a-determl nation whether the
                                                    -r
               •      »

Array disagrees with this 
-------
10.  On the date for final compliance as shown on the attachments,



compliance with air and water standards must be demonstrable by



testing and positive reporting of the achievement of compliance, rather



than by the mere completion of construction of pollution abatement




faciiltles.	:		—
     Upon the Army's demonstration of compliance, there will be a




continuing obligation to comply with applica-ble discharge and emission




limitations under the CWA and CAA respectively.  . These limitations are




embodied In each facility's National Pollutant Discharge Elimination




System permit under the OVA and in the pertinent State Implementation.




Plan under the CAA.



     Ccnflict Resolution



11.   Anticipated non-compliance with, cr alleged violations of, this




.agreement shall be brought to the attention of the Administrator of the




Environmental Protection Agency for resolution by EPA and the Army.




If necessary, the Director, Office of Management and Budget shall be




notified  pursuant to sections 1-602 and 1-603  of Executive  Order 12088.


                        *

The-Director, Office of Management and Budget shall consider such "steps-
                        *



as are necessary to resolve any conflicts and remedy the violations.




     Sanctions



12.  In the event cf violations of air or water standards or the terms cf




this agreement by the Army, sanctions under the  authority of section




.1-604  of Executive Order 12083, as well as enforcement procedures

-------
established by the Clean Air Act and the Clean Water Act are available

as enforcement mechanisms in addition to the conflict resolution
                                    •
procedures cited in paragraph 11.

13. Provided that the Compliance Schedules, as attached, are met,
this.agreement is^-conaidered-to be-inrliau of any-.other EPA or-gedaral-
enforcement action with regard.tsa-ziis DARCOM facilities named in

? aragraph 4,  for the pollution indicated In paragraph 5.  This  agreement

in no way modifies section 303 of the CAA and section 504 of  the CWA.

14.  This agreement in no way addresses potential liability of the Amy

regarding ncn-coinpliance penalties under section 120 CAA by  the

facilities subject to this agreement.
                                  Signed:    ^      ' y      "
                                           Alan J. Gibes
                                          Assistant Secretary- of the Army
                                          for Installations ,  Logistics
                                          and Financial Management
                                          Marvin B. Duming
                                          Assistant Administrator for  *
                                            Enforcement
                                          Environmental Protection Agency

-------
 Facili t
                                   Attachment   a

                                              NPDES Permit f

Aberdeen Proving Ground  Earford Co, .MD       MD0021237
Project Description

    This~ projectriiT7oiveisr-upgrading-o€ -jtiie—main-sewage
 treatment giant sad-connection of. ,6.1 ,
-to—the oower—sys-tao«	™=,	:—
C en? 1 i an c e S ch'edul a •

     ]'.  Final design start

     2.  Final design ccaplei

     3.  Construction award

     4.  CcnstrTiction ccraplej.

     5.  Achieve cczialian
                                           May  1978

                                           March 1979

                                           June 1979

                                          .June 1981'

                                           Septersber 1981
    arks
 NONE
Prccress  Reports
 EPA, Region III
 Curtis Building
 6th & Walnut Streets';
•Philadelphia, Pennsylvania    19106

 Water Resource Administration
 Thomas Andrews, Director
 Tawes State Office Building
 Annapolis, Maryland   21401

-------
Facility

 .^aniston Azsy Depot  Lcwndes Co./  AL
                               *
Project Description
   NPDES Permit 5

   AL0002553
      This project involves upgrading of the industrial
 waste trsataent  facility and the  existing _sewage treataenl
 plant.
.Compliance Schedule
                          •

    •  ] .  Final design, start •
    >       •         •
      2.  Final design complete

      3.  -Construction award


      4.  Construction ccnplete
                        •
      3™  2 i i»< 4 a u -A i " '' ! * »T ^ a^g*a
       •  f»«»
• March  1979

 December  1979

 Karch  1980

 November  1981
       1      •
 February  1232
 P.ertarks
 None
 Prscrass P.sscrrs
 SPA, Region  T7
 343 Courtland Streettf N.2.
 Atlanta, Georgia    30308
                      . *
 Alabama Water Improvement Commission
 James W. Warr,  Director
 State Office Building
 . Montgomery/  Alabama  36130

-------
                                  ,
                                          NPDES Permit 5

                                          TH0002381
 Hols ton  Army  Anno  Plant  Kingspor

Project Description

      This  project  will- involve construction  of a new treatment
"facility1 for  collection and  treatment of  all liquid industrial
 wastes at Eolstsh
          ' Schedule
         _
     J'.  Final design start

     2.  Final" design complete

     3 .  Construction- award

     4.  Construction complete

     5.  Achieve compliance
                                   August  1975
                                     .         •
                                   April 1979

                                   September 1979

                                  ' May. 1982

                                   November  1982
Progress Resorts
 SPA, Reg-Ton
 345 Courtland Street> N.E.
 Atlanta, Georgia   30308

 Division of Water Quality Control
 Tennessee Department of Public Health
 621 Cordell Hull Building
 Nashville, Tennessee   37219

-------
                                   Attachment     d


Facility             "'                       NPDES  Perrxit ?

 -one  Star Amy Anno  Plant  Texarkana, TX     TXOQ21768

Project Description           '                     -

  , • 'This project consists of the. upgrading  of  the  waste
 treatment-facility— for-lead  removal  f rota-electroplating _dis
 charges, -in addition
 controls. .      !   -
Compliance Schedule  •         .     •••       	

     ]. Final design start      "        September 1930

     2. Final design complete            June  1981

     3. Construction award.               October 1981

     4. Ccnsliruction 'ccsal'ete      '   "   June  19 82

     5. Achieve compliance               August 1932
    *          *•*•     "•           *        "'•'*«
„--..,.-!. _                                   	

      The scope  and compliance  schedule of this facility shall
be subject to revision"within  90  days pending the-negotiation
of a  less stringent NPDSS perait liait for lead with SPA
Reg/ion VI and the  State of  Texas.

Prccress P.eccrts
 EPA,  Region VI
 First International Suilding
 1201  Ela Street
 Dallas,  Texas   75270

 Texas Dept. of Water Resources
 Harvey Davis, Director
 P.O.  Hox 13087 Capitol Station
 Austin,  Texas   78711

-------
                                    A*- f» a /-»*»^o r^ 7*
                                    W ^^w*«M»*C** W
 Milan Amy Anno Plan '  Milan, TN

Project  Description
               NPDES  Permit

               TN000006Q
      This project-will involve upgrading of the existing Indus-
 -triaL-uas ta—treataent. plantlta...treat_pinjc. water discharges.  __.
      ].  Final design start

      2.  Final design complete

      3. 'Construction award

      4.  Construction complete

      5.  Achieve ccnpiiance
September .1977

February 1979
•

May 1979
      •       •
December 1930
     •
March 1931
- None
 Prccress Reports

 EPA, Region IV
 34S Courtland Street> N.E.
 Atlanta, Georgia   30303
              f
 D. Elmo Lunh, Director
 Division of Water Quality Control
 621 Cordell Hull Building
 Nashville, Tennessee    37219

-------
                                   Attachment       f



Facility                                   NPDES Perait $
                                                         •
- New Cumberland Army Depot   Fairfield, PA PA003S385

Project Description

           proje«rt--invo-lves-.-the 'upgrading-of the- exis ting
                                    '
     ]. Final  design start
                         •                      •

     2. Final  design couplets            June 1979

     3. Construction award      •         August  1979

     4. ' Constructic'n ccnplete. .     .      May 1980

     5. Achieve  ccapliance               July 10CO
  None
Procress  ?.e?crts

  EPA,  P.egicn III
  Curtis Building
-''6th S Walnut Streets
  Philadelphia, Pennsylvania   19106

  Department of Environmental Resources
  Willian Middendorf,  Director
  P.O.  Box 2063
  Karrisburg, Pa.   17120

-------
                                   Actacrunent n
 Facility                                       NPDES Pemit §

 L-.uie Bluff Arsenal  Pine Bluff, AR             AR0034622

 Project Description
ia-35
.This project involves the tie-in of drainage systems
5. buildings-to the-existing waste treatment- facility »-.
Ccrtpliar.ee  Schedule'               •'         •      '
^^•tfHMVHM^MMHM*M^H^H)^^>BOT^H*MMHMWBMI^H^HM*Mr           *          •            •

      J.  FinaA desigr. start    '          March" 137S

      2.  Final design complete           July 1979

      3 .  Construction award              September 13.79
•    *   *      m

      4.  Construction, cocplete           March 1930

      5.  AchieTa compliance              April 1980
     Compliance schedule based en  FY 79  funds"be'ing successfully
 rsprogr?.Trr*,ed. ...'._
 Prccrsss  Reports
EPA, Region  IV
First  International  Building
1201 Sin  Street
Dallas, Texas    75270

Arkansas  Department  of  Pollution Control
   s Ecology
Jarrell S. Southall, Director
8001 National Drive
Little Rock, Arkansas    72209

-------
                                    Attachaent
        h
 Facility
     NPDES Perr.it *
 Radford Amy Ammo  Plant   Montgomery .Co. , VA  VA.0.000248
 Project Description
                    •
	  ._Th-is  pjrpject^will. upgrade ^the existing' industrial vasts
 treataent'^raciiity-to improve~tre&-taantVbf~ .fTTfl upi'n_•&:.from ______
 - munitions                                         ''"
 Ccnpliar.cs Schedule
      3.  Final'design start
      2.  Final design ccnplete
      3.  Construction award.
      '4.  Construction "ccaplete
      5.- Achieve ccsisliance
NA
March  1373
•June 1978
December 1980
January 19 SI
  None
 Progress Reports
  SPA,  Region'III
  Curtis Building
  6th & Walnut Streets/
  Philadelphia, Penn.   19106
  Virginia Stats Water Control Board
  Robert Davis, Director
  2111 No. Hamilton Street
  Richmond, Va.   23230

-------
                                   Attachment
Facility

 Redstone  Arsenal   Redstone, AL
                              •

Project Description
           NPDES Perniit §

           ALOOQQQ19
      This  project will  upgrade  three  existing sewage trsataenl
 plants  and connect  miscellaneous  discharges  to the sanitary
Compliance' -Schedule

  '  * 1 . Final 'design- start'

     2; Final' design complete

     "3 . ' Construction award
        * •

     4 . Construction complete

     5 . Achieve compliance
NA

January 1980

April 1980.

November 1931

Tebruary 1932
 None
?rcgress Reports

 E?Af  Region IV
 345 Courtland Street',,».2.
 Atlanta,  Georgia   30308

 Alabama Water laproveaent Commission
 James W.  Warr, Director
 State Office Building
 Montgomery, Alabama   36130

-------
Facility
 Seneca Army Depot   Romulus, NY
Project Description
                                   Attachment   j
                                              NPDES Permit
                                              NY0021296
 requirement.
Compliance Schedule
     ]. Final design start     Fehruarv 19 79
     2. Final design ccinolete  February 1980
     3. Construction award     Anril 19 80
     4.- Construction ccaclete. November 1981
     5. Achieve compliance  _   Decenier 1981

Remarks
 Ncne
Progress Reports
• SPA, Region II
 25 Federal Plaza
 Room 1009
 New York, N.Y.   10007
 Dept. of Environmental Conservation
 Region VII
 100 • EizT./cod Davis Road
 No. Sysacuse,  N.Y.   13212

-------
Monday
July 28, 1980
Part VI
Environmental

Protection  Agency

Statement of Policy on the Labejing
Requirements for Exported Pesticides,
Devices, and Pesticide Active Ingredients
and the Procedures for Exporting
Unregistered Pesticides

-------
 50274	Federal Register / Vol. 45. No. 146  /  Monday, July 28,1980 / Rules and Regulations
 ENVIRONMENTAL PROTECTION
   -.ENCY

 ,0 CFH Parts 162, 163,164,165,166,
 167, 168, 163, 170, 171. 172, 173, 174,
 175, 176, 177, 178, 179, and 180

 [FRL 1546-S]

 Statement of Policy on the Labeling
 Requirements for Exported Pesticides,
 Devices, and Pesticide Active
 Ingredients and the Procedures for
 Exporting Unregistered Pesticides

 AGENCY: Office of Enforcement,
 Environmental Protection Agency (EPA
 or the Agency).
 ACTION: Notice of policy statement.

 SUMMARY: The Federal Insecticide.
 Fungicide, and Rodenticide Act (FTFRA
 or the Act) was amended by the Federal
 Pesticide Act of 1978 on September 30,
 1978. Section 17{a) of the Act was
 modified so that pesticides, devices, and
 active ingredients used in producing
 pesticides which are manufactured for
 export must now bear certain minimal
 labeling, and Cr.2 producers of such
 products are now subject to the
 requirements of both F1FRA sections 7
 [establishment registration) and 8
 (books and records). In addition, unless
 a pesticide is registered under section 3
   is being sold under section 6(a)(l) it
  .nnot be lawfully exported unless,
 prior to export. (1)  the foreign purchaser
 has signed a statement acknowledging
 that the purchaser  understands  that the
 pesticide is unregistered and therefore
 cannot be sold in the United States, and
 (2) a copy of that statement has been
 transmitted to EPA for transmittal to the
 appropriate officials of the importing
 country. This foreign purchaser
 acknowledgement statement must be
 acquired by the exporter and
 transmitted to EPA for the first shipment
 of each unregistered pesticide to a
 particular purchaser for each importing
 country, annually.
  This notice informs the public of the
 scope of the.new labeling requirements
 and of the procedures that an exporter
 of unregistered pesticides must follow to
 acquire acknowledgement statements
 which will be transmitted by the U.S.
 Government to the  government of the
 importing country.
 EFFECTIVE DATES: Labeling. Labeling
 requirements for exported pesticides,
 devices, and pesticide active ingredients
 became effective March 29.1979,
 (Federal Pesticide Act of 1978, Pub. L
95-396, 92 Stat. 833). Therefore, exported
products which fall within the purview
 ^f this notice must now bear labels
  hich comply with the statutory
 dquirements of FIFRA section 17(a)(l).
   Purchaser Acknowledgement
 Statements. After thirty days from the
 date of this notice, exporters of
 unregistered pesticides will be in
 violation of FIFRA if the foreign
 purchaser acknowledgement statements
 have not been acquired before shipment
 and transmitted to EPA in accordance
 with this policy.
 FOR FURTHER INFORMATION CONTACT:
 John ]. Neylan III, Office of Enforcement,
 Pesticides and Toxic Substances
 Enforcement Division (EN-342), EPA,
 401 M Street, S.W.. Washington, D.C.
 20460 (202) 755-1212.
 SUPPLEMENTARY INFORMATION: On
 Wednesday, July 18.1979, EPA's Office
 of Enforcement published a proposed
 statement of policy on the labeling
 requirements for exported pesticides,
 devices, and pesticide active ingredients
 and the procedures for exporting
 unregistered pesticides, [44 FR 41955].
 That proposed policy statement
 explained in some detail what
 information would be required to appear
 on the labels or labeling of pesticides,
 devices, or pesticide active ingredients
 destined for export in order to be
 considered in compliance with the law.
 It also described the  procedures for
 acquiring from a foreign purchaser of
 unregistered pesticides a statement in
 which the purchaser acknowledges the
 registration status of the pesticide. Both
 of these requirements became effective
 180 days after the date of enactment of
 the Federal Pesticide Act of 1978 (March
 29,1979).'
  The July 18 notice invited the public to
 comment on the proposed policy before
 September 17,1979. Twenty-three
 comments were received. Following is a
 summary of the major modifications to
 the policy statement  made as a result of
 the comments.
  (1) A more detailed explanation was
 included of which products will be
 considered as not registered for use in
 the United States, for purposes of this
 policy statement.
  (2) The policy statement explains in
greater detail what labeling is expected
to appear on exported pesticides,
devices, and pesticide active
ingredients.
  Appendix A contains summaries of
the comments made to  the July 18,1979
policy statement and the Agency's
response to them.
  Accordingly, the Office of
Enforcement's general statement of
policy on the labeling requirements for
exported pesticides, devices, and
pesticide active ingredients and the
  1 Pub. L 95-398. 92 Stat. 819. September 30,1978,
Section 16[b).
 procedures for exporting unregistered
 pesticide are set forth below.
   Dated: July 10, I960.
 Jeffrey C. Miller,
 Acting Assistant Administrator for
 Enforcement.  ,

 L Summary of Policy

   Pesticides, devices, and active
 ingredients used in producing pesticides
 which are manufactured for export must
 now bear labeling which will serve to '
 both identify the product and the
 producer and to protect persons who
 come in contact with the product.
 Certain of the label items must be
 written in both the English language and
 in the language of the importing country.
 These bilingual labeling requirements
 apply to the product's ingredient
 statement and its warning and
 precautionary statements. Exporters of
 pesticides which are not registered for
 use in the United States (in accordance
 with this policy) must obtain a
 statement from the foreign purchaser of
 the pesticide in which the purchaser
 acknowledges the registration sta-tus of
 the product. The pesticide must also
 bear labeling to indicate that it-is not
 registered in the United States. For
 purposes of this policy an unregistered
 pesticide is one which (1) contains an
 active ingredient not found in a
 federally registered product; or (2)  bears
 labeling for a use which is currently
 subject to denial or cancellation of
 registration; or (3) is not similar in
 composition and use pattern to a
 federally registered product
  The acknowledgement statement must
 (1) identify the purchaser, the exporter,
 the product's identity and the product's
 destination; (2) be obtained for the first
 shipment of a particular pesticide to a
 particular purchaser for each importing
 country, annually; (3) be obtained before
 exportation takes place: and (4) be
 transmitted to EPA within seven (7)
 days of receipt by the exporter.

 n. Labeling  Requirements
  Section 17(a) of FIFRA has been
 amended to provide as follows:
  (a) Pesticides and Devices Intended for
 Export.—notwithstanding any other provision
 of this Act. no pesticide or device or active
 ingredient used in producing a pesticide
 intended solely for export to any foreign"
 country shall  be deemed in violation of this
 Act—
  (1) when prepared or packaged according
 to the specifications or directions of the
 foreign purchaser, except that producers of
such pesticides and devices and active
ingredients used in producing pesticides shall
be subject to sections 2(p). 2|q)(l)(A). (C). (D).
(El. (G). and (H). 2(q)(2)(A). (B). (C](i) and
(iii), and (D), 7, and 8 of this Act;

-------
              Federal Register / Vol.  45. No. 146  /  Monday. July 28.  1980 /  Rules and Regulations       50275
   Every exported pesticide, device, and
 active ingredient used in producing a
 pesticide must bear a label or labeling,
 in English or in the language of the
 importing country, which meets the
 requirements of FIFRA section 17(a)(l).
 In addition, certain information which
 will satisfy FIFRA sections 2(q)(l)(E).
 (G). and (H) and 2 (q)(2)(A) and (D) must
 also appear on the label or labeling so
 as to provide bilingual (in other words,
 in English and in the language of the
 importing country) information  to
 anyone who handles or comes in contact
 with these products. Any language in
 which official government business is
 conducted in the country or which is the
 predominately  spoken language of the
 country, is acceptable as the second
 language on the label
   Pursuant to Section 17{a)(l), all
 exported pesticides, devices, and active
 ingredients used in producing pesticides
 must bear labels or labeling which:
   (a) bear EPA Establishment Numbers;
   (b) have ingredient statements;
   (c) have the name and address of the
 producer or registrant;
   (d) have statements of net weight or
 measure;
   [ej if highly toxic, bear skull and
 crossbones and statements of practical
 treatment in case of poisoning;
   (f) include warning and caution
 statements;
   (g) do not make false representations;
   (h) are not in imitation of other
 products; and
   (i) in the case of unregistered
 pesticides, bear the statement "Not
 Registered for Use in the United States
 of America." All such required
 statements must be conspicuous and
 readable.
  To satisfy FIFRA section 2(q)(l)(E),
 the labeling provisions set forth  below
 must appear in the English language and
 in the language  of the importing  country.
 This section specifies that required
 statements must be represented ". .  . in
 such terms as to render it likely to be
 read and understood by the ordinary
 individual .  . ." Therefore, the following
 information must appear bilingually on
 exported product labeling:
 '(a) the warning and caution
 statements;       • -
  (b) the ingredient statement
  (c) where required, the word "poison"
 and the statement of practical treatment;
 and
  (d) the statement "Not Registered for
Use in the United States of America."
  The following may provide more
specific guidance on particular elements
which must appear on the label or
labeling of each exported product:
  a. EPA Establishment Number. The
Establishment Number may appear
 anywhere on the label or immediate
 container in accordance with the
 establishment registration labeling
 requirements set forth in 40 CFR
 § 162.10(f).
   b. Precautionary Statements. Warning
 or caution statements must be biligual
 and must be adequate for the protection
 of persons handling the pesticide,
 particularly with respect to general
 lexicological hazards and
 environmental, physical, or chemical
 hazards. Where, the bilingual translation
 is obviously inappropriate to protect
 residents of the importing country, (for
 example, where a label calls for a gas
 mask meeting the specification of the
 U.S. Bureau of Mines) an equivalent
 caution may be substituted.
   c. Unregistered Products. Labels of
 pesticides which are not registered
 under FIFRA (See Products Subject to
 the Requirement for an
 Acknowledgement Statement below)
 must prominently display the following
 statement "Not Registered for Use in
 the United States of America." This
 statement must appear bilingually.
   d. Ingredient Statement. The
 ingredient statement must appear
 bilingually unless the ingredients are
 easily identifiable despite their being
 listed in a foreign language.
  e. Use Classification Statement. The
 statement of use classification
 (Restricted Use Pesticide or General Use
 Pesticide) must appear on the labeling of
 the pesticide; however, summary
 statements regarding the terms of the
 restriction, e.g., "For retail sale to and
 application only by Certified
Applicators . . ." are not required.
  f. Identity of Parties. Name and
address of the producer, registrant, or
person produced for must appear in the
labeling.
  g. Net Weight. The net weight must
appear on the labeling in either
conventional English units or metric
units.
  h. Highly Toxic Pesticides. If the
pesticide is highly toxic, the skull and
crossbones, the word "Poison", and  a
statement of practical treatment must
appear on the labeling. The word
"Poison" and the statement of practical
treatment shall be bilingual. The skull
and crossbones may be in red or black.
For guidance on what pesticides are
highly, toxic, see 40 CFR § 162.10 (h).
  The Agency is  concerned that labeling
required by FIFRA not conflict with
labeling requirements of the importing
country. Such a situation might arise, for
example, where pesticides are being
exported to a foreign country with strict
labeling and registration laws such as
this country has. To avoid such potential
conflicts, yet  still meet the statutory
 requirements of FIFRA, exporters may
 use supplemental labeling. Pesticides,
 devices, and active ingredients used in
 producing pesticides may, therefore,
 bear a label with the appropriate
 information required by FIFRA section
 17(a)(l) or may be accompanied by
 supplemental labeling in instances
 where FIFRA required labeling is in
 contravention of foreign labeling
 requirements. Supplemental labeling
 may be attached to or accompany the
 product container or shipping container.

 III. Foreign Purchaser Acknowledgment
 Statement
   Section 17 of FIFRA has been further
 amended to provide as follows:
   (a) Pesticides and Devices  Intended for
 Export.—Notwithstanding any other
 provision of this Act, no pesticide or device
 or active ingredient used in producing a
 pesticide intended solely for  export to any
 foreign country shall be deemed in violation
 of this Act—
   (2) In the case of any pesticide other than a
 pesticide registered under section 3 or sold
 under section 6(a)(l) of this Act. if, prior to
 export, the foreign purchaser has signed a
 statement acknowledging that the purchaser
 understands that such pesticide is not
 registered for use in the United States and
 cannot be sold in the United States under the
 Act. A copy of that statement shall be
 transmitted to an appropriate official of the
 government of the importing country.
   This notice also delineates what
 pesticide products are affected by this
 provision and procedures  EPA believes
 would satisfy the purposes of section
 17(a)(2).

 IV. Products Subject to the
 Requirements for an Acknowledgment
 Statement
   Many pesticides which are produced
 in the United States solely for export
 contain active ingredients that are also
 registered as components  of pesticides
 used within the United States. However,
 the export formulations in many cases
 contain slightly different percentages of
 active ingredients and are labeled
 differently. Several factors dictate these
 minor modifications in formulation and
 labeling, such as different  systems of
 measurement, pests to be controlled
 which are different from those for which
 the same or a similar pesticide product
 is used in the United States, and
 requirements for labeling in a language
 other than English.
  The Agency believes that Congress
 did not intend the requirement for
 obtaining an acknowledgement
 statement which is applicable to
 "unregistered" pesticides to apply to
products which are minor variations on •
formulations registered in  the United
States and which contain only active

-------
 50276       Federal Register  /  Vol. 45.  No. 146  /  Monday.  July  28. 1980 / Rules and Regulations
 ingredients «.v  v        •   •"•!  -•l-
 United States >• •           ••*  \g<--'. v s
 view that the c»p...: a : • . u.ner.'.s were
 meant to apply in cases in which either
 (1) an adverse decision concerning the
 use of the pesticide in the United States
 has been made, or (2) no decision has
 been made concerning use of the
 pesticide.. The requirement for obtaining
 an acknowledgement statement from a
 foreign purchaser will apply to pesticide
 products in which:
   (a)'The pesticide active ingredient has
 been judged to pose "unreasonable
 adverse effects" to man or the
 environment, and the registrations of
 products with that active ingredient
 have been cancelled or denied: or
   (b) Either, (1) no assessment or no
 conclusive assessment of the hazard
 resulting from use of the pesticide has
 been made by EPA (while the pesticide
 may have been used under limited
 experimental or emergency conditions),
 (2) the pesticide has never been
 registered under section 3 because
 registration for the pesticide active
 ingredient has not been sought  or has
 not yet been granted, or (3) the  pesticide
 is being exported for a use which is
 substantially different from  any
 currently registered use of that  pesticide
 (e.g., a pesticide which is registered in
 this country for use as a termiticide is
 exported bearing directions  for use on
 food crops).
  Consequently, the Agency interprets
 section 17(a)(2) to apply to:
  (a) All pesticide products which
 contain an active ingredient that is not
 found in a federally registered product;
  (b) All pesticide products  bearing
 labeling for a use which is currently
 subject to denial or cancellation of
 registration (section 17(a)(2) will also
 apply to uses not considered by the
 Administrator during a cancellation or
 denial determination): and
  (c) All pesticide products which are
 not similar in composition and use
pattern to a federally registered product.
  To be considered similar in
composition and use pattern, a pesticide
product must contain only the same
ingredient or combination of active
ingredients and must have the same
category of toxicity as a federally
registered product. Also, the use pattern
must be similar to the use pattern of the
federally registered pesticide to which it
is being compared. Registrations
involving changes in use patterns such
as changes from non-food to  food use,
outdoor to indoor use, terrestrial to
aquatic use, or non-domestic to
domestic use. are not considered to
qualify as similar use patterns. Pesticide
uses which were never reviewed during
a cancellation or denial of registration
 !p'erm;nHtion (such as a pesticide use
 in a (.rop which is not grown in the
 L'ni'.ed States) also do not qualify as a
 similar use.
   Pesticide products which are subject
 to the requirements of section 17(a)(2)
 must also bear the label statement, "Not
 Registered for Use in the United States
 of America" stipulated by section
 2(g)(l)(H) of this Act.
  A pesticide product which has been
 registered under Section 24(c) of FIFRA
 will be considered as registered for
 purposes of this policy. A pesticide
 product which may be legally used only
 under an experimental use permit
 (Section 5) or an emergency exemption
 (Section 18) will not be considered as
 federally registered. Nor will a pesticide
 product whose distribution and use are
 legal in intrastate commerce because the
 producer has filed an application for
 federal registration in accordance with
 the procedures found in 40 CFR § 162.17.
 Technical grade and manufacturing use
 pesticides which are not federally
 registered will be considered as
 registered for purposes of this policy, if
 they qualify as being similar in
 composition to a registered formulation.
 use pesticide, (i.e., if the products have
 the same active ingredients and
 category of acute toxicity).

 V. Procedures
  Section 17(a)(2) requires that before a
 pesticide which is not registered for use
 in the United States can be exported, the
 foreign purchaser of the pesticide must
 acknowledge in writing that he
 understands the registration status of
 th"e pesticide and that the pesticide
 cannot be sold in the United States. An
 exporter of unregistered pesticides must
 have received the required
 acknowledgement statement before the
 product is released for shipment. The
 Agency feels that requiring exporters to
 have in hand the purchaser
 acknowledgement statement before
 exportation takes place is the only way
 to assure that foreign purchasers comply
 with these new FIFRA export
requirements. The Agency recognizes
 that this requirement may cause some
 disruption in the export of pesticides.
However, any such delays will be
visited only upon exporters of
unregistered pesticides, and then only
 for the first shipment to a foreign
purchaser, in a particular country,
 annually. The information required on
the acknowledgement statement, along
xvith a certification signed  by the
exporter, must be transmitted to the
Environmental Protection Agency within
seven days of receipt by the exporter, or
by the date of export, whichever occurs
first. The certification must state that.
 the shipment did not take place before
 the exporter had the signed
 acknowledgement statement in hand.
   The Agency will consider the receipt
 of purchaser acknowledgement
 statements by. local company
 representatives in foreign countries to
 be receipt by the exporter. Nevertheless.
 the information required by the
 acknowledgement statement must still
 be transmitted to EPA within seven
 days of receipt, or by the date of export.
 whichever occurs first
 Acknowledgement statements may be
 acquired at any time in advance of
 shipment. For example, an exporter that
 ships to  the same foreign purchasers
 year after year may acquire at the
 beginning of a year all of the
 acknowledgement statements which are
 anticipated to be needed.
   The Agency will transmit the
 acknowledgement statements to
 appropriate foreign officials through the
 Department of State. Statements will be
 transmitted promptly after receipt.
   The Agency believes that the purpose
 of the purchaser acknowledgement
 statement is to advise foreign
 governments that pesticides which have
 been judged by the United States to be
 hazardous to human health or the
 environment, or pesticides for which no
 hazard assessment has been made, are
 being exported by U.S. producers to
 their country.  Foreign governments may
 then use such information as they
 desire, perhaps, for example, in
 evaluating the risk of continued use of
 the pesticide in that country versus the
 benefits  that pesticide provides. The
 Agency does not consider that the
 acknowledgement statement is primarily
 intended to serve as preshipment
 notification to foreign governments in
 order that they may intercept shipments
 of such pesticides. Nevertheless,
 because  of the Agency's concern that
 acknowledgement statements reach
 foreign governments  in a timely manner,
 the information contained in the
 acknowledgement statement will be
 forwarded to foreign governments
 promptly upon receipt by EPA.
   As an  information mechanism, the
 purchaser acknowledgement statement
 serves the purpose of alerting the foreign
 government that a certain pesticide is
• entering  its country. The Agency
 believes  that the first notice fulfills this
 purpose; repetitive notices would be of
 only marginal value, and in cases of a
 high volume of exports to a foreign
 country,  might result in a flood of paper.
 After considering the administrative
 burdens  placed on exporters, EPA. and
 foreign governments and the value of
 repetitive notices, the Agency has
 concluded that each exporter should

-------
             Federal Register / Vol. 45. No.  146 / Monday. July 28.  1980 / Rules  and Regulations	50277
 complete and have signed a purchaser
 acknowledgement statement, for the
 first shipment of a particular product to
 a particular purchaser for each
 importing country, annually. A shipment
 of the same product to a different
 purchaser or to the same purchaser for
 disposition to a different importing
 country would also trigger the
 requirement for obtaining a signed
 acknowledgement statement from the
 foreign purchaser. A second shipment  •
 during the same calendar year, involving
 the same product, purchaser, and
 importing country would not trigger this
 requirement Any change in the
 variables—different purchaser, different
 product, different importing country—
 will result in the need for obtaining a
 new purchaser acknowledgement
 statement
  In summary, the procedures that an
 exporter of unregistered pesticides must
 follow in obtaining and transmitting
 foreign purchaser acknowledgement
 statements are:
  (a) The exporter must provide  the
 foreign purchaser with instructions
 about the required information on an
 acknowledgement statement and inform
 the foreign purchaser that shipment of
 the pesticide cannot be undertaken
 unless the exporter has received from
 the foreign purchaser a properly
 completed, signed, and dated
 acknowledgement statement;
  (b) The exporter must secure, prior to
 shipment, an acknowledgement
 statement which contains the
 information outlined in the Required
 Information section of this notice. Such
 a statement must be secured for the first
 purchase each year of a particular
 pesticide product by a foreign purchaser
 destined for a particular country;
  (c) The exporter must forward  the
 information required on the
 acknowledgement statement, along with
 the certification that exportation did not
 take place until a signed
 acknowledgement statement was
 received, within seven (7) days of
 receipt, or by the date of exportation,
 whichever occurs  first, to the following
 address: Environmental Protection
 Agency, Pesticides and Toxic
 Substances, Enforcement Division (EN-
 342). 401 M Street SW.. Washington,
D.C. 20460.
  Attention: Export Acknowledgement
Statement.

VI. Required Information
  As previously stated, a foreign
purchaser of a pesticide which is not
registered for use in the United States
must sign a statement acknowledging
his understanding that the product is
 unregistered and cannot be sold in this
 country. The Agency does not intend to
 prescribe a format for this
 acknowledgement statement. However,
 the statement must include the following
 information:
   (a) Name and address of the exporter;
   (b) Name  and address of the foreign
 purchaser
   (c) Name of the product and the active
 ingredient and an indication that the
 purchaser understands that the product
 is not registered for use in the United
 States:
   (d) Destination of the export shipment,
 if different than purchaser's address;
   (e) Signature of the foreign purchaser;
 and
   (fj Date of the foreign purchaser's
 signature.

 VII. Confidentiality
  Persons submitting the information
 specified in Part VI may assert a claim
 of business confidentiality by marking
 this information as "FIFRA Confidential
 Business Information." Information so
 marked will not be disclosed, with the
 exception of disclosure to the foreign
 government except in accordance with
 the procedures set forth in 40 CFR Part
 2. 7 USC 136h, and this policy statement.
 If such claim is not asserted, EPA may
 disclose the  information to the public
 without providing notice of disclosure or
 an opportunity to object
 Notwithstanding any claim of
 confidentiality, the acknowledgement
 statement will be forwarded to the
 appropriate foreign government in its
 entirety as required by section 17.

 VIII. Relationship  to Other Statutory
 Requirements
  Producers  of pesticides/devices, and
 active ingredients  used in producing
pesticides which are intended for export
are subject to the establishment
registration procedures, including the ..
report requirements, as well as the
record keeping requirements of FIFRA.
The Agency has proposed amendments
 to the regulations which are
 promulgated under the authority of
 those parts of the Act (sections 7 and 8)
 to bring them into  conformity with the
newly amended FIFRA. These
regulations are found at 40 CFR Part 167
and Part 169, respectively.
  Pesticides, devices, and pesticide
active ingredients  for export are not
considered to be in violation of FIFRA
when produced according to the
directions of the foreign purchaser,
when properly labeled and, in the case
of unregistered pesticides, when the
foreign purchaser has signed a
statement in which he acknowledges
that he understands the registration
status of the  pesticide and the exporter
 has forwarded the statement to EPA.
 Exported pesticides, devices, and active
 ingredients used in producing pesticides
 which do not bear labels or labeling in
 compliance with FIFRA section 17(a){l)
 will be considered to be misbranded.
 Exporters of such products will be
 subject to civil or criminal liabilities for
 violation of FIFRA sections 12(a)(l) (D)
 or (E)—misbranding. Exporters of
 unregistered pesticides will be  subject to
 civil or criminal liabilities for violation
 of FIFRA section 12(a)(l](A>—selling or
 distributing a pesticide which is not
 registered—if they fail to secure, prior to
 export, a properly completed, signed,
 and dated acknowledgement statement
 from the foreign purchaser of the
 pesticide. Falsification of the required
 certification may subject an exporter to
 sanctions under IB U.S.C. 1001.
 Appendix A.—Significant Comments
 and Responses
 General Comments
  Comment No. 1. Applicability of
 Rulemaking Procedures. Two
 commenters stated that the Agency
 should have implemented the export
 provisions of FIFRA Jhrough the
 procedures established by the
 Administrative Procedures Act for the
 promulgation of "substantive" rules. The
 Agency disagrees. As mentioned
 previously, these requirements  for
 export labeling and purchaser
 acknowledgement statements were
 statutorily effective March 29,1979,180
 days from enactment of the Federal
 Pesticide Act of 1978. The law lists the
 type of information required on an
 exported pesticide's labeling and the
 legislative history makes it clear that
 purchaser acknowledgement statements
 are to be transferred to foreign
 governments in the same manner that
 cancellation notices are furnished. The
 Agency's position, therefore, is  that
 there is no need for rulemaking but
 rather there is a need for a general
 statement of policy on such matters as:
 (a) what  would constitute minimally
 acceptable labeling, (b) how such
 labeling could be attached or
 accompany shipments, and (c) how   _
 foreign purchaser acknowledgement
 statements are to be transmitted to
 foreign governments.
  Comment No. 2. Use of Suspended
 and Cancelled Pesticides List. Another
commenter suggested that foreign
countries can be adequately informed  of
 the hazards of U.S. manufactured
pesticides through' an expansion of the
Suspended and Cancelled Pesticides
List. This is not the intended function of
 the Suspended and Cancelled Pesticides
List. That list constitutes only a guide

-------
 50270
Federal  Register / Vol. 45. No. 146 / Monday, July 28. 1980 /  Rules and Regulations
 for Government officials; it is not the
 final authority on the status of a given
 pesticide. It is the intent of Congress
 that the procedures that are followed for
 notifying foreign governments of the
 suspension or cancellation of pesticides
 be those which are also used  to inform
 them that an unregistered pesticide will
 be entering their country. Therefore, the
 channel of communication described in
 this policy is derived from the
 procedures already used  to notify
 foreign governments of major
 suspension or cancellation actions.
   Comment No. 3. Scope  of the FIFRA
 Section 17 Requirements. A number of
 commenters addressed the definition
 contained in this policy statement of an
 unregistered pesticide. The Agency
 agrees that clarification on this point is
 necessary. It is not EPA's intent to limit
 export of" a chemical if it is properly
 labeled and the exporter complies with
 the procedures for obtaining and
 transmitting to EPA a properly executed
 acknowledgement statement.  A more
 detailed explanation of which products
 will be regarded as unregistered for the
 purposes of this policy has been given.
 One commenter objected to including
 products with denied or cancelled uses
 and products with different composition
 or use patterns with products  which
 contained no registered active
 ingredient. In drafting this policy
 statement. EPA adopted a broad
 interpretation of the registration status
 of a  pesticide.
  The Agency could have required
 exporters of ail pesticide products that
 were not registered under section 3 to
 acquire an acknowledgement  statement
 from the foreign purchaser. The effect of
 this would be that an acknowledgement
 statement would have been required for
 the overwhelming majority of exported
 pesticides since most exports  differ
 slightly in formulation or directions for
 use from the U.S. registered product, or
 ;hs labels are written in a foreign
 language. The EPA clearly stated in the
 proposed policy statement that in its
 view Congress did not intend  that
 exported products with minor variations
 from EPA registered pesticides be
 subject to the export notification
 procedures. However, products with
 cancelled uses or with substantial
 differences in composition or use
patterns cannot be considered products
with minor variations. The Agency must,
 therefore, reject this comment.
  Comment No. 4. Status of Certain
Unregistered Pesticides. One commenter
suggested that experimental use
products be treated as registered
products; another commenter thought
that products with temporary tolerances
                          should be considered as if they were
                          registered. Since registration data for
                          such products are not complete, it has
                          consistently been Agency policy to treat
                          experimental use products and products
                          with temporary tolerances as
                          unregistered products. Products which
                          bear registrations under section 24(c) of
                          FIFRA will, however, be treated as
                          registered products. Products undergoing
                          Rebuttable Presumption Against
                          Registration will be considered in
                          accordance with their registration status
                          at the time of export. It was suggested
                          by one commenter that those pesticides
                          which were registered by a foreign
                          country should not be subject to the
                          requirement for an acknowledgement
                          statement. In order to adequately
                          enforce a policy which took this
                          approach, the EPA would have to
                          evaluate the internal registration
                          procedures conducted by other countries
                          and to regulate exports based upon the
                          policies of the importing country. Thus,
                          EPA policy would be different for
                          similar shipments going to different
                          countries. The Agency rejects this
                          comment. Not only would it be
                          administratively difficult to operate such
                          an export program, but such a policy
                          fails to recognize the point of having the
                          acknowledgement statement To inform
                          foreign governments of the U.S.
                          registration status of a pesticide.
                            Comment No. 5. Non-Commercial
                          Exportation. Another commenter
                          requested clarification on the
                          application of the notice provision to
                          pesticides which are exported without a
                          commercial transaction. There are two
                          possible categories of products  to which
                          this comment might apply:  the first
                          would be small amounts of pesticide
                          exported for research purposes only; the
                          second would be large shipments
                          exported to a foreign establishment of
                          the domestic company which
                          manufactures it. Research quantities are
                          subject to the labeling rules of this
                          policy but not to the acknowledgement
                          statement requirement. Large shipments
                          transferred from a domestic facility to a
                          foreign facility of the same company will
                          be treated in accordance with their U.S.
                          registration status. That is,' if the product
                          is registered (in accordance with the use
                          of that term in this policy),  no
                          acknowledgement statement is required;
                          if the product is  not registered, an
                          acknowledgement statement will be
                          required.
                            Comment No.  6. Technical and
                          Multiple Use Chemicals. Some
                          commenters asked for clarification of
                          the impact of this policy upon
                          formulated and technical grade products
                          and multi-use products. Formulated and
 technical grade products which are
 subject to FIFRA are subject to this
 policy. The label on the exported
 product must comply with section 17 of ^
 FIFRA. A multi-use product for which n J
 pesticide claims are made and which is
 not an active ingredient in any pesticide
 product in the United States is not
 subject to this policy, even if it is
 subsequently processed into a pesticide
 in another country.

 Labeling Comments
  Comment No. 7. Use  of Bilingual
 Labeling. A number of commenters
 stated that the law did not require
 bilingual labeling. The  law states that an
 exported pesticides, device, or pesticide
 active ingredient must bear labeling in
 conformance with FIFRA section
 2(q)(l)(E). The FIFRA states in section
 2(q)(l)(E) that a pesticide is misbranded
 if:
  Any word, statement, or other information
 required by or under authority of this Act to
 appear on the label or labeling is  not
 prominently placed thereon  ...  in such
 terms as to render it likely to be read and
 understood by the ordinary individual under
 customary conditions of purchase and use;
 (Emphasis added.)
  The EPA interprets this passage to
 apply to ordinary individuals  in the
 importing country as well as in the
 United States. Thus, the bilingual
 requirements are meant to communicate.
 some basic information about the
 product to as many handlers of the
 pesticide as possible. International
 symbols, suggested by one commenter,  •
 could not adequately communicate all
 the required label elements, although
 they may be used in addition  to the
 required wording. Commenters asked ..
 for guidance regarding EPA's
 enforcement of the bilingual requirement
 in two specific instances: when the
 importing country has several official
 dialects, or when English is an official
 government language. Any language  in
 which official government business is
 commonly conducted in the country,  or
 which is the predominately spoken
 language of the country, is acceptable as
 the second language on the label. If
 English is one of these languages, then a
 bilingual label is optional, except as
 may be required by the importing
 country. One commenter asked if a
 translation of the U.S. label would be
 satisfactory'. Such a label would be
 acceptable if the necessary elements
 appeared both in English and in the
 foreign language.
  Comment No. 8. Foreign Labeling
Requirements. Several commenters
asked about the application of this
policy to labels ivhich comply  with the
laws of the importing country. It is not

-------
              Federal Register / Vol. 45. No.  146 / Monday.  July  28. 1980 /.Rules and Regulations	50279
 the intention of this policy to supersede
 the labeling requirements of foreign
 governments. However. FIFRA now   •
 requires that exported pesticides,
 devices, and pesticide active ingredients
 bear certain minimal labeling. If the
 labeling which currently appears on
 exported pesticides does not meet the
 minimum FIFRA requirements, even
 though it may meet the foreign country's
 requirements, additional labeling must
 be added to satisfy U.S. law.
   Comment No. 9. Supplemental
 Labeling. Several commenters suggested
 that supplemental labeling be liberally
 allowed. The Agency intends to be as
 flexible as possible in this respect.
 Exporters will be permitted to use a
 variety of types of labeling to comply
 with the FIFRA export requirements. x
 The Agency's principal interest will be
 to ascertain that products to which this
 policy applies bear labels or labeling
 which, taken together, conform to the
 FIFRA section 17(a](l) requirements.  •
  Comment No. 10. Establishment
 Numbers. One commenter requested the
 option of substituting another code for
 the EPA Establishment Number on the
 label. The Act clearly requires that an
 Establishment Number appear on the
 label. The Agency must reject this
 suggestion since permitting other means
 of identifying the production
 establishment would negate the
 usefulness of such numbers.
  Comment No. 11. Restricted Use
 Pesticides. Several commenters
 requested guidance on label
 requirements for exported restricted use
 pesticides. If the product is a restricted
 use pesticide, then the statement
 "Restricted Use Pesticide" must appear
 on the label or labeling. The
 supplementary statement of the terms
 and conditions of restriction is not
 required.
 Acknowledgment Statement
  Comment No. 12. Prior Possession of
 Acknowledgement Statements. A
 number of commenters questioned the
 requirement that the acknowledgement
statements be in the exporter's
possession before shipment of the
pesticide can take place. Other
commenters stated that in their opinion
foreign importers,  through oversight or
bureaucratic inefficiency, will not
comply with the acknowledgement
statement requirement. In the proposed
policy statement, the Agency clearly
recognized the problem of non-
compliance by foreign importers. For
this precise reason, EPA must reject the
contention that acknowledgement
statements should not be required to be
in the exporter's control before shipment
can take place. A more liberal
  interpretation of what constitutes
  receipt of the acknowledgement
  statements has been provided in the
  final policy statement to facilitate
  compliance. One commenter suggested
  that a signed acknowledgement in the
  hands  of a local company representative
  be considered a receipt by the exporter.
  The Agency agrees that this would be
  acceptable so long as the information
  required on the -acknowledgement
  statement is sent to EPA within the
  stated  time period. If a company
  anticipates several orders in a year, the
  acknowledgement statements may be
  obtained in advance of the actual order.
  One commenter stated that the
  requirement that acknowledgement
  statements be sent to EPA within seven
  days of receipt by the exporter was too
  restrictive. This commenter suggested
  that transmittal of the  acknowledgement
  statement should be tied to the date of
  shipment. The Agency disagrees. Where
  possible, acknowledgement statements
  will be sent to foreign governments as
  far in advance of shipment as possible.
  This will provide the government some
  time to review the information received.
  The Agency feels more timely
  notification will occur if transmittal of
  the acknowledgement statement is tied
  to date of receipt.
   Comment No. 13. Certifications. Some
 .commenters objected to filing, along
  with the acknowledgement statement, a
  certification that the order was not
  shipped before the acknowledgement
 statement was received. The Agency
 believes that a certification statement is
 necessary. While some monitoring of
 compliance will.be through inspection of
 required books and records,  a
 certification requirement will serve to
 remind exporters that shipment must
 wait until the acknowledgement
 statement has been received.
   Comment No. 14. Destination of
 Shipment. One commenter suggested
 that there was no need to include in the
 acknowledgement statement the
 destination of the export shipment, if
 different than the purchaser's address.
 This comment is rejected because
 without this information the Agency
 would be unable to determine if-the
 labeling complied with the bilingual
 requirements nor would it know the
 proper place to send the
 acknowledgement statement.
   Comment No. 15. Annual Reporting.
 Several commenters stated that the
 requirement that a new
> acknowledgement statement be
 acquired each year that a particular
 product is exported is overly
 burdensome. They point out that the law
 requires an acknowledgement statement
 only once per country, not once per
 country, per year. The Agency must
 reject this comment. Although FIFRA is
 not clear on this point, the law seems to
 indicate that an acknowledgement
 statement .should be acquired for each.
 export shipment of an unregistered
 pesticide. It is the Agency's position that
 imposing such a requirement would be  a
 burden for all parties concerned—
 exporters, importers, and the U.S.
 Government, as well as foreign
 governments—beyond any regulatory
 purpose it may  serve. The requirement
 to send an acknowledgement statement
 once per year, which is similar to that
 being considered, under the Toxic
 Substances Control Act, is not overly
 burdensome, and yet accomplishes the
 purpose of regular notification to foreign
 governments.
  Comment No. 16. Notification of
 Foreign Governments. Several
 commenters questioned the procedure
 for notifying foreign governments. It was
 suggested that either the foreign
 purchaser or the exporter should
 directly notify the foreign government.
 The EPA rejects this proposal. First,, it
 would be difficult, if not impossible, for
 the Agency to monitor compliance under
 such a procedure. Second, as previously
 explained, the procedure for
 transmitting acknowledgement
 statements parallels that of the
 notification of foreign governments of
 suspended or cancelled registrations. It
 is the understanding of the Agency that
 such a procedure, namely government-
 to-government contact, was the intent of
 Congress.
  Comment No. 17. Problems with
 Importing Countries. Two commenters
 suggested that the policy be different for
 socialist or communist countries. These
 comir.enters cited their experience
 exporting pesticides to these countries
 where the "importer" is an agency of the
government. These import agendas are
 said by the ccmmonters to be staffed by
 very conservative bureaucrats who are
 reluctant to sign unusual requests. As
has been discussed earlier, it is not the
intent of this Agency to write a different
export policy for diiferent countries.
However, should numerous problems
arise with any particular country,  the
Agency will work with industry and the
Department cf State to solve them.
IFR Doc. (JO-2T055 F,!ed 7-:5-80:8:45 am]
BILLING CODE 6560-Ot-M

-------

                                                   OFFICE OF ENFORCEMENT
MEMORANDUM

SUBJECT:


FROM:


TO:
             Request Procedures  for Pesticide  Samples
             and" Followup on Pesticide Complaints
             John S. Seitz, Chief
             Compliance Monitoring Branch
             PTSED Staff
                                         V
     Recent confusion regarding requests  for  pesticide  samples  or
investigations has resulted in a need  to  formalize procedures  for
making such requests.  This memorandum and  attachments  describe
the new procedures.

     Situations which are referred  to  the regions can be  divided
into three major categories: 1) pesticide sample or  label  required,
2} complaint followup required, and  3) requests for  large  numbers
of any type of sample or investigation. 'Attachment  1 outlines
subcategories and appropriate responses for each.

     1.  Pesticide Sample or Label  Required

          Initiator of the request  should complete EPA  Form
          8500-1 "Special Request for  Sample"  (attachment  2)
          according-to directions in attachment 3.   This
          form should be given to the  Chief,  Compliance
          Monitoring Branch.  The request will be reviewed,
          authorized, and transmitted  to  the  region
          by the compliance monitoring coordinator for  that
          region.

     2»'x Complaint Followup Required

          Initiator should write down  all pertinent  information
          including who made the complaint, whert and where he/
          she can be reached, complete description of the  problem,
          and any memos, labels, advertising,  references,  etc.  that
          are pertinent.  This information  (which can be  hand-
          written if it's readable)  should be  given  to  the Chief,
          Compliance Monitoring Branch.  The  compliance monitoring
          coordinator will forward  the information to the  region.

-------
Large Numbers of Samples or Investigations

Initiator should provide all pertinent information to
the Chief, Compliance Monitoring Branch.  Mike Wood
will act as coordinator for all large requests.
Mr. Conroy will authorize the forwarding of these
requests to the regions.

-------
                                 Attachment I
                                  PROCEDURES
                    PESTICIDE SAMPLE REQUESTS AND REFERRALS
      SITUATION
Pesticide Sample Required

 Physical sample
 required for
 chemical or
 efficacy testing
 Documentary sample
 required:  label,
 pamphlets or
 advertising to
 be- reviewed
     gistered
 product, mis-
 branding,
 claims differ

 Complaint Followup Required

 Marketplace
 investigation:
 susoended/can-
 celled, health
 hazard
 Complaint:
 advertising
 followup
,Incident report:
    soning, ill-
   ^,  crop damage,
   Disuse
PAPER WORK
Sample request
form (8500-1)
-need registration
number
-check ERSS for
establishment
address and
recent production
-health hazards
are "urgent"
Sample request
form as above
except note:
Documentary
sample per
manual

Sample request
form, documentary
sample (see
above)
Buck slip for-
warding informa-
tion for
investigation;
phone call to
notify

Buckslip or memo
forwarding com-
plaint:  please
investigate and
document as
necessary

Memo forwarding
information, and/or
phone call,
depending on
severity or
public
interest
APPROVING
OFFICIAL
CMB STAFF
CMB STAFF
                                                    CMB STAFF
Chief, CMB
   SENT TO
Regional contact*
Regional contact
                  Regional contact
CMB STAFF
Pesticides Branch
Chief
Regional contact


Regional contact
AS
NECESSARY
AS NECESSARY

-------
-v SITUATION
                                  PAPER WORK
                       APPROVING
                       OFFICIAL
                     SENT TO
3.  Large Numbers  of  Samples or Investigations Required
a.  Large number  of
    samples  required
b.  Large numbers  of
    investigations/
    inspections
    required

c.  Milti-region
    request for
    samples,
    inspections

•REGIONAL CONTACTS

REGION

REGION I   ..-••'
REST™ ii
REC    III
pr    . iv
RL   .iJ V
REGION VI
REGION VII
REGION VIII
REGION IX
REGION X

FOLLOWUP
Contact Mike
Wood  (472-3701)
for instructions

Contact Mike
Wood  (472-3701)
for instructions
Contact Mike
Wood  (472-3701)
for instructions
Director, PTSED   Enforcement Division
                  Director
                  Pesticide  Branch Chiei

Director, PTSED   Enforcement Division
                  Director
                  Pesticide  Branch Chiei
Director, PTSED   Enforcement Division
                  Director
                  Pesticide  Branch Chief
CONTACT

C. Lincoln
S. Fenichel
J. Smith
R. Clark
G. Marsh
A. Anderson
J. Wicklund
B. Harding
R. Mandel
D. Donaldson
PESTICIDES BRANCH CHIEF

C. .Lincoln ..
S. Fenichel
N. Davis
R. Clark
M. Wrich
N. Dyer
J. Wicklund
L. Johnson
R. M. Stenburg
R. Poss
Originals of sample  request form and copies of referrals will be kept  in a regional
pesticide sample/referral  file.

v;•*..•:•.•-••- --.^v-•••>•.:.-•-.-»•-•'• -;.-;•. • .«<•;—-<• •••.•-->-T

PE.MS followup  should be  made periodically to determine status of sample.

?hc    alls to regional  contact  should be made when PENS followup is not possible or
she    o action.

-------
                                   Attachment 3

         Directions For Completing Form 8500-1 Special Request For Sample

                   DATE OF REQUEST

                   From: Compliance Monitoring Branch      ••                   •
                   Pesticides & Toxic Substances
                   Enforcement Division EN-342
                   Washington, D.C.

                   NAME OF ECONOMIC POISON

                   NAME AND MAILING ADDRESS OF REGISTRANT
                   This name and address should be the site at which  the  pesticide is
                   actually manufactured, formulated or distributed.   It  should  include
                   a street address which the inspector can use to locate the  company
                   and the establishment number if available.   Please check with
                   Carol Buckingham, Establishment Registration Support System coordi-
                   nator (755-2047), to make sure of the address, establishment  number,
                   and to verify that the product was actually produced recently^ at
                   that site.  This is to save state and regional inspectors unneces-   .    . y
••• •••••••       •   -sarv"trips to sites "that do not produce the pesticide'requested.   •'•'•'"'•'••-	•••"

Lc                  LAB TO RECEIVE SAMPLE
                   If a physical sample is requested for chemical or  efficacy  testing,
                   a laboratory address should be specified.   This laboratory  may be
                   a state pesticide lab, NEIC, Beltsville or  a contractor.                ..   ['

.ock  6:             SPECIFIC SAMPLE SIZE REQUESTED
                   Unless there is a specific reason for a large sample,  "MINIMUM11
                   should be specified in this block.  If documentary samples  are
                   requested, this block should read "DOCUMENTARY.1
                                                                  n
.ock  7:             DATE SAMPLE REQUIRED                      -             •       •••-. ••
                   Samples needed in less than 60 days should be marked "URGENT" and
                   justification given in Block 9.  All others will be collected when
                   the region or state can reasonably collect them.  In this case,
                   this block should remain blank.

.ock  8:             REGISTRATION NUMBER    -        -        -         -
               - .   This number should be obtained from label, fiche or Registration
 •                  Division.
ock   : .      '      REASON FOR COLLECTICN                                •      •       •  .
                   This block should contain all relevant information which resulted
                   in the request for collection of a sample.  The phrases "complaint",
                   "unregistered product" "misleading advertising" are not adequate.
                   Reference to letters or memos should be included as needed.  This
                   block should also contain the name, organization and phone number
                   of the requestor in case questions or problems arise.

-------
- Block 10-15:          Should remain blank.  The region or state will complete  these block:

  Slock 16:             SIGNATURE OF APPROVING OFFICIAL
                        This block will be completed by the Compliance Monitoring Brandt
                        regional liaison, Branch Chief or the PTSED  Director, as appropria'

-------
                                        •. OOVUMMtMT MHHTtMO OT'iCt 1972-722-709
            SPECIAL REQUEST FOR SAMPLE
                NOTE:  U«« o rapoiat* form for
                •aeh product r«qu*«t.
                                                                                        DATE OF REQUEST
 TOi
                FROM!
        Director, Pesticide Enforcement Division
        Environmental Protection Agency
        Washington, D.C.  20250
        Attn: National Sampling and Recall Section
 NAME OF ECONOMIC POISON (Mumt b» tmn« product •• on /«iW-
-------
     ENFORCEMENT FACTS
       AND STRATEGY
   *********************
        COMPLIANCE
   MONITORING PROCEDURES
WATER PURIFICATION DEVICES


       October 1930
              Pesticides &  Toxic  Substances
                   Enforcement  Division
                   Office of  Enforcement
           U.  3.  Environmental  Protection  Agency
                  Washington, D.  C.   20460

-------
STRATEGY OVERVIEW - - - -- - - -- -- -- - ----- 1

BACKGROUND ---------------------- • - 2

P.irjLATSD INDUSTRY ------------------- 3
APPLICATION OF FIPRA ------------------ 4
   Requirements of FI?RA
   FIFRA Enforcement Authorities

RE'-EDIES ------------------------ 6
   General
   Mi sb rand ing Purifier Claims
   Ineffective Water Purifiers
   Recall
   Other Violations of FIFRA
   Criminal Citations

COMPLIANCE MONITORING ----------------- 9
   Program Development Overviev
   Guidelines for* Select ion of Devices To Be Tested
   Inspection
   Post Inspection
   Testing
   Pesticide Enforcement Management System (PEMS)
   Outreach

CASE DEVELOPMENT -------------------- 14

ALLOCATION OF RESPONSIBILITIES ------------ -15

ENFORCEMENT FACTS AND STRATEGY ---- ---- ---- -19

-------
'trp.tegy Over view	

     Water purifiers are products which are intended to render
•av water safe to drink by removing pests (microorganisms) through
       clerical or physical means.   Water purification devices
       te pests (microorganisms)  from water by using a physical
:ethod such as ultraviolet light, filtration,  or other non-ch'emical
:ear.s.   To qualify as a "purifier", the product oust remove all
.isease causing microorganisms from the water, including bacteria,
•iruses, and cysts.   Since devices  are not subject to the regis-
• ration requirements under FIFRA, regulation of them falls entirely
vn the Office of Enforcement,  which must determine if they comply
•ith the other requirements of the  Federal Insecticide, Fungicide,
.rvi Rodenticide Act  to which they are subject.  The key to the
:crrliar.ce determination will be  verification of label claims
••hrough a program of product testing.

     The testing program will examine the purifier claim used by
-.any products.   If a product claims to be a purifier but it does
:ot remove test organisms in the  efficacy test, the product is
.eemed  to be misbranded and subject to enforcement action under
"I??..-.,  including Stop Sale Orders to remove the product from the
larketplacs.  The testing scheme  designed for this program consists
:f two"phases.   Phase I tests the ability of the products to
•emove environmental coliforms.   Phase II tests specific bacterial,
•iral and protozoan  pathogens likely to be found in water such
is Pseudomonas aerogenosa,  Poliovirus and Giardia lamblia.  To'
•ucstantiate a purifier claim,  a  product must pass both phases.
."r.us, if it fails Phase I,  enforcement actions will be taken,
.-: ^^it spending time and money on  the Phase II tests.
 I
     The goal of the program is to  remove from the market those
;rcducts which do not purify water  to protect  the health of persons
,-ho night rely on the products for  safe drinking water.-
                               -1-

-------
Backsround
                  by persons whose community water supply may be
                  «   I  ^    ^ ^     _!_•_.    »          ___!_
temporarily contaminated, and by vacationers who may encounter water
of questionable quality.  Consequently, failure of a product to
adequately purify water may present a serious public health hazard.

     Because purification of water involves the killing of micro-
organisms, which are defined as pests in Section 2 of FIFRA, these
products are regulated by the Environmental Protection Agency.
There are two kinds of water purifiers:  Those which employ a chemical
means to purify water, and those which use a physical method.  While
both types are subject to the provisions of FIFRA, including but not
limited to, Sections 7, 8, and 12 as well as Section 2(p) and (q),
only purifiers utilizing a chemical must obtain product registration
as prescribed by Section 3 of the Act.  Under Section 25(c)(4) of
FIFRA the Administrator is authorized to declare a device subject to
the Act.  Water Purification devices are among those devices subject
to the Act (see ?ed. Reg. Vol. 41, No. 225, page 51065, November 19,
1976).                                           '

     The registration process for chemical purifiers is central to
the Agency's ability to evaluate the risks and benefits presented
by the product.  If data submitted to the Agency does not support
the label claims made for the chemical purifier, the Agency will
not register the product.  Enforcement of the labeling and misbrand-
ing provisions of FIFRA is very straightforward for chemical-based
water purifiers.   If a manufacturer makes claims on a label that do
not appear on the label accepted by the Agency at the time of regis-
tration, then the manufacturer has violated FIFRA by "making claims
in excess of those accepted at the time of registration," which is
a nil sb rand ing violation.

     'vater purifiers which use a physical means of microorganism
elimination are devices, and are therefore subject to the same
requirements of FIFRA as the chemical water purifiers except that
they are exempt from product registration requirements.  Conse-
quently, since a premarket label review based on test data
was not performed,  products may appear on the market with
label claims which falsely exaggerate the capabilities of the
product.  If the  claims/are found to be "false or misleading," the
product is misbranded as defined in FIFRA Section 2(q) and subject
to enforcement action.

     The 3?A cannot require the manufacturer to substantiate the
claims made for the product,  so to evaluate the performance of such
devices, SPA must sample and test the devices.   The results of labo-
ratory analysis will document or call into question claims made
on the labeling.   The test results will also form the basis for
enforcement actions brought against a manufacturer making false or
in is", e ad ing claims.

-------
     Water purification device producers are generally small
cosinesses, although a few large companies are also in the market.
There are approximately 50 purification devices now on the market.
Producers must register their establishments, but there'nay be some
producers who have not done this.

     Almost any available physical method that might kill a micro-
organism is employed in at least one product.  The most popular are
ultraviolet (UV) light, micropore filtration, chlorine generators,
and ozone generators.  Ultrasound, reverse osmosis, electrolysis,
and distillation are other known methods used by purification
devices (See Appendix I).  These types of devices are called "point-
of-use" treatment products, since the water is treated immediately
before use.  "Small systems" treatment products treat water intended
for use in small communities - generally several taps and a distri-
bution net-.orl-: are part of the system.  "Small systems" treatment
units are also regulated under FI7RA but the quality of the water
produced is regulated by the Safe Drinking Water Act.   Since the
oublic is protected under another Act' and the resources of the Office
of Enforcement are limited, these products will not be tested as part
of this program.  However, if such pro-ducts are found to be ineffective,
they may be subject to enforcement actions under 7IFRA.
                               -3-

-------
Artlication of FIFRA
     FIFRA and its implementing regulations clearly apply to devices.,
The requirements of these regulations are outlined below.  State
lavs are often ambiguous where devices are concerned.

     Since it is desirable that Stop Sale Use or Removal Orders
have nation-wide applicability, this policy is to be administered
as a federal program.  State inspectors who may collect evidence
will turn that evidence over to the appropriate Regional office
for enforcement actions.
Requirements of FIFRA
     Producers of water purification devices are regulated under
     ,  the applicable sections include but are not limited to §2(p)
and (q), 1, S*and 12 of FIFRA (see 40 CFR '52.10 and 41  Federal
Register 51065, November 19,  1976).  Based on these sections, the
water purification devices are subject to the following  requirements
     o —i
      Establishment Registration (Section 7)
        -Registration of all producer establishments;  establishment
            registration number on all products
        -Annual reporting of products

     "Books and Records (Section 8)
        -Must keep records of brand name of device
        -Must keep records of production data
        -Must keep records of distribution
        -Must allow an authorized Inspector to examine
            these records

     'Product must be properly labeled (Section 2 (p);  40 CFR 162.10)
        -Must bear the Establishment Registration Number
        -Must include warning and caution statements
        -Must not be an imitation of other products

     "Product must not be misbranded (Section 2(q)).  A product
        may be misbranded if its label:
        -Lacks adequate directions for use
        -Lacks adequate warning or caution statements
        -Bears a statement which is false or misleading in any
            particular
        -Bears a false or misleading statement concerning the
            effectiveness of a product
        -Bears a statement which directly or indirectly implies that the
            device is recommended or endorsed by any agency of the
            Federal Government
                               -d-

-------
     For greater detail, consult 41 Pede. J. Register 5*065,
November 19, 1976.  All requirements of device producers described
ir, that document apply to producers of water purification devices.


FIFRA Enforcement Authorities

     Failure to adhere to any of the above requirements of FIFRA may
be an unlawful act under §12 of FIFRA as follows:

     "Failure to register the establishment [Section 12(a)(2)(X)]
     'Failure to keep books and records or to permit inspection of
        books and records [Section 12 (a)(2)(B)]
     •'•'.isbranding [Section 12 (a)(l)(F)]
     "Failure to file production reports [Section 12 (a)d)(N)]


-------
3-a r. s r a 1

     FIFRA provides several remedies for violations of..its provi-
sions.  If the purifier efficacy claims are found to be false, a
serious public health hazard can exist, and a Stop Sale, Use,  or
Removal Order will be issued immediately to limit the availability
of the product.  Penalties for other violations are to be determined
through*application of the general FIFRA penalty policy and matrix
(39 Federal Register 2771, July 31, 1974).   Civil penalties for
~i'branding violations,  which are applied in addition to Stop Sale
Orders, are to be determined', by consulting the penalty matrix for
Ineffective Water Purifiers, below.  If there are severely misleading
claims, particularly in advertising material, the case may be
referred to the Federal Trade Commission through headquarters.

Xisbranding Purifier Claims

     Water Purification Devices which fail the purifier efficacy test
are cisbranded.  A Stop Sale,  Use or Removal Order will be issued to the
manufacturer of any product which fails the efficacy test.  The Stop
Sale is issued because of the health hazard presented by the continued
sale or use of the product, and will not be lifted until the product
comes into compliance with the Act.

     In addition to the Stop Sale Order, a civil penalty will be
assessed as described below.  The Civil Penalty-must be assessed
within fourteen days of the Stop Sale Order.  _

(This is consistent with the penalties for similar violations in the
current FIFRA Penalty Matrix.)

Ineffective Water Purifiers


                           I      II      III      IV      V

1.   Category A           5000    5000    5000     5000    5000

2.   Category B           1000    1750    2500     3200    4500
         See A.  S.  Conroy's Memorandum of September 12,  1930,  "Interim
 .nal Regulation Section 13,  FIFRA."
                               -6-

-------
Category A - Products in this category failed Phase I of the testing
             protocol (see Strategy Overview page 1).  Phase I tests
             the ability of the product to remove a known group of
             pathogens which commonly occur in water, so products
             which fail are presenting the consumer with- a potentially
             severe health hazard.

Category 3 - Products in this category passed Phase I but failed
             Phase II.  Since viruses and cysts are pathogens as
             well as bacteria, a health hasard is also presented
             by these products, although the hazard is somewhat
             reduced by the removal of the coliform bacteria.

                  Some products in this category nearly passed
             the efficacy test.  It may be that a slight change to
             either the label instructions or the product itself
             would bring the product into compliance with the Act. 2j
             A Stop Sale Order would be issued in such cases, but it
             may be lifted when the manufacturer agrees that he will
             immediately incorporate those changes which appear to
             have a reasonable likelihood of remedying the problem.
             The "modified" device is, of course, subject to testing.
     Another remedy that is used either as an alternative to a civil
 proceeding or in addition to one is a recall action.  Recalls nay
 js voluntary or compulsory.  If this remedy is employed, the guidance
 .n Section 12 of the Case proceeding Manual should be followed.
    2j  For example, UV light kills viruses and bacteria but may
permit G. lamblia cysts to persist in water.  Since the cysts are
relatively large, a pre-fliter on the system could predictably
remove them.  Another example would be a chlorine generator whose
directions do not explicitly indicate the concentration and contact
time that are necessary for chlorine to effectively disinfect water,

-------
Cther Violations of FIFHA
     As described in the section on the Application of FI7RA,
the Agency has authority to take enforcement action when
provisions cf FIFRA are violate!.   Violations which.do not
involve the purification claim (e.g.  violation of Sections 2(p)
and (q), 1 and 8) are also to be handled in the regions according
to current enforcement policy.

     If enforcement actions based  on violations of FIFRA which
do not include the efficacy of the product are taken before the
efficacy tests are complete, the complaint or warning should
clearly state that additional action may be taken if the results
of the efficacy test should prove  to be unsatisfactory.  We recom-
neni that all civil actions be initiated at the same time.
Criminal Citations

     Willful violations of FIFRA may justify the filing of
criminal charges against a manufacturer.   PTSSD concurrence
would be required for criminal actions.
                               -3-

-------
 C-iven below are procedures  for the  compliance monitoring aspects  of  the
•am with description  of  responsibilities ar.I  data  flow
 7ulielir.es  for Selection of Devices To Be Tested

 0  CM3-PTS3) will  select the  devices to be tested and determine the
   order of testing based on  criteria noted below.

 0  Only  "point-of-use"  devices will be tested.  These devices consist
   of  those intended for use  in  a single family household, camper,
   boat,  etc.

 0  Tvo categories  will  be established to help determine the  order
   of  testing.

   -   The first  category,  vhich  will be given the highest
       priority,  will contain  those products for -which
       there is reason to believe that a violation
       has occured.  This will be determined by consumer
       or competitor complaints,  scientific judgment based
       on the study of product design, and failure of the
       device in  similar tests.

   -   The second category will contain all other products.
       The order  of testing for this category will be determined
       by such  neutral criteria as the number produced and dis-
       tributed, and the availability of testing space.  If
       production data is not  available for all 'devices, the
       order of testing  will be determined by random selection.
     --PTSn) will prepare  the sample request forms and forward
    hem to the appropriate Region for collection.
 inspection

 0  At the opening conference:

   -  The inspector should request efficacy data from the
      manufacturer pertaining to his/her device(s).  The
      manufacturer cannot however, be required to submit
      this data.

   -  The inspector should advise the manufacturer that
      his/her"product is not being singled out for attention.
      The collection of his/her device is part of a nationwide
      effort to test water tjurification devices.
                                  -9-

-------
     0  Inspection of books ani records will be  performed  in accordance
        with the Pesticides Inspection 'fenual for the  purpose of deter-
        mining compliance with the record keeping requirements (§3)'.

     °  An official sample of the device will be collected at the producer
        establishment according to the Pesticides Inspection Manual.   The
        official sa-ole will include labeling (including instructions  'for
        installation) and all other docanentation as required (Notice  of
        Inspection, Receipt for Samples, etc.).

        -  "Optional Bauipment", such as a pre-filter,  which
           is required for the quality of water  the  laboratory
           will be using should also be collected.   Specific
           guidance will be provided on the sample request .
           fora.

        -  Because many of these devices are very expensive,  the .
           inspector should make an attempt to have  the manufacturer
           donate the device.  Many manufacturers have  already
           indicated a desire to have their devices  tested,  and
           a willingness to donate then for this purpose.

        -  If the manufacturer refuses to donate the
           device, the inspector should offer to purchase  it.

        -  IVo samples of the device will be collected unless
           the ccs t of the device exceeds S700.

     *  If the manufacturer requests to install  the  device himself,
        arrangements with the testing laboratory should be made
        If entry is denied:

        -  The inspector should follow established procedures
           for denied  entry. £'

        -  If a distributor  of  the  product  can be located
           through  reviewing -the advertising or contacting a
           local trade association,  then a  marketplace  sample
           can be obtained.
    £/  Barlow's Decision:  Guidance  to Regional Personnel:  Conduct
:f Inspections  after the Barlow's Decision (April 11, 1979)
                                      -1O

-------
        -  If a product sanple obtained from the marketplace
           fails the efficacy tests, a warrant to conduct an
           in-depth bocks and records inspection nay be
           obtained.  This will be necessary if production
           and distribution data is needed.
III. ?cst Inspection
        When the requested sample has been collected,  the "PRD
        Acknowledgment" copy of the sample request form will be
        forwarded to CM3-PTSED with the "Sample Identification"
        section completed.

        All non-confidential information obtained  by the inspector
        will be placed in the enforcement jacket and forv&rded
        to the testing laboratory along with the device(s).

        -  A second copy of the device's labeling  is to be assembled
           by the inspector and forwarded to OB-PISH) for contract
           rsanagesent purposes.
     Testing

     e  Efficacy testing will be  performed by the  State of New York,
        Department of Health, Division of Laboratories  and Research.

     8  Each device will be examined  when received by the laboratory
        for any possible defects  resulting from shipment.

     8  Chain of custody procedures will be followed  for all official
        samples.                             -  •

     8  The device will be subjected  to a series of microbial challenges
        until it fails or e:
-------
CM3-PTS3) is to be kept informed of the testing status of the device.
This information is to include:

-  date the official sample was received

-  date testing was initiated and completed

v.r.en testing is ccnpleted, the laboratory will review the test
results and determine if the device has failed efficacy testing.
All test results will be placed in the device's enforcement jacke
                                                                         t.
        -  All enforcement  jackets will go directly to the appropriate
           Region from the  testing laboratory  for  review to determine
           violations, and  to initiate enforcenent action.

        -  A copy of the test results will be  forwarded to CM3-PT3H5
           from the testing laboratory to monitor the contract.

      8  The testing laboratory will retain all devices for which
        violations exist until enforcement action is completed
        or the case is placed in permanent abeyance.


V.    Pesticide Enforcement  Management Systea (PSHS)

   .   The Regions will keep  PISS) informed as to the enforcement status of
the device by entering relevant information, such as the date they issued
a  particular order or penalty, the results of  the enforcenent action, etc.
into  the ?E-S Computer system.


71 .   Outreach

      i-Cany .manufacturers of  water purification  devices do not appear to be
aware of Section 7 establishment registration  requirements.  To help notify
industry of these requirements,  a letter to potential manufacturers and
their trade associations has been prepared (Appendix III^

     The responses from this letter will allow the Agency to compile an
accurate list of manufacturers,  their products, and production and distri-
bution data.

     A press release has also been prepared announcing the program to the
public and notifying industry of the establishment registration requirements
~f « ^^-r-3 .' y.
 -
     As a result of this outreach program, it is anticipated that the
public and the industry will report the existence of various companies
which they suspect are not in compliance with the Act (establishments not
registered, products are ineffective, etc.).  All information obtained by
the Regions should be forwarded to CM3-PTSED, Comp"1 lance Monitoring
Coordinator.
                                       -12-

-------
     Microbiological data generated by this program will be submitted tc the
Journal of Applied and Environmental Microbiology for pjblication after the
enforcement cases are completed.  The results of the tests may also be
presented at the 1?32 Annual Meetings of the American Society for Microbiology.

     The results of this program are also of interest to the National
Sanitation Foundation and D-19, Committee on Water Microbiology of the-
American Society for Testing Materials.   It is pssible that presentations
will be made to these groups.

     Regions may release information concerning individual cases in the sane
manner that such information is handled in other civil proceedings.

-------

           PTSED

o revievs test results and .
  labeling
o maintains a file of test
  results, labeling, and action
  taken
                                                         PTSED

                                            o requests samples
                                            o monitors program
                sample
                request
              notification of
              action taken
           Region
o reviews lab's report, labeling
  and any records collected to'
  determine possible violations
o determines enforcement response
  and initiates action
o maintains official enforcement
  file en devices
             Region
o sets up enforcement jacket
o collects samples, performs
  inspections
o sends PRD Acknowledgment to
  CMB-PTSED
o sends copy of labeling to
  CMB-PTSED
                sample &
                enforcement jacket
                     test results &
                  enforcement jacket
           test results
                                                        Testing
                                                       Laboratory
                              •13-a-

-------
     Case development will proceed in accordance with the Case
^-cceeiings "ar.ual.   The Regions are advised to avail themselves
   the option of Enforcement Review through headquarters.  The
_^bel review will be done "by the Registration Division using
the product performance criteria developed for evaluating both
chenical and physical water purifiers and the data on product
performance from the efficacy test.
     Please note that a civil complaint should be issued along with
the 3top Sale, Use or Removal Order when the product fails the
efficacy tests.
                               -14.-

-------
Ihis chart is a guide to the responsibilities for the different tasks in the water
^uriiication device enforcement crosram.
           Headouarters (PTSZD)
                 Regions
1.    Identification of Purifier Devices

     0  Information sources:   ERSS,
        consumer queries,  competitor
        coiplaints,  advertising, other.
1.   Identification of Purifier Devices

     8  Regions submit information on
        nerf products they become aware
        of to Compliance Monitoring
        Branch
     Selection of Devices to be Tested

     0   Compliance Monitoring Branch
        updates list of known devices
        and selects devices.

     *   Policy & Strategy Branch will
        evaluate Ueitral Inspection
        Scheme.  All known devices
        vill be tested.
     Allocation of Inspections              :

     9   Compliance Monitoring Branch  deter-
        mines  names and  locations  of  device
        •oroiucer establishments; assigns
        Inspections to appropriate Regions;
        prepares sample  request forms and
        sends  them to Regions.
                                                4.   Inspections and Sample Collection

                                                     0  Regions assign  inspectors to
                                                        conduct establishment and/or
                                                        bocks  and  records  inspections
                                                        and  product sample and docu-   ~
                                                        mentary material collection.
                                                        (inspections may be made by
                                                        Federal or State inspectors.)

                                                     e  Inspector  performs inspection
                                                        according  to ?I?RA procedures
                                                        and  guidance; special instruc-
                                                        tions  may  appear on the sample
                                                        request form.

-------
                                                             Resion
                                                    Inspector ships sample(s)  and
                                                    one set of documentary material
                                                    to testing laboratory;  send a "
                                                    copy of documentary sample to
                                                    headauarter's.
Testing of Devices

0  Laboratory (Environmental Health
   Center, State of New York, Depart-
   ment of Health, Albany, N.Y.)~
   performs efficacy test according
   to PISH) approved protocol; furnishes
   results etc. to PTSED and the
   Region. (See N.3.  below.) The lab
   will keep the device until litigation
   is ccsroleted.
Determination of Violations

   The testing laboratory indicates
   whether the product passed or
   failed the efficacy test.
Determination of Violations

*  Region reviews inspection data
   and its set of documentary
   material to determine existence
   of violations under FIFRA
   Sections 7, 8, or 12 as well
   as well as Section 2(q) ads-
   branding violations.
                                                 •  v
                                                    The regions are strongly
                                                    advised,  particularly early
                                                    in the program to send the
                                                    jacket to headquarters for a
                                                    pesticide Enforcement Review.
                                                    The reviewers compare testing
                                                    results aj^lnst label and
                                                    advertising claims to deter-
                                                    mine if purifier claims are
                                                    false and misleading (misbrand-
                                                    ing violation).  N.B-.   The
                                                    enforcement jacket accompanies
                                                    the sample to the laboratory.
                                                    The laboratory inserts the data
                                                    from the testing program and
                                                    forwards  the jacket to Regions
                                                    •which nay forward them to head-
                                                    quarters  for Enforcement Review;
                                                    the jacket and the review will
                                                    then be sent back to the appro-
                                                    priate Region.
                                 -16-

-------
           Headquarters  (PTSZD)
                 Regions
                                                         Based on the laboratory's
                                                         determination, the Regions
                                                         may initiate action on the
                                                         purifier claim.  This should
                                                         not preclude discussion of
                                                         the case with headquarters.
7.  Determination of Appropriate
    Zr.forcemer.t Response

    8  If aisbrandins violation based on
       the purifier claim has occurred,
       headquarters may provide additional
       information based on historical files.
       Appropriate records and recommendations
       will be for varied to the Regions.  If
       advertising is seriously misleading, a
       referral to the Federal Trade Commission
       will also be made.
7.   Determination of Appropriate
     Enforcement Restcnse
        A Stop Sale, Use or Removal
        Order (SSURO) will be issued
        for all products -which fail
        efficacy test.  A civil penalty
        is also assessed.
        Region applies general FI?RA
        civil penalty policy and
        matrix to determine appropriate
        level of actions for ail
        violations.
     Znforcement Actions, Litigation,
     Settlement

     0  ?TS3) may, under exceptional
        circumstances, initiate
        enforcement actions.

     e  Sections of the agreements
        which involve label or product
        improvements to bring the product
        into compliance are to be sent to
        PTSZD for concurrence.
     Enforcement Actions. Litigation.
     Settlement

     9  Regions will initiate
        enforcement actions
        (warning letters, civil
        complaints, SSURO1s).

     0  Region may obtain expert
        testimony from headquarters
        reviewers or laboratory
        scientists.
9.   Completed Case Piles

     8  PTSSD will maintain a file
        of all test data results and
        copies of Final Orders for use
        in documenting the possible need
        for regulatory or legislative
        changes.
     Completed Case Files  •

     *  The Region should retain
        completed case files-, in-
        cluding all relevant
        documents.

     0  A copy of the Final Order
        should be sent to PTSED.
                                      -17-

-------
           Headquarters (PTSZD)
                 Regions
10.  Publicitr
        i^ , r  I  - f* ^^^
        k, ,G_ v Gi - * '^
        - Press Release
        - Letters .to manufacturers and
             trade associations.

        Release of data generated by
        testing program.  (laboratory and
        Compliance Monitoring Branch;
        - Publication of Scientific data
             in appropriate journals
        - Presentation in proper forums.

        Consumer Information determined as
        a result of the whole program.
        - number distributed
        - type of use/risk factor
        - conclusion to be drawn from the
10.  Publicity
        Release of information about
        individual cases in the ss
        manner as "other pesticide d!
        cases.
                                      -18-

-------
Enforcement Facts and Strategy
v-peniix I:   Types cf Ririfier Products                       20
Appendix II:  Legal Definitions,  "Purifier" anl "Device"      22
Appendix III:  Publicily and Outreach                           33
                                      -19-

-------
                                                                   Appendix I
     Water purification devices employ a variety of techniques to purify water.
The =02 1 cccaon techniques are:

     9  Ultraviolet light - Light of wavelengths around 260nm damages the KIA,
        of exposed organisms.  If the exposure time is sufficient, the organisms
        are no longer viable.  Light may also be absorbed by the bonds of certain
        complex organic molecules which could result in photolysis of those mole-
        cules.  Efficacy of this method depends heavily on the engineering of the
        whole system.  The protocols used by the Canadians are the basis of the
        screening phase of the US EPA Water Purification Device Testing Protocol.
        Duplicative verification of results on the saz& types of products used
        to'develop the protocol is useful to the U.S.  and Canadian Enforcement
        Programs.

        Submicron ?iltration - Some products filter water through "sieves" whose
        pores are about 0.4 micron.  Since a typical bacterium is 1 micron in
        •iiamster, these products frequently make purifier claims.  Unfortunately,
        a very large virus would be only 0.1 micron in diameter and 3023 bacteria
        are capable of changing shape.  The filter would consequently not work.

        Ultrasound - High frequency sound causes pulse waves to form in water.  The
        rapid changes in water pressure result in "shearing forces" which-cause
        bacterial cell walls to break.  This technique is used in a research setting
        to avoid chemical denaturing of macromolecules and cellular organelles.
        Whether it would be efficent on the scale necessary to purify water is un-
        known.

        Chlorine generators -  These devices electrolyse salt (NaCl)'to fora chlorine.
        The chlorine acts as a disinfectant to purify water.  These products are devices
        and not chemical pesticides because the product which enters channels of trade
        is not a chemical.  The consumer generates the pesticide at the site of use
        for his own use and not for sale or distribution.  Unfortunately, since there
        has been virtually no regulation of these products, the label directions may
        not be sufficiently explicit to ensure efficacy of the product.  Chlorine
        levels can be tested using a simple test kit and the presence of adequate
        levels of free chlorine for a minimum contact time would ensure a reasonably
        pure water.

        Ozone generators - Oxygen from air is electrically ionized to fora ozone, a
        powerful oxidizing agent and disinfectant.  Unlike chlorine, ozone''does not
        persist (it rapidly decomposes to oxygen) and cannot be easily measured.  It
        is difficult for consumers to know if the device is actually working or if
        some minor product failure has resulted in lower levels of ozone production.
        Installation is complex - often done by the seller - and cheaper products
        may be unsafe electrically.

        Electric current -  Presumably the microorganisms are electrocuted by the
        passa^ of an electric current through a water reservoir.

        Distillers -  These products condense steam from boiled water.

                                      -20-

-------
        Microorganisms are killed by boiling.  Distillation can concentrate
        certain organic compounds.

        Reverse Osr-.ogis -  High quality organic polymer membranes
        selectively filter water. This product is similar in principle
        to a kidney dialysis machine. It is a potentialy workable means
        of purifying water since the pores of the membrane act as a
        molecular sieve.  Cocplex organic molecules are prevented frcn
        crossing over to the "pure water" side of the membrane. Viruses,
        bacteria and protozoans would also be retained on the "impure
        side".  Maintenance of these products is important.  A damaged
        me.-brane would not purify water.  There is some indication that
        old membranes may themselves be colonzied by some forms of bacteria
        which use the organic polymer as a food source.

     Two types of products which are labeled as water nurifers will not be
tested:

     0  Potable vater "purifers" - These products use the term purifier on
        their labeling 'out are clearly intended for use on water that
        is already ptable (i.e., faucet "purifiers" for use on municipally
        treated water),  ".anifacturers of these products should be warned
        that use of the tern "purifier" is for products which process
        untreated water.  (See 41 Federal Register 32778, August 5,  1976)
        Other enforcement actions may also be necessary.

     *  Large purifiers which treat water for groups of twenty-fivepersons_
        or core.  These products are regulated by FIFRA.  However, the quality
        of the water is requlated by the Safe Drinking Water Act.   Since
        the public is protected by another act and the resources of the Office
        of Enforcement are limited, these products will not be included in this
        program.  (These are also known as "small systems" purifiers.)

-------
                                                             Appendix II
                   Legal Definitions,  "Purifier"  and  "Device
     Since the enforcement strategy and penalty plicy rests on the
definitions of "water purifer" aid "devices,"  the  following material
is attached to support the definitions used in this document:

A.  Purifier:
      1.  FTC ruling in the matter of 3ibco Products Corpany'Inc., Et  Al.
          (63 FTC (1965)  pg. 917).              :           "
      2.  Guidelines for Registering Pesticide  Products in the United  States
          Section G:  Product Performance  Standards  for Water Purification
          Devices.

      J>.  EPA ruling In re Contact Industries.  Inc.,  I.P.  & R. Docket  Ho. 11-136
          (1973) pg. F::

      Devices

      Pest Ccntol Devices and Device Producers: Consolidation and Clarification
      of Requirements.  Federal Register, vol. 41,  no. 225  (11/19/1976).

-------
                                                          CRU
                          IN THE MATTER OP •

           ••SD3CO PRODUCTS COMPANY^ IXC., ET. AL.  .

   ORDEB, OPLVION, ETC., IN EECABO TO THE ALLEGED VIOLATION OP THE
   '               %FEDEEAL TRADE CO'.LMISSIOK ACT       '  "
     -  .            ' Complaint' June *' '9*4^-Deu»ifMjto«. 22, IMS'
   .Order' requiring a* New Jersey  manufacturer' of" water Yilbators to  cease
   ^f;.OU?fepre?"tia=  the eff<**v«ess ar.d capability of ito water filtration
   «--.• tuuts-and deceptively guaranteeing the perionaance of JBCA units. .
                                                  i   •      -iS17

•-S32V-1                      -t Opinion
 -..2. Implied ..Representations  Respecting -Micro-organisms and
•Viruses
 '  Complaint counsel charges that by the use of such words as^'pure,*7
 "purify" and "clean" and the phrase  "pure  drinking and cooking
• water are vital to the health of your family * * *" in connection with
 the unit, respondents are implicitly representing that disease-carry-
 ing water will be rsace safe for drinking through the use of the Sibco
 "Purifier."                '       ..........
   Respondents 'admit that the  unit will not kill micro-organisms
 but maintain  that the  words quoted  above  do not constitute an
 implicit  representation to  this  effect Moreover,  respondents al-
 Jeged in their answer that the literature  accompanying the unit
 contains a specific disclaimer that it does not kill bacteria.    •.'
   We conclude from  the evidence that respondents' water purifier
 does not in "fact  remove water-borne micro-organisms or viruses
' capable of causing diseases. Moreover,  we hold  that the statements
 in respondents'  advertisements  and form  letters — that  their unit
 will /'purify and  filter" water, will ensure  "clean" water, will cor-
 rect "bad"  water, will give "pure  drinking and  cooking water"
 which is "vital to the health  of your  family"  and will filter "im-
 purities" found in the consumer's water supply — constitute repre-
 sentations that  respondents' unit will remove bacteria and  other
 disease-causing germs.  We find that a potential purchaser who
'has or  believes  he has or may 'have contaminated water  could
 easily be led ,by statements of  the type quoted  above  to believe
 that respondents' unit  will make his water potable. Giant Foods,
 Iric. v.F.T.C. 332 F. 2d 977 (1963).      .   .        '•""  *  ""
   With respect to the disclaimer used by  respondents in one bro-
 chure, we ha%-e no way of knowing from the evidence whether all-
 of respondents' prospective customers actually received  this pam-
 phlet. Furthermore, this disclr.irr.er was not inserted until respond-
 ents' precomplaint negotiations with complaint counsel. Finally, the
 presence of  this disclaimer ':.   •.'.e of  respondents' brochures does
 not negnte the contrary :mr-    ':.•:! in the affirmative representa-
 tions contained  in their adw • : ;"j:onts  and sales literature  as to
 the purifying qualities of tluir  unit.

-------
i.x^r-w  frc.r,  Draft 3i\Suioart G:   Guidelines  for Recistraticn-of Pesticides f
Toe  Ur.'-.ec Scacas:  rrccuct Perron inca Stancards  (pg4  145-146).  (Full  text
available frcr,  -U.ecdq'jurt2i
             ments:  representative levels of organic1 and inorganic soil

           contamination; various water temperatures; the specific dosage
                       * ,
           and  exposure  period recommended for the proposed produce; a

           variety  of test microorganisms representative of the target pests
                                                              r'
           to be  controlled; and quantitative determination of the level of

           microbial  contamination of the vater before and after treatment.

            (ii)   Performance standard.  The treatment nust eliminate all

           test microorganisms from the water,

            (3)  Vater  treatment units,  (i)  Water purifier units.  Any unit

           intended for  the treatment of rav water to eliminate the potential

         "  health hazard posed by microorganisms is identified as a water

           purifier.   The unit may rely on physical filtration* (pesticidal

           device), or chemical treatment (pesticide), or a combination thereof,

           to achieve the intended purpose of purifying microbiologically non-

           potable  vater by eliminating vatar-borme pathogens in the vater

           itself.  Those units, such as submicron membranes and absolute filters,
                                                         •

           which  rely solely on a physical means for removal of microorganisms

           from vater, are identified under the Act as devices, and are subject

           to regulation but not registration.  The test requirements indicated

           below  are  for the units containing an antimicrobial agent.

            (A)  Test standard.  Controlled simulated-use studies for the

           vater  purifier unit must be conducted under conditions representing

           actual use employing a defined raw vater source containing a high

           level  of microbiological pollution.  The test design wil'  vary
                                        145

-------
vith different types of units and pasterns of use, but nust include


such basic elements as: representative levels of organic and la-
              * *

organic soil contamination; various water temperatures; documen-


tation of the antimicrobial concentration found in the test system;


and quantitative determinations of the microbial contamination


level of the water before and after passage through the unit.  The


duration of effectiveness or effective capacity of the unit before


a replacement is necessary oust be documented.


  (B)  Performance standard.  The treatment must eliminate the


microbisl pollution in the rav vater.


  (ii)  Potable vater'treatment unit.  Any unit intended for ?hys7


leal and/or chemical treatment of sicrobiologicaliy potable vater


from a municipal treatment facility to remove undesirable tastes


odors, chemicals, or other aesthetically objectionable properties


is identified as a potable vater treatment unit.  A substrate such


as activated charcoal (with- or without a bacteripstatic agent) is


incorporated into the unit for this terminal processing treatment


of potable water prior to consumption.  Sines the requirements of


the Safe Drinking Vater Act do permit aunicipally-treated drinking


vater to contain a limited number of harmless "saprophytic" bacteria


which are commonly recognized contaminants of vater, an antimicrobial


agent is sometimes incorporated in a potable water treatment unit


to provide bacteriostatic activity against these contaminants.  Only


potable water treatment units containing a bacteriostatic agent are


order the purview of Che Act.
                                146'

-------
."Ex'erpt fror,  In re Contact Industries,  Inc. (pg. 6-8).   (Full  text of .document
•'available  from headquarters.)
                      ENViROir.r.;nAL PROTECTION AGENCY
                     BEFORE THE REGIONAL ADMINISTRATOR
     In re
            Contact  Industries,  Inc.,       )     I.F.  &  R.  Docket  No.  II-186C
                         Respondent         )     '     Initial  Decision
     .  _    The term purifier connotes a product which eliminates impurities
      and polluting natter.  He are in agreement with the conclusion of
      Complainant's expert witness that the "word Durifier is sufficir^-tU/
      broad to include ridding the air of nb.iectionables, including mirrn-
      organisnu as they would exist."  An air purifier would therefore
      cleanse the air of air-borne bacteria, virus, and fungi particles.  If
      Respondent had intended for the product to bs understood to be merely
      an air freshener or deodorizer, the label could have contained the
                                                           «
      term air freshener (cf. Respondent's Ex. 7) or been limited to the
      claim that the product was an industrial odor absorbent and nbt also
      a glycolized air purifier.  In fact, the latter phrase would be
      somewhat redundant in the context in which it is employed on the
     • label if all that was intended thereby was to inform the consumer
      that the product functions as an air freshener.  As indicated by
     •Complainant's expert wi trices, the term air purifier especially when

-------
                          .   - 7 -

taken together with the word "Sanicidc" on the label would indicate
that the prcJjct is intended to rid the air of genus, that is,
bacteria or viruses.       •
     "Sanicide" is printed in bold-face, conspicuous type on the front
of the label.  The word also appears at the top of the back of the
label in type which is in larger and bolder print than all other words
on that side of the label.  It is clear that the word "Sanicide" is
meant to provide the rr.ost conspicuous reference to the product.
     "Scnicide" implies both a sanitizing and a killing action or, at
the least, a killing action.  Sanitize means to free from dirt, genrs,
etc., as by cleaning or sterilizing.-  The suffix -cide means killer
or killing.  Ses lobster's Third New International Dictionary  (1955).
A consumer would, v:e believe, recognize the meaning of the suffix
-cide as is evidenced by the coroon usage of words such as homicide,
pesticide, and insecticide.
     In interpreting broad remedial legislation, the consumer  is not
assumed to be «n expert or one possessing special knowledge cr
ability, and includes "the ignorant, the unthinking, and the credulous."
United States v. An Article. . .Consisting of 216 Ortoned Catties,
supra at p. 740 and cases cited therein; United States v. An Arficle
of Drug. . .47 Shipping Cartons.  .  .. 331 F.Supp. 912, 917 (D. f-'d.
1971).  Nor can v:e assume that the buying public will exercise great
selectivity and caution in what they choose to believe of what they

-------
                               - 8 -

read.  United States v. Article:, of Drug, Etc., 263 F.Supp. 212 (D.
Neb. 19CJ7).  Cf. Holhros Watch C.Qinp^.ny v. Federal Tr?.clc Co:rm'r.sicn,
310 F.2d 8G3, , 859 (O.C. Cir. 195?.), cert, denied 372 IKS. 976
(1952), rehearing denied 374 U.S. 857 (1963), and cases cited therein.
A consumer would be justified in believing that the product he purchased
had the capability of both cleansing the area sprayed (sanitizing) and
killing microorganisms present in the area sprayed.  This  is especially
so when the term "Sanicide" is read in conjunction with representations
that the product is an air purifier or a glycolized air purifier.
Certainly, the use of the prefix sani- with the suffix -cide has
greater significance than the use of that prefix in other  cont.exts
disclosed  in the record.
     Antimicrobial agents are specifically included es ere of the
classes of sanitizers or pesticides subject to registration under  the
act.   (See section !C2.3(ff) of.the regulations  (4C.CrR 161.3(ff})}.
The claim  that the product Superior Sanicide Air Purifier  is an air
purifier when read in conjunction with the word "Sanicide" would indi-
cate that  the product is indeed an antimicrobial agent "intended to
reduce the number of living bacteria or viable virus particles on
inanimate  surfaces, in water, or in air", in this case.  See 40 CFR
                                        V
162.3(ff)(2)(i)(B) (Emphasis supplied).    Thus, representations made
     I/  Microorgrtsiisiis, including but not limited to algae, fungi,
and bacteria, and viruses have been declared by the Administrator to
be pests \vhcn they exist under circumstances that wake tlicvn deleterious
to man or the environment (See 40 CFR 162.14(b)(4) and (5.)).

-------
                                                       'NOTICES
                                                                          510C3
               (PPi 6*6-5]
  PEST CONTRAL  DEVICES  AND  DEVICE
               PRODUCERS
      Consolidation and Clarification of
              Requirements
               I.  PURPOSE

    ' Requirements  applicable • to  pest
—Jr.trol  devices  and  device  producers
 have  been set  forth in  various regula-
 tions  promulgated pursuant to the Fed-
 era] Insecticide. Fungicide, and Roden-
 ticide Act, as amended (86 Stat. 973; 89
 S:at. 751:  7 U.S.C. 135 etseq.)  ("FTFRA"
 or "the Act"). The purpose of  this notice
 is to provide a consolidation and clarifi-
 cation o.'  all such requirements. •

             II. DcriMITIONS

   At section 2'h)  of FIFRA (7 U.S.C. 136
 (h))  the  term  "device" is  defined  to
 mean:
 • • •  any  Instrument or contrivance (other
 t-sn a ftreirmi which is Intended  for trap-
 ping, destroying, repelling, or mitigating any
 pest or any othe:  torn of plant cr animal
 life (other than man and other than bacteria.
 virus, or otaer microorganism on or In living.
 man  or other living animals):  but not  In-
 cluding equipment used for the  application
 of  pesticides when  sold scpartely thereJrom.

   To  more clearly identify the  types of
 products to which the requirements dis-
 cussed in  this Notice  apply, the  term
 "device"  must  be contrasted with the
 term "pesticide." which is defined at sec-
 tion 2'u> of FIFRA to mean:
 • • • any substar.ee or mixture of substances
 Intended for preventing,  destroying, repel-
 ling,  or mitigating any pest, and any sub-
 stance or  mixture of  substances  Intended
 for xise as plant regulator, defoliant, or des'.c-
   Thus, if  fin article  uses  physical  or
 mechnntcr.t raenns to trap,  destroy, re-
 peal, or mitigate any plant or animal We
 declared to be a pest at 40 CFR 162.14, it
 Is cor.r.idrrcd to be a device. If the article
 incorporates a substance or  mixture of
 substances intended  to prevent, destroy.
 repeal,  or mitigate  any pest, it is  con-
 sidered to be a pesticide.

     XIX.  DEVICES SUWECT  TO  rat ACT

   Section 25(C) (4)  of FIFRA (7 U.S.C.
 136w(c) 14)) provides that the Adminis-
 trator may specify  those classes of de-
 vices which shall  be  subject to any  pro-
 vision  of paragraph 2(q)(l)  (7 U.S.C.
 136(q)(l'>  or section 7 (7  U.S.C. l?Ce)
 of this  Act  upon his determination  that
 application  of  such  provision'is  neces-
 sary to effectuate the  purposes of  this
 Act. On July 3, 1975. the Administrator
 promulgated relations (40 F.R. 2S242)
 amending 40 CFR Part 162 pursuant to
 this authority. 40 CFR 162.15 now  pro-
 vides that devices as defined in FIFRA
 section  2'h) are  subject to the require-
 ments c: FTFRA section 2'q) fl) (A)-(G)
 and to tiiose provisions of FTFRA section
 7 which are necessary to effectuate the
 purposes  of FIFRA with   respect  to
 devices. '
   The  preamble to these regulations  at
 40 F.R.  28266 declared that to effectuate
 the purposes of the  Act.' devices subject
 to sections 2«j> (1) and 7 include but axe
 not limited to:
   (A)  Certain  ultra-rlolet light systems,
 ozone generators, water filters and air filters
 (except  those   containing  substances  or
 mixtures of substances which are pesticides),
 and ultrasonic devices, for which claUrJ are
 made to kill. Inactivate,  entrap,  or  sup-
 press the growth of tungl, bacteria, or viruses
 in various sites;  (B) certain high frequency
 sound generators, carbide canr.ocs. foils, and
 rotating  devices, fcr which claims are rssde
 to repel birds; 1C) blacfc light traps, fly traps.
 electronic and heat screens, fly ribbons, and
 fir paper, for which claims are  made to kill
 or entrap certain  lasecu;  and ID)  mole
 thumpers, sound repellents, foils and rotat-
 ing  devices, for  which claims are made  to
 repel certain mammals.

   The preamble  further  specifies those
 instruments declared to be of a character
 unnecessary to be subject to this  Act in
 order to earn'  out the purposes  of the
 Act. These include:
   (1) Those  which depend for  their effec-
 tiveness  more upon the performance of the
 person usin? the device than  on the  per-
 formance oi  the device itself,  and
   (21 Those  which operate to  entrap  rer-
' tvbrate animals.
   Products generally  falling  within, these
 two categories Include rat and mouse traps.
 fly swatters, tillage equipment for weed  con-
 trol and fish traps.
   Section 8 of FIFRA <7 U.S.C. 136f) '
 provides for such record-keeping  and
 record  inspection reo.uirements  as the
 Administrator determines necessary for
 effective enforcement of the Act. Section
 17 specifies the requirements to be placed
 on the imimrt and export of  devices. In
 neither  of these sections is there  a  pro-
 vision  that  the  Administrator  declare
 those classes of devices subject to these
 sections of the Act; and in the attendant
 reflations, no specification Is made. For
 purposes of enforcement, the Agency will
 consider those classes of devices declared
 to be subjec; to regulation under section
 25(c) (4) of the Act as subject to  regula-
 tion under sections 8 and 17 as well.
  IV. SCMMARY or FTFRA PROVISIONS
         APPLICABLE TO DEVICES
   Any instrument declared to be a device
 under 40 CFR 162.15 is. upon Introduc-
 tion into channels of trade, subject to the
 provisions discussed  below. Those provi-
 sions of the amended FTFRA which per-
 tain to devices are in many respects sim-
 ilar  to those under the 1947 FTFRA (61
 Stat. 163;  7 U.S.C.  135-13Sk). In both
 Acts the Agency is authorized to Inspect
 records  showing the  delivery, movement.
 or holding  of  devices  (7  U.S.C.  135c,
 136f);  to obtain  samples of any device
 in the marketplace (7 U.S.C. 135d. 136;);
 to seize  any misbranded device (7 U.S.C.
 135g. 136k); to initiate criminal proceed-
 ings against any person violating  any
 provision of the Act ^7 U.S.C. 135f, 13SZ);
 and. in cooperation  with the Secretary
 of the Treasury, to sample, examine, and
 detain any  imported device which  vio-
 lates the provisions of the Act (7 U.S.C.
 135h,1360).
   The differences in the provisions of the
 two  Acts with respect  to requirements
 applicable to devices, lie primarily in the
 greater  specification of  jurisdiction  and
 regulatory requirements provided by the
 1972 amendments. For example, while a
• device, unlike a pesticide, is not  subject
 to the section 3 registration requirement
 of FEFRA. section 12 of the Act makes
 clear the intent of the Act that  subject
 devices and persons dealing Mth.devlces
 be held  responsible for those obligations.
 other than registration, that are imposed
 by the Act. Jurisdiction  to regulate de-
 vices is expanded to intra- as  well as
 Interstate commerce  (7  U.S.C. 136J(a)
 (1». Similarly,  section   9(a>   of  the
 amended FTFRA specifies that entry for
 the purpose of inspecting and obtaining
 samples of  devices "packaged, labeled.
 and  released for  shipment is permitted
 into  "any establishment or other place
 where • •  • devices are  held for  dis-
 tribution or sale  (7 U.S.C. 136g(a)).
   With respect to  affirmative regulatory
 requirements,  section 2
-------
                                                  NOIILti
 (BORATIOJf  Of SPECtnC
 icNT3 ArrucAEix TO Devices

 •::ticr. JfsHJ).  Miscrandiny Pro-
    (A) misbrand-
   /
 -is     Isleadtng statement concern-
 e '«..   .sltloa o* the product;
 j«e cr  misleading statement coneera-
 s e'ectiveness o!  the product;
 -Lse cr  T--«'«-«^'-E: staument aixiat the
 or tie  prcduc: lor par poses otiier
 a::e or
                   comparison  trttli
  Et&tement directly or tndlreeUy  im-
  •.:-.c.t tie  device ts recorntnendea or
 ;? on '-be safety or the product.

 Section 7. Begistration-of Establish-
 s (7  U.S.C. 136e). On November 6.
  rer.Jstions  <40 CFR Part 167)  for
 rnpiernentation of section 7, Rcgls-
 ;r. of Establishments, were published
 5 Fzrs?.At P.ECISTER (33  F.R. 30557).
 :-cope of the requirements is set forth
 lG7.2(a) : "AH establishments, as de-
: in this prirt, which produce any
 ::de or device subject to the provl-
-, of this section,  must be registered,
•.ixat  to  Uie  requirements  of  these
iations • •  •" At 5 167.Hk)  the term
 :ce" is dcf.ned as ..... any de\-lce
 its of devices as defined by the  Act
 del-"'— 'ned  by  the Administrator
pursuant to section 25(c)  to be subject
to  the  provisions  of  section  7  ol the
Act."
  Section 7 Imposes three basic require-
ments:  (1) Registration of device-pro-
ducing   establishments.   (2)  labeling
which ref.ects the EPA establishment
number ass;pned to the establvshmer.t in
which the device was produced, and  (3)
•submission of annual production reports.
  All establishments  in  which  devices
subject  to  the Act are  produced must be
resistered  with the Environmental Pro-
tection  Agency  as producing establish-
ments. This  includes  foreign establish-
ments in which  devices shipped to  the
United States are  produced, as  well as
establishments  located  in the  United
States which produce devices for export.
  To register establishments, producers
should  obtain from  an  EPA regional
ofuce the  Application lor  Registration
of  Pesticide-Producing  Establishments
(EPA Form 3540-3). The applications re-
quire such information as the name and
address  of the  company headquarters
and the names and addresses  of all  de-
vice-producing   establishments  owned
and operated b~ the company. This  ap-
plication must be  submitted  to  the  re-
(rional office on  or before January  18.
1976. Upon receipt of a completed appli-
cation,  the regional office shall register
each establishment listed  and shall  as-
sign each  establishment an EPA estab-
lishment number.  This EPA  establish-
ment number must be displayed on all
devices released for shipment by the es-
tablishment after 90 days after the pro-
ducer is notified of the assigned number.
   The  production reports (EPA  Form
3540-16)  must be  submitted to  the  re-
gional  office  within  thirty days  after
noti^ca-tion of resistration and by Feb-
ruary 1  each year thereafter.
   C. Secfion  8.  Books and Records (7
U.S.C.  136H. On  September 18,  1974,
regulations (40  CFR  Part  169)  for  the
implementation of section 8. Books and
Records, were published In the FEDERAL
REGISTER  (39 FJL 33512). Pursuant to
the authority of section 8 requires
 that  distributors, carriers,  dealers  or
 other persons who sell or deliver (or of-
 fer to sell or  deliver)  devices declared
 subject to  the Act.  allow  inspection  of
 the records they have pertaining to the
 following:
   (1) The delivery or holding of  the de-
• vice and quantity held: <2> Date of ship-
 ment and receipt; (3) Name and address
 of consignee and consignor; and (4) Any
 guarantees received  pursuant to  section
   D. Section 17. Imports and £rports-(7
 U.S.C. I36o). On August 1. 1975. regula-
 tions (19 CFR Part 12.1) fcr the imple-
 mentation of section 17. Imports and Ex-
 ports, were published In the FTSRSAL REG-
 ISTER (40 FR 32321). These regulations
 require that devices produced by foreign
 manufacturers and imported into • the
 United  States  comply with  all require-
 ments applicable to domestic producers,
 In addition, the regulations  require an
 importer to submit to EPA a Notice  of
 Arrival of Pesticides a.nd Devices  (EPA
 Form 3540-1. available at any EPA of-
 fice) for review and determination as  to
 whether the shipment should be sampled
 and/or permitted entry  into  the United
 States.  The Act also provides that sam-
 ples inr.y be collected and examined and
 that shipments may be permitted entry,
 detained  until brought Into compliance,
 destroyed, or re-exported.
   With respect to Devices  produced  in
 this country for export, section 17(a>  of
 the  FIFRA as amended requires that
 such devices must be prepared or packed •
 in accordance  with the specifications  or
 directions of the foreign purchaser and
 that  producers  of siicli devices  must
 maintain books a::d records pursuant  to
 section 8va).

      VI. ENFORCEMENT ACTHORITTES
   Section 9(a.)  (7  U.S.C. 136(g) (a) )  of
 the Act authorizes officers or the Agency
 to inspect  any establishment or other
 place whore :v device is he'.d for distribu-
 tion or sale In order to obtain a sample  of
 the device r..s packaged,  labeled and re-
 leased for shipment, nnrl s:rmplos of any
 containers or kv'oellng for the ilcvlce. Of-
 liccrs of the Agency are also  authorized
                          FEDERAL RtGISTES. VOL <1, MO. J2S—FRIDAY. NOVEMBER 19, 1976

-------
                                          to Inspect books and records required to
                                          be maintained under section  8 (a)  and
                                          copies  of records which  are  available
                                          under section 8(b).
                                            Pursuant to section 12(a> (2) (E) of the
                                          Act, it is unlawful lor any person to re-
                                          fuse to keep or to permit Inspection of
                                          books and records, or to refuse to permit
                                          inspection of an establishment. Pursuant
                                          to section 12ta)(l)(F) of the Act.  it is
                                          unlawful  to sell or distribute any device
                                          which is  misbranded.  Finally,  pursuant
                                          to section 12 »L) of  the  Act, It is
                                          unlawful to violate any provision of sec-
                                        tion 7.
                                            Upon a  finding of any unlawful  act.'
                                          the Administrator may assess a  civil
                                          penalty pursuant to section 14(a) of the
                                          Act or initiate criminal proceedings pur-
                                          suant  to  section. H'b) of the Act. If.
                                         upon Inspection or tests, a device is  be-
                                        ' lleved to be in violation of  the Act. or if
                                          It  is believed that a device is Intended to
                                         be distributed or sold in violation of  the
                                         Act, a  Step Sale, Use or Removal Order
                                         may be issued pursuant to section 13(a).
                                         Additionally.'section 13'b)  authorizes in "
                                         rea seizure proceedings in a iederal dis-
                                        .trict court against any device which is
                                         misbranded or which, when used in  ac-
                                         cordance with the requirements imposed
                                         under the Act causes unreasonable ad-
                                         verse  eSects  upon the  environment
                                       • Finally, the Administrator may seek  In-
                                         Junctive relief pursuant to section 16(c)
                                         to  prevent and restrain .violations of the
                                         Act.
                                                 VTL PUBLIC COMMENT
                                          The Administrative Procedure Act <5
                                        U-S.C. 533(b)> provides that the solici-
                                        tation of comments is  not required  of
                                        Federal  agencies   for  "interpretative
                                        rules, general statements of  policy,  or
                                        rules of agency organization, procedure.
                                        or  practice." EPA has  determined  that
                                        this Notice  falls within this exemption
                                        from the requirement  to solocit public
                                        comment.  Nonetheless, interested  per-»
                                        sons may submit written comments re-
                                        garding  the policy set forth  in  this
                                        Notice to the Pesticides and Toxic Sub-
                                        stances Enforcement Division (EN-342),
                                        Office  of Enforcement. U.S. Environ-
                                        mental  Protection  Agency.  401 M St.,
                                        SW., Washington.  D.C.  20460.  Three
                                        copies of these comments should be-sub-
                                        mltted to facilitate the work of the EPA
                                        and others interested In inspecting such
                                        documents.
                                          Dated: November  8. 1976.
                                                      STANLEY  \V. Lxcno.
                                                    Assistant Administrator
                                                            for Enforcement.
                                         |PR Doc.?C~341I9 Filed 11-18-76:8:45 *m|
KDERAl lECISTEf. VOl. 41. NO. MS—FRIDAY. NOVEMBER 19. W6

-------
       PEST CONTROL DEVICES PROCEDURES
           Consolidation and Clarification of
                   Requirements
                    Correction
         In m Doc. 76-34113 appearing on page
       5K'C3 In the Issue for Friday, November
       10, 1976, on page 51056, middJe  column.
       third  lull  paragraph, in the 12th line,
       "January  18. 1975"  should  have read
       "January 18, 1977".
KDUM'tUISTtt, VOl. 41. NO. 23,-TUISOAr, NOVEM5« 30. 1976

-------
                        Publicity and Outreach

invlromental News Release
Letter to Manufacturers  and Professional Associations

-------
rA        Environmental
-f
 Una L  U
                 r
                                                      DRAFT
                                             Sibbison  (202) 755-0344
EPA WILL              The Environnental Protection Agency  said today it
INVESTIGATE
tfATIR           is initiating a program to tes.t the ability of non-
PURIFIERS
                chemical water purification devices to  purify water.

                EPA said it will take enforcement action  against the
                manufacturer of any product which fails in the tests to
                remove microorganisms that could cause  disease.
                                         *
                A non-chemical water purification device  is a product
                which uses a physical means to eliminate  microorganisms,
                such as bacteria and viruses,  from previously untreated
                water.  These physical means include ultraviolet
                radiation, filtration, reverse osmosis, distillation,
                and ozone or chlorine generation.

                Water purification devices are most often used in areas
                where municipally treated water is not  available and
                the individual is dependent on water from a well, lake,
                or stream.  Often the quality of this water is of
                questionable safety because it may be contaminated, with
                disease causing microorganisms.

                If a water purification device fails to eliminate
                these microorganisms, there is a'risk of  causina such
                diseases as hepatitis, dysentery, and infection of
                the stomach and intestines.

                EPA will have about 50 water purification devices
                tested by the State of New York Department of Health,
                Division of Laboratories and Research,  Environmental
                Health Center,  in Albany.

                A.E. Conroy II,  of EPA's Office of Enforcement, said
                the Agency has received aomplaints from consumers
                indicating that some of the devices do  not work
                properly.  In addition, he said, a 1979 study published
                by the Canadian Environmental  Health Directorate
                concerning three ty-.res of purifiers using ultraviolet
                light showed that two of them  effectively removed
                bacteria but a third device did not.
                                     ^
                                     (more)

-------
                             -2-

"We have reason to believe that users of some of these
purifiers sold in the United States may be exposed to
dangerous levels of microorganisms," Conroy said.

Under Section 7 of the Federal Insectiicde, Fungicide, and
Rodenticide Act, all manufacturers of water purification
devices are required to register with the Environmental
Protection Agency and submit annual production reports on
their devices. This information is crucial, Conroy said,
to the Agency's ability to successfully carry out this
monitoring program and protect the public health.

Once a manufacturer has been registered, he or she will
receive an EPA establishment registration number which
must appear on the device's label.  If a consumer should
find a water purification device that does not bear an
EPA establishment registration number on its label, he or she
should write to A.E. Conroy II, U.S. EPA, EN-342, 401 M Street,
S.W., Washington, D.C. 20460, Attention: Water Purification Devices,

                             ft*

-------
  Letter to Manufacturers and Professional Associations
 To Vfriom It May Concern:

      The Environmental Protection Agency (EPA) has recently become aware
 of the fact that many manufacturers  of water purification devices do not
 realize they are required  to 'register  their establishments with the Agency."

      We have learned that  your  firm  may be a manufacturer of water purifi-
 cation devices and therefore subject,  along with the device, to the Federal
 Insecticide, Fungicide, and Rodenticide Act as Amended (FIF3A).  A device
 is defined in FIFRA as "any instrument or  contrivance...which is intended
 for trapping, destrDyings-repelling, or mitigating any pest...."  Bacteria,
 viruses and other microorganisms  are considered pests under FIFRA section
 2(t) and 40 CFR 162.14 (b)(4) and (5).

      Any product which claims to  purify water must make previously untreated
 .water, suitable.for .human census?tIon 4i..e.,--eliminate, all pathogenic micro- •»
 organisrr.3).  This definition of a water purifier comes from a 1954 rulir.?
 in Federal Trade Co.TuT.ission v.  Sibco and has recently been reiterated in a
 IS 7 3 E?A decision In re Ccn-act Industries Inc.

      There are basically two broad categories of water purifiers, those
 which use a chemical means to destroy  the  microorganisms and those which
 use a physical means.  Purifiers  which use a chemical means are considered
 pesticides and subject to  registration requirements in section 3 and section
 7 of the Act_(product and  establishment registration).  Those which use
 a physical means are considered devices and subject only to those registration
 requirements in section 7  (establishment registration).    Examples of such
 devices include but are not limited  to: Ultraviolet light systems, submicron
 filters, reverse osmosis units, distillers, chlorine generators, and ozone
 generators.

      All manufacturers of water purification devices are required to register
 their establishments with  the Agency and submit annual production and distri-
 bution data on their devices.   Enclosed you will find a copy of FIFRA, two
 Federal Register Notices,  and 40  CFR 162.15 clarifying the Agency's authority
, and requirements of the Act.  -; --. .--. -•  ...•-.-.•••  .. -..-••- •-••  •••• •••-- ••••; ••_•• • •_ • ••

     . Also enclosed is EPA  form  3540-8, Application for Registration of
 Pesticide Producing Establishment.   If you manufacture water purification
 devices, please complete EPA form 3540-8 if you have not already done so.

-------
     Once an I?A estabhlishsent number has "been assigned, EPA fora 3540-16,
Pesticides Report for Pesticide-Producing Establishments, will be sent
to you for cccpletion.  Include either the words "point-of-use" or "saall
STcter:" in parentheses after the product naae, depending on the intended
use of the product.  Point-of-use purifiers are those intended for use in
a single family household, caziper, boat, etc.  Small systems would- be used
for industrial or ccooercial purposes or to supply water for twenty-five
people or nore.

     If you do not manufacture water purification devices, we would greatly
appreciate it if you would inform us at the address given below so that we
nay rezove your name froa our list.

     If you have ary questions concerning your product and whether it is subjec
to FI7RA, please contact Josephine Huang, Toxicologist,  U.S. SPA, EI-342, 401
K Street S.W., Washington, B.C.  20460, (202) 472-3701.
                                         Sincerely yours,
                                     A. E. Conroy II, Director
                                  Pesticides and Toxic Substances
                                       Enforcement Division
Enclosures

-------
t-rort Documents

  • Protocol for Product Testing
   &iraft available from headquarters)
   Criteria for Review Tean Analysis
   (under developnent)
   List of Products
   (under development)

-------
X0"1**,
      ~-
             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                           WASHINGTON. C.C.  20460
                                  I7IS80

                                                     OFFICE OF ENFORCEMENT
     MEMORANDUM

     SUBJECT:  Routine Use  of SEC  "10-K"  Statements in TSCA and FIPRA
              Civil  Penalty Actions

     TO:       Regional Enforcement  Division Directors

     Introduction

         The  Office  of Enforcement  is  interested in the financial
     status  of companies  charged with TSCA  or FIPRA violations
     for  two reasons:   (l)  to establish appropriate civil
     penalties and  (2)  to challenge corporate claims that
     severe  economic  consequences  will  result from civil
     penalty assessments.

         At present,  the Regions  utilize Dun and Bradstreet
     publications to  determine the general  financial condition
     of a business  enterprise.  However,  the general level of
     detail  provided  by the  Dun and Bradstreet publications,
     if used as  the only  source of information,  may provide
     an incomplete  and potentially misleading picture of a
     company's financial  condition.

         In exploring various alternative  sources of financial
     information, PTSED has  discovered  a  potentially excellent'
     tool for  determining financial status:   the ''10-K"  state-
     ments filed by companies  with the  Securities and Exchange
     Commission  (SEC).   The  purpose  of  this  memo is to explain what
     10-K statements  are  and how they can be used in the TSCA/
     ?I?RA enforcement  program to  improve our ability to determine
     financial status.

     The""10-K  Statement

     Purpose ofxlO-K  Statement

         A basic purpose of the federal  securities laws is to
     provide disclosure of  financial and  other information on
     companies seeking to raise capital through  the public
     offering  of their  securities  and companies  whose securities
     are  already publicly held.  The goal is to  enable investors
     to evaluate the  securities of these  companies on an informed
     and  realistic  basis.

-------
                           -2-

     The Securities Exchange Act of 1934 deals in  large
part with securities already outstanding and requires the
registration of securities listed  on a national securities
exchange as well as over the counter securities in which
there  is a substantial public interest.  Companies which
issue  registered securities must file annual and other
periodic reports designed to provide a public file of
current material information.  Currently over 11,000 com-
panies file disclosure statements  with the SEC (July 1980
estimate).

Contents of 10-K Statement

     The 10-K statement is the official annual business
and financial report which must be filed by most companies.
The financial section (Part I) must be filed within 90
days of a company's fiscal year end.  Supporting data
(Part  II) of the 10-K contains the information normally
required in a proxy statement.  Schedules to financial
statements may be filed by amendment within the 120-day
limit.  No other source of corporate information provides
more comprehensive or current information about a  company
than this report with its schedules, exhibits and  amendments.
The following is a description of  the items contained in parts I
avnd II of the 10-K statement that  pertain to a company's
financial status.

Form 10-K

     Business.  Identifies principal products and services
of the company,  principal markets and methods of distribution
and, if "material", competitive factors;  backlog and
expectation of fulfillment;  availability of raw materials;
importance of patents,  licenses,  and franchises;  estimated
cost of research;  number of employees;  and effects of com-
pliance with ecological laws.

 -"  Summary of Operations.   Summary of operations for each
of the last five fiscal years and any additional years
required to keep the summary from being misleading (Per-share
earnings and dividends are included).  Includes explanatory
material describing reasons for changes in revenues,  earnings,
etc.

     Properties.  Location and character of principal plants,
mines, and other important properties and if held in fee or
leased.

     Parents and Subsidiaries.  List or diagram of all
parents and subsidiaries and for each named, the percentage
of voting securities owned or other basis of control.

-------
                           -3-

     Legal Proceedings.  Brief description of material legal
proceedings pending.  When civil rights or ecological status
are involved, proceedings must "be disclosed.        ,.

     Executive Officers of the Registrant.  List of all
executive officers, nature of positions and offices held.

Enforcement Use of 10-K Statements

Civil Penalty Assessment

     A 10-K statement will greatly assist the Regions in
applying the adjustment factors as required by the TSCA
civil penalty process.  Section 16 of TSCA provides for
civil penalty amounts which range up to $25,000 per violation.
A number of factors must be considered in assessing a civil
penalty:

     "In determining the amount of a civil penalty, the
Administrator shall take into account the nature, circum-
stances, extent, and gravity of the violation or violations
and, with respect to the violator, ability to pay, effect
on ability to continue to do business, any history of prior
such violations, the degree of culpability, and other such
matters as justice may require" (Section 16,  TSCA).

     The gravity based penalty in the Civil Penalty System
(Federal Register, September 10,  1930) developed to implement
this Section reflects the seriousness of the violation's
threat to health and environment.  The 10-K statement is not
applicable to this part of the Agency penalty assessment.
However TSCA also requires the Agency to consider certain
adjustment factors related to the violator. The following
is a discussion of the ways EPA can use 10-K statements
during its deliberations concerning the applicability of the
adjustment factors to a particular company.

     1.  Violation History

     The TSCA Gravity Based Penalty is designed to apply
to "first offenders.']/ Where a violator has demonstrated
a similar history of violations,  the Act requires the
penalty to be-adjusted upward.  Generally, companies with
multiple establishments are considered as one when deter-
mining violation history.  Thus,  if one establishment of
a company commits a TSCA violation, it counts as history
when another establishment of the same company, anywhere in
the country, commits another TSCA violation.   The same policy
applies where a parent corporation in the substantially
similar line of business as that of its subsidiary, commits
a violation.  Because many large  companies are comprised of
smaller corporate entities with different names than their

-------
parent company, it is sometimes difficult to  identify past
violations.

     The 10-K statement should "be  requested whenever-there
is any question about the corporate holdings  of a violator
during civil penalty assessment.   This  is particularly true
where a large corporation is involved since there is an
increased likelihood of subsidiary companies.  This information
can then be used to determine if any part of  the company
has committed TSCA violations in the past.

     2.  Ability to Pay and Ability to Continue in Business

     Section 16 of TSCA lists "ability to pay" and "ability
to continue in business" as two adjustment factors.  The
TSCA penalty policy states that "the distinctions between
the two are so narrow and artificial that they are treated
as one." Consequently "ability to pay" will henceforth
be used to include "ability to continue in business."
Measuring a firm's ability to pay a cash penalty without
ceasing to be operable can be extremely complex.


     The current formula in the TSCA penalty  policy determines
ability to pay by reference to the company's  yearly net
income as determined by a fixed percentage of total sales.
This formula may not yield a complete.and accurate picture
of the company's ability to pay.

     Since the 10-K statement provides a more comprehensive
summary of financial status, it is suggested  that the Regions
take the following steps in reviewing 10-K statements to
determine ability to pay.

     1.  Look at the assets of the company for the most current
         two year period.  The factors in this category include
 	      cash on hand, marketable securities, receivables, inven-
         tories, current assets, property, plant and equipment,
         and depreciation.  All of these factors should be summed
         and to obtain the total assets of the firm.

     2.,xLook at the liabilities of the company for the most
         current two year period.   The factors in this category
         include accounts payable, notes payable, taxes due-, total
         current liabilities, long term debt, and shareholders
         equity.                                               '

     3.  Look at the income statement of the  company for the
         most current two year period.  The factors in this
         category include net revenue, cost of goods,  gross
         profit, general and administrative expenses, income
         before tax, extraordinary items, and net income.

-------
»	.		=5=	

     The income section of the 10-K statement is the most
useful for assessing a company's ability to pay a civil penalty
(item 3 above).  In particular, the gross profit of a company
provides a good picture of the stability of a company.  Gross
profit is the income that the company derives after the deduction
of the coat of goods.  It does not reflect the general and adminis-
trative expenses associated with running the business.

     The gross income should be compared with the net income of
the company.  Net income reflects the "bottom line" on a company's
profitability.  A negative net income may indicate that the company
cannot afford to stay in business if a civil penalty is assessed.
However this may not be true in view of the company's gross income.
For instance non-recurring "extraordinary" items may have caused a
temporary loss.  If so, the company can probably afford to pay a
civil penalty.  Additionally, the Region should remember that a
company can liquidate assets to meet penalty amounts and still
remain in business.

     In complex cases,  the Region may need to rely on a management
division economist or an accountant to analyze the firm's ability
to pay and, on a case by case basis, to evaluate the proposed
penalty.   The usual case can be satisfactorily evaluated by
an analysis of the gross and net income figures on the 10-K_
statement.

Obtaining 10-K Statements

     The Regions should obtain 10-K statements before assessing
civil penalties in enforcement actions.  A 10-K statement may-
be obtained in various  ways.  EPA regional offices in San
Francisco,  Chicago, and New York may contact the local SEC
office to obtain 10-K statements for companies with headquarters
located in the Region.   In addition, the SEC Headquarters in
Washington will mail out 10-K statements upon request.
Inquiries should be mailed to the SEC, 500 N.   Capital Street,
Washington, D.C. 20549-  Regions must specify the name of
tn"e company and the years for which the 10-K is requested.
A.nominal fee is charged for this service;  twenty-four hour
response is possible upon request.

     I hope that the Regions will begin using this important
tool immediately.  Please contact Russell 3. Selman of my
staff if any questions- arise at 755-9404.
                            Conroy II,
                   Pesticides and ToxicTSubstances
                         Enforcement Division

-------
 °ampSe  Extracted
 COMPANY  PROFILE
 0592799  PROFILE   LAST FILED:  79/07/31 CO HO: C321300000
  CENESCO INC             •    ••                     .    .     .
  CENESCO PAR*
  NASHVILLE  TO 37202
  THCORPORATED IN:' TH'           .          .
  EXCHANGE: MYS   TICXZR SYMBOL: CCO    "    '    " :  ..  '••"   ..  '."   .  :.
  SIC FILE NO: 1-3083     IRS HO: 62-0211340   COSTP: 3713323
  SIC COOES: 2311 2331 3143 3144 5661
  DESCRIPTION OF BUSINESS: MANUFACTURES AND RETAILS CLOTHING. OPERATIONS ARZ
 DIVIDED INTO POUR SEGMENTS:  FOOTWEAR. HEN'S APPAREL, SPECIALTY RETAILING AND
 VARIETY RETAILING.  OPERATES 61 MANUFACTURING PLANTS' AND WAREHOUSES AND
 APPROXIMATELY 1,400 RETAIL STORES AND  LEASE DEPARTMENTS THROUGHOUT THE U.S. AND
 CANADA.   .
  FISCAL YEAR' END! 07/31  '.;    t .  •   .    '•      ..         .'•..••
  10-K      79/07/31                                          '
  ASS-  .    79/07/31
  10-q      79/04/30
  "PRSPCr "•  .79/02/-13
   EZCST S08  78/05/01
•0592791': 10-K  .. :   .'•'• .OAIt:.-79/07/31"'.CO .»:.0321300000-
 •.6EHESCb-tNC -•••'  .""": •:•'•''-••."*.•   '••'»••.'.'.•'. •/'-;: ''  '••'"''?
•• '.SHARES OF.-COW10N STCCJC: U,620,920t   ••'-. .   ..:•'•• •• -. .  ':
  "NUMSER OF SHAREHOLDERS: 32,403 "  "
  KUMBER OF EMPLOYEES:  25,300
  PARENTS:  ___
 H/A         " .         -
  SUBSIDIARIES:          '       '  •'
 BBC, IHC.;  "v
 COLLZCE CSOVS TRUCX COMPANY:
.FLACC BROS. OF PUERTO RICSJ, INC.;    -,.   -
-.CEHEJUL.aETAti.. (3)RPOaATION: •   '•: •..'•.'.'-' '•'. X ' -'
 GENES CO APPAREL AND FOCTVEAR. (FAR EAST)' LrMTTED;
 CENL2ATHER INCORPCRATID:
 S. H. CRESS OF LOUISIANA, INC.;
 CEMESCO rTALIA S.P.A. :
 TENNESSEE RAVENWOOD PROPERTIES, IMC'.;
 CCO.PROPERTIES, TNC.;_, .         . .
'CENESCD CROC? IHC.:'"  !J..'.." '•'-'' ''•'*' ''•'•"•••"''V!.'•'••
 UNIVERSAL SHOE'AND APPAREL KPORT, INC.;
 HENRI BENDEL, INC.;
 I. MILLER 4 SONS, INC.;
 S. H. KRESS AND COMPANY;
 V. J. ELMORE AND COMPANY:
     PCD MERCER COMPANY, INC.;   •
     SHOPS INCORPORATES;
   !EN RESTAURANT'CORPORATION: ,.../.
  ./fESCO APPAREL LIMITED: .
"ACSEU-SURPASS-SHOE.STORES, LIMITED;   '"'  '  '  ,

-------
     10-K Extract  com.
                                                 LIABILITIES
    ACCOUNTS PAY ABU                   75,347,000             87.035,000
    NOTES PAYABLE                 '   '27,365,000             78,365,000
    TAXES Out             .                   M/A                   It/A
   • TOTAL CURRENT LIAB.               117,174,000            187,078,000
    LOW TERM DEBT.          .-   -.     129,928,000  .          I26>662r,000
    SHAREHOLDERS EQUITY •    "''""      90,698,000             84.104..000      .    "
                                               INCOME STATEMENT
    HET REVENUE                       992,925,000          1,048,351,000
    COST OF GOODS                     672,812,000            705,740,000
    CROSS PROFIT              .     .  320,113,000  .      .   .342..6U.OOO.  .
    SELL, GEN. S ADMIN. £XP.:          292,157;000          "  302,960,000
    INCOME BEFORE TAX                  (1,045,000)            19,364,000
    EXTRAORDINARY ITEM                       N/A                    N/A
    NET INCOME                          6,332,000             14,936,000   .
   ' . COMMENTS:         . '   .           •            .  .  •          •'.'...       :
    EXTRAORDINARY ITEM IS OPERATING LOSS CARRYFORWARD
    FOOTNOTES:
   . ACCOUNTING PRINCIPLES:  ACCOUNTING CHANGE FOR .COMPUTING THE U.S. TAX
 .  PROVISION    •       .   :  • ••    •• •  ••••.-":..'•;•••'. ' •  •-.' .'    -.  .   .'.  ••• •  '•   •
    MERCER AND/OR ACQUISITION:   PURCHASE, TENNESSEE RAVENVMD PROPERTIES, INC.,
   PAYMENT IN CASH                              .           .
    PRINCIPLES OF CONSOLIDATION:  CENESCO FINANCIAL CORP. CARRIED ON EQOITIf
:i-^ateV<:YH^V'.->-^—-?^^
 •  • -DEPRECIATION:  SUM OF'DIGITS': DOUBLE OECLINfTIC BAtAHCEV PRINCIPAL METHOD" IS  -
   STRAICKT LIVE
  -  INVENTORIES:  FIFO: RETAIL METHOD USED  FOR  RETAIL COMPANIES
    SHORT TERM DEBT:  LINE OF  CREDIT: COMPENSATING BALANCE: RESTRICTING   .
    LONG TERM DEST:  COLLATERALI2ED: CONVERTIBLE:  RESTRICTING:  AMENDED:
   "^ORDINATED SOTS, SENIOR SINKING FUND NOTE,  SUBORDINATED DEBENTURES, FIRST
      ''CAGE NOTES
      AXES}. NET OPERATING LOSS CARRYFORWARD,  566,433,000, EXPIRES'IN 1985.-V •    '• •
;•;;- STOOC OPTION:  .CNQUALIFIEOMCEY -EMPLOYEES  STOCK OPTION. PLAN, EMPLOYEE '.  .   ...
  . INCENTIVE PLANS-A i 3   •••"••    . "     . ' ''    •'  '  ' '    '  '  '•'••;  "'.'.•.-
 .'  ' FOREIGN OPERATIONS:  TRANSLATION CAINS'  OR LOSSES. .    '            .      .   \_
 . •  .LEASES:. .CAPITALIZED: EXPENSED: .FASB 13:  SUBLEASES. ..   ....  ..'•-..  .      -   :.
• ::-:':.7E7i3tqii'-PLANS:.1  'FUNDED-.- COST ACCRUED:' VESTED  aENErrrs EXCEEDED-'ASSETS'• '.•'-.':'.'?:,
 :.' 'COKMrTKENTS/CONTINCENCIESi . -LEASES:. LTTICATIONS    ......       .  ..-'..'.,,.
   ..SUBSEQUEyr EVENTS: : •»/•>'  -''•'•'.:•   •'  ..''•••.."..'.-• •—'. ''.•'•••'.•••'-.  '••'.• :;  '•'• ;';  •-.•••.>.
    OTHER FOOTNOTES:  aEPLACEXSNT COSTS: QUARTERLY FINANCIAL  DATA: SEGMENT
   INFORMATION: COMMON STOCK:  SUPPLEMENTARY  INCOME STATEMENT t^ORMATION: CAPITAL
   STOCX, PR£?ERSED STOCK: .RECEIVABLES: CURRENT  ASSETS OF OPERATIONS BEING
   DIVESTED: INVESTMENTS. AND LONG TERM RECEIVABLES: FIXED ASSETS OF OPERATIONS '
   BEING OIVESTEO: SUBORDINATED COMMITMENT TO  FOREIGN  FINANCE  SUBSIDIARY:
   PROVISION FOR OPERATIONS BEING DIVESTED ANT  RETAIL  STORE CLOSINGS
     The cost for retrieval and display of the above information (all
     3 reports) is in the approximate range of S6.00 to S 12.00 de-
     pending on search complexity and system vendor used.

-------
  10-K Extract  cont.
  OISOO SIDES LIMITED;
  CZNISCO 07 CANADA CO. LTD.;
  CONTINENTAL SHOE SALES CORPORATION LTD.;
  SJOE VILLA LIMITED;
  J. A. JOHNSTON COMPANY OP CANADA LIMITED:
 .1EVARO SHOE STORES OF CAKADA LIMITED;
' 'OOTt* SHOES,'LIMITED;          ' •
  CEHESCO WORLD APPAREL, LTD.;
  PINEBHOOK REALTY CORP.;
  CENESCO INTERNATIONAL CORP.;
  PULTON PROCESS & CHEMICAL CORPORATIOH
    LEGAL PROCEEDINGS:
  VIOLATION OF SECURITIES, IMPROPER SUSPENSION  OP  EXCHANGE RIGHTS  OF HOLDERS OP
•  SERIES C STOCK AND SERIES 8 STOCK, CLASS ACTION,  OENCO AND MICHAEL V. CRAKES
  7. CEJfESCO, INC., DISPOSITION ADVERSE, APPEAL'PENDING; .
  VIOLATION OF SECURITIES, IMPROPER SUSPENSION  OP THE  RIGHT TO EXCHANGE SERIES B
  STOCK, FALSE AND MISLEADING STATEMENTS, ERWIN CXMP,  ET AL. V. CENESCO, INC.,
  DISPOSITION ADVERSE SUMMARY JUDGEMENT, OTHER  ISSUES  PENDING:
 .VIOLATION OF SECURITIES, WRONGFUL'.REFUSAL TO  HAKE DEPOSITS TO SINKING FUND,
  GEORGE THOMAS, ET AL. V. CENESCO, INC., DISPOSITION  PENDING;
  VIOLATION OF ANTITRUST, RETAIL PRICE FIXING,  VARIOUS CLASSES OF  CHARGE ACCOUNT
  CUSTOMERS V. CENESCO, ISC. AND CERTAIN RETAILERS, DEFENDANTS IN  SEVERAL
 -ACII.OHS, DI.SPOSITIOH..EfNpINC; .•.-.';.•-. ,.-..-~,;^*;>..>.; •'- -T^- V^'v :»• r-.^-,r+.~^.
 •:?»LAWO», OF'ssoiftifitsVTALSE^^^^
  STOCK PRICES,  CLASS ACTION, LILA ZIPSIN V. CENESCO,  INC.,  DISPOSITION PENDING:
  VIOLATION OF SEOJRITIES. CLASS ACTION, CENESCO,  INC.,  CENESCO FINANCIAL CORP.,
  LEEDS SHOES, INC. ET AL. DEFENDANTS, DISPOSITION  PENDING:
  VIOLATION OF SECURITIES, FALSE AND MISLEADING STATEMENTS,  INFLATING COMMON
 f!TOCK PRICES,  FORMER OWNERS OF AN ACQUIRED CORPORATION V.  CENESCO,  INC.,
 WISPOSmON PENDING
    DIRECTORS AND. OFFICERS:           .   -.'       '..••••       •    •/.   -.     •  .  •
 JtANICAN,  JOHN  L.: CHAIRMAN',..PRESIDENT AND'CHIEF"EXECUTIVE  OFF.ICER   '  '    .'   '"
'•-BOWLES-,  RAL?» H.; EXECUTIVE VTCE PRESIDENT',• GENERAL  MANAGER  OF .RETAIUNC.' .-  "
  LANCSTAFF,  GEORGE 0-:- SXEOJTIVE VICE ?3*SIDENT, GENERAL  MANAGER  OF  FCOT'-tAR
 SHELTON,  LARRY'B.;  EXECUTIVE VICE PRESIDENT,  CENE3JAL MANAGER OF  MEN'S APPAREL
 .WIRE,. WILLIAK  S.  K; • VICE-PRESIDENT .--FINANCE AKO-.tREASUREJt, CHIEF  FINANCIAL   •
"OF7ICZR'•'•••••• ;     -.•.•:••••--••  '   '  •     ..-•     • •: •     ••  .•..".•   '••-....•
>..CU8K, THpMAS-;B.r-VICE-pRESTDENT', ..GENERAL -COUNSEL .'.      ...  ' 	-.!'. '".'   '•'•''•'•
'O'CONNOR, WILLIAM C,;  SECRETARY, ASSISTANT  GENERAL COUNSEL
 WHITE, JIXMIE  D.: VICE PRESIDENT,  CHIEF ACCOUNTING OFFICER
    EXHIBITS:  COMPUTATION EARNINGS  PER SHARE:   REVOLVING  CREDIT AGREEMENT,
. 3/13/79, CjttDUP OF U  BANKS  AND  GENESCO  FINANCIAL  CORPORATION;  EMPLOYMENT
 ACREEMENTT^AMENBED,  9/25/79,  CENESCO AND  JOHN L.  HANICAN:  STOCKHOLDERS'
 PROPOSAL, ^FUTURE  STOCX OPTION  PLANS,  ANNUAL MEETING  12/4/78;  CENESCO
 RETIREMENT  SAVINGS  PLAN,  1/1/79;   HIGHLIGHTS  OF THE GENESCO  RETIREMENT  SAVINGS
 PLAN;  CENESCO. SETIHEXSNT. PLAN,. 1/1/79, SUMMARY PLAH-DESCSIPTION;    .;'..    -.   '
 ••' •  AVDTTOR::PRICE  WAtERhOOSE: 4 'COi  .  '." - ••"•' ••-•   *   " - '•' ''  -.:•.•"•••:•• "•'•; .
    AUDITOR'S 'REPORT: UNQUALIFIED

    FISCAL YEAR  OF  REPORT                  1979                    197S
                                             J.       ASSETS          *
    CASH          '•••-•.      •   12,371,000              20,576,000
 .   MARKETABLE SECURITIES .   .  -..  ^.- .••-,/..• N/A,.._,,;...,,,  ..,-,. .-.H/A-......
* ''RECEIVABLES  '  ' '  ""   '• " *"'"""r 24,337,000'"  ''  '"       27,374,000
    WVENTORIES                  •      197,687,000            213,471,000
    CURRENT ASSETS                  •  242,226,000            294,419,000
    PROP, PLANT  AND EQUIP.              98,350,000            102,451,000
    DEPRECIATION                               Jf/A                    H/A
   TOTAL ASSETS                       360,127,000 .           426,933,000

-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
                 WASHINGTON. D.C.  20460
                                                                          nl/'
\
                                 • •••%  17  i *^^**
                                 -   I i   — -'
                                 • — v  I I   lwW-<

                                                               OFFICE OF ENFORCEMENT
       MEMORANDUM

       SUBJECT:  Regulation of Public Health  Related  Disinfectant  Products

       TO:       Enforcement Division Directors
                 Pesticide Branch Chiefs

            In  a memorandum dated July 31,  1980, we requested  a  temporary  stop
       to the collection of sample requests intended  for  testing at  the  Chemical
       and Biological  Investigations Branch,  Beltsville,  MD.   This action  was
       requested to  facilitate an on-going  review  of  the  Agency's  Disinfectant
       Monitoring Program.

            We  have  at  this tine completed  our evaluation of  the disinfectant
       program.  Based  on this review we have developed a new  program plan  for
       monitoring claims of selected disinfectant  products.   The major program
       changes  are as  follows:

                 o   Testing of medical related disinfectant products
                     only

                 o   A  new testing procedure for determining efficacy
                     failures

                 o   Beltsville will perform both chemical analysis and
                     biological efficacy testing

                 o   Failure of a product to destroy Ps. aeruginoaa will
                     be  considered equal to  failure of a product  to destroy
                     S.  choleraeuis or S. aureus

-------
     We are in Che process of selecting disinfectant products  to be
tested under this program and will be forwarding  sample  requests to
   • Regions beginning February 1, 1981.  Appropriate measures  should
   taken to facilitate the collection of these requests.  We have
attached for your reviev several documents which  explain the details
of this program.

     We look forward to your help and cooperation on this program.  Please
address any questions or comments by January 12,  1981, to Josephine Huang,
Toxiologist, U.S. EPA, EN-342, 401 M Street S.W., Washington D.C. 20460.
                                        A. E. Conroy fLl, Director
                                      Pesticides and CToxi^ Substances
                                         Enforcement Qivj/sion
Attachments
cc:   W. Boatoyan

-------
                     Table of Attachments
Attachment A :  Program Development Strategy
                (To be placed in the Case Proceedings Manual
                and Inspectors Manual)
Attachment B :
Summary of Data Collection and Data Flow
(To be placed in the Case Proceedings Manual
and Inspectors Manual)
Attachment C :
Laboratory Procedures/Enforcement Actions
(To be placed in the Case Proceedings Manual)
Attachment D :  Test Level I
                (To be placed in the Case Proceedings Manual)
Attachment E :
Test Level II
(To be placed in the Case Proceedings Manual)
Attachment F :
Request to Stop Collection of Sample Requests
for Testing at Beltsville.

-------
                                                                            trruceeoiiijj
                                                              and  Inspectors Manual
                PROGRAM DEVELOPMENT STRATEGY
A.
Criteria of Selection:
       o Sample requests will include only those disinfectant
         products with public health related claims,  such  as
         those used on clinic or hospital premises.

       o Selection of products to be tested will focus on:

            - disinfectant products far which there
              is reason to believe that a violation
              has occured; this will be determined
              by consumer or competitor complaints
              and scientific judgment based on the
              study of product formulation

            - disinfectant products widely used on
              hospital or clinic premises

            - disinfectant products produced and
              distributed in large volumes
B.
Data Collection and Data Flow:
       o Samples to be tested will be selected by:

            - Headquarters/Pesticides and Toxic
              Substances Enforcement Division -
              Compliance Monitoring Branch (PTSED-
              CMB)

       o PTSED-ChB will send the sample requests to the Regions
         for collection on a quarterly basis (approximately 40
         sample requests on a national level every three months)

       o The Regions will set-up an I.D. jacket for each sample
         requested.

-------
o When the requested sample has been collected, the PRD
  Acknowledgment copy will be forwarded to the Compliance
  Monitoring Branch with the "Sample Identification"
  Section of the request form completed.  This will inform
  Headquarters that an inspector has been assigned and the
  sample collected.

o The regional (or state) inspector will obtain and/or com-
  plete all information necessary for sample collection
  (see the Pesticide Inspector's Manual for instructions).

     - All information obtained by the inspector
       will be placed in the I.D. jacket and for-
       warded to Beltsville along with the requested
       sample.

     - This information will include a copy of the
       product label in addition to the label
       attached to the sample container.  This
       copy is intended for the sample's I.D.
       jacket.

o Beltsville will perform the chemical analysis and bio-
  logical efficacy tests for sample requests originating
  from Headquarters.

     - These samples will be retained ac the Beltsville
       laboratory for a two year period.

o Once testing has been completed:

     - All test results will be placed in the
       sample's 1.0. jacket and sent to the
       Regions.

o The Beltsville laboratory will forward a copy of the test
  results to:

     - Headquarters/Compliance Monitoring Branch
       (PTSED)

     - Headquarters/Disinfectant Branch (OPTS)
                         -2-

-------
                   COMPLIANCE MONITORING
                   BRANCH (PTSED)

                   o request samples


                   o review test results
                    request &
                  I.D.  Jacket
                      \
                            REGION
                   o set-up 1.0. Jacket
                   o inspector assigned
                   o sample collected
                   o PRD Acknowledgment
                     to Headquarters
                   o reports compiled &
                     placed in 1.0.  Jacket
                     sample &
                  I.D.  Jacket
                      PRD Acknowledgment
                      copv of special
                      request form
I.D. Jacket S
test results
                          BELTSVILLE
o chemical analysisX.
o biological
                                                 test results
                        efficacy testing.
                         test
                      results
                     DISINFECTANTS BRANCH
                     (OPTS)
                   o record test results
                     in the establishment's
                     enforcement record

-------
       o All I.D. jacket* will be retained on file at the appropriate
         Region.
            - In some instances the Regions may be re-
              quested to forward a copy of information
              retained in the I.D. jacket to Headquarters
              for review.
C.     Monitoring Failures for Enforcement Action;

       o Test failures are of two types:
                           X
            • Formulation violations/chemical defects -
              product does not comply with accepted
              labeling

            - Biological efficacy - product does not
              effectively eliminate certain organisms
              as claimed by the manufacturer

       o The Regions will initiate all enforcement actions.
                               -3-

-------
                                                                 flace  in  case
         LABORATORY PROCEDURES/ENFORCEMENT ACTIONS               Proceedings  Manual
    Testing Scheme (BeUsville):
          o  All samples requested under Chit program will
             undergo chemical analysis prior to efficacy
             testing.

          o  The A.O.A.C. "Use Dilution Method" (modified
             for soil load 1-step cleaner disinfectants)
             will be used to test the efficacy of disinfect-
             ants products with, claims against the following
             organisms:

                  -Salmonella choleraesuis
                  -Staphylococcus aureus
                  -Pseudomonas aeruginosa

          o  60 carriers will be tested for each of the above
             organisms.

II.   Definition of Failures/Enforcement Procedures;

     A.  Test Level I:

          o  3 samples  representing different batches will be
             tested at  this level.

          o  Each sample will be tested against each of the above
             mentioned  organisms.

          o  The definition of failure at Level I will be based
             on the performance standards required by OPTS for
             registration of disinfectant products (a sample which
             fails in 2 or more of the 60 carriers in any test is
             determined co have failed efficacy testing).

          o  A product  will be determined to have failed efficacy
             testing at Level I if the product fails to destroy an;
             organism in 2 or more of the 3 samples.

                  -For  each batch which fails efficacy
                   testing at Level I, the manufacturer
                   will be issued a stop sale, use or
                   removal order against the batches
                   from which the samples were collected.

-------
     o  If the product fails at Level I:

             - The manufacturer will be in-
               formed of the product's  failure
               and that 5 additional samples
               (each representing a different
               batch) will be collected for
               testing at Level II.

             - A civil complaint will be issued
               for violations at Level  I according
               to the Penalty Matrix.

     o  If only 1 sample out of the three batches tested
        fails to effectively eliminate  the test organism,
        then the product will be determined to have success-
        fully passed efficacy testing.

B.   Test Level II:

     o  If a product is determined to have failed Level I
        testing, 5 additional samples representing different
        batches will be collected for testing at Level II.

     o  Each sample  will be tested against the organism(s)
        the product  fails to destroy in Level I.

     o  60 carriers  will be tested for  each organism.

     o  At Level II, 2 or more failures out of the 60
        carriers tested for each organism in each sample
        constitutes  failure of the batch to meet efficacy
        requirements.

     o  The definition of product failure at Level II will
        be based on  the upper bound of  the 95Z Confidence
        Interval for 2 failures out of  60 carriers.  The 95!
        Confidence Level - 5 failures out of 60 carries.

     0  A product will be determined to have failed efficacy
        testing at Level II if the product fails to destroy
        any organism in 3 or more of the five samples.

     o  OPTS will initiate action to cancel product registra-
        tion for efficacy failure at Level II based on the
        95Z Confidence Interval.
                              -2-

-------
Representative* froa PTSED agreed that failure  to
effectively eliminate the test organism (based  on
the minimum of 2 failures out of 60 carriers) in
any of the samples tested will result in:

     - a stop sale, use or removal order
       issued against the batch from which
       the samples failing efficacy testing
       were collected

     - a civil complaint issued according
       to the Penalty Matrix
                       -3-

-------
                                                                   Place in Case
                                                                   Proceedings Manual


TEST  LEVEL  I


Definition  of  Failure/Enforcement Action;

Definition  of  Failure:


1)    Sample Failure    *> failure to destroy the test organism in 2 or more out of
                         the 60 carriers

                         Enforcement Action; a stop sale, use or removal order
                                             will be issued on the batch from
                                             uhich the sample was collected

                                             a civil penalty will be issued
                                             for failure of the batch to meet
                                             efficacy requirements

2)  '  Product Failure  = failure to destroy any test organism in 2 or more out of
                         the 3 samples

                         Enforcement Action; initiate Level II testing


EXAMPLE
\
Product X with claims against Ps. eeruginosa; S. choleraesuis; S. aureus


                       Failure out of 60 carriers

Sample  f       Ps.  aeruginosa   S. cholaraesuis    S. aureus     Enforcement Action

    1               *4/60            1/60             0/60       *stop sale, use cr
                                                                  removal order and
                                                                  civil penalty

    2               *7/60            0/60             1/60       *stop sale, use or
                                                                  removal order and
                                                                  civil penalty

    3           %    *3/60            1/60             0/60       *stop sale, use or
                                                                  removal order and
                                                                  civil penalty


The product fails  to destroy Ps.  aecuoanosa in Samples U, »2 .and S3
thus  Level  II  testing is to be initiated.

At  Level  II only those  organisms  the product failed to destroy at Level
~ are to  be tested.

-------
    w L.C'.'.'i 11
                                     Proceedinqs  Manual
 Definition of Failure/Enforceaent A*tion;
                                     «
 Definition of Failure;
 1)   Sample Failure   = failure to  destroy the  test organism in 2  or more of.
                         the 60  carriers

                         Enforcement Action:  a stop  sale, use or removal  order
                                             will be issued  on the  batch  froa
                                             which the sample was collected

                                             a civil penalty will be  issued
                                             for failure of  the  batch to
                                             meet efficacy requirements

 2)   Product Failure   = failure to  destroy any  test organism in 3  or core of
                         the five samples based  on the 95^ Confidence Interval
                         for 2 failures out  of 60 carriers;  Confidence Inteval
                         s 5 or  more failures out of the 60  carriers  (see ex-
                         ample below, Possibility B)

                         Enforcement Action:  procedures will be  initiated  to
                                             cancel  product  registration

 3)   A product is  determined to have failed  efficacy testing if 3  or more
     of the  five samples fail testing.  For  those products  vfaich fail in cnly
     1 or 2  samples enforcement  actions will be taken against the  batches frca
  .   which  the samples  failing  efficacy tests were  collected.

         Enforcement Action: a  stop sale, use or removal order  will  be issued
                             on the batch from which the saaole was  collected
EXAMPLE
                             a civil penally will be issued for failure of the
                             batch to meet efficacy requirements
Product X with claims against Ps. aerugincsa; S. choleraesuis; S. aureus.
At Level I Product X successfully destroyed S. cholaraesuis and S. aurais
but failed to destroy Ps. aerugincsa
Sample $

   1

   2

   3

   4

   5
Failure out of 60 carriers

    ' Ps. aerugincsa

         *4/60

         *4/60

         *5/60

         '*6/60

      •   *3/60
   Enforcement Action

* a step sale, use or
  removal order will be
  issued a^inst the pro-
  duct batch fron which
  the sample failing effi-
  cacy test was collected;
  a civil penalty will
  also be issued against
  these batches

-------
- Possibility B
 ^» ^HM 4iW OT <•» ••» •••


     *

 Sample  $


  1


  2


  3


  4
      X

  5
?allure out of 60 carriers

     •Pa. aerugLncea

          *7/60

       •  *20/60

          *4/60

          «6/60
    Unfo
t Action
* a stop sale, use or
  reooval order will be
  issued agiinst the pro-
  duct batch from which
  the sample failing effi-
  cacy test was collected;
  a civil penalty will"
  also be issved against
  these batches
 Since -product I fails  to destroy the test  organise in 3 or taore of the sagroles
 tested based en the 955 Confidence  Interval  for 2  failures out  of 60  carriers
 (product failed in saaolea £1, ?3«  .?4, 
-------
                             JUL 3 I  IScO
3UBJECT:   Request  tn  Stop Collection of 3oa?le
           Requests for  T«i3tir.^ at iJeltsville

lOt        Snforceaent Division Directors
           Pesticide Sranch Chicfa


     .t*c arc  in  f.ne prr»c*;s3 of evaluatini  the  A^»:ncy's Disinfectant
lonitocin^ ?rr»^ra«.  Tne  objective of our  review is to establish  an
c!Ct-ctivc  monitor iny  system for t;ie purpose of  irrorovin^ teat pro-
ccJur'.-j and  data  flow bctwcun Ucacquarturs, tn«* notions, an.1
3clt3villc.
     Until  further  notice,  appropriatr; 3»!3sure3 should fc«.«
   stn-j collection  of  all  octstanding s-a.-n?!*^  requ^ats int«-.n-.ied
    ttr-wtinq  at  the  Che.-aica!  a.nJ Siolo.-jirai  Invtstijations Jronch,
j^ltsvillo,  .-!J.

          cooperation  in tais matter is aooreciatr-3.
                                A. 2. Conroy  II?  director
                             Pesticides anJ Touic 3ubs
                                  Znforcca»»nt Division

-------
Tuesday
March 3, 1931
Part III



Environmental

Protection Agency

Pesticide Registration, Reregistration, and
Classification Procedures; Clarification of
Policies on Special Packaging

-------
 .5104
Fcdrr=I Register  /  Vol. 46. No. 41  /  Tuesday. Mnrcn 3. 1981 / Rules ana Kesuiaucns
 :NVIRCNVENTAL PROTECTION
 ;G£.\CY   .

 OC-rRPart 1E2
                   2500118]

     ,ide Registration, Registration,
 nd Classification Procedure;
 :iarific2tion of Pciicy Issues en
 :pec:al Packaging

 .SSNCY: Environmental Protection
 vje.-.cy (EPA).
 ,CTION: Rule rsiated notice.

 .•JMMARY: This interpretation of the
 hiiu-resistant packaging regulation (-JO
 15?. 152.15) provides clarification on
 everal aspects of the regulation. This
 nterpretation becarr.e necessary
 •ecause the pesticide industry had
 uised a number of questions which the
 cency fasis can best be resolved by
 -is publication. It is intended  that
 hrcu§h these clarifications the affected
 esticide registrants will be in a  better
 osition to comply with the regulation
 y March 9, 1981. when it becomes
 ffective.
 Oft RJRTHSa INFORMATION CONTACT:
 '.csaii.-.a L Gross. Registration Division
 TS-rerQ. Office of-Pesticide Programs.
 Ir.vironmental Protection Agency. Rra.
 C7. CM=2. 1321 Jefferson Davis
 Highway. Arlington, VA 22202. (703-
 5-   ••'51).
      MENTAL INFORMATION: On
 •f.-j...; 9. 1379. the  Environmental
 roteciion Agency (EPA) issued final
 ^sulaticns which  require certain toxic
 esticides to be in  special, i.e., child-
 2s;stsnt. packaging aftar March  9, 1931.
 "he regulations are now contained in 40
 IFR 162.15. Because so many registrants
 .ave had questions about the
 T.piemer.iaticn of these regulations,
 !?A has decided to publish this Notice.
 c answer those questions and to clarify
 he regulations in areas where they
 night be unclear. These clarifications
•an be used immediately in order to
.mer.d registrations with respect to
:hi!d-resis£ant packaging. Where EPA
:roposes to amend the regulations.
hose amendments will of course-
-eceme effective after full notice and
^eminent ralemaking.
\. Eye and Skin Im'atioa Criteria
 Mar.y questions  were received
:oncerning the conduct and
r.terpretation  of eye and skin irritation
.f-idies. As indicated in the preamble to
he final regulations (-M FR 13021),
estina for a pesticide's eye and skin
rritation effects should be done in
• c'    -nee with the National Academy
                         of Science/National Research Council
                         Publication 1133 protocols.
                         B. "Inherently Child-Resistant" Products
                           A number of registrants have
                         questioned whether their products need
                         to be tested for child-resistant
                         effectiveness, contending that they are
                         "inherently" child-resistant. These
                         products fail into two main categories:
                         (1) those where it is claimed that the
                         package is intrinsically ur.oper.able by
                         children, and therefore "inherently"
                         child-resistant, and (2) those where it is
                         admitted that the product is toxic and
                         accessible to children, but where it is
                         contended that it would not be possible
                         for a child to consume or be exposed to
                         a sufficiently large amount of the toxic
                         pesticide to cause him harm.
                           It is the agency's position that neither
                         of these classes of products is
                         "inherently child-resistant." In the first
                         case, where product design is the basis
                         for the "inherently child-resistant "
                         claim, it will be necessary for that
                         package to be tested, like all other
                         pesticide packages, in accordance with
                         the Consumer Product Safety
                         Commission protocols, as discussed  in
                        ' the regulations and clarified below. In
                         the second case, it is open to the
                         registrant to attempt to show that its
                         product  fails within the exemption
                         category of 40 CFR 162.16(c)(3). on the
                         ground that despite the pesticide's
                         meeting  of one or more of the loxicity
                         criteria,  it is not hazardous to man. The
                         registrant must show that a child could
                         not be exposed to a toxic or harmful
                         amount of the pesticide. The fact that a
                         pesticide has not been implicated in  a
                         large number of accidents involving
                         children is not in itself sufficient-
                         grounds  for exemption. Product specific
                         test data and an appropriate scientific
                         rationale must be submitted in support
                         of an exemption request.

                         C. Distinction Between "Exempt From
                         Special Packaging" and "Not Being
                         Subject to Special Packaging"
                           Many  registrants are requesting
                         exemptions for products, when in
                         actuality they are asking if their product
                         is subject to the regulation. An exempt
                         ia only appropriate for a product which
                         is subject to the regulation.
                           A product whose label does not allow
                         for residential use. is classified for
                         restricted use. or does not meet the
                         toxicity criteria, is generally not subject
                         to the special packaging regulations.  A
                         product "allows for residential use" if its
                         label either directly recommends
                         residential use or reasonably can be
                         interpreted to permit residential use.
                           Determining the potential for
                         residential use from the label directions
 may be difficult. Many ornamental
 plants and garden vegetables, for
 example, arc grown by the individual
 homeowner and. there!"jre. a  label
 which lists them can be interpreted 23
 permitting residential use. Residential
 use thus may not be automatically
 excluded for a relatively large number of
 products. In fact. th'e'sa.T.e formuiaticn
 may be used, for example, by the
 commercial vegetable grower as well as
 the home gardener raising the same
 crop. The registrant of a product is best
 aware of the actual use area/user group
 of the pesticide. The registrant is
 therefore in a position to either choose
 proper labeling (see I below) for those
 products not intended to be used by the
 homeowner or to choose child-resistant
 packaging for those products  used and
 stored in residential areas. For those
 products which will not enter the
 residential area even by use of a
 serviceperson (see I below) the agency
 will continue to follow its  customary
 distinction between pesticides products
 entering the home  market  and those
 which are intended for commercial
 production of food crops and
 ornamental plants. This distinction has
 over the years been accomplished by a
 number of means, for example", use
 directions and size limitations. On a  .
 case-by-case basis, and in case of
 'uncertainties, the agency has  also  '
 allowed or requested label language
 such as "for agricultural use orJy." or
 "not for use in or around the home."
   The regulations provide  for
 exemptions under two circumstarrces:
 (1) technical infeasibility or (2) where a
 product's meeting of the toxicity criteria
 is not indicative of a genuine hazard to
 man.
   Technically feasible means  that the
 technology exists to produce special
• packaging for a  particular pesticide. The
 agency is not required to find  either that
 the packing is readily available or that it
 will lend itself conveniently Jo the
 existing packages or packaging  •
 equipment of the registrant. EPA
 considers practicability and
 appropriateness to be components of
 technical feasibility. In EPA'a  view.
 packaging is practicable if it is
 susceptible to modern mass production
 and assembly line techniques  and
. appropriate if it is chemically
 compatible with the pesticide  contained
 in the package.1
   This definition is consistent with thai of the
 Consumer Product Safety Commission (CPSC).
 published in the Federal Register 01 February-15k
 19,-: (37 FR 1427).

-------
              Federal Register  /  Vol. 46.  No. 41  / Tuesday, March 3.  1S31 /  Rules and Regulations       ISlC-i
 •D. "Dormant" Pesticide Registrations

   A pesticide whose registration is '
 "dorrr.ar.t" is cni which is vniicly
 registered with EPA but is net currently
 in production. Obviously, the registrant
 of a "dormant" product subject to the
 chi'd-resistar.t packaging regulations
 must ccmpiy'with these regulations
 when it either begins cr renews
 production after March 9.1931.

 E. Voluntary Child-Resistant Packaging

 •  A auaber of registrants whose
 products are not required to be in child-
 resistant packaging have asked whether
 they may nonetheless use it. The anwer
 'is yes. However, once a registrant
 chooses to use child-resistant packaging.
 the registrant must comply in all
 respects with the child-resistant
 packaging regulations. It would be
 misleading to the public to have two
 types of child-resistant packaging—
 voluntary and compulsory—which were
 nat of equal safety or effectiveness.

 F. Product To.xicity and Child-Resistant
 Packaging
   A pesticide product's toxicity places it
 in one of three categories in regard to
 child-resistant packaging. These are:
   1. Those products which clearly meet
 or exceed the toxidty  criteria in 40 CFR
 162.16(c)(2). These products must be in
 child-resistant packaging unless the-
 registrant can demonstrate grounds for
 an exemption under 40 CFR 162.16(cj(3).
   2. Those products for which the
 existing toxicity data are not precise
 enough to indicate whether the product
.meets or exceeds the tcxidty criteria of
 40 CFR 162.:S(c](2). The registrants of
 these products may either do further
 testing to determine the precise toxicity
 of their products, cr they may concede
 that their products are sufficiently toxic
 to be Li child-resistant packaging, and
 ccmp'.y with the chiid-resistar.t
 packaging regulations. This second
 situation does  not constitute voluntary
 child-resistant packaging. There are
 three notable situations where this may
 occur.
   (i) For purposes of precautionary
 labeling the agency may have
 considered oraUoxicity data sufficient
 to show that the" product was in toxicity
 category  III (LD»« of from 500 through
 5,000 mg/kg). but not specific enough to
 determine whether the product has an
 LD»of 1.5 g/kg or less.
   (ii) Eye irritation studies may have
 been submitted which showed corneal
 effects past day 7. and the study may
 have been terminated without
 determining whether the effects were
 reversible in 21 days. Such a study was
 sufficient for purposes of precautionary
 Inbeiin? (category 1) but is no longer
 adequate to determine whether or not
 child-resistant packaging (CH?) is
 needed.
   (iii) The third situation applies to skin
 irritation studies using an exposure
 period of 24 hours. These studies would
 not necessarily allow a conclusion.as to
 whether the criteria for CRP have been
 exceeded.
   3. Those products which clearly do
 not meet the toxicity criteria in 40 CFR
 162.16(c](2). These products are not  '
 required to be in child-resistant
 packaging, although a registrant may
 choose  to use child-resistant packaging
 voluntarily, in accordance with £ above.
 G. Released for Shipment
   The phrase "released for shipment" is
 defined as follows: "A product is
 released for shipment by a producing
 establishment when it is the intent of the
 producer to introduce the product into
 commerce." Products at the distributor
 and  retail levels are considered to have
 been previously released for shipment
 by the producing establishment
 H. Testing Procedure for ChUd-Resistant
 Packaging Which Requires a Tool for
 Opening
   As the regulations indicate, the
 protocol testing procedures of the
 Consumer Product Safety Commission  '
 (CPSC) 16 CFR 1700.20) are to be  '
 followed in testing the child-resistant
 packaging of pesticides. The CPSC
 policy for testing child-resistant
 packaging which requires a tool to open
 the packaging, published in the Federal
 Register of October 13.1972 (37 FR
 21632). will also be followed The test
 policy is that
   1. children need not be given the tool
 during the test unless the tool and
 product are marketed together, and
   2. adults will be given the tool for
 testing.

 L Limited Exception for Products Sold
 to, and Used by, Servicepersons
  EPA has  determined, based on
comments submitted by various industry
groups, that pesticides which are used in
 residential areas by janitors,
 professional pest control applicators,
 exterminators, swimming pool
 operators, lawncare and landscaping
 personnel, and other similar people need
not be in child-resistant packaging. This
is because the storage and usage
patterns generally employed by these
people are such that a significant hazard
to  young children is not apparent.
  Therefore. EPA plans to propose to  .
amend the present child-resistant
packaging regulations to provide that
pesticides applied and used by
 Servicepersons. as defined below, will
 not be within the scope of the
 regulations. EPA's proposed
 amendments to the regulations •.•.•::! b?
 published shortly, and will be subject to
 public comment. In the meantime. EPA
 will exercise its prosecutional discre:::.-
 not to enforca the child-resistant
 packaging regulations against these
 manufacturers who comply with these
 restrictive measures enumerated beio-.v.
   EPA now plans to propose
 amendments which are substantially as
 follows:
   1. Serviceperscn. As used in the child-
 resistant packaging regulations, a
 serviceperson is defined as one who
 provides a sen-ice cf controlling pests
 without delivering any unapplied'
 pesticide  to any person so served. The
 term "serviceperscn" includes, but is no
 limited to, a janitor, pest control
 operator,  maintenance person, la%vncare
 and landscaping personnel
 "Serviceperson" does not  include a
 household servant such as maid.
 housekeeper, or private gardener.
   2. A pesticide which meets the criteria
 for child-resistant packaging and is
 distributed only to Servicepersons cay
 be marketed without child-resistant
 packaging if the registrant labels its
 product (either by conventional or
 sticker label), "Cr.ly for Sale to. Use.
 and Storage by Servicepersons." This
 statement must be in type  at least as
 large as the  child hazard warning
 statement. Sale or other distribution of a
 pesticide labeled in this way to a person
 other than a serviceperscn will violate
 FTFRA section 12(a)(2)(F), once the
 restriction is imposed by regulation. Use
 of a pesticide labeled in this way by
 anyone other than a serviceperson will
 be a violation of FIFRA section
J. Testing Each Size of a Design

  The regulations provide that.
"Standards for special packaging shall
be evaluated for each size of a design
used' pursuant to the Consumer Product
Safety Commission protocols  specified
in 16 CFR 1700.20 ..... 40 CFR
162.16(d](3). In explaining the  necessity
for testing each size of a design, the
Preamble to the final regulations stated
that:
  Tests do not have to be run on each
pesticide product, only en each special
packaging design f * *. However, in
5 102.16(d)(3) a requirement has been added
to test- each size of a closure disitn used. !n
discussions with the Consumer Product
Safely Commission. EPA was advised that
changing the size of a design often reduces
the child-resistant effectiveness. RequiriT'j
each closure sizs to be tested wi:i «ii— .::::; :c

-------
 13105
Federal  Register / Vol.  46.  No. 41  / Tuesday.  March 3. 1921  / Rules and Reflations
 :r.e pos$:«:-.!v of an ineffective packase being
 -s.-^e'.ed ,-i-i rS ::o:3).
   E.-A reccgr.izss that this preambia
 lanausr-e is somewhat arr.bisuous.
 brssuse it refers both to the testing of
 :'• " -*t;r8 special packaging design and
       testing of the closure size aione.
 ,.  .i it was the intent cf the drafters of
 the resuiaticr.s to require that the entire
 special package be  tested for its child-
 resistant effectiveness.5 the preamble
 '.a.-.ruage apparently prompted same
 ret:srants to test only the closure size
 which thsy intended to use on their
 pesticide product.
   In view of the closeness cf the March
 9. 193*. deadlir.e for compliance with the
 special packaging regulations. EPA is
 now prepared to resolve this possible
 ambiguity by permitting pesticide
 registrants to certify that their pesticides
 packages are in  compliance with the
 regulations based solely on the testing
 of each closure size. EPA will then
 propose amended regulations, to be
 open for public comment, which will
 -ake it clear that the phrase "each size
 of a design" means  the entire package.
 The entire  package  will be denned to
 consist of the following elements:
 belonging to a specific AS7M (American
 Sociery for Testing and Materials)
 classification of packages; being made
 by a particular packaging manufacturer.
 having a specific trade name: being a
 specific model/style number; having a
 p?—'— ilar shape; having a particular size
 {      ; capacity) container/package;
 h.   J a particular size closure (if
 applicable): having a specific liner (if   •
 applicable); and having the container/
 closure or package being constructed of
 a particular material.
  EPA recognizes that  the time and
 expense necessary to test each specific
 package cf each  product requiring
 regis'-ration would be considerable.
 Accordingly, to lessen  the impact which
 wculd occur if such testing were
 required. EPA will offer manufacturers
 an alternative method by which the
 packaging of products can be certified.'
 1: is ceiievad that this scheme provides
 a reasonable degree of assurance that a
 package not tested -will still meet the
 effectiveness specifications for special
 packaging.
  : As eariy as the 1377 proposed regulations. EPA
s'3!td that. "lUJr.cer 'J-.:3 regulation it is intended
'--.a: '.he entire package be tested. Containers which.
'.cf exa.T.cie. use sat'e'.y ciosures which are not
corr.pa!-.;:« with the container body are not
acceptable" (*Z TH i323S).
  1 However, should a pesticide package be tested
arc four.d not to estr.?!y with the child-resistant
e.'fK-.iveresi standards of 16 CFR 1700.23. it will not
I* a defer.!* !h«ii the similar product on which the
rc::s'.-ar.t rsi:ed d.d meet :huw standards.
L'.:.-.i.:ely. each spec:al paciage must be evalaaled
03     ' raer.t*.
                              EPA's proposal is set forth 'below, in
                           the hope that some manufacturers will
                           voluntarily comply with it before it
                           becomes effective.

                           Proposed Tsstirg Scheme

                              If a registrant uses a package other
                           than she exact package system for which
                           the protocol test data are available. EPA
                           will accept certification if the package
                           used meets the following criteria:
                              (1) Package shape: The package for
                           which protocol data are available must
                           be a conventional shape, e.g.,
                           cylindrical, rectangular, square, and the
                           package for which certification is
                           sought,  even if different from the shape
                           of the package tested, must also be
                           conventional in shape. If an "F* style
                           metal can or a conical metal can are
                           involved, the shape used must be the
                           same as the shape tested. Ail
                           npnconventional package shapes, e.g.,
                           hourglass configuration, triangular
                           packages, must be tested individually.
                             (2) Container/package material: The
                           material of the package/container for
                           which certification is sought'must be
                           genetically equivalent and have the
                           same physical/chemical properties (e.g.,
                           bursting strength, tear strength, etc.) as
                           the material of the package for which
                           protocol data are available.  Different
                           materials include polypropylene, low
                           density  polyethylene (LDFE), high
                           density  polyethylene (HOPE), glass, tin
                           plate (steel), aluminum, etc.  If data are  •
                           available for a glass package and an
                           LDPE package is used, it must be tested.
                             (3) Volume of the package: For
                           certification on the basis of data      •  '
                           involving a package other than the exact
                           one used by the registrant, the protocol
                           test data must demonstrate that the
                           package tested has a child-resistant
                           effectiveness of 38 percent of more after
                           demonstration. The size of the package
                           used must fall within the limits set forth"
                           below. The 88 percent figure was
                           chosen,  based on statistical  analysis, to
                           ensure that a  package similar but not  .
                           identical to the one  tested would mset
                           the 30 percent and 35 percent
                           effectiveness  testing requirements of the
                           CPSC protocols. See 16 CFR 1700.20. If a
                           registrant wants to certify that its
                           package is child-resistant on the basis of
                           testing the package actually  used, a
                           minimum of 30 percent child-resistant
                           effectiveness  after a demonstration is
                           proper.
                             1. To use test data from a package
                           which contains 0 to 8 fL oz~,4 the
                             • Volumes measured in cubic inches can be
                           converted to P.yid ounces ustna the rule that 1 fl.
                           oz. = 1.3 cu. in. Numbers should be rounded to the
                           sext highest whole number.
 registrant's package must be the exact
 size of the package Vested.
   2. To use test data from a package
 which contains 3-54 fl. oz.,4 the
 registrant's package can be equal to or
 as much as twice the size of the package
 test. For example, if an 3 fl. oz. package
 has been tested, its data (assuming that
 all other factors were equal) cculd be
 used for a package frora 3 to 16 fi. oz.
   3. To use data from a package which
 is larger than 54 fl. oz..4 the registrant's
 package can be equal to or as much as
 1.5 times the volume of the package
 tested.
   4. Closure/package: The closure/
 package used must be the same ASTM
 classification, the same model/style, the
 same model/style number.
 manufacturer, and trade name as the
 package tested.
   5. Closure size: For certification on the
 basis of data involving a closure other
 than the exact  one used by the
 registrant, the protocol test data must
 demonstrate that the closure tested has
 a child-resistant effectiveness of 38
 percent or more after demonstration
 (see (3) above)/The size of the closure
 used must fall within the limits set forth
 below:
   a. To use data from a closure with a
 diameter less than 20 mm or greater
 than 45 mm, the registrant's closure
 must be the exact size of the closure
 tested
  b. If the registrant wishes to rely on
 data from one other closure, which is
 between 20 and 45 mm in diameter.
 inclusive, he may do so, provided that
 the diameter of the registrant's closure is
 in the size range between 20 and 45 nun
 inclusive and is between 1 and 1.15
 times that of the closure tested.
 (Numbers should be.rounded to the next
 highest whole number). For example, a
 registrant with  a 28 sim closure could
 rely on test data for a 24 mm closure.
  c. If the registrant wishes to rely on
 test data for two closures, which are
 between 20 and 45 mm in diameter,
 inclusive, and within 10 mm of each
 other, he may rely on  that data for any
 closure which fails between the two
 tested. For example, if a 24 mm and a 33..
mm closure of the same design were
 tested, the registrant could certify to the
 child-resistant effectiveness of its
similar closures which were 28. 28. and
30 mm in diameter.             .  -
  6. Closure material: The material of
 the closure used must be genetically
equivalent and  have the same physical/
chemical properties, i.e., bursting
strength, tear strength, etc.. as the
closure material for which protocol data
are available.

-------
               Federal Resister  /  Vol. 46. Xc.  41 / Tuesdav. March 3,  1981  /  Rules  and  Reflations
                                                                           131C
    7. Liners: The materials cf the
  registrant's liner and the Sir.er on whose
  test data the resistrar.t wishes to rely
  must be identical. This is because, in :h3
  experience of the Consumer Product
  Safety Commission, the cicsure liner is
  an integral cart of the child-resistant
  package, ar.d char.str.g the liner may
  impair or eliminate ths child-resistant
 . effectiveness of a closure or packaging
  design.' In the situation where test data
  exist for a closure-liner system that
  differs from the cicsure-liner system
  used or.ly in terms of closure diameter
  (>20 mm and <45 mm) certification is
  permissible if:
    a. closure diameter used is greater   .
  than the diameter tested but is within
  the permissible range (size used is equal
  to or greater than the size tested and
  equal to or less than 1.15 times the size.
  tested), then the closure to be used need
  not be tested if scientific data exist to
  demonstrate that the mechanical
  properties of the closure-liner system
  used ars comparable to that tested. An
.  example is if a 24 mm closure with a
  PVC liner is tested, then its data maybe
  used for certification of a 28 nun version
  of the same closure with a PVC liner,
  provided there is scientific evidence that
  the 23 mm closure-liner system has
  mechanical properties similar to the 24
  mm closure-liner system or
   b. test data exist for two closure sizes
 with a difference equal to or 'ess thaa 10
 mm. .the liner used in the two closure
 sizes for which data exist must be the
 same as the liner in the size used, then
 the closure to be used need not be
 tested. An example would be the test'
 data for a 24 mm and 23 mm cicsure.
 both with a vinyl pulp backed liner.
 These data can  be used for the
 certification cf a 23 mm closure with a
 vinyl pulp backed liner.
   The agency acknowledges that only a
 limited amount of data are available on
 large size packages. Consequently,
 exceptions will be considered in those
 cases where a registrant has submitted
 appropriate sciar.tific and technical
 data.

 X. Label Language

   The particular wording of the label
 giving directions for child-resistant
 packaging opening and closing
 instructions is at the discretion of the
 registrant, so long as it clearly explains
 to the adult user how to use the
 package.
  'This is why evan an 3??a:s:i:!y minor
 mndificjiian in the liner, such as idJirt an insert
 for promotional purposes, may r«?uire retcsti.-.q !o
 «nsii« ihar ihe chili-,-?sis:ani e:'fec:ivere« of she
 cicju.t or pocxa-je ha» noi b«n imp.nred.
 L Certification of Child-Resistant
 Effectiveness
    Ac=sri'.-.g '.o 40 C7R ;52.15{e). the
 arr.cr.iJrtvj.-.ti fsr child-resistant
 packaging shall include a certification
 by the registrant that the package meets
 the standards of § 152.15fd).
   The registrant is furthermore required
 to maintain records concerning the
 package (§ 152.1S(fj) which include a.
 complete copy of the data resulting from
 the tests conducted in accordance with
 § 152.l6(d). As indicated under J, above.
 the agency realizes  that it was net made
 entirely clear whether certification as to
 the child-resistant effectiveness of a
 particular package should be based on
 protocol tests  carried out on the entire
 package or merely the closure.
 Therefore, by March 9,1S81, the agency
 is allowing two types of certifications,
 both of which  will equally serve to
 comply with the regulation. After the
 agency has formally proposed and
 published a final regulation concerning
 the testing of package designs (see J,
 above) certain packages may have to be
 retested and recertified.
   (a) Certification of effectiveness
 based on testing.scheme listed under J
 above. If the protocol test data in the
 registrant's files show that either the
 exact package or a package meeting the
 criteria enumerated under J, above, has
 been tested, the registrant shall certify
 that the package meets the effectiveness
 criteria for child-resistance. The
 certification statement must include the
 registration number of ths product, the
 registered product name, the registrant's
 name and address, date, the name, tide,
 and signature of the company official.
 The certification, which should be
 submitted in triplicate, should include at
 a minimum the following statement
  1 hereby certify that the special package*
 for this product and all applicable
 supplementary registered distributor
 products have been tested and found to meet
 the requirements of 40 CFR 162.:6(d).
 Standards cf Special Packaging.
  I understand that 1 am recviired !o retain
 the records described in 40 C5R l£2.:5(f](i).
 (2), and (3) for as long as the registration is
 valid. These records shall be available upon
 request, for inspection or copying purposes or
 for submission to EPA. funhermore. I certify
 that should the scecai  packaging for £is
 product be changed, I will update this
 certification statement.
  Additionally, if the product  is  sold in
 several sizes of packages all the size?
 which this certification applies must be-
 listed.
  (b) Certification of effectiveness
based on testing the  package closure
only. If the protocol test data in the
registrant's files show that the closure
used has been tested for effectiveness
  but it was actually tested on a ccr.tair.r.:
  (package) other than the one used or
  outside the limitations of '.he scheme
  listed under J, above, he  shsl! certify :hs
  effectiveness on the basis of th= exact
  size closure. The certification staterr.sr.:.
  which should be submitted in triplicate,
  shall include the information listed
  under (a) above and snail include af a
  minimum the following statement:
    I hereby certify that the exact c:csu:2  us si
  on ths package of this product  ar.d d'.i
  applicable suppie.T.entaily rsw's:e.'=:i
  distributor-products have beer. ;=s:2d ar.d
  found to tneet the requirements of 40 C7R
  162.IG(d). Standards for Special Packaging.
    I understand that I am required :o retain
  the records described in 40 CFR ;C-;.:5ii];:J.
  (2), and (3) for as long as the registration is
  valid. Thess records shall be available upon
  request, for inspection and copying purposes
  or for submission to EPA. Furtherr.ore. I
  certify that should the special packaging for
  this product be changed. I will update this
  certification statement
    If a product is sold in a line of several
  size packages, some of these packages
  may be certifiable under method (a) and
  some under (b). In, this case two
  certification statements are required.
  one for those packages meeting  the
  specifications of (a) and one for those
  which meet the specifications of (b).
    (c) Information concerning the
  package/closure used. The child-
  resistant packaging regulation does not
 _require the registrant to submit
 "information concerning the type and
  make of child-resistant packaging used.
_ although this information is  part cf these
  records which must be kept, and which
  must be available for inspection and
  submission upon request by EPA. The
  agency at this time, however/requests
  the cooperation of registrants to supply
  this information voluntarily  as an
  addendum to the certification statement
 This request is made for purposes of
 gathering in/cr.r.u'.:;.- on the variety  of
 packages and/or closures which have
 undergone extensive testing to allow
 certification by (a) above, for example.
 The agency feels that this information
 will be extremely helpful in providing
 data which may permit it to  propose  a
 more liberal testing scheme than the cnc
 listed under J. The information
 requested is as follows: Product sizest
 name of special packaging
 manufacturer, name of special
 packaging and model/style: (ASTM
 classification); closure sizes, and liners
 used.

 M. Amended Product Registrations for
 Child-Resistant Packaging (CRP)
   There are basically three types of
 amended registration applications that
 may  be submitted in conjunction with

-------
             Federal
Register /  Vcl.  45.  No. 41  /  Tuesc.iy. March  3,  1931 / Rules and
  :?. 5^cc.ji ?uckdg:r.'i; Rcgulaticns. An
  mer.d.T.erfl may be filed to indicate the
  se c: special packaging and :o submit
  •5 asjc.c'.stac certification statement:
  .-: amendment may be filed to revise
  " '''-n? to remove a package from the
      ':: the special packaging
     j::;.-.s: cr an amendment may be
  '.ed ;.o change the product formulation
  : submit  new :o.x:c;ty data to remove a
  esticide frcm :he sccpe o:  the special  •
  ackagir.g regulations. The  registrant
  -.us: ind:cate the use of special
  ackagi." en Form 8570-11 and must
  esigr.ate  CR Package ia Box 5 under
  type of amendment."
  1. Amendments for child-resistant
  ackaging certification: The registrant
  :ust submit the required certification
  :atement (original and two copies)
  long with the amended application. If
  hilc-resistar.t packaging instructions
  :r opening and resecuring such
  ackaging appear on the product label
  : on an accompanying circular, then
  -.e label or circular must be submitted.
 :' uie instructions are on the container
  r closure, only a  copy of the
 is ructions should be submitted.
  ' 2. Labeling amendments: Registrants  '
 -.us: file an amended application to
 3v:;e ;'neir labeling to indicate specific
 .onresidential use areas, or restricted
 :se. i.e.. the elected restriction of
 •urchasa.  storage, and use only by a
 erviceperson; see section I. Registrants
     xish  lo amend their registrations to
      .fferent labels for the same
  :.,_-ct may do so. The same product
 .-.ay be packaged in child-resistant
  acsag:ns and non-child-resistant
  ackaging in accordance with sections
 '•. through  L of this Notice. The revised
 ibeling must be submitted to and
 eviewed by EPA  to determine if it
 :orr.p!ies with the special packaging
 sg'jia'.icns. If sticker labels are used on
 .n interim basis che sticker must be
 ubrnitted  with the amendment.
  3. Revisions to registrations to submit
 ;e\v toxicity data  and/or to change
 crmulaticns: A product may be less
 oxic than is currently  indicated by its
 sgistration and precautionary labeling.
 :ome registrants may subject their
 .voduct to additional testing to
 ieterrr.ine  its prscise toxicity. or they
 nay reformulate their products so  that
 hey do not meet the toxicity criteria
 incer 40 CFR 162.16{cj(2) (see F. 2
 above). If a product  is reformulated an
 3pp!ica!ion for amended or new
 •°2istration must be filed as for any
 other formulation  change. If the
registrant's retesting indicates that the
rrcdvjct is  more toxic than previously
.ndicated.  the registrant must submit
'>    ew test data  to  EPA. pursuant to
                  F1FRA section 6(a](:). If this toxicity
                  testing also indicates that the
                  registrant's product should be placed in
                  a new (either higher or lower) toxicity
                  category for labeling prupcsss under 40
                  CFR~lG2.10(h)(l). the registrant must file
                  an application for amended registration.
                  If the new toxicity testing indicates that
                  the registrant's product is less tcxic than
                  previously known, so that child-resistant
                  packaging is not required but does not
                  require that the product be placed into a
                  different category, the registrant is not
                  required, to bring this information to
                  EPA's attention. However, it would be
                  helpful for him to do so, in order to-
                  avoid unnecessary enforcement actions
                  in regard to the child-resistant
                  packaging regulations.

                  NT. Child-Resistant Packaging
                  Certification for Registration of a New
                  Pesticide Product Which Meets the
                  Criteria
                    1. Fsrsts. An applicant  for the
                  registration of a new pesticide product
                  must indicate the use of special
                  packaging on Form 3570-01 but a sample
                  of the packaging need not be submitted.
                  The applicant must submit the required
                  certification  statement (original  and  two
                  copies).
                    2. When csrtificciion Is required.
                  Applicants may initiate registration
                  procedures for new products before they
                 • obtain the child-resistant packaging
                 'data for certification. However,  the
                  child-resistant effectiveness certification
                  must be submitted before any new
                  product registration is issued after
                  March 9,1SS1.
                    3. Labeling. Instructions for opening
                  and resecuring child-resistant packaging
                  may appear en either the  product label.
                  accompanying labeling or circular, the
                  container itself, or the closure.
                  Instructions for special  packaging on the
                  label or circular will normally be
                  submitted, as labeling is required for a
                  new registration. If such instructions
                  appear on the container or closure, then
                  a copy of the instructions should be
                  submitted. The container  or closure
                  should not be submitted.
                  O. Requesting Exemptions
                    The Special Packaging Regulations
                  allow for exemption from chiid-resistant
                  packaging of those products which meet
                  the criteria for required special
                  packaging only on the basis of technical
                  infeasibiiity or on  the basis .that  the
                  hazards indicated by the toxicity criteria
                  are not indicative of hazard to man.
                    An exemption should be mailed or
                  delivered to Ms. D. Jean Jenkins. Special
                  Packaging Coordinator. Registration     .
                  Division (TS-767). Office of Pesticide
                  Programs. Environmental  Protection
 Acency. Rm. E-317, 401 M St. SW.,
 Washington. D.C. 20460. (202-7S3-3930).
   The regulation states that in order fur
 an exemption to be jrantcd it must be
 based on sufficient data which
 accompany the request, to support the
 decision. Additionally, it provides that
 any such decision  snail be published in
 the Federal Register-and shall be
 applicable  to any product with identical
 or substantially similar composition and
 intended uses.
   Initially,  the procedures and data
 necessary to consider an exemption
 request will be  determined en an
 individual basis. However, this
 document recommends certain
 procedures and data to help the agency
 in its consideration of requests for
 exemption. The agency requests but
 does not require that an exemption:
   1. Be written in the English language.
   2. Contain the name, address, and
 telephone number  of the registrant
   3. Contain the Pesticide Registration
 Number and name of the Pesticide
 Product Manager.
   4. Contain an explicit request for
 exemption  from special packaging
 requirements.                     •  "
   5. Identify the particular product for
 which the exemption is sought
   6. Describe the package size of the
 product for which the .exemption is
 sought
   7. Be typewritten.  •
   8. Be accompanied by at least two
 copies of the request
   9. Explain the reason for the
• exemption based on one or more of the
 following grounds:
   a. If the justification is based on the
 hazard indicated by the toxicity criteria
 in 40 CFR 162.16(c)(2) not being
 indicative of the risk to man. the
 justification shall state how the lack of.
 human exposure, certain
 pharmacological mechanisms,  or other
 human experience  evidence6 for the
 product clearly  support granting of the
 exemption.
   b. If the exemption is requested
 because special packaging is not
 technologically feasible (which includes
 compatible, practicable, or appropriate
 for the product), the justification shall
 explain why. '
   c. Where  the exemption request is
 based upon an allegation that special
 packaging is incompatible with the
 particular product or would seriously
 and adversely compromise the utility or
 stability of a product, the registrant shall
  'Human experience data, indicating the lack of
 acc:der.:s, are considered helpful but not primary
 evidence for an e.vompnon.

-------
              Federal Register  /  Vol. 46.  No. 41  / Tuesday.  Nfarch 3. 1931  /  Rules  and  Reauistions


. submit adequate evidence :o support the
 allegation.
   d. If the allegation of incompatibility             '                      "'    .
 is based upon "the fact that the shelf-life
 of the product Units package choice, the
 exemption shall outline the particular
 limitation and snail include a  time
 schedule /or the registrant to reestablish
 sheif-iifs data.
   Granting exemptions: Where the                      "                                   •
 agency deternir.es that reasonable
 grounds for an exemption are  presented.
 the  acer.cy shall publish that decision in            "
 the  Federal Register, and it shall be
 applicable to any product with identical
 or substantially similar composition and
 intended uses.                                _  •
   "Reasonable grounds" for granting an                                            •
 exemption are information and data
 sufficient to support the.conclusion that:                '                   '
   (a) The hazard indicated by the                         .
 toxicity criteria  in 40 CFR 162.16(c)(2]                •"                 ..      "     .
 are  not indicative of the risk to man. .                      '•
   (b) Special packaging is not
 technically feasible, which includes                           -              •
 compatible, practicable, or appropriate                             '
 for the product
   Denying exemptions: Where the                    '
 agency determines that reasonable
 grounds  for an exemption are not
 presented, the exemption shall be
 denied, and the  registrant notified  in
 writing of the denial, including a brief
 statement of the reasons therefor.
   Effect  of filing an exemption: The      .                    .         .         .
 filing of an exemption shall not have the           •'       •    '  .     '
 effect of staying the regulation from
 which the exemption is sought
 Therefore, products subject to  special
 packaging shall  be considered to be in
 violation of the law unless packaged in
 special packaging during the agency's              •                 •                  -
 consideration of the exemption request
 after March 9.1S31.P.                                        .  '
 Data Compensation                  .           -
   In accordance with the data
 compensation regulations contained in
.40 CFR 162.9-1. and particularly
 paragraph (b)(17) thereof, all
 amendments  to registration which  are
 made solely to achieve compliance with
 the special packaging regulations and
 which do not require EPA to review
 scientific data before deciding  whether
 to permit the  amended registration, will
 not be subject to the data compensation
 provisions of FIFRA sections 3(c)(l)(D]
 and  3(c)(2)(B).
 (Sec. 25(c](3) as amended (Pub. L 92-316. 88
 Slat.  983: P-jb. L 94-140. 39 Stat. 735: Pub. L
 95-396. 9: Stat. 619: 7 U.S.C. 136 et aeq.))
  Dated: Jjnuary ZS. 1981.
 Edwin L Johnson.
 Deputy Assi'aaat Administrator for Pesticide
 Programs.
 iFS Due. 81-6718 F-.k-J 3-J-rt: 143 jm|
 EILUNO CCOE ISoO-H-U

-------
                STRATEGY FOR THE ENFORCEMENT
              OF THE CHILD RESISTANT PACKAGING
                   REGULATION UNDER FIFRA
OVERVIEW

REQUIREMENTS OF THE RULE

     Appli cabi1i ty
     Exceptions
     Exemptions
     Specific Requirements

REGULATED  INDUSTRY
ENFORCEMENT

     Objectives
     Voluntary  Compliance
     Violations
     Inspection Scheme
     Violation  Detection Priorities

ADMINISTRATIVE  CONSIDERATIONS

     Program Management and Allocation of Responsibilities
     Program Integration

-------
S t r a t_* g_y_ fqr_the Enforc em_e n t of the Child R_e s i s t a n t
fV? k\gj 'n g_R~e g uT_aYi^n^l)~ri"d_e r~ JFTF_R_A^ "  "	    " ~	

Overvi ew
    On March 9, 1979, the Environmental Protection Agency
published a final  rule at 44 Federal Rsgjster  13019  (40
CFR 152.15) which requires c h~i 1 d "re's i VtYn t packaging  (CRP)
of certain pesticides labeled for residential  use.   The
intent of the rule is to reduce the number of  accidental
exposures by children to pesticides.
                                  resistant packaging  for
    The rule also requires affected registrants to submit
applications for amended registration and maintain records on_
child resistant test data.

    Possible violations include misbranding, failure to keep
records, failure to file reports, and falsification of data.

    It is anticipated that states operating under grants will
have major responsibility for conducting inspections concerning
the CRP requirements.  The Regions will handle the casework since
these types of violations would not be in violation of many
State statutes.  Concurrence from PTSED is required for enforce-
ment actions resulting from violations of the CRP regulation.
Headquarters support will be available for data review and to
answer questions on whether or not a product meets the criteria
that trigger the requirement for child resistant packaging.
In addition, PTSED will  provide inspection targeting information.

Requirements of the Rule
App1i cabi1i ty

    As indicated in the overview, child resistant packaging  is
required for any pesticide product released for shipment after
March 9, 1981, if (1) its labeling allows for residential use,

-------
                           -2-


(2) it has not been classified for restricted  use,  and  (3)  it
meets  certain toxicity  criteria.   In  addition,  registrants  with
products subject to the rule must  amend  their  registrations to
reflect changes  in  packaging and  certify  that  the  packaging
complies with the CRP regulation.

    For your information  certain  terms  used  in  the  Strategy have
been defined below:

    3   "Released for shipment" is  defined as  that  point  in  time
        when it  is  the  intent of  the  producer  to  introduce  the
        product  into commerce.  Intent  exists  in  any  of  the
        fol1owi ng situations:

        (1)  a producer  asserts that  what  is  being  sampled  is
            representative  of what is actually  sold;

        (2)  a product is  stored in an area  where  finished
            products are  held for  shipment  in  the  ordinary
            course  of business (warehouses,  loadino  docks,
            etc.);

        (3)  the  custom  of the pesticide  chemical  industry
            indicates that  similarly  situated  products are
            intendedforrelease;or

        (4)  the  custom  of the particular  producer  indicates that
            similarly situated products  have  been  intended  for
            release in  the  past.


    0    "Residential use" - A pesticide  meets  this  criterion  if
        it is applied (other than  by  a  commercial  applicator)
        directly to humans  or pets or is  applied  in,  on  or
        around all  structures, vehicles,  or  areas  associated with
        the  household or  homelife  or  noncommercial  areas where
        children spend  time, including,  but  not  limited  to  gardens,
        houses,  yards,  patios, mobile homes,  campers  and
        recreational vehicles, noncommercial  campsites,  home
        swimming pools, educational,  lounging,  and  recreational
        areas of preschools, nurseries,  and  day  camps, etc.
        Furthermore, residential  use  is  determined  by whether
        a product has a use on the label  which  is within the
        meaning  of  residential use.   A  registrant  may have  a
        product  that is not really intended  for  residential
        use, but the labeling is  either  vague  concerning use
        areas, or use areas are actually  omitted.   Such  a
        product  is  subject  to the  child  resistant  requirements
        unless its  registration and  label  are  amended to indicate
        a strictly  non-residential or agricultural  application.

-------
                              -3-
        "Toxicity  criteria"  are  defined  in  44  Federal  Register
        13019 (March  9,  1979)  and  at  40  CFR 1 62. i 6 (C) ( ?•)•.
Exceptions  to  CRP
        "Dormant"  Product  Registration

        A  dormant  product  registration-  is  defined  as  a  product
        which  is  not  currently  in  production  but  retains  valid
        EPA registration.   For  a product  not  in production  and
        which  is  not  scheduled  to  be  released for  shipment  on
        or after  March  9,  1981,  an  amended  registration,
        special  packaging  certification  and other  related
        forms  need  not  be  submitted at  this time.   However,  at
        any time  after  March  9,  1981,  if  the  product  is  put  back
        into production, an  amended registration,  child  resistant
        certification,  etc.,  must  be  submitted  before  the
        product  is  released  for  shipment  if it  meets  the
        criteria  for  special  packaging.

        Toxicity  Data

        If the toxicity of a  product  is  not known  to  the  level  of
        specificity necessary to determine  whether or  not the
        toxicity  criteria  are met  (e.g.,  the  information  on  file
        with EPA  is extrapolated data),  the registrant  may  perform
        additional  testing.   If  testing  indicates  that  the  toxicity
        criteria  are  not met, the  product  is  not  required to
        have child  resistant  packaging.   However,  if  the  regis-
        trant  does  not  conduct  further  testing  when the  toxicity
        is not known  to the  necessary  level  of  specificity,
        child  resistant packaging  is  required.

        Products  for  Residential Use  by  a  Serviceperson

        The Agency  has  decided  to  remove  from the  scope  of  CRP
        requirements  certain  products  which meet  the  criteria
        for special packaging but  are  not  normally stored in
        areas  where children  could  likely  have  access  to  them.
        Examples  include products  used  by  janitors in  nurseries
        or daycare  centers and  products  used  by exterminators or
        lawncare  servicepersons .   To  accomplish this,  EPA will
        allow  products  such  as  those  listed above  to  be  sold and
        distributed without  child  resistant packaging  if  such
        products  bear a statement  restricting the  sale,  use, and
        storage  to  servicepersons.

-------
                             -4-
        T'nis provision has been communicated to producers
        through a Federal  Register Notice issued March 3, 1931;
        it will also appear in proposed revisions to Section 3
        Registration regulations.   Until  it appears in final
        regulations, EPA will  use  prosecutorial discretion and
        not take enforcement action if a. subject product is
       • not specially packaged but is  labeled or sticker-labeled
        with a statement restricting the product's sale, use,
        and storage to servicepersons, e.g., "Only for Sale
        to, Use, and Storage by Servicepersons."  The statement
        must appear in type size at least as large as the
        child hazard warning statement.  Labels need not be
        submitted to the Agency for approval but must be submitted
        for the official label file used to determine compliance
        with FIFRA.

    0   A registrant may amend his/her registration so that
        the new label does not allow for residential uses.
        In such a case the product bearing the new approved
        label would no longer  be subject to the special  packag-
        i ng requ i rement.

Exemptions to CRP

    Exemptions may be granted  by the Director of the Regis-
tration Division for products  for  which special packaging is
not technically feasible or where  the  toxicity criteria  are
not indicative of hazard to humans.

    Nota that only the- Agency  may  grant an exemption.  It is
not up to the registrant to decide if  he or she is exempt
or— not, based on the two factors listed in the above paragraph.

Specific Requirements for  Registrants  of
Products Subject to the Special  Packaging Requirement

    0   Develop and test special packaging

        "Special packaging" refers to  packaging that is  designed
        and constructed to be  significantly difficult for
        children under five years  old  to  open or obtain  a
        toxic or harmful  amount of the substance contained
        therein within a reasonable time.  In addition,  it
        should not be difficult for normal  adults  to use pro-
        perly.  Effectiveness  testing  procedures which must
        be used are those  specified by the Consumer Product
        Safety Commission  (CPSC) at 16 CFR 1700.20(a), (b),
        and (-c).  Effectiveness specifications and standards
        for special  packaging  are  delineated in 40 CFR 162.16.

    0   Amend registration - Certification

        Prior to changing  a product's  packaging, the registrant
        must submit an application for an amended  registration
        and have it approved by EPA.   Instead of submitting

-------
                       -5-
detailed information demonstrating that the packaging
meets the requirements,  the registrant shall  include
with his application a certification that the package
meets the standards of §162.16(d).  An applicant for
a new registration shall  also submit a certification
statement that the package meets  the standards.

Utilize special packaging

Products subject to the  requirement must be in child
resistant packaging if released  for shipment  after
March 9, 1981 .

Recordkeeping

Certain records must be  retained  by the applicant or
registrant  for as  long as the registration  is valid.
These records  shall be available, upon request,  for
inspection  and copying purposes  or for submission
to EPA.  The records which must  be kept are:

(1)  A full  description of the package  including:

    (i)  A  full description of the container  including

         (A)  Itsdimensions,and
         (B)  Its  composition; and

   (ii)  A  full description of the closure  or special
         package,  if appropriate, including:

         (A)  The  name of its manufacturer,

         (B)  The  manufacturer's  designation  (title)
              for  the  special  packaging closure  or
              the  physical working of  the special
              packaging  mechanism, and

         (C)  The  explicit directions  for proper use
              of the closure or  special  packaging
              and  the  placement  of these directions
              on the package;

(2)   A complete copy of  the data  resulting  from  the
     tests  conducted in  accordance with §162.16(d);
     and

(3)   Data demonstrating  the compatibility of  the
     pesticide formulation with  the entire  package to
     determine that the  chemical  and physical charac-
     teristics of  the  substance  will  not interfere
     with the  safety and  efficacy of the pesticide
     and functioning of  the special  package.

-------
                             -6-
Note: The registrant may not have actual  data on file if the
      company did not perform the testing but, instead, relied
      en verification from others such as the company which
      produces the packaging.  The registrant should hav's a
      letter or literature verifying  that the packaging has
      been tested and met the CRP standards.

Regulated Industry
    The regulated community consists of registrants of those
products subject to these regulations.   Estimates suggest that
approximately 9000 products may be involved.

    The Registration Division of EPA has prepared a pre-
liminary list of types of products which are expected to be
covered by the CRP regulations if used  and stored in and around
residential areas.  (See attachment.)   A second, more complete
list will  be developed and forwarded as soon as  it is available

    A company may remove its product from these  requirements by
amending the label to  remove residential uses,  stickering or
amending the label so  that sale, use and storage is restricted.
to a serviceperson, or by receiving an  exemption.

Enforcement
Objectives

    The objective- is to-assure compliance with this regulation
so as to minimize or eliminate accidental  exposures to highly
poisonous pesticides used in and around residential areas.

Outreach

    Registrants should be aware of the regulation through its
publication in the Federal  Regi ster.    In .addition, the Glass
Packaging Institute prepared and distributed,  with EPA's
concurrence,  a pamphlet entitled,  "Pesticides  and Protective
Packaging."  Personnel in the Registration Division are generally
available to  answer any questions  and  clarify  the requirements
for registrants.

Violations

        Misbranding - §12(a)(1)(E) of  FIFRA

-------
                   -7-
to §25(c){3)."  Failure to h a v a special packaging
for those products released for shipment after March,
9, 1981, would make the product misbranded if it is
subject to the special  packaging requirement.

    There are three variations of this violation:

         (1)   No special  packaging,  although required.

         (2)  Company's new toxicity test data indicate
              that such packaging is not required,  but
              the Agency does not agree that the
              toxicity  data support  their conclusion
              (e.g., improperly conducted toxicity
              tests or  incorrect toxicity tests
              uti1i zed).

         (3)   Company changes packaging, but it  does
              not meet  the child resistant requirements
              because tests were incorrectly done or the
              tests were  conducted  on the incorrect
              container size.


Failure to File Reports Required -  §12(a)(2)(N)  of  FIFRA

    It is unlawful for  a  person who  is a registrant to
fail  to file  reports required by this Act.  Prior to
changing a pesticide's  packaging, the registrant
must  submit  an application for amended registration to
EPA.   Failure  to do so  prior to distributing the product
in new packaging would  be  in violation of this section.

    In addition, the registrant is  required to
submit a certification  statement with the amended
registration  application.

Failure to Maintain Reports Required - §12(a)(2)(3) of FIFRA

    It is unlawful for  a  registrant  to fail  to maintain
reports required, by FIFRA.  The regulation requires
the registrant to submit  a certification that the
product is in  compliance  as opposed  to detailed   data
supporting this.  However, it is required that the
detailed data  be maintained and be  subject to Agency
inspection or  request for  submission.  The registrant
is not required to have such data on file if the firm
relied on testing conducted by others such as the package
supplier.  In  lieu of such data he  or she must have
some  verification on file  that the  product is in compliance.

-------
                            -8-


            In  some  cases,  the  company  may  claim  that  the  parent
        company/company  headquarters  has  the  data.   This  should
        be noted on  the  inspection  report and sent  to  the
        appropriate  region.   The  regional  office  should  forward
        this  to PTSED so that a  request for the  data ca-n. be  sent  to
        the  company's headquarters  by  OPP.

    '    Falsification of Application/Report or of Records
        Maintained  or of Exemption  Request  -  §12(a)(2)(M)  of
        FIFRA or Title 13 of.the  U.S.  Code.

            It  is  unlawful  to falsify  all  or  part of any  appli-
        cation  for  registration,  any  records  required  to  be
        maintained  pursuant  to  §8,  or  any report  filed  under
        this  Act.   Thus, falsification  of an  application  for
        amended registration, the certification,  or data  such  as
        test  protocol and results would be  in violation  of FIFRA.
        Title 13 of  the  U.S.  Code also  makes  this type  of  activity
        i11egal .

INSPECTION SCHEME

    Inspections to  determine  compliance with  these  special packaging
requirements  should  be incorporated into  a  state/region's  existing
inspection program,  which should  be based on  a Neutral  Administra-
tive Inspection Scheme.   Generally, only  producer establishments
will be inspected  for compliance  with  the CRP regulation.   Prior
to inspecting a pesticide producing establishment,  the  appropriate
personnel  (inspector or  whomever  is designated to do this)
should determine if  the  company  produces  any  of  the products
on the attached list prepared by  the  Registration Division.
If so, the inspector should  check for  compliance  with
the child  resistant  requirements.

    Reports  from inspections  involving  possible  violations of
these  requirements  should be  forwarded  to the regional  office
for case review and  appropriate  enforcement action.

Violation  Detection  Priorities

    During an inspection, it  is  helpful to  establish priorities
for detecting violations.  The  following  table gives the  general
priority ranking for violation  detection.  The following  is
meant  only as a guide to decision making  and  is  not a  rigid  OE
poli cy.

Priority 1 -  Misbranding

    Failure  to  utilize Child  Resistant  Packaging  where  required.
This will  probably  be the most  common  violation  found  initially.

-------
                               -9-
 Priority  2  -  Failure  to  Maintain  Records

     Such  records  may  be  necessary to  verify  compliance  with  the
 regulations.   This  includes  test  data  which  either  (a)  show  the
 package  meets  the child  resistant requirement  (CPSC  test  results)
 or  (b) show the product's  actual  toxicity  does  not meet the
 criteria.

 Priority  3  -  Failure  to  File Reports

     This  refers to  a  company's  failure  to  amend  the  registration
 prior  to  a  packaging  change.  This  should  not  be a  frequent  viola-
 tion but  is easy  to determine.

 Priority  4  -  Falsification  of Data

     While this  is  one  of  the most serious  violations, it  should
 not  be encountered  frequently.   Child  Resistant  Tests are
 expensive (approximately  $3000)  and may be conducted under
 contract  if a  company's  test results  are  suspect.

 ADMINISTRATIVE  CONSIDERATIONS
 PROGRAM  MANAGEMENT  AND  ALLOCATION  OF  RESPONSIBILITIES

     State  and  regional"  personnel  if  appropriate  will  be  responsi-
ble  for  conducting  inspections  and documenting cases.

     With  regard  to  actual  casework,  issuing  penalties, notices  of
 warning,  etc., the  regions  will  have  primary  responsibility  but  •
 must  request and  receive  concurrence  from  PTSED.
 This  is  necessary for 3  reasons:

     1)   A  violation  of  the  child  resistant  requirement
         is  not a  violation  of many state laws.

     2)   Some companies  may  have  received exemptions  or
         the product  may  not  be  subject  based  on  toxicity  data
         onfilewithEPA.

     3)   The Registration  Division  may consider cancellation
         action for  those  products  which remain in  violation.

     PTSED's Case  Development  and  Legal  Branch will  be  respon-
 sible  for  resolving  questionable  cases, i.e., those  for
 which  there is some  doubt.or  question as to  the  product's

-------
                            -ID-
status or the validity of the data, and reviewing concurrence
requests .

Program In t_e_g_r a t i on

    The Case Development and Legal Branch, PTSEO, will coordinate
with the Regions and the Registration Division to resolve any
questions regarding the child resistant packaging requirement  •
and the status of  products covered.

    The Regions will coordinate with the States regarding the
enforcement of the special packaging requirements.

-------
             ;;!!TED STATES ENVIRONMENTAL PROTECTION AGENCY

                           WASHINGTON, D.C. 20460
«• --*«V-
                                                           PESTICIDES AN 3 ToVTc
  SU3JECT:   Enforcement  Strategy  Concerning  C'.iild-Resistant Packaging of
            Pesticide  Products.
 TO:
          Jack Neylan
          Pesticide Toxic Substances
          Enforcement Division  (EN-342)
 As  a  follow-up  to our  recent  meeting  concerning  an enforcement strategy
 on  cccr.pliance with CRP regulations we are  providing to you a list of
 generic products for which  an unqualified  assumption can be made that
 they  need  to be  in CRP if used and stored  in the household.  This is con-
 sidered phase I of the strategy.  Phase  II will  consist of a more refined
 list  which will be based on the actual CRP amendments we receive.
  1.  Disinfectants

  Product

  1.  Calcium
     hypochlorite
                    Concentration
                         65%
 2.
6.

7.

3.

9.
Lithium
hyprochlorite       35%

Sodium dichloro
s- triazine trione
and Trichloro-s
triazine trione     98-1001

Mono (Trichloro
tetra (monopotassium
dichloro) penta-s-
triazinetrione      99*

Hydrochloric acid   3%

Phosphroric acid    17%

Chlorophenolics     6!>

Sulfamic Acid       20%

Quaternary Ammonium
Compounds           10 S
 10..  Parafomaldehyde     953

 11.  Formaldehyde        37%
                                        Use
                                        swimming pool
                                               Swimming  pool

                                               Toilet  bowl

                                               n        M

                                               Disinfectant

                                               Toilet  bowl


                                               General disinfectant

-------
2.    Insecticide and Rodenticide
Pesticide Chs~ical

1. Carbophenothion


2. Chlordane


3. Chlorpyrifos  (Dursba'n)


4. Cryolite

5. Diazinon



6. Dimethoate  (Cygon)

7. Disulfoton  (Disystox)



8. Dyfonate

9. Ethion


10.Imidan

11.Lindane


12. Metaidenyde


13. Mexacarbate  (Zectran)


14. Naled

15. Propoxur (Baygon)

16. Phosphorus (white)
At and Above Requiring CR?

        1.4


        2S.O


        9.0


        15.0

        7.0



        17.0

        0.4



        1.2

        3.5


        10.0

        6.5


        20.0


        2.0


        18.0

        6.2

        1.1
                                                            Remarks

                                                       Some lawn use
                                                       products

                                                       Termite control
                                                       products

                                                       Sprays for outdoor
                                                       Ornamentals

                                                       Plant dusts

                                                       Many plants and garden
                                                       sprays; encapsulated
                                                       diazinon does not require CR?
                                                       Systemic insecticides
                                                       for indoor and outdoors
                                                       plants
                                                       Some combinations with
                                                       lawn fertilizer
                                                       Borer sprays, dog
                                                       di-ps

                                                       Slug and snail
                                                       control

                                                       Insect, slug and
                                                       Snail control
                                                       Rodenticide

-------
3. Herbicides and Funcicides
Chemical                 Formulation / % A.I,

Bis  (tributyltir.) oxide       Above 0.5%
Paraquat

Pentachlorophenol

Chlorothaionil

Copper-8-quinolinolate
any %

above 88%

above 40%

above 5%
       I/-/
Refco Engler, Gnief//
Disinfectants Branch
Registration Division (TS-767)
cc:  D. Campt
R. Gross
J. Jenkins
H. Harrison
J. Akerman
     Use

V.'ood Presenva'tive

Homeowner herbicide

Wood preservative

Homeowner fungicide

Wood preservative

-------
General Compliance Strategy for Products Subject to the FIFRA
                  Label Improvement Program

0 vervi ew
     On June 5, 1980 EPA published in the Federal Register (45 FR
37884) a notice initiating a program to improve pesticide labeling.
The Label Improvement Program (LIP) was initiated to upgrade pro-
duct labeling in an attempt to better protect health and the environ-
ment as well as further defining legal  use of a product.  This program
was designed to work in conjunction with currently existing registra-
tion programs and to respond rapidly to labeling needs identified by
the Agency.   To date, four major label  improvement program notices
have been issued and are in effect.  Two additional  label  improvement
program notices have been  recently issued but are not yet in effect.

Regulated Industry	
     Some label improvement rules  affect all  registrants, while
others affect only registrants of  certain products.

Requirements of the Rule
Submission of Applications	
     The Office of Pesticide Programs (OPP),  Registration.Oivisi on
(RD) will notify each registrant of an  affected product  by  certified
letter or a  certified mail  copy of a PR Notice that  his  product is
subject to specific requirements under  that label improvement program
revision.  For each affected product, the registrant is  required  to
submit the following to EPA:
     1) An application  for amended registration (EPA Form 8570-11).
     2) Five copies of  draft labeling incorporating  required  changes.

-------
                                - 2 -
     3) If necessary,  a Statement of Confidential  Formula (EPA Form
        8570-4).
     Registrants must  normally submit applications within 60
calendar days of receipt of the LIP Notice.   The Agency will state
any deviation from this deadline in the LIP  Notice.
     Products for which the Agency has not received an application
for amended registration within the stated deadline will  be  subject
to cancellation.  The  Agency will issue a Notice of Intent to Cancel
for any such product,  effective 30 days from its receipt, unless
within that time the registrant or an interested party with  the
consent of the registrant,  either applies for amended registration
or requests a hearing  under section 6 of FIFRA.
Exemption from Compensation Requirements	
   •  In many cases an  amended registration to meet the requirements
of a Label Improvement Program Notice will not  be  subject to com-
pensation requirements.  If this is the case, the  Offer to Pay or
Certification Statement will not be required.to  be submitted to RO
and approval of labeling submitted will not  convert registrations
to conditional status.  Each notice will address the compensation
status of applications submitted in response to  the LIP Notice.
Processing of Applications	
     Generally, the Registration Division will  review labels
for compliance with the requirements of the  LIP  Notice.  A regis-
tration amendment submitted in response to a LIP Notice is not
complete until the amended  labeling is submitted and accepted by
RD.  If draft labeling is  not acceptable, RD will  notify  the
registrant of the deficiencies by letter and give  the registrant
75 calendar days to submit  amended labeling. Amended labeling

-------
                              - 3 -
must be limited to changes required by the letter in order to
maintain the exemption from compensation requirements.
Combined Application in Response to Multiple Label Improvement
Notices
     Applicants receiving multiple notices requiring LIP labeling
amendments for the same product may combine responses into one
application for amended registration provided the relevant LIP
Notices are clearly referenced.  Applications that are non-compen-
sable under FIFRA section 3(c)(1)(0) may not be combined with
     /
applications that are compensable.  The submission deadline for
combined applications for amended registration is the later of
the deadlines established in the LIP Notices.
Time Frames for Compliance	
     Any product released for shipment 180 calendar days after the
registrant receives RO's acceptance of amended labeling must bear
that accepted label.  Registrants are responsible for compliance
by their sub-registrants (distributors).
     Products that have been released for shipment and are in
retail  channels of trade prior to the 180 day deadline may continue
to be distributed in commerce, sold and used until supplies are
exhausted.
Enforcement Objectives

     The objective of LIP compliance program is to ensure that
product labeling is in compliance with the requirements of the
various Label Improvement Program Notices.  This  will  be accom-
plished through producer establishment inspections.

-------
                                - 4 -


Types of Violations
     Producers not complying with the requirements of..the notices

issued under the Label  Improvement Program are in violation of

of FIFRA section 12(a)(l)(E) in that their products are misbranded

under sections 2(q)(l)(F) and (G).  Products being sold in violation

of a cancellation order are in violation of FIFRA section 12(a)(2)(L)

and subject to the penalties thereunder. "

            X

Administrative Considerations

     The Office of Pesticide Programs has issued four major label

improvement notices (See Attachments) which are currently in effect

with two more LIP Notices issued but not yet in.effect.  The four

existing LIP Notices are listed below in order of inspectional

targetting priority according to their potential  hazard.

     1) Fumigants - Issued 12-4-80 - This LIP Notice requires

registrants of products containing certain active ingredients to

add additional precautionary. 1abeling , misuse statements  and storage

anddisposalstatements.

     2) Termiti ci des -  Issued 11-7-81 - This LIP  Notice requires

registrants of termiticide products  containing one of the active

ingredients listed in  the LIP Notice to revise use directions of

their product, use the  appropriate storage and disposal statements,

add a misuse statement, and reformat their labels.
                               \
     3) Anti foul ing Paints - Issued  3-9-82 - This LIP Notice required

registrants of all  antifouling paints to make extensive revision

of their product's  labeling.

-------
                               - 3 -

     4) Salt Water Ernes is - Issued 11-30-80 - This LIP Notice
requires all registrants to delete salt water emesis statements
from their labeling.  Since the revision was a -simple-deletion,
registrants were not required to submit amended labeling for review
     Two more LIP Notices have been recently issued dealing with
worker reentry intervals and disposal requirements.  As they become
effective they will be included for targetting in the inspectional
program.
Targetting Inspections	

     The Registration Division, OPP is responsible for compiling
lists for each LIP Notice consisting of:
     1) The name and address of each registrant affected;
     2) The name and registration number of each product affected;
     3) The registration status of each product affected, i.e.,
        compliance, pending, or subject to cancellation; and
     4) The date of acceptance of the amended labeling if the
        product is in compliance.
These lists, which the Compliance Monitoring Staff will  forward to
the Regions, will be a basis for the States' or Regions' inspection
targetting.
      States should target inspections* based on the priority as-
signed to each LIP Notice in this document and on the current
registration status of products regulated under each Notice. .
To identify inspection targets, States should first list under
each LIP Notice the registrants and the number of their products
whose: a) product labels are subject to cancellation for failure
A0nlyproducer establishmentsshouldbe targettedforinspection
under this guidance.  Marketplace inspections  are not appropriate
for determining compliance with this rule.   Products  in  the  channels
of trade prior to the date when amended final  printed labeling
must appear on a product may continue to be sold.  Therefore,  it
would not be an effective use of resources  to  determine  the  existence
of violations based on marketplace samples.

-------
                                -u-
to respond to the.LIP Notice;  and b) label  amendments RO has
approved.  Inspection priorities will  not include registrants
whose products have label  amendments pending with RO. -Priority
for inspection should then be  as'signed on the following basis:
     1) Registrants of products subject to  cancellation for failure
        to respond to the  LIP  Notice.   These registrants should
        be ranked based on the number  of their products subject to
        the LIP Notices in the following order:  Fumigants,  Termi-
        ticides, Antifouling Paints and Salt Water Emesis.
     2) Registrants with the most number of products with accepted
        amended labels subject to any  LIP Notices in the following
        order: Fumigants,  Termiticides, Antifouling Paints  and
        Salt Water Emesis.
     After determining inspectional priorities for the LIP, the
States should integrate these  priorities with the criteria  listed
in the FY 84 Cooperative Agreement Guidance for  scheduling
producer establishment inspections (past violative history, products
subject to Label Improvement Program,  products subject to Child
Resistant Packaging (CRP)  regulations, and  Restricted Use Pesticides)
The highest priority in scheduling inspections should be given  to
those producers which meet the largest number of these criteria.

Inspections	
     Inspectors will examine products  released for shipment at
the producer establishment to  determine compliance with the terms
of the LIP Notice.   Registrants have 180 calendar days following
acceptance of amended labeling to bring the product into compliance .
Any product released for shipment after this 180 calendar day period
must bear accepted  amended labeling.
     Registrants with products not in  compliance with  any LIP
Notice will be issued a Stop Sale Use  or Removal Order (SSURO)  by

-------
                                -• 7 -
the State or EPA in addition to any enforcement action taken by
the State or EPA.  The SSURO will  be removed only "after the registrant
brings the product into compliance.  SSURO's will not'be lifted for
cancelled products sold in violation of a cancellation order.
Issuance of a SSURO is an appropriate response to non-compliance
as the LIP is designed to mitigate the risks of handling pesticides
through labeling changes and the registrant is given ample time
to make and incorporate these changes on the label.
Allocation of Responsibilities
Headquarters Responsibility	
a) Provide Regions with a compliance strategy for Label
   Improvement Program,
b) Provide Regions with copies of  each LIP Notice,
c) Provide list of registrants affected by a Notice,
   status of the products affected and date of accep-
   tance of final printed labeling for each product
   in compliance.
Regional Responsibility	
a) Provide copies of all pertinent materials to the States.
b) Provide guidance and assistance for State enforcement
   efforts.
c) Assist in issuance of SSURO's.

State Responsibility	
a) Schedule and conduct inspections of affected registrants.
b) Issue SSURO's to non-complying  registrants.
c) Take enforcement actions where  appropriate.

-------
I t\r/7 ?     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                     3TON. D.C.  2

                                     JAM 12/3
V  ..ej?                       WASHINGTON. D.C. 20460


                                           
-------

-------
                                  -2-

A.  Primary Enforcement Responsibility -

    1.  ' What is it?      ..  ..     ..; '   '   .   ;      .

             When a governiiEnt entity, be  it  EPA or State,  has prinary
        enforcement responsibility,  it has the first (or primary)  option
        for investigating and taking appropriate enforcement action
        against pesticide'use violations.

    2.   How does a State get  it?

             In brief,  there  are three ways by which a State shall have
        primary responsibility for pesticide  use enforcement:

        a.   A State will have the primary  responsibility for pesticide
            use enforcement if, upon request  by the State,  EPA has
            determined  .that 1) the State has  adequate pesticide use
            laws and regulations, 2) the State has  adequate procedures
            for implementing  these laws and regulations,  and 3)  the
            State will  keep records and make  reports shaving conpliance
            with 1) and 2)  above.

        b.   Notwithstanding this, any State with a  cooperative agreement
            with EPA to cooperate in the enforcement of FIFRA, pursuant
            to Section  23,  shall immediately  upon imp lensntation of that
            agreement,  have primary responsibility  for pesticide use .
            enforcement within its borders.

        c.   A State may also  receive primary  responsibility for use en-
            forcers nt if EPA  determines that  the State has  an approved
            plan under  section 4 for certifying applicators and the plan
         •   msets the criteria of a.  above.

             If at any tins  after September 30,  1978,  a State asks  for  and
        receives a determination that it meets the  test of  adequate laws,
        regulations,  and procedures  under  a.  above,  implements a coopera-
        tive enforcement agreement with EPA or,  upon final  approval of its
        section 4 Plan,  receives a determination that the plan meets the
        criteria of a.  above, that State shall have primary enforcement
        responsibility  for  use violations  within that State.
                 x
             If a State with  a cooperative enforcement agreement chooses to
        withdraw from that  agreement,  the  State will lose- their primary
        enforcement responsibility upon the date of termination of the co-
        operative agreement.   Should that  same'state have an approved  State

-------
                            -3-
    Plan under section b, EPA will review that plan for enforcement ade-.
    quacy as soon as practical to determine whether the State can regairj
    use enforcement prinacy.

3.  Who has it?

         The following States,  as of the date of this memorandum, have
    primary enforcement responsibility for pesticide use violations:
    Region I               Region IV              Region VIII

    Connecticut            Kentucky               Montana
    Ne.tf Hampshire          Mississippi            North Dakota
    Vermont                North Carolina         South Dakota
                           Tennessee

    Region II              Region V               Region IX
                                                         \J
    New Jersey             Indiana   '             Arizona
    New York               Michigan               California
    Puerto Rico     '       Minnesota              Guam
    Virgin Islands                                Hawaii

    Region III             Region VI              Region X

    D. C. _,                Arkansas               Idaho
    Dela/are               Louisiana              Oregon
    Maryland               lies Mexico             Washington
    Pennsylvania           Oklahoma
    Virginia               Texas
    West Virginia
                           Region VTI
                           Iowa
                           Kansas
 I/
 Arizona divides responsibility for use' enforcement between the
 structural Pest Control Board and the Arizona Board of Pesticide
 Control (Agriculture).  EPA has a cooperative enforcernant agree-
 ment with the former, not the latter.  Therefore,  Arizona has
 primary use enforcement responsibility for pesticide use viola-
 tions that come within the jurisdiction of the Structural Pest
 Control Board; EPA has responsibility for all other use enforce-
 ment activities.  If there are other instances of very distin-
 guishable separation of use enforcemsnt authority within a State
 and EPA has a cooperative enforcement agreement with only one of
 the authorities,  the region should bring this to the attention
 of PTSED.

-------
    Who does not have it?

         The following States, as of the date of this..memorandum,  do
    not have prirrsry enforcenEnt responsibility for pesticide use
    violations; EPA continues to have primary responsibility.

    Pegion I                    Region VII          Region  X

    Maine*                      Missouri*     ,      Alaska*
    Massachusetts               Nebraska
    Rhode Island*

    Region IV            .       Region VIII

    Alabama*                    Colorado*
    Florida*                    Utah*
    Georgia                     Wyoming*
    South Carolina*

    Region V                    Region IX

    Illinois*                   Trust Territories
    Ohio*                       Samoa
    Wisconsin*
       * EPA will be conducting a rapid evaluation (to be conpleted
         within 6 months of the date of enactment of this law)  of
         these State's §4 Plans in order to determine the enforce-
         ment adequacy of the State's pesticide use laws, regulations,
         and procedures.

5.  What is EPA's role in pesticide use enforcensnt?

         In States that do not have primary use enforcement  responsi-
    bility, EPA will have the prinHry responsibility.  In those States
    where EPA has the primary responsibility for pesticide use  enforce-
    ment,  Congress has affirmatively provided that the Agency my
    inspect the books and records and work  establishments of commer-
    cial applicators and "for hire" applicators.   Also,  saaples nny
    be taken of pesticides or use dilutions of pesticides held  by
    those applicators.  "For hire" applicators are those applicators
    that are in the business of applying pesticides.   Exsroies  of
    "for hire" applicators,  for whom controlling pests is all or  part
    of their occupation,  are structural pest control operators, aerial
    applicators,  arborists,  lawn maintenance workers,  and janitorial
    service workers.  Nothing in this Act precludes the Agency  from '

-------
                              -5-

    continuing routine use surveillance,  (i.e.  use observations where
    there is no prior evidence of misuse) whether or not that surveil-
    lance takes place in a State that has primary use enforcement
    responsibility.  However, in those States having primary use
    enforcement responsibility, the Agency nay  not include within that
    routine surveillance visits to commercial or "for hire" applicator
    establishments for purposes of sampling or reviewing bodes and
    records.  In those States, routine use surveillance shall be con-
    fined to application sites where entry has  been gained by consent
    of the owner.  Any information or evidence that points to a signi-
    ficant violation of FIFRA (i.e. one which we would deem worthy of
    further investigation) shall be referred to the State if that State
    State has primary enforcement responsibility.

6.  How will the referral of complaints or infcreation indicating
    use violations of FIFRA work?

         Section 27(a) of the amended FIFRA requires that EPA refer
    any complaints or other information alleging or indicating a
    significant violation of the pesticide use  provisions of FIFRA
    to the appropriate State officials for their investigation.   Of
    course,  such referral need only be made when the State has pri-  •
    raary use enforcement responsibility.   Further, if the State dees
    not commence appropriate enforcement action within thirty 'days,
    EPA may act upon the complaint or information.

         If any information or complaint,  indicating or alleging a
    significant violation of FIFRA, is received after September  30,
    1978, and the alleged violation took  place  in a State with pri-
    mary use enforcement responsibility,  such information or com-
    plaint shall imcnediately be referred  to the appropriate official
    in that State.  Any such information  or complaint received in
    EPA headquarters shall be referred to the State via the appropri-
    ate regional office.  Regions will be responsible for immediately
    establishing working relationships with States for the orderly
    flow of information on enforcement activities and for determining
    who the appropriate State officials for handling such information
    are.  The State will have thirty days to initiate appropriate
    enforcement action upon making a determination that a possible
    violation of either FIFRA or the State pesticide law has occurred.
    It is expected that appropriate enforcement action will be t • .en
    by the State under that State's pesticide law in cases where  the  -
    evidence indicates either, a violation of only the-State law or
    both the State law and FIFRA.

-------
                            -6-

     At the conclusion of the thirty day time period, the regional
office shall request information on the status of the particular
investigation.  Obviously, in some cases States may.be unable to
investigate and commence appropriate enforcement action, particular-
ly in complicated cases, within the thirty day tine frane referred
to in the amended FIFRA.  Regions should use their discretion when *•
determining whether to extend the time period for a State to com-
mence appropriate enforcement action or to request return of the
case file.  It is expected that States will forward all evidence
obtained in an investigation to the EPA regional office: 1) where
no enforcement proceedings have been initiated within thirty days
of a determination of a possible violation of State law and FIFRA,
2) where the investigation determines that a possible violation
of only FIFRA occurred, (not State law), or 3) where EPA deter-
mines that the enforcement action taken by the State is not
appropriate to the alleged violation.  Until regulations are
in place for rescinding primary enforcement responsibility
for failure by the State to assure enforcement of State           ;
pesticide use regulations,  a region shall request concurrence     '
from their PTSED regional coordinator before overriding any
State enforcement action.

     Complete and thorough documentation must be kept of all
referrals to States of complaints or information on alleged
use violations and subsequent follow-up actions by States.  A
draft complaint referral form is attached for use by those
regions without any current referral form (Appendix B).  Two
copies of this form, with additional attached information,
where appropriate, shall be completed and forwarded to the
appropriate State official immediately upon receipt of any
complaint or information about a use violation.   Within thirty
days (or longer, if extended), the State should be instructed
to return one copy of the State form with a brief description
of the disposition of the case, i.e. either a notation of the
kind of enforcement action taken (e.g.  2 month suspension of
applicator's license) or an explanation as to why no enforce-
ment action was taken (e.g.  not-a violation of State la/).  If
no report on the disposition of a case is received within a
suitable period of tine, the region shall follow-up with either
a written or telephonic request for such information.  Such
records will be necessary for future determinations as to
whether States are properly discharging their enforcement res- -
ponsibilities in the pesticide use area.

-------
                                -7-
    7.  Hew should emergencies arising cut of the use of pesticides be
        handled?

             When the region becomes aware of emergency conditions arising
        out of the use of pesticides, they should immediately inform the
        appropriate State officials.   State officials are to be requested
        to respond to the emergency;  the region should offer whatever
        assistance they can.  If State officials indicate that they are
        unwilling or unable to adequately respond to the emergency, the
        region should respond to the fullest extent possible.

     Should you have any questions concerning this interim policy, please
contact your PTSED regional coordinator or Jack Ne/lan (755-0997).
                                  A.  E.  Conroy II, (Director
                               Pesticides and ToxicNauis tances
                                     Enforcement Division
Attachments

-------
    •SEC. :s. STATE PRIMARY ENFORCEMENT RESPONSIBILITY.
      "(a)  For the purposes of thi.i Act. a State ihall have primary en-
    forcement responsibility for pt-iticide use violations during any period
    for which the Administrator determines that such State—
          "(J)  has adopted adequate pesticide use laics and regulations.:
        Provided, That the Administrator may not require, a State to have
        pesticide use laws that are mor<> stringent than this Act}
          u(5)  has adopted and ii implementing adeuuate procedures for
        the enforcement of such State laics and regulations,' and
          u(3)  wilt keep -ruch records and make such reports showing
        compliance with paragraphs (1) and (2} of this subsection as the
        Administrator may require by regulation,
      "(b)  Notwithstanding the  provisions of subsection (a) of this sec'
    tion, any State that enters into a cooperative agreement \oith, the Ad-
    minis trat or under -section 23 of this Act for the enforcement of vesti'
    cide use restrictions shall have the primary enforcement responsibility
    for pesticide use violations. Any State thai has a, plan approved by the
    Administrator in accordance with the requirements of section 4 of this
    Act that the Administrator determines meets the criteria set out in sub-
    section (a) of this  section shall  have the primary enforcement respon-
    sibility for pesticide use violations. The^Administrator^hail make, such
    determinations i.cith respect to State plan-i under section 4 of this Act
    in effect on the  d-zte of enactment of the Federal Pesticide Act of 1978
    not Inter than -rix month,* after  that date.
     "(c) The Administrator'thall have primary enforcement responsi-
   bility for those. State* that do not have primary enforcement rf.sponsi-
   bilify under thin Act. Notwithstanding the provisions  of section -2(e\
    (J)'(if this Act* during any period when the Administrator ha-1 such.
   enforcement responsibility, section X(b] of this Act shall apply to the
                                                             suc.
                                                              the
boohs and records of commercial applied-tors and to any applicator who
holds or applies -pes'timd**. or use dilutio-ru of pesticides, only to provide
a. service of controlling pests without delivering any unapplied pesti-
   -        -
   cide- to any -person so served, and section 0(a} of thii Act shall apply to
   the p.stabli-ihmenf. or other place where pesticide* or devices are held for
   application by such persons with, respect to pesticide or devices held
   for such, application^

  ' "SEC. 17. FAILURE  BY THE STATE  TO  ASSURE ENFORCEMENT  OF
             STATE PESTICIDE USE  REGULATIONS.

     " (a)  Upon -receipt of any complaint or other information alleging or
   indicating a sigrdncznt violation of the pesticide ^se provisions of this
   Act. the Administrator shall refer the matter to the ippro-priate 'State
   Officials for their investigation of the matter co^n-iistent icith the  rv-
   quirements  of thin Act. If. icithin thirty days, the State hns not com.-
   menced appropriate enforcement action, the Administrator may  act
   upon the complaint or information to the extent authorized under thin
 •  Act.
     "(5)  Whenever the Admini.ttnzf.or determines that a. Stale having
<•   primary enforcement responsibility for pesticide u*e it'oMtiona i-s not .
   camiing out^ (or cannot carry out due to the lack of adequate legal au-
   thority) such. re.rpor).ribilit.y. the Administrator shall notify the State.
   Such notice shall specify those aspects of the administration of the'
  • State program  that are determined to be inadequate. The State shall
   have ninety  days after receipt of the notice  to correct any deficiencies.
   If after that time the Administrator determines that the State program.
   remain* inadeiruuite, the Administrator m
-------
 .>.REFERRAL  FORM
                                                                       Date Rec'd
inscription of Alleged Corrplaint or Information
(Disposition
Referred to:
                                 Referred by:
                                 For further information, contact
Date referred
Date response du

-------
. /
-------
                                  -2-

     Basically  the Stats  plans  will be  measured  against the standards
sat  forth in sections  26(a)(l)  and  (2)  of  the  amended FIFPA.   They
require  that the State:

          (1) has adopted  adequate pesticide use laws and
          regulations; Provided, 'that the  Administrator may
          not require  a State to  have pesticide  use  laws
          that  are more stringent than  this Act; [and]

          (2) has adopted  and is  implementing  adequate pro-
          cedures for  the  enforcement of such  State  laws and
          regulations;...

     tthile  there is a  presumption that  States  with approved applicator
certification plans have  adopted  adequate  laws for violations  involv-
ing  restricted  use pesticides,  it will  still be  necessary to make
certain  that their laws and regulations are also adequate for  viola-
tions involving general use pesticides. It is  clear,  however,  that the
focus of the review will be on  the question whether  each State has,  in
fact, established adequate procedures for  enforcing  against use viola-
tions and whether the/ are implementing those  procedures adequately.
Some of  the procedural aspects  that will be examined  include:   1.  Are
sufficient State resources committed to the investigation and"  actual
enforcement of  use violations;  2. Are  complaints of  pesticide misuse
follcwed-up promptly and concluded in a timely manner;   3.  Are State
personnel properly trained to handle investigations  and enforcement
actions involving allegations of pesticide misuse;   4.  Do substantive
complaints of misuse actually result in State  enforcement action;  and
5. is the State enforcenent action appropriate in light of the viola-
tion and the enforcement options open to the State enforcement Agency?

     Since EPA regional representatives are the  most  knowledgable  about
the status of pesticide enforcement in  the States in  their  regions,  it
will be essential to the success of the review of each  State's plan  and
operating procedures to have strong regional participation on  March  23rd.
Although the Regions' views can either  be  presented in  writing in
advance of the irseting or  in person on  March 23rd (or both), if a  Region
is of the opinion that a particular State  should  not be granted primary
use enforcement responsibility/ it should  plan to send  a representative
to the March meeting to discuss that position  with the  Headquarters
personnel.  For States where the regional office  thinks there  is little
question about the appropriateness of granting State primary use enforce-
ment, it would be sufficient to submit  such a  recommendation in writing
before March 23rd.  Once a decision has been made about the status of
each of the thirteen States, letters will be prepared for  Mr.  Costle's

-------
                                 -3-

signature notifying the various State lead agencies about EPA's deci-  .
sion. In addition, each State being granted primary use enforcement
responsibility in accordance with the new section 26 will be asked to
meet certain minimal reporting requirements concerning pesticide use
enforcement until final regulations implementing sections 26 and 27
are implemented.

     I would appreciate it if each of the seven Regions that have State
plans to be reviewed at the March meeting would notify Mr. Ulfelder
whether or not they plan to be represented at that meeting. If you have
any questions about the. review of the thirteen State plans, please direc
your questions to Mr. Ulfelder at 472-3701.
                                                        7——
                                     A. E. Conroy II,^Direct
                                 Pesticides and Toxiq Substc	
                                       Enforcement Division
Attachments

-------
                             ATTACHMENT A



   List of States With Approved Section 4 Plans, But .Without CEAS








REGION I:          Maine



RE3ION 17:         Alabama



                   Florida



                   Georgia



                   South Carolina "



RE3ION V:          Illinois



                   Ohio



                   Wisconsin



REGION VII:        Missouri



R33ION VIII:      'Utah



                   Wyoming



REGION IX:         Arizona (Agricultural Use Only)



REION X:          Alaska -

-------
                              ATTACHMENT B
Friday, Kerch 23, 1979
Location:  EPA Headquarters
           Washington, D.C.
           3rd Floor Conf. Pro., East Tower
           Room Mo. 344
I.   9:00 a.m. - 12:00 noon
     The following States will be reviewed:
     Region I:          Maine
     Region IV:         Alabama
                        Florida
                        Georgia
                        South Carolina
     Region V:          Illinois
                        Ohio
                        Wisconsin-
II.  1:30 p.m. - 4:30 p.m.
     The following States will be reviewed:
     Region VII:        Missouri
     Region VIII:       Utah
                        Wyoming
     Region K:         Arizona
     Region X:          Alaska

-------
            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             V.'ASHINGTCN. D.C.  20460
                                  r..,-...
                                           :
                                                            OFFICE'Or ENFORCEMENT
MEMORANDUM
                                                              i
SUBJECT:   Clarification of Primary Use Enforcement Responsibility Guidance

TO:        Regional Pesticide Branch Chiefs
           Regional Enforcement Division Directors
     On January 4 of last year, the Pesticides and Toxic Substances
Enforcement Division (PTSED) sent cut an interim policy statement
describing procedures for EPA/State cooperation in the area of primary
responsibility for enforcing pesticide use violations.  This memorandum
supplements the January 4 guidance by expanding upon the proper Agency -
response to receipt of a State file which indicates a pesticide use
violations.

     Since the amended FIrRA, per sections 26 and 27, directs the Agency
to allow the States to have first option for bringing enforcement actions
against violators of pesticide use requirements, EPA should take no
action except in emergencies as described under section 27(c), based on
any otate file until thi appropriate Region consults with the State on
the investigatory or enforcement status of the case.  After the State
has been allowed time to conduct its inquiry, the Region should request
a statement indicating the proposed enforcement action chosen by the
State.  If the State's action is not "appropriate" (see section 27(a))
in light of the gravity of the alleged violation, the Region should
after obtaining concurrence from the Office of Enforcement's Pesticides
and Toxic Substances Enforcement Division, send a notice to the State
(1) ccinmunicating its disagreement with the selected action, (2) re-
commending the type of State action which the Agency would consider to
be "appropriate", and (3) notifying the State that it has 50 days to
commence an appropriate action.             -

-------
                                        - 2 -       •               '

     As a general operating principle, the Regions should avoid using  •
already-scarce Federal resources merely to reinforce state enforcement
actions taken in response to minor violations of the pesticide..laws.
Rather the Regional Offices, in accordance with stated Agency goals of
protecting public health  and safety and preserving sensitive ecosystems,
should be careful to focus their efforts and resources on those situations
which significantly endanger public health or the environment and which
are not otherwise appropriately addressed by state actions.
                                         Lchard D. Wilson
                                 Deputy Assistant Administrator
                                     for General Enforcement

-------
              Utilicu iiATES t.SYiKONMuNTAL PROTECTION AGENCY
                                            18690
MEMORANDUM

SUBJECT:  Appropriate Documents to be Presented by  State
          Inspectors Conducting Pesticide Use  Inspections  in
          States Having Primacy

TO:       Enforcement Division Directors
          Air 6 Hazardous Materials Division Directors
          Pesticide Branch Chiefs
     At present most State inspectors conducting pesticide
use inspections present credentials headed:   "United  States
Environmental Protection Agency".  The credential  later
identifies the inspector as "an employee of  the State of
	."  This credential has been supplied by the  Agency
as a convenience to States which have cooperative  enforcement
agreements with EPA.   (EPA Form 3540-28  (Rev. 4-78))
                                                              •
     These credentials were designed before  primacy when
States conducted use inspections for violations of FIFRA
under the auspices of a cooperative agreement.  Pursuant to
Section 26, most States now exercise primary enforcement
responsibility for all use violations.  Use  inspections are,
therefore, primarily a State activity.  Consequently, use
inspections in States with primacy are undertaken  under the
authority of State law, (this is true even where the  use
inspections are Federally funded).
                                                            *
     Therefore, during use inspections, it is appropriate
for State inspectors to present credentials  which  indicate
that the inspectors are acting under authority  of  State law.
The existing Federally supplied credentinla  are misleading
since they are headed "United States Environmental Protection
Agency." In the fu£urjL«_State inspectors conducting pesticide
use inspections fihsatasaprasent credentials that are issued
by their, State employers.  If State credentials do not
already exist, the State is responsible for  designing
providing such credentials to their inspectors*

-------
     It. iii additionally nccossary  .Cor Statas  to  cease using
the rcderully supplied "I^ou-icu of  Ia:;,ycction"  forr.-.,  (EPA
Fcr:.i 3540-2  (Itev. 3-75)).  The present foru erroneously
identifies use inspections as beinc,- authorised under the
authority of the "U.S. Environmental Protection  Agency". The
    es are responsible for drafting nev.' Notice of  Inspection
       The States must design their Notice of  Inspection
forn in a manner which parallels tho liPA  form.   A  consistent
format will greatly aid the indexing of the information in
the Agency computer.  The State Notice of Inspection form
should indicate the relevant State statutes which  authorize
the inspection.  While States await the printing of  the nev;
forms, they may use the Federally  supplied forms if  all
indicia of Federal authority are obscured.

     It should also be noted that  State inspectors conducting
use inspections cannot rely upon FIFRA for authority to take
affidavits. Consequently the Agency affidavit  forsi (EPA Form
3540-11 (Rev. 9-75)) may not be used by States during use
inspections.  If State law grants  this power,  of course, the
inspector nay take an affidavit according to State pro-
cedures.

     I hope that the Regions will  implement these  guidelines
during the next 60 days.   Please contact John  Martin of ny
staff at 755-1075 if you have any questions.
                         A. E. Conroy II, Director
                      Pesticides and Toxic Substances
                           Enforcement Division

-------
404       Federal  Register / VoL 4& No. 3 / Wednesday.  January 5.  1983 / Rules  and Regulations
                                ENVIRONMENTAL PROTECTION
                                AGENCY

                                40 CFfl Part 173

                                (OP* 00159; PH-fFL 2215-3]

                                Federal Insecticide, Fungicide, and
                                Rodenticide Act, State Primary
                                Enforcement Responsibilities

                                AGiMCV: Environmental Protection
                                Agency (EPA).
                                ACTION: Final interpretive rule.

                                SUMMABY: This rule states EPA's
                                interpretation of several of the key
                                provisions In sections 28 and 27 of the
                                Federal Insecticide. Fungicide, and
                                Rodenticide Act (FTFRA). but does not
                                impose substantive requirements on the
                                State*. Sections 29 and 27 established a
                                standard and procedure for according
                                States the primary enforcement
                                responsibility for pesticide use
                                violations {primacy). The rule also
                                provides operational substance to the
                                criteria used by EPA for primacy related
                                decisionmakiag, and ensures that such
                                decsionmakicg is consistent throughout
                                the regions.
                                smcnvz DATK This role will not takes
                                effect before the end of 60 calendar days
                                of continuous session of Congress after

-------
the date of publication. EPA will publish
• notice of ine actual effective date of
this rule. See SUPPIEMIMTAMY
INFORMATION fur further detail*.
ro* narrow INFOMMATIOM CONTACT:
Laura Campbell. Pea'Jcidei and Toxic
Substances Enforoer»eat Division (£,V»
342). Office of Pesticides and Toxic
Substances, Environmental Protection
Agency. Rm. M-2a24£, 401 M SU SW,
Washington. OC. 20480, (2J2-382-S56G).
               MFORUATIOfe
Back
  In 1978. Congress enacted Pub. L 85-
338 which contained numerous revision*
to the Federal Inaecticide. Fungicide.
and Rodenticide Act (7 U.S.C. 136 e<
*et/. J. One of the changes added two
new sections to FIFRA. section* 28 and
27.  U.SJ1 138w-l and 138W-Z. wfaxh
together established • standard and
procedure for according States the
primary enforcement n^mniAitt+y for
pesticide tae rJolabon* (primacy}.
  Section 28 provides three saeibccb by
winch a State can obtain prnaecy.
Section 2S(a) requires a State to be
accorded primacy if the AdoinistraJoT
finds that the State has (l) adopted
adequate uee laws. (2) adopted
adequate procedures for hap]eru?r..fa3
those laws, asd (3) agreed to fcrep such
records aad gvakf each reports as the
Administrator may require by
regulation. Section 26(b) allow* a Stale
to obtain primacy if the State has aa
approved tecc'oa 4 certificatian plan
thai meets ths criteria set fcrth in
section 26{aJ. or if a State enters isio a
cscperative a green eat for the
enforsessat of pesticide CM restrictions
under secScn 23.
  Secties 27 authorizes die
Adzunistratar ts override or rescind a
grant of primacy in certain situations.
Section 2T(a) requires the Administrator
to refer cg=£icar:t allegories* cf
pesticide s*e violations to the States. If
a State dees not commence appropriate
enforcement actioa within 20 days of
such referral, EPA may bring ils own
enforcement nctlna.
  Section 2Tjb] audsoriaej me
Administrator to rescind the primary
enforcement responsibility of a Slate if
she finds that the State is not carrying
out such responsibility. Tie
Administrator initiates a rescission
proceeding by notifying the State of
those aspects of the Slate's pesticide use
en forcemeat program which the
Administrator haa foend to be
inadequate, if the State does not correct
the deficiencies in its programs within 90
days, the Administrator may rescind the
States'* primary enforcement
responsibility in whole or in part. EPA
 hus promulgated procedures which
 govern !::£ conduct of a proceeding to
 reicint! Sti^e prjnacv. These procedures
 wure publi.shed in lh» Federal Register
 of May 11. 19fll (46 FR 28058). {« CFR
 Part 17JJ.
  S-c:ion  2Tfr) authorizes the
 Aftairijitrator lo take immediate action
 to abate an emergency situation where
 the State is ooabie or unwilling to
 respond to the cri&is.
  As in evident from die above
 description, several of the operative
 term* in sections 23 and 27 require
 further definition. This rule clarifies the
 meaning, of such words «s "adequate"
 and "appropriate" which FIFRA seta
 forth as the criteria for rao*t of die
 decisions  which will be r>»^f 'i**H*r
 these two  ««rti/»t»«. The rale also seta
 guidelines to be T**^ by EPA in mjltlna
                 *^^^*m^ afio> essures
that such
by limits^, arthsvgh riot ^
Agency discretion in the orimacy area.
  Specifically, this rale addresses Xhe
  UATtsTtCj? X3XQCS*
  I. Procedares EPA «nU follov whea
  femng »flg«afin-M ,at so State
with mare strfejent pesticide cse laws
than the Federal law should be granted
primacy. Although EPA cannot require a
Stare to enact a pestidde use law that Ls
mere stricg^cl  than rTFHA. there is no
prohibition against granting primacy  to a
State whose pesticde use law is more-'
stringent.
  One. comment so£**3ted  a chaste in
the requirement that State  laboratories
conducting sample analysis perticipate
in EPA's check umple program. The
comment stated that the National
Enforcement Investigation  Center
(NGQ check sample program should be
coordinated wnh me American
Association of  Peat Control Officials
(AAPCO). The  NE1C check sample
program is currently coordinated with
the AAPCO check sample program. The
rule has been changed to reflect this
comment

-------
 Further tnfaraution on Effective Oat* of
 ThisRuls)
   On December 17. 1800. the Federal
 Insecticide. Fungicide, iad Rodenticida
 Act extension bill (Pub. L »-W9) '
   •ame law. This bill amended several
    ions of FIFRA. hctmHng section 25
  .. rulemaking. Section 4 of the
 Extension Act adds a new paragraph,
 section 25(e). to FIFRA which requires
 EPA to submit final regulation* to
 Congress for revlaw before tha
 regulation* become effective. Copies of
 this rule have been transmitted to
 appropriate office* in both Houses of
 Congress,         .•          _
   Under section 4 of the 1380 FIFRA
 Extension Act this rule will r.ot take
 effect before tha end of GO calendar days
 of continuous session of Congress after
 tho date of publication of this rule. Since
 the actual length of this waiting period
 cay be affected by Congressional
 action. It is not possible, at this time, to
 specify a date on which this regulation
 will become effective. Therefore, at the
 appropriate time EPA will publish a
 notice acr.cuacing the end of the
 legislative-review period and notifying
 the publlcrjf the actual effective date cf
-this regulation.

 Cotnpliaaca With the- Regulatory
 Flexibility Ad
   I hereby certify that this rule will not
 have a significant economic Impact on
 small entities. The role affects only
 r  '• pesticide control agencies, which
      3t scall entitles under the
    .iatcrjr Flexibility Act S U.S.C. 601
 et seq.
 Compliance With Executive Order
   Under-Executive Order 12231. EPA
 rsust fudge whether a regulation is
 "Major" and therefore subject to the
 requireceat of a Regulatory Impact
 Analysis. This regulation la not Major
 since it is Interpretive in nature and
 docs not contain new substantive
 requirements. The regulation:
   1. Does not have an annual effect on
 the economy of SI 00 million or more.
   2. Will not substantially increase
 costs to consumers, indusiry.  or
 government.
   3. Will not have a significant adverse
 effect on competition, employment,
 Investment, productivity, or innovation.
   This regulation was submitted to the
 Office of Management and  Budget for
 review as required by Executive Order
 32291. (Sec. 2S(a](l) (7 U.S.C. 136w)).
 [Note: This rule will not appear in the
 Code of Federal Regulations.)

 L Appropriate Enforcement Action
   A, Procedures Governing Referrals. \.
 General. Section 27(a) requires EPA  to
refer to the States any Information it
receives indicating a significant
violation of pesticide use laws. If a State
has not commenced appropriate
enforcement action within 30 days. EPA
may act on the information.
  Given current resource limitations,
EPA Is not In a position to monitor State
responses to every allegation of
pastldda misuse referred by the Agency.
Rather, tha Agency will focu* its    ,
oversight activities on evaluating the
overall success of State pesticide
enforcement programs, aad will track.
on a case-by-case basis, only those
allegations involving particularly serious
violations. Such "significant" allegations
will be formally referred to the Slates
and tracked by EPA, while other less
serious complaint* will be forwarded to
the States for information purposes only.
  2. Cfitsria for tt'snificant cases. To
determine which alleged violations are
sufficiently significant to warrant formal
referral and tracking, the regions will go
through a two step process. First tha
regions. In consultation with each State.
will identify priority areas for referral
These priority areas will consist of those
pesticide activities in tha State which
present the greatest potential for harm
to health or tha environment (e.g. the
application of a pesticide by a certain
method to a particular crop, such as
ground application of endria to apple
trees). Tha selection of these priority
areas will depend primarily en the
results of pesticide enforcement program
evaluations conducted by the States and
the regions. The priority  areas will be
revised on an annual basis based upon
the effectiveness of tha program in
reducing, the harm associated with
pesticide use.
  Thereafter SPA will determine on a
case-by'Csse basis which allegations in
these priority areas involve sufficiently
"significant" violations to be formally
referred to tha State and Cracked. If a
complaint received by EPA alleges a
minor infraction which clearly presents
little or no danger to health or the
environment or if the information
contains patently spurious allegations.
tuch as those from sources which have
repeatedly proved unreliable, the matter
will be forwarded to the  State for
information purposes only.
  3. The 30-day time period. The Agency
interprets  the term "commence
appropriate enforcement action" In
section 27{a) to require States to initiate
a judicial or administrative action in the
nature  of an enforcement proceeding, if
one is warranted. Starting an
investigation of the matter would not be
sufficient. If (he State does not
commence an appropriate
administrative, civil, or criminal
- enforcement response. EPA would then
 be permitted, although not required, to
 bring it* owa enforcement action,
   Although section 27(a) permits EPA to
 act If the State ha* not commenced an
 enforcement action wiUtfinO days, the
 Agency recognize* that States may not
 be able to complete .their Investigation
 of many formal referrals in so short a
 time. The time needed to Investigate a
 possible use violation will vary widely.
 depending upon the nature of the
 referral A referral which simply
 conveys an unsubstantiated allegation
 will usually require more investigation
 than a referral which partially or fully
 documents a pesticide use violation.
 Consequently, the Agency wishes to.
 develop a flexible approach towards the
 tracking of referrals.
   To accomplish this objective. EPA i*
 adopting a system in. which the referral
 process is broken down into two stages.
 investigation and prosecution.
   4. The investigsUan stage. Following
 the formal written referral of an
 allegation of a significant pesticide use
 violation, the appropriate regional
 pesticide official will contact the State
 to learn the result* of the Investigation
 and the State's intended enforcement
 response to the violation. If the State
 has not conducted aa adequate
 Investigation of the alleged violation, the
 region may choose to pursue its own
 investigation or enforcement action after
 notice to the State. As a general rule.
 however, the regional office will attempt
 to correct any deficiencies in the
 investigation through informal
 communication with the State.
   An investigation will b« considered
 adequate if the State has (1) followed
 proper sampling and other evidence-
 gathering techniques. (2) responded
 expeditiously to the referral, so that
 evidence is preserved to the extent
 possible, and (3) documented all
 inculpatory or exculpatory events or
 information.
   5. Tho prosecution stage. After
 completion of the Investigation, the
 State will have 30 days, the prosecution
 stage, to commence the enforcement
 action, if one Is warranted. An
 appropriate enforcement response may
 consist of required training in proper
 pesticide use. Issuance of a warning
 letter, assessment of an administrative
 civil penalty, referral  of the case to a
 pesticide control board or State's
 Attorney for action, or other similar
 enforcement remedy available under
 State law. The 30-day period may be
 extended when necessitated by the
 procedural characteristics of a State's '
 regulatory structure (se« Unit V.A.
 Hypothetical 1).

-------
           Federal Register / Vul. 48, No.  3 / Wednesday.  January  5. 19flJ / Rules and Reuuianons   .^   4U7
  If. after consultation with the Slute.
EPA determines that the Slate's
intended enforcement response la the
violation is Inappropriate (see
•ubdjvision B). EPA may bring its own
action after notice to the State. Regional
attorney* will not, however, initiate an
enforcement proceeding looner than 30
days after the matter wai referred to the
State.
  At times, a State may find that the
particular enforcement remedy it views
as the appropriate response to a use
violation is not available under the
State's pesticide control laws. Therefore
the State may. at any time, request EPA
to act upon a violation utilizing remedies
available under FIFRA. In these
Instances, of course, EPA will
Immediately pursue its own action, if
one is'warranted.
  To illustrate better the proposed
referral system, two hypothetical
situations are described in Unit V. A.
  B. Appropriate Enforcement Action. 1.
General: After the Agency learns of the
enforcement action. \i any. the State
proposes to bring  against the violator.
the EPA regional pesticide cfHce will
consider, in consultation with the State.
whether the proposed action is
"appropriate", relative to the remedies
available to the State under its pesticide
control legislation. EPA interprets the
modifier "appropriate" In section 27(a)
of FIFRA to require that the severity of
the proposed enforcement action
correlate to the gravity of the violation.
  It is not possible in this Interpretive
Rule to prescribe the specific
enforcement action which will constitute
an appropriate response to a particular
violation. There an too many variables
which will influence the treatment  of a
use violation, including the disparity
between the types of enforcement
remedies available under the various
Slate pesticide control statutes. Thia
document can. however, establish
criteria to be employed in evaluating the
appropriateness of a proposed State
enforcement action. More detailed
guidance on evaluating relative gravity
is contained in EPA'a "Guidelines for
the Assessment of Civil Penalties under
Section 14(a)  of the Federal Insecticide.
Fungicide, and Rodenticide Act as
amended", published in the Federal
Regster of July 31.1974 (39 FR 27711).
The Guidelines establish dollar amounts
to be applied under the Federal statute
to use violations in civil penalty
proceedings. Regional personnel can use
these figures as a  guide in evaluating the
gravity of a particular violation. The
Agency will not require that a State
response to a violation have a monetary
impact equivalent to that of a dvtl
penalty which EPA would Impose under
 the Guidelines. Rather, the dollar
 amounts contained In the penalty
 matrices can be used by regional
 personnel to define the relative gravity
 of a violation by comparing the figures
 applicable to different violations.
  2. Gravity of the violation. The
 Agency believes that the gravity of a
 pesticide use violation Is dependent
 upon the risk the violation poses to
 human health and the environment. The
 factors which determine the degree of
 risk presented by a use violation can be
 divided Into two categories: factors
 related to the particular action which
 constituted the violation and factors
 related to the pesticide involved in the
 incident.
  a. Risk associated with the violativa
 action. The circumstances surrounding
 the violative action partially determine
 the risk the violation presents to human
 health or the environment. To assess the
 degree of such risk. State and regional
 personnel should ask such questions as:
  L Did the violation occur in a highly
 populated area, or near residences.
 schools, churches, shopping centers.
 public parks or public roads, so that
 health was endangered?
  11. Did the violation occur near an
 environmentally sensitive area, such aa
 a lake or stream which provides
 drinking water to the surrounding
 community, a wildlife sanctuary, a
 commercial fishery, or other natural
 areas?
  iii. Did a structural application
 threaten to contaminate food cr food
 service equipment?
  iv. Did the violation have the potential
 to affect a large cr a small area?
  T. What was the  actual ham which
resulted from the violation?
  vi. Was the nature of the violation
such that serious consequences wera
likely to result?
  This lest question is designed to take
 Into account the variation in the
inherent risk associated with different
 categories of use violations. For
 example, a drift violation resulting from
 improper aerial application generally
 presents a greater risk of harm than a
 storage violation, since the latter
 infraction does net necessarily involve
 the improper exposure of the pesticide
 to the environment
  b. Risk associated with the pesticide.
The factors which will be crucial in
 evaluating the risk associated with the
 pesticide itself Include:
  L The acute toxidty of the pesticide or
 pesticides involved in the incident The
 toxidty of a pesticide will be indicated
 by the "human hazard signal word" on
 the la'uels (see 40 CFR 162.10). "Danger"
 or "Poison" are indicators of a highly
 toxic pestidde while "Warning- and
 "Caution" signify successively less toxic
 substances.
   ii. The chronic effects associated with
 the pestidde. if known.
   ill. The amouJUrTihe pesticide
 involved in the Inddent relative to the
 manner of application (e.g., aerial versus
 structural).
   iv. Other data concerning the harm a
 pestidde may causa to human health or
 the environment such as data
 concerning persistence or residue
 capability.
   An analysis of the interrelationship
 between these two categories of risk
 factors should yield a notion of the
 relative gravity of the violation  and the
 severity of the action which should be
 taken in response.
   3. Category of applicator, size of
 business, and history of prior violation.
 Gravity is not the only factor which EPA
 will take into account in evaluating the
 propriety of an enforcement action.
 Secticn 14 of FIFRA requires that
 distinctions in the severity of an
 enforcement response be made  between
 the categories of persons who commit
 usa violations. The Intent of Congress,
 as expressed In section 14. is that
 commercial pestidde-applicatora who
 violate use requirements will be subject
 to more stringent penalties that  other
 persons who  violate use restrictions.
 Congress also envisioned that the size of
 the violator's business will be a factor in
 determining the severity of the penalty.
 In addition, section 14 distinguishes
 between violators who have committed
 previous infractions and those who &n .
 first offenders. Thus,' the issuance of a
 warning letter by a State to a person or
 firm who has been repeatedly warned in
 the past about a certain violation would
 not generally be considered an
 appropriate response to the violation.
   4. Knowins violations: criminal
penalties. The state of mind of the
 violator is another important'
 consideration. In extreme circumstances
 where the civil penalty remedy is
 inappropriate, it is the Agency's policy
 to pursue a criminal action against
 persons who knowingly violate a
 provision of FIFRA. EPA will be
 particularly interested in pursuing
 criminal prosecution for those violations
 which involve a death or serious bodily
 injury or la which the violator has
 demonstrated a reckless or wanton
 disregard for human safety.
 environmental values or the terras of the
 statute. To be appropriate, a State's
 response to a knowing violation under
 the circumstances indicated above must
 be similarly severe.
  5. Deterrence. It should be noted that
 the appropriateness of an enforcement

-------
408
Federal Remitter /  Vol. 48.  No. 3  / Wednesday. January 5. 1983  / RuJes  and  Kegulations
action it • dynamic, rather thin • static.
concept Because it U dynamic.
penalties must be periodically
evaluated. If a certain violation U
occurring more frequently, the leniency
of tha remediea which have been
applied to this infraction in the pa»t
should ba questioned Consequently,
what is appropriate ifl ona year may be
viewed as an inadequate response in the
next.
  The factors described above, together
with the aforementioned Guideline*.
should help to clarify the Agency's
                             definition o/"appropriate enforcement
                             action.** To understand belter how the
                             criteria described above can be tued to
                             evaluate whether • proposed State
                             enforcement action is appropriate, the
                             reader la referred to the hypothetical
                             fact situations in Appendix B.

                             0. Criteria Governing Grants of Primacy
                               Section 29 of FIFRA sets forth the
                             general criteria which apply to EPA'i
                             decision  whether to grant primacy to a
                             State:'
  "(a) For ih* purpose* of ihh Aci. s Smeihall have primary enforcement
responsibility lot pesticide use violations durteg any period for »hich (he Ad'
miruurator determines thai such Slate—
       •*(1)  has adopted adequate pesticide use unr» and regulations; Pro-
     vided. That the Administrator may not require a State (o ha»e pesticide
     u'jg laws ihai are more stringent than this Ac:;
       "(2)  has adopted and is implementing adequate procedure* for the
     enforcement of such State laws and  regulations; and
       "(3)  »iil keep such  records and mike such repofiv vhouing com-
     pliance wiin  paragraphs  (|) and (2) of (his subseviion as the  Ad-
     ministrate* may require by regulation.
  "(b) Notwithstanding the provisions of  subjection (a) of (his section, any
State ifut emert into a cooperative agreement with the Adrnmisir«or under
section 23 of this Act for the enforcement cf pesticide use restrictions shall
have th« primary enforcement responsibility for pesticide use violations. Any
State that has a plan approved by the Administrator in accordance *uh the re-
quirernern* of section 4 of this Act that the Administrator determines meets
the crnerii set out is subieciion (a) of (h»s section $ha!l have !he primary en-
forcer*™ responsibility fat pesticide use violations. Th* Administrator Oiall
make such  determinations »ith respewt 10 State plan* under Section 4 of this
Act m effect on September 30. 1978 not later than March Jl. H7».
  Thus, a Stata nay obtain primacy bi
 vo ways; (1) by demonstrating that the
   .•rents of its use enforcement
 .cgram. cr of its-approved certification
program, satisfy the rwo nain criteria in
section ZS(a). (adequate laws and
adequate procedures implementing
these laws}, or (2) by entering into a   '
cooperative agreement for the
enfcrcesent of use restrictions.
provided the tenss of the agreement do
not specify otherwise. The Agency will
also  evaluate lha adequacy of a State's
LIB enforcement program before
conferring primacy by this latter
method.
  A. Adequate Lam and Regulation*.
To be considered adequate, a Stale's
pesticide control legislation must
address at least the following areas:
  1. Use restrictions. State pesticide
control legislation will be considered
adequate for purposes of assuming full
primat) if State law prohibits those acts
which *.-r; proscribed ur.der FIFRA and
which -».iie to pesticide use. The
activi!i»i presently proscribed under
FIFRA . .-.ude:.

  a.  L!si .' * registered pesticide in a
martn". •. '.nsistent with its label
!HFRA«~';onl2(a)(2)(C)).
                               b. Us* of a pesticide which is under
                             an exparimental use permit contrary to
                             the provisions of the permit (section
                               c. Use cf a pesticide in tests on
                             humans contrary to the provisions of
                             section igaj{2)fP).
                               d. Violation of the provision in section
                             3(d](1)(c) requiring pesticides to be
                             applied for any restricted ose only by or
                             under the direct supervision of a
                             certified applicator. Violations of
                             suspension or cancellation. orders are
                             not considered use violations for*
                             purposes of the primacy program.
                               States may be granted partial primacy
                             If they regulate leas than all categories
                             of use violations. For example. EPA may
                             in the future decide to issue "other
                             regulatory restrictions" on use under
                             section 3(d)(l)(C}(ii), (such as a
                             requirement to notify area residents
                             before pesticide spraying). If such a
                             restriction were issued, (and not
                             reflected  on pesticide product labels).
                             each State would automatically have
                             partial primacy extending to all  cf the
                             categories Hs'ed abov» which are
                             proscribed by State law. unless  the
                             Slate already has authority to enforce
                             such restrictions. A State with partial
                             prmacy would obtain full primary by
                             enacting a prohibition tracking the
 lection 3fd)(l)(C](U) re.friction.
   2. Authority to enter. To carry out
 effectively their use enforcement          ,
 responsibilities. State officials should be
 able to enter, through consent, warrant.
 or other authority, premises or facilities
 when pesticide use violation! may
 occur. States should also have
 concomitant authority to take pesticide
 samples as part of the use inspection
 process.
   3. Flexible remedies. Finally, State
 legislation must provide for a
 sufficiently diverse and flexible array of
 enforcement remedies. The State should
 be able to select from among the
 available alternatives an enforcement
 remedy that is particularly suited to the
 gravity of the violation. Without such
 flexibility, a State may frequently be
 forced to  underpenalize violators, and
 thereby fail significantly to deter future
 use violations. Thus, in order to satisfy
 the "adequate laws" criterion. Stales
 should demonstrate that they are able
 to:
   a. Issue Warning Letters  or Notices of
 N'oncompliaace;
   b. Pursue administrative or civil
 actions resulting in an adverse economic
 impact upon the violator. e.g., license or
 certifica-tioa suspensions or civil penalty
 assessments: and
   c. Pursue criminal sanctions for
 knowing violations.
   B. Adequate Pncedurey for Enforcing
 the Lam. In order to obtain primacy.
 States must not only demonstrate
 adequate  regulatory authority, but must
 also show that they have adopted
 procedures to Implement the authority.
 These procedures must facilitate the
 quick and effective prevention.
 discovery, end prosecution of pesticide
 use violations.
   1. Training.  One step towards this
 objective  is the training of enforcement
 personnel At  a minimum. States, in
 cooperation with EPA. should
 implement procedures to train
 inspection personnel in such areasjes
 violation discovery, obtaining consent.
 preservation of evidence, and sampling
 procedures. Enforcement personnel
 should be adequately  versed in case
 development procedures and the
 maintenance  of proper case files.
  Instruction in these  techniques should
 take the form of both on-ihe-job (raining
 and the use of prepared training
materials. The Agency also considers a
continuing education program to be a
crucial training procedure, so that
enforcement personnel can  be kept
abreast of legal developments and
technological advances.

-------
           Federal  Register / Vol.  43. No. 3 / Wednesday. January 5. 1983 /  Rules and Regulations
                                                                          409
  2. Samp/ing techniques and
laboratory capability. Requests for
primacy thould also »how thai the Stale
it technologically capable of conducting
a use enforcement program. States mutt
have ready access to the equipment
necessary to perform sampling and
laboratory analysis, and should
implement a quality assurance program
to train laboratory personnel and
protect the integrity of analytical data.
Laboratories conducting sample
analyses must also agree to participate
in EPA (NEIC) Check Sample programs
which are designed to ensure minimum
standards of analytical capability. (Such
a program is already operational for
formulation samples, and a residue
sample program is also under
consideration). The EPA Check Sample
program Is coordinated with the
Association of American Pesticide
Control Officials (AAPCO) to reduce
unnecessary duplication of effort. The
EPA will be guided in evaluating the
adequacy of State analytical procedures
by official compilations of approved
analytical methods, such as the Food
asd Drug Administration's (FDA)
Pesticide Analytical Manual, the CEPAC
(Collaborative Interr-alicnal Pesticides
Analytical Council] Handbook, the EPA
Manual of Chemical Methods for
Pesticides, and Official Analytical
Chemists Analytical Procedures. For
additional guidance on  adequate
samplirg techniques. States should
cor.suit EPA's FIFRA Inspectors Manual
or contact the appropriate regional
office.
  3. Processing  ccmplaints.  SIcca a
significant portion of pesticida use
violations are identified through reports
from outside E?A or the State lead
agency, the State must implement a
system for quickly processing and
reacting to complaints or other
information Indicating a violation. An
adequate referral  system should contain:
  a. A method for funneling complaints
to a central organizational unit for
review.
  b. A logging system to record th*
receipt of the complaint and to track the
stages of the follow-up investigation.
  c. A mechanism for referring the
complaint to the appropriate
investigative personnel
  d. A system for allowing a rapid
determination of the status of the case.
  e. A procedure for notifying citizens of
 the ultimate disposition of their
 complaints.
   4. Compliance monitoring and
 enforcement. Along with the abova
 described enforcement procedures.
 Slates must provide assurance that
 sufficient manpower and financial
 resources are available to conduct a
 compliance monitoring program, i.e.,
 either planned or responsive use
 Inspections. In addition. States must
 Implement procedures to pursue
 enforcement actions  expeditiously
 against violators identified through
 compliance monitoring activities.
  The Agency also believes that
 program planning and the establishment
 of enforcement priorities is an integral
 part of an adequate enforcement
 program. Such planning, taking into
 account the national  program priorities
 as manifested through the grant
 negotiation process, as well as the
 priorities specific to the Individual State,
 will help assure that  compliance
 monitoring and enforcement resources
 •re properly allocated.
   5. Education. Slates should implement
 a program to inform their constituencies
 of applicable pesticide use restrictions
 and responsibilities. Examples of
 education methods Include
 disseminating compliance information
 through cooperative extension services.
 seminars, publications similar to the
 Federal Register, newspapers, and
 public assistance offices where persons
 can call to ask questions or report
 violations. Such an educational program
 will promote voluntary compliance and
 Is essential to effective enforcement.
 States should also  develop procedures
 for soliciting input  from the public
 regarding the administration of the
 pesticide use enforcement program.
 ITT. Criteria Governing Rescission of
 Primacy Under Section 27(b)
  Section 27(b) authorizes the
 Administrator to rescind primacy from a
 State in certain situations:
  "(b) Whenever the Administrator determines that a State having primary
enforcement reiponsibiiity for pesticide use violations is not carrying out (or
cannot carry out due :o the lack cf adequate legal authority) such responsibili-
ty, the Administrator shall notify the  State. Such notice shall specify those
sspecn of the administration of the  State program that are determined to be
inadequate. The State shall have ninety days after receipt of the notice to cor--
reel any deficiencies. If after that  time the Adminisiraior determines thai the
State program remains inadequate, the Administrator m«y rncind, in »ncle
or in pan, the State's primary enforcement, responsibility for pesticide use
violations.
  In deciding whether a State is not
carrying out or cannot carry out. its use
enforcement responsibilities, the
Administrator will apply the criteria for
an adequate program set forth in Unit 0
to the performance of the State during
the time the State had primacy.
  A. Adequate Laws. The legal authority
can conduct an adequate use
enforcement program is a criterion
which affects both the decision to grant
primacy and the decision to rescind it.
Within the context of rescission, the
Administrator will assess the impact of
any amendments or supplements to the
State's pesticide use laws and
regulations. If legislative changes have
adversely affected the State's ability to
collect information or bring enforcement
actions, the State  may be subject to a
rescission action on grounds of
Inadequate laws.
  E Adequate Procedures. In
determining whether a State which has
adequate legal tools is carrying out its
use enforcement obligations, the Agency
will examine the efficacy of the
procedures adopted by the State to
Implement its pesticide laws. The
Agency will be particularly interested in
the remedies the State has actually
applied to the various use violations.
The lack of sufficient correlation
between the gravity of a use violation
and the severity of the enforcement
response would be evidence that the
State's arsenal of remedies is not being
applied in a flexible manner.
  In addition. EPA will evaluate each
program element listed in Unit ILfl.. in
light of the performance of the Slate
during the period the State had primary
use enforcement responsibility.
  I. Training. The Administrator will
note whether any difficulties
encountered by the Slate in enforcing
pesticide use restrictions have resulted
from a lack of adequate training of State
enforcement personnel.
  2. Sampling techniques and
laboratory capability. The
Administrator will consider whether the
State's sampling techniques end

-------
analytical capabilities are enhancing or
hindering the State'i ability to unearth
and prosecute snccessfuDy persona who
miiasa penticides. Another Important
consideration will be the degree to
  hich State laboratory and umpling
   icedurej have kept pace with
  -velcpmenU in analytical technology.
  3. Pncsatiag comp/a/nac The
Administrator will examine whether
complaints have been processed quickly
and efficiently. The degree to which
citizens alleging a MM violation seek
redreu from EPA  after first directing
their complain! to the Slate will be
considered. In addition. the
Administrator will take Into account the
performance cf the State in responding
to allegations referred to the State by
EPA under section 27(a) of FTFRA.
  4. Compliance mon/torrng and
enforcement. Under this element, the
Administrator will compare the State'*
level of compliance monitoring activities
with that of other  comparable States.
The EPA will review State case files to
determine whether tho State has
aggressively Investigated a case bsfsra
deciding on the disposition of the
natter. The ETA will also nrvestjgita
whether a State'i  Attorney General'*
office or other presecutcrial authorities
have dascsstrated a wiSirgness  to
pursue cases referred by the State's
pesticide control lead agency.  '
   The Agency will examine whether
Stats ec/crceineat resources have been
    c'.ed towards the more significant
    rcemeat problem areas, and
.. Aether enforcement priorities have
keen Devaluated  as the demands of an
adequate program change over time.
   S. Education. The Administrator will
evaluate whether  the State's education
program is encouraging voluntary
compliance with pesticide ate
restrictions. As part of this process, the
Administrator will note those use
violations which are at least partially
attributable to the violator's lack  of
familiarity with applicable laws and
regulations. The Administrator will also
review State procedures for facilitating
public participation in the enforcement
program.
   These criteria are indices of the
adequacy of a State's use enforcement
program, but they do not cunclusiveiy
determine whether a  Stale is dist  barging
its primacy responsibilities. Since the
Agency's goal is to protect the public
from the risks associated with
pesticides, one of  EPA'k central inquin.'s
will be whether the State's primacy
program assures compliance with
pesiicide use restrictions. F.PA. in
e\aluating State program adequacy, will
consider both the  deficiencies of the
program and the success of the program
In achieving compliance.
IV. Emergancy Respoas*
  Notwitajtaadin* other provisions of
sections 28 and 27. the Administrator
may, after notification to the State, take
Immediate action to abate emergency
situations if tha Stale is "unwilling or
unable adequately to respond to the
emergency."
  FTFRA does not define "emergency
conditions." Other EPA-admiaisteied
statute*, however, characterize
emergencies in fairly consistent terms.
The consensus of these statutes is that
an emergency presents a risk of harm to
human health or the environment that is
both serious and imminent, and that
requires immediate abatement action,
  p»amn!»« of a£e-reUted emergency
situations ore:
  1. Contamination of a building by a
highly toxic pesticide.
  2. Hospitaiiza lions, deaths, or other
severe health effects resulting from use
of a pesticide.
  X A geographically specific pattern of
use or misuse which presents
unreasonable risk of advene effects to
health or sensitive natural areas. This
situation may occur, for example, if a
hazardous pesticide is consistently
misHsed in a particular area so that the
net effect is the creation of substantial
endangerment to the environment, such
as runoff into a  water supply.
  A. -UavnUiog'. When EPA learns cf '
aa emergency situation. Agency
representatives eust notify tha affected
State. These representatives will try to
obtaia a coaaitmeni from the State as
to (a) what the Sute is  capable of doing
In response to the situs tioa, and (b)
when the State intends to respond to the
crisis.
  Emergencies, by nature, require the
quickest possible response. In most
cases, due to proximity, the Slate will
have the opportunity to be first on the
scene. If the State manifests an
unwillingness to respond rapidly to the
situation, or if the State cannot give
assurances that it will respond more
quickly than EPA could respond.'Agsncy
emergency response teams will be
activated.
  B. "Unable". The EPA will
immediately take action to abate an
emc'aoncy if Ihs Slate is unable t<>  rin
so. The Agency interprets "unable" to
mean  thai other the State dot s not have
the authority to adequately respond or
lh.it the State Is incapable of solving the
problem due to  tt^e lack of tethnolr^y or
resources.
  1. Authority. The EPA c;in  utilize its
autOority in section 16(c> of KIFRA  to
seek, in conjunction with  the
Department of Justice, a district court
order preventing or restraining misuse of
a pesticide. States should also bo able to
address • use-related emergency In this
manner or by the rapid Issuance of an
enforceable stop-use order or other
similar means. If the State lacks this
authority and the emergency conditions
warrant a legal response in the nature of
specific enforcement or equitable relief,
EPA may Initiate its own action after
notice to the State.
  2. Technical capability. Some
emergency situations may present
problems which the States are
technologically incapable of solving. In
these instances, if EPA possesses the
requisite technology or equipment the
Agency will immediately respond to the
crisis. For example, where a dissolved
organic pesticide has contaminated a
surface water system. EPA would
activate its portable advanced waste
treatment unit, a resource that is not
generally available to the States.
  The EPA will also take action if the
State cannot rapidly commit  the
necessary manpower to the emergency
situation. In most cases EPA  will not.
however, initiate a response oa this
basis if the State has developed an
emergency response plan detailing the
procedures to be followed in  •
counteracting a pesticide emergency.

V. Hypothetical Situations
  In reading the hypothetical* in Units
A and B. asruxne that the cases
discussed fall usder priority referral
areas discussed In Unit LA-2.
  A. Action by Citizen. Hypothetical 1.
EPA refers to the State a citizen's
allegation fiiat an aerial applicator has
allowed pesticides to drift over his
property. After 22 days, the EPA Region
obtains the results of State's
investigation and learns that  the State
plans to issue a warning letter to the
applicator. The EPA advocates a more
firm response and. after discussion, the
State agrees to suspend the applicator's
certification. The Stale certification
board does not meet, however, until two
months later. In this instance, the Region
may decide to extend the normal 30 day
prosecution stage to accommodate the
schedule cf the board.
  Hypothetical 2. A  citizen calls EPA
vtith information concerning a fish kill
wh.ch occurred m a  stream near his
residenre. The citizen  claims that he
reported his information to the Stcte. but
State officials have not responded to his
cor.plairt. The TP.Ys Regional official
calN the State, and learns that the State
did indeed kr.ow of the problem, but has
not yet had the opportunity to
investigate (ho allegation. The Regional

-------
official, believing the allegation to b«
lignificant. formally refers the complaint
o tht State, and the Stale agrees that
he matter ihould bt investigated within
  da^t. After 20 dayt. the Region learns
        Jtste has not yet beaun its
    ____ Slion. ID this case, the Region
    jegin it< own inquiry into the
natter, and may commence its own
•nforcement  action, after notice to the
>!ate. provided that 30 days have
japsed from the date of the referral.
  B. Action by State. In both of (hesa
lypolheticals, usuae that the State has
hosen a Warning Letter a* the
 ppropriata enforcement response.
  Hypothetical I. Mr. Smith operates a
 ae-man crop dusting company. Smith i*
 ired to spray Herbicide A over a power
 or.p«..y's lengthy right-of-way. The
•ght-of-way Is bounded on one Bide by
 residential development and on th»
 ther by a wooded area. Smith performs
 :e aer.al applicaticn aoidii high
 wiriin3 wtndj la contravention of tha
 istroctio^s on the herbicide'* label. A
 .gnificast pcrticn of the herbicide drift*
 =10 ihe weeded area. Herbicide A.
 hich ccntauis ths hazard ward
 jaeger" on its lacd. is a highly toxic
 r.d persistent restricted use peatkids.
 .r.ith has no reccrd of prior pesticide-
 :!atcd violations with gavemacci
 uticida ccstrcl cfDc=a.
  Th* Agency would consider tha
 acanca of a warning letter to be an
 .apaiJEriate response to  this violation.
  * ^^^crscc/3i?tf with the violotirt
   ^^^Rrtiiately fn this instance, tha
      .e did not mult Li damage to
 ii..;:s or sensitive enviroruseaJaJ
 MS, But at tha time (he violation was
 .•oir-itted, the risk that kara would
  suit L-cm the misuse was quite
 jmficar.t. given tha high swirling
 inds and the proximity of a residential
 .'ighbcrhood. Only chance prevented
  e herbicide from drifting Into anN
  habited area. The risk of hann waa
  so increased by the fact that a yreat
  al of land was subject to drift given
  » length of the target area.
  b. Risk associated with the pesticide.
  .>rb:cids A is labelled "danger" end is
  :refcr» an acatcly toxic Catenary i
  sticide ander |.o.<«>d cooking
racks were to b«s used.
  c. Other factors. Under FIFRA. the
Issuance of a Notice of Warning is the
maximum enforcement response to a use
violation commi'ted.by a private
applicator with no history of prior
violations. Thus, the Agency would, of
course, view  the proposed State
enforcement action as appropriate. If the
violation were repeated, a more
stringent enforcement action would be
warranted.
  Dated- f>c«mUr 12. 18S2.
Icfcn W. ttenuodci. [r.
Actirj AdmLntttrator.
(TB Dot f*4 KM I 4 «>
aaiMCOCt tsso

-------
        '•     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON. D.C. 20460


                           APR 2 1 1983
                                                           OFFICE Of
                                                    PESTICIDES AND TOXIC SUBSTANCES
 EM08AMDUM

S!''UECT:   Final  F IT'S 4 Cooperative Agreenent Prog ran Guidance

TO:        Air and Waste Management Division Directors
          Environnental Service Division Directors
          Pesticide Branch Chiefs


     Attached is tne final guidance for the FY^4 FIFtfA cooperative
agreement program.   This document combines guidance for both the
pesticides enforcement and the applicator certification and train-
ing programs.  For  your convenience, the sections entitled FY 1984
FIF-iA Cooperative Agreenent Program Guidance and FIF.^A Cooperative
Agreenent Program Guidance are included in their entirety.  Thesy
sections  replace the FY 1 kJ33 Cooperative Agreenent Pro?ran Guidance
and the FIFRA Cooperative Agreement Program Guidance sections in
the FY33  guidance.   Also, nany of the Appendices in the FYo3 cjM-
an c a hove either been an ended, revised or r •» placed ana five new
^"oendic^s have  been added.

     This final  guidance has been modified in response to nost
comments  on the  earlier draft.  Specifically, the following areas
have been changed:

     o Bas e Al1otment
     o Product/Faci1ity Related Priority Setting Model
       (Appendix I, addendum)
     o Nonfunded Priority Program
     o §26 and §27  Interpretive Rule Procedures
     o LIP and CRP  Inspection Strategies
          /'

     For  FY84, the  enforcement cooperative agreement base funding
level has been increased from $45,000 to 560,000.  The weighted
factors used to  distribute the funds remaining after each State's
base allotments  were subtracted from the total program allotment
have also been revised to reflect new data on the numbers of private
and commercial applicators reported for FY32.

-------
                              2-
     Comi'ie-i tors aske-i if a State couH conduct, as part  of  its
  rst quarter outputs, the product/facility priority setting.
  ates who are 'unable to complete their product/faci1ity priority
setting prior to the awarding of their FY84 cooperative  agreement
may include that portion of their priority setting as part  of
their first quarter outputs.  Part III, Award Conditions of the EPA
Notification of Assistance Award Action for such States  must  include
* condition requiring States to conduct product/facility priority
setting by no later than the end of the first quarter.

     The section on nonfunded priority problems has been clar-
ified.  Some States' current pesticide programs may already
address pesticide problems identified through priority setting.
In such cases, States are requested to provide this information
as a supplement tn their cooperative agreement applications so
that EPA will have a complete picture of how a State is  addres-
sing all its pesticide problems.  This information will  aid the
Regions in evaluating the State's cooperative agreement  application.

     All States must update their previous years use priority
sotting and include it in t^eir FY84 cooperative agreement
applications.

     The final guidance document summarizes and expands  the
procedures to be followed by the Regions in reviewing State
investigations and enforcement actions un^or the Interpretive
  |'e for FIFRA §§25 and 27.  The Regional  offices and the States
  il annually define significant cases to  ne tracked by  £'JH
. fter referral to the State.  The uji/1a."!c~ outlines the  orocedures
yMch the Regions must follow 1) in revi f.-;-* PC the adequacy of
State investigations or enforcement *ctio" s and ?. ) before cu""1u:t-
i n g a Federal investigation or taking F e '1 H r a 1 enforcement action.

     Finally, inspection strategies for the LIP and^CRP  programs
are included in Appendix XI and Appendix XII.  The Office of
Pesticide Programs, Registration Division  will provide the
required data as outlined in the inspection strategies.

     If you have any questions, please contact John Martin,
of my staff, at (202) 382-5572.    •                      -          .
                                      •*• '
                              M. a. Conroy/'jn, Director
                             Compliance Monitoring Staff
                     Office of Pesticidesa'nd Toxic Substances
                                         '\
Attachment

-------
                         TABLE UF CONTENTS
	FY 1984 FIFRA COOPERATIVE AGREEMENT PROGRAM GUIDANCE

ENFORCEMENT                                             1
A11otment of Funds                                      1
  InitialAl1otment                                     1
  Adjustments  to Initial Allotment                      2
  Final Allotment                                       2
  Alternati ve  Funding                                   2

National Priorities                                     3
APPLICATOR CERTIFICATION AND TRAINING
Allot "lent of Funds                                      5
  InitialAl1otment                                     5
  Final Allot ment                                       6
Attachments: Allotment Schedules

-------
    FY  1984 FIFRA COOPERATIVE AGREEMENT PROGRAM GUIDANCE
         ^
This annual guidance outlines Regional funding allotments and
discusses  national priorities to be followed by the Regions in
implementing FY84 cooperative agreements for pesticides enforce-
ment and applicator certification and training.  The Compliance
Monitoring Staff  (CMS) of the Office of Pesticides and Toxic
Substances Compliance Monitoring Staff (OPTS) expects to receive
56,913,400 to fund State and Indian Tribe cooperative enforcement
programs and has  received 52,000,000 for funding cooperative
applicator certification and training programs.
	i	
ENFORCEMENT
Allotment of Funds	

The President's annual budget submission to the Congress requests
an overall program appropriation for pesticides enforcement
cooperative agreements.  Individual State allotments for financial
assistance are initially determined by application of a two s'tep
formula.  States are to use these initial allotments to develop,
w i t n their respective Regional offices, work programs that meet
both State and Agency needs. [40 CFR Part 35.115(h)]  Final allot-
ments will be based on the States'  initial  allotments and a
redistribution of surplus funds.

Initial  Allotment
Because of a proposed reduction in the amount of pesticides
enforcement cooperative agreement funds available for FY84, EPA
Headquarters'  initial financial assistance allotments will  con-
sider only those States, Territories and Indian Tribes presently
participating  in the pesticides cooperative agreement program.
Any non-participating State (Ohio, Nebraska,  Colorado, Wyoming,
and Alaska) or Indian Tribe which wishes to. be included in  the
final allotment, must send EPA a  written commitment  to submit
an application and participate in the program prior  June 15,  1983.

For FY84, £PA  Headquarters will first determine the  initial
Regional  allotments for pesticides enforcement cooperative
agreements by  adding the following:  560,000 for each participating
State, Puerto  Rico and the District  of Columbia (-17); 525,000
for the Virgin Islands; and 510,000  for each  participating  Ter-
ritory (•*) which comprise  a base  level  of  funding.   The initial
Regional  allotment also includes  10% of the available funds (1*
per Region) as pesticides  enforcement incentive funds; and
5200,000  for cooperative agreements  with Indian Tribes (7).

-------
                                 -2-
Then, Headquarters will distribute the funds remaining after the
base  funds, pesticides enforcement incentive funds and Indian
Tribe funds are subtracted from the proposed budget ap-propriation
according to the following factors and weightings:

      1981 July 1, 1981, Provisional Estimates of Popula-  20%
          tion, U.S. Bureau of the Census - April 1982.

      1982 Number of Pesticide Producing Establishments    20%
          per State - FIFRA and TSCA Enforcement System
          (FATES) printout, December 23,  1982, CMS.
          (Numbers do not include Custom Blenders).

      1982 Number of Certified Private Applicators per     10%
          State, September 30, 1982, CMS.
     1982 Number of Certified Commercial Applicators per  20%
          State, September 30, 1982, CMS.
          (Individual categories were counted separately).

     1932 Estimated Number of Farms Per State - Crop      20%
          Reporting Board, (SRS) U.S. Department of
          Agriculture (USDA) Farm'Numbers,. August 1982.

     1982 Estimated Farm Acreage Per State - Crop         10%
          Reporting Board, SRS, USDA Farm Numbers,
          August 1982.

Each Region's initial allotment is  obtained by adding the appro-
priate base amount for each of its  States, Territories or Indian
Tribes, the proportioned amount determined by the above factors
and weightings and the pesticides enforcement incentive funds.

Each State's initial  allotment is obtained by adding the appro-
priate base amount and the proportioned amount determined by the
above factors and .weightings.  The  pesticides enforcement incentive
funds will  be used by the Regional  Administrator to reward innovative
or exceptional pesticides enforcement programs.   (Regional and
State allotments are  attached.)

Adjustments to Initial Allotment

Regions should not award funds based solely on a State's initial
allotment but rather  based on the negotiated need of the State.
The Regional Administrator may modify any State  allotment as
necessary as long as  total funding  for all  States does not exceed
the Regional allotment.   40 CFR Part 35.115(d) states that the
Administrator or the  Regional Administrator 'may  use funds not
awarded or  committed  to  an applicant to supplement  awards to
ot^er applicants for  pesticides enforcement.

-------
                              -3-

     A11otment	

ne Regional office must furnish the following information  i'n
riting to Headquarters no later than July 1, 1983:

     1. ' The names of States and Indian Tribes that will be
         participating in Fiscal Year 1984.

     2.  The anticipated financial  assistance funding level
         for each participating State and Indian Tribe.

ne EPA Headquarters will make the final allotment of cooperative
greement funds and notify the Regional offices in writing  by
•jly 15, 1983.  This final allotment will include a reallotment
f funds from Regions whose States do not need their entire
n'tial  allotments to Regions whose  States demonstrate a need
or additional funding.  The final Regional  allotment consists
f the sum of each participating State's final allotment and
2 s t i c i d e enforcement incentive funds and will be included  in
a c h Region's FY84 operating budget.

ne Regions will  base the distribution of cooperative agree-
2 n t funds on both the allotment schedule and the thorougnness
f the State's own priority setting  process.   The States should
•jpntify priority enforcement problem areas  by a  method similar
    at outlined  in the Priority Setting section  of the State
   •cation Standards and Evaluation Procedures,  Appendix I ana
: s addendum, so  that resource allotment decisions will  be
 sad  on objective measures.   The Region will  sase final  State
 •rjing  allotment decisions for State applications on the initial
 lotrnent,  the demonstrated pesticide enforcement priorities
  the State and  the exceptional  nature of a  program justifying
vard  of a  portion of the pesticide  enforcement  incentive funds.

'ternative Fundina
i e Regional  Administrator may  use current year funds remaining
•tar the initial  State  awards  to  1)  supplement existing awards
•  2) award  new partially  funded  cooperative agreements  for
ie next  year.   A  partially  funded cooperative agreement is a
?w agreement that  would  begin  immediately after the current
^operative  agreement  hacl  ended  and  is  funded, partially,  witn
j r r e n t year  funds.

srtially funded cooperative  agreements  offer  States a method
'"  maintaining  program continuity  during  EPA's transition
•om  fiscal year to  fiscal year.   All  funds  must be  obligated
i  accordance with  the legislative restrictions that limit
ie anount of funds  that can  be  obligated  in  the fourth  quarter.
lese funds  shall  not  be used to extend  budget or  project
?  '  ds of existing  cooperative  agreements.

-------
                              -4-
Nati ona1 Priorities
Each year, Headquarters formulates national pesticide enforcement
priorities based on major recurring areas of concern identified
by the States through their priority setting systems and on related
information from other sources.

Based on the available data and priorities established by States
that conducted priority setting in their FY83 cooperative agree-
ment applications, Headquarters has identified the following
general areas of concern as National Priorities for FY84.

     1)  Drift from pesticide application;

     2)  Misuse by pest control operators during structural
         applications;

     3)  Disposal  of pesticides and pesticide containers;
         and

     4)  Pesticide use problems associated with major spray
         programs, i.e. gypsy moth, forest service (conifer
         release), and mosquito control.                   '  •

     5)  Worker exposure to pesticides  before,  during and
         after appl i cati on.

The EPA has designated these areas of concern as national
priorities to guide the States in  their priority setting process.
Although  these areas  may not be of apparent concern in  all  States,
the States should  consider these areas  as they  develop  data  for
use in setting their  individual priorities.  After considering
pertinent data,  a  State may find that some or all  of  these  areas
are not priority problems  in the State.  In that case,  the  State
should, of course,  direct  its enforcement resources to  those
areas which do present major pesticide  problems..

-------
                              -5-
APPLICATOR CERTIFICATION AND TRAINING
A 11otment of Funds
The President's annual budget submission to the Congress requests
an overall financial assistance program appropriation for pesticide
applicator certification and training cooperative agreements.
Individual State allotments for financial  assistance are initally
determined by application of a two step formula including certain
factors and weightings described below.  States are to use these
initial allotments to develop, with their respective Regional
offices, work programs that meet both State and Agency needs.
[40 CFR Part 35.115(i)]

Initial Allotment
In FY34 financial assistance funds for the pesticides applicator
certification programs with States will be alloted from FY33
fjnds .!

?or FY34, EPA Headquarters will first determine the initial
Regional allotment for pesticide applicator certification and
training cooperative agreements by adding $10,000 for each parti-
cipating State which comprises a base level of funding.  Each.
.Regional allotment will also include an amount for cooperative
.agreements with Indian Tribes that are approved and operating
before the issuance of this guidance document.

Then, Headquarters will distribute the funds remaining after the
oase funds and Indian Tribe funds are subtracted fro
-------
                               -6-
          Regional  discretionary allotment for            10%
          pesticide applicator certification and
          training  programs.

Each Region's initial  allotment is obtained by adding for
each of its States  the base funding amount, the proportioned
amount determined by the above factors and weightings and the
Regional  discretionary allotment for pesticide applicator
certification and training.

Each State's  initial allotment is obtained by adding the base
funding amount and  the proportioned amount determined by the above
factors and weightings.   The Regional  discretionary allotment for
pesticide applicator certification and training programs will
be used by the Regional  Administrator  to reward exceptional
programs. (Regional and  State initial  allotments attached).

Final  Allotment

The irritial  allotment  will  become the  State's final  allotment.
However,  if a State cannot  use its entire initial  allotment
the unused funds will  be redistributed by the Regional  Adminis-
trator to other  States, within the Region requiring additional
assistance.  Prior  to  awarding unused  funds to another  State the
Regions must  inform CMS  where these unused funds will  be used.

-------
               UNITED STATES.ENVIRONMENTAL PROTECTION AGENCY

                           WASHINGTON, D.C. 20460




                              April 11,  1983
                                                             OPFICE OF
                                                      PESTICIDES AND TOXIC SUBSTANCES
ME MO SAND I'M .

TO:       Addressees
           :                            I

SUBJECT: Revised State and Regional  Initial Allotments
         for Pesticide Enforcement Cooperative Agreements       '



     Attached is a copy of t n e revised State and  Regional  Initial
Allotments for Pesticides Enforcement Cooperative Agreements  for
FY.?» and the supporting allotment formul-a  data.   This allotment
schedule incorporates tv/o najor changes:
                                                                t
     •°  Utilizes the numbers of private and commercial  certified
        applicators on September 30,  \'}-i2 ,  instead  of the  1931
        n u "i fc e r s .  ~he 1 ? 8 2 numbers were unavailable when  the
        previous allocation was ;nade  on January  11, 1933.
     0
        Base funding level was increased from  $-15,000  to  $50,000
        per state.   This change was recommended by the Association
        of Ame r i can Pes t i c i de Control Officials and the  State-
        r'lFRA Issues Research and Evaluation Group.

     This allotment schedule is based on the President's  FY84
budget request of $5,918,400 for pesticide enforcement cooperative
agreements.  These  allotments should be used in planning  the FY84
pesticide enforcement program with the States  in your  Region.   As
indicated in the  Draft FY84 Cooperative Agreement Program Guidance
the Initial Allotment Schedule may be revised  to provide  funding
for any non-participating  State (Ohio, Nebraska, Colorado, Wyoming
and Alaska) making  a written commitment, prior to June 15, 1983, to
apply  for a grant.   The. final allotment schedule will  be  issued by
July 15,  1933.
                                 Conroy if,; Director
                          Compliance M o n i tW ing Staff
                    Office of Pesticides and Toxic Substances
 . 1 1 achment

-------
                State and Regional Initial Allotments for Pesticide
                    Enforcement Cooperative Agreements for FY84
\
Reg. I
CT
ME
HA
r«H
RI
VT
Regional Incentive
•-' Regional Totals
Reg. II
NJ
NY •
PR
V!
Regional Incentive
Regional Totals
Reg-, ill
DC
CE
MO
PA
VA
* VA
Regional Incentive
Formul
Percent
.627
.383
1.155
.214
.226
.232

2.837

2.275
4.912
1 .243
-

8.430

.112
.227
1.010
2.981
1.779
.677

la Funding
Amounts
19,708
12.038
36,303
6,726
7,104
7,292

89,171

71,507
154,392
39,069
'

264,968

• 3,520
7,135
31,746
93,697
55,917
21,279

Base
Funding "
60,000
60,000
60,000
60,000
60,000
60,000
69,000
429,000

60,000
50,000
60,000
25,000
69,000
274,000

60,000
60,000
60,000
60,000
60,000
60,000
69,000
Total
Funding
79,708
72,038
96,303
66,726
67,104
67,292
69,000
518,171

131,507
214,392
99,069
25,000
69,000
538,963

63,520
67,135
91,746
153,697
115,917
81,279
69,000
Regional  Totals               6.78b213,294429,000642,294

-------
                                    -2-
Reg. IV
AL
FL
GA
KY
MS
NC
SC
TN
Regional Incentive
Regional Totals
Reg. V
r '
i '<
1 1 *
• '. i
MN
OH
WI
Regional Incentive
Regional Totals
Reg. VI
AR
lA
i\M
CK
TX
Regional Incentive
Formula
Percent

1.665
4.376
3.154
3.060
1 .369
3.103
1.189
2.910

20.826

A. 636
2.517
2.533
2.661
-
2.731

15.128

1 .487
1 .362
.921
2.107
10.331

Funding
Amount

52,333
137,544
99,135
96,180
43,030
97,532
37,372
91,466

654,592

147,238
79,113
79,616
83,639
-
85,840

475,496

46,739
58,525
28, 9^8
66,226
324,719

Base
Funding

60,000
60,000
60,000
60,000
60,000
60,000
60,000
60,000
69,000
549,000

60,000
60,000
60,000
60,000
-
60,000
69,000
369,000

60, COO
50,000
60,000
60,000
60,000
69,000
Total
Funding
•
1V2.333
197,544
159,135
156,180
103,030
157,532
97,372
151,466
69,000
1,203,592

207,288
139,113
139,616
143,639
-
145,840
69,000
344,496

106,739
118,525
88,948
126,226
334,719
69,000
Totals
                                                                       ••'Oil

-------
-3-
Reg. VII
IA
KS
MO
NB
Regional Incentive
Regional Totals
Reg. VIII
CO
MT
NO
SD
7
WY
Indian Tribes(6)
Regional Incentive
Regional Totals
Reg. IX
AZ
CA
HI
NV
An Sarcod
Gua.T.
Mariana Is.
~"ust Terr-.
• indian Tribes(2)
Regional Incentive
Formula
Percent

2.848
2.097
3.172
-

8.117

-
1.201
1.422
1.310
.615
-
-

4.548

1.481 .
9.322
.369
.427
-
-
-
-
-

Funding
Amount

89,517
65,912
99,700
-'

255,129

-
37,749
44,696
41,175
19,330
-
-

142,950

46,550
293,005
11,598;
13,421
- •
-
-
-
-

Base
Funding

60,000
60,000
60,000
-
69,000
249,000

-
60,000
60,000
60,000
60,000
-
100,000
69,000
409,000

60,000
60,000
60,000
60,000
10,000
10,000
10,000
10,000
100,000
69,000
Total
Funding

149,517
125,912
159,700
-
69,000
504,129

-
97,749
104,696
101,175
79,330
-
100.000
69,000
551 ,950

106,550
353,005
71,598
73,421
10,000
10,000
10,000
10,000
100,000
69,000

-------
                                        -4-
Formula
Percent
Reg. X
AK
ID 1.254
OR 1.656
WA 2.119
Regional Incentive
Funding Base ....
Amount Funding

-
39,415 60,000
.-*
52,051 60,000
66,603 60,000
69,000
Total
Funding

-
99,415
112,051
126,603
69,000
Regional Totals              5.029158,069249,000407,069
Total  to Regions           100.008       3,143,400      3,775,000       6-.918.400

-------
                     FY84 FIFRA ENFORCEMENT GRANT
                        Allotment Formula Data

                            March 21. 1983
     The attached table shows the statlsical  data used in developing
the formula for the allotment of the FY84 Pesticides Enforcement
Grants.  Only data from the 45 states participating in the program
plus Puerto Rico and the District of Columbia are Included.  The
other territories and the Indian Tribes do not receive any formula
funds.  The statistics  used in the formula were amended to include
the 1982 certified applicator numbers and include the following:

Popu1ati on

     July 1, 1981 Provisional Estimates of the Population -
     Bureau of Census,  April  1982.                         i

Farm Numbers and Acreage

     1982 Preliminary estimates - Crop Reporting Board, SRS,  USDA,
     August 1982..

Producer Establ i shmen't s                     '         "

     FATES Data  System  - December 23, 1982 printout.  Numbers used
do not include Custom Blenders.

Private Applicators

     Number of Private  Applicators certified  on September 30, 1982.

Commercial Applicators

     Number of Commercial  Applicators certified on  September'30,
1982.    Individual categories  were counted separably.

-------
Rey.   1




      CT



      ME



      MA



      NH




      Rl



      VI




      Keg. Total




Retj.  II



      NJ




      NY



      PR




      Reg. Total




Reg. Ill



      DC




      DE




      MD




      PA




      VA




      W VA




      Reg. Total
Pop nl at Ion
Stdt.«
(jooo)
3.134
1.133
5,773
936
y53
516
12.415
7 , 41)4
17.602
3.186
TH.15?
631
59cJ
4,263
11.871
5.430
1.952
74-774-5-
%

.290
.105
.534
.OB7
.08B
.048
1.152
.685
1.628
.295
776118
.058
.055
.394
1.098
.502
.181
2.288
Farms
State

4 ,.300
7,900
5,300
3,200
750
7,500
28,950
9,500
50,000
31.837
9T7:nT
0
3,400
18,000
60,000
60,000
20,600
TOTffffff
i

.03H
.071
.047
.029
.007
.067
.259
.085
.446
.284
.8T5"
0
.030
.161
.536
.536
.184
1.447
F iirin Acroiii]o.
Sf.iiti;
(1UOO)
4'Jl)
1.560
630
. 540
80
1 , 700
5,000
1,030
9,500
1.750
1 2.2110"
0
660
2.750
8.800
9,800
4.300
[767370
1'i-st. . Pro'lticers
"1- ' ,t U>

. UOb
Ml
.OO/
.006
.001
.019
.055
.011
.105
.019
.135
0
.007
.030
.097
.108
.048
.290
52
19
113
14
23
5
266
271
280
53
' "fil-l
6
16
78
233
66
22
4"2T
%

.150
.055
.327
.040
.066
.014
.652
.783
.809
.153
T7W
.017
.046
.225
.673
^91
.064
1.216
Private Aj>plic.
State

2,074
2.975
1,879
803
338
2,565
10.634
3,270
15,507
16,260
"3T.03T
0
2,260
8.288
32,780
15.687
14,129
T37i"4T
1

.021
.031
.019
.008
.004
.027
.110
.034
.160
.1'68
.362
0
.023
.086
.338
.1162
.146
.755
Cnimn A
State

2.005
1.698
3.622
725
981
928
9.959
11,073
28,846
5,296
45,215
601
1,089
1.865
3,903
4.577
.880
12,915
plic.
1

.123
.104
.221
.044
.060
.057
.609
.677
1.764
.324
2.765
.037
.066
.114
.239
.280
.054
.790
' \l \. I.* | M
Fonmila
Fun

.627
.383
1.155
.214
.226
.232
2.837
2.275
4.912
1.243
8.430
.112
.227
.1.010
2.981
1.779
.677
6.786

-------
Reg.  IV



      AL



      FL




      GA



      KY




      MS




      NC



      sc



      TN




      Heg. Total



Reg.  -V




      II.




      IN



      MI




      MM




      OH




      Ml




      Reg. Total
Population
State
(1000)
3,917
10.183
5,574
3,662
2,531
5,953
3,167
4.612
39,599
11,462
5,468
9,204
4.094
-
4,742
3T.W
1
.362
.942
.515
.339
.234
.551
.293
.427
3.663
1.060
.506
.851
.379
0
.439
17?rc
Farms
State
57,000
41,000
58,000
101.000
53,000
88,000
33.000
95.000
526,000
104,000
89,000
65,000
103,000
-
92,000
•45TTOW
%
.522
.366
.518
.902
.473
.786
.295
.848
4.710
.928
.794
.580
.919
0
.821
~4~7042
Farm Ac
State
(1000|_
12,300
13,000
15,200
14,500
1 4 , 500
11,100
6,100
13,400
100,100
28,700
17,000
11,500
30,400
-
18,500
10 6", 100
rt'dijt!
1
.136
.144
.168
.160
.160
.123
.067
.148
1.106"
.317
.188
.127
.336
0
.205
1.173
Post. Producers
Stati;
129
864
281
89
64
182
79
140
1,828
418
166
184
152
-
152
1.072
1
.373
2.497
.812
- .257
.185
.526
.228
.405
5.283
1.208
.480
.532
.439
0
.439
Private Applic.
State
9,977
17,308
34,865
86,257
8,632
52,292
12,391
79,441
301,163
53,808
15,000
6,041
20,000
-
28.737
I
3.0981123,586
%
.103
.179
.360
.890
.089
.540
.128
.820
3.109
.556
.155
.062
.206
0
.297
1.276
Zomm A
State
2,757
4.059
12.771
8.376
3,733
9.432
2,914
4,292
48,334
10,087
6.443
6,226
6,247
-
8,677
37,680
plic.
1
.169
.248
.781
.512
.228
.577
.178
.262
2.955
.617
.394
.381
.382
0
.530
2.304
< ~ _dl %
Formula '
Funds
1.665
4.376
3.154
3.060
1.369
3.103
1.189
2.910
20.826
4.686
2.517
2.533
2.661
.000
2.731
15.128

-------
Reg. VI
AR
LA
NH
OK
TX
Reg. Total
Reg. VII
IA
KS
MO
NR
Reg. Total
Key. VIII
CO
MT
NO
SO
'JT
WY
Reg. Total
Popul at ion
St,ite
(1000)

2,296
4,308
1.328
3,!00
14,766
757/W

2,899
2,383
4,941
Tff,27J

-
793
658
686
1,518
-
3,655
%
.212
.398
.123
.287
1.366
TT556

.268
.220
.457
0
.945

0
.073
.061
.063
.140
0
.337
F a rms
State

57,000
37,500
13,500
71,000
185,000
1547(100"

117,000
76,000
117,000
Tio'.oW

-
24,000
38,000
37,000
12,900
-
111,900
%

.509
.335
.121
.634
1.651
•J.TB7I

1.044
.678
1.044
0
TJ66

0
.214
.339
.330
.115
.0
.998
F.jn;i Ac
Stat.?
(100U)

16,400
10,200
47,400
34,300
138,400
74T,701T

33,800
48.500
31,400
TfJ.ffio

-
62,100
41,700
44,500
12,300
-
160,600
r.
'i.

.18]
.113
.524
.379
1.531
7.V?8

.374
.536
.347
0
f.T57

0
.687
.461
.492
.136
0
1.776]
Post. Producers
State

52
146
19
b8
508
783

220
100
204
"52'4T

-
25
38
56
22
-
HI
*

.150
.422
.055
.168
1.468
"fT2~6I

.636
.289
.590
0
iTSlT

0
.072
.110
.162
.064
0
.408
Private Appl ic.
State
20,807
38,316
3,004
26,856
118,493
207,476

19,609
16,054
52,886
-
88,549

-
7,828
17.527
14.930
5,562
-
45,847
%

.215
.396
.031
.277
1.223
2.R?

.202
.166
.546
0
.914

0
'.081
.181
.154
.057
0
.473
Corrcn A
State

3,596
3,237
1,104
5,929
50,567
64,433

5,305
3,397
3,079
-
11,781

-
1,214
4.426
1,782
1,679
-
9,101
pile.
I

.220
.198
.067
.362
3.092
3.939

.324
.208
.188
0
.720

0
.074
.270
.109
.103
0
.556
X) «
> .ula
Funds

1.487
1.862
.921
-2.107
10.331
16.708

2.848
2.097
3.172
.000
T.I 17

.000
1.201
1.422
1.310
.615
.000
4.54^

-------



IX
AZ
CA
HI

NV


Reg. Total
LMJ. X
AK
II)


OR
WA
Reg. Total
National Totals
Populat
State
(1000)

2,794
24,196
981

845


28,816

-
959


2.651
4,217
7.827
216,266
ion
f


.258
2.238
.091

.078


2". 665"

0
.089


.245
.390
.724
20.003
Farms
State


7 , 200
80,000
4,300

2,900


94,400

-
24.000


36,000
39,000
99,000
2.240.587




.064
.714
.038

.026


.842

0
.214


.321
.348
.883
20.012
Farm Ac
State
(1000)

39,000
33.700
1.960

8,900


83,560

-
15,100


18,300
16,300
49,700
904,050
-r»;



.431
.3/3
.022

.098


.924

0
.167


.202
.180
.549
9.993
I'est. F
State


94
rt»6
37

29


1,046

-
45


92
139
276
6.921
•reducers
%


.272
2.560
.107

.084


3.023

0
.130


.266
.402
.798
20.001
Private
State


992
40.000
4,640

773


46,405

-
9.572


11.467
15.677
36,716
968.557
Applic.
I


.010
.413
.048

.008


.479

0
.099


.118
.162
.379
9.999
Coinm App
State


7,286
49,466
1,032

2,179


59.963

-
9,077


8.245
10.426
27,748
372.129
.lie. .



.446
3.024
.063

.133


3.666

0
.555


.504
.637
1.696
20.000
'al X
Formula '
Funds
i
1.481'
9.3^';
.369|

.427|


11.599

.000
1.254


1.656
2.111?
5.02^'
100.00:1
(45 States
plus DC & PR)

-------
                                        FfeB  24  t9S3
FT 03 State Certification  Breakout  - S  in Thousands
(Funds to support act f
\
Reojon I
Regional
Connecticut
Maine
Massachusetts
ftew Hampshire
Rhode Island
Vernont
TOTAL


P A rj i 3 r | J
Regional
New Jersey
ftew York;
Puerto Rico
Virgin Islands
TOTAL
Region 1 11
Regional
Delaware
01 strict of Columbia
Maryland
Pennsylvania
Virginia
Vfcst Virginia


3.3
11.5
u.a
12.4
in.fi
in.*
11.1
71.3



3.i
16.7
21.0
17.3
in. 2
76.7
/
4.6
10. *
10.5
16.7
22.6
19.8
ja.S
vities in FY 84)

Reqion IV
Regional
Alabama
Florida
feorgla
Kentucky
Mi ssisslppl
North Carol ina
South Carol 1na
Tennessee
-C7AL
^fc;on V
=eOonal
[1 1 inoi S
tnrli ana
Michigan
Minnesota
Ohio
W1 sconsln
TOTAL








..-
8.0
lfi.9
22.3
23.^
2
-------
                                                    FEB 24  !9SJ
                                    -2-
legion VI
Regional
Arkansas
Louisiana
riew Mexico
Oklahorj
Texas
TOTAL

    en VII
Iowa
 « - m A . •• «
 ' S , . -T •
(fed.  Program)
•»f\f«i
i j i ">.
                      13.3
                      22.1
                      11.5
                      19.5
                      18.2
                      ft*. 7
                       3.1
                      22.2
                      13.2
                      II. ~>
                      57.7
                     Region  X
                     Regional
                     Alaska
                     Idaho
                     Oregon
                     Washington
                                     2.4
                                    10.3
                                    11.1
                                    17.3
                                    11.7
Region VIII
Regional          ...2.8
Colorado
 (Fed. Program)
Montana          13.1
North Dakota     17.7
South Dakota     15.n
Utah             12.1
Wyoming (no fed. S
                                                TOTAL
                                                Reaicn !X
                                                                  50.7
                                                                  1.5
Ca'i'c.-r.ia        37.4
H>wa:i            11.3
Nevada (NO  
-------
TABLE OF CONTENTS

FIFRA COOPERATIVE AGREEMENT PROGRAM GUIDANCE


REQUIRED APPLICATION ELEMENTS
Ability to Implement the Program
State Certifying Statements
Authority to Conduct the Proposed Program
Authority to Accept Federal Funds
Designation of Lead Agency
Discussion of Performance
Enforcement Management Plan Development
Defining State Program Objectives
Setting Priorities
Enforcement Work Program
Act ion Plan
Nonfunded Priority Program
Proposed Budget
Enforcement Conditions of the Coonerative Agreement
Quality Assurance 5 Procedures
Case Preparation and Enforcement
State Records and Reports
solicitor Certification, and Training Management
Plan Devel opment
Defining State Program Objectives
Aoolicator Certification and Training Work Program
Action Plan
Program Budget
Applicator Certification and Training
Conditions of the Cooperative Agreement
State Reports
2
2
2
2
2
3
4
4
4
7
7
8
9
10
10
12
14
15
15
15
15
16
16
16

-------
          tPA APPLICATION AND AWARD PROCEDURES
Summary of EPA Role                                     18
  Headquarters responsi bi1 ity      '                     18
  Regional responsibility                               Id

Application Submission                                  19

Appl i cation Revi ew                                      19
  Techni ca1 and Program Review                          19
  Admin istrative Review                                 21
	PROGRAM MANAGEMENT AND ACCOUNTABILITY	

Accountability Under the Cooperative Agreement          22

Training                                                22

Regional Reporting                                      22

Program Evaluation                                      23
  Mid-year Evaluation                                   23
  End-of-year Evaluation                                24
  Evaluation Report  ,                                   24

Modification, Suspension, or Termination                24


Appendices:  I through  XV

-------
                       Introducti on


Section 23 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizes, the U.S. Environmental Protection Agency to enter
into cooperative agreements with the States and Indian...Tribes
for pesticides enforcement and for applicator certification and
training.  Regulations governing financial assistance to parti-
cipants in the cooperative pesticides enforcement and applicator
certification and training programs are found at 40 CFR Part
35.001 to 35.605.  This guidance document, developed by the
Compliance Monitoring Staff (CMS) of the Office of Pesticides
and Toxic Substances (OPTS),  supplements those regulations by
setting forth in detail the required elements of cooperative
agreement applications, the process of awarding financial  assist-
ance and requirements for program management.

Financial assistance in the form of cooperative agreements for the
pesticides enforcement program is designed to support (a)  improved
coordination of a cooperative Federa1/State pesticides enforcement
program, (b) more efficient allocation of resources through
improved planning and management, and (c) program review and
evaluation.   The program which a State conducts under the  cooper-
ative agreement should provide for pesticides enforcement  that
satisfies both State and Federal pesticide laws.  Areas  of mutual
pesticides enforcement include use/misuse investigations,  producer
establishment inspections, experimental  use permit inspections,
Tarketplace inspections, restricted use pesticide surveillance,
and applicator certification  enforcement inspections.

Financial assistance ir, the form of cooperative agreements for
the pesticide applicator certification and training program is
d e s i gned to support  fTl the pesticide applicator cert i f i c a t i o n
and training program, (b.) more efficient allocation of resources
through improved program planning and management and (c) improved
program review and evaluation.  The program conducted by the
State should provide pesticide applicator certification  and
training to all persons who wish to use restricted use pesticides.
State work programs  conducted under the cooperative agreement
will include an estimate of ,the number of applicators to be
certified or recertified b/' the State, the number of training
sessions to be monitored and  the number or frequency of  .the
certification test ing sessions.

In FY84 States are encouraged to consolidate their pesticides
enforcement and applicator certification and training cooperative
agreement applications.  The  consolidated cooperative agreement
process is voluntary.  A State which chooses to follow this process
may develop a single application for separate financial  assistance
programs that are administered by the same agency within the
State.  Consolidating cooperative agreement applications does
not alter existing statutory  requirements governing eligibility,
matching funds or maintainence of effort.  Consolidating coopera-
tive agreement applications does eliminate, duplicating similar
procedures in each individual  assistance application.  The single
consolidated application will  reduce excessive paperwork and
administrative costs.

-------
                   REQUIRED  APPLICATION  ELEMENTS
 The  formal  application  for  assistance  will consist of an
 "Application  for  Federal Assistance",  EPA Form No. 5700-33,
 and  shall  include  all elements outlined  in this section.   This
 form contains  a  section  entitled  "Part  IV Narrative Statement"
 which  the  new  40  CFR  Part 35.130  simplifies and replaces.

 In addition to meeting  the  requirements  contained in 40 CFR
.Part 30, a  complete assistance application must contain the
 fol 1 owi ng  elements:

   -   o  Ability to  Implement the Program  including certifying
        statements  that  the  State  program is consistent with
        EPA-approved strategies and  there are no impediments to
        the  State's ability  to carry out  the program; designation
        of  a lead  agency; and a discussion of the State's per-
        formance  to date  under the existing award.

      o  State Program  Management Plan detailing a list of program
        ODjectives  and priorities; and  a  description of the process
        through which  the State identifies priorities.

      o  Work Program specifying the  work years and amount and
        source  of  funding estimated  to  be needed for each program
        element including any outputs required; a schedule  for
        accomplishment of outputs; and  an identification of the
        agency  responsible for each  of  the elements and outputs.

      o  Conditions  of  the Cooperative Agreement containing  a
        statement that the State agrees toToTTow the quality
        assurance,  and case preparation and enforcement or
        certification  and training requirements.

-------
                               -2-


Ability to Implement the Program ""
State Certifying Statements
Each applicant must certify that there are no impediments to the
State's ability to carry out its proposed program or programs.
Applicants with continuing cooperative agreement programs are
not required to annually certify their ability to carry out the
proposed programs unless one or more of the areas described below
has changed.  The applicant should address the areas described
below as well as any others which might pose problems.

Authority to Conduct the Proposed Program	

A State must have enacted legislation which empowers it to:

     o Enter into a cooperative agreement with EPA, and

     o Conduct specific activities proposed under the
       cooperative agreement or consolidated agreement.

Authority to Accept Federal Funds	'

A State which can only implement a program under a cooperative
agreement with prior authorization by its legislature to spend
Federal funds must include a statement indicating the date on
which such authorization will  be obtained.  Commitment of EPA
funds will be contingent upon  such authorization by the State
legislature.

Designation of Lead Agency	

Although several  State agencies may be responsible for regulating
various aspects of pesticide manufacture,  handling, and use,  EPA
will  enter into only one cooperative agreement with a State
for pesticide enforcement and  only one cooperative agreement  for
pesticide applicator certification and training.

The Governor of the State, through a letter to the Regional
office, should designate a separate lead  agency  which will  be
responsible for each of the cooperative agreement programs or
a single lead Agency responsible for both  programs under a
consolidated agreement.  The designated lead  agency(ies)  must
have the authority to  enter into contracts or interagency -agree-
ments with other agencies for  the performance of all  necessary
activities.

-------
                               -3-
Discussion of Performance
Each State 1s required to provide a discussion of progress under
its current cooperative agreement.   In this  di scussi on ,• the State
shall examine the appropriateness of its  established  priorities
as well as the quality and effectiveness  of  its compliance moni-
toring and enforcement activities.   For the  applicator  certifi-
cation and training program,  the State shall  disucss  the number
of training programs in which the State participated;  the
number of training sessions  monitored; the  number of  individuals
examined for certification,  for recertification;  the  number of
certification sessions conducted, recertification sessions
conducted; and any changes made to  training  materials.

-------
                              -4-
 Enforcement  Management  Plan Development
 0 e f i n i ng  State  Prog ram Objectives
 Each  State  should  define objectives which support the achievement
 of  the  national  priorities, adjusted for the particular needs of
 the State.   Identification of  specific  State pesticide problem
 areas  is  central to the task of developing the  State objectives
 (see  Priority  Setting, below).

 State  objectives may  include management oriented objectives such
 as  improving planning of the enforcement program, achieving
 greater compliance through increased compliance monitoring  in
 certain areas  or improving the quality  or availability of
 compliance  information.

 Priority  Setti ng	

 To  attain its  objectivr.s; the  State should establish enforcement
 priorities  that  permit L."se most efficient use of resources  and
 personnel.   The  priority setting process will enable a State to
 concentrate  its  training, compliance monitoring, and enforcement
 programs  on  specific  pesticide manufacturing, distribution, and
 use activities which  pose a risk to health or the environment.

 Use or  Product Related Priorities
As  part  of the process of setting general objectives for its
pesticides enforcement program, the State should identify specific
problem  areas related to pesticide use, production, distribution
and disposal.  To identify priority pesticide problems, the
State  should develop a mechanism which analyzes information from
.a variety of sources.  The result of the State's analysis should
be  a  list of specific pesticide problems in the State.  Following
is  a  discussion of basic elements which should be involved in
the priority setting process.

Review of Information Sources

In  establishing priorities, the States should consult as many
information sources as are reasonably accessible.   The most
accessible Information source is likely to be a State's enforcement
and complaint files.  These records should indicate trends In
certain  use and non-use violations, and recurrence of violations
involving specific pesticide producing or distribution establish-
ments, pesticides or practices, as well as potential  associations
between  a pesticide or application practice and nealth or
environmental incidents.

-------
                                -5-


 Infornation  related  to  potential  areas of priority  concern  would
 be  found  in  State  records  on  local  pesticide  production  and  dis-
  •i but ion  establishments,  or  pesticides and pesticide  practices
  ommonly  used  in  the  State.   The  State may wish  to  consider
 information  concerning  chemicals  which pose more  serious  health
 and  environmental  risks  such  as restricted use pesticides,  emer-
 gency  or  experimental use  pesticides, and special  local  use
 registrations  as  well as application methods  most  likely  to
 result  in  harm if  improperly  carried out.

 Finally,  the State should  identify  and consider  the  concerns  of
 persons in the State  who may  be exposed to pesticides  or  otherwise
 affected  by  the pesticides enforcement program.   The EPA  considers
 a State effort to  gain  public participation in the  planning
 process to be  an  important element  of the .program.   Each  State
 may  use a  variety  of  means to identify the concerns  of the  public
 and  involve  them  in  the  State planning process.   The States,  in
.formulating  their  policy,  may wish  to use EPA's  Public Participa-
 tion Policy, January  19, 1981,  46 Fed. Reg. 5736,  as a guide.

 Establishing Priority Setting Criteria

 Since  States may  have a  large body  of information  to review  and
 analyze,  each  State  should develop  a set of criteria for  use  in.
 ranking problem areas.   For use-related problems,  these  criteria
 nay  reflect  such  factors as the degree of actual  or  potential
 harm to health or  the environment and the degree  of  public  concern.
  'r  product/facility  related  problems, violation  history  and.
  equency  of past  establishment inspections may  be  pertinent
 criteria.

 Ranking of Specific  Problems

 Once the  information  has been reviewed and criteria  have  been
 established  for setting  priorities, each State shoul'd  develop
 its  list  of  priority  problems.  Using the selected  criteria,  the
 State  can  develop  a  hierarchy of  areas of priority  concern.   The
 level  of  priority  will  provide  a  basis for the allocation of
 resources  in the  State's Action Plan.

 The  above  mentioned  elements  are  general guidelines  to be followed
 by  the  States  in  developing priorities. .-The  Compliance Monitoring
 Staff  (CMS)  of the Office  of  Pesticides and Toxic  Substances
 (OPTS)  has also developed  documents outlining a  step by step
 approach  for setting  use and  product/facility related  priorities.
 (See Appendix  I and  addendum) Each  State is free  to  follow these
 models, to modify  them,  or to establish its own  similarly objective
 priority  setting  methodology.

-------
                              -6-


In any case, however, the State should include in its application
not only a listing of its general program objectives and specific
areas of priority concern, but also a discussion of the methodology
used to develop' and rank its priorities.   All  State priorities
should be as specific as possible, but must either be'placed into
one of the following (fixed) broad types  of pesticides problem
areas under each activity for use-related priorities (See also
Appendix I  p.29) or one of the 5 broad types  of pesticide problems
areas under each activity for product;/faci 1 i ty-rel ated priorities
(See also Addendum to Appendix I).

Use-related Priorities

Home/Yard Incidents                  ;
     - Involving PCO1s
     - Involving homeowner's personal use of  pesticides
Other Urban Incidents
Agricultural Incidents
     - Involving Aerial  Application
     - Involving Ground  Application
     - Not Involving Application
;lon-Urban, Right-of-Way  Incidents
     - Involving Aerial  Application  :
     - Involving Ground  Application
Woodland Incidents
Incidents at Other Sites

Product/Facility-related Priorities

Violators within the State
Establishments not visited within the State
Inspected Establishments with no  violations detected
Others (from Action Plan activity categories)
Educational  Activity

-------
                            -7-


Enforcement Work Program
.'he Work Program must specify the workyears and the source of
funding for each program element, including any outputs and an
identification of the agency responsible for each of the elements
and outputs. (40 CFR Part 35.130)

Acti on Plan	

Once  the State has developed its list of priorities for both use-
related and product/facility-related priorities, it "should describe
its plan for carrying out a balanced program that addresses each
of these areas during the agreement period.  Outputs the State
proposes to accomplish during the agreement period mu st be ai med
primarily at solving and dealing with pesticide problems identified
by the priority settinq process.  However,  the plan may also
include any other activities not identified by priority setting
such  as responding to non-priority complaints provided these
activities  relate to violations of FIFRA.

A pesticides enforcement program that consists of elements from
both  State  pesticide statutes and FIFRA should contain outputs
for the activity categories which are defined as follows:

Use/Misuse  Inspection is a FIFRA or State  inspection.  FIFRA
use/misuse  inspections are conducted to discover violations
'escribed in FIFRA Sections 12(a)(2)(F,& G).  State use/misuse
 nspections would be conducted under State  statutes.  A State  or
Federal use inspection is an inspection identified under a neutral
or routine  inspection scheme to monitor or  observe the use of
pesticides.  A State .of Federal mi suse inspection is an inspection
identified  as  a "for.cause" inspection such as a follow-up to  a
complaint,  referral  or tip.

Monitoring  the Certification Program is a  FIFRA or State
T)inspection  at pesticide dealers to determine if Restricted
Use Pesticides are being sold in violation  of FIFRA Section
12(a)(2)(F) or State statute; 2) Inspection of applicators
to determine if they are properly licensed  and maintaining
records.

Producer Establishment Inspection is a FIFRA inspection of an
establishment  where  pesticides or devices  are held for distri-
bution or sale for the purpose of inspecting and obtaining
samples.  While conducting pesticide producer establishment
inspections States should review product labels for compliance
with  the Label  Improvement Program (LIP).   The Office of Pesti-
cide  Programs  (OPP)  has issued guidelines  for the upgrading of
pesticide product labels for several classes of pesticides as
well  as replacing or modifying certain labeling requirements.
(See  Appendix  XI) The States should also inspect pesticide pro-
ducts that  are subject to the Child Resistant Packaging (CRP)

-------
                               -8-


regulatlons issued by OPP.l  CRP inspections should be conducted
in accordance with enforcement strategy (See Appendix XII) and
the inspection guidelines previously issued by CMS.^

Marketplace Inspection is a FIFRA or State inspection at the
retail sale, distribution or wholesale level for determination
of product registration, labeling violations,  or product decom-
position.  Marketplace inspection samples  must b:e samples of
unregistered products, products with violative labeling, pro-
ducts subject to decomposition, or products unavailable at
producer establishment inspections.   States should give market-
place inspections a low level of priority  unless product violation
rates and compliance ratios show that such inspections will
prevent significant harm.                       '

Other Inspection is a FIFRA or State inspection.  Under FIFRA
this would include custom blender and import inspections,
section 18 and 24(c) inspections etc.  Under the State program,
this might include bulk tank sampling at  repackaging establish-
ments, inspection of the calibration of application equipment,
etc.

Experimental Use Inspection is a FIFRA or  State 'inspection to
monitor experimental use permits.  Samples should only be
collected if a violation is suspected.  Inspections must be
conducted on site; telephone inspections  or mon i.tor i n gs will not.
be credited under the cooperative
agreement.

Educational Activity is a State outreach  or related activity
directed towards educating or providing additional  informa-
tion to consumers of pesticides or pesticide services designed
to increase compliance with State pesticide laws and FIFRA.

Npnfunded Priority Program	
The Agency is aware that not all  States'  pesticide  priority
problems are addressed in the Federal  cooperative  agreement.
Some States' current pesticide programs  may  already  address
pesticide problems identified through  priority  setting.   In
such cases, States are requested  to provide  this  information  as
a supplement to their cooperative agreement  applications  so  that
EPA will have a complete picture  of how  a  State is  addressing
all its pesticide problems.  'This will  aid the  Regions  in
evaluating the State's application.
1 40 CFR Part  162.16Final  Rule for Child  Resistant  Packaging,
  March 19,  1979,  FR  Notice  pages  13019  through  13024.
2 CRP Inspection  Guidelines  issued  by  A.  E.  Conroy  II,  dated
  March 29,  1982.

-------
                               -9-


Proposed Budget          	
Each application must contain the State's proposed budget for
the program.  Expenditures for personnel, fringe benefrts,  travel,
equipment, and supplies must be supported by itemized statements
or fact sheets detailing their necessity.

When funding activities under this agreement,  EPA will  give
priority to ongoing operating expenses that are directly related
to the enforcement of pesticide law, e.g.,  inspections,  invest-
igations, sample analyses, and travel.

EPA's share of the "total  project cost" should not exceed 85» of
the total award.  The State's share may be  paid in direct or
allowable indirect or in-kind contributions.

The application must also  contain a summary of work  hours or
work years devoted to each of the following activity categories:
Administration, Supervisory, Inspectional (non-priority  and
priority, broken down by specific use-related  and product/faci1ity^
related activities as identified under priority setting  for the
State), Analytical, Analytical Support, Clerical and Legal.

-------
                              -10-


Enforcement Conditions of the Cooperative Agreement


Pesticides enforcement cooperative agreement awards are subject
to the regulations found at 40 CFR Part 35.001 through 35.605,
entitled "State and Local Assistance",  as well as the "EPA General
Grant Regulations and Procedures" (40 CFR Part 30).  In addition,
the applicant must agree to the conditions described below before
obtaining an award.

Quality Assurance & Procedures	

Quality Assurance Plan	
For FY84 States are required by the EPA Grants Administration
Division (GAD) to include quality assurance plans for analytical
laboratories under the cooperative agreement:  All  analytical
laboratories involved in environmental  monitoring must have
submitted a quality assurance plan within 90 days of award of the
FY84 cooperative agreements.  To assist States in complying with
this requirement, CMS has developed model quality assurance
guidelines.  The States may use these guidelines or develop
their own.  Each Region has an individual assigned  as quality
assurance officer and that person will  be available to assist"
the State in development of a quality assurance program.
(see Appendi x XIII)

FIF-vA Forms and Procedures.  During all inspections and sample
collections performed under the authority of FIFRA, inspectors
shall use standard forms and procedures as outlined in the EPA
Pesticides Inspection Manual.  To assure sample integrity, EPA
chain-of-custody procedures shall be adopted during sampling,
handling, shipping, storage, and analysis of pesticides collected
under Federal law.

State Forms and Procedures.  During all inspections, observations,
and sample collections performed under  authority of State law,
State procedures and forms should be used.  During  sampling,'
handling, shipping, storage and analysis of pesticides collected
under State law, State chain-of-custody procedures  should be
fol1 owed.

Referral and Inspection Procedures under FIFRA 526.  Under the
Final Interpretive Rule governing FIFRA Sections 26 and 27 (40
CFR Part 173), EPA and each State will  annually define significant
cases to be tracked by EPA after referral to the State.
(FIFRA State Primary Enforcement Responsibilities,  Final  Inter-
pretive Rule, January 5, 1983, 48 FR Notice pages 404-411)

After EPA formally refers a significant case to a State,  the Agency
will contact the State to learn the results of the  investigation.
The Region should determine whether the State has conducted an
adequate investigation.  An investigation should be considered
adequate if the State has 1) followed proper sampling and other
evidence gathering techniques, 2)responded expeditiously  to the

-------
                               -11-

referral, and 3)documented all inculpatory or exculpatory events
or information.   If the Region cannot negotiate an adequate
  "vestigation with the State, the Region may pursue its own
  vestigation after notice to the State.  That notice should
summarize the facts relating to the State investigation, discuss
the reasons for EPA's determination that the action is inadequate,
and state that the EPA will initiate its own investigation.

Analyti cal Methods.  Pesticide samples collected shall be analyzed
by the State1aboratory, or other laboratories specified in the
agreement, using the EPA Manual of Chemical Methods for Pesticides,
Association Of Analytical Chemists (AOAC), The State laboratory
may use the Collaborative International Pesticides Analytical
Council Limited (CIPAC) Handbook, the FDA Pesticide Analytical
Manual (PAM), or other approved analytical methods for sample
analysis.  All violative samples shall be verified by a check
analysis performed by a second chemist.

Cross Contamination Screening.  States shall establish a cross
contamination screening program in accordance with EPA Cross
Contamination Guidelines. (See revised Appendix III.)

Check Sample. The  State shall participate in the EPA (NEIC)
Chec'< Sample Program.  Under this program, EPA submits known
pesticide samples  to State laboratories for analysis and cross
contamination screening.  The States will submit a report
indicating the methodology used and results of the analysis to
^°A.  EPA will review the report and inform the States regarding
  * accuracy of their analysis and the methodology selected.  If
- State failed to  obtain the correct results, EPA will assess
the problem and provide assistance to the State laboratory, if
requested*. This program also assists in determining if the States
are screening pesticides for cross contamination,  since the
check sample may be contaminated with another pesticide.

Check Analysis Procedure.  The State shall participate in the
Sample Check Analysis Procedure.  A check analysis is a second
analysis of a sample originally analyzed by a State laboratory.
It i s usually done when:

    o  A State which is unsure of the results of an analysis
       requests an impartial  or second analysis before
       initiating  an enforcement action.

    o  A State requests that EPA take the enforcement action
       and EPA desires to check the State's analysis.

Samples in these instances would be sent to either another State
laboratory or EPA  for a check analysis.

Training of Analytical Chemists.  EPA will provide knowledgeable
personnelfor the  training of analytical chemists.  The States
should avail themselves of EPA courses offering training to
  ^mists on proper analytical procedures, instrumentation, and
  , hodology.  Personnel from EPA are available, if requested, to
"review State laboratories and discuss areas of improvement.

-------
                               -12-
States are also encouraged to participate on their own in profes-
sional association  meetings such  as those held by AO'AC,  as well
as other professional  training courses.

Provision of Analysis  Results.  The State shall  send a copy of
the results of anysample.analysis  made  under the authority of
FIFRA to the person from whom the sample was collected.

Submission/Retentionof  Reports.   Copies of all  inspectional and
analyti cal reports  shal1  be retained by  the State for examination
by EPA or forwarded to the Regional office.

Training of Case Preparation Officers and Inspectors.  EPA will
provide  for the training of State case preparation officers,
attorneys and inspectors.

Special  Projects.   The EPA/National Environmental Investigation
Center (N EIC) will  provide, on a  limited basis,  investigation
and laboratory support for special  State pesticide problems
s u c h a s :

     o  Af f i riTiat'l .3 compliance monitoring of major pesticide
        spray programs;  and

     o  Response to pesticide incidents  for which States  did
        not include resources in  the cooperative agreement
        appli cati on .2

Case Preparation and Enforcement	'

The State shall review the quality  and adequacy  of evidence
gathered in the course of  all investigatory activities performed
under the cooperative  agreement.   For misuse cases,  the  States
could establish a  committee to review inspectors' findings and
determine if any violations of State or  Federal  law  exist.  This
committee would provide  the States  with  an objective enforcement
framework for all  misuse cases.

State Cases
The State must review the quality and sufficiency of evidence
gathered in the course of all  investigative activities performed
under the cooperative agreement.

If the evidence reveals  a violation  of only the State's  pesticide
laws, the State shall pursue an  appropriate remedy provided by
State law.
   All  special  projects  assistance requests  shall  be submitted
   to the appropriate Regional  Office  as  soon  as  the State
   determines  a need for such  assistance.   EPA Headquarters  in
   conjunction  with  the  Regions  will  evaluate  each  request based
   on the seriousness of the problem  and  the amount of  EPA resources
   avai1 able.

-------
                             •13-


If evidence reveals a violation of both State and Federal  law,
the state may bring appropriate enforcement  action under State
law or refer the case to EPA for action under FIFRA.   In the event
that a case is referred to EPA for action,  the Agency-case
preparation officer should review the case  file to ensure  that
the State inspection procedures adhere to  basic constitutional
guarantees.  If the State evidence gathered  by State  inspectors
was legally obtained and is within the scope of admissible evidence,
EPA should proceed with the case.

Since States with cooperative agreements  have primary enforcement
responsibility for pesticide use violations, the Regions and States
should follow the Final  Interpretive Rule  governing Sections 26
and 27.(48FR pages 404-411, January 5, 1983)

Under the Final Interpretive Rule [governing FIFRA Sections 26 and
27 (40 CFR Part 173)],  EPA and each State  will  annually  define
significant cases to be tracked by EPA after referral to the State.

The State must commence appropriate enforcement action for cases
tracked under the Interpretive Rule within  30 days after completion
of the investigation.  The Region may, after negotiation with
the State, extend this  period if required  by the procedural
characteristics of the  State's regulatory  structure.

If the Region determines that the State's  intended enforcement
response to the violation is inappropriate,  EPA should first
attempt to negotiate an appropriate State  enforcement response.
If a State is unwilling or unable to alter  its  original  enforce-
ment response, EPA may  bring its own action  after notice to the
State.  That notice should summarize the  facts  relating  to the
State's enforcement response, discuss reasons for EPA's  determin-*"
ation that the enforcement action is inadequate and state  that
EPA will initiate its own enforcement action.  (See the  Final
Interpretive Rule governing Sections 26 and  27, 48FR  pages 404-411,
January 5, 1983, Section 58 for criteria)   Regional  attorneys
should not, however, initiate an enforcement action sooner than
30 days after the matter was referred to  the State.

For all pesticide cases, if a State feels  that  the most  appropriate
enforcement action is not available under  State law,  it  may
refer the case to EPA for enforcement under  FIFRA.

Federal Cases
Where evidence reveals a possible  violation  of  Federal  law  only,
the State shall  immediately forward  the  information  to  the  EPA
Regional office  and prepare testimony  and  provide  witnesses  as
necessary.

-------
                               -14-


State Records and Reports	
Semi-Annual Reports
The State should submit semi-annual  reports  to the Regional  Office
within 15 working days after the end of the  second and  fourth
quarters.  Each report should compare actual  accomplishments
with the projections as specified in the cooperative agreement.

Records of Enforcement Actions	

The State should maintain records regarding  enforcement  actions.
These records should include the type of violation,  who  was
involved (e.g. applicator,  producer, homeowner),  certification
status of the applicator, name of the pesticide,  application
site and method, compliance history  of the violator, and the
type of enforcement  action  taken.  This information  will be
used in developing the State's future enforcement priorities.

EPA Report of Enforcement Actions

EPA shall furnish the State with copies of all enforcement  actions
taken as a result of inspections conducted by the State  and  -
referred to EPA for  action.  This information will be  useful to
the State in future  priority setting.

-------
                               -15-


Applicator Certification and Training Management Plan Development


Defining State Program Objectives	

The States should define objectives which support the achievement
of the national goal of training applicators in the safe handling
and use of pesticides, especially restricted use pesticides.
State objectives may include management oriented objectives such
as: 1) improving planning of the certification program; and 2)
recommending areas of additional  training because of use problems
encountered through the pesticides enforcement cooperative agree-
ment or to provide applicators with information regarding the
impact of other Federal statutes on applicators.

Applicator Certification and Training Work Program	


The work program must specify the work years and amount and
source of funding estimated to be needed for each program element
including any outputs required, a schedule for accomplishment of
outputs and an identification of the agency responsible for each
of the elements and outputs (40 CFR Part 35.130).

Action Plan	

Once the State' has identified its program objectives, it must
describe its plan for carrying out a balanced program that addresses
each of the program objectives under the agreement.

A pesticide applicator certification and training program that
meets the requirements of both State pesticide statutes and
FIFRA should contain at least the following elements/outputs.

     o Number of training sessions in which the State will
       part i ci pate. 4
     o Number of training sessions which the State will  monitor.
     o Number of individuals to be examined for certification.
     o Number of applicators to be examined for recertification.
     o Number of certification sessions the State will  conduct.
     o Number of recertification  sessions the State  will conduct.
     o Any changes the State will make to training materials.
  EPA Regi on VI I  has developed a training slide and tape  presentation
  on how disposal  of pesticide wastes  and used  pesticide  containers
  by applicators  is regulated under the Resource Conservation  and
  Recovery  Act (RCRA).  This presentation can  be obtained for  State
  training  sessions by contacting Roger Gold,  Ph.d.,  University  of
 •Nebraska, Institute of Agriculture and Natural Resources,  101  Former
  Vet Science Building,  East Campus, Lincoln,  Nebraska   68583.

  Additional training slide and tape presentations  can  be obtained
  for State training sessions by contacting Dr. James  Parochetti,
  Program Leader  -- Pesticides, Applicator Training and  Weed  Science,
  U. S. Department of Agriculture, Extension Service,  Washington,
  D. C.  20250

-------
                               -16-


These outputs should be listed separately for private applicators
and for commercial applicators.  For commercial applicators, the
outputs should be broken down by certification category as well.

Proposed Budget	

Each application must contain the State's proposed budget for
the program.  Expenditures for personnel, fringe benefits, travel,
equipment, and supplies must be supported by itemized statements
or fact sheets detailing their necessity.

The EPA's share of the "total project cost" shall  not exceed,'
50% of the total award.  The State's share may be  paid in direct
or allowable indirect or in-kind contributions.
Applicator Certification and Training
Conditions of the Cooperative '
 _   ._.-.-  ^
ive  Agreement
Pesticide applicator certification and training cooperative
agreement awards are subject to the regulations found at ".0 CFR
Part 35.001 through 35.605, entitled State and Local  Assistance,
as will as the EPA General  Grant -Regulations and Procedu-cs (40
CFR Part 30).  In addition  the applicant must agree to the
conditions described below  before obtaining an award.

State Reports	

The States will submit a semi-annual report corresponding to
the project and budget period of the cooperative agreement.
This semi-annual report must be submitted within 30 days after
the end of the second and fourth quarters of the Cooperative
Agreement outputs and will  include:

     1. The total number of applicators, private and  commercial,
        by category, currently certified.
     2. The number of applicators, private and commercial, by
        category, certified during the last reporting period.
     3. The number of applicators, private and commercial, by
        category, recertified during the last reporting period.

The States are required to  submit an annual report  corresponding
to the project and budget period of the cooperative agreement.
This annual report for both the State plan and Cooperative
Agreement outputs will include:

     1. The total number of applicators, private and  commercial,
        by category, currently certified.
     2. The number of applicators, private and commercial, by
        category, certified during the last reporting period.
     3. The number of applicators, private and commercial, by
        category, recertified during the last reporting period.
     4. Any changes in commercial applicator subcategories.
  Certification and Training Program Directive #81-2 issued  by
  A. E. Conrov II,  dated 9-10-81.

-------
                               -17-
        A summary of enforcement activities related to use of
        restricted use pesticides during the last reporting period
        Any significant proposed changes in required standards  of
        competency.
        Proposed changes in plans and procedures  for enforcement
        activities related to use of restricted use pesticides  for
        the next reporting period.
        Any other proposed changes from the State plan that would
        significantly affect the State certification program.^
The States nay combine the Annual  FIFRA  §4 State
and the final report of outputs accomplished und
agreement, since the first three reported  items  under th
Plan annual report are identical to the  outputs  reported
the cooperative agreement.
  Plan report
der the cooperative
 under the State
          under

-------
                               -18-
           EPA APPLICATION AND AWARD PROCEDURES
Summary of EPA Role
EPA Headquarters has the primary responsibility for:

     o Developing national  priorities  and strategies  for
       the pesticides enforcement program and applicator
       certification and training program;
     o Preparing guidance for implementing  and managing
       the programs;
     o Making funds available to the Regions for
       disbursement to the  States;
     o Providing a special  review of applications
       upon written request from the Regional offices;  and
     o Developing laboratory support for State personnel.

EPA  Regi onal Offi ces have  primary  responsibility  for:

     o Providing applicants with annual  guidance and
       application criteria to be used  in awarding
       cooperative agreements;
     o Notifying eligible State agencies of the availability
       of funds ;
     o Working closely with the States  to develop  a •
       complementary Federal/State  program  which considers
       State as  well as  EPA priorities  and  resources;
     o Negotiating outputs  with applicants;
     o Reviewing and approving applications;
     o Developing training  for State personnel; and
     o Conducting Mid-year  and End-of-year.program
       evaluatlons.

Each participating Region should establish  a cooperative agreement
Review Panel to  review and  evaluate all  pesticides enforcement  and
applicator certification and training  cooperative  agreement
applications.  This panel  should consist of at least  one member
from each of the following  offices:

          o Regional Air and Waste  Management Division/or
            Waste Management Division
          o Regional Grants Administration  Office, and
          o CMS  (Grants  and Evaluation  Group).

-------
                               -19-


AppHcatlon Submission
To apply for a cooperative agreement under FIFRA, a State must
submit an'"Application for Federal  Assistance", EPA Form No.
5700-33 complete with all  elements  required by the guidance.
(See Appendix V)

Applications must be submitted at least 60 days prior to the
beginning of the budget period.  (40 CFR Part 35.140)

Application Review	


The Regional Administrator will review each completed cooperative
agreement application and  should approve,  conditionally approve,
or disapprove the application within 60 days of receipt. (40 CFR
Part 35.141)

The Agency  will  allocate funding for cooperative agreements on
the basis of the appropriateness of the State's program plan
when compared to the criteria set forth in the Required Application
Elements section of this guidance and the  State and Local Assistance
regulations. (40 CFR Part  35.001 through 35.605)

Each application will be subject to two reviews:

          o Technical and  Program Review;  and
          o Administrative Review.

Technical and Program Review	

A technical and  program review will be made by the Cooperative
Agreement Review Panel to  determine the merit of the proposed
outputs in  view  of the objectives and priorities of the cooperative
pesticides  enforcement program and  applicator certification and
training program.  For the pesticides enforcement cooperative
agreement applications, CMS has developed  a form for use by the
review panel in  determining answers to basic evaluation questions.
(See Appendi x VI.)

CMS has also developed Output Time  Factors for use in evaluating
pesticides  enforcement cooperative  agreement applications for
financial assistance.  The following time  factors were obtained
by averaging figures submitted to CMS by the States:

                                                  Work Hours to
          Acti vi ty     '                         Complete Acti vi ty

          Agricultural Use Inspection                   20
          Non-agricultural Use Inspection                20
          Experimental Use Inspection                   15
          Producer Establishment Inspection             15
          Marketplace Inspection ,                        5

-------
                               -20-


                                                  Work Hours to
          Act i vi ty                              Complete Activi ty
          Import Tnspecti on                             10
          Dealer Record Inspection                       5
          Applicator License and Record Inspection       5
          Sample Collection and Preparation               5
          Sample Analysis  (Formulation and Residue)      11

These figures take into account all inspectional  or  analytical
time spent to complete an  activity, including supervisory time,
travel  time, document preparation, sample shipment,  etc.  The
work hours given also include the prorated time for  administrative
activities of inspectors and chemists.  Additional time for
administrative, case preparation, legal, clerical, and program
planning activities time may be charged if the State can show
that such activities are prerequisites to conducting the program.

The Regional office should compare each State's proposed outputs
and the personnel  requested in the pesticides enforcement cooper-
ative agreement application with the work years computed by
using the output time factors amounts shown  above.  The purpose
of these romyutations is to determine if the State's requested
work hour levels (or work  years) for inspectional  and  analytical
outputs are consistent with the work hours computed  for each
activity using  the above output time factors.  An  Output Time
Factors Computations Worksheet has been developed  to assist the
Regions in this comparison.  (See Appendix VII.)

 he Regions should use these time factors as a guide in negotiating
and evaluating  pesticides  enforcement cooperative  agreement
applications.  The number  of inspections, samples, and analyses
multiplied by the  appropriate time factors should  equal the
approximate number of work hours which each  State  requested to
complete the projected outputs under the cooperative agreement.
To ensure equal treatment  of all States, CMS has  identified a
normal  work year as consisting of 1800 hours after allowing for
1 eave and hoii days .

Deviations from these time factors can be expected due to differ-
ences.in travel time, local  procedures, etc.  However, the Regions
should  not permit  work hours grossly in excess of  these computed
levels.  Significant differences between the amount  requested
and the amount  computed must be justified, e.g., the need for
extensive travel time.  If an applicant's commitments  are in
excess  of those indicated  by the computations, the Regional
Office  must assure itself  that the quality of work is  not  suf-
fering  at the expense of the quantity of outputs.

The Review Panel will evaluate both pesticides enforcement and
applicator certification and training cooperative  agreement
applications to determine  whether:

-------
                               -21-
     o The application contains all  elements outlined in
       the Required Application Elements section of this
       gui dance;
     o The applicant's priority-setting process is adequate;
       (for pesticides enforcement agreements only)
     o The outputs are appropriate based on the priorities
       or objectives set by the State;
     o The applicant's objectives and expected results are
       consistent and compatible with EPA priorities
       and policies; and
     o It is feasibile to achieve such  objectives  in view of
       the State's existing problems, program authority, and
       resources.

Administrative Review	

The Regional Grants Administration Office will perform an
administrative evaluation to determine  whether the application
meets the requirements of the EPA General Grant Regulations  (40
CFR Part 30) and  regulations for State  and Local Assistance  (40
CFR Part 35.001 through 35.605 Appendix VIII).  At each stage  of
the evaluation, the State may be required to provide further
information or to amend the application to satisfy the concerns
of the Agency.

-------
                               -22-
              •PROGRAM MANAGEMENT AND ACCOUNTABILITY
After award of the cooperative agreements,  both States and the
Regions will have program management responsibilities  in the
areas of accountability, training,  reporting,  evaluation and
agreement modification.

Accountability under the Cooperat1ve Agreement


States must maintain accounting records for funds awarded under
each agreement (including receipts,•State matching contributions,
and expenditures) in accordance with all  applicable EPA grant
regulations and with generally accepted accounting principles.
Headquarters suggests that the Regional Grants Administration
Office review State accounting practices  and procedures prior to
award of funding to assure t;,e State's ability to maintain
appropriate records.

State expenditures under the agreement must follow cost categories
(i.e., budget line item or program  elements) established in the
original agreement.  Deviations may be made by the State from the
proposed budget as long as they are in accordance with the general
grant regulations or approved by the EPA  Regional project officer.

Training


Training under