Compliance Regulations and Guidance Affecting your Industry

This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.

This guidance addresses new and abbreviated new (human and veterinary) drug application products and specified biologics regulated by CDER and CVM as well as nonapplication drug products. Within this scope, the guidance is applicable to all manufacturers of drug substances, drug products, and specified biologics (including intermediate and drug product components) over the life cycle of the products (references to 21 CFR part 211 are merely examples of related regulation). Within the context of this guidance, the term manufacturers includes human drug, veterinary drug, and specified biologic sponsors and applicants (21 CFR 99.3(f)).

Use Form W-11 to confirm that an employee is a qualified employee under the HIRE Act. You can use another similar statement if it contains the information above and the employee signs it under penalties of perjury.

The present guidelines represent an initial consolidated version containing additions, suggestions and corrections from various people representing associations, companies and the field of science. Feedback of any kind is very much welcome and can be submitted to the abovementioned e-mail address. The document will be further revised throughout next year and is scheduled to be replaced by an updated version at the end of 2011.

The safety data sheet (SDS) plays a key role in this respect. On the one hand, it has to enable the processing industry and business in general to recognise potential hazards during the production and manufacturing processes. At the same time, it has to provide the necessary basis to evaluate potential dangers to health and the environment in the finished products.

Based on current knowledge, possible risks from what are known as nano-objects can arise when they are free or when they are released from products.
 

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

Effective Date: This rule is effective March 7, 2011.
 

Under the Hiring Incentives to Restore Employment (HIRE) Act, two new tax benefits are available to employers who hire certain previously unemployed workers (“qualified employees”).  The first, the payroll tax exemption, provides employers with an exemption from the employer’s 6.2 percent share of social security tax on wages paid to qualifying employees, effective for wages paid from March 19, 2010 through December 31, 2010.

The second provision is for an up to $1000 tax credit for retaining those newly hired employees for over a year, provided their second 6 month period wages are at least 80% of the first 6 months.

Effective Date: March 18, 2010

The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food labeling regulations that are issued between January 1, 2011, and December 31, 2012. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 8, 2008, FDA established January 2, 2012, as the uniform compliance date for food labeling regulations issued between January 1, 2009, and December 31, 2010 (January 1, 2012 fell on a Sunday; therefore the uniform compliance date was January 2, 2012).

DATES: This rule is effective December 15, 2010. Submit either electronic or written comments by February 14, 2011. 

As per the amendment, tests on substances carried out within the framework of this Directive shall be conducted according to the requirements of Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency.

 

 With a view to facilitating worldwide trade while protecting human health and the environment, harmonised criteria for classification and labelling and rules for safety data sheets have been carefully developed over a period of more than 10 years within the United Nations (UN) structure, resulting in the Globally Harmonised System of Classification and Labelling of Chemicals, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is being amended.

This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of chemical substances, mixtures and certain specific articles, while enhancing competitiveness and innovation. This Regulation follows various declarations whereby the Community confirmed its intention to contribute to the global harmonisation of criteria for classification and labelling, not only at UN level, but also through the incorporation of the internationally agreed GHS criteria into Community law.

This document provides technical guidance for MSCAs and manufacturers, importers and downstream users on preparing a CLH dossier under the CLP Regulation. Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures (the CLP Regulation) entered into force on 20 January 2009. The CLP Regulation specifies that Member State2 competent authorities (MSCAs) as well as manufacturers, importers or downstream users may submit proposals for harmonised classification and labeling of substances to the European Chemicals Agency.

Entered into force in June 2007, REACH or Registration, Evaluation, Authorisation and Restriction of Chemicals is a European Union Regulation. As per the REACH guidelines, all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year are mandated to register these substances with a new European Chemical Agency (ECHA) in Helsinki, Finland. The present guidance also addresses the issue of chemical 'substances of very high concern' (SVHC) because of their potential negative impacts on human health or the environment.

The Clean Air Act defines EPA's responsibilities for protecting and improving the nation's air quality and the stratospheric ozone layer. The Clean Air Act was enacted by Congress and named as the Title 42 Chapter 85. The act majorly focuses on how to reduce smog and air pollution. Also, the act aims to initiate and accelerate a national research and development program to achieve the prevention and control of air pollution.

Moreover, the act encourages research and development program for prevention and control of air pollution and states that the Administrator shall establish a national research and development program for the prevention and control of air pollution and conduct, and promote the coordination and acceleration of, research, investigations, experiments, demonstrations, surveys, and studies relating to the causes, effects (including health and welfare effects), extent, prevention, and control of air pollution.

The act, enacted by the Senate and House of Representatives of the United States of America in Congress assembled, attempts to counter the increasing energy problems in the U.S. It addresses the need of energy reliability and cut down the foreign energy dependability. The act stresses improving and increasing  domestic energy sources.

The bill amends the art 3 of title V of the National Energy Conservation Policy Act (42 U.S.C. 8251 et seq.), Uniform Time Act of 1966 by changing the start and end dates of daylight saving time, beginning in 2007. The bill also encourages individuals to make energy-conscious purchases and enjoy tax benefit provisions, which is introduced by this bill.  

Effective Date: August 8, 2005

The Environmental, Health, and Safety (EHS) Guidelines are technical reference documents with general and industry-specific examples of Good International Industry Practice (GIIP). These General EHS Guidelines are designed to be used together with the relevant Industry Sector EHS Guidelines, which provide guidance to users on EHS issues in specific industry sectors.

The EHS Guidelines contain the performance levels and measures that are normally acceptable to IFC and are generally considered to be achievable in new facilities at reasonable costs by existing technology. For IFC-financed projects, application of the EHS Guidelines to existing facilities may involve the establishment of site-specific targets with an appropriate timetable for achieving them. The environmental assessment process may recommend alternative (higher or lower) levels or measures, which, if acceptable to IFC, become project- or site-specific requirements. The guidance also elaborates the General Approach to the Management of EHS Issues at the Facility or Project Level. 

Subpart D--Regulations Pertaining to State Registration of Pesticides to Meet Special Local Needs

Sec. 162.150 General

Authority: 7 U.S.C. 136v, 136w.

Source: 46 FR 2014, Jan. 7, 1981, unless otherwise noted.

(a) Scope. This subpart sets forth regulations governing the registration by any State of pesticide products, or uses thereof, formulated for distribution and use within the State to meet special local needs under sec. 24(c) of the Act. It also sets forth regulations governing the exercise by the Administrator of the power to disapprove specific State registrations and to suspend a State's registration authority under sec. 24(c). Unless otherwise indicated, any reference herein to registrations issued by a State includes amendments of registrations issued by States.

(b) Applicability. This subpart applies only to State registration authority granted by sec. 24(c) of FIFRA. It does not apply to any  authority granted, or procedures established, by State law with respect  to registration, licensing, or approval required for use within the  State of federally registered pesticide products.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 32097, June 19, 1995]

Sec. 162.151 Definitions

Unless otherwise indicated, terms used in this subpart have the meanings set forth in FIFRA and in subpart A of this part. In addition, as used in this subpart, the following terms have the meanings set forth below:

(a) Federally registered means currently registered under sec. 3 of the Act, after having been initially registered under the Federal

Insecticide, Fungicide, and Rodenticide Act of 1947 (Pub. L. 86-139; 73

Stat. 286; June 25, 1947) by the Secretary of Agriculture or under FIFRA by the Administrator.

(b) Manufacturing-use product means any pesticide product other than a product to be labeled with directions for end use. This term includes any product intended for use as a pesticide after re-formulation or repackaging.

(c) New product means a pesticide product which is not a federally registered product.

(d) Pest problem means (1) a pest infestation and its consequences, or (2) any condition for which the use of plant regulators, defoliants, or desiccants would be appropriate.

(e) Product or pesticide product means a pesticide offered for distribution and use, and includes any labeled container and any supplemental labeling.

(f) Similar composition refers to a pesticide product which contains only the same active ingredient(s), or combination of active ingredients and which is in the same category of toxicity, as a federally registered pesticide product.

(g) Similar product means a pesticide product which, when compared to a federally registered product, has a similar composition and a similar use pattern.

(h) Similar use pattern refers to a use of a pesticide product which, when compared to a federally registered use of a product with a similar composition, does not require a change in precautionary labeling under Sec. 156.10(h) of this chapter, and which is substantially the same as the federally registered use. Registrations involving changed use patterns are not included in this term.

(i) Special local need means an existing or imminent pest problem within a State for which the State lead agency, based upon satisfactory supporting information, has determined that an appropriate federally registered pesticide product is not sufficiently available.

(j) State or State lead agency as used in this subpart means the State agency designated by the State to be responsible for registering pesticides to meet special local needs under sec. 24(c) of the Act.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988]

Sec. 162.152 State Registration Authority

(a) Statutory limitations. In accordance with sec. 24(c) of the Act, each State is authorized to register a new end use product for any use, or an additional use of a federally registered pesticide product, if the following conditions exist:

(1) There is a special local need for the use within the State;

(2) The use is covered by necessary tolerances, exemptions or other clearances under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346 et seq.), if the use is a food or feed use;

(3) Registration for the same use has not previously been denied, disapproved, suspended or cancelled by the Administrator, or voluntarily cancelled by the registrant subsequent to issuance by the Administrator of a notice of intent to cancel that registration, because of health or environmental concerns about an ingredient contained in the pesticide product, unless such denial, disapproval, suspension or cancellation has been superseded by subsequent action of the Administrator; and

(4) The registration is in accord with the purposes of FIFRA.

(b) Types of registrations--(1) Amendments to federal registrations.

(i) Subject to the provisions of paragraphs (a) and (b)(1)(ii)(iv) of this section, States may register any new use of a federally registered pesticide product.

(ii) A State may register any use of a federally registered product for which registration of other uses of the product was denied, disapproved, suspended, or cancelled by the Administrator, provided that the State may register a use not considered by the Administrator in reaching such a determination only after the State consults with appropriate EPA personnel.

(iii) Except as provided in paragraph (a) (3) of this section, a State may register any use of a federally registered product for which registration of some or all uses has been voluntarily cancelled by the registrant, provided that a State may register such a use only after the State has consulted with appropriate EPA personnel.

(iv) A State may not register an amendment to a federally registered manufacturing-use product.

 (2) New products. (i) Subject to the provisions of paragraph (a) and subparagraphs (b)(2) (ii) and (iii) of this section, a State may issue registrations to meet special local needs for the following types of new end-use products:

 (A) A product which is identical in composition to a federally registered product, but which has differences in packaging, or in the identity of the formulator.

 (B) A product which contains the same active and inert ingredients as a federally registered product, but in different percentages.

(C) Subject to the requirements of paragraph (b)(2)(ii) of this section, a product containing a new combination of active, or active and inert, ingredients.

(ii) A State may register a new product only if each of the active ingredients in the new product is present because of the use of one or more federally registered products and if each of the inert ingredients in the new product is contained in a federally registered product.

 (iii) A State may not register a new manufacturing-use product.

 (iv) A State may register any use of a new product containing an ingredient described in paragraph (a)(3) of this section, if the new product registration is for a formulation or a use not included in the denial, disapproval, suspension, or cancellation, or if the federally registered use was voluntarily cancelled without a prior notice of intent to cancel by the Administrator. However, a formulation or use of such a new product which was not considered by the Administrator during such proceedings, or which was not the subject of a notice of intent to cancel, may be registered by a State only after the State consults with appropriate EPA personnel regarding the registration application.

(c) Effect of State registration. (1) A State registration issued under FIFRA sec. 24(c) which meets the conditions described in paragraphs (a) and (b) of this section, and which is not disapproved by the Administrator under Sec. 162.154, shall be considered a federal registration, but shall authorize distribution and use only within that State. Accordingly, such registrations are subject to all provisions of FIFRA which apply to currently registered products, including provisions for cancellation and suspension of registrations, and re-registration of products.

 (2) A State may require, as a condition of distribution or use of a pesticide product within the State, that the pesticide product be registered under State law as well as under FIFRA. Neither FIFRA sec 24(c) nor Secs. 162.150-162.156 affects a State's right under its own law to revoke, suspend, cancel, or otherwise affect such a registration issued under State law. However, the federal registration, whether issued under FIFRA sec. 3 or 24(c), is not affected by such a State action.

Sec. 162.153 State Registration Procedures

(a) Application for registration. States shall require all applicants for registration to submit the following information:

(1) Name and address of the applicant and any other person whose name will appear on the labeling or in the directions for use.

(2) The name of the pesticide product, and, if the application is for an amendment to a federally registered product, the EPA registration number of that product.

(3) A copy of proposed labeling, including all claims made for the product as well as directions for its use to meet the special local need, consisting of:

(i) For a new product, a copy of the complete proposed labeling; or,

(ii) For an additional use of a federally registered product, a copy of proposed supplemental labeling and a copy of the labeling for the federally registered product.

(4) The complete formula of the product, if the application is for a new product registration.

(5) Any other information which is required to be reviewed prior to registration under this section.

(b) Special local need determination. In reviewing any application for registration, the State shall determine whether there is a special local need for the registration. Situations which a State may consider as not involving a special local need may include, but are not limited to, applications for registrations to control a pest problem present on a nationwide basis, or for use of a pesticide product registered by other States on an interregional or nationwide basis.

(c) Unreasonable adverse effects determination. (1) Prior to issuing a registration in the following cases, the State shall determine that use of the product for which registration is sought will not cause unreasonable adverse effects on man or the environment, when used in accordance with labeling directions or widespread and commonly recognized practices:

(i) For use of a product which has a composition not similar to any federally registered product.

(ii) For use of a project involving a use pattern not similar to any federally registered use of the same product or of a product with a similar composition.

 (iii) For use of a product for which other uses of the same product, or of a product with a similar composition, have had registration denied, disapproved, suspended, or cancelled by the Administrator.

(2) Determinations required by paragraph (c)(1) of this section shall be based on data and criteria consistent with those sections of part 152 of this chapter, applicable to the type of product or use under consideration. Such determinations may also involve consideration of the effect of the anticipated classification of the product or use under Sec. 162.153(h)

(d) Efficacy determination. Prior to registration of any use of a product for public health purposes--that is, a use which could result in substantial harm to the public health if the product does not perform its intended function, the State shall determine that the product warrants the claims made for it in the registration application. Such determinations shall be based on criteria specified in applicable sections of part 152 of this chapter and on any additional criteria established by the State.

(e) Labeling requirements. (1) Prior to issuing any registration, the State shall review the proposed labeling submitted with the application to determine compliance with this paragraph. In addition, the State shall review a copy of the final printed labeling as soon as practical after a registration is issued in order to verify compliance with this paragraph.

(2) For a new product, the State must, as a condition of the registration, require that the product be accompanied from the time it enters the stream of commerce by labeling meeting all applicable criteria of Sec. 156.10 of this chapter. New product labeling must all contain:

  (i) A statement identifying the State where registration is to be valid.

  (ii) The special local need registration number assigned by the State.

(3) Except as provided in paragraph (e)(4) of this section, as a condition for a registration of an additional use of a federally registered product, the State must require that at the time of sale to users, labeling from the federally registered product be accompanied by supplemental labeling which contains:

    (i) A statement identifying the State where registration is valid.

    (ii) Directions for use to meet the special local need which satisfy the criteria of Sec. 156.10(i) of this chapter.

    (iii) The trade name of the product.

    (iv) The name and address of the section 24(c) registrant.

    (v) The EPA registration number of the federally registered product.

    (vi) The special local need registration number assigned by the State.

    (vii) A statement prohibiting use of the product in a manner inconsistent with all applicable directions, restrictions, and precautions found in the labeling of the federally registered product and accompanying supplemental labeling.

 (4) When a federally registered product is already in the stream of commerce at the time the State issues a registration for an additional use of that product, the State must ensure that supplemental labeling for the additional use, meeting the criteria of paragraph (e)(3) of this section, is made available to purchasers and users of the product within 45 days of the date on which the State approves the final printed supplemental labeling.

(5) If a State classifies for restricted use a product or use registered by the State, which is not required to be so classified by

paragraph (g) of this section, then the State may require supplemental labeling for the product or use containing additional appropriate precautions, and a statement that the product or use is for restricted use within that State.

(f) Packaging and coloration standards. All products registered by a State must meet all appropriate packaging standards prescribed by the Administrator under sec. 25(c)(3) of FIFRA. State registered products must also meet all appropriate standards for coloration, or discoloration, established by regulation under sec. 25(c) of FIFRA, including the standards contained in subpart H of part 153 of this chapter. Prior to issuing any registration, the State shall determine that the product will conform to these requirements.

(g) Classification. (1) As part of the registration of any product or use, a State shall classify the product or use as a restricted use pesticide if:

(i) The product is identical or similar in composition to a federally registered product:

(A) For which all federally registered uses have been classified as restricted by the Administrator; or

(B) For which a use similar to the State registered use has been classified as restricted by the Administrator; or

(ii) The State registered product or use meets the criteria for classification as a restricted use pesticide under the applicable provisions of Sec. 152.170 of this chapter.

(2) [Reserved]

(h) Notification and Submission of Data.

(1) Within ten working days from the date a State issues, amends, or revokes a registration, the State shall notify EPA, in writing, of the action. Notification of State registrations or amendments thereto, shall include the effective date of the registration or amendment, a confidential statement of the formula of any new product, and a copy of the draft labeling reviewed and approved by the State, provided that labeling previously approved by the Administrator as part of a federal registration need not be submitted.

(2) Notification of State registrations or amendments shall be supplemented by the State sending to EPA a copy of the final printed labeling approved by the State within 60 days after the effective date of the registration or amendment.

(3) Notification of revocation of a registration by a State shall indicate the effective date of revocation, and shall state the reasons for revocation.

(4) The Administrator or his designee may request, when appropriate, that a State submit to EPA any data used by the State to determine that unreasonable adverse effects will not be caused when the State registers any use described in paragraph (c)(1) of this section. Within 15 working days of receipt of such a request from EPA, the State shall submit two copies of the requested data.

 (i) Federal Register Publication. The Administrator shall publish in the Federal Register, on a regular basis, a summary of all State registrations made under sec. 24(c) during a previous reporting period established by the Administrator. For each product or use registered, the notice shall indicate:

    (1) The name of the product.

    (2) The name of the registrant.

    (3) The registered use(s) of the product.

    (4) The effective date of the State registration.

    (5) If the registration is for an additional use of a federally registered product, whether the State registration involves a changed use pattern.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 32097, June 19, 1995]

Sec. 162.155 Suspension of State Registration Authority

(a) General. (1) If the Administrator finds that a State is not capable of exercising, or has failed to exercise, adequate control over its registration program, so that the State cannot ensure that registrations issued by it will be in accord with the purposes of FIFRA, then the Administrator may suspend the State's authority to register pesticides under sec. 24(c) of the Act. Registrations issued by the State after suspension of its authority will not be considered valid under FIFRA. Registrations issued by the State prior to suspension will not be affected by the suspension.

(2) The Administrator may suspend all or any part of a State's registration authority, as appropriate.

(b) Grounds for Suspension. (1) The Administrator may suspend a State's registration authority due to lack of, or failure to exercise, adequate control by the State over its sec. 24(c) registration program. Adequate control includes, but is not limited to, all of the following:

 (i) Access to appropriate scientific and technical personnel to review data and make determinations as required by Sec. 162.153.

(ii) Registration procedures satisfying Sec. 162.153.

(iii) Complete and accurate records of State registrations.

(iv) Adequate legal authority. (A) To deny, suspend, revoke, or amend a State registration when the registration is not in compliance with FIFRA, this subpart, or State law, or when necessary to prevent unreasonable adverse effects on the environment.

(B) To enter, at reasonable times, by consent, warrant, or other legal means, any establishment where pesticides are produced or held for distribution or sale, to inspect, sample, and observe whether pesticides are being produced or distributed in compliance with FIFRA, this subpart, State law, and the terms of any State registration.

(2) The Administrator may suspend a State's registration authority

if the State fails to exercise the controls specified in paragraph (b)(1) of this section, or if the State refuses to correct within a reasonable time any other significant deficiencies in its regulatory program, as specified by the Administrator in a notice of intent to suspend.

(c) Procedures for Suspension. (1) Prior to suspending the registration authority of any State, the Administrator will notify the State lead agency, in writing, of the Administrator's intent to suspend, and of the specific grounds for suspension. The notice of intent will specify whether the suspension will be complete or partial, and will provide the State an opportunity to respond and a reasonable amount of time, not less than 30 days from the date the notice is received, in which to correct the deficiencies specified in the notice. If the State does not correct the specified deficiencies within the reasonable time allowed by the notice, or if the Administrator has not withdrawn the notice of intent before that time, the notice of intent will be published in the Federal Register, and the public given an opportunity to comment thereon.

(2) If requested by the affected State lead agency within 30 days of receipt of the notice of intent to suspend, an informal consultation between appropriate State and EPA officials will be held to discuss the proposed suspension. In such a case, the Administrator shall not make a final decision on the proposed suspension until after the consultation.

The Administrator shall consider all relevant information presented at the consultation, or in any other appropriate manner, in determining whether to suspend the State's authority. If the Administrator determines, on the basis of such information, that the deficiencies listed in the notice of intent no longer exist, or will be corrected in a reasonable time, then the Administrator will withdraw, in writing, the notice of intent to suspend.

(3) Within ten days of the date a notice of intent to suspend is published in the Federal Register, a State may request a public hearing to consider the proposed suspension. If a hearing is requested, the Administrator will:

 (i) Schedule a public hearing to be held in that State.

(ii) Publish in the Federal Register a notice announcing the date, time, and location of the hearing.

(iii) Appoint a presiding officer who shall preside over the hearing.

(iv) Prescribe additional, appropriate procedures for the conduct of the hearing, including procedures for the presentation of relevant material evidence from the State, EPA, or members of the public who would be affected by the outcome of the hearing. Evidence may be presented in either oral or written form, at the discretion of the Administrator.

(4) Following the close of any hearing held under paragraph (c)(3) of this section, the presiding officer shall make a recommended decision that the State's authority to register pesticides under sec. 24(c) of FIFRA be suspended, in whole or in part, or that the State's authority not be suspended and that the notice of intent to suspend be withdrawn.

(5) Any recommended decision made by a presiding officer under paragraph (c)(4) of this section may be appealed to the Administrator within 30 days after its issuance by the State or by EPA. Any recommended decision which is not appealed, or which the Administrator does not review on his own initiative, will become a final Agency action 30 days after its issuance.

(6) If no hearing is requested under paragraph (c)(3) of this section, or if a recommended decision is appealed to the Administrator under paragraph (c)(5) of this section, the Administrator shall issue a final order either suspending the State's authority to register pesticides under section 24(c) of FIFRA, in whole or in part, or withdrawing the notice of intent to suspend.

(7) Any final order suspending State registration authority, issued under paragraph (c) (5) or (6) of this section, will specify the grounds therefore and an effective date for the suspension. If the suspension is merely partial, the notice of suspension will specify the types of registrations which will not be recognized as valid under sec. 24(c). All final orders issued under paragraph (c)(5) or (6) will be published in the Federal Register.

(d) Termination of suspension. Suspension of a State's authority will be effective for the period specified in the notice of suspension, or if no period was specified, until such time as the Administrator is satisfied that the State can and will exercise adequate control over its program. In the latter case, the Administrator will notify the State that the suspension is terminated, or that it will be terminated on a specific date. In either case, the Administrator will publish a notice of the termination of suspension in the Federal Register.

(e) Judicial review. Any State whose authority to register pesticides has been finally suspended by the Administrator may seek judicial review of the Administrator's decision under sec. 16 of FIFRA, at any time prior to termination of the suspension. Such suspension shall remain in effect during the period of judicial review unless otherwise ordered by the Administrator.

Sec. 162.156 General Requirements

(a) Requirements for distribution and use. (1) Any product whose State registration has been issued in accordance with Secs. 162.152 and 162.153 may be distributed and used in that State, subject to the following provisions of the Act and the regulations promulgated there under:

    (i) Sec. 12(a)(1) (A) through (E), in accordance with:

    (A) Sec. 2(q)(1) (A) through (G).

    (B) Sec. 2(q)(2) (A) through (D).

    (ii) Sec. 12(a)(2) (A) through (G) and (I) through (P).

    (2) A product or use classified by a State for restricted use under

Sec. 162.153(g) may be used only by, or under the direct supervision of, an applicator certified under a plan approved by EPA in accordance with sec. 4 of FIFRA.

(3) State registrations which are not issued in accordance with Sec. 162.152 (a) and (b)(2) (i), (ii) and (iii) are not authorized by section 24(c) and are not considered valid for any purposes under FIFRA. When the Administrator determines that a registration is invalid, the Administrator shall notify the registering State that the registration is invalid, and may specify the reason for the invalidity.

(b) Establishment registration requirements. No person may produce any pesticide, including any pesticide registered by a State under section 24(c), unless the establishment in which it is produced is registered by the Administrator in accordance with sec. 7 of FIFRA and 40 CFR part 167.

(c) Books and records requirements. All producers of pesticides, including those producers of pesticides registered by States under sec. 24(c), must maintain records in accordance with the requirements imposed under sec. 8 of FIFRA and 40 CFR part 169.

The objective of FIFRA is to provide federal control of pesticide distribution, sale, and use. All pesticides used in the United States must be registered (licensed) by EPA. Registration assures that pesticides will be properly labeled and that, if used in accordance with specifications, they will not cause unreasonable harm to the environment. Use of each registered pesticide must be consistent with use directions contained on the label or labeling.

FIFRA was essentially rewritten in 1972 when it was amended by the Federal Environmental Pesticide Control Act (FEPCA). The law has been amended numerous times since 1972, including some significant amendments in the form of the Food Quality Protection Act (FQPA) of 1996. In its current form, FIFRA mandates that EPA regulate the use and sale of pesticides to protect human health and preserve the environment.

FIFRA provides EPA with the authority to oversee the sale and use of pesticides. However, because FIFRA does not fully preempt state/tribal or local law, each state/tribe and local government may also regulate pesticide use.

Effective Date: May 22, 2008

This manual prescribes the safety and health requirements for all Corps of Engineers activities and operations. The provisions of this manual implement and supplement the safety and health standards and requirements contained in 29 CFR 1910, 29 CFR 1926, 29 CFR 1960, 30 CFR 56, EO 12196, DODI 6055.1, DODI 6055.3, AR 40-5, AR 385-10, AR 385-11, AR 385-40, and FAR Clause 52.236-13. Where more stringent safety and occupational health standards are set forth in these requirements and regulations, the more stringent standards shall apply. This manual supersedes EM 385-1-1, 3 September 1996.

This manual applies to Headquarters, US Army Corps of Engineers (HQUSACE) elements, major subordinate commands, districts, centers, laboratories, and field operating activities (FOA), as well as USACE and Naval Facilities (NAVFAC) Engineering Command contracts.
 

Publication Date: 3 November 2003

Pursuant to section 206 of the Federal Power Act, the Federal Energy Regulatory Commission amends its regulations to improve the management of risk and the subsequent use of credit in the organized wholesale electric markets. Each Regional Transmission Organization (RTO) and Independent System Operator (ISO) will be required to submit a compliance filing including tariff revisions to comply with the amended regulations or to demonstrate that its existing tariff already satisfies the regulations. This Final Rule adopts reforms to credit policies used in organized wholesale electric power markets.
 
Background: The Commission has long been actively interested in the credit practices of the wholesale electric markets. In crafting the pro forma Open Access Transmission Tariff (OATT) in Order No. 888, the Commission directed that each transmission provider’s tariff include reasonable creditworthiness standards. However, in response to the credit downgrades in the energy industry of 2001-2002, and the resulting severe contraction in the credit markets, the Commission held a technical conference in which it received significant testimony that it should take action regarding credit practices in the organized electricity markets.
 
The Need for Credit Reform in the Organized Wholesale Electric Markets: Sound credit practices are necessary to prevent a disruption in the system, and it is not acceptable to wait until after a disruption to implement the necessary standards. The Commission acknowledges the short-term costs of compliance with the credit practices required in this Final Rule but finds that they are outweighed by the stability that those credit practices provide to the markets and their participants. Therefore, in compliance filings to be submitted providing tariff revisions to comply with the Final Rule, ISOs and RTOs should apply these standards to market participants.
 

Effective Date: This Final Rule will become effective on [insert date 30 days after publication in the FEDERAL REGISTER]
 

General. The following requirements apply to all ladders as indicated, including job-made ladders.

1926.1053(a)(1)

Ladders shall be capable of supporting the following loads without failure:

1926.1053(a)(1)(i)

Each self-supporting portable ladder: At least four times the maximum intended load, except that each extra-heavy-duty type 1A metal or plastic ladder shall sustain at least 3.3 time the maximum intended load. The ability of a ladder to sustain the loads indicated in this paragraph shall be determined by applying or transmitting the requisite load to the ladder in a downward vertical direction. Ladders built and tested in conformance with the applicable provisions of appendix A of this subpart will be deemed to meet this requirement.

1926.1053(a)(1)(ii)

Each portable ladder that is not self-supporting: At least four times the maximum intended load, except that each extra-heavy-duty type 1A metal or plastic ladders shall sustain at least 3.3 times the maximum intended load. The ability of a ladder to sustain the loads indicated in this paragraph shall be determined by applying or transmitting the requisite load to the ladder in a downward vertical direction when the ladder is placed at an angle of 75 1/2 degrees from the horizontal. Ladders built and tested in conformance with the applicable provisions of appendix A will be deemed to meet this requirement.

1926.1053(a)(1)(iii)

Each Fixed ladder: At least two loads of 250 pounds (114 kg) each, concentrated between any two consecutive attachments (the number and position of additional concentrated loads of 250 pounds (114 kg) each, determined from anticipated usage of the ladder, shall also be included), plus anticipated loads caused by ice buildup, winds, rigging, and impact loads resulting from the use of ladder safety devices. Each step or rung shall be capable of supporting a single concentrated load of a least 250 pounds (114 kg) applied in the middle of the step or rung. Ladders built in conformance with the applicable provisions of appendix A will be deemed to meet this requirement.

1926.1053(a)(2)

Ladder rungs, cleats, and steps shall be parallel, level, and uniformly spaced when the ladder is in position for use.

1926.1053(a)(3)

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1926.1053(a)(3)(i)

Rungs, cleats, and steps of portable ladders (except as provided below) and fixed ladders (including individual-rung/step ladders) shall be spaced not less than 10 inches (25 cm) apart, nor more than 14 inches (36 cm) apart, as measured between center lines of the rungs, cleats and steps.

1926.1053(a)(3)(ii)

Rungs, cleats, and steps of step stools shall be not less than 8 inches (20 cm) apart, nor more than 12 inches (31 cm) apart, as measured between center lines of the rungs, cleats, and steps.

1926.1053(a)(3)(iii)

Rungs, cleats, and steps of the base section of extension trestle ladders shall be not less than 8 inches (20 cm) nor more than 18 inches (46 cm) apart, as measured between center lines of the rungs, cleats, and steps. The rung spacing on the extension section of the extension trestle ladder shall be not less than 6 inches (15 cm) nor more than 12 inches (31 cm), as measured between center lines of the rungs, cleats, and steps.

1926.1053(a)(4)

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1926.1053(a)(4)(i)

The minimum clear distance between the sides of individual-rung/step ladders and the minimum clear distance between the side rails of other fixed ladders shall be 16 inches (41 cm).

1926.1053(a)(4)(ii)

The minimum clear distance between side rails for all portable ladders shall be 11 1/2 inches (29 cm).

1926.1053(a)(5)

The rungs of individual-rung/step ladders shall be shaped such that employees' feet cannot slide off the end of the rungs.

1926.1053(a)(6)

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1926.1053(a)(6)(i)

The rungs and steps of fixed metal ladders manufactured after March 15, 1991, shall be corrugated, knurled, dimpled, coated with skid-resistant material, or otherwise treated to minimize slipping.

1926.1053(a)(6)(ii)

The rungs and steps of portable metal ladders shall be corrugated, knurled, dimpled, coated with skid-resistant material, or otherwise treated to minimize slipping.

1926.1053(a)(7)

Ladders shall not be tied or fastened together to provide longer sections unless they are specifically designed for such use.

1926.1053(a)(8)

A metal spreader or locking device shall be provided on each stepladder to hold the front and back sections in an open position when the ladder is being used.

1926.1053(a)(9)

When splicing is required to obtain a given length of side rail, the resulting side rail must be at least equivalent in strength to a one-piece side rail made of the same material.

1926.1053(a)(10)

Except when portable ladders are used to gain access to fixed ladders (such as those on utility towers, billboards, and other structures where the bottom of the fixed ladder is elevated to limit access), when two or more separate ladders are used to reach an elevated work area, the ladders shall be offset with a platform or landing between the ladders. (The requirements to have guardrail systems with toeboards for falling object and overhead protection on platforms and landings are set forth in subpart M of this part.)

1926.1053(a)(11)

Ladder components shall be surfaced so as to prevent injury to an employee from punctures or lacerations, and to prevent snagging of clothing.

1926.1053(a)(12)

Wood ladders shall not be coated with any opaque covering, except for identification or warning labels which may be placed on one face only of a side rail.

1926.1053(a)(13)

The minimum perpendicular clearance between fixed ladder rungs, cleats, and steps, and any obstruction behind the ladder shall be 7 inches (18 cm), except in the case of an elevator pit ladder for which a minimum perpendicular clearance of 4 1/2 inches (11 cm) is required.

1926.1053(a)(14)

The minimum perpendicular clearance between the center line of fixed ladder rungs, cleats, and steps, and any obstruction on the climbing side of the ladder shall be 30 inches (76 cm), except as provided in paragraph (a)(15) of this section.

1926.1053(a)(15)

When unavoidable obstructions are encountered, the minimum perpendicular clearance between the centerline of fixed ladder rungs, cleats, and steps, and the obstruction on the climbing side of the ladder may be reduced to 24 inches (61 cm), provided that a deflection device is installed to guide employees around the obstruction.

1926.1053(a)(16)

Through fixed ladders at their point of access/egress shall have a step-across distance of not less than 7 inches (18 cm) nor more than 12 inches (30 cm) as measured from the centerline of the steps or rungs to the nearest edge of the landing area. If the normal step-across distance exceeds 12 inches (30 cm), a landing platform shall be provided to reduce the distance to the specified limit.

1926.1053(a)(17)

Fixed ladders without cages or wells shall have a clear width to the nearest permanent object of at least 15 inches (30 cm) on each side of the centerline of the ladder.

1926.1053(a)(18)

Fixed ladders shall be provided with cages, wells, ladder safety devices, or self-retracting lifelines where the length of climb is less than 24 feet (7.3 m) but the top of the ladder is at a distance greater than 24 feet (7.3 m) above lower levels.

1926.1053(a)(19)

Where the total length of a climb equals or exceeds 24 feet (7.3 m), fixed ladders shall be equipped with one of the following:

1926.1053(a)(19)(i)

Ladder safety devices; or

1926.1053(a)(19)(ii)

Self-retracting lifelines, and rest platforms at intervals not to exceed 150 feet (45.7 m); or

1926.1053(a)(19)(iii)

A cage or well, and multiple ladder sections, each ladder section not to exceed 50 feet (15.2 m) in length. Ladder sections shall be offset from adjacent sections, and landing platforms shall be provided at maximum intervals of 50 feet (15.2 m).

1926.1053(a)(20)

Cages for fixed ladders shall conform to all of the following:

1926.1053(a)(20)(i)

Horizontal bands shall be fastened to the side rails of rail ladders, or directly to the structure, building, or equipment for individual-rung ladders;

1926.1053(a)(20)(ii)

Vertical bars shall be on the inside of the horizontal bands and shall be fastened to them;

1926.1053(a)(20)(iii)

Cages shall extend not less than 27 inches (66 cm), or more than 30 inches (76 cm) from the centerline of the step or rung (excluding the flare at the bottom of the cage), and shall not be less than 27 inches (68 cm) in width;

1926.1053(a)(20)(iv)

The inside of the cage shall be clear of projections;

1926.1053(a)(20)(v)

Horizontal bands shall be spaced not more than 4 feet (1.2 m) on center vertically;

1926.1053(a)(20)(vi)

Vertical bars shall be spaced at intervals not more than 9 1/2 inches (24 cm) on center horizontally;

1926.1053(a)(20)(vii)

the bottom of the cage shall be at a level not less than 7 feet (2.1 m) nor more than 8 feet (2.4 m) above the point of access to the bottom of the ladder. The bottom of the cage shall be flared not less than 4 inches (10 cm) all around within the distance between the bottom horizontal band and the next higher band;

1926.1053(a)(20)(viii)

The top of the cage shall be a minimum of 42 inches (1.1 m) above the top of the platform, or the point of access at the top of the ladder, with provision for access to the platform or other point of access.

1926.1053(a)(21)

Wells for fixed ladders shall conform to all of the following:

1926.1053(a)(21)(i)

They shall completely encircle the ladder;

1926.1053(a)(21)(ii)

They shall be free of projections;

1926.1053(a)(21)(iii)

Their inside face on the climbing side of the ladder shall extend not less than 27 inches (68 cm) nor more than 30 inches (76 cm) from the centerline of the step or rung;

1926.1053(a)(21)(iv)

The inside clear width shall be at least 30 inches (76 cm);

1926.1053(a)(21)(v)

The bottom of the wall on the access side shall start at a level not less than 7 feet (2.1 m) nor more than 8 feet (2.4 m) above the point of access to the bottom of the ladder.

1926.1053(a)(22)

Ladder safety devices, and related support systems, for fixed ladders shall conform to all of the following:

1926.1053(a)(22)(i)

They shall be capable of withstanding without failure a drop test consisting of an 18-inch (41 cm) drop of a 500-pound (226 kg) weight;

1926.1053(a)(22)(ii)

They shall permit the employee using the device to ascend or descend without continually having to hold, push, or pull any part of the device, leaving both hands free for climbing;

1926.1053(a)(22)(iii)

They shall be activated within 2 feet (.61 m) after a fall occurs, and limit the descending velocity of an employee to 7 feet/sec. (2.1 m/sec.) or less;

1926.1053(a)(22)(iv)

The connection between the carrier or lifeline and the point of attachment to the body belt or harness shall not exceed 9 inches (23 cm) in length.

1926.1053(a)(23)

The mounting of ladder safety devices for fixed ladders shall conform to the following:

1926.1053(a)(23)(i)

Mountings for rigid carriers shall be attached at each end of the carrier, with intermediate mountings, as necessary, spaced along the entire length of the carrier, to provide the strength necessary to stop employees' falls;

1926.1053(a)(23)(ii)

Mountings for flexible carriers shall be attached at each end of the carrier. When the system is exposed to wind, cable guides for flexible carriers shall be installed at a minimum spacing of 25 feet (7.6 m) and maximum spacing of 40 feet (12.2 m) along the entire length of the carrier, to prevent wind damage to the system.

1926.1053(a)(23)(iii)

The design and installation of mountings and cable guides shall not reduce the design strength of the ladder.

1926.1053(a)(24)

The side rails of through or side-step fixed ladders shall extend 42 inches (1.1 m) above the top of the access level or landing platform served by the ladder. For a parapet ladder, the access level shall be the roof if the parapet is cut to permit passage through the parapet; if the parapet is continuous, the access level shall be the top of the parapet.

1926.1053(a)(25)

For through-fixed-ladder extensions, the steps or rungs shall be omitted from the extension and the extension of the side rails shall be flared to provide not less than 24 inches (61 cm) nor more than 30 inches (76 cm) clearance between side rails. Where ladder safety devices are provided, the maximum clearance between side rails of the extensions shall not exceed 36 inches (91 cm).

1926.1053(a)(26)

For side-step fixed ladders, the side rails and the steps or rungs shall be continuous in the extension.

1926.1053(a)(27)

Individual-rung/step ladders, except those used where their access openings are covered with manhole covers or hatches, shall extend at least 42 inches (1.1 m) above an access level or landing platform either by the continuation of the rung spacings as horizontal grab bars or by providing vertical grab bars that shall have the same lateral spacing as the vertical legs of the rungs.

1926.1053(b)

Use. The following requirements apply to the use of all ladders, including job-made ladders, except as otherwise indicated:

1926.1053(b)(1)

When portable ladders are used for access to an upper landing surface, the ladder side rails shall extend at least 3 feet (.9 m) above the upper landing surface to which the ladder is used to gain access; or, when such an extension is not possible because of the ladder's length, then the ladder shall be secured at its top to a rigid support that will not deflect, and a grasping device, such as a grabrail, shall be provided to assist employees in mounting and dismounting the ladder. In no case shall the extension be such that ladder deflection under a load would, by itself, cause the ladder to slip off its support.

1926.1053(b)(2)

Ladders shall be maintained free of oil, grease, and other slipping hazards.

1926.1053(b)(3)

Ladders shall not be loaded beyond the maximum intended load for which they were built, nor beyond their manufacturer's rated capacity.

1926.1053(b)(4)

Ladders shall be used only for the purpose for which they were designed.

1926.1053(b)(5)

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1926.1053(b)(5)(i)

Non-self-supporting ladders shall be used at an angle such that the horizontal distance from the top support to the foot of the ladder is approximately one-quarter of the working length of the ladder (the distance along the ladder between the foot and the top support).

1926.1053(b)(5)(ii)

Wood job-made ladders with spliced side rails shall be used at an angle such that the horizontal distance is one-eighth the working length of the ladder.

1926.1053(b)(5)(iii)

Fixed ladders shall be used at a pitch no greater than 90 degrees from the horizontal, as measured to the back side of the ladder.

1926.1053(b)(6)

Ladders shall be used only on stable and level surfaces unless secured to prevent accidental displacement.

1926.1053(b)(7)

Ladders shall not be used on slippery surfaces unless secured or provided with slip-resistant feet to prevent accidental displacement. Slip-resistant feet shall not be used as a substitute for care in placing, lashing, or holding a ladder that is used upon slippery surfaces including, but not limited to, flat metal or concrete surfaces that are constructed so they cannot be prevented from becoming slippery.

1926.1053(b)(8)

Ladders placed in any location where they can be displaced by workplace activities or traffic, such as in passageways, doorways, or driveways, shall be secured to prevent accidental displacement, or a barricade shall be used to keep the activities or traffic away from the ladder.

1926.1053(b)(9)

The area around the top and bottom of ladders shall be kept clear.

1926.1053(b)(10)

The top of a non-self-supporting ladder shall be placed with the two rails supported equally unless it is equipped with a single support attachment.

1926.1053(b)(11)

Ladders shall not be moved, shifted, or extended while occupied.

1926.1053(b)(12)

Ladders shall have nonconductive siderails if they are used where the employee or the ladder could contact exposed energized electrical equipment, except as provided in 1926.951(c)(1) of this part.

1926.1053(b)(13)

The top or top step of a stepladder shall not be used as a step.

1926.1053(b)(14)

Cross-bracing on the rear section of stepladders shall not be used for climbing unless the ladders are designed and provided with steps for climbing on both front and rear sections.

1926.1053(b)(15)

Ladders shall be inspected by a competent person for visible defects on a periodic basis and after any occurrence that could affect their safe use.

1926.1053(b)(16)

Portable ladders with structural defects, such as, but not limited to, broken or missing rungs, cleats, or steps, broken or split rails, corroded components, or other faulty or defective components, shall either be immediately marked in a manner that readily identifies them as defective, or be tagged with "Do Not Use" or similar language, and shall be withdrawn from service until repaired.

1926.1053(b)(17)

Fixed ladders with structural defects, such as, but not limited to, broken or missing rungs, cleats, or steps, broken or split rails, or corroded components, shall be withdrawn from service until repaired. The requirement to withdraw a defective ladder from service is satisfied if the ladder is either:

1926.1053(b)(17)(i)

Immediately tagged with "Do Not Use" or similar language;

1926.1053(b)(17)(ii)

Marked in a manner that readily identifies it as defective;

1926.1053(b)(17)(iii)

Or blocked (such as with a plywood attachment that spans several rungs).

1926.1053(b)(18)

Ladder repairs shall restore the ladder to a condition meeting its original design criteria, before the ladder is returned to use.

1926.1053(b)(19)

Single-rail ladders shall not be used.

1926.1053(b)(20)

When ascending or descending a ladder, the user shall face the ladder.

1926.1053(b)(21)

Each employee shall use at least one hand to grasp the ladder when progressing up and/or down the ladder.

1926.1053(b)(22)

An employee shall not carry any object or load that could cause the employee to lose balance and fall.

[55 FR 47689, Nov. 14, 1990; 56 FR 2585, Jan. 23, 1991; 56 FR 41794, Aug. 23, 1991]